Ocugen Inc. Announces Nirdosh Jagota, Ph.D. as Senior Vice President, Regulatory Affairs, Compliance & Safety

 

Research, News, and Market Data on Ocugen

 

MALVERN, Pa., Jan. 24, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced the appointment of Nirdosh Jagota, Ph.D.,  as Senior Vice President (SVP), Regulatory Affairs, compliance and safety.

He’ll be responsible for ensuring the global strategy, development and execution of regulatory activities for the company’s pipeline, including gene therapies and vaccines, are aligned with local and international registration requirements. His responsibilities include supporting commercialization. He will serve as a member of Ocugen’s management team, reporting directly to the CEO.

Dr. Jagota is a seasoned biopharmaceutical regulatory professional with 30 years of experience in leading roles in drug development and regulatory sciences for vaccines, biologics and small molecules. Prior to joining Ocugen, he was Executive Vice President and Chief Regulatory Officer of Arcturus Therapeutics. Before joining Arcuturs he was Senior Vice President in Global Regulatory Affairs and Safety. Over the course of his career, Dr. Jagota has held leadership positions with Genentech, Roche, and Pfizer.

“We’ve been making progress on our regulatory efforts, and Nirdosh’s arrival comes at an important time. He brings the experience, knowledge and successful track record of bringing many biopharmaceuticals and vaccines, through high performance teams, to the market. This is an investment into Ocugen’s future work with national and international regulatory agencies,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“Ocugen is a company with the talent and expertise to tackle some of the world’s most challenging health issues, and I’m excited to be joining this team,” commented Nirdosh Jagota, Ph.D.

Dr. Jagota’s work has had international impact, managing teams spanning more than 20 countries, successfully shaping regulatory strategy across multiple therapeutic categories and establishing centers of excellence. In his career, Dr. Jagota has led and contributed to development, approval, and expansion of more than 30 vaccines and therapeutics including Ervebo®, Vaxneuvance™, Gardasil^®9, Kadcyla^®, Erivedge^®, Zelboraf^®, and Keytruda^®.

Dr. Jagota holds a Ph.D. in pharmaceutical sciences from University of Georgia and an M.S. in biotechnology from University of Toledo, Ohio. and a BS/MS in pharmacy from Indian Institute of Technology (IIT) Varanasi. 

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and develop a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

Neovasc Announces Publication Supporting the Neovasc Reducer Device

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – January 20, 2022 –  Neovasc, Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the publication of an article entitled, The Effectiveness of CS Reducer for the Treatment of Refractory Angina a Meta-Analysis in the Canadian Journal of Cardiology.

The articles lead author and senior authors are Aviram Hochstadt, M.D., and Maayan Konigstein, M.D., Sourasky Medical Center and the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. The publication provides a meta-analysis assessing the effects of coronary sinus narrowing in a total of 846 patients across nine prospective studies. The primary outcome was the proportion of patients improving 1 class in the Canadian Cardiovascular Society (CSS) angina score.

Improvement of 1 CSS class occurred in 76% (95% CI 73%-80%) of patients. Improvement of 2 CSS classes was observed in 40% of patients (95% CI of 35-46%). Procedure success was 98%, with no major and 3% minor peri-procedural complications. Patients walking distances, as measured by the six-minute walk test, also significantly improved.

The authors concluded, This meta-analysis of clinical studies describing the outcomes of patients with refractory angina implanted with the Reducer for CS narrowing, demonstrates its safety and efficacy. The vast majority of patients experienced improvement in angina severity, quality of life, and functional performance.

“Publication of this meta-analysis is another meaningful milestone for the Reducer,” stated Fred Colen, President & Chief Executive Officer of Neovasc. “From the very beginning, our company has focused on developing high-quality data to support the adoption of the therapy. As the evidence supporting the safety and effectiveness continues to mount, we are seeing continued expansion of the technology in the marketplace. We look forward to sharing our Q4 2021 results and providing further details of our COSIRA-II randomized controlled trial on our upcoming earnings call.”

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives because of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com .

Contacts

Investors:

Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:

Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the significance of the meta-analysis for the Reducer, anticipated timelines regarding the provision of Q4 2021 results and details on the COSIRA-II trial, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained atorwww.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether because of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether because of new information, future events or otherwise, except as required by law.

	Image Courtesy of MIT Research

Checkpoint Blockade Inhibitors Combined With Immune System Stimulation to Fight Cancer

 

Anne Trafton | MIT
News Office

Stimulating the body’s immune system to attack tumors is a promising way to treat cancer. Scientists are working on two complementary strategies to achieve that: taking off the brakes that tumors put on the immune system; and “stepping on the gas,” or delivering molecules that jumpstart immune cells.

However, when jumpstarting the immune system, researchers have to be careful not to overstimulate it, which can cause severe and potentially fatal side effects. A team of MIT researchers has now developed a new way to deliver a stimulatory molecule called IL-12 directly to tumors, avoiding the toxic effects that can occur when immunostimulatory drugs are given throughout the body.

 

“Even beyond this particular case of IL-12, which we really hope will have some impact, it’s a strategy that you could apply to any of these immunostimulatory drugs,” – Darrell Irvine, member of the Ragon Institute of MGH, MIT, and Harvard.

 

In a study of mice, this new treatment eliminated many tumors when delivered along with an FDA-approved drug that takes the brakes off the immune system.

