Latest news with #FDA-designated
Malaysian Reserve
4 days ago
- Health
- Malaysian Reserve
CareONE Concierge Now Accepting Candidates for Alzheimer's Device Study
Study offers patients the opportunity to try an experimental, non-drug therapy for Alzheimer's using an FDA-designated Breakthrough Device ATLANTA, July 10, 2025 /PRNewswire/ — CareONE Concierge has announced the launch of a new research study to evaluate an innovative wearable device aimed at addressing cognitive symptoms associated with Alzheimer's-related dementia. The study will utilize NeuroEM Therapeutics'® TEMT-RF cap, a non-invasive device that has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). Alzheimer's disease is a growing global health crisis, affecting nearly 7 million Americans and is projected to impact nearly 13 million by 2050. Despite decades of research, treatment options remain limited, with most current therapies only addressing symptoms rather than the underlying causes of cognitive decline. NeuroEM Therapeutics is pioneering Transcranial Electromagnetic Treatment using Radio Frequencies (TEMT-RF) as a potentially groundbreaking approach to treating the disease at its root. The lightweight, wearable device delivers electromagnetic waves similar to those produced by cell phone signals from multiple emitters. It is being investigated for its potential to break apart toxic protein oligomers within neurons throughout the brain. These oligomers—clusters of beta-amyloid and tau proteins—are thought to drive the progression of Alzheimer's disease. By disrupting these harmful accumulations, TEMT-RF may help restore neuronal function and slow cognitive decline. 'We all know friends and family members who have been impacted by Alzheimer's or dementia,' said Peter Bechtel, CEO of CareONE Concierge. 'This study represents a potential turning point in the fight against these devastating conditions. By participating in this study, individuals have the opportunity to experience cutting-edge, non-drug therapy while contributing to groundbreaking advancements in Alzheimer's treatment.' This study is independently conducted by CareONE Concierge and is designed for individuals with mild to moderate Alzheimer's-related dementia. Participants will be required to wear the device twice daily for one hour, follow a structured research protocol, and complete cognitive assessments throughout the study. Dr. Edward Goodwin, Chief Scientist at NeuroEM, emphasized the scientific foundation behind TEMT-RF, stating, 'Our research has shown that TEMT-RF has the potential to impact the key biological processes associated with Alzheimer's disease. This study will help us gather more real-world data on how the device affects cognitive function and overall brain health.' 'NeuroEM is excited to partner with CareONE Concierge,' stated Chuck Papageorgiou, CEO of NeuroEM Therapeutics. 'Our objective is to promote safe, effective, and non-invasive technologies for cognitive health, and research initiatives like this are essential in helping us uncover the full potential of TEMT-RF. With Alzheimer's cases increasing, innovative research such as this provides new hope for patients, caregivers, and the future of cognitive health. Together, we can take meaningful steps toward a future where memory loss is no longer an inevitable part of aging.' CareONE Concierge is now accepting qualified participants for the study. For more information or to apply, please email CT@ or apply at About CareONE ConciergeCareONE Concierge is committed to delivering Preventative Healthcare solutions that meet the needs of patients, providers, and the healthcare system. The company works with physicians, patients, and healthcare systems to develop turnkey solutions that increase patient outcomes while enhancing revenue and quality metrics. To learn more, visit . About NeuroEM Therapeutics®NeuroEM Therapeutics is leading the way in the development and clinical testing of bioengineered technology to reverse the cognitive decline associated with Alzheimer's disease and other neurodegenerative conditions. Built upon a decade of groundbreaking research conducted at Tampa-based research facilities at the University of South Florida (USF), the company received the first Breakthrough Device status from the U.S. Food and Drug Administration (FDA) to treat Alzheimer's disease. NeuroEM's continued dedication to cutting-edge research is bringing to market a first-in-class wearable device designed for in-home use to extend healthy longevity using patented Transcranial Electromagnetic Treatment leveraging Radio Frequencies (TEMT-RF) technology. To learn more, visit Media Contact:Wendy Stevens, Study Manager(919) 600-9930wstevens@
Yahoo
21-05-2025
- Business
- Yahoo
IBN Coverage: NRx Pharmaceuticals (NASDAQ: NRXP) to Present at Wall Street Conference on May 21
