electroCore, Inc. Broadens Patient Access to gammaCore with Launch of U.S. Telehealth Portal and Online Store

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
Jan. 11, 2022 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the launch of an e-commerce shop for patients residing in 
the United States. The site, which can be accessed through www.gammacore.com, allows patients to complete a telehealth consult for a prescription and purchase gammaCore Sapphire™, a non-invasive vagus nerve stimulator (nVNS) device, online.

The online store offers therapy to patients for FDA-cleared indications like migraine and cluster headache. The store platform is powered by 
Vytal, LLC and allows patients to obtain a prescription via telehealth consult, purchase the therapy directly from the site, have a member of the 
U.S. electroCore customer service team provide post-purchase video conference training, and receive the device at their doorstep.

“The launch of an online store is a tremendous step forward in our company’s cash pay, direct-to-consumer strategy,” stated  Joshua Lev, Chief Strategy Officer at electroCore. “More and more patients are utilizing online channels to manage their health, and the launch of our new online store builds on the trend of patients taking control of their healthcare. We are very excited to offer patients the ability to obtain nVNS therapy from the comfort of their home. The new functionality provides direct access to millions of migraine and cluster headache sufferers who can benefit from gammaCore nVNS therapy.”

“We are thrilled to be a part of electroCore’s direct-to-consumer initiative to treat migraines and cluster headaches. Our end-to-end solution for patient access to gammaCore allows a seamless patient experience that should help patients access this unique, proven therapy,” said  Jerry Gross, Founder and CEO of Vytal.

About Vytal, LLC.
Vytal is a healthcare technology company offering comprehensive, compliant technology solutions that enable manufacturers, pharmacies, provider networks, wellness ecommerce companies, and virtual health platforms to manage, grow, and scale their operations. Vytal’s data-driven direct-to-consumer ecommerce platform enables healthcare manufacturers to reach more patients and boost brand awareness. For more information visit https://www.vytal.care.

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^TM
gammaCoreTM (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 important warnings and precautions before using or prescribing this product.

For more information, please visit www.gammacore.com.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore 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 business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the Company’s business prospects in 
the United States (including its e-commerce initiative) and other new markets 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™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, 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
[email protected] 

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
[email protected] 

PDS Biotech Granted Patent for its Novel HPV16 Immunotherapy

Research, News, and Market Data on PDS Biotech

 

Extends patent protection of PDS0101 by the United States Patent and Trademark Office Until October 2037

FLORHAM PARK, N.J., Jan. 10, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced that it has been granted U.S. Patent Application No. 15,724,818 titled “Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof” by the United States Patent and Trademark Office (USPTO).

The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture of short protein fragments derived from the cancer-causing virus, HPV16.  The composition promotes the induction of killer (CD8+) T-cells by the immune system that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients’ genetic makeup. 

HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers.  More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer.  Some of these cancers have been reported to be increasing in incidence over the last few years. 

“We remain excited about the promising early efficacy and safety data from our ongoing Phase 2 clinical trials.  The early clinical data coupled with the recent grant of the PDS0101 patent that runs into late 2037 puts PDS Biotech in a strong position to progress commercialization of the product to address a significant unmet need for more effective treatment of advanced HPV-associated cancers,” stated Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. 

In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study (NCT04260126) in first-line treatment of recurrent or metastatic head and neck cancer, and also in second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. 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) and breast, colon, lung, prostate and ovarian cancers.  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, 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.

CONTACT: Investor Contact:

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

 

Research, News, and Market Data on Ocugen

 

• Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months
• Persistence of memory B and T cell immune responses at six months post second dose
• Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and after the booster dose may confer durable and long-term protective efficacy
• No serious adverse events such as hospitalizations or deaths were reported
• Effectiveness of COVAXIN™ against the Omicron strain is currently being studied and will be reported shortly
  

MALVERN, Pa., Jan. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN™ (BBV152), in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

“As the COVID-19 virus continues to evolve, so does our understanding of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability.”

