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 

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 

Tuesday, December 14, 2021

Genprex (GNPX)
Reqorsa Could Be The First Systemic Gene Therapy

Genprex Inc is a U.S.-based clinical-stage gene therapy company. It is engaged in developing a new approach to treating cancer based on its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy. Oncoprex, which has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis in cancer cells and modulates the immune response against cancer cells.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

Genprex Has Developed a Proprietary System For Gene Delivery.  The Oncoprex technology uses nanoparticles to deliver genes using intravenous administration rather than a viral vector delivered directly to the tumor site. The company’s first product, Reqorsa, uses the Oncoprex system to deliver a tumor suppressor gene. Reqorsa began a Phase 1/2 clinical trial in non-small cell lung cancer (NSCLC) and is expect to being a Phase 1/2 immunotherapy combination trial in early 2022.


Gene Therapy With A Tumor Suppressor Reqorsa was developed to deliver TUSC2 gene, a tumor suppressor gene.  TUSC2 has been shown to stop pathways of cancer cell proliferation and start pathways that lead to cell death (apoptosis). These pathways may be additive or synergistic with actions of other drugs that act through intracellular signaling …

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

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

Helius Medical Technologies, Inc. Announces Issuance of U.S. Patent for Wireless PoNS®

Research, News, and Market Data on Helius Medical Technologies

 

Patent Readies Company for Next Generation of PoNS Therapy

NEWTOWN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (Helius or the Company), a neurotech company focused on neurological wellness, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,197,994, which is directed to systems for providing non-invasive neurorehabilitation of a patient. The patent is similar in scope to prior Helius patents for the Portable Neuromodulation Stimulator (PoNS) device but expressly recites that the communications between the mouthpiece and controller are done wirelessly.

“We are pleased to announce our new patent, which will allow for a wireless connection between the mouthpiece and controller of our PoNS device,” said Dane Andreeff, President and Chief Executive Officer of Helius. “PoNS is the first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma, and this patent is an important building block for future generations of PoNS therapy.”

Helius now owns 34 U.S. and 46 foreign patents expiring between 2026 and 2036, and exclusively licenses nine U.S. medical method patents expiring between 2029 and 2031.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP).

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visit www.heliusmedical.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “future,” “goal,” “aim” and similar expressions.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

electroCore, Inc. Provides Update on nVNS to Treat Post Traumatic Stress Disorder

News and Market Data on electroCore

 

ROCKAWAY, NJ, 
Dec. 14, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today provided an update on the ongoing clinical research to assess the potential of gammaCore (non-invasive vagal nerve stimulation; nVNS) to treat Post Traumatic Stress Disorder (“PTSD”).

PTSD is a debilitating disorder triggered by experiencing or witnessing a traumatic event that is increasingly common. Approximately 15 million adults in the US will have PTSD during a given year and it is particularly concerning to the Military and Veteran’s Administration (VA).

In a study published on 
December 6^th, 2021, in the Journal of Affective Disorders Reports, 20 patients suffering from PTSD were exposed to personalized traumatic scripts followed by an immediate stimulation by an active or sham non-invasive vagus nerve stimulator (“nVNS”). The results showed that three-months of treatment with nVNS led to a 31% reduction (p<0.013) in PTSD symptoms compared to sham on the PTSD Checklist (“PCL”), as well as a significant decrease in hyperarousal symptoms (p=0.008) and a decrease in overall and somatic (gastric) anxiety. At the conclusion of the study, patients who continued using nVNS for a further 3 month open-label period showed significant improvement in their overall symptoms reported by the Clinical Global Index (p=0.003). Furthermore, nVNS effectively blocked the increase in the levels of the inflammatory cytokine IL-6 that is overexpressed in patients with PTSD who are exposed to a traumatic script (p<0.05).

electroCore is currently collaborating with investigators on two Randomized, sham-controlled clinical trials to further confirm the efficacy of nVNS as a treatment for PTSD. (Table 1)

