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Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment

NLS Pharmaceutics

NLS Pharmaceutics Ltd. (Nasdaq: NLSP”) (“NLS”) and Kadimastem Ltd. (“Kadimastem”), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, in collaboration with iTolerance Inc. (“iTolerance”), a U.S. based regenerative medicine company, announced today the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration (“FDA”) on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem’s allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance’s immunomodulator (iTOL-100). Kadimastem and iTolerance believe that the completion of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development Foundation. iTOL-102 was evaluated at the fast-track center for testing at the Diabetes Research Institute (“DRI”) at the University of Miami School of Medicine, where it was designated as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with full compatibility between IsletRx cells and iTOL-100. Prior to the meeting with the FDA, Kadimastem and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical development plans. This guidance is instrumental in moving forward with the next stages of development. Based on the feedback provided at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a First-in-Human clinical trial. Kadimastem believes its collaboration with iTolerance signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting regulatory approvals for commercialization of a potential cure for type 1 diabetes. iTOL-100 is an immunomodulatory microgel technology being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem’s IsletRx human stem cell-derived islets. Kadimastem’s IsletRx is a clinical-grade product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “I believe that the feedback from the FDA is a critical milestone in the development of iTOL-102, and we are encouraged by their support for our innovative approach to treating Type 1 diabetes. We believe that the successful outcome of this meeting validates our commitment to bring a game-changing therapy to patients, one that could ultimately eliminate the need for chronic life-long immunosuppression. We look forward to continuing our collaboration with Kadimastem and working closely with the FDA.” Alex Zwyer, CEO of NLS, commented, “I believe that the news demonstrates the strength of the proposed merger of NLS and Kadimastem and its technology platform to build a healthy, strong merged company that will benefit shareholders.” Kadimastem Executive Chairman and CEO Ronen Twito said, "The promising results from the fast-track center for testing at the DRI, combined with the comprehensive studies conducted by iTolerance and Kadimastem, enabled us to complete this important milestone. We are working closely with the FDA on the necessary steps needed to implement this potential innovative technology for patients with Type 1 diabetes and demonstrate a novel islet cell transplantation approach with no need for immunosuppression.” About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). About iTolerance, Inc. iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islet to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com. We are a clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs. This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS and Kadimastem are using forward-looking statements when they discuss the belief that the results of the pre-IND meeting with the FDA demonstrates the strength of the proposed merger; that the meeting with the FDA is a significant milestone in the development of iTOL-102, and the expected benefits of iTOL-102 in the treatment of diabetes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: risks related to the companies’ ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies’ products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; the companies’ patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or both of the companies; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, neither Kadimastem nor NLS undertakes any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading “Risk Factors” in NLS’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”), which is available on the SEC’s website, www.sec.gov, and in subsequent filings made by NLS with the SEC, including under the heading “Risk Factors” in NLS’s registration statement on Form F-4, filed with the SEC on December 27, 2024. This press release may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under Kadimastem’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the company's activity, as well as developments in the general environment and external factors affecting the company's activity. The company's results and achievements in the future may differ materially from any presented herein and the company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This press release does not constitute a proposal to purchase the company's securities or an invitation to receive such offers. Investment in securities in general and in the company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. No Offer or Solicitation: This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information about the Transaction and Where to Find ItIn connection with the proposed transaction, NLS has filed a Registration Statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or any other document that NLS may file with the SEC. The proxy statement (if and when available) will be mailed or delivered to shareholders of NLS and Kadimastem. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus (if and when available) and other documents containing important information about NLS and Kadimastem and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on NLS’s website at www.nlspharma.com. Participants in the Solicitation: NLS, Kadimastem, and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NLS and Kadimastem shareholders in respect of the proposed transaction. Information about the directors and executive officers of NLS, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in NLS’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on May 15, 2024. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above. Contact Details NLS Pharmaceutics Ltd. NLS Pharmaceutics Ltd. +41 44 512 21 50 contact@nls-pharma.com Kadimastem Ltd. Sarah Bazak +972 73-797-1615 s.bazak@kadimastem.com Company Website https://nlspharmaceutics.com/

February 25, 2025 07:00 AM Eastern Standard Time

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NAVEX One: The Trusted Partner for NIS2 Risk Alignment

NAVEX Global

NAVEX, the global leader in integrated risk and compliance management software, is pleased to offer the first GRC solution to holistically address NIS2 across training, policies and assessment – all on one platform, NAVEX One. NAVEX continues to provide risk and compliance professionals with the tools they need to align with the latest cybersecurity regulations. As organizations face increasing regulatory demands, NAVEX One integrates policy management, training and risk assessment resources to ensure seamless compliance with the European Union’s Network and Information Security Directive (NIS2). The NIS2 Directive raises the bar for cybersecurity and reporting standards across industries, including banking, healthcare, manufacturing and energy. Organizations must not only comply with these heightened regulations but also ensure their cybersecurity frameworks are strong enough to withstand evolving threats. “NIS2 is a critical milestone in cybersecurity regulation, and organizations need a partner that helps them do more than just check the compliance box,” said A.G. Lambert, chief product officer at NAVEX. “NAVEX One empowers compliance and risk professionals to build a sustainable and proactive approach to cybersecurity, ensuring their programs are compliant and resilient against emerging threats.” NAVEX One serves as an essential tool in the journey toward risk and compliance maturity, helping organizations: Conduct proactive risk assessments to identify and mitigate vulnerabilities Centralize and streamline policy management to meet regulatory expectations Strengthen cybersecurity posture with comprehensive security awareness training Stay ahead of evolving cybersecurity requirements through continuous program improvement and board-ready reporting Extend training, policies and cyber risk practices to align third parties with its cyber risk standards “Organizations today require more than just static risk and compliance checklists—they need dynamic, integrated solutions that evolve with regulatory changes and emerging risks,” said Kyle Martin, vice president of risk solutions at NAVEX. “NAVEX One’s content and capabilities give businesses the confidence to proactively address NIS2 requirements while reinforcing their broader risk management strategies.” By integrating these capabilities within a single platform, NAVEX One simplifies compliance, reduces risk exposure, and supports organizations in building future-proof compliance programs. Click here, for more information on NAVEX One and the NIS2 Directive. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Navex Global scott.levesque@navex.com Company Website https://navex.com