Additional data from the analysis found that more than 75 percent of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN^™. After receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies (PRNT₅₀) GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 10·9, 161·0, 264·7, and 174·2 fold from baseline at six months post second dose, respectively.

“Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection,” said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

The booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

About Ocugen, Inc.
Ocugen, Inc. is 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. 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. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including statements about data published on the preprint server, medRxiv, by Bharat Biotech, which found that COVAXIN™, when administered as a booster dose, generated a five-fold increase in neutralizing titers, an important predictor of vaccine efficacy, and the potential for this data to support our application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN™ in pediatric patients or our planned biologics license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN™ for use in adult patients, as well as statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN™. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for EUA of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. 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
+1 484 237 3398
[email protected] 

Please submit investor-related inquiries to: [email protected] 

COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

 

Research, News, and Market Data on Ocugen

 

• Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months
• Persistence of memory B and T cell immune responses at six months post second dose
• Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and after the booster dose may confer durable and long-term protective efficacy
• No serious adverse events such as hospitalizations or deaths were reported
• Effectiveness of COVAXIN™ against the Omicron strain is currently being studied and will be reported shortly
  

MALVERN, Pa., Jan. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted positive results from a Phase 2 analysis of the vaccine candidate, COVAXIN™ (BBV152), in participants ages 12-64, receiving a booster dose six months following a second dose on the pre-print server, medRxiv. The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy.

“As the COVID-19 virus continues to evolve, so does our understanding of the efficacy of vaccines and the critical role they play in protecting people from serious disease, hospitalization and death,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “These booster data provide critical information about how COVAXIN™ can be used in the ongoing battle against COVID-19. We are encouraged by these results which continue to suggest that COVAXIN™ remains an important, broad-spectrum vaccine candidate with durability.”

Additional data from the analysis found that more than 75 percent of all participants had a detectible neutralizing antibody response six months post their second dose of COVAXIN^™. After receiving the booster, participants also saw an increase in antibody titers (at day 28) that were higher than those achieved after the two-dose primary series. Wild-type neutralizing antibodies (PRNT₅₀) GMTs at one month after a booster dose against Alpha, Beta, Delta and Delta plus variants were increased 10·9, 161·0, 264·7, and 174·2 fold from baseline at six months post second dose, respectively.

“Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines. Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection,” said Huma Qamar, MD, MPH, CMI, Associate Vice President, Clinical Development, Ocugen, Inc.

The booster dose analysis also found no serious adverse events, including hospitalization or death, were reported.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 180 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.

About Ocugen, Inc.
Ocugen, Inc. is 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. 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. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including statements about data published on the preprint server, medRxiv, by Bharat Biotech, which found that COVAXIN™, when administered as a booster dose, generated a five-fold increase in neutralizing titers, an important predictor of vaccine efficacy, and the potential for this data to support our application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of COVAXIN™ in pediatric patients or our planned biologics license application (BLA), assuming the clinical hold is lifted, for approval of COVAXIN™ for use in adult patients, as well as statements regarding the potential short and long-term benefits of receiving a booster dose of COVAXIN™. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for EUA of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. 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
+1 484 237 3398
[email protected] 

Please submit investor-related inquiries to: [email protected] 

PDS Biotech Granted Patent for its Novel HPV16 Immunotherapy

Research, News, and Market Data on PDS Biotech

 

Extends patent protection of PDS0101 by the United States Patent and Trademark Office Until October 2037

FLORHAM PARK, N.J., Jan. 10, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced that it has been granted U.S. Patent Application No. 15,724,818 titled “Novel HPV16 Non HLA-Restricted T-cell Vaccines, Composition and Methods of Use Thereof” by the United States Patent and Trademark Office (USPTO).

The newly issued patent covers the PDS0101 immunotherapy which consists of a combination of the Versamune technology platform with a unique mixture of short protein fragments derived from the cancer-causing virus, HPV16.  The composition promotes the induction of killer (CD8+) T-cells by the immune system that recognize, and attack cancers caused by infection with HPV16 irrespective of the patients’ genetic makeup. 