Table 1. Ongoing Studies of nVNS in PTSD and Related Disorders
Study	Size	Location
nVNS in posttraumatic stress	88	VA San Diego Healthcare System,  San Diego, CA
Sympathetic overactivity in PTSD	100	Atlanta VA Medical Center,  Decatur, GA

“PTSD is a devastating condition that affects family and individuals across 
the United States. Whether it affects our active-duty service men and women, our Veteran’s, or friends and family, there are very few treatments that can decrease the signs and symptoms of nVNS” said  Dan Goldberger, CEO of electroCore. “gammaCore, which is currently cleared by the FDA for most forms of primary headache, offers the potential to provide a safe, convenient and effective treatment for people with PTSD. We look forward to reporting on our clinical and regulatory progress in 2022.”

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

For more information, visit www.electrocore.com.

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

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

gammaCore is contraindicated for patients if they:

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

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

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

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

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 (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with Post Traumatic Stress Disorder (PTSD), the potential of nVNS generally and gammaCore in particular 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 CockrellCG Capital
404-736-3838
ecor@cg.capital

or

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

	Image Credit – Pixabay - TherapeuticShroom

Psychedelic Medicine – The Next Breakthrough in Mental Health Treatment?

 

A Quick Look at 8 Small Caps in the Growing Psychedelics Space

After decades of restrictive regulation and social stigma, psychedelics are gaining headwinds as a potential treatment for various mental health conditions.

The term “psychedelic drugs” holds different meanings to different people. In counterculture, the term may refer to “magic mushrooms” or other drugs, such as ecstasy.  Purposely used to trigger hallucinations or altered states of consciousness, psychedelic drugs became popular in the 1960s, which led to harsh restrictions not only on possession and use for recreational purposes, but also on medical research.

Legal Hurdles

Research on the use of psychedelics was returning promising results in the early 20^th century.  The Controlled Substances Act of 1970, following the increase in recreational use in the 60s, put up a barrier to researching the potential benefits, even for medical usage. A roadblock that the industry is only now starting to find a way past.

In recent years, the Food and Drug Administration (FDA) has granted psychedelic compounds Breakthrough Therapy status, which has opened the door to new research studies and the potential development of new medications.  Recently, research and approval of new drugs has progressed past phase 2 trials for the use of psilocybin – the naturally occurring psychedelic prodrug compound produced by numerous fungi species – as treatment for depressive disorder. In another example, a drug proposed for the treatment of certain PTSD diagnoses is heading towards a second phase 3 trial, with full FDA approval possible as early as 2022.

Beyond FDA Approval

Potential FDA approval is just the first step. The United States Drug Enforcement Administration (DEA), and, by proxy, the Controlled Substances Act, are next in line.  Psychedelic compounds generally fall into Schedule 1 classification: the most restrictive.  By law, Schedule 1 drugs cannot be prescribed to treat any condition under any circumstances. While this may seem insurmountable, full FDA approval of a drug would likely force the DEA to reevaluate their position.

Beyond Federal regulation, there’s also individual state laws. Consider the current state of cannabis and marijuana legalization and decriminalization from state to state.  While some have fully approved the use of marijuana both recreationally and medically, others have varying levels of restriction on either use-case.  The same is likely to be true for the use of psychedelics for medicinal use.

Prescriptions

Proposed psychedelic treatments often run in-tandem with hours of mental health therapy sessions.  In fact, more than 90% of the cost associated with the entire regimen is attributed to therapy in some cases. While this exceeds the costs associated with the current treatment schedule for these conditions, proven increased efficacy of psychedelics, especially in treatment of previously untreatable conditions, would reduce third-party payer expenditures.

Considering the toll the opioid epidemic has taken, there is also likely to be increased scrutiny on the prescription of psychedelic therapies, even if the DEA adjusts their classification. 

Even with numerous hurdles, several doctors, organizations, and companies see the potential of psychedelics as treatment for various mental health issues, including depression, PTSD, anxiety, eating disorders, and substance use disorders.  In most cases, early research has shown efficacy surpassing any currently available treatment schedule.  In some, psychedelics may represent a portion of the first truly effective treatment schedule. 

