Independent Publication Reports Neovasc Reducer™ Demonstrates Cost Savings

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS, Feb. 04, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (Neovasc or the Company) (NASDAQ, TSX: NVCN) today announced the publication of cost-effectiveness studies supporting the use of the Neovasc Reducer™ (“Reducer”).

The two analyses, authored by Americo Cicchetti, Graduate School of Health Economics and Management (ALTEMS) at the Catholic University of Sacro Cuore, Rome, included a budget impact analysis and a cost-utility analysis. The evaluations, both of which were positive for the Reducer therapy, considered direct healthcare costs from the perspective of the National Health Service in Italy. The budget impact analysis examined a five-year timeframe, while the cost-utility analysis utilized a “lifetime” horizon.

Quality of life measures

• The budget impact analysis and cost-utility model each demonstrated that the Reducer therapy can lead to an increase in the quality of life in patients with refractory angina.

Cost effectiveness measures

• In the cost-utility analysis, the Reducer therapy received the best possible outcome, a dominance profile, meaning the intervention is not just cost-effective, but cost-saving for the healthcare system.

• In the budget impact analysis, the higher initial costs due an initial ramp in Reducer implants are adequately compensated in the short term by the better clinical outcomes, with consequent savings for the National Health Service in Italy starting in year four.

The authors highlight the growing number of patients suffering from persistent and disabling symptoms of angina – in part due to the advances in pharmacological and interventional fields that have prolonged the survival of patients.

Dr. Fabrizio Oliva, Director of Cardiology and Interventional Cardiology, Niguarda Hospital, Milan, and President-elect of the Italian National Association of Hospital Cardiologists, commented, “We see patients with refractory angina frequently. A therapy that improves quality of life and is less costly to implement is highly unusual and should be highlighted. The data are particularly relevant in the context of strong budget constraints in many countries – a constraint that has been exacerbated by the COVID pandemic.”

“The data from the ALTEMS analyses are particularly relevant because patients with refractory angina have limited treatment options, and they tend to place a hefty financial burden on healthcare systems,” commented Fred Colen, President and Chief Executive Officer of Neovasc. “The new Italian publication builds upon our previously reported cost-effectiveness data and recent reimbursement wins in the United Kingdom, France, Germany, and the United States and it demonstrates fantastic progress against our objectives.”

About Reducer

The Reducer is CE-marked in the European Union and being studied in the United States in the COSIRA-III clinical trial 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, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle.

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 results of the cost-effectiveness studies, the growing incidence of refractory angina and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described 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.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Independent Publication Reports Neovasc Reducer™ Demonstrates Cost Savings

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS, Feb. 04, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (Neovasc or the Company) (NASDAQ, TSX: NVCN) today announced the publication of cost-effectiveness studies supporting the use of the Neovasc Reducer™ (“Reducer”).

The two analyses, authored by Americo Cicchetti, Graduate School of Health Economics and Management (ALTEMS) at the Catholic University of Sacro Cuore, Rome, included a budget impact analysis and a cost-utility analysis. The evaluations, both of which were positive for the Reducer therapy, considered direct healthcare costs from the perspective of the National Health Service in Italy. The budget impact analysis examined a five-year timeframe, while the cost-utility analysis utilized a “lifetime” horizon.

Quality of life measures

• The budget impact analysis and cost-utility model each demonstrated that the Reducer therapy can lead to an increase in the quality of life in patients with refractory angina.

Cost effectiveness measures

• In the cost-utility analysis, the Reducer therapy received the best possible outcome, a dominance profile, meaning the intervention is not just cost-effective, but cost-saving for the healthcare system.

• In the budget impact analysis, the higher initial costs due an initial ramp in Reducer implants are adequately compensated in the short term by the better clinical outcomes, with consequent savings for the National Health Service in Italy starting in year four.

The authors highlight the growing number of patients suffering from persistent and disabling symptoms of angina – in part due to the advances in pharmacological and interventional fields that have prolonged the survival of patients.

Dr. Fabrizio Oliva, Director of Cardiology and Interventional Cardiology, Niguarda Hospital, Milan, and President-elect of the Italian National Association of Hospital Cardiologists, commented, “We see patients with refractory angina frequently. A therapy that improves quality of life and is less costly to implement is highly unusual and should be highlighted. The data are particularly relevant in the context of strong budget constraints in many countries – a constraint that has been exacerbated by the COVID pandemic.”