HPV16 is the most oncogenic or cancer-causing type of HPV, and is by far the most prevalent in patients with advanced HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal and vulvar cancers.  More than 40,500 patients are diagnosed with HPV16-associated cancers each year according to the International Journal of Cancer.  Some of these cancers have been reported to be increasing in incidence over the last few years. 

“We remain excited about the promising early efficacy and safety data from our ongoing Phase 2 clinical trials.  The early clinical data coupled with the recent grant of the PDS0101 patent that runs into late 2037 puts PDS Biotech in a strong position to progress commercialization of the product to address a significant unmet need for more effective treatment of advanced HPV-associated cancers,” stated Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. 

In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study (NCT04260126) in first-line treatment of recurrent or metastatic head and neck cancer, and also in second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. 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) and breast, colon, lung, prostate and ovarian cancers.  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, 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.

CONTACT: Investor Contact:

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

BioSig to Present at the 27th Annual International AF Symposium

News and Market Data on BioSig Technologies

 

PURE EP (TM) System to be highlighted in a Spotlight Session by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health

Westport, CT, Jan. 07, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company would be presenting at the 27th Annual International Atrial Fibrillation Symposium on January 13-15, 2022.

Clinical observations collected with BioSig’s PURE EP™ System will be presented by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health during Spotlight Session: Complex AF Case Study Utilizing a New Standard in Signal Processing on January 13, 2022, from 8:30-9:30 AM ET.

“Dr. Lakkireddy is highly regarded for his passionate commitment to those suffering from complex arrhythmias and for his leadership in the field of electrophysiology, and we are thrilled to have him represent our technology at this benchmark industry event. We would like to thank the course directors, Drs. Ruskin, Mansour, Reddy, Keane, Jais, and the entire faculty for bringing the electrophysiology community together during this important industry event. We look forward to reconnecting with our physician partners and our peers as we gear up for an impactful clinical and commercial year,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

During the event, BioSig will be exhibiting at booth 403. The Company’s executive, commercial and clinical teams will host demonstrations of the PURE EP™ System and some of its platform technology’s latest software and algorithmic features for arrhythmia care.

The conference will also be broadcast live. To register for the event and stream the live presentation, please follow this link: https://register.rcsreg.com/r2/afs2022/ga/top.html

To date, more than 73 physicians have completed over 1800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About 27^7h Annual International AF Symposium
This intensive, highly focused three-day symposium brings together the world’s leading medical scientists to share in a highly interactive environment the most recent advances in the field of atrial fibrillation. The primary objective of the meeting is to provide attendees with a thorough and practical course on the current state of the art in the field of atrial fibrillation in a scholarly and collegial atmosphere, as well as an opportunity to network with colleagues and faculty between sessions. More information about the event on  www.afsymposium.com.

About BioSig Technologies


BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880,
[email protected]
203-409-5444, x133

Source: BioSig Technologies, Inc.

BioSig to Present at the 27th Annual International AF Symposium

News and Market Data on BioSig Technologies

 

PURE EP (TM) System to be highlighted in a Spotlight Session by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health

Westport, CT, Jan. 07, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company would be presenting at the 27th Annual International Atrial Fibrillation Symposium on January 13-15, 2022.

Clinical observations collected with BioSig’s PURE EP™ System will be presented by DJ Lakkireddy, M.D., Kansas City Heart Rhythm Institute at HCA Midwest Health during Spotlight Session: Complex AF Case Study Utilizing a New Standard in Signal Processing on January 13, 2022, from 8:30-9:30 AM ET.

