Category: Health

Release – Tonix Pharmaceuticals Announces Oral Presentations Involving TNX-1500 (Fc-Modified Anti-CD40L mAb) at the International Congress of The Transplantation Society (TTS 2022)

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Research, News, and Market Data on TNXP

CHATHAM, N.J., Sept. 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced three oral presentations by academic collaborators at the 29th International Congress of The Transplantation Society (TTS 2022) being held September 10-14, 2022 in Buenos Aires, Argentina, and virtually. Copies of the presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.

Oral Presentation Details

Title:Long-term rejection free renal allograft survival with Fc-modified anti-CD154 antibody monotherapy in nonhuman primates
Date:Monday, September 12, 2022
Time:4:35 p.m. EDT (17:35 ART)
Session:Campfire Session: Models, mechanisms & therapies
PresenterGrace Lassiter, M.D., Research Fellow of the Kawai Lab
  
Title:Monotherapy with TNX-1500, a Fc-modified anti-CD154mAb, prolongs cardiac allograft survival in cynomolgus monkeys
Date:Tuesday, September 13, 2022
Time:3:25 p.m. EDT (16:25 ART)
Session:Mini-Oral Abstracts Session: Snap-shots of thoracic transplantation
PresenterKohei Kinoshita, M.D., Research Fellow of the Pierson Lab
  
Title:Long-term (>1 year) rejection/TMA free survival of kidney xenografts with triple xenoantigen knockout and multiple human transgenes in nonhuman primates
Date:Wednesday, September 14, 2022
Time:10:00 a.m EDT (11:00 ART)
Session:Mini-Oral Abstracts Session: Xenotransplantation
PresenterGrace Lassiter, M.D., Research Fellow of the Kawai Lab

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com 
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com 
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com 
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.Released September 6, 2022

Biotech and Pharmaceutical Companies How they are Different

Posted on by cpatches
Image Credit: Pixabay (Pexels)

The Differences Investors Should Know Between Biotech Companies and Pharmaceutical Manufacturers

In mid-June of this year, the stock market seemed to have changed. The oil sector that had been up for most of the year began trending down, and most other industries that had been hard hit began moving up in a mid-year “V” shape. The new leader replacing oil was biotech, which had been one of the hardest hit at the beginning of the year. It makes sense that biotech trades with its own cycles – it’s a very different sector. There is reason to believe that fundamentals favor the biotech sector now, below we discuss the nuances of these very interesting companies, and explain how they are different than other drug companies..

With biotech stocks, regulators, financiers, the highly educated, geniuses, technology, and investors all come together to help people in the most important way – life and health. For investors, it provides its own set of challenges, and at least two possible rewards. If an investor uncovers the stock that has the right mix of science, money and regulatory approval, they may not only cash in like few other sectors, but also be part of improving the health of generations to come.

Above, I did use the word “possible”. This is true of all stocks in all sectors, but the volatility in the biotech sector is a demonstration of the adage that for bigger potential rewards, one would have to increase their risk. Companies in this industry, often startups with great patents, burn through millions of dollars, often with zero earnings, and with any potential for earnings years off and contingent on being right about their science and the products it can provide. This means stock selection in biotech requires a deeper understanding of the company and potential for its work than in other sectors.


What’s included in the Biotechnology Sector?

Biotechnology focuses on novel drug development and clinical research aimed at treating diseases and medical conditions.

They are almost always unprofitable, and many have no revenue at all. In fact, some stock analysts would suggest that the main distinction between a biotech and a pharmaceutical company lies in profitability. Biotechnology is often characterized as being more research and development than manufacturing. They serve as incubators for the ideas that lead to the next “miracle” cures. But, drug development has a long development timeline. A successful candidate can take a decade or more to go from idea to available medicine. That’s if it is among the roughly 10% of prospective candidates that reaches approval for use.

Why would anyone invest in a company that is developing a pipeline of potential products that each have about a 10% chance of approval? Because breakthrough drugs, and the potential for breakthroughs, each step forward on the path toward approval often provides a huge upward move in the stock price. Even if not eventually approved. Conversely failure to move forward often comes with a rapid decline from disappointment.


Differences Between Biotech and Pharmaceuticals

There is a lot of overlap and a gray area between what is biotech and what is pharmaceutical. Here are some guidelines of where the differences often lay.