“The data from the ALTEMS analyses are particularly relevant because patients with refractory angina have limited treatment options, and they tend to place a hefty financial burden on healthcare systems,” commented Fred Colen, President and Chief Executive Officer of Neovasc. “The new Italian publication builds upon our previously reported cost-effectiveness data and recent reimbursement wins in the United Kingdom, France, Germany, and the United States and it demonstrates fantastic progress against our objectives.”

About Reducer

The Reducer is CE-marked in the European Union and being studied in the United States in the COSIRA-III clinical trial 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, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle.

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 results of the cost-effectiveness studies, the growing incidence of refractory angina and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described 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.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ProMIS Neurosciences Appoints Renowned Neuroscientists, Dr. Guy Rouleau and Dr. Alain Dagher to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Mass. , Feb. 03, 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 appointed Drs. Guy Rouleau and Alain Dagher to its scientific advisory board (SAB).

Dr. Guy Rouleau, MD, PhD, is Director of The Neuro (Montreal Neurological Institute-Hospital), Chair of the Department of Neurology and Neurosurgery of McGill University, Director of the Department of Neuroscience of McGill University Health Centre, and co-founder of the Tanenbaum Open Science Institute. Over the last two decades, Dr. Rouleau and his team have focused on identifying genes associated with neurological and psychiatric diseases, including autism, amyotrophic lateral sclerosis, hereditary neuropathies, epilepsy and schizophrenia, as well as providing a better understanding of the molecular mechanisms that lead to disease symptoms.

Dr. Alain Dagher, MD, has been an attending neurologist at the Montreal Neurological Institute since 1997. His clinical specialty is movement disorders, with a focus on Parkinson’s Disease. His main research interest is functional brain imaging to understand the function of the basal ganglia, frontal lobes and dopamine in reward-seeking behaviors. This research has shed light on the cognitive deficits in Parkinson’s disease, stress and anxiety, schizophrenia, drug addiction, obesity, and pathological gambling and other behavioral addictions.

“On behalf of the ProMIS executive team I am delighted to welcome Drs. Rouleau and Dagher to our scientific advisory board”, stated Dr. Neil Cashman, ProMIS Chief Scientific Officer. “Their outstanding scientific contributions to a broad area of neurodegenerative, neurological and neuropsychiatric diseases is an excellent fit with ProMIS’s technology platform and portfolio of antibodies selectively targeting the toxic, misfolded proteins that are implicated in these devastating disorders.”

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting 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.

  Image: ACS Laboratories

The Viral Landscape and the Seven that Can Lead to Cancer

 

One-fifth. Nearly 20% of cancers worldwide are caused by a virus.

These viruses don’t cause cancer until long after they initially infect a person. Rather, the viruses teach the cells they take over how to escape the natural biological process of cell death. This strategy sets these altered cells on a path for other genetic changes that can cause full-blown cancer years down the road.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and opinions of Ronald C. Desrosiers, Professor of Pathology, Vice-chair for Research, University of Miami

 

As a microbiologist and researcher of viruses, I seek to understand how viruses affect living cells and the health of the people who are infected. These particular viruses are unique and interesting, both for their effects on patients and because of the potential ways they might be treated or prevented.

 

The Viral Landscape

All known viruses can be categorized into one of 22 distinct families. Five of these families are called “persisting,” because once a person is infected, the virus remains in their body for life. One example is the herpes virus that causes chickenpox in children and can reappear later in life as shingles. This ability to survive over the long term helps the virus spread from person to person.

There are seven known viruses that can cause cancer. Five of them are members of persistent virus families. The human papillomavirus, commonly known as HPV and known to cause cervical cancer, is in the papilloma family. The Epstein-Barr virus, which causes Hodgkin lymphomas, and the Kaposi’s sarcoma-associated virus, are both in the herpes family. The human T-lymphotropic virus, which can cause a type of leukemia, is what’s known as a retrovirus. And Merkel cell polyoma virus, which causes Merkel cell carcinoma, is in the polyoma family.

All five of these viruses contain genetic code for one or more proteins that teach cells how to avoid cell death, effectively immortalizing them and promoting cell growth. The cancer cells that develop from these oncogenic viruses all contain their original viruses’ genetic information, even when they appear years after the initial infection. But only a small percentage of people who are infected with one of these five oncogenic viruses ultimately develop the full-blown cancer associated with it.