“Dr. Lakkireddy is highly regarded for his passionate commitment to those suffering from complex arrhythmias and for his leadership in the field of electrophysiology, and we are thrilled to have him represent our technology at this benchmark industry event. We would like to thank the course directors, Drs. Ruskin, Mansour, Reddy, Keane, Jais, and the entire faculty for bringing the electrophysiology community together during this important industry event. We look forward to reconnecting with our physician partners and our peers as we gear up for an impactful clinical and commercial year,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

During the event, BioSig will be exhibiting at booth 403. The Company’s executive, commercial and clinical teams will host demonstrations of the PURE EP™ System and some of its platform technology’s latest software and algorithmic features for arrhythmia care.

The conference will also be broadcast live. To register for the event and stream the live presentation, please follow this link: https://register.rcsreg.com/r2/afs2022/ga/top.html

To date, more than 73 physicians have completed over 1800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About 27^7h Annual International AF Symposium
This intensive, highly focused three-day symposium brings together the world’s leading medical scientists to share in a highly interactive environment the most recent advances in the field of atrial fibrillation. The primary objective of the meeting is to provide attendees with a thorough and practical course on the current state of the art in the field of atrial fibrillation in a scholarly and collegial atmosphere, as well as an opportunity to network with colleagues and faculty between sessions. More information about the event on  www.afsymposium.com.

About BioSig Technologies


BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880,
[email protected]
203-409-5444, x133

Source: BioSig Technologies, Inc.

Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205

Research, News, and Market Data on Cocrystal Pharma

 

Response to pre-IND briefing package supports pathway to initiating a Phase 1 clinical study in 2022

BOTHELL, Wash., Jan. 06, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces receipt of guidance from the U.S. Food and Drug Administration (FDA) for the further development of CDI-45205, Cocrystal’s novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery. The FDA’s guidance was received in a written response to Cocrystal’s pre-Investigational New Drug (IND) briefing package that was submitted in October 2021.

“The FDA’s response contained extensive and valuable responses to a list of questions we proposed in our pre-IND briefing package, providing key insights on advancing the non-clinical and clinical development of CDI-45205,” said Sam Lee, Ph.D., President and interim co-CEO of Cocrystal. “The FDA’s guidance marks an important milestone in our continued development of CDI-45205. We now have a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.”

The FDA’s response covered topics including preclinical studies, manufacturing, pharmacology and toxicology, and clinical development plans for CDI-45205 for Phase 1 and Phase 2 studies. In preparation for clinical development, Cocrystal intends to conduct CDI-45205 formulation development, IND-enabling studies and virology assessments, as well as API drug manufacturing for use in preclinical and clinical studies.

CDI-45205 is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also in 2022 with an orally administered main protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based technology platform to discover replication inhibitors for oral administration.

“Our COVID-19 programs feature novel inhibitors that are specifically designed to block viral replication of SARS-CoV-2,” said James Martin, Cocrystal’s CFO and interim co-CEO. “Our inhibitors have shown antiviral activity against various SARS-CoV-2 variants to date, including the Alpha, Beta, Gamma and Delta variants, and now even the Omicron variant. CDI-45205 is not a quick-to-market repurposed drug. Because of its design, we remain highly confident in the broad-spectrum antiviral ability of our compound CDI-45205 in addressing SARS-CoV-2 and variants.”

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to initiate two Phase 1 studies in 2022, our further development of CDI-45205 and using its platform to discover replication inhibitors, and the potential efficacy of antiviral inhibitors against existing and new variants of COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current CRO and future CROs and CMOs, the impact of the COVID-19 pandemic including new variants on the national and global economy, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
[email protected]

Source: Cocrystal Pharma, Inc.

BioSig to Present at the 24th Annual Virtual Needham Growth Conference

News and Market Data on BioSig Technologies

 

BioSig exits 2021 having completed more than 1800 patient cases with the PURE EP™ System.

Westport, CT, Jan. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it it will present at the 24^th Annual Virtual Needham Growth Conference on Friday, January 14^th , 2022 at 4:15 PM ET.

To register for the live webcast of the event, please click here.

A replay of the presentation will also be available on the BioSig Website.

For parties interested in scheduling a one-on-one meeting with BioSig management, please contact your Needham representative.