Biotechnology ventures tend to be more entrepreneurial pursuits with a lot on the line for the success of an idea, while pharmaceutical companies have an ongoing business and can better gauge and manage business risk. One reason is pharmaceutical companies often have a large diversified portfolio of approved drugs they market. They may also have drugs in various stages of research and development, but these costs are usually investments in future products using current revenue.

A biotechnology firm is often based on “new” science and driven to develop a useful and profitable application for the science. An example of a growing segment of biotech is biopharma which develops drugs originating living organisms.

Large pharmaceutical companies often pay stable dividends to shareholders, this is rare in companies that fall under the biotech umbrella, if there are earnings it may be reinvested in moving forward the study of drugs in development. Many biotechs’ strength is to explore and develop, not to market the successful result. Large pharmaceutical companies, like Johnson and Johnson (JNJ)or Eli Lilly (LLY) are marketing machines, they look to smaller biotech to be an incubator to keep their portfolio of products fresh.

The two industries also stand apart when it comes to valuation and business evaluation. Models and valuation derived from cash flow are quite relevant in assessing pharmaceutical stocks. While many analysts gamely attempt to construct discounted cash flow models for early-stage biotechs, the reality is that success is often thumbs-up or thumbs-down (“drug works” or “drug doesn’t work”).


The FDA Has Final Say

As the regulatory body that approves new drugs for the U.S. market, as well as issues permits for human clinical trials, the Food and Drug Administration (FDA) is the gatekeeper for every biotech firm. Investors should have some understanding of the FDA process and requirements or follow an analyst covering the sector that does. In order to get FDA approval, biotechs must establish a sufficient body of information that the drug is safe and effective. This is generally done through a series of at least three clinical trials.

If the trials meet the goals for safety and efficacy, the company files a request for approval called a New Drug Application (NDA). If the NDA is approved, the FDA sets the date a decision will be made by on the application.


Product Pipeline

A biotech’s pipeline is the future of the company. Investors focus a great deal on the number of entrants in the pipeline, the stages of study they are at, and the overall science, and competing products (if any). It’s critical to establish valuation forecasts.

Different biotech companies tend to operate in different stages of a product’s development. The stages are, most commonly, preclinical testing, enabling studies, clinical trials, and biologics licensing. A company that is focused on the early stage of research and development will conduct preliminary research to determine whether an idea may successfully be used against a disease or ailment. It attempts to answer, “can this technology become a product?”. This step requires translating the technology into a product. Preclinical testing is the phase of product development when a company must show that its proposed product is safe. They must also determine what the pharmacokinetics (PK) pharmacodynamics (PD) are. PK shows what happens to a drug once it enters the body, ie: how quickly its absorbed, distributed, metabolized, and excreted. Studies done for the express purpose of convincing the FDA to approve the start of clinical trials in humans are called Investigational New Drug (IND)-enabling.

Once a startup has received approval from the FDA to begin clinical trials for their product, they progress through a series of phases depending on how their product fares. These phases are:

Phase 1 This first trial’s main purpose is to determine that the product is safe for use in humans. The number of participants is kept as small as possible, and may be limited to patients who are farther along in a disease state or who have exhausted other options for treatment.

Phase 2 The second phase continues to confirm that the product is safe, but increases the number of participants and tries to determine the optimum dose and regimen.

Phase 3 Typically the last clinical trial phase and is designed to determine whether the treatment is truly effective, and is expanded to include enough people so the potential side effects are more likely to be captured in the data.

The biologics license application (BLA) is the process by which a biologic that has successfully completed clinical trials applies to the FDA to be sold to the public. A new drug application (NDA) is the same process, but for pharmaceuticals.


Take Away

Biotech investing can be very rewarding. Investors need to understand the company and the risks, and also the stage in the pipeline and the success of recent trials. Failed attempts by companies in this sector at devising the next wonder drug outnumber successes. One success may easily make up for some failures for investors.   With research into the company and even reliance on trusted analysts that specialize in biotechs, an investor can increase their chances of uncovering oversized profits. We encourage you, if you are not signed up for Channelchek and the research by Noble Capital Markets equity analysts delivered to your inbox each morning, to take the time and register with us now.


Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.universitylabpartners.org/blog/product-development-in-life-science

https://biotechhealth.com/biotech-vs-pharma/

https://www.qualio.com/blog/biotech-vs-pharma

Release – Baudax Bio Announces Closing of $6.2 Million Public Offering

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Baudax Bio Announces Closing of $6.2 Million Public Offering

Research, News, and Market Data on Baudax Bio

September 01, 2022 2:56pm EDT

MALVERN, Pa., Sept. 01, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the closing of its previously announced public offering of an aggregate of 11,819,172 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock purchase warrants, at a public offering price of $0.525 per share (or pre-funded warrant) and accompanying warrants. Each share of common stock (or pre-funded warrant) was sold in the offering together with a Series A-1 warrant to purchase one share of common stock at an exercise price of $0.525 per share and a Series A-2 warrant to purchase one share of common stock at an exercise price of $0.525 per share. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants are exercisable immediately and will expire thirteen months from the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $6.2 million. The Company intends to use the net proceeds from this offering for pipeline development activities and general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-266499), which was declared effective by the Securities and Exchange Commission (the “SEC”) on August 29, 2022. The offering was made only by means of a prospectus which is a part of the effective registration statement. A final prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at 
placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs.

Forward Looking
Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding market conditions and the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Investor Relations
Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com 


Primary Logo

Source: Baudax Bio, Inc.

Released September 1, 2022

 


Release – Onconova Therapeutics to Present at the H.C. Wainwright 24th Annual Global Investment Conference

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Onconova Therapeutics to Present at the H.C. Wainwright 24th Annual Global Investment Conference

News and Market Data on Onconova Therapeutics

NEWTOWN, Pa., Sept. 01, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will be participating virtually in the H.C. Wainwright 24th Annual Global Investment Conference, which is taking place in a hybrid format at the Lotte New York Palace Hotel.

A corporate overview presented by Steven Fruchtman, M.D., President & CEO of Onconova, will be available on-demand beginning on Monday, September 12, 2022, at 7:00 a.m. ET. The presentation can be viewed here or on the “Corporate Events and
Presentations” section of the Onconova website and will be archived for 90 days. Dr. Fruchtman and other members of the Onconova management team will also be available for virtual one-on-one meetings through the conference from September 12 – 16, 2022. Those interested in requesting a meeting should contact their H.C. Wainwright representative. 

About
Onconova Therapeutics, Inc.

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-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored 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.

Company
Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680

ir@onconova.us
https://www.onconova.com/contact/

Investor
Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200

bmackle@lifesciadvisors.com

 


Release – Ocugen Appoints Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA, as Chief Medical Officer and Promotes Arun Upadhyay, PhD, to Chief Scientific Officer

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Ocugen Appoints Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA, as Chief Medical Officer and Promotes Arun Upadhyay, PhD, to Chief Scientific Officer

Research, News, and Market Data on Ocugen

September 1, 2022

MALVERN, Pa., Sept. 01, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the appointment of Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA, as Chief Medical Officer. Arun Upadhyay, PhD, previously Senior Vice President, Research & Development, will now serve as the Company’s Chief Scientific Officer, overseeing the development and manufacturing of Ocugen’s clinical and commercial product portfolio and evaluating new technologies.

“We are extremely pleased to have Dr. Hopkins driving our clinical programs as his expertise across the industry along with his work at the U.S. Food and Drug Administration, and the Biomedical Advanced Research and Development Authority will provide us with tremendous insights in bringing innovative solutions to patients,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

“Dr. Upadhyay has been invaluable in establishing Ocugen’s unique modifier gene delivery platform and collaborating with our partner Bharat Biotech in the development of COVAXIN™,” said Dr. Musunuri. “It’s truly been a pleasure working alongside him for the past several years, and we look to his scientific leadership to deliver new breakthroughs in medicine.”

Dr. Hopkins has more than 25 years’ experience as a physician and clinical researcher. In addition to his work in government organizations, he has held senior level positions at Merck Research Labs, DynPort Vaccine Company, Emergent BioSolutions, and Aeras. He has developed and commercialized multiple vaccine and therapeutic products, Phases 1 through 4. Prior to joining Ocugen, he was the Chief Medical Officer at Adaptive Phage Therapeutics where he oversaw regulatory affairs, clinical development, and clinical operations.