February 18, 2025 12:50 PM Eastern Standard Time

SBC Medical (NASDAQ: SBC) Announces New Translation App After Zacks & Sidoti Initiate Coverage, Emphasize Strong Growth

Benzinga

By Gerelyn Terzo, Benzinga With a potential Goldilocks setup in the economy being encouraged in part by a resilient consumer, the broader stock market was hovering near record territory toward the end of last year. Not to be outdone, healthcare-related companies have also been rallying, as evidenced by a gain of almost 20% in the S&P 500 Health Care Sector Index over the past 12 months. One of the stocks that has captured the attention of Wall Street of late is Tokyo-based SBC Medical Group (NASDAQ: SBC), a fast-growing service provider in the burgeoning medical aesthetics market that trades on Nasdaq. Most recently, Zacks Small-Cap Research (SCR) and Sidoti & Company have initiated coverage on the stock. In the October report, Zacks emphasized SBC Medical Group’s expansion efforts comprising both mergers and acquisitions, and organic growth, owing to a growing franchisee network and revenue base buttressed by a strong balance sheet. SBC Medical has been an early mover in Japan’s aesthetic medicine market, which according to the analyst firm, serves as a tailwind for future growth. Zacks SCR believes SBC Medical has “significant value.” Investors who are looking to back a leader in the medical innovation space can learn more about the opportunity in SBC Medical stock here. SBC Medical’s Growing Revenue Chief among the catalysts for the outlook in the report is SBC Medical’s strong reported revenue growth. The company’s revenue has been growing year-over-year, increasing from $174 million in 2022 to $194 million in 2023. Total revenues for the nine months ending Sep. 30, 2024 were $160 million, representing an increase of 23% from $131 million in the same period of 2023, SBC said. As a franchisor, SBC Medical has been growing its footprint amid a rising number of clinics in its vast network that contribute royalty revenue. In addition to Japan, the company also operates clinics in Los Angeles and Ho Chi Minh City, Vietnam, and has set its sights on a global expansion. SBC Medical is also operating in the black, reporting that with net income for the nine months ending Sep. 30, 2024 of $40.1 million, compared to $24.3 million in the same period of 2023. The company’s performance is being fueled by rising royalty income and other revenue streams with high gross margins, it says. Capitalizing On Medical Tourism For New Revenue Opportunities In 2025 The company has announced numerous initiatives to enhance its revenue streams in order to continue to grow its business both domestically and internationally. In January, SBC announced the launch of its proprietary translation app tailored for medical aesthetics staff and the full-scale implementation of its Inbound-Focused Clinics initiative. SBC says this move is designed to address the growing demand for medical tourism and to ensure that international patients can seamlessly experience Japan's advanced medical aesthetic treatments. Within Asia, rising awareness of aesthetic care and the increasing appeal of medical tourism are positioning countries like Japan, South Korea, and Thailand as top destinations for international patients, SBC notes. In Japan, the influx of foreign patients seeking high-quality medical aesthetics continues to rise. SBC alone says it welcomes over 10,000 inbound patients annually, with inquiries surpassing 20,000 each year. China remains a key market driver, though demand from English-speaking regions is also on the rise, the company says. Recognizing this trend, SBC says it is scaling up its operational capacity and implementing innovative solutions to support sustainable growth in this dynamic sector. Striving To Shift Communication With A Specialized Translation App To address language barriers, SBC has developed a translation app tailored specifically for medical aesthetics. It says the app ensures the accurate translation of specialized terminology, facilitating seamless communication between clinic staff and international patients. Currently supporting English and Chinese, the app plays a pivotal role in enabling smooth consultations and pre-treatment explanations. By creating a welcoming environment where language is no obstacle, SBC says it is empowering patients to feel secure and confident in their treatment choices. Future plans include expanding the app's language capabilities and rolling it out across all clinics nationwide, ensuring comprehensive accessibility for a global clientele, SBC noted. SBC Medical’s Valuation: Opportunities And Risks Zacks SCR pointed out that the medical aesthetic market is one that lacks direct competitors despite some companies offering similar services to SBC Medical. As a result, it is difficult to make apples-to-apples comparisons on the stock valuation as analysts typically do. In response, the Zacks analyst has taken a subset of the medical aesthetics space specializing in the healthcare sector to determine a fair valuation. The estimate is contingent upon the company executing on its growth plans as well as a broadening of its initiatives. Zacks SCR is encouraged by SBC Medical’s engagement with the industry, as evidenced by its participation in the Aesthetic Surgery and Laser Society (ASLS) aesthetic medicine conference in Korea held earlier this year. The firm also mentioned SBC Medical’s recently inked partnership with Tokyo-based technology provider B4A, which provides high-tech business solutions. SBC Medical’s mettle was tested amid a business combination with Pono Capital Two, a deal that was completed in Septemb er 2024, paving the way for the stock’s debut on Nasdaq. When it comes to investing, there are no sure things. Zacks SCR and Sidoti have also outlined potential risks that investors might consider. Among them is the uncertain nature of the wider aesthetic medical industry, which is heavily dependent on emerging technology for its growth. SBC’s international presence presents a foreign exchange risk since Its businesses are transacted in Japanese yen but translated into U.S. dollars for reporting purposes, a dynamic that has affected the company’s year-to-date financial performance in 2024. Investors who believe that the benefits outweigh the risks in SBC Medical’s stock can dive deeper into some of the company’s latest developments and offerings here. Featured photo by nattanan23 on Pixabay Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 07, 2025 08:35 AM Eastern Standard Time