“Even beyond this particular case of IL-12, which we really hope will have some impact, it’s a strategy that you could apply to any of these immunostimulatory drugs,” says Darrell Irvine, who is the Underwood-Prescott Professor with appointments in MIT’s departments of Biological Engineering and Materials Science and Engineering; an associate director of MIT’s Koch Institute for Integrative Cancer Research; and a member of the Ragon Institute of MGH, MIT, and Harvard.

The researchers have filed for patents on their strategy, and the technology has been licensed to a startup that hopes to begin clinical trials by the end of 2022.

Irvine and Dane Wittrup, the Carbon P. Dubbs Professor of Chemical Engineering and Electrical Engineering and a member of the Koch Institute, are the senior authors of the study, which appears today in Nature Biomedical Engineering. MIT graduate student Yash Agarwal is the paper’s lead author.

 

Stepping on the Gas

As tumors develop, they secrete molecules that disable nearby T-cells and other immune cells, allowing the tumors to grow unchecked. Drugs known as checkpoint blockade inhibitors, which can take these brakes off the immune system, are now used to treat some types of cancer, but many other types are resistant to this kind of treatment.

Combining checkpoint inhibitors with drugs that stimulate the immune system could potentially make cancer immunotherapy work for more patients. Cytokines, which are immune chemicals naturally produced by the body, are one class of drugs that researchers have tried as a way to “step on the gas.” However, in clinical trials, these drugs have shown too many toxic side effects, ranging from flu-like symptoms to organ failure.

“If you soak the patient in cytokines, their whole body reacts and you get such a strong, toxic side effect that you can’t reach the levels you wish you could within the tumor and get the effects that you want,” Wittrup says.

To try to avoid those side effects, Wittrup and Irvine have been working on ways to deliver cytokines in a more targeted way. In a 2019 study, they showed that they could deliver the cytokines IL-12 and IL-2 directly to tumors by attaching the cytokines to a collagen-binding protein. This protein then sticks to collagen found in tumors, which usually have large amounts of collagen.

This strategy worked well in a study of mice, but the researchers wanted to find a way to make cytokines bind even more strongly to tumors. In their new study, they replaced the collagen-binding protein with aluminum hydroxide. This compound, also called alum, is often used as a vaccine adjuvant (a drug that helps boost the immune response to vaccination).

“One major advantage of alum is that the particles are on the micron size scale, so when you inject them in people or in mice, they stay wherever you inject them for weeks, going on to months sometimes,” Agarwal says.

 

Fighting Tumors

To test the effectiveness of this treatment, the researchers gave mice one injection of IL-12 or IL-2 bound to alum particles, and treated the mice with a checkpoint blockade inhibitor called anti-PD1 every few days.

In mouse models of three types of cancer, the researchers found that the tumors were eliminated in 50 to 90 percent of the mice. In a model where breast cancer cells were transplanted into mice, and then metastasized to the lungs, one injection at the breast cancer site also cleared the metastatic tumors, even though IL-12 was not injected into the lungs.

Alum-IL-12 particles given without the checkpoint blockade inhibitors also showed some ability to stimulate the immune system to fight tumors.

Further studies showed that IL-12 stimulates the production of another cytokine called interferon gamma, and these two molecules work together to activate T cells as well as dendritic cells and macrophages. The treatment also stimulates memory T cells that may be able to respond to tumors that regrow.

The researchers also found that the treated mice did not show any of the side effects that are seen when IL-12 is given systemically. The startup company that has licensed the technology plans to first test IL-12-alum particles on their own, and if that treatment is shown to be safe, they hope to test Il-12 in combination with checkpoint blockade inhibitors.

The new approach of attaching molecules to alum could also be used to deliver other types of immunostimulatory drugs, the researchers say.

“This whole class of drugs that involves stepping on the gas has largely not succeeded yet. Our hope is that this opens the way to test any of those drugs,” Irvine says.

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This article originally appeared in MIT News on January 10, 2022 and has been Shared with Permission

 

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Neovasc Announces Publication Supporting the Neovasc Reducer Device

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – January 20, 2022 –  Neovasc, Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the publication of an article entitled, The Effectiveness of CS Reducer for the Treatment of Refractory Angina a Meta-Analysis in the Canadian Journal of Cardiology.

The articles lead author and senior authors are Aviram Hochstadt, M.D., and Maayan Konigstein, M.D., Sourasky Medical Center and the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. The publication provides a meta-analysis assessing the effects of coronary sinus narrowing in a total of 846 patients across nine prospective studies. The primary outcome was the proportion of patients improving 1 class in the Canadian Cardiovascular Society (CSS) angina score.

Improvement of 1 CSS class occurred in 76% (95% CI 73%-80%) of patients. Improvement of 2 CSS classes was observed in 40% of patients (95% CI of 35-46%). Procedure success was 98%, with no major and 3% minor peri-procedural complications. Patients walking distances, as measured by the six-minute walk test, also significantly improved.

The authors concluded, This meta-analysis of clinical studies describing the outcomes of patients with refractory angina implanted with the Reducer for CS narrowing, demonstrates its safety and efficacy. The vast majority of patients experienced improvement in angina severity, quality of life, and functional performance.

“Publication of this meta-analysis is another meaningful milestone for the Reducer,” stated Fred Colen, President & Chief Executive Officer of Neovasc. “From the very beginning, our company has focused on developing high-quality data to support the adoption of the therapy. As the evidence supporting the safety and effectiveness continues to mount, we are seeing continued expansion of the technology in the marketplace. We look forward to sharing our Q4 2021 results and providing further details of our COSIRA-II randomized controlled trial on our upcoming earnings call.”