“I look forward to bringing my vaccines and therapeutics experience to Ocugen,” said Dr. Hopkins. “It’s imperative that we provide additional options in the fight against COVID-19, as well as deliver new gene and cell therapies to address unmet medical need.”

Dr. Upadhyay has spent more than 20 years in discovery research and innovation developing novel therapeutic modalities and drug-delivery technologies. He has been leading nonclinical, early-to-late-stage global product development and manufacturing, bioanalyses, and clinical trial supply management. Dr. Upadhyay has led multiple successful regulatory submissions in the U.S. He has worked extensively in drug development—ranging from small molecules to biologics, and advanced cell and gene therapy modalities. Prior to joining Ocugen, he led ophthalmic drug development and delivery research at the University of Colorado Denver in the Department of Pharmaceutical Sciences. There, Dr. Upadhyay was instrumental in developing novel approaches for sustained and targeted drug delivery of peptides, proteins, RNA, and DNA to cells and tissues. Dr. Upadhyay also led engineering of polymeric micro and nano carriers’ system of vaccine antigens to enhance immunogenicity and protective immunity.

“I’m excited to expand my role at Ocugen and lead our R&D and manufacturing teams to advance our product pipeline and evolve the Company in gene therapy and regenerative medicine,” said Dr. Upadhyay.

Dr. Hopkins and Dr. Upadhyay are part of Ocugen’s leadership team, reporting directly to the Chief Executive Officer.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

 

 


Catalyst Series – Lineage Cell Therapeutics (LCTX)

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This is Catalyst – a new short-form video series that asks senior executives the questions investors want answered. Exclusively on Channelchek. Brian Culley, CEO of Lineage Cell Therapeutics provides an update on the company’s OpRegen program for the treatment of dry age-related macular degeneration and answers questions regarding the latest developments with Lineage’s OPC1 program for spinal cord injury, and how they are managing in the current challenging biotech environment. All in less than three minutes.

Research, News, and Advanced Market Data on LCTX

Baudax Bio (BXRX) – Priced Common Offering; Reducing Price Target

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Wednesday, August 31, 2022

Baudax Bio (BXRX)
Priced Common Offering; Reducing Price Target

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Priced $6.2 million offering. Late Monday, Baudax announced the pricing of its public offering. The offering of 11.819 million shares of common or pre-funded warrants at a public offering price of $0.525 per share were sold as a unit. Each share or warrant unit included a Series A-1 warrant to purchase one share at $0.525, and a Series A-2 warrant to purchase one share at $0.525.  The Series A-1 warrant is exercisable immediately with a 5 year expiration, while the Series A-2 warrant expires 13 months from date of issuance. The gross proceeds of the offering, expected to close on or about September 1st, are around $6.2 million. Baudax intends to use the net proceeds from the offering for pipeline development activities and general corporate purposes.

Pricing is at depressed levels.  While funding needs were anticipated, the Baudax offering of common shares and warrants are coming near all-time lows.  The common stock price, at the $0.525 offering level, has declined 31% since the Q2 financials were released August 11th. …

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. 

Fireside Chat Replay – Lineage Cell Therapeutics (LCTX) CEO Brian Culley

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Lineage Cell Therapeutics CEO Brian Culley is joined by Noble Capital Markets Senior Research Analyst Robert LeBoyer for a Q & A session featuring questions asked by the live audience throughout the event.

Research, News, and Advanced Market Data on LCTX


Information on upcoming live virtual roadshows


Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Release- BioSig Strengthens Marketing and Sales Teams, Appoints National Account Executives to Scale Commercial Growth

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BioSig Strengthens Marketing and Sales Teams, Appoints National Account Executives to Scale Commercial Growth

News and Market Data on BioSig Technologies

August 30, 2022

Westport, CT, Aug. 30, 2022 (GLOBE NEWSWIRE) —

  • Company increases sales
    efforts and strategy, adds new National Account Executives to accelerate
    commercial growth
  • Strengthens marketing
    team with new marketing and communications programs highlighting
    competitive market advantage

 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that it has expanded its marketing and sales teams to scale and support the national commercial rollout of its PURE EP™ System.