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Cognition Therapeutics Presents Phase 2 Results For Drug To Fight DLB At International Conference

Benzinga

By Meg Flippin, Benzinga Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders including dementia with Lewy bodies (DLB), had the opportunity to raise awareness about its experimental drug zervimesine (CT1812) when the company presented trial results in a podium presentation at the International Lewy Body Dementia Conference (ILBDC). The eighth International Lewy Body Dementia Conference, held in Amsterdam last week, drew an international audience of advocates, scientists and physicians looking for ways to fight this debilitating disease. Zervimesine is an experimental, orally delivered small molecule oligomer antagonist designed to treat this progressive form of dementia. Cognition Therapeutics recently reported positive topline results of its exploratory phase 2 SHIMMER study for the drug, announcing zervimesine produced strong therapeutic responses across behavioral, functional, cognitive and movement measures in patients with DLB. “Older adults with DLB are often placed in care facilities not because of memory issues, but due to the severity of neuropsychiatric or motor symptoms that overwhelm their caregivers,” said James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, who was the study director for SHIMMER. “Patients on zervimesine had fewer cognitive fluctuations and showed better motor control than placebo-treated patients. The results from this exploratory phase 2 trial demonstrated zervimesine could have a meaningful, positive impact on DLB patients across multiple measures of cognitive, behavioral, movement and functional performance, potentially enabling people with DLB to live at home with the assistance of their care partners.” DLB Drug Holds Promise DLB is a progressive form of dementia characterized by symptoms that fluctuate in severity and can be difficult to diagnose early. It can cause people to have hallucinations, delusions and anxiety as well as cognitive declines that impair their thinking and reasoning. It can cause uncontrollable changes in alertness, sleep disruptions, tremors and slow movement. DLB impacts about 1.4 million people in the U.S. and is the costliest form of dementia. The double-blind, placebo-controlled phase 2 SHIMMER study had 130 adults enrolled who were evenly divided into groups that received either a placebo or a daily dose of zervimesine for six months. Cognition Therapeutics reported the study met its primary endpoint of safety and tolerability. As presented at ILBDC, zervimesine-treated DLB patients scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI) A-L at the end of the study. This tool describes the frequency and severity of 12 separate behavioral symptoms. The impact on the NPI scale in the SHIMMER trial means that patients receiving zervimesine had fewer or less severe hallucinations and delusions and less anxiety and agitation than placebo-treated patients, the company noted. These symptoms are a hallmark of DLB and can be debilitating for patients. The improvement in these behavioral symptoms was measured not only for patients but also their care partners, who reported improvements in their levels of distress caused by these symptoms. Patients, Caregivers Benefit From Zervimesine Patients who received zervimesine also preserved 52% more of their ability to care for themselves, measured by the activities of daily living (ADCS-ADL) scale, compared to those taking the placebo. Cognition said this was likely due to the improvements in behavioral symptoms as well as a 91% reduction in cognitive fluctuations in zervimesine-treated patients. Cognitive fluctuations are another hallmark of DLB and are described as a non-responsive state that can occur suddenly and last for hours. The person experiencing the fluctuation may or may not be aware that it is happening. On top of all that, the company said that based on trial results, zervimesine treatment allowed patients to maintain 62% better motor function – including gait, balance and tremors – than those on the placebo. “Dr. Galvin’s presentation is an important opportunity to educate an international audience of advocates, scientists and physicians about the impressive efficacy signals that were observed in participants treated with zervimesine (CT1812),” said Anthony O. Caggiano, MD, PhD, Cognition’s CMO and head of R&D. “The improvement we observed across behavioral, cognitive, functional and motor symptoms in zervimesine-treated participants suggest a broad and meaningful impact on their daily lives. These results reinforce zervimesine’s potential to address the complex and debilitating symptoms of this disease.” Featured photo by Pawel Czerwinski on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 06, 2025 09:00 AM Eastern Standard Time

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New Prostate Cancer Hope? Bayer-Funded Phase 2 Study To Test Combination Of RedHill's Opaganib And Bayer’s Darolutamide, To Overcome Androgen Resistance