The psychedelic medicine market is expected to grow exponentially as FDA approvals start to come in, with some speculating the market will reach a value of over $3 billion by 2026.

 

Companies Involved in Psychedelic Medicine

PsyBio
Therapeutics – PSYBF

PsyBio is a biotechnology company focused on discovery and development of psycho-targeted therapeutics to potentially improve mental and neurological health. They are currently researching and developing treatments based on psychoactive tryptamines originally discovered in hallucinogenic mushrooms, as well as other tryptamines, phenethylamines, and combinations thereof.

PsyBio has built a portfolio of more than 80 molecules. Their development focus is “cheaper, faster, greener psychedelic inspired compound discovery and production.”

Recently, the company announced the successful completion of their initial pre-Investigational New Drug application meeting with the FDA as part of the regulatory submission process

View the most recent research report on PSYBF at the link
above for applicable disclosures

Filament
Health – FLHLF

Filament Health is an exclusively natural psychedelic drug discovery and extraction technology company.  Their focus is in bringing safe, approved, natural psychedelic medicines to market as soon as possible. Filment’s wholly owned subsidiary Psilo Scientific propagates psychedelic plants, conducts research, performs extraction, runs in-house trials, and distributes IP and drug candidates.

Recently, the company announced FDA authorization to initiate its first clinical trial using psychedelic substances, a first for the direct administration of psilocin (rather than its prodrug psilocybin). The Translational Psychedelic Research Program at the University of California San Francisco will lead the phase 1 trial.

The company also anticipates FDA authorization of a phase 2 trial for PEX010, to test safety and efficacy in the treatment of Major Depressive Disorder by year end.

View the most recent research report on PSYBF at the link
above for applicable disclosures

Levitee
Labs – LVTTF

Levitee Labs is focused on mental health and addiction treatments through the integration of psychedelic medicines and therapies. Leveraging an M&A regimen, they aim to create a centralized network of complementary integrative assets.  The company’s current portfolio includes Levitee Clinics – a group of addiction and pain treatment clinics, Levitee Pharmacies – specializing in filling prescriptions for substance use, mental health, and chronic pain patients, BlockMD – an electronic prescription platform in the addiction treatment space, and Earth Circle Organics – a wholesaler of supplements and superfood products.

Revive
Therapeutics – RVVTF

Revive Therapeutics is a life sciences company focused on research and development of therapeutics for rare disorders and infections diseases.  Revive boasts a robust cannabinoid pharmaceutical portfolio focused on rare inflammatory diseases. Recently, they acquired Psilocin Pharma. This acquisition positions them to advance psilocybin-based therapeutics.  They are also exploring the use of Bucillamine for the potential treatment of infectious diseases, including COVID-19.

On the recent acquisition of Psilocin Pharma, Revive CEO Michael Frank stated: “Psilocin Pharma has the platform, relationships, and know-how to develop psylocibin-based products that are key to this emerging psychedelics industry. We feel this acquisition will complement Revive and be a strong addition to our current clinical initiatives in liver disease and inflammation.”

In November, the company announced it had entered into a research collaboration agreement with PharmaTher Holdings to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle path technology for neuropsychiatric disorders.

Cybin
– CYBN

Cybin is an ethical biopharmaceutical company focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

The company’s pipeline currently includes 6 programs, including EMBARK, utilizing psilocybin for mental distress in frontline healthcare workers, currently in phase 1 trial. Other preclinical programs include studying psychedelic effects on the brain and psilocybin as treatment for major depressive disorder and alcohol use disorder.

At the end of November, Cybin announced that the FDA had authorized an investigator-initiated randomized, placebo-controlled phase 2 clinical trial evaluating psychotherapy with psilocybin for frontline worders experiencing COVID-related distress.

Field
Trip Health – FTRP

Field Trip is focused on an integrated, evidence-based approach to healing utilizing psychedelic-enhanced therapies. Their portfolio includes Field Trip Health – technology empowered clinics providing psychedelic therapies, Field Trip Digital – an app & resources platform, and Field Trip Discovery – their drug development division focused on psychedelic molecules.

