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Reid Hoffman Wished Death Upon Trump & Funded ‘Lawfare;’ He Must Be Removed from Microsoft’s Board & Defense Innovation Board

NLPC

Following the assassination attempt of former President Donald Trump in Butler, Pa. on Saturday, National Legal and Policy Center (NLPC) is calling upon tech entrepreneur Reid Hoffman to resign his seat on the board of directors for Microsoft Corporation. Should he refuse to step down, then the Microsoft Chairman and Lead Independent Director must take steps along with fellow directors to remove him. The shareholder group is also calling for Hoffman’s removal from the Defense Innovation Board (DIB), a body organized under the Federal Advisory Committee Act to make recommendations regarding technological modernization of the military. DIB is currently chaired by Michael Bloomberg. At the billionaires’ retreat in Sun Valley, Idaho, this week, Mr. Hoffman reportedly engaged in a vigorous debate with fellow tech executive Peter Thiel over how the LinkedIn co-founder’s funding of “lawfare” has turned Trump into a “martyr.” According to a report by Puck News, Mr. Hoffman responded to Mr. Thiel, “Yeah, I wish I had made him an actual martyr.” Previously, Hoffman was also widely known for introducing Jeffrey Epstein to other Silicon Valley figures. According to Luke Perlot, associate director of NLPC’s Corporate Integrity Project: “As shareholders of Microsoft, we call on Mr. Hoffman to resign, or be removed, from the board of directors. His ongoing presence on the board is a stain on Microsoft’s reputation and would implicitly condone his statements and actions.” According to Paul Chesser, director of NLPC’s Corporate Integrity Project: “Sarcasm or not, Hoffman has made clear that he doesn’t think Donald Trump has any civil rights, and that he and other billionaires should pick the president, not the American people. Some holders of great wealth seek to help the less fortunate or promote freedom and decency. Hoffman has instead sought to undermine democratic norms and values. We repeat our call that we made last year that Mr. Hoffman be removed from Microsoft’s board as well as the Defense Innovation Board.” According to Peter Flaherty, NLPC Chairman: “The Defense Innovation Board is engaged in the task of using technology to strengthen our defense in a dangerous world. It conducts serious business. It is no place for an unserious character like Reid Hoffman. For one thing, his associations with Jeffrey Epstein make him a security threat. For another, funding lawsuits by the likes of E. Jean Carroll and wishing martyrdom on Donald Trump should disqualify him from any government board or position.” Founded in 1991, the National Legal and Policy Center promotes ethics in public life through research, investigation, education and legal action. Contact Details National Legal and Policy Center Dan Rene +1 202-329-8357 drene@nlpc.org Company Website http://www.nlpc.org

July 14, 2024 09:45 AM Eastern Daylight Time

Autonomix's Trial Results Show Meaningful Reduction In Pain For Patients Suffering From Pancreatic Cancer