The other two viruses, hepatitis B, in the hepadna family, and hepatitis C, in the flavi family, are somewhat different. Most people infected with those viruses are able to fight the infection through their own immunity and eliminate the virus.

However, in people who are not able to fight off the infection, long-term infections of these viruses often cause extensive liver damage. These people are at risk of developing a type of liver cancer called hepatocellular carcinoma, because the body’s attempts to repair the damaged liver tissue increase the chance of a cancer-related mutation. The viruses themselves do not teach the liver cells to become immortal or transform themselves, the way the other five oncogenic viruses do to the cells they target.

These viral-induced cancers are serious health threats. Hepatocellular carcinoma, for instance, kills approximately 800,000 people a year, making it the third-deadliest cancer globally. About three-quarters of those killed have had hepatitis virus infections in the past.

HPV is similarly dangerous. The cervical cancer it causes kills some 311,000 people a year worldwide, making it the deadliest cancer in women until recently. That number includes 36,000 women in the U.S. But HPV doesn’t just put women at risk. A similar number of people in the U.S. die each year from anal and throat cancers linked to HPV.

 

 

Reasons for Optimism

The first viral vaccine to protect against HPV infection and its associated cancers was approved for use in the U.S. in 2006. It has proved to be highly effective at preventing both HPV infection and the subsequent development of cervical carcinoma.

HPV vaccines are now widely available around the globe. The HPV vaccine is safe, with very mild side effects. It is recommended for children starting at ages 11 to 12, since different individuals become sexually active at different ages. The protective effects of the vaccine last beyond 10 years, and booster shots are available.

Older people – typically up to 26 years of age – can also receive the HPV vaccine. By preventing infection in the first place, the vaccine also prevents the subsequent cancers that may result from a viral infection.

The vaccine for hepatitis B virus has been similarly successful over a longer time period. Introduced in 1986, it was recognized as the first anti-cancer vaccine. Since then, more than a billion people worldwide have received it. The vaccine has been shown to be extremely safe and effective.

 

Vaccines
Save Lives

The numbers of cancers prevented and lives saved by the vaccines against the hepatitis B virus and human papillomavirus are enormous and indisputable. In 2019, 46% of adolescents ages 13 to 17 in the U.S. had not received their recommended HPV vaccines. In 2020 in Mississippi, HPV vaccine coverage in adolescents reached a meager 32%.

But the U.S. is better off than some other industrialized nations. In Japan, the current rate of HPV vaccine coverage in adolescents is less than 1% because of false reports of adverse events in 2013. Despite repeated, definitive discrediting of these claims, vaccine uptake in Japan has not rebounded.

Vaccination campaigns have eradicated smallpox and effectively eliminated polio, measles and certain other infectious diseases. Let’s hope that ongoing vaccine efforts can make HPV-induced cancers and hepatitis B virus-induced cancers a thing of the past as well.

 

Suggested Reading

How Diet Affects Tumors

Learning to Speak the Language of Viruses

Understanding the FDA Medical Device Approval Pathways Helps Investors

The Results of the Last Five Years of Market Crash Talk

 

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ProMIS Neurosciences Appoints Renowned Neuroscientists, Dr. Guy Rouleau and Dr. Alain Dagher to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Mass. , Feb. 03, 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 appointed Drs. Guy Rouleau and Alain Dagher to its scientific advisory board (SAB).

Dr. Guy Rouleau, MD, PhD, is Director of The Neuro (Montreal Neurological Institute-Hospital), Chair of the Department of Neurology and Neurosurgery of McGill University, Director of the Department of Neuroscience of McGill University Health Centre, and co-founder of the Tanenbaum Open Science Institute. Over the last two decades, Dr. Rouleau and his team have focused on identifying genes associated with neurological and psychiatric diseases, including autism, amyotrophic lateral sclerosis, hereditary neuropathies, epilepsy and schizophrenia, as well as providing a better understanding of the molecular mechanisms that lead to disease symptoms.

Dr. Alain Dagher, MD, has been an attending neurologist at the Montreal Neurological Institute since 1997. His clinical specialty is movement disorders, with a focus on Parkinson’s Disease. His main research interest is functional brain imaging to understand the function of the basal ganglia, frontal lobes and dopamine in reward-seeking behaviors. This research has shed light on the cognitive deficits in Parkinson’s disease, stress and anxiety, schizophrenia, drug addiction, obesity, and pathological gambling and other behavioral addictions.