Field Trip’s treatment regimen includes analysis, therapy session, psychedelic exploration, and integration. Their treatment program is designed to help individuals suffering from treatment resistant mental health conditions such as depression, anxiety, and trauma.

Compass
Pathways – CMPS

Compass is a mental health care company focused on acceleration patient access to psilocybin therapy.  COMP360, a proprietary formulation of synthetic psilocybin, is focused on those suffering from treatment resistant depression. They received FDA Breakthrough Therapy designation for the program in 2018 and completed a phase 2b study in 233 patients in late 2021. According to the company, this was the largest randomized, controlled, double-blind psilocybin therapy clinical trial ever conducted. They expect to begin phase 3 in 2022. Compass is also running a phase 2 clinical trial of their psilocybin therapy for treatment of PTSD.

ATAI
Life Sciences – ATAI

ATAI is a biopharmaceutical company focused on highly effective mental health treatments that address the unmet needs to patients. The company utilizes proprietary technology and big-data approaches to accelerate drug discovery.

The company has two programs currently in phase 2: PCN-101 for patients experiencing treatment resistant depression, and RL-007 for the treatment of Cognitive Impairment Associated with Schizophrenia. Recently, Atai announced a successful outcome of the phase 2a biomarker trial of RL-007. They also have two programs currently in phase 1: DMZ-1002 for the treatment of opioid use disorder, and GRX-917 for the treatment of anxiety disorder.

In Conclusion

Mental health awareness has increased significantly in recent years, while the development of medications has not kept up with the demand for treatment.  The implementation of psychedelics, in conjunction with a therapy schedule, may create a path to wellness not previously available for many patients.  Early efficacy trials have certainly shown the potential that lies ahead. 

Investing in an early-stage medical platform company, like any other investment, carries its own risks. Before making an investment decision in any company, make sure you understand the risks associated, and consult your investment advisor.

Chris Patches
Channelchek Contributor

Suggested Reading:

Psychedelic Laws and Investments May Follow Cannabis’ Success

Acceptance of Psychedelics for Wellness and Recreation

Sources:

https://www.amjmed.com/article/S0002-9343(21)00521-0/fulltext

https://medicine.umich.edu/dept/psychiatry/news/archive/202108/therapeutic-potential-psychedelics-psychiatric-disorders

https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

https://www.financialnewsmedia.com/north-american-psychedelic-drugs-market-expected-to-reach-a-value-of-3-184-billion-in-2026/

https://www.psybiolife.com/press

https://filament.health/our-technology/

https://finance.yahoo.com/news/filament-health-announces-fda-authorization-114500736.html

https://leviteelabs.com/category/press-releases/

https://revivethera.com/2020/02/revive-enters-into-psychedelics-market-with-letter-of-intent-to-acquire-psilocin-pharma-corp/

https://revivethera.com/2021/11/revive-therapeutics-enters-into-research-collaboration-agreement-with-pharmather-for-development-of-psilocybin-microneedle-patch/

https://cybin.com/development-pipeline/

https://ir.cybin.com/investors/news/news-details/2021/Cybin-Announces-FDA-Investigational-New-Drug-and-Institutional-Review-Board-Approvals-for-a-Co-Funded-Phase-2-Clinical-Trial-to-Treat-Frontline-Clinicians-Experiencing-COVID-Related-Distress/default.aspx

https://www.fieldtriphealth.com/our-treatments#treatment

https://compasspathways.com/

https://www.atai.life/programs/

 

Stay up to date. Follow us:

electroCore, Inc. Provides Update on nVNS to Treat Post Traumatic Stress Disorder

News and Market Data on electroCore

 

ROCKAWAY, NJ, 
Dec. 14, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today provided an update on the ongoing clinical research to assess the potential of gammaCore (non-invasive vagal nerve stimulation; nVNS) to treat Post Traumatic Stress Disorder (“PTSD”).