This article was published by IBN, a multifaceted communications organization engaged in connecting public companies to the investment community. LOS ANGELES, CA - May 21, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that Founder and CEO Dr. Jonathan Javitt will deliver a company update at the Wall Street Conference on May 21, 2025, in Palm Beach, Florida. NRx is one of six companies invited to present at the high-profile event, which is expected to draw more than 1,000 attendees representing over $1 trillion in investment capital. The presentation will highlight the company's progress toward FDA approval of NRX-100, a preservative-free intravenous ketamine formulation, as well as its strategic acquisition plans for HOPE clinics focused on treating suicidal depression, PTSD, and related conditions. To view the full press release, visit About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. For more information, please visit NOTE TO INVESTORS: IBN is a multifaceted financial news, content creation and publishing company utilized by both public and private companies to optimize investor awareness and recognition. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: The latest news and updates relating to NRXP are available in the company's newsroom at Forward Looking Statements Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law. About IBN IBN is a cutting-edge communications and digital engagement platform providing tailored Platform Solutions for select private and public companies. Over the course of 19+ years, IBN has introduced over 70 investor facing brands to the investment public and amassed a collective audience of millions of social media followers. These distinctive investor brands amplify recognition and reach as well as help fulfill the unique needs of our rapidly growing and diverse base of client-partners. IBN will continue to expand our branded network of influential properties as well as leverage the energy and experience of our team of professionals to best serve our clients. IBN's Platform Solutions provide access to: (1) our Dynamic Brand Portfolio (DBP) through 70+ investor facing brands; (2) article and editorial syndication to 5,000+ news outlets; (3) full-scale distribution to a growing Social Media Network (SMN) ; (4) a network of wire solutions via InvestorWire to effectively reach target markets and demographics; (5) Press Release Enhancement to ensure accuracy and impact; (6) a full array of corporate communications solutions; and (7) total news coverage solutions. For more information, please visit Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published: Media Contact IBNLos Angeles, OfficeEditor@ View the original release on Sign in to access your portfolio
Yahoo
12-05-2025
- Business
- Yahoo
NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Report First Quarter 2025 Financial Results on May 15, 2025
WILMINGTON, Del., May 12, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its first quarter 2025 financial results after the market closes on Thursday, May 15, 2025 via press release, which will be available on the Company's website at The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30pm ET the same day. A live webcast of the conference call will be available on the Company's website at Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically +1-800-717-1738 or internationally +1-646-307-1865. About NRx Pharmaceuticals, Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. About HOPE Therapeutics, Therapeutics, Inc. ( a subsidiary of NRx Pharmaceuticals, is a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. Notice Regarding Forward-Looking StatementsThe information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the satisfaction of closing conditions necessary to consummate the acquisition of Kadima, Neurospa and Dura, and obtaining financing necessary to consummate the acquisitions. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, liquidity, Hope Therapeutic's ability to consummate the acquisitions of providers for its national network, the Company's ability to raise adequate capital to fund such acquisitions, and the Company's ability to spin-off Hope Therapeutics. 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 most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information:Matthew DuffyCo-CEO, Hope Therapeutics, Business Officer, NRx Pharmaceuticals, Inc. mduffy@ Brian KorbManaging Partner, astr Partners(917) View original content to download multimedia: SOURCE NRx Pharmaceuticals, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-04-2025
- Business
- Yahoo
Ligand Subsidiary Pelthos Therapeutics to Combine with Channel Therapeutics