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Autonomix Medical (NASDAQ: AMIX) is a cutting-edge medical technology company developing targeted nerve therapies to revolutionize how diseases involving the peripheral nervous system are diagnosed and treated. The company's ongoing proof-of-concept (PoC) human clinical trial is evaluating the safety and efficacy of radiofrequency (RF) ablation in a transvascular approach to reduce pain associated with pancreatic cancer and, to date, has demonstrated extremely compelling results. If successful, Autonomix has the potential to dramatically impact patient well-being and improve quality of life, offering new hope for patients enduring pancreatic cancer pain. Key Trial Insights The initial phase of the clinical trial involved five lead in patients who underwent the procedure without complications or significant adverse events. Some 60% of these subjects experienced a significant reduction in pain, with a mean decrease of 6.33 points on the Visual Analogue Scale (VAS) pain scale, dropping from a baseline of 8.0 to 1.67 just seven days post-procedure. Patients also reported quick pain relief, with some feeling better as soon as one day after the procedure. A detailed look at the data should provide Autonomix with important insight into optimizing the procedure, particularly the catheter entry point, where three of the five patients who benefited with meaningful pain reduction had femoral access to the catheter and the two that did not respond had brachial access. The primary objective of this PoC trial is to assess the success rate of ablating relevant nerves to mitigate pain in patients with pancreatic cancer using radiofrequency ablation. Secondary objectives include evaluating device- and procedure-related adverse events up to six weeks post-procedure, changes in pain levels and improvements in quality of life from pre- to post-procedure. Autonomix is proceeding with enrolling an additional 20 subjects to participate in the study and expects to complete enrollment by the end of 2024. The company expects to report topline results from all 20 subjects in the first half of next year. Clinical Trial Testimonials According to Autonomix, patients in the responder group reported substantial improvements in their quality of life. On average, these patients noted a 78% enhancement in how they viewed their overall health and a 45% boost in how they viewed their life quality, within seven days of the procedure. This rapid relief is crucial for individuals facing end-of-life situations due to advanced pancreatic cancer, offering them a better quality of life during their remaining time. Patient testimonial s further emphasize the impact of the procedure. Before the procedure, patients can struggle with debilitating pain, which affects their ability to sleep, eat and perform daily activities. Post-procedure, patients experienced immediate, life-changing pain relief and could sleep on their back, return to work and attend social events. Additionally, one patient stated they no longer needed painkillers, and experienced significant improvements in overall health and quality of life. This transformation underscores the procedure's potential to greatly enhance the lives of patients suffering from pancreatic cancer pain. Technical Approach And Future Plans Autonomix's technology aims to improve upon current pain management methods, which often rely on systemic drugs like opioids or invasive procedures that can have severe side effects. Autonomix’s catheter-based system is also designed to detect and ablate pain-associated neural signals more accurately. While the current trial focuses on pancreatic cancer-related pain, Autonomix also plans to explore other indications in the future based on these promising results. A New Dawn In Pain Management Autonomix’s innovative approach to pain management for pancreatic cancer patients is showing encouraging potential. The initial success of its PoC clinical trial offers a glimpse into a possible future where patients suffering from severe pain can find relief through precise and effective medical technology. As the company gathers more data, the medical community awaits its results, which could revolutionize pain management far beyond just pancreatic cancer pain and have applications across all pain and diseases of the peripheral nervous system. Featured photo by Alexander Grey on Unsplash Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

July 12, 2024 08:45 AM Eastern Daylight Time

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Nevis Brands CEO Announces Strong Q2 Financial Results and Growth Plans

Nevis Brands

Nevis Brands CEO John Kueber joined Steve Darling from Proactive to announce the company's financial results for the second quarter, ending May 31st, 2024. Nevis reported cannabis beverage royalty revenues totaling $436,532, with a Cost of Goods Sold amounting to $145,170 and a Gross Profit of $291,392. This performance marks a 15 percent increase over revenues from the previous quarter. Kueber expressed his satisfaction with the company's growing revenues and positive EBITDA. He highlighted the ongoing expansion of Nevis's presence in active states, the development of their product line, and the increasing number of dispensaries selling Nevis products. According to Kueber, Q2 revenues were generated from sales in Washington, Oregon, California, Nevada, Colorado, Arizona, Ohio, and Missouri. He also mentioned that Michigan and Mississippi are still in pre-production phases and are expected to contribute to revenues in the third quarter. Looking ahead, Kueber emphasized Nevis's commitment to innovation, with plans to introduce new products to existing markets in 2024, ensuring the company continues to capture market share and drive growth. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

July 11, 2024 10:13 AM Eastern Daylight Time

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Cure Alzheimer’s Fund Announces 19th Straight Year of Record Results

Alzheimer’s Disease Research Foundation

Cure Alzheimer’s Fund has announced that 2023 marked its 19th consecutive year of record-breaking results for contributions raised to fund research into Alzheimer’s disease. A total of $34.8 million for the year represented an increase of more than 8% from 2022 in funds received through more than 22,000 generous gifts. In 2023, 114 research grants representing $27.8 million were issued to 147 scientists in 11 countries, the most ever in a single year. “Cure Alzheimer’s Fund exists to fund research that will end the burden of Alzheimer’s disease, and we are proud that in 2023 we supported more projects than ever before in our history. Our research, fundraising and all other activities are detailed with full transparency in our annual report,” said Meg Smith, CEO of Cure Alzheimer’s Fund. “New drugs to treat early-stage Alzheimer’s patients demonstrate the power of scientific perseverance and bring hope to our community. However, 6.9 million Americans are living with an Alzheimer’s diagnosis—and there are still no disease-altering treatments for most of them. More and better answers are needed to prevent the expected doubling of this patient population by 2050. We celebrate the progress that has been made and we stay determined to accelerate the progress necessary to benefit everyone at risk of, or living with, Alzheimer’s disease.” The 2023 Annual Report detailing the financial results and research investments is now available in the reports section of the Cure Alzheimer’s Fund website, CureAlz.org, or through this link: bit.ly/CureAlz2023AReport About Cure Alzheimer’s Fund Cure Alzheimer’s Fund is a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer’s disease. Since its founding in 2004, Cure Alzheimer’s Fund has provided 853 grants to more than 300 of the world’s leading researchers and contributed $204 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer’s disease. Cure Alzheimer’s Fund has received a 4-star rating for more than 12 consecutive years from Charity Navigator. Our Board of Directors, Trustees and a core group of other donors direct their donations to CureAlz overhead expenses so that 100% of general donations go to our research program. For more information, visit CureAlz.org. To learn about the impact of Alzheimer’s on women and women working toward a cure, visit WomenandAlzheimers.org. Contact Details Cure Alzheimer's Fund Barbara Chambers +1 978-417-9890 BChambers@CureAlz.org Company Website https://curealz.org