BioSig recently doubled the size of its sales organization, with plans of tripling it before the fourth quarter of this year. The Company appointed a new team of National Account Executives who will be strategically located throughout the U.S. to support and accelerate sales growth and adoption of the PURE EP™ System. The new sales executives will expand the Company’s growing commercial pipeline, as it continues to see an increase in medical centers entering into 60-day evaluation agreements for its novel signal processing technology.

Additionally, BioSig has expanded its marketing team, with investment in top-tier industry talent that will help drive and enhance the Company’s brand equity and awareness to better reflect the Company’s values. These new efforts include a fully integrated marketing and communications strategy that will support the commercial team and should provide the tools to increase BioSig’s competitive position in the market.  

“As a growing enterprise, we are dedicated to sourcing, developing, and retaining the best talent for our company. I view our recent investment in our commercial, sales, and marketing teams as a complimentary catalyst for BioSig’s new commercial strategy and longterm growth. We are thrilled to have attracted these outstanding industry leaders, and look forward to leveraging their wealth of knowledge and expertise,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

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 novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights. The Company is in a national commercial launch of the PURE EP™ System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  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(T.M.) signals over conventional sources.

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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) 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.


Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 

Primary Logo

Source: BioSig Technologies, Inc.

Released
August 30, 2022

Release – Baudax Bio Announces Pricing of $6.2 Million Public Offering

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Baudax Bio Announces Pricing of $6.2 Million Public Offering

Research, News, and Market Data on Baudax Bio

August 29, 2022 10:04pm EDT

MALVERN, Pa., Aug. 29, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the pricing of its public offering of an aggregate of 11,819,172 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock purchase warrants, at a public offering price of $0.525 per share (or pre-funded warrant) and accompanying warrants. Each share of common stock (or pre-funded warrant) was sold in the offering together with a Series A-1 warrant to purchase one share of common stock at an exercise price of $0.525 per share and a Series A-2 warrant to purchase one share of common stock at an exercise price of $0.525 per share. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants are exercisable immediately and will expire thirteen months from the date of issuance. The closing of the offering is expected to occur on or about September 1, 2022, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $6.2 million. The Company intends to use the net proceeds from this offering for pipeline development activities and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-266499), which was declared effective by the Securities and Exchange Commission (the “SEC”) on August 29, 2022. The offering is being made only by means of a prospectus which is a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About
Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs.

Forward
Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding market conditions, the satisfaction of the closing conditions of the offering and the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com  

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com 


Primary Logo

Source: Baudax Bio, Inc.

Released
August 29, 2022


Catalyst Series – BioSig Technologies (BSGM)

Posted on by Admin

Introducing Catalyst – a new short-form video series that asks senior executives the questions investors want answered. Exclusively on Channelchek. Gray Fleming, BioSig Technologies’ Chief Commercial Officer answers questions regarding innovation in Electrophysiology, technological advancements that benefit physicians, clinical data of the company’s proprietary system, PURE EP, and software enhancements contributing to procedural timesaving. All in less than four minutes.

Research, News, and Advanced Market Data on BSGM

Treating Chronic Heavy Drinkers with Hallucinogens – Results are More than Promising

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Image Credit: Cottonbro (Pexels)


Psilocybin-Assisted Psychotherapy vs. Placebo in the Treatment of Adult Patients With Alcohol Use Disorder

“Psilocybin administered in combination with psychotherapy produced robust decreases in the percentage of heavy drinking days compared with those produced by active placebo and psychotherapy.” This is the result of a study designed to see if the ingredient in “magic mushrooms,” coupled with therapy, curbs drinking in adults with alcohol use disorder. The study, published in JAMA Psychiatry, said drinking was curbed for at least eight months, and nearly half the participants receiving psilocybin stopped drinking entirely. 


Introduction

Psilocybin and other classic psychedelics to treat neuropsychiatric conditions have been experiencing a resurgence in study not seen since the 1960s. Alcohol use disorder (AUD) is considered a particularly promising target for treatment with psychedelics. Six clinical trials published between 1966 and 1971 demonstrated that participants with alcohol dependence treated with lysergic acid diethylamide (LSD) showed signs of remission during follow-up nearly twice as often as those not treated. Picking up on this line of research, after more than 40 years, a study published in 2015 demonstrated that moderately high doses of psilocybin (21 to 28 mg/70 kg) were well tolerated by participants with alcohol dependence, and large reductions in drinking were observed over a 32-week follow-up period.