Proposed transaction will raise $50 million in equity capital and enhance a publicly traded biopharmaceutical company focused on launching Pelthos' ZELSUVMI™ ZELSUVMI is an FDA-designated novel drug and the first and only prescription medication approved for the treatment of Molluscum contagiosum infections administered at home by parents, patients, and caregivers Ligand is entitled to a 13% royalty on worldwide sales of ZELSUVMI Transaction is expected to close in the summer of 2025 JUPITER, Fla. and FREEHOLD, N.J., April 17, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated ('Ligand') (Nasdaq: LGND) and Channel Therapeutics Corporation ('Channel') (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, today announced the signing of a definitive merger agreement to combine Ligand's wholly owned subsidiaries, Pelthos Therapeutics Inc. and LNHC, Inc. (collectively 'Pelthos') with CHRO Merger Sub Inc., a wholly owned subsidiary of Channel. The merger will be supported by $50 million in capital raised from a group of strategic investors led by Murchinson ('Investor Group'). Upon completion of the transaction, the combined company will operate under the name Pelthos Therapeutics Inc. and trade on the NYSE American exchange under the ticker PTHS. The combined company will initially focus on accelerating the commercialization of Pelthos' ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of Molluscum contagiosum infections ('molluscum') in adults and pediatric patients one year of age and older.1 ZELSUVMI was approved by the U.S. Food and Drug Administration (FDA) in 2024 and is the first and only prescription therapy for molluscum infections approved for use at home by patients, parents, and caregivers. The combined company will also retain Channel's existing NaV 1.7 development programs for the treatment of various types of chronic pain, acute and chronic eye pain, and post-surgical nerve blocks. An update on Channel's animal efficacy study for its eye pain program will be forthcoming. 'This transaction presents a compelling opportunity to launch a commercial-ready product, with significant financial backing from Murchinson, that has the potential to deliver both near and long-term value to our shareholders,' said Todd Davis, CEO of Ligand. 'We executed a complex restructuring to acquire the Pelthos assets, incubated the technology that became ZELSUVMI, achieved FDA approval for this first-in-class medication, and assembled a world-class team, to bring this therapy to market. Our ability to identify highly differentiated assets and execute customized transactions to maximize their value with equity and royalty rights distinguishes Ligand's business model and value creation strategy.' Frank Knuettel II, CEO of Channel Therapeutics, commented, 'We are very excited about the merger with Pelthos. We have performed extensive due diligence on the ZELSUVMI market opportunity and their team and operations, and we believe this is an extraordinary opportunity for current Channel shareholders. Strategically, it provides the potential for near-term revenue generation from an FDA-approved drug, the opportunity to advance Channel's existing NaV 1.7 programs, and expanded capitalization from strong, long-standing investors.' Molluscum contagiosum is a poxvirus and one of the most common skin infections seen by dermatologists, pediatric dermatologists, and pediatricians, afflicting an estimated 16.7 million people in the United States. 2,3 Molluscum infections spread to others through contact with infected persons or contaminated objects like towels, toys, furniture, swimming pools, and other surfaces. Children are the most vulnerable to molluscum infections. Adults with weakened immune systems or who are sexually active with a molluscum-infected partner are also particularly vulnerable. Molluscum infections present with raised, flesh-colored or red bumps that can appear anywhere on the body, including the face, hands, trunk, genitals, back of the knees, armpits, and other sensitive areas. People with molluscum may suffer discomfort from itching, secondary bacterial infections from scratching, or atopic dermatitis, as well as immense social stigma from having visible molluscum lesions, which typically last for months and frequently last for years. Scott Plesha, CEO of Pelthos, added, 'There is a significant unmet medical need for an easy-to-use, safe, and efficacious treatment option for molluscum that can be applied by patients, parents, or caregivers at home via prescription. We believe ZELSUVMI will complement pediatric and adult dermatologists', general pediatricians', and all other health care providers' current efforts to treat molluscum while reducing the need for repeated invasive in-office procedures and the associated wait times needed to treat this highly infectious disease. Having commercialized both dermatology and pain management products, I am excited to lead the combined company into this next growth phase.' Transaction Details Under the terms of the merger