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™  signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals. (www.biosig.com).

The Company’s first product, PURE EP ™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. To date, 73 physicians have completed over 1,800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The technology is regularly used in some of the country’s highest-ranked hospitals, including St. David’s Medical Center in Austin, TX, Mayo Clinic campuses in Florida, Minnesota, and Arizona, and University of Pennsylvania in Philadelphia, PA.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
[email protected]
203-409-5444, x133

Source: BioSig Technologies, Inc.

BioSig to Present at the 24th Annual Virtual Needham Growth Conference

News and Market Data on BioSig Technologies

 

BioSig exits 2021 having completed more than 1800 patient cases with the PURE EP™ System.

Westport, CT, Jan. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it it will present at the 24^th Annual Virtual Needham Growth Conference on Friday, January 14^th , 2022 at 4:15 PM ET.

To register for the live webcast of the event, please click here.

A replay of the presentation will also be available on the BioSig Website.

For parties interested in scheduling a one-on-one meeting with BioSig management, please contact your Needham representative.

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™  signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 2050¹. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually².

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals. (www.biosig.com).

The Company’s first product, PURE EP ™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. To date, 73 physicians have completed over 1,800 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The technology is regularly used in some of the country’s highest-ranked hospitals, including St. David’s Medical Center in Austin, TX, Mayo Clinic campuses in Florida, Minnesota, and Arizona, and University of Pennsylvania in Philadelphia, PA.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health.

² Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
[email protected]
203-409-5444, x133

Source: BioSig Technologies, Inc.

Cocrystal Pharma Receives FDA Guidance to Advance Clinical Development of its COVID-19 Antiviral CDI-45205

Research, News, and Market Data on Cocrystal Pharma

 

Response to pre-IND briefing package supports pathway to initiating a Phase 1 clinical study in 2022

BOTHELL, Wash., Jan. 06, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces receipt of guidance from the U.S. Food and Drug Administration (FDA) for the further development of CDI-45205, Cocrystal’s novel SARS-CoV-2 main protease inhibitor as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery. The FDA’s guidance was received in a written response to Cocrystal’s pre-Investigational New Drug (IND) briefing package that was submitted in October 2021.

“The FDA’s response contained extensive and valuable responses to a list of questions we proposed in our pre-IND briefing package, providing key insights on advancing the non-clinical and clinical development of CDI-45205,” said Sam Lee, Ph.D., President and interim co-CEO of Cocrystal. “The FDA’s guidance marks an important milestone in our continued development of CDI-45205. We now have a clearer pathway for our planned Phase 1 single-ascending-dose and multiple-ascending-dose study that we expect to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.”

The FDA’s response covered topics including preclinical studies, manufacturing, pharmacology and toxicology, and clinical development plans for CDI-45205 for Phase 1 and Phase 2 studies. In preparation for clinical development, Cocrystal intends to conduct CDI-45205 formulation development, IND-enabling studies and virology assessments, as well as API drug manufacturing for use in preclinical and clinical studies.

CDI-45205 is one of three COVID-19 programs underway at Cocrystal. In the second COVID-19 program, the Company plans to begin a Phase 1 study also in 2022 with an orally administered main protease inhibitor. In the third COVID-19 program, Cocrystal is using its unique structure-based technology platform to discover replication inhibitors for oral administration.

“Our COVID-19 programs feature novel inhibitors that are specifically designed to block viral replication of SARS-CoV-2,” said James Martin, Cocrystal’s CFO and interim co-CEO. “Our inhibitors have shown antiviral activity against various SARS-CoV-2 variants to date, including the Alpha, Beta, Gamma and Delta variants, and now even the Omicron variant. CDI-45205 is not a quick-to-market repurposed drug. Because of its design, we remain highly confident in the broad-spectrum antiviral ability of our compound CDI-45205 in addressing SARS-CoV-2 and variants.”