PTSD is a debilitating disorder triggered by experiencing or witnessing a traumatic event that is increasingly common. Approximately 15 million adults in the US will have PTSD during a given year and it is particularly concerning to the Military and Veteran’s Administration (VA).

In a study published on 
December 6^th, 2021, in the Journal of Affective Disorders Reports, 20 patients suffering from PTSD were exposed to personalized traumatic scripts followed by an immediate stimulation by an active or sham non-invasive vagus nerve stimulator (“nVNS”). The results showed that three-months of treatment with nVNS led to a 31% reduction (p<0.013) in PTSD symptoms compared to sham on the PTSD Checklist (“PCL”), as well as a significant decrease in hyperarousal symptoms (p=0.008) and a decrease in overall and somatic (gastric) anxiety. At the conclusion of the study, patients who continued using nVNS for a further 3 month open-label period showed significant improvement in their overall symptoms reported by the Clinical Global Index (p=0.003). Furthermore, nVNS effectively blocked the increase in the levels of the inflammatory cytokine IL-6 that is overexpressed in patients with PTSD who are exposed to a traumatic script (p<0.05).

electroCore is currently collaborating with investigators on two Randomized, sham-controlled clinical trials to further confirm the efficacy of nVNS as a treatment for PTSD. (Table 1)

Table 1. Ongoing Studies of nVNS in PTSD and Related Disorders
Study	Size	Location
nVNS in posttraumatic stress	88	VA San Diego Healthcare System,  San Diego, CA
Sympathetic overactivity in PTSD	100	Atlanta VA Medical Center,  Decatur, GA

“PTSD is a devastating condition that affects family and individuals across 
the United States. Whether it affects our active-duty service men and women, our Veteran’s, or friends and family, there are very few treatments that can decrease the signs and symptoms of nVNS” said  Dan Goldberger, CEO of electroCore. “gammaCore, which is currently cleared by the FDA for most forms of primary headache, offers the potential to provide a safe, convenient and effective treatment for people with PTSD. We look forward to reporting on our clinical and regulatory progress in 2022.”

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

For more information, visit www.electrocore.com.

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

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

gammaCore is contraindicated for patients if they:

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

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

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

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

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 (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with Post Traumatic Stress Disorder (PTSD), the potential of nVNS generally and gammaCore in particular 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 CockrellCG Capital
404-736-3838
ecor@cg.capital

or

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

Helius Medical Technologies, Inc. Announces Issuance of U.S. Patent for Wireless PoNS®

Research, News, and Market Data on Helius Medical Technologies

 

Patent Readies Company for Next Generation of PoNS Therapy

NEWTOWN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (Helius or the Company), a neurotech company focused on neurological wellness, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,197,994, which is directed to systems for providing non-invasive neurorehabilitation of a patient. The patent is similar in scope to prior Helius patents for the Portable Neuromodulation Stimulator (PoNS) device but expressly recites that the communications between the mouthpiece and controller are done wirelessly.

“We are pleased to announce our new patent, which will allow for a wireless connection between the mouthpiece and controller of our PoNS device,” said Dane Andreeff, President and Chief Executive Officer of Helius. “PoNS is the first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma, and this patent is an important building block for future generations of PoNS therapy.”

Helius now owns 34 U.S. and 46 foreign patents expiring between 2026 and 2036, and exclusively licenses nine U.S. medical method patents expiring between 2029 and 2031.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP).

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visit www.heliusmedical.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “future,” “goal,” “aim” and similar expressions.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Cocrystal Pharma Interim Co-CEOs Sam Lee, President and James Martin, CFO make a formal corporate presentation. Afterwards they are joined by Noble Capital Markets Senior Research Analyst Robert LeBoyer for a Q & A session. Research, News, and Advanced Market Data on COCP Information on upcoming live virtual roadshows 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.

electroCore Announces New Patent for Stroke and TIA Treatment

News and Market Data on electroCore

 

ROCKAWAY, NJ, 
Dec. 13, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office (USPTO) has issued 
U.S. Patent No. 11,191,953 to the Company, relating to the treatment of stroke symptoms.