Benzinga

By Meg Flippin Benzinga It is often said that, “Prostate cancer is the cancer you die with, not because of,” but according to RedHill Biopharma (NASDAQ: RDHL), based on data published in Frontiers in Public Health, around 400,000 men a year worldwide would probably disagree with that statement. With global prevalence set to double to 2.9 million cases a year by 2040, early detection of prostate cancer (PC) often leads to a favorable outcome, with many patients thankfully responding very well to treatment. However, RedHill says around 20% of men with prostate cancer will either not respond to the current standard of care androgen receptor signaling inhibitor therapies, or will become resistant to these drugs, and will advance to a point where current treatments offer no additional hope. Patients who develop what is known as metastatic castrate-resistant prostate cancer (mCRPC) and are not responsive to hormone therapy, are left with virtually no treatment options. Invariably, they will go on to die from their cancer, the company says. But potentially, there may be some hope thanks to a clinical collaboration, funded by Bayer AG (ETR: BAYN), a large global pharma company, and the Ramsay Hospital Foundation, between RedHill, Bayer and Australian cancer researchers. The collaboration will involve a study to test the potentially enhancing effect of RedHill’s treatment, opaganib, in combination with Bayer’s darolutamide, in overcoming resistance to androgen receptor pathway inhibition (ARPI) treatment. First approved in 2021, and now approved in more than 80 countries, Bayer’s darolutamide was the fastest -growing androgen receptor blocker in the U.S. and continues to enjoy a strong growth trajectory, with sales in 2024 almost doubling 2023’s numbers. With more positive clinical data unveiled last year, and the expectation of additional approvals in more markets and across more prostate cancer indications, Bayer expects sales of darolutamide to peak at around $3 billion a year – potentially making it one of the most successful drugs in the prostate cancer space. Treating Advanced Stage Prostate Cancer A major driver of prostate cancer is androgen receptor signaling, which is why using chemical castration or androgen deprivation therapy has become a standard care treatment. Unfortunately, patients with advanced PC, and in particular those who have already progressed to mCRPC, become or are resistant to it, RedHill reports. However, the company also notes that according to the results of laboratory studies involving leading ARPI therapy, darolutamide, there may be a way to boost sensitivity to therapy and potentially overcome resistance – with the addition of another drug, opaganib. Opaganib is RedHill’s first-in-class, novel and orally-administered selective inhibitor of sphingosine kinase-2 (SPHK2). Opaganib has shown anti-inflammatory, anti-cancer and antiviral activity, and its mechanism of action, being an intracellular sphingolipid pathway modifier with multiple cell-level functions, including potential inhibition of tumor growth, supports the hypothesis that it could boost the efficacy of darolutamide, the company says. Cancer cells can block a cell-level process called apoptosis (programmed cell death), preventing the body from getting rid of unneeded or abnormal/unhealthy cells – a critical weapon our bodies use in fighting the spread of cancer. RedHill says prior research has shown that opaganib enhances androgen receptor signaling inhibitor efficacy in vitro through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS) and may potentially provide the key to overcoming darolutamide resistance in men with mCRPC. The company says, it is opaganib’s potential ability to induce metabolic stress in tumor cells that may be at the heart of the hope this study could bring people with mCRPC. With the prevalence of prostate cancer set to double over the next 15 years and only a 28% five-year relative survival rate in people with stage 4 prostate cancer, there is a significant need for new approaches in treating mCRPC patients. Pinpointing Who Is Most Likely To Benefit Patients with a poor prognosis due to ARPI resistance are most likely to benefit from an opaganib/darolutamide combination treatment approach, and identifying these patients will be key, RedHill says. As such, another innovation, a companion lipid biomarker test called PCPro, will be used to identify the right patients as part of the study. “Men with mCRPC have few treatment options available to them, and those positive for the PCPro marker of ARPI-resistance seem to have a particularly poor prognosis,” said Dr. Mark Levitt, RedHill’s chief scientific officer. “If the addition of opaganib can reduce the resistance to darolutamide therapy, this would represent a significant breakthrough in improving the ability to manage advanced treatment-resistant mCRPC for improved outcomes.” Phase 2 Trial Launching Soon Supported by Bayer and the Ramsay Hospital Foundation, the potential effectiveness of the opaganib/darolutamide combination will be put to the test in an 80-patient phase 2 clinical trial, due to start shortly. The placebo-controlled, randomized phase 2 study will evaluate the effect of opaganib, in combination with Bayer’s darolutamide, in overcoming resistance to standard-of-care androgen receptor pathway inhibition (ARPI) treatment in men with mCRPC who have not already received the newer AR signaling inhibitors such as enzalutamide, apalutamide, darolutamide or abiraterone. A primary endpoint of improved 12-month radiographic progression-free survival (rPFS) will be the key assessment of success in the study, but several secondary and exploratory endpoints will also be evaluated, the company noted. “The approach of developing therapeutic combinations and the companion lipid biomarker, PCPro, in parallel, is unique in metabolic targeting in metastatic prostate cancer, and this exciting study may provide proof of concept by testing the ability of sphingosine kinase-2 (SPHK2) inhibitors, such as opaganib, to overcome resistance to ARPI treatment,” said Professor Lisa Horvath, world-renowned prostate cancer researcher and chief clinical officer and director of research at Chris O’Brien Lifehouse. Sydney’s Chris O’Brien Lifehouse is a not-for-profit, comprehensive cancer hospital, that also developed the concept of using a PCPro marker-directed opaganib/darolutamide combination approach. “Cancer cells may block apoptosis (programmed cell death), an important cell-level process designed to help the body get rid of unneeded or abnormal/unhealthy cells – critical in fighting the spread of cancer,” Horvath said. Trial Partners Pedigree Australia is a global leader in the field, and the driving force behind this collaboration is Horvath and her team from Chris O’Brien Lifehouse. The trial will be led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd. (ANZUP), a leading Cancer Cooperative Trials Group specializing in conducting studies for prostate, bladder, kidney, testicular and penile cancers. Prostate cancer diagnoses are expected to surge as the population around the world ages, and fighting this deadly disease just took on new urgency. If this combination of RedHill’s opaganib and darolutamide proves itself in this study, it may go on to play an important role in helping to improve the prospects for hundreds of thousands of men with advanced prostate cancer who currently have a very bleak outlook. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 05, 2025 08:35 AM Eastern Standard Time