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to initiate two Phase 1 studies in 2022, our further development of CDI-45205 and using its platform to discover replication inhibitors, and the potential efficacy of antiviral inhibitors against existing and new variants of COVID-19. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current CRO and future CROs and CMOs, the impact of the COVID-19 pandemic including new variants on the national and global economy, the cooperation of the FDA in accelerating development in our COVID-19 program, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
[email protected]

Source: Cocrystal Pharma, Inc.

Neovasc Announces First Patient Enrollment in COSIRA-II Trial

Research, News, and Market Data on Neovasc

 

COSIRA-II Trial Designed to Study the Neovasc Reducer™ for Patients with Refractory Angina

VANCOUVER and MINNEAPOLIS – (  NewMediaWire ) – January 05, 2022 – Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) (“Neovasc” or the “Company”) today announced enrollment of the first patient in the COSIRA-II clinical trial. COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a pivotal trial that will study the Neovasc Reducer™ (“Reducer”), designed to reduce angina symptoms in patients with refractory angina. The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.

View video about the COSIRA-II trial here >.

The first patient was enrolled at St. Francis Hospital & Heart Center, Roslyn, NY, under the care of Ziad Ali, M.D., DPhil., and Principal Investigator Evan Shlofmitz, D.O. The patient has a history of chronic refractory angina and previously endured multiple cardiac catheterization procedures at various hospitals to treat his recurrent symptoms. None of the previous procedures was successful at alleviating his chest pain.

“Enrollment of the first patient in COSIRA-II is a major step forward for patients in the United States suffering from chronic chest pain,” stated COSIRA-II Executive Steering Committee member Allen Jeremias, M.D., St. Francis Hospital & Heart Center, Roslyn, NY. “For the first time, patients that experience the debilitating effects of refractory angina have access to an FDA-designated ‘Breakthrough Medical Device’ in a placebo-controlled trial. The COSIRA-II Trial offers hope for patients that previously had a poor prognosis and faced a future of unrelenting chest pain.”

COSIRA-II is 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.

“We are pleased to commence COSIRA-II and grateful that the Centers for Medicare and Medicaid Services has determined the device and the procedure are eligible for reimbursement in the United States during the clinical trial,” commented Fred Colen, Chief Executive Officer at Neovasc. “The coverage determination is a big win for us. COSIRA-II is a major investment for the Company. We are grateful to our staff and the investigators for their relentless work to finalize all the required deliverables on schedule, such as FDA approval, local hospital review board approval, qualification processes, site training, and all required legal contracts and documentation by the end of 2021, enabling this first enrollment. Finalization of the reimbursement rate for the trial procedure will enable Medicare beneficiaries eligible for the trial to have greater access.”

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: [email protected]

Media:

Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: [email protected]

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, the intention to utilize the COSIRA-II trial in support of the Company’s PMA to the FDA for approval of the Reducer in the United States, the anticipated size of the COSIRA-II trial, potential reimbursement that will allow appropriate Medicare beneficiaries access to the 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 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.

	Image Credit: Community Eye Health (Flickr)

COVID is a Virus – So Why are Researchers Treating it With Antibiotics?

 

If you have a cold, don’t ask your doctor for antibiotics – that’s the golden rule. They’re for bacterial infections, not viral. We’re told not only that they won’t work, but that by using antibiotics when they aren’t needed, we’re helping bacteria become resistant to them.

 

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 Mostafa Rateb, Lecturer in Drug Discovery, University of the West of Scotland.

 

Yet in a recent study conducted in an Egyptian hospital, we showed that treating moderate-to-severe COVID patients with either one of two antibiotics (ceftazidime or cefepime, in combination with a steroid) resulted in similar recovery times compared to patients given standard treatment.

This standard treatment, authorized by the Egyptian government and approved by the World Health Organization, was made up of at least seven different medications, suggesting that treating COVID with antibiotics could be a much simpler way of making people better.

Yet by doing this, we went against the established medical convention that antibiotics aren’t for viruses. So why did we break this rule?