“On behalf of the ProMIS executive team I am delighted to welcome Drs. Rouleau and Dagher to our scientific advisory board”, stated Dr. Neil Cashman, ProMIS Chief Scientific Officer. “Their outstanding scientific contributions to a broad area of neurodegenerative, neurological and neuropsychiatric diseases is an excellent fit with ProMIS’s technology platform and portfolio of antibodies selectively targeting the toxic, misfolded proteins that are implicated in these devastating disorders.”

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting 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 Complete Dismissal of Securities Class Action Complaint with Prejudice

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire> ) – February 02, 2022 –  Neovasc Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN), today announced the complete dismissal of the consolidated amended complaint in the shareholder class action case captioned In re Neovasc Inc. Securities Litigation, Case No. 7:20-cv-09313, filed in the United States District Court for the Southern District of New York. The consolidated amended complaint was dismissed in its entirety with prejudice and without leave to amend.

“From the beginning, we committed to vigorously defend against these allegations,” said Fred Colen, Chief Executive Officer of Neovasc. “We could not be more pleased with the Courts decision to completely dismiss this action with prejudice, which is a clear rejection of the claims advanced in this litigation. We intend to continue to focus on our important mission of creating better outcomes for difficult-to-treat cardiology patients as we move forward.”

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 growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described 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.sedar.com or www.sec.gov ). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

PDS Biotech Announces Preliminary Efficacy Achievement in VERSATILE-002 Phase 2 Trial of PDS0101 in Combination With KEYTRUDA® (pembrolizumab) in Advanced Head and Neck Cancer

Research, News, and Market Data on PDS Biotech

 

Achievement of initial efficacy milestone allows full enrollment of checkpoint inhibitor naïve cohort

FLORHAM PARK, N.J., Feb. 02, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer achieved its preliminary objective response benchmarks. The trial, which studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab), will now progress to full enrollment of 54 patients in this group of checkpoint inhibitor (CPI) naïve patients. As pre-specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more) confirmed by two separate measurements among at least four or more of the first 17 patients in the CPI naïve arm allows that arm to progress to full enrollment. We anticipate these data will be presented in more detail at an upcoming medical conference.  

VERSATILE-002, being conducted in collaboration with Merck (known as MSD outside the US and Canada), is being studied in two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group have not been previously treated with a checkpoint inhibitor (CPI naïve). An initial assessment of the combination in a second group of 21 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.   

“The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence of our novel Versamune^® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with KEYTRUDA^® has the potential to significantly improve clinical outcomes for patients with advanced HPV16-positive head and neck cancers.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.  

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PsyBio Therapeutics to Participate in Citi’s Psychedelic Drug Video Call Series

Research, News, and Market Data on PsyBio

 

 OXFORD, Ohio and COCONUT CREEK, Fla., Feb. 2, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced that Evan Levine, Chairman and Chief Executive Officer of the Company, will participate in Citi’s Psychedelic Drug Video Call Series.

Hosted by Neena Bitritto-Garg, Vice President Research Analyst, Biotech, the fireside chat with PsyBio will take place on Thursday, February 3, 2022 at 10:00am Eastern Time.

To register for the event, please contact your appropriate Citi representative directly.

To schedule a meeting with the PsyBio management team, please contact KCSA Strategic Communications by emailing PsyBio@kcsa.com.

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA- approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (“TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

Wednesday, February 02, 2022

BioSig Technologies (BSGM)
Everything To See Here

BioSig Technologies, Inc. is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. PURE EP is a computerized system designed to reveal the full range of cardiac signals and to provide physicians with signal clarity during procedures performed to address cardiac arrhythmias. The PURE EP System has received FDA 510(k) clearance and installed its first commercial sale in February 2021. The company looks to apply their unique bioelectronic technology across additional disease conditions, including nervous system disorders, auto-immune diseases, hypertension, and pain.

Gregory Aurand, Senior Research Analyst, Noble Capital Markets, Inc.