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Biotech Investing: How PRVs Can Unlock Major Opportunities

Raz

In the world of biotechnology investing, companies often struggle to bring new drugs to market. Developing treatments for rare diseases can be incredibly expensive, and because these conditions affect relatively few patients, the financial payoff isn't always clear. To help incentivize drugmakers, the U.S. government created the Priority Review Voucher (PRV) program in 2007. PRVs act as a powerful tool that can significantly speed up the FDA approval process, making them a highly valuable asset—especially to major pharmaceutical companies. A PRV is awarded when a company gains approval for a drug that treats a rare pediatric disease (RPD), a tropical disease, or serves as a medical countermeasure for serious public health threats. Normally, FDA drug approvals take around 10 months, but using a PRV shortens that timeline to just six months. This four-month head start can be a game-changer, allowing companies to get a competitive edge or generate extra sales from blockbuster drugs. Since these vouchers don’t expire and can be freely bought and sold, they often end up in the hands of big pharmaceutical companies willing to pay top dollar for the advantage. PRV prices have historically hovered around $100 million, but with uncertainty surrounding the renewal of the rare pediatric disease PRV program, recent sales have surged past $150 million. If the program isn’t renewed, PRVs could become even scarcer, potentially driving prices even higher. Big pharma companies are fiercely competing for these vouchers, particularly in lucrative fields like obesity treatments, where shaving months off a drug’s approval timeline could mean capturing billions in market share. For small biotech companies, receiving a PRV can be a major financial boost. Take Day One Biopharmaceuticals (NASDAQ: DAWN) as an example. The company was awarded a PRV after its pediatric cancer drug, OJEMDA (tovorafenib), received FDA approval. Rather than using the voucher itself, Day One sold it for $108 million, securing much-needed funding without diluting shareholder value. This kind of transaction highlights why PRVs can be a game-changer for biotech firms—providing an immediate cash infusion that can support further drug development. With PRVs becoming an increasingly hot commodity, investors should keep an eye on biotech companies with potential voucher-earning drugs in development. With PRVs becoming increasingly valuable, several biotech companies could be next in line to benefit. Let’s take a look at three stocks with potential PRVs on the horizon. OS Therapies: OS Therapies (NYSE-A: OSTX) is emerging as a strong contender for a Priority Review Voucher (PRV), a potential game-changer for the company. The company is developing OST-HER2, an immunotherapy designed to prevent the spread of osteosarcoma (OS), a rare and aggressive bone cancer that primarily affects children and young adults. Because OS Therapies holds a Rare Pediatric Disease Designation (RPDD) from the FDA, an approval for OST-HER2 would make it eligible for a PRV—potentially bringing in around $150 million in non-dilutive funding. For a small biotech company, this is a game-changing opportunity. "The data we generated in our Phase 2b trial with OST-HER2 provides the first glimmer of hope in over 40 years that a paradigm shift could radically change the course of this deadly disease," said CEO Paul Romness. If OS Therapies secures FDA approval, not only would it mark a major breakthrough for osteosarcoma treatment, but the PRV could also provide the financial runway needed for future expansion. OS Therapies has already hit a key milestone, achieving the primary endpoint in its Phase 2b trial for OST-HER2. The treatment demonstrated a 33% Event-Free Survival (EFS) rate at 12 months, compared to just 20% in historical controls. Even more compelling, 91% of patients treated with OST-HER2 were alive at the one-year mark, versus 80% in the control group. These results indicate a significant improvement over existing treatment options, which have remained largely unchanged for decades. With these promising results in hand, OS Therapies plans to file for FDA approval (Biologics Licensing Application, or BLA) in late 2025, with potential approval by mid-2026. If successful, the company would receive a PRV just before the program sunsets, making it one of the last biotechs to benefit from this lucrative incentive. Financial Stability and Growth Potential Despite being a small-cap biotech, OS Therapies has positioned itself well financially. Over the past six months, the company raised $13.1 million through an IPO and a subsequent private placement. These funds are earmarked for final clinical trial payments, commercial manufacturing, and regulatory expenses—all crucial steps toward bringing OST-HER2 to market. Moreover, OS Therapies recently acquired key clinical assets from Ayala, including two additional Listeria-based immunotherapy candidates for lung and prostate cancer. This acquisition not only expands the company’s pipeline but also significantly reduces future cash obligations, improving long-term financial prospects. The Bigger Picture Beyond osteosarcoma, OST-HER2 has potential applications in other HER2-positive cancers, including breast cancer and canine osteosarcoma, where it has already received conditional approval from the U.S. Department of Agriculture. Additionally, the company is advancing its tunable Antibody Drug Conjugate (tADC) platform, a next-generation cancer therapy designed to improve targeted drug delivery. With multiple clinical programs, a solid financial strategy, and a real chance at securing a PRV, OS Therapies stands out as a compelling investment opportunity in biotech. If OST-HER2 gains FDA approval, the PRV could provide a significant financial boost—offering the company valuable resources for further development and creating substantial upside potential for investors. SpringWorks Therapeutics: SpringWorks Therapeutics (Nasdaq: SWTX) is a biotech company focused on developing treatments for severe rare diseases and cancer. Its first FDA-approved drug, OGSIVEO® (nirogacestat), treats desmoid tumors, but the company’s next major opportunity lies with mirdametinib—a drug currently in development for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), a rare condition that causes tumors to form along nerves. In the ReNeu trial, mirdametinib showed impressive results in both adults and children, reducing tumor size and improving pain and quality of life. Because of these promising outcomes, the FDA has granted Priority Review status to the drug, with a decision expected by February 28, 2025. If mirdametinib is approved, SpringWorks could earn a Priority Review Voucher (PRV), which would be a highly valuable asset for the company. A PRV allows for a faster approval process, providing a significant advantage for drugmakers. The company could choose to sell the PRV for a substantial financial boost, potentially funding future drug development or pipeline expansion without diluting shareholder value. With SpringWorks poised to potentially earn a PRV through mirdametinib, 2025 could be a pivotal year for the company, positioning it as a leader in rare disease treatments. Investors should keep a close eye on SpringWorks as it works toward FDA approval for mirdametinib and the possible PRV windfall. PTC Therapeutics PTC Therapeutics, Inc. (NASDAQ: PTCT) is a biopharmaceutical company dedicated to developing innovative treatments for rare diseases. The company has two important drugs that could earn PRVs in the near future, each representing a valuable opportunity for investors. First, vatiquinone, a drug for Friedreich ataxia (FA)—a rare, progressive disease that affects the nervous system—has been submitted for FDA approval. The company believes this drug could fill a big gap in treatment for both children and adults with FA, as there are very few options available right now. Vatiquinone has shown strong results in clinical trials, with evidence of slowing disease progression and improving quality of life. If approved, it could earn PTC a PRV, which could then be sold for a significant financial boost. The second drug, Sepiapterin, is being developed for phenylketonuria (PKU), a rare metabolic disorder that can cause serious developmental issues. PTC recently submitted Sepiapterin for FDA approval, based on promising trial results showing it can help patients manage the disease and even reduce their reliance on strict diets. If this drug gets FDA approval, it could also bring in a PRV for PTC, providing an additional source of funding. With two drugs in the pipeline that have the potential to earn PRVs, PTC Therapeutics is an exciting company to watch. These PRVs could provide significant financial support, helping the company continue its important work in rare disease treatments. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by O S Therapies Inc to assist in the production and distribution of content related to OSTX. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