 

Necessity the Mother of Invention

Traditionally, creating new drugs to treat diseases takes a long time. Trying to develop a new treatment can take years, costs a lot of money, and has a very low success rate. Nevertheless, this process is generally acceptable when targeting common diseases.

However, this time-consuming process is not viable when there is a high threat posed by an emerging infectious disease, such as Zika, Ebola, Mers and now COVID. Without quick action or effective treatments that are ready to go, emerging diseases can evolve into pandemics that take a lot of lives. There have been hundreds of millions of confirmed cases of COVID, for example, and over 5.4 million deaths globally. Because of this, when faced with a new threat, drug developers and major pharmaceutical companies look for quicker alternatives to the typical drug-development process. One practical strategy is drug repurposing. This is where drugs already created and approved for one use are tested to see if they can also help treat the new disease.

As the drugs have already been shown to be safe, and plenty is known about how they work, this is potentially a much less risky and time-consuming way of coming up with a treatment for the new disease. It’s a strategy that’s been used often in the past – and one my colleagues and I wanted to try to use it during COVID because of the pressing need.

 

Finding a New Purpose

Drug repurposing begins by using computer-based techniques to model how existing drugs and the new disease-causing agent – in this case the coronavirus – might interact. Drugs that show promise are then tested in real-life lab studies to validate the computer’s findings and confirm that they could be of clinical use.

With a viral disease like COVID, a drug considered for repurposing should show one of these three qualities: it should either be able to inhibit one or more stages of the coronavirus’s replication cycle; relieve the bad effects of the virus; or manipulate the immune system so that the body can deal with the virus.

And surprisingly, antibiotics are often the substances that show potential. Although viruses are different then bacteria, they are sometimes also impacted by antibiotics. The statement that antibiotics don’t work against viruses doesn’t apply 100% of the time.

For example, in response to the Zika crisis five or so years ago, an American study evaluated more than 2,000 drugs already approved by the US Food and Drug Administration to see if they could potentially be safely used in pregnancy against the virus. The study found that the antibiotic azithromycin could reduce the proliferation of the virus in the brains of unborn children, thus potentially protecting against microcephaly, a condition caused by the virus in newborns.

Separately, testing also showed that the antibiotic novobiocin had a strong antiviral effect against the Zika virus. And a 2016 drug-repurposing study conducted in Thailand identified minocycline as a promising antiviral drug against dengue virus, with this antibiotic inhibiting the virus’s growth at various stages of its life cycle.

All of these studies gave us confidence that repurposing antibiotics as COVID treatments was a plausible idea.

 

But Why Ceftazidime or Cefepime?

Research had already shown that a number of antibiotics were good at stopping the coronavirus reproducing in lab tests – including ceftazidime and others of the same class, which is known as “beta-lactams”. We therefore knew this drug class had potential.

And when we ran computer simulations of how ceftazidime and cefepime (another beta-lactam) would interact with the virus, they were both effective at disrupting its protease, a key enzyme the virus uses to reproduce.

Ceftazidime and cefepime are also broad-spectrum antibiotics that are widely used to treat critically ill patients who pick up infections in hospital. As COVID patients often end up with other infections at the same time, we also thought these drugs might help badly ill patients by clearing other infections they might have, helping prevent conditions such as pneumonia.

However, it isn’t clear how much of the antibiotics’ effect in our Egyptian hospital study was down to clearing co-infections versus how much was due to them attacking the coronavirus directly. Indeed, the notion that beta-lactams have antiviral properties is based on computer simulations and lab experiments – it hasn’t been definitively proven.

Nevertheless, our work has made a good case that these drugs can fight the coronavirus. While we still need to use antibiotics carefully, they might therefore have a role to play against COVID in the future.

 

Suggested Reading:

Scientists Now Better Understand Viral Mutations

How Adjuvants Increase Vaccine Potency

The Computer Chip Shortage, Where We Are Now

Can Market Strength Last into 2022?

 

 

 

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