The newly issued patent is related to methods for treating the acute symptoms of stroke or transient ischemic attack (TIA), a temporary period of symptoms similar to those of a stroke, according to a treatment paradigm based on the application of a transcutaneous, non-invasive electrical impulse or stimulation.  

This newly allowed patent is owned by the Company and reinforces development efforts associated with certain investigator-initiated trials in the area of stroke which is the second highest cause of death and third leading cause of disability globally. Earlier this year, the Company announced full enrollment of the TR-VENUS study of non-invasive vagal nerve stimulation (nVNS) for the acute treatment of stroke.

“We are pleased with this latest patent issuance relating to another potential important use of electroCore’s non-invasive approach to treating patients with vagus nerve stimulation that has devastating impacts on people’s lives,” commented JP Errico, a founder, board member and investor of the Company, who was also a co-inventor of the new patent. “Every year, roughly 15 million people worldwide suffer strokes, and our non-invasive vagus nerve stimulator technology may be an effective acute treatment to reduce the damaging effects to the brains of these patients. With ongoing investigator-initiated trials in stroke, and our newly issued patent, we look forward to understanding nVNS’s potential role in the treatment paradigm for stroke patients worldwide.”

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
gammaCore^TM (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, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

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

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

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

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

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 issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with acute stroke or TIA, the potential of nVNS generally and gammaCore in particular 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 CockrellCG Capital
404-736-3838
ecor@cg.capital

or

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

Onconova Therapeutics Appoints Adar Makovski Silverstein, Ph.D., As Director, Corporate Development

News and Market Data on Onconova Therapeutics

 

NEWTOWN, Pa., Dec. 13, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Dr. Adar Makovski Silverstein has joined Onconova as Director, Corporate Development.

“Adar’s deep scientific expertise in oncology and business development experience at leading biotechnology companies, most recently at Amgen, make her an excellent addition to our team at Onconova,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We are thrilled to have her join us and look forward to benefitting from her insights. Her strong scientific background and business development experience will be valuable assets as we seek to advance our own pipeline and evaluate new opportunities for potential strategic expansion.”

Dr. Makovski Silverstein joins Onconova from Amgen, where she worked as Sr. Licensing Associate, Business Development, External R&D. At Amgen, Dr. Makovski Silverstein was responsible for evaluating external scientific opportunities across all therapeutic areas and managing processes within business development and cross functional teams. Prior to her time at Amgen, Dr. Makovski Silverstein interned as a member of the Research Program Management Team at Regeneron. She also previously worked as a marketing analyst graduate student consultant at Roche Sequencing Solutions. Dr. Makovski Silverstein earned her Ph.D. in Biotechnology from Bar-Ilan University in Israel and completed a post-doctoral fellowship at the City of Hope in Duarte, California.

Dr. Makovski Silverstein commented, “This is an exciting time to be joining Onconova. Narazaciclib’s differentiated inhibitory profile gives it best-in-class potential across multiple indications. Rigosertib is also advancing in a robust investigator-initiated program that has generated compelling early clinical data in multiple indications. The team leading the development of these programs at Onconova is impressive, and I look forward to working with them to advance novel therapies for patients with cancer.”

About Onconova Therapeutics
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors
929-469-3859
bmackle@lifesciadvisors.com

BioSig to Host Conference Call on December 21, 2021

News and Market Data on BioSig Technologies

 

Westport, CT, Dec. 13, 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 would host a conference call on Tuesday, December 21, 2021, at 2 PM ET.

Conference Call Details
Date: Tuesday, December 21, 2021
Time: 2:00 PM Eastern Time (ET)
Dial-in number for US callers (toll-free): 877-407-8293
Dial-in number for U.S. and international callers (toll): +1 201-689-8349

To join the conference call online, please click here:
BioSig Webcast

A webcast replay will be available two hours after the event’s conclusion and archived for six months.

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 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 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
aballou@biosigtech.com
203-409-5444, x133

Source: BioSig Technologies, Inc.