February 05, 2025 07:00 AM Eastern Standard Time

Therma Bright Reaffirms Its Position As A Key Player In The $4.2 Billion Compression Market With New Venowave Orders

TBRIF

Last year was a pivotal year for cutting-edge diagnostic and medical device technologies developer Therma Bright Inc. (TSXV:THRM) (OTCQB:TBRIF) for many reasons. Its flagship product, Venowave VW5, a medical compression pump that is lightweight, compact, and battery-operated, which is designed to treat and alleviate the symptoms associated with poor circulation in the lower extremities, received the permanent Healthcare Common Procedure Coding System (HCPCS) code from the U.S. Department of Health & Human Services' Centers for Medicare and Medicaid Services (CMS). The company received the new Venowave VW5 permanent HCPCS Level II code E0683 for this first-of-its-kind solution, as well as a CMS pricing determination marking a critical milestone for the company. This FDA-designated Durable Medical Equipment (DME) device is currently the only Medicare-approved, reimbursable, mobile mechanical compression system available in the US under its HCPCS code E0683, which provides a simple and comfortable mobile treatment solution for patients needing to accelerate post-operative recovery periods while also managing longer-term pain and swelling issues. The codes went live on October 1st, and as expected, this attracted a lot of interest from a number of potential distributors across the country. The company engaged some of these distributors in pilot tests for nationwide launches of the initial Venowave sales program to gauge Medicare/Medicaid reimbursement timelines and billing procedures as well as any rejections that occurred. The distributors had success in the pilot trials, reaffirming the demand for Venowave. For instance, the DME Authority initially took up 25 units, which received 100% reimbursement, and later took 175 more units, which were all also reimbursed, illustrating the traction of Venowave in the market. For context, the DME Authority provides nationally exclusive niche therapy smart devices to hospitals and physician practices with the first-ever white-glove, turn-key, technology-driven capability that delivers true “hospital to home” continuum-of-care coverage. Following the pilot tests, Therma Bright announced it had signed a letter of intent (LOI) for a Venowave distribution program with DME Authority across the US. Through this distribution program, DME Authority would collaborate with multiple tenured and qualified network partners to establish no less than three comprehensive U.S. distribution agreements. As outlined in the LOI, these 'Premier Distributor Partner' contracts would require a minimum foundational inventory purchase of $2 million and collectively commit to a total inventory purchase of $6 million in Venowave VW5 devices within the first six months of 2025, with a minimum equal inventory purchase requirement between Q3 and Q4, 2025. On January 21, Therma Bright announced that it had secured a purchase order for 1,750 Venowave VW5 from the DME Authority, which would offer HCPCS code reimbursements that total about $1.43 million. This purchase order brings both companies one step closer to the outlined LOI that positions DME as a 'Premier Distributor Partner' for the company. Earlier in the year, Therma Bright announced that it had secured an initial purchase order for 100 Venowave VW5 units from another national distribution partner called Valor Medical. The initial purchase order was based on the success of the distributor's pilot tests around the HCPCS code reimbursement program and confirmation that Venowave was indeed a superior product compared to what was in the market. As a new national distribution partner of Therma Bright, Valor Medical looks to fill the immediate needs of its current network of medical practitioners and their patients. According to this distributor and its partners, they receive upwards of 100 doctor referrals per day for vascular compression therapy solutions and have seen great success in securing HCPCS code reimbursements within a normal 30- to 60-day timeframe. Valor Medical and its partners intend to place orders on a regular basis, perhaps every few weeks, as they build greater awareness of the Venowave VW5 solution with their end clients. This initial purchase order for 100 Venowave VW5 units offers HCPCS code reimbursements that total a minimum of $81,955. "We are excited to partner with Therma Bright in offering the Venowave VW5 to our national distribution network," shared Cindy Sebek Quick, Partner of Valor Medical Solutions. "This initial 100-unit purchase will fill the immediate demand of our partners, who anticipate early adoption of this special vascular compression therapy solution.” According to a report from Straits Research, the global compression therapy market was worth about $4.18 billion in 2024 and is projected to grow to $6.72 billion by 2033, representing a CAGR of 7.30%, which bodes well for Therma Bright. With 1,850 Venowave orders in the first month of this year alone and new distribution partners in the pipeline, the company is reaffirming its position as a key player in the US compression market. Moreover, the company’s second product is also helping position it as a key player in the medical device market and creating new potential areas for growth. Therma Bright is currently pursuing a U.S. Food and Drug Administration (FDA) 513(g) request to obtain information regarding the classification and regulatory requirements for its acoustic AI Digital Cough Technology (DCT) as a remote therapeutic monitoring solution. The DCT platform with partner AI4LYF is focused on supporting healthcare decision-making by improving the ability to collect, organize, and display cough and respiratory data for healthcare providers, as well as epidemiologists who are public health workers that investigate respiratory patterns. The company is also looking to get reimbursement codes through CMS that allow for this type of remote therapeutic monitoring device. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and has been compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website https://razorpitch.com/