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

Initiating Coverage. BioSig Technologies, Inc. is commercializing a proprietary high-fidelity, low noise cardiac signal processing platform that we believe is a game-changing technology. Somewhat like viewing high-definition TVs vs. standard-definition sets, the PURE EP System, compared to current platforms, provides electrophysiologists (EPs) with advanced signal clarity during electrophysiology ablation procedures that target heart electrical signal misfires. We are initiating coverage.


Target market is high revenue electrophysiology arrhythmia procedures.  Arrhythmias are a growing healthcare concern and ablation procedures to alleviate the problem are improving the situation. The PURE EP System, by improving clinical outcomes, can advance ablation as the standard of care. While PURE EP currently has FDA clearance, the company is also seeking to obtain CE Mark, expanding the …

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. 

PsyBio Therapeutics to Participate in Citi’s Psychedelic Drug Video Call Series

Research, News, and Market Data on PsyBio

 

 OXFORD, Ohio and COCONUT CREEK, Fla., Feb. 2, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today announced that Evan Levine, Chairman and Chief Executive Officer of the Company, will participate in Citi’s Psychedelic Drug Video Call Series.

Hosted by Neena Bitritto-Garg, Vice President Research Analyst, Biotech, the fireside chat with PsyBio will take place on Thursday, February 3, 2022 at 10:00am Eastern Time.

To register for the event, please contact your appropriate Citi representative directly.

To schedule a meeting with the PsyBio management team, please contact KCSA Strategic Communications by emailing PsyBio@kcsa.com.

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA- approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (“TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

  Image Credit: MIT

Capsules Instead of Vaccines for RNA and DNA Therapeutics

 

Anne Trafton | MIT News Office

Like most vaccines, RNA vaccines have to be injected, which can be an obstacle for people who fear needles. Now, a team of MIT researchers has developed a way to deliver RNA in a capsule that can be swallowed, which they hope could help make people more receptive to them.

In addition to making vaccines easier to tolerate, this approach could also be used to deliver other kinds of therapeutic RNA or DNA directly to the digestive tract, which could make it easier to treat gastrointestinal disorders such as ulcers.

“Nucleic acids, in particular RNA, can be extremely sensitive to degradation particularly in the digestive tract. Overcoming this challenge opens up multiple approaches to therapy, including potential vaccination through the oral route,” says Giovanni Traverso, the Karl van Tassel Career Development Assistant Professor of Mechanical Engineering at MIT and a gastroenterologist at Brigham and Women’s Hospital.

In a new study, Traverso and his colleagues showed that they could use the capsule they developed to deliver up to 150 micrograms of RNA — more than the amount used in mRNA Covid vaccines — in the stomach of pigs.

Traverso and Robert Langer, the David H. Koch Institute Professor at MIT and a member of MIT’s Koch Institute for Integrative Cancer Research, are the senior authors of the study. Alex Abramson PhD ’19 and MIT postdocs Ameya Kirtane and Yunhua Shi are the lead authors of the study, which appears today in the journal Matter.

 

Oral Drug Delivery

For several years, Langer’s and Traverso’s labs have been developing novel ways to deliver drugs to the gastrointestinal tract. In 2019, the researchers designed a capsule that, after being swallowed, can place solid drugs, such as insulin, into the lining of the stomach.

The pill, about the size of a blueberry, has a high, steep dome inspired by the leopard tortoise. Just as the tortoise is able to right itself if it rolls onto its back, the capsule is able to orient itself so that its contents can be injected into the lining of the stomach.

In 2021, the researchers showed that they could use the capsule to deliver large molecules such as monoclonal antibodies in liquid form. Next, the researchers decided to try to use the capsule to deliver nucleic acids, which are also large molecules.

Nucleic acids are susceptible to degradation when they enter the body, so they need to be carried by protective particles. For this study, the MIT team used a new type of polymeric nanoparticle that Langer’s and Traverso’s labs had recently developed.

These particles, which can deliver RNA with high efficiency, are made from a type of polymer called poly(beta-amino esters). The MIT team’s previous work showed that branched versions of these polymers are more effective than linear polymers at protecting nucleic acids and getting them into cells. They also showed that using two of these polymers together is more effective than just one.

“We made a library of branched, hybrid poly(beta-amino esters), and we found that the lead polymers within them would do better than the lead polymers within the linear library,” Kirtane says. “What that allows us to do now is to reduce the total amount of nanoparticles that we are administering.”