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives because of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com .

Contacts

Investors:

Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:

Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the significance of the meta-analysis for the Reducer, anticipated timelines regarding the provision of Q4 2021 results and details on the COSIRA-II trial, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained atorwww.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether because of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether because of new information, future events or otherwise, except as required by law.

Avivagen Inc. Announces Results for Fiscal Year Ending October 31, 2021

Research, News, and Market Data on Avivagen

 

OTTAWA, Ontario, January 19, 2022–(BUSINESS WIRE)–Avivagen Inc. (TSXV:VIV) (“Avivagen” or the “Company”) today reported its audited financial results for the year ended October 31, 2021. Unless otherwise noted, all figures are in Canadian currency.

The Corporation’s Audited Financial Statements for the year ended October 31, 2021, and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the year ended October 31, 2021, should be read in conjunction with the Corporation’s Financial Statements as well as its Management’s Discussion and Analysis for the year ended October 31, 2021.

“2021 has been an important year for Avivagen as we continued to establish ourselves and our OxC-beta™ product in a growing number of markets worldwide, with OxC-beta™ now approved for sale in seven countries. The AB Vista-distribution agreement (US, Brazil and Thailand), increased product use by Philippines distributor UNAHCO, first commercial use of OxC-beta in sows (new product application), and becoming the cornerstone ingredient in a top selling premium brand of pet food in Taiwan highlight the progress achieved in 2021. Unfortunately, the ongoing Covid-19 pandemic with accompanying disruptions in the global supply chain and continued outbreaks of African Swine Fever (ASF) in Southeast Asia have led to an extremely challenging economic environment for all businesses, including many of Avivagen’s current customers. As a direct result of this, previously announced contracts with Melder and Transformadora have been pushed back. During this same period, potential new customers have completed numerous successful animal trials, with the expectation of new additional sales with our Mexican customers to follow,” says Kym Anthony, Chief Executive Officer.

Throughout this challenging period, Avivagen has continued to set a foundation for strong growth in 2022 and beyond. Initiatives include investment in a major toxicology study which is near completion, investment in additional inventory and further progress on obtaining our non-objection letter from the U.S. Food and Drug Administration (“FDA”), activities which we expect to contribute to future growth. Looking ahead, the Company expects to make further inroads in existing and new markets in Asia and the Americas in the coming year, progressing our relationships with customers in a number of key markets and continuing to grow many of the early-stage customer and partner relationships we successfully established in 2021 which are substantially additive as our customers have displayed growing and recurring revenue models.

Previously announced agreements with AB Vista and UNAHCO to supply OxC-beta™ to feed producers in the United States, Brazil, Thailand and the Philippines are expected to result in recognized revenue beginning in the early part of 2022. The Company is also expecting to receive regulatory approval for the use of OxC-beta™ in a number of large and important Asian feed production markets in the coming year.

The Company reported revenues of $1,295,991 ($1,177,857 in the year ending October 31, 2020) and a comprehensive loss of $(6,394,159) for the year ended October 31, 2021. This compares to a comprehensive loss in the year ending October 31, 2020 of $(4,751,287). As at October 31, 2021, the Company reported total assets of $3,477,774 (current assets of $3,216,022), total liabilities of $7,430,439, and shareholders’ deficit of ($3,952,665).

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, expectation as to the completion of toxicology studies, the anticipated continuation of shipments to customers based on recurring orders, timing of future shipments and revenue recognition, expectations as to additional regulatory approvals, and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, sales and use of Avivagen’s products may not grow in the manner anticipated, toxicology studies may not be completed in the time frames expected, initial orders may not result in recurring or repeat orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Contacts

Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

Avivagen Inc. Announces Results for Fiscal Year Ending October 31, 2021

Research, News, and Market Data on Avivagen

 

OTTAWA, Ontario, January 19, 2022–(BUSINESS WIRE)–Avivagen Inc. (TSXV:VIV) (“Avivagen” or the “Company”) today reported its audited financial results for the year ended October 31, 2021. Unless otherwise noted, all figures are in Canadian currency.

The Corporation’s Audited Financial Statements for the year ended October 31, 2021, and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the year ended October 31, 2021, should be read in conjunction with the Corporation’s Financial Statements as well as its Management’s Discussion and Analysis for the year ended October 31, 2021.

“2021 has been an important year for Avivagen as we continued to establish ourselves and our OxC-beta™ product in a growing number of markets worldwide, with OxC-beta™ now approved for sale in seven countries. The AB Vista-distribution agreement (US, Brazil and Thailand), increased product use by Philippines distributor UNAHCO, first commercial use of OxC-beta in sows (new product application), and becoming the cornerstone ingredient in a top selling premium brand of pet food in Taiwan highlight the progress achieved in 2021. Unfortunately, the ongoing Covid-19 pandemic with accompanying disruptions in the global supply chain and continued outbreaks of African Swine Fever (ASF) in Southeast Asia have led to an extremely challenging economic environment for all businesses, including many of Avivagen’s current customers. As a direct result of this, previously announced contracts with Melder and Transformadora have been pushed back. During this same period, potential new customers have completed numerous successful animal trials, with the expectation of new additional sales with our Mexican customers to follow,” says Kym Anthony, Chief Executive Officer.