February 03, 2025 07:00 AM Eastern Standard Time

Therma Bright Inc. (OTC: TBRIF) Expands in $6.72 Billion Compression Market

TBRIF

In an aging world where healthcare costs are rising, the demand for cost-effective, non-invasive treatments is skyrocketing. One sector seeing a surge in interest is compression therapy, a market projected to grow from $4.18 billion in 2024 to $6.72 billion by 2033. Traditionally dominated by compression stockings and bulky pneumatic devices, the space is undergoing a technological shift toward portable, user-friendly solutions—opening the door for companies developing next-generation devices. One under-the-radar player making moves in this space is Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). The company’s Venowave VW5, an FDA-cleared, battery-powered compression device, has been gaining traction in the U.S. market, especially following recent reimbursement approvals from Medicare and private insurers. With a growing distribution network, strong early sales, and a huge addressable market, Therma Bright is quickly positioning itself as a compelling small-cap investment in a sector experiencing major tailwinds. With reimbursement momentum building and major distribution deals already in place, is Therma Bright an overlooked gem in the booming compression therapy industry? Let’s take a closer look at the opportunity. Therma Bright Inc.: Advancing Medical Innovation with Venowave VW5 Therma Bright Inc. is a developer and investment partner in advanced diagnostic and medical device technologies. The company focuses on delivering high-quality, innovative healthcare solutions to both consumers and medical professionals. Milestone Achievement: HCPCS Code Reimbursement Secured in Record Time Therma Bright and its nationwide U.S. distribution partners have successfully secured Medicare and Medicaid HCPCS Level II code reimbursements within just 60 days. Since October 1, 2024, over 110 Venowave VW5 units have been deployed across the U.S. in pilot tests, with 25 units already receiving full reimbursement through commercial health networks and federal healthcare programs. The remaining 85 units are anticipated to follow suit soon. Given these strong results, the company has initiated discussions on scaling sales, optimizing delivery logistics, and ramping up manufacturing with its distribution partners. "Our U.S. national distributors are highly impressed with the speed of CMS reimbursements for the Venowave VW5," said Rob Fia, CEO of Therma Bright. "Typically, brand-new HCPCS Level II codes require more time to process, but our code has been efficiently handled within 60 days. This sets a strong precedent for even faster reimbursements in the future and supports our commercialization efforts." Expanding U.S. Distribution with DME Authority Therma Bright has signed a Letter of Intent (LOI) with DME Authority, a Nashville-based distributor, to significantly expand Venowave’s reach. Under this agreement, DME Authority will establish at least three comprehensive distribution agreements, requiring an initial inventory purchase of $2 million. Collectively, these partners will commit to purchasing $6 million worth of Venowave VW5 units within the first six months of 2025, with an equal commitment for Q3 and Q4. DME Authority will also acquire Therma Bright’s remaining in-stock inventory as part of this agreement, ensuring seamless market expansion. "Our strategy to secure Venowave’s HCPCS code was crucial, and the timing couldn’t be better," said Erick Gosse, CEO of DME Authority. "Medicare patients have lacked a mobile mechanical compression solution—Venowave now fills that gap effectively." Product Overview: Venowave VW5 The Venowave VW5 is a compact, battery-operated peristaltic pump designed to improve vascular and lymphatic flow in the lower limbs. It qualifies for Medicare and Medicaid reimbursement under 10 medical indications and is the only Medicare-approved mobile mechanical compression system under HCPCS code E0683. Clinically Proven Benefits: Increases venous blood flow by 64% within 2 minutes and by 88% after 50 minutes of use. Enhanced Mobility: Lightweight (250g), discreet, and wireless, allowing patients to remain active during treatment. FDA-Designated Durable Medical Equipment (DME): Designed for repeated use across multiple patients. Major Purchase Orders Driving Market Expansion Therma Bright continues to strengthen its market presence through key purchase agreements: Valor Medical Solutions: Placed an initial order for 100 Venowave VW5 units following successful pilot trials. The purchase equates to a minimum of $81,955 USD in HCPCS code reimbursements ($117,952 CAD). Valor anticipates increasing its orders biweekly to meet growing demand. DME Authority: Confirmed a major purchase order of 1,750 Venowave VW5 units, totaling $1.43 million USD ($2.05 million CAD) in reimbursements. This milestone further solidifies DME’s role as a Premier Distributor Partner for Therma Bright. Market Outlook: Seizing a Growing Opportunity The global compression therapy market, valued at $4.18 billion in 2024, is projected to grow to $6.72 billion by 2033, representing a CAGR of 7.3%. Therma Bright is well-positioned to capitalize on this expanding market through strategic partnerships, timely reimbursements, and the increasing adoption of Venowave VW5. "With strong distributor commitments, rapid reimbursement processing, and increasing patient demand, we anticipate significant revenue growth in 2025 and beyond," added Rob Fia. Therma Bright remains committed to innovation, accessibility, and enhancing patient care as it scales its commercialization efforts for Venowave VW5 in the U.S. healthcare market. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and has been compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website https://razorpitch.com/