agreement, Channel will acquire 100% of the issued and outstanding equity interests of Pelthos, and will change its name to Pelthos Therapeutics Inc. In connection with the transaction, Ligand has agreed to invest $18 million in the combined company and the Investor Group has agreed to invest $32 million for a total of $50 million. Upon completion of the transaction, Mr. Plesha will become CEO of the combined company and Mr. Knuettel will become CFO. The Board of Directors will consist of Mr. Plesha, two independent directors, Peter Greenleaf and Matt Pauls, two board members appointed by Ligand, and an additional two independent directors who are reasonably acceptable to Murchinson, both of whom are current Channel board members. The transaction is expected to close in the summer of 2025, subject to customary closing conditions. AdvisorsLatham & Watkins LLP is serving as lead counsel to Ligand. Raymond James & Associates, Inc. is serving as financial advisor to Ligand and Pelthos. Sullivan & Worcester LLP is serving as Channel's legal counsel. Kelley Drye & Warren LLP represented Murchinson. About ZELSUVMI™ (berdazimer) topical gel, 10.3%ZELSUVMI (berdazimer) topical gel, 10.3% is a nitric oxide (NO) releasing agent indicated for the topical treatment of Molluscum contagiosum in adults and pediatric patients one year of age and older. ZELSUVMI received a novel drug designation from the U.S. Food and Drug Administration in 2024 and is the first and only approved topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician's office, or other medical setting to treat this highly contagious viral skin infection. The product was developed using Pelthos' proprietary nitric oxide-based technology platform, NITRICIL™. Ligand acquired the rights to ZELSUVMI and all the assets related to the NITRICIL technology platform from Novan, Inc. in September 2023. Complete prescribing information and important safety information is available at About Pelthos Therapeutics Pelthos Therapeutics is a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The company's lead product ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of Molluscum contagiosum, was approved by the U.S. Food and Drug Administration in 2024. In addition to ZELSUVMI, Pelthos has a pipeline of potential product candidates that utilize its proprietary nitric oxide-based technology platform, NITRICIL™. Pelthos is a subsidiary of Ligand Pharmaceuticals and will remain so until the completion of the transaction. More information is available at Follow Pelthos on LinkedIn and X. About Murchinson Founded by Marc J. Bistricer in 2012, Murchinson seeks to identify and invest in high-value opportunities across global markets. The firm leverages a disciplined, patient, and innovative investment approach to uncover value. Murchinson seeks to identify undervalued assets and opportunities in complex, evolving industries—particularly where innovation, regulatory shifts, and strategic changes create the potential for significant value creation. The firm is committed to generating superior, risk-adjusted returns by focusing on investments that have strong underlying fundamentals, operational improvement potential, and sustainable growth drivers. Learn more at About Channel Channel Therapeutics Corporation is a clinical-stage biotechnology company focused on developing and commercializing novel, non-opioid, non-addictive therapeutics to alleviate pain. Channel's initial clinical focus is to selectively target the sodium ion-channel known as NaV1.7 for the treatment of various types of chronic pain, acute and chronic eye pain and post-surgical nerve blocks. For company updates and to learn more about Channel, visit or follow us on social media. About Ligand PharmaceuticalsLigand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Our business model seeks to generate value for stockholders by creating a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Our business model is based on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing our technology to help partners discover and develop medicines. We partner with other pharmaceutical companies to attempt to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate our revenue. We operate two infrastructure-light royalty generating technology IP platform technologies. Our Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Our NITRICIL™ platform technology facilitates tunable dosing, permitting an adjustable drug release profile to allow proprietary formulations that target a broad range of indications. We have established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Gilead Sciences and Baxter International. For more information, please visit Follow Ligand on X and LinkedIn. We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts. Forward-Looking Statements This press release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding Ligand and Channel's current expectations. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as 'plans,' 'believes,' 'expects,' 'anticipates,' and 'will,' and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, references to our expectations regarding (i) our belief that investors should feel encouraged that Pelthos has a strong development path towards successfully launching drugs with considerable market opportunities, (ii) the timing of clinical and regulatory events of us and our partners, (iii) the timing of the initiation or completion of preclinical studies and clinical trials by us and our partners; (iv) the timing of product launches, including ZELSUVMI; (v) guidance regarding projected financial results for 2025 and beyond, and (vii) the timing and likelihood of closing the merger between Pelthos and Channel, and (vii) the listing of the combined company on the NYSE American, (viii) the anticipated benefits of the merger between Pelthos and Channel and (ix) the combined company's opportunities, strategy and plans following the merger. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties related to there being no guarantee that the trading price of the combined company's Common Stock will be indicative of the combined company's value or that the combined company's Common Stock will become an attractive investment in the future; we may rely on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections and may not receive expected revenue; we and our partners may not be able to timely or successfully advance any product(s) in our internal or partnered pipeline or receive regulatory approval and there may not be a market for the product(s) even if successfully developed and approved; and changes in general economic conditions, including as a result of war, conflict, epidemic diseases, the implementation of tariffs, and ongoing or future litigation could expose us to significant liabilities and have a material adverse effect on us. These and other risks and uncertainties are described more fully in our filings with the U.S. Securities and Exchange Commission. The information in this press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law. 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. Contacts For Ligand/Pelthos:Investors:Melanie Hermaninvestors@ (858) 550-7761 Media:Kellie Walshmedia@ 315-6072 For Channel: Investors/Media:Mike MoyerManaging Director, LifeSci Advisors, LLCmmoyer@ For Murchinson:Longacre Square PartnersDan Zacchei / Ashley Areopagitamurchinson@ 1 Please see ZELSUVMI™ (berdazimer) topical gel full prescribing information available at for important safety information or US Census Bureau. QuickFacts: United States.2022. 3 Hebert AA, et al. J Clin Aesthet Dermatol. 2023 Aug;16(8 Suppl 1):S4-S11
Globe and Mail
15-04-2025
- Health
- Globe and Mail
Vivos Inc. Reports Continued Progress in India Human Clinical Trial for RadioGel® Precision Radionuclide Therapy™
Kennewick, WA, April 15, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to share new developments in its ongoing human clinical trial in India for RadioGel ® Precision Radionuclide Therapy ™, an FDA-designated Breakthrough Device for the treatment of solid tumors. The latest results highlight both technical progress and growing clinical validation. This update builds upon the initial results released in February 2025, which confirmed the safety of RadioGel ® in the first five patients. As of this report, ten patients with cancerous nodes have now been successfully treated, further establishing a strong safety profile while generating promising early evidence of efficacy. Clinical Milestones: Safety, Precision, and Innovation Every patient in the trial has met the primary safety endpoint, confirmed through PET imaging showing precise retention of the therapeutic Yttrium-90 isotope at the injection site—with no observed adverse events. Patients continue to recover well with no complications, monitored under disciplined clinical follow-up protocols. Importantly, two of the ten patients presented with tumors in direct contact with the trachea and carotid artery, anatomical regions often considered inoperable or high-risk for radiation damage. Yet, RadioGel ® achieved successful treatment without injuring adjacent critical tissues, underscoring the therapy's high Therapeutic Ratio and the core rationale behind the FDA's Breakthrough Device designation. These outcomes affirm the unique advantage of RadioGel ®: internal, highly localized beta radiation delivered directly within the tumor, sparing healthy tissue and enabling outpatient treatment with minimal post-procedure restrictions. Ongoing Innovation and Technical Exchange with U.S. Investigators Led by a highly experienced principal investigator in India, the clinical team has introduced new technical