Throughout this challenging period, Avivagen has continued to set a foundation for strong growth in 2022 and beyond. Initiatives include investment in a major toxicology study which is near completion, investment in additional inventory and further progress on obtaining our non-objection letter from the U.S. Food and Drug Administration (“FDA”), activities which we expect to contribute to future growth. Looking ahead, the Company expects to make further inroads in existing and new markets in Asia and the Americas in the coming year, progressing our relationships with customers in a number of key markets and continuing to grow many of the early-stage customer and partner relationships we successfully established in 2021 which are substantially additive as our customers have displayed growing and recurring revenue models.

Previously announced agreements with AB Vista and UNAHCO to supply OxC-beta™ to feed producers in the United States, Brazil, Thailand and the Philippines are expected to result in recognized revenue beginning in the early part of 2022. The Company is also expecting to receive regulatory approval for the use of OxC-beta™ in a number of large and important Asian feed production markets in the coming year.

The Company reported revenues of $1,295,991 ($1,177,857 in the year ending October 31, 2020) and a comprehensive loss of $(6,394,159) for the year ended October 31, 2021. This compares to a comprehensive loss in the year ending October 31, 2020 of $(4,751,287). As at October 31, 2021, the Company reported total assets of $3,477,774 (current assets of $3,216,022), total liabilities of $7,430,439, and shareholders’ deficit of ($3,952,665).

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, expectation as to the completion of toxicology studies, the anticipated continuation of shipments to customers based on recurring orders, timing of future shipments and revenue recognition, expectations as to additional regulatory approvals, and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, sales and use of Avivagen’s products may not grow in the manner anticipated, toxicology studies may not be completed in the time frames expected, initial orders may not result in recurring or repeat orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Contacts

Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

Tuesday, January 18, 2022

Stem Holdings (STMH)(STEM:CA)
Reports Full Year FY2021 Results

Stem Holdings Inc is engaged in the purchasing, improving, and leasing of properties and finance assets which are operated by third parties and are used for the cultivation and retail sale of marijuana. Its properties includes 42nd Street, and Mulino Farm which are used for agriculture. The company generates its revenue in the form of rental income from tenants.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

FY2021 Results. Stem reported net revenue of revenue of $35.8 million compared to $14.0 million last year. Excluding the subsequently divested Driven operations, net revenue totaled $20.9 million, up 49% y-o-y. Adjusted EBITDA loss for the year totaled $5.8 million, compared to a loss of $5.4 million in fiscal 2020. Stem reported a net loss of $64.6 million for the year, including $52.3 million of non-cash impairment charges. Reported EPS loss was $0.40.


FY4Q21.  Although Stem did not disclose fourth quarter 2021 results, by our calculations net revenue was $9.2 million, up from $5.2 million in the year ago period but down from the $10.6 million in the fiscal third quarter. Driven results are included for the full quarter. Reflecting the Driven impairment charge, net loss was $55.2 million, or $0.23 per share …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

electroCore Announces Shareholder Letter and Full-Year 2021 Business Update

News and Market Data on electroCore

 

Company anticipates full-year 2021 revenue of approximately $5.5 million, an approximately 55% increase over full-year 2020

ROCKAWAY, N.J., 
Jan. 18, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR) today published a letter from the company’s Board of Directors to shareholders. The letter is included in its entirety, below:

Dear Shareholders:

We continue to be excited about the long-term prospects of our Company and would like to share some of the reasons for our optimism.

We are investing in marketing initiatives that we believe will make our gammaCore™ therapy available directly to consumers through multiple channels at a very compelling price. Among these channels are our newly launched e-commerce storefronts in the 
United Kingdom (
UK) and 
the United States (US). Headache patients can now access gammaCore therapy simply by going to our web site and filling out a short questionnaire. The questionnaire is reviewed by a Health Care Professional who can write prescriptions for the therapy and moved into a shopping cart on our e-commerce storefront. After the gammaCore product is received by the patient, our customer experience team provides a variety of hands-on tools for patient training and support. Our team then stays in regular contact with the patient, providing further support during the course of the therapy and reminders about refill opportunities.

In parallel with our online stores, we have launched our gConcierge and gCDirect programs for a growing number of physician prescribers in the US. These new programs allow physicians to offer their patients the opportunity to purchase gammaCore therapy directly through their offices (gConcierge) or directly from us (gCDirect). We have broadened our call points from the traditional neurology headache specialists to include a wider range of medical providers who manage patients’ headache conditions, including those in primary care, women’s health, pain management, functional and integrative medicine, as well as chiropractors and Doctor of Pharmacy (PharmDs). In total, we have had approximately 200 prescribers write scripts through the gConcierge and gCDirect programs, all of whom have patients that can be supported by our in-house customer experience team.

With the early growth and promise of success among these newly established, streamlined consumer access initiatives, we are planning to aggressively ramp up our spending on Direct-to-Consumer advertising and other promotional activities. Our goal is to drive consumer awareness and funnel that interest to our e-commerce stores and provider partners.

In our legacy business channels, we have continued to grow our 
Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) business in 
the United States, our National Health Service (
NHS) business in the 
United Kingdom, and our distributor relationships around the world. We plan to continue to invest in growth from these channels as we move through 2022, strengthened by our Direct-to-Consumer initiatives and advertising spend. While we continue to work towards expanding commercial insurance coverage for gammaCore in 
the United States, we recognize the barrier high deductible plans represent for many Americans and anticipate they will benefit significantly from our newly launched cash pay programs, even when coverage is available.