January 31, 2025 07:30 AM Eastern Standard Time

Wire Industries Partners with Birches Health to Create Safer, More Responsible Gaming Environment

WagerWire

Wire Industries, Inc., a technology and media company that owns and operates sports betting marketplace WagerWire, announced today that it has partnered with Birches Health, a leading behavioral healthcare company that specializes in the online and confidential prevention and treatment of problem gambling-related challenges. This partnership complements the work Wire Industries has already done to promote responsible gaming by redefining what it means for bettors to have control over their entertainment time participating in real-money gaming and daily fantasy sports. Through this partnership, Wire Industries will propel awareness of responsible gaming and increase bettors’ access to important guidance and tools to ensure they are better informed and aware of the signs of problem gambling and prepared to take steps to address it if they see themselves or others exhibiting those signs. Wire Industries and Birches Health will work together to create clinical materials tailored to the needs of the modern bettor. In addition, Birches Health clinicians will appear on Wire Industries Spaces interviews held live on X.com, Birches Health content will be integrated across the WagerWire app and specific Birches Health and WagerWire co-created resources and tools will live across each partner’s website. “Wire Industries was created with the sole purpose to empower bettors and create an environment of responsible gaming,” said Wire Industries CEO Zach Doctor. “By working with Birches Health, we join ourselves with another innovative company in the industry that is also doing whatever they can to create more awareness, tools and resources for the bettor all while reinforcing our commitment to responsible gaming. We hope others in the industry see this innovation as a way to better the modern bettor and follow suit.” Birches Health is a modern digital healthcare company specializing in the prevention and treatment of behavioral addictions, with a primary focus on gambling disorder and related mental health issues in the United States. Utilizing a three-tiered strategic approach—education, engagement, and treatment—Birches Health offers free online learning modules, self-assessments, tools, and educational content to promote Responsible Gaming and prevent problem behaviors. For individuals in need, personalized treatment plans are crafted and led by licensed, specialized behavioral health clinicians available 24/7. Dedicated to providing convenient and comprehensive care, Birches Health empowers individuals to address behavioral health challenges effectively. “We applaud WagerWire and their team for a focus on making resources and education available and empowering their users to make healthier lifestyle choices.,” said Elliott Rapaport, Founder of Birches Health. “Partnering with Wire Industries to make sure that treatment options through WagerWire, FantasyWire and its other platforms are available to those who may need them creates a culture of sustainable play for all participants.” As part of this initiative, WagerWire and Birches Health are also exploring opportunities to integrate AI-driven tools and personalized support pathways into the WagerWire platform, further enhancing user education and care accessibility. This partnership will also further Wire Industries as an innovative, forward-thinking disruptor in all aspects associated with the gaming world. About Wire Industries Wire Industries Inc was founded with the mission to bring a more efficient, open, and entertaining market to real money gaming of all types, unlocking value for the entire ecosystem. The company was established in 2021 and owns and operates Wire Technologies and Wire Media Group. Wire Technologies is the company’s marketplace division including WagerWire, FantasyWire, PonyWire and ContestWire, while Wire Media Group operates their media network and affiliate marketing division. You can download their flagship product WagerWire in the Apple App Store and Google Play, and find them @WagerWire on Twitter/X, TikTok and LinkedIn, or @WagerWireLive on Instagram. Wire Industries is dedicated to providing a responsible gaming environment. If you think you or someone you know may have a gambling problem, resources are available. Call 1-800-GAMBLER or reach out to their Chief Responsibly Officer Carolina Young directly at live@wagerwire.com. About Birches Health Birches Health provides modern, clinician-led solutions for Responsible Gaming and Problem Gambling care covered by insurance. For more information, visit Birches Health at bircheshealth.com or email partnerships@bircheshealth.com. Contact Details Sterling Randle srandle@hotpaperlantern.com

January 30, 2025 09:01 AM Eastern Standard Time

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