July 11, 2024 09:30 AM Eastern Daylight Time

Erectile Function Vs Erectile Dysfunction: How MangoRx’s (NASDAQ: MGRX) Product Sets Itself Apart and Caters to a Large Market (Pun Intended)

Benzinga

By Meg Flippin, Benzinga Ever since the pandemic, telemedicine has been taking off, and for good reason. It's easy, convenient and increases access for people around the globe. It can also be game-changing for men dealing with what they may consider embarrassing medical conditions like erectile dysfunction. After all, being seen online by a physician enables them to avoid any in-person awkward conversations. Not to mention it can be a lot cheaper and more accessible. And let's not forget the countless men who may not have a problem getting an erection but who want to enhance their performance and enjoy a prolonged and enhanced experience with their partner. They, too, can benefit from such products but often don’t obtain a prescription because they are embarrassed – such products are no longer only for erectile dysfunction but also for improved erectile function. Despite the benefits, it's only recently that men-focused healthcare companies have begun popping up online. They are changing the landscape, making it easy for men to seek help for conditions that aren’t life-threatening but can be life-altering, like ED or to simply keep it up for longer. Mangoceuticals, Inc. (NASDAQ: MGRX), which goes by MangoRx, is among them. It is taking the shame out of getting help and getting hard with its telemedicine platform and ED drugs, and is committed to a more accepting and educational approach to men’s health. Patients don’t have to come into an office to get a prescription. Everything is done online and in minutes. Fast delivery means customers are up and performing in no time. No Shame With MangoRx MangoRx is changing the narrative on ED with its fun and humorous brand voice meant to encourage and empower men to get the help they need. MangoRx uses cheeky humor and quite frankly straightforward language to market towards millions of men to, as they put it, simply have better sex. Taking the shame and awkwardness about common problem, the company is focused on developing, marketing and selling a variety of men’s health and wellness products in the area of ED, hair growth, weight loss and hormone replacement therapies. It leverages a telemedicine platform to discreetly treat its growing base of patients–it's a big market opportunity for MangoRx, especially for the treatment of ED. ED is a widespread and global problem that is rapidly growing, even among young adults. By the end of 2025 there are forecast to be about 322 million cases of ED. As a result, the market for ED drugs and treatments is projected to grow from $3 billion today to over $7 billion by 2032, representing a CAGR of 9% during the forecast period. Many cases of this treatable condition go undiagnosed, however, because of embarrassment. MangoRx’s opportunity isn’t only limited to men suffering from ED. The company’s product can also be used as a performance enhancer. With billions of men sexually active around the globe, the performance enhancement market is also a big one for the company. Drugs like Cialis and Viagra are household names, but there are others on the market that claim to offer benefits over the incumbent. MangoRx says it’s in that category. Its ED pill, Mango, is fast-acting, and the company says very effective. Mango hits the bloodstream in as little as ten minutes and lasts for up to four hours. That gives it a leg up over Viagra, which takes up to 60 minutes to work, and Cialis, which takes about 30 minutes. Treatments start at $12.50 a tablet, making it an affordable option compared to some of its rivals which include Hims & Hers (NYSE: HIMS), Maximus Tribe and Nu Image. Whether you are using it to perform or to enhance the experience, there is no pre-gaming or wining and dining with Mango. Ten minutes after taking the pill, you are ready to go for hours to come. Viagra And Cialis With A Twist Mango is created using a formula of the same active ingredients in Cialis (Tadalafil) and Viagra (Sildenafil). But instead of using just either of the two substances that have been proven to increase blood flow to the penis alone, Mango adds Oxytocin, the so-called love hormone that helps stimulate feelings of intimacy and L-Arginine, an amino acid that opens blood vessels and helps increase blood flow, to the mix. All four of the substances are FDA-approved and have been on the market for years. The result: a fast-acting pill that lasts for hours. Spontaneity is in with Mango. Developing a fast-acting ED pill that’s wallet-sized and tastes good is an achievement in itself, but MangoRx makes it easy to obtain the drugs, which is another game changer. Mango requires a prescription, but obtaining it is easy on MangoRx’s telemedicine platform. After completing an online telehealth visit, one of its network of medical providers will review and approve a prescription. MangoRx will ship it in a discreet box to maintain privacy. It's as simple as that, which appeals to its growing customer base. Sales in MangoRx’s first quarter rose 108%. Whether men need help with ED or want to enhance their sexual experiences, MangoRx makes it easy. The telemedicine platform is quick, easy and discreet. The pills are fast-acting, effective and affordable. With all that to offer, MangoRx seems to be on the way up – like its growing base of clients. Featured photo by Becca Tapert 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