Looking beyond primary headache, we anticipate reporting on our multiple clinical programs over the course of 2022. Ongoing trials continue to be conducted with our gammaCore therapy in secondary headache, traumatic brain injury (concussion), post traumatic stress disorder (PTSD), stroke, opioid use disorder, Parkinson’s, postoperative ileus, and other potential indications. We anticipate many of these programs will generate results that can support expanded labels and additional uses for gammaCore nVNS therapy, and support potentially expanded total addressable markets for our therapy. We believe nVNS therapy will be highly differentiated in conditions like concussion, PTSD, stroke, and opioid use disorder where there are few effective therapies currently.

Finally, as we expand our commercial initiatives, we are also looking beyond organic growth opportunities and exploring ways to accelerate our growth through acquisitions that enhance and leverage the distribution channels we are developing.

We have also continued to expand our intellectual property portfolio, especially in digital health and smartphone-integrated and smartphone-connected non-invasive therapy, which may provide us with opportunities to leverage our patents. We believe our intellectual property will be the foundation of next generation neuromodulation devices in the market, including our own nVNS devices. 

We look forward to enabling health care providers in their use of Remote Patient Monitoring and Remote Therapeutic Monitoring, which have been identified as critical areas for practice revenue growth in the future.

Preliminary Unaudited Financial Results for Full-Year 2021 

Full-Year 2021 Revenue: electroCore anticipates full-year 2021 revenue will be approximately 
$5.5 million. This would represent an approximately 55% increase over full-year 2020 revenue of 
$3.5 million.

Government Channels: During the full-year 2021, the Company expects to recognize revenue of approximately 
$3.3 million pursuant to the 
VA and 
DoD originating prescriptions or in excess of 60% growth as compared to 
$2.0 million during the full-year 2020. One hundred 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
December 31, 2021, as compared to 71 facilities through full-year 2020. With roughly 1,800 Federal Supply Schedule (FSS) eligible treatment facilities to which we have access, we believe the US government channel remains a significant opportunity for revenue generation. 

Outside of the U.S.: During the year-ending 
December 31, 2021, electroCore expects to recognize revenue of approximately 
$1.5 million outside of the US, as compared to 
$1.1 million during the fiscal 2020, representing year-over-year growth of approximately 36%. These results are primarily due to the stellar work and dedication of our 
UK subsidiary, led by  Iain Strickland VP, Global Sales and Strategy, who gracefully navigated the funding transition for our gammaCore product in 
England from the 
NHS Innovation and Technology Payment (ITP) Program to the MedTech Funding Mandate Policy 2021/2022. 

Commercial: During the year-ending 
December 31, 2021, electroCore expects to recognize revenue of approximately 
$680,000 or approximately 89% growth compared to 
$360,000 in full-year 2020. These figures include revenues from the commercial payer and cash pay channels in the US through our new online store, our gConcierge, and our gCDirect programs discussed above. 

Research and Development: During fiscal 2021, the Company continued to make progress across its clinical programs. The Company received four new 510(k) clearances. Additionally, on 
January 11, 2022, the Company received Breakthrough Designation from the 
Food and Drug Administration for the treatment of PTSD.

Cash: The Company ended the fourth quarter of 2021 with approximately 
$34.7 million of cash, cash equivalents and marketable securities. Net cash used in operations is expected to be approximately 
$13.6 million for the full-year 2021 as compared to 
$20.1 million and 
$45.1 million reported in 2020 and 2019, respectively.

During 2021, we accessed the capital markets to strengthen our balance sheet by approximately 
$25.7 million, which will give us the resources to make the transformational changes to our business we envision for the future. As we move into 2022, we continue to position the Company to take advantage of additional steps that could expand our business including, for example through acquisitions, by enabling the Company to access the capital markets as opportunities warrant.

 We are proud of the progress we have made and are excited about the future. Thank you for your continued support.

With best wishes,
electroCore Board of Directors

 

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™

gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

The 
U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck. gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:
Letter of authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download
Patient information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore: https://www.fda.gov/media/139970/download

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s expectations for revenue and cash used in operations during the fourth quarter and full year of 2021, growth through acquisitions, its expectations for future performance, as well as electroCore’s business prospects (including its e-commerce initiative, and gConcierge and gCDirect programs) and clinical and product development plans for 2022 and beyond, its pipeline or potential markets (including cash pay programs) for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe, 
Qatar, 
Taiwan, and 
China) and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Neovasc Announces Case Series of First U.S. Reducer Implants Published In Peer-Reviewed Journal

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – January 18, 2022 –  Neovasc Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the publication of a case series in the journal Cardiovascular Revascularization Medicine describing successful uses of the Neovasc Reducer™ (Reducer) under a compassionate use protocol in the United States.The patients were treated under the care of Ryan Gindi, M.D., and the procedures were performed by Gerald Koenig, M.D., Ph.D, both from the Division of Cardiology, Henry Ford Hospital, Detroit. Following the commencement of the COSIRA-II Trial in the United States, qualifying patients are now eligible to be treated in a clinical trial for the device.

We are pleased to publish the one-year outcomes of the first two patients treated with the Reducer device in the United States, stated Dr. Gindi. As a clinical cardiologist in a large metropolitan practice, I am confronted with the challenges of treating patients with refractory angina every day. Its gratifying to see the positive impact the Reducer device has had on our patients.