Offering additional proof-of-concept, a multisite randomized clinical trial evaluated the efficacy of psilocybin-assisted psychotherapy for the treatment of AUD. The outcomes of the double-blind trial were reported on August 24 in a peer-reviewed journal for clinicians; highlights of the study appear to confirm earlier studies.

 

Method of Study

Men and women, 93 in all, between the ages of 25 and 65, that were being treated for AUD participated in the multiyear study. Roughly half of the participants took one psilocybin pill, followed by another a month later. The remaining participants served as a control group and were unknowingly administered a placebo (Benadryl).

Prior to the first medication/placebo dose, participants had up to a dozen counseling sessions given by a pair of psychotherapists. The therapists worked to help the participants set objectives to minimize their alcoholic drinks and to help them navigate what could be very emotional psilocybin experiences.

The study was originally designed to randomize up to 180 participants. However, following an indefinite mandatory suspension of recruitment beginning on March 19, 2020, due to the outbreak of COVID-19, enrollment for this trial was halted at 95 randomized participants.


Participants

Participants were recruited from March 12, 2014, to May 13, 2015, at the University of New Mexico and from July 9, 2015, to March 19, 2020, at New York University, using advertisements in local media. The 25 to 65-year-olds had a diagnosis of alcohol dependence determined by the Structured Clinical Interview and had at least four heavy drinking days during the 30 days prior to screening (defined as five or more drinks in a day for a man and four or more drinks in a day for a woman). Excluded were those with major psychiatric and drug use disorders, any hallucinogen use in the past year or more than 25 lifetime uses, medical conditions that contraindicated either of the study medications, use of exclusionary medications, and current treatment for AUD.


Trial Design

Qualifying participants were assessed at screening, baseline (week 0), and weeks 4, 5, 8, 9, 12, 24, and 36. They were randomly assigned to receive either psilocybin or Benadryl (diphenhydramine), administered in two 8-hour sessions at weeks 4 and 8. All participants who completed the double-blind observation period (weeks 5 to 36) and still met safety criteria were offered an open-label psilocybin session at week 38, including four additional psychotherapy sessions and assessment for an additional 18 weeks.

Participants received up to a total of $560 for completing assessments in the course of the trial but were not reimbursed for attending the therapy and medication sessions.

 

Randomization and Blinding

Randomization was stratified by site. A study pharmacist at each site generated the randomization sequence and assigned treatment in order of randomization. All other study staff and investigators, as well as participants, were blind to treatment assignment.


Image: Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder (JAMA Network


Dosage

Study medication was taken orally in a single capsule of unvarying appearance and weight. Psilocybin doses were weight-based to control for participant body weight. Doses for the first session were psilocybin, 25 mg/70 kg, or diphenhydramine, 50 mg. Participants received an increased dose in the second session if there were no dose-limiting adverse events and if they agreed to the increase. The increased dose of psilocybin was 30 mg/70 kg if the participant’s total score on the Pahnke-Richards Mystical Experience Questionnaire (MEQ)42 was 0.6 or greater in the first session (indicating a robust subjective response to the 25 mg/70 kg dose) or 40 mg/70 kg if the MEQ total score in the first session was less than 0.6. The increased dose of diphenhydramine was 100 mg regardless of subjective response.

 

Administration of Study Medication

Psilocybin was administered in the morning; participants were required to stay in the session room with the therapists for at least 8 hours after. During the session, participants were encouraged to lie on a couch wearing eyeshades and headphones, providing a standardized playlist of music. Other medications were available in the session room to treat hypertension, severe anxiety, or psychotic symptoms as specified in the protocol.

Blood pressure and heart rate were measured at 30- to 60-minute intervals during the first 6 hours of each session. After each, participants and therapists were asked to guess which medication had been administered and rate their degree of certainty on a 100-point visual analog scale (0?=?not at all confident; 100?=?extremely confident). This uncovered a flaw in the study as Benadryl was ineffective in maintaining the blind intention after drug administration, so biased expectancies could have influenced results.