To test the particles, the researchers first injected them into the stomachs of mice, without using the delivery capsule. The RNA that they delivered codes for a reporter protein that can be detected in tissue if cells successfully take up the RNA. The researchers found the reporter protein in the stomachs of the mice and also in the liver, suggesting that RNA had been taken up in other organs of the body and then carried to the liver, which filters the blood.

Next, the researchers freeze-dried the RNA-nanoparticle complexes and packaged them into their drug delivery capsules. Working with scientists at Novo Nordisk, they were able to load about 50 micrograms of mRNA per capsule, and delivered three capsules into the stomachs of pigs, for a total of 150 micrograms of mRNA. This is the more than the amount of mRNA in the Covid vaccines now in use, which have 30 to 100 micrograms of mRNA.

In the pig studies, the researchers found that the reporter protein was successfully produced by cells of the stomach, but they did not see it elsewhere in the body. In future work, they hope to increase RNA uptake in other organs by changing the composition of the nanoparticles or giving larger doses. However, it may also be possible to generate a strong immune response with delivery only to the stomach, Abramson says.

“There are many immune cells in the gastrointestinal tract, and stimulating the immune system of the gastrointestinal tract is a known way of creating an immune response,” he says.

 

Immune Activation

The researchers now plan to investigate whether they can create a systemic immune response, including activation of B and T cells, by delivering mRNA vaccines using their capsule. This approach could also be used to create targeted treatments for gastrointestinal diseases, which can be difficult to treat using traditional injection under the skin.

“When you have systemic delivery through intravenous injection or subcutaneous injection, it’s not very easy to target the stomach,” Abramson says. “We see this as a potential way to treat different diseases that are present in the gastrointestinal tract.”

Novo Nordisk, which partially funded the research, has licensed the drug-delivery capsule technology and hopes to test it in clinical trials. The research was also funded by the National Institutes of Health, the National Science Foundation Graduate Research Fellowships Program, a PhRMA Foundation postdoctoral fellowship, the Division of Gastroenterology at Brigham and Women’s Hospital, and MIT’s Department of Mechanical Engineering.

 

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PDS Biotech Announces Preliminary Efficacy Achievement in VERSATILE-002 Phase 2 Trial of PDS0101 in Combination With KEYTRUDA® (pembrolizumab) in Advanced Head and Neck Cancer

Research, News, and Market Data on PDS Biotech

 

Achievement of initial efficacy milestone allows full enrollment of checkpoint inhibitor naïve cohort

FLORHAM PARK, N.J., Feb. 02, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced its VERSATILE-002 Phase 2 study for the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer achieved its preliminary objective response benchmarks. The trial, which studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab), will now progress to full enrollment of 54 patients in this group of checkpoint inhibitor (CPI) naïve patients. As pre-specified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more) confirmed by two separate measurements among at least four or more of the first 17 patients in the CPI naïve arm allows that arm to progress to full enrollment. We anticipate these data will be presented in more detail at an upcoming medical conference.  

VERSATILE-002, being conducted in collaboration with Merck (known as MSD outside the US and Canada), is being studied in two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group have not been previously treated with a checkpoint inhibitor (CPI naïve). An initial assessment of the combination in a second group of 21 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.   

“The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence of our novel Versamune^® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with KEYTRUDA^® has the potential to significantly improve clinical outcomes for patients with advanced HPV16-positive head and neck cancers.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.  

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Neovasc Announces Complete Dismissal of Securities Class Action Complaint with Prejudice

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire> ) – February 02, 2022 –  Neovasc Inc. (Neovasc or the Company) ( NASDAQ , TSX : NVCN), today announced the complete dismissal of the consolidated amended complaint in the shareholder class action case captioned In re Neovasc Inc. Securities Litigation, Case No. 7:20-cv-09313, filed in the United States District Court for the Southern District of New York. The consolidated amended complaint was dismissed in its entirety with prejudice and without leave to amend.

“From the beginning, we committed to vigorously defend against these allegations,” said Fred Colen, Chief Executive Officer of Neovasc. “We could not be more pleased with the Courts decision to completely dismiss this action with prejudice, which is a clear rejection of the claims advanced in this litigation. We intend to continue to focus on our important mission of creating better outcomes for difficult-to-treat cardiology patients as we move forward.”

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 growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described 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.sedar.com or www.sec.gov ). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.