The first patient treated with the Reducer is a 59-year-old male with diabetes suffering from severe coronary artery disease and debilitating refractory angina. The patient had a history of multiple stenting procedures, radiation therapy to treat blocked stents, and extensive medications to treat his chest pain. Despite all efforts to alleviate his anginal symptoms, he lived a significantly restricted lifestyle because of his chest pain. After implantation of the Reducer device, the patient became largely asymptomatic and did not require any further interventional therapy. He described walking several miles around Washington, D.C. without angina.

The second patient is another 59-year-old male with an extensive history of coronary artery disease who previously suffered multiple heart attacks, underwent coronary artery bypass surgery and had multiple stenting procedures to control his symptoms. Despite all efforts and extensive medications, he remained severely restricted by his angina, and was subsequently treated with the Reducer device. A year following the procedure, he described being able to ride a bicycle 35 miles on hilly terrain without angina.

It’s encouraging to see such positive results on the first two patients treated with the Reducer in the United States,” said Dr. Koenig. I have seen first-hand the positive impact that it can have on patients, and we are excited to participate in the COSIRA-II clinical trial at Henry Ford Hospital.

COSIRA-II is a clinical trial designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.

Now that the COSIRA-II clinical study is underway, we have the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States, commented Fred Colen, Chief Executive Officer at Neovasc. It is rewarding to see such positive results on the early US patients treated under compassionate use.

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Contacts

Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, potential benefits of the Reducer, details of the COSIRA-II trails, the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

ProMIS Neurosciences Announces Antibody Program for Schizophrenia Therapy and Recruitment of Dr. Carsten Korth to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, announced today that it has initiated a program to develop monoclonal antibodies to treat schizophrenia and other chronic mental illnesses. Schizophrenia is a clinical term for a severely disabling neuropsychiatric disease that disrupts employment, families and communities, and likely has heterogenous biological origins.

The biomedical literature has implicated protein misfolding as one cause of schizophrenia. A candidate for a key misfolding protein in schizophrenia was first identified in a Scottish family with a neurodevelopmental syndrome including schizophrenia, such that the gene was named “disrupted in schizophrenia” (DISC1). DISC1, and its genetically-linked protein interactors in the brain, represent a new platform target for ProMIS, given its outstanding track record of predicting and validating misfolding-specific epitopes using proprietary computational approaches.

Dr. Carsten Korth, biological psychiatrist and pioneer on the role of DISC1 in chronic mental illness, has been recruited to the ProMIS Scientific Advisory Board to share his expertise and scientific acumen on this subject. Dr. Korth, a board-certified psychiatrist and Professor of Molecular Neuropathology at University of Dusseldorf, has found that DISC1 pathological aggregates can be detected in the brains of persons dying with sporadic schizophrenia, and that overexpression of human DISC1 leading to DISC1 aggregates in a rat model leads to signs of mental illness similar to those seen in human patients. “ProMIS is now digging deep into the biological basis and treatment for these psychotic scourges of mankind; it is a pleasure to participate and advise on such an effort,” stated Dr. Korth.

“We now have tools – including ProMIS’ proprietary computational algorithms – to approach schizophrenia and related diseases for druggable misfolded protein targets,” stated Dr. Neil Cashman, ProMIS’ Chief Scientific Officer. “This represents a true confluence of opportunity for ProMIS in psychiatric diseases, just like we have accomplished for neurodegenerative diseases.”

About ProMIS Neuroscience
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting misfolded proteins such as toxic misfolded oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF
Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

ProMIS Neurosciences Announces Antibody Program for Schizophrenia Therapy and Recruitment of Dr. Carsten Korth to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, announced today that it has initiated a program to develop monoclonal antibodies to treat schizophrenia and other chronic mental illnesses. Schizophrenia is a clinical term for a severely disabling neuropsychiatric disease that disrupts employment, families and communities, and likely has heterogenous biological origins.

The biomedical literature has implicated protein misfolding as one cause of schizophrenia. A candidate for a key misfolding protein in schizophrenia was first identified in a Scottish family with a neurodevelopmental syndrome including schizophrenia, such that the gene was named “disrupted in schizophrenia” (DISC1). DISC1, and its genetically-linked protein interactors in the brain, represent a new platform target for ProMIS, given its outstanding track record of predicting and validating misfolding-specific epitopes using proprietary computational approaches.

Dr. Carsten Korth, biological psychiatrist and pioneer on the role of DISC1 in chronic mental illness, has been recruited to the ProMIS Scientific Advisory Board to share his expertise and scientific acumen on this subject. Dr. Korth, a board-certified psychiatrist and Professor of Molecular Neuropathology at University of Dusseldorf, has found that DISC1 pathological aggregates can be detected in the brains of persons dying with sporadic schizophrenia, and that overexpression of human DISC1 leading to DISC1 aggregates in a rat model leads to signs of mental illness similar to those seen in human patients. “ProMIS is now digging deep into the biological basis and treatment for these psychotic scourges of mankind; it is a pleasure to participate and advise on such an effort,” stated Dr. Korth.

“We now have tools – including ProMIS’ proprietary computational algorithms – to approach schizophrenia and related diseases for druggable misfolded protein targets,” stated Dr. Neil Cashman, ProMIS’ Chief Scientific Officer. “This represents a true confluence of opportunity for ProMIS in psychiatric diseases, just like we have accomplished for neurodegenerative diseases.”

