BioSig Expands Its Clinical Footprint In Florida

News and Market Data on BioSig Technologies

The Company’s signal processing technology for arrhythmia care is being installed in a leading HCA Healthcare-operated facility in Southeast Florida

Westport, CT, Dec. 16, 2021 (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 is installing a PURE EP™ System for an evaluation at the HCA Healthcare-operated Westside Regional Medical Center in Plantation, FL.

Westside Regional Medical Center is an award-winning 250-bed hospital recognized for providing a wide array of services to the residents of Broward County, South Florida, and visitors from around the world. The hospital’s electrophysiology program is one of the most frequented in Broward County, offering advanced diagnostic services and multiple modalities for diagnosing and treating arrhythmia.¹. In addition to its comprehensive cardiovascular services, Westside Regional Medical Center is certified as a Comprehensive Stroke Center by the Agency for Health Care Administration (ACHA). Westside Regional Medical Center is a facility of HCA East Florida, the most extensive healthcare system in Eastern Florida and an affiliate of Hospital Corporation of America (HCA). HCA East Florida has 14 hospitals, multiple ambulatory surgery centers, physician practices, free-standing emergency care facilities, and a supply chain center, and an integrated regional lab.²

“Our new installation agreement with Westside Regional Medical Center increases our clinical reach across the state, with an installation in both the north and south regions of Florida. We are thrilled to partner with another leading HCA Healthcare-operated institution and continue to solidify our commitment to arrhythmia patient care across the state of Florida,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

To date, 73 physicians have completed over 1750 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 Company’s most recent evaluation adds to its clinical footprint in Florida, which also includes Mayo Clinic’s Florida Campus, a national Medical Center of Excellence.

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.

About 2,300 Americans die from heart disease each day – an average of one death every 38 seconds³. In 2016, 1.6 million Texas adults reported that they had been diagnosed with heart disease or stroke⁴. There were 336,462 hospitalizations of adult Texans related to heart disease in 2016, at an age-adjusted rate of 124.0 per 10,000 adults⁵. The direct and indirect costs of heart disease and stroke in the U.S. are estimated to be $329.7 billion, and the cost is projected to increase to $749 billion by 2035⁶.

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 Arrhythmia Specialties – Westside Regional Medical Center: westsideregional.com

² Hospital News and Healthcare Report – 2020: southfloridahospitalnews.com

³ Heart disease and stroke statistics – 2018 update: a report from the American Heart Association

⁴ Texas Behavioral Risk Factor Surveillance System Public Use Data File, 2016, Center for Health Statistics, Texas Department of State Health Services

⁵ Texas Hospital Inpatient Discharge Public Use Data, Texas Health Care Information Collection, 2016, Center for Health Statistics, Texas Department of State Health Services

⁶ Heart disease and stroke statistics – 2018 update: a report from the American Heart Association

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.

New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

Research, News, and Market Data on Ocugen

• Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection
• Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses
• Memory T and B cells persisted for at least 6 months post vaccination
• Data suggest COVAXIN™ (BBV152) may provide protection against current and future variants
• Effectiveness of COVAXIN™ (BBV152) against the Omicron variant is currently being studied
  

MALVERN, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN™ (BBV152), from a third-party study were published on the preprint server, medRxiv. The data compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN™ (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells.  

In addition to controlling infections, the adaptive immune system creates immunological memory, such as memory B and T cells, to enable long-term protection against a virus. In the analysis, COVAXIN™ (BBV1542) generated T-cells against both spike and nucleocapsid proteins in nearly 85 percent of subjects that persisted for at least 6 months. This data supports previous findings that COVAXIN™ (BBV152) is able to induce long-term memory.

“As a whole-virion inactivated vaccine, we anticipated COVAXIN™ would produce an immune response against multiple antigens present in the SARS-CoV-2 virus, such as spike and nucleoprotein antibodies,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“The results of this analysis are extremely important findings as we continue to learn about how the virus is mutating and how we can address variants of concern with vaccines, especially with the emergence of Omicron,” said David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania and member of Ocugen’s Vaccine Scientific Advisory Board. “Given that current variants of concern exhibit mutations concentrated in the spike protein of the virus, vaccines like COVAXIN™ that can generate broad immune memory beyond the spike protein are a promising tool to protect us from emerging variants of concern.”  

Ocugen is currently evaluating COVAXIN™ (BBV152) against the Omicron variant and plans to share the data as soon as they are available.

Earlier this year, Ocugen’s co-development partner, Bharat Biotech, announced data from a Phase 3 trial that included nearly 25,800 participants. In the study, published in The Lancet, COVAXIN™ (BBV152) demonstrated 77.8% overall efficacy, 93.4% efficacy against severe illness (which requires hospitalization, intensive care and/or a ventilator) and 65.2% efficacy against the Delta variant. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group.

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™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ 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™ 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™. 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 statements about data published on the preprint server, medRxiv, which found that COVAXIN™ generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells, and our expectation that COVAXIN can generate potential long-term immunological memory. 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 risk that the data published on medRxiv, which is preliminary and subject to ongoing peer review, may not be accepted for publication without changes, if at all, may contain errors that render the reported information erroneous, or may not be accepted by the scientific or medical community; 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 inversely impact our ability to advance the development of COVAXIN™ in the United States, the implications that this clinical hold may have for our request for emergency use authorization for COVAXIN for pediatric use; commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as 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 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 we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA) or emergency use authorization (EUA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial which is currently subject to clinical hold; any additional chemistry, manufacturing and controls information that we may be required to submit to 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; 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
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com