refinements to the treatment methodology, including deep-needle injection techniques, precision image guidance, and the use of saline spacers to enhance dose control and organ protection. These protocol advancements are being actively reviewed in discussions with Mayo Clinic investigators who are preparing for a parallel clinical study in the United States. The study in India, has been approved to treat 30 patients. A formal request is being prepared for the Ethics Committee to approve up to 50 patients, enabling evaluation of RadioGel ® in a broader range of tumor types, including those located deeper in the body such as lung and pancreatic cancers. Strategic Presence in India and Global Pathway Vivos is concurrently laying the groundwork for a permanent operational footprint in India, including plans to open a corporate office and to establish a regional manufacturing facility for yttrium phosphate microparticles. This infrastructure will support the clinical rollout and eventual commercial availability of RadioGel ® in India—serving as a strategic hub for future global expansion. The results of the India trial, including comprehensive clinical and imaging data, will be submitted for peer-reviewed publication later this year. This milestone is expected to significantly enhance the therapy's visibility among physicians and oncologists and support regulatory submissions globally. Regulatory Engagement and Market Entry Strategy Building on the FDA 'Breakthrough Device' status of Radiogel ® Precision Radionuclide Therapy ™, Vivos is sharing preliminary India trial data directly with the FDA to support the company's goal to submit an Investigational Device Exemption (IDE) within the next 90 days While the company is encouraged by its regulatory progress, it also acknowledges the inherent unpredictability of the U.S. regulatory environment, particularly amid shifting priorities and evolving review protocols under the new FDA administration. As such, Vivos continues to pursue a multi-track global strategy to ensure momentum regardless of domestic regulatory timing. Importantly, the clinical and commercial potential for RadioGel ® outside the U.S. is significant, particularly in regions with streamlined regulatory pathways and increasing demand for innovative, minimally invasive cancer therapies. Vivos views its expanding presence in India not only as a foundation for local commercialization, but also as a strategic hub for broader international adoption—especially in markets where the burden of solid tumors remains high and treatment innovation is urgently needed. The cancer treatment market in India presents a significant and growing opportunity for innovative therapies like RadioGel ®. In 2023, the market was valued at approximately USD 4.21 billion and is projected to reach USD 5.89 billion by 2030. Given the substantial size and growth of the Indian cancer treatment market, progress and adoption of RadioGel ® in international markets like India present a substantial opportunity to enhance long-term shareholder value. By establishing a presence in these expanding markets, Vivos can diversify its revenue streams and accelerate the global recognition of Radiogel ® as a globally relevant oncology solution. CEO Statement Dr. Michael Korenko, President and CEO of Vivos Inc., stated: 'With every patient treated, the value of RadioGel ® becomes more evident. We are witnessing precise, safe, and promising therapy outcomes in tumors that traditionally pose high treatment risk. These results not only reinforce our confidence in the technology, but also validates the FDA's designation of RadioGel ® as a Breakthrough Device. We are optimistic about what lies ahead in India and globally—as we move toward making this therapy accessible to patients in urgent need of new cancer treatment options.' Additionally, our companion IsoPet ® animal data has been generating impressive results which complement the human therapy data. We will share the exciting developments from our Isopet ® animal health division in the near future. About Vivos Inc. (OTCQB: RDGL) Vivos Inc. is a radiotherapeutic oncology company pioneering the use of Yttrium-90-based injectable hydrogel technology to treat tumors in both animals (IsoPet ®) and humans (RadioGel ®). The company's Precision Radionuclide Therapy ™ (PRnT ™) platform delivers targeted internal radiation from within the tumor, minimizing damage to healthy tissue and reducing patient recovery time. RadioGel®, designated as a Breakthrough Device by the U.S. FDA, uses a hydrogel matrix to confine beta radiation within the tumor, delivering more than 90% of its therapeutic effect within 10 days. Treatment can be administered in an outpatient setting with no post-procedure radiation risk to family or caregivers. RadioGel ® is currently not approved for human commercial use.