About ProMIS Neuroscience
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting misfolded proteins such as toxic misfolded oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF
Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

Neovasc Announces Case Series of First U.S. Reducer Implants Published In Peer-Reviewed Journal

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – January 18, 2022 –  Neovasc Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN) today announced the publication of a case series in the journal Cardiovascular Revascularization Medicine describing successful uses of the Neovasc Reducer™ (Reducer) under a compassionate use protocol in the United States.The patients were treated under the care of Ryan Gindi, M.D., and the procedures were performed by Gerald Koenig, M.D., Ph.D, both from the Division of Cardiology, Henry Ford Hospital, Detroit. Following the commencement of the COSIRA-II Trial in the United States, qualifying patients are now eligible to be treated in a clinical trial for the device.

We are pleased to publish the one-year outcomes of the first two patients treated with the Reducer device in the United States, stated Dr. Gindi. As a clinical cardiologist in a large metropolitan practice, I am confronted with the challenges of treating patients with refractory angina every day. Its gratifying to see the positive impact the Reducer device has had on our patients.

The first patient treated with the Reducer is a 59-year-old male with diabetes suffering from severe coronary artery disease and debilitating refractory angina. The patient had a history of multiple stenting procedures, radiation therapy to treat blocked stents, and extensive medications to treat his chest pain. Despite all efforts to alleviate his anginal symptoms, he lived a significantly restricted lifestyle because of his chest pain. After implantation of the Reducer device, the patient became largely asymptomatic and did not require any further interventional therapy. He described walking several miles around Washington, D.C. without angina.

The second patient is another 59-year-old male with an extensive history of coronary artery disease who previously suffered multiple heart attacks, underwent coronary artery bypass surgery and had multiple stenting procedures to control his symptoms. Despite all efforts and extensive medications, he remained severely restricted by his angina, and was subsequently treated with the Reducer device. A year following the procedure, he described being able to ride a bicycle 35 miles on hilly terrain without angina.

It’s encouraging to see such positive results on the first two patients treated with the Reducer in the United States,” said Dr. Koenig. I have seen first-hand the positive impact that it can have on patients, and we are excited to participate in the COSIRA-II clinical trial at Henry Ford Hospital.

COSIRA-II is a clinical trial designed to evaluate the safety and effectiveness of the Reducer in treating patients suffering from refractory angina. The randomized, double blinded, placebo-controlled trial will enroll approximately 380 patients in the United States and Canada at as many as 50 investigational sites. The primary endpoint of the trial is the change in exercise tolerance testing time measured at six months via a treadmill test.

Now that the COSIRA-II clinical study is underway, we have the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States, commented Fred Colen, Chief Executive Officer at Neovasc. It is rewarding to see such positive results on the early US patients treated under compassionate use.

About Reducer

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

While the Reducer is not approved for commercial use in the United States, the FDA has granted Breakthrough Device designation to the Reducer. This designation is granted by the FDA to prioritize review of subsequent regulatory submissions for a device that demonstrates compelling potential to provide a more effective treatment of a life-threatening or irreversibly debilitating disease, represents breakthrough technology for which no approved alternatives exist or offers significant advantages over existing alternatives, and the availability of which is in the best interest of patients.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Contacts

Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, potential benefits of the Reducer, details of the COSIRA-II trails, the opportunity to bring the Reducer therapy to patients suffering from refractory angina in the United States, the growing incidence of refractory angina and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2021 (copies of which may be obtained at www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law. www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

electroCore Announces Shareholder Letter and Full-Year 2021 Business Update

News and Market Data on electroCore

 

Company anticipates full-year 2021 revenue of approximately $5.5 million, an approximately 55% increase over full-year 2020

ROCKAWAY, N.J., 
Jan. 18, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR) today published a letter from the company’s Board of Directors to shareholders. The letter is included in its entirety, below:

Dear Shareholders:

We continue to be excited about the long-term prospects of our Company and would like to share some of the reasons for our optimism.

We are investing in marketing initiatives that we believe will make our gammaCore™ therapy available directly to consumers through multiple channels at a very compelling price. Among these channels are our newly launched e-commerce storefronts in the 
United Kingdom (
UK) and 
the United States (US). Headache patients can now access gammaCore therapy simply by going to our web site and filling out a short questionnaire. The questionnaire is reviewed by a Health Care Professional who can write prescriptions for the therapy and moved into a shopping cart on our e-commerce storefront. After the gammaCore product is received by the patient, our customer experience team provides a variety of hands-on tools for patient training and support. Our team then stays in regular contact with the patient, providing further support during the course of the therapy and reminders about refill opportunities.

In parallel with our online stores, we have launched our gConcierge and gCDirect programs for a growing number of physician prescribers in the US. These new programs allow physicians to offer their patients the opportunity to purchase gammaCore therapy directly through their offices (gConcierge) or directly from us (gCDirect). We have broadened our call points from the traditional neurology headache specialists to include a wider range of medical providers who manage patients’ headache conditions, including those in primary care, women’s health, pain management, functional and integrative medicine, as well as chiropractors and Doctor of Pharmacy (PharmDs). In total, we have had approximately 200 prescribers write scripts through the gConcierge and gCDirect programs, all of whom have patients that can be supported by our in-house customer experience team.

With the early growth and promise of success among these newly established, streamlined consumer access initiatives, we are planning to aggressively ramp up our spending on Direct-to-Consumer advertising and other promotional activities. Our goal is to drive consumer awareness and funnel that interest to our e-commerce stores and provider partners.