Outcome

The primary alcohol consumption outcome was measured as the percentage of heavy drinking days during weeks 5 to 32. Drinking was assessed at weeks 8, 12, 24, and 36 using the timeline follow-back method. One standard drink was defined as 14 g of ethanol. Secondary outcomes included the percentage of drinking days, mean drinks per day, and dichotomous outcomes. Hair or fingernail samples were collected at week 24 and assayed for ethyl glucuronide (EtG) concentration to confirm self-reported abstinence.

There were 204 reported adverse events (119 in the psilocybin group and 85 in the Benadryl group) during the 32 weeks following the first administration of the study medications. Three serious adverse events were reported, all in the Benadryl group. One participant had two psychiatric admissions due to suicidal ideation during binge drinking episodes. Another participant was hospitalized for a Mallory-Weiss tear due to severe vomiting during a binge drinking episode.


Psilocybin in the US

There is a growing cry to take psychedelics medically mainstream. The federal government appears to be moving forward to unwind some strict prohibitions on psychedelic research. In May, the Substance Abuse and Mental Health Services Administration released a letter saying that the agency now agrees that psychedelics hold promise in psychiatric care. It is exploring the creation of a task force to assess how the medicines could be used safely in clinical settings.

In the U.S. nearly 15 million people age 12 or older have AUD, according to the 2019 National Survey on Drug Use and Health.

 

Take Away

Participants suffering from problem drinking were given psilocybin along with psychotherapy. The result of the study medication was a robust and sustained decrease in drinking. These results support further study of psilocybin-assisted treatment for adults with AUD.

A recent NobleCon investor event featured a panel presentation with representatives of related fields discussing both regulatory reform and the results of their treatments and studies. There were also panel presentations from the management of companies providing promising treatments from once taboo sources. Click on links below (Suggested Content) to watch these presentations.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content



PsyBio Therapeutics (PSYBF) NobleCon18 Presentation Replay

Psyched Wellness (PSYCF) NobleCon18 Presentation Replay




Wesana Health (WSNAF) NobleCon18 Presentation Replay

Mental Wellness: Psychedelics? NobleCon18, Panel Replay


Sources

JAMA
Clinical trial Protocol

https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2795625

https://www.wsj.com/articles/psychedelic-compound-in-magic-mushrooms-shows-new-promise-as-alcohol-addiction-treatment-11661354909?mod=Searchresults_pos1&page=1

https://cde.drugabuse.gov/instrument/d89c8e23-16e5-625a-e040-bb89ad43465d

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Release – BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

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BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

News and Market Data on BioSig Technologies

August 24, 2022

Westport, CT, Aug. 24, 2022 (GLOBE NEWSWIRE) —

  • Leading Medical Center
    of Excellence adds second PURE EP™ System for evaluation, broadening
    physician access to the Company’s signal processing technology
  • PURE EP™ is now being
    evaluated at both Main and Fairview campuses of Cleveland Clinic’s Heart,
    Vascular & Thoracic Institute 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that it has installed a second evaluation system at the Cleveland Clinic. The additional installation will support the medical center’s clinical evaluation of the PURE EP™ System and expand physician access to the Company’s signal processing technology. 

“I am pleased to see the growing interest and demand for our technology at The Cleveland Clinic. The additional unit will enable more physicians the opportunity to experience the superior signal quality of the PURE EP™ System on a broad range of cases.” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

Consistent with its stated national commercial strategy, the Company’s customer-centered approach aims to maximize the clinical value and deployment of the PURE EP™ System which has gained interest in several electrophysiology labs in the Midwest. The Company recently expanded its clinical footprint in Illinois with an additional evaluation agreement at a leading medical center in Springfield, the state capital.

Looking ahead, BioSig will serve as a partner at the upcoming Cleveland Clinic Global EP Summit 2022, due to take place this coming September. This annual forum convenes over 40 global experts and highlights the latest practice insights across the spectrum of electrophysiology care.

 

About
Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. As a leader in arrhythmia treatment and diagnosis, Cleveland Clinic medical centers include state-of-the-art electrophysiology laboratories, world-class physicians and researchers, and the latest cutting-edge technologies and protocols deployed for the treatment of heart abnormalities. To learn more, visit clevelandclinic.org.

 

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 novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights. The Company is in a national commercial launch of the PURE EP™ System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  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(T.M.) signals over conventional sources.

 

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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) 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.


Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 

Primary Logo

Source: BioSig Technologies, Inc.

Released
August 24, 2022