In our legacy business channels, we have continued to grow our 
Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) business in 
the United States, our National Health Service (
NHS) business in the 
United Kingdom, and our distributor relationships around the world. We plan to continue to invest in growth from these channels as we move through 2022, strengthened by our Direct-to-Consumer initiatives and advertising spend. While we continue to work towards expanding commercial insurance coverage for gammaCore in 
the United States, we recognize the barrier high deductible plans represent for many Americans and anticipate they will benefit significantly from our newly launched cash pay programs, even when coverage is available.

Looking beyond primary headache, we anticipate reporting on our multiple clinical programs over the course of 2022. Ongoing trials continue to be conducted with our gammaCore therapy in secondary headache, traumatic brain injury (concussion), post traumatic stress disorder (PTSD), stroke, opioid use disorder, Parkinson’s, postoperative ileus, and other potential indications. We anticipate many of these programs will generate results that can support expanded labels and additional uses for gammaCore nVNS therapy, and support potentially expanded total addressable markets for our therapy. We believe nVNS therapy will be highly differentiated in conditions like concussion, PTSD, stroke, and opioid use disorder where there are few effective therapies currently.

Finally, as we expand our commercial initiatives, we are also looking beyond organic growth opportunities and exploring ways to accelerate our growth through acquisitions that enhance and leverage the distribution channels we are developing.

We have also continued to expand our intellectual property portfolio, especially in digital health and smartphone-integrated and smartphone-connected non-invasive therapy, which may provide us with opportunities to leverage our patents. We believe our intellectual property will be the foundation of next generation neuromodulation devices in the market, including our own nVNS devices. 

We look forward to enabling health care providers in their use of Remote Patient Monitoring and Remote Therapeutic Monitoring, which have been identified as critical areas for practice revenue growth in the future.

Preliminary Unaudited Financial Results for Full-Year 2021 

Full-Year 2021 Revenue: electroCore anticipates full-year 2021 revenue will be approximately 
$5.5 million. This would represent an approximately 55% increase over full-year 2020 revenue of 
$3.5 million.

Government Channels: During the full-year 2021, the Company expects to recognize revenue of approximately 
$3.3 million pursuant to the 
VA and 
DoD originating prescriptions or in excess of 60% growth as compared to 
$2.0 million during the full-year 2020. One hundred 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
December 31, 2021, as compared to 71 facilities through full-year 2020. With roughly 1,800 Federal Supply Schedule (FSS) eligible treatment facilities to which we have access, we believe the US government channel remains a significant opportunity for revenue generation. 

Outside of the U.S.: During the year-ending 
December 31, 2021, electroCore expects to recognize revenue of approximately 
$1.5 million outside of the US, as compared to 
$1.1 million during the fiscal 2020, representing year-over-year growth of approximately 36%. These results are primarily due to the stellar work and dedication of our 
UK subsidiary, led by  Iain Strickland VP, Global Sales and Strategy, who gracefully navigated the funding transition for our gammaCore product in 
England from the 
NHS Innovation and Technology Payment (ITP) Program to the MedTech Funding Mandate Policy 2021/2022. 

Commercial: During the year-ending 
December 31, 2021, electroCore expects to recognize revenue of approximately 
$680,000 or approximately 89% growth compared to 
$360,000 in full-year 2020. These figures include revenues from the commercial payer and cash pay channels in the US through our new online store, our gConcierge, and our gCDirect programs discussed above. 

Research and Development: During fiscal 2021, the Company continued to make progress across its clinical programs. The Company received four new 510(k) clearances. Additionally, on 
January 11, 2022, the Company received Breakthrough Designation from the 
Food and Drug Administration for the treatment of PTSD.

Cash: The Company ended the fourth quarter of 2021 with approximately 
$34.7 million of cash, cash equivalents and marketable securities. Net cash used in operations is expected to be approximately 
$13.6 million for the full-year 2021 as compared to 
$20.1 million and 
$45.1 million reported in 2020 and 2019, respectively.

During 2021, we accessed the capital markets to strengthen our balance sheet by approximately 
$25.7 million, which will give us the resources to make the transformational changes to our business we envision for the future. As we move into 2022, we continue to position the Company to take advantage of additional steps that could expand our business including, for example through acquisitions, by enabling the Company to access the capital markets as opportunities warrant.

 We are proud of the progress we have made and are excited about the future. Thank you for your continued support.

With best wishes,
electroCore Board of Directors

 

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™

gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

The 
U.S. FDA has cleared the gammaCore Sapphire CV (nVNS) device under an emergency use authorization for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing an exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved pharmacologic therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, using noninvasive vagus nerve stimulation (nVNS) on either side of the patient’s neck. gammaCore Sapphire CV has been authorized only for the duration of the statement that circumstances exist that warrant authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbbb-3(b)(1), until the authorization is terminated or revoked.

More information can be found at:
Letter of authorization: https://www.fda.gov/media/139967/download
Fact sheet for healthcare workers: https://www.fda.gov/media/139968/download
Patient information sheet: https://www.fda.gov/media/139969/download
Instructions for use of gammaCore: https://www.fda.gov/media/139970/download

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s expectations for revenue and cash used in operations during the fourth quarter and full year of 2021, growth through acquisitions, its expectations for future performance, as well as electroCore’s business prospects (including its e-commerce initiative, and gConcierge and gCDirect programs) and clinical and product development plans for 2022 and beyond, its pipeline or potential markets (including cash pay programs) for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe, 
Qatar, 
Taiwan, and 
China) and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com