July 10, 2024 09:15 AM Eastern Daylight Time

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Functional Medicine Network Strengthens Leadership with Appointment of Visionary Chief Financial Officer

Forum Health

Forum Health, LLC, the first nationwide network of integrative and functional medicine providers, is pleased to announce the appointment of Sean Whelan as its new chief financial officer. With a distinguished career spanning over three decades, including nearly two decades in healthcare services, Sean brings a proven track record and results-driven leadership to Forum Health. Learn more about Forum Health. Phil Hagerman, Forum Health CEO: "Mr. Whelan is an experienced financial executive with expertise in driving growth and leading transformation. His deep understanding of healthcare economics and commitment to financial stewardship will undoubtedly pilot Forum Health to the next phase of profitable growth.” As CFO, Whelan will lead strategic financial initiatives to enhance operational efficiency, mitigate risks, and foster expansion in a dynamic healthcare environment. Additionally, he will implement robust financial planning, foster stakeholder relationships, and guide investments in innovation and compliance, to ensure Forum Health remains competitive and resilient while delivering superior patient care. Sean Whelan, Forum Health CFO: "I am honored to join such a talented, forward-thinking leadership team at Forum Health that is at the forefront of redefining healthcare. Together, we will continue to push the boundaries of what is possible and deliver exceptional outcomes for our patients, clinics and many stakeholders." Whelan's accomplished background includes CFO roles at InfuSystem Holdings (NYSE MKT: INFU), Diplomat Pharmacy (NYSE: DPLO), and Smile America Partners, and both CEO and CFO roles at Encore Rehabilitation Services. At Diplomat, he led the company’s successful 2014 Initial Public Offering, and helped grow the business from $200 million to $4.5 billion during his tenure. He has held key leadership roles in closely held, private equity backed, and public companies. Sean also presently serves on the Board of Directors of Zomedica (NYSE MKT: ZOM) and the University of Michigan’s Ross School of Business Alumni Board of Governors. For more information about Forum Health and its services, please visit www.forumhealth.com. About Forum Health, LLC Forum Health, LLC is a nationwide provider of personalized healthcare steeped in the powerful principles of functional and integrative medicine. Our providers take a root-cause approach to care exploring lifestyle, environment, and genetics to help each patient achieve their ultimate health goals. Members have access to advanced medical treatments and technology, with care plans informed by data analytics and collaborative relationships. For more, visit www.forumhealth.com. Contact Details Forum Health Britt Wittelsberger +1 410-852-0738 bwittelsberger@forumhealth.com Company Website https://forumhealth.com

July 10, 2024 08:50 AM Eastern Daylight Time

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Disproportionate Rise In Pancreatic Cancer Among Young Women Highlights High Unmet Need To Find Safe, Effective Treatments – Is Hope On The Horizon?

Benzinga

By Anthony Termini, Benzinga In 2023, television personality Maria Menounos acknowledged that she had been diagnosed with pancreatic cancer. Fortunately for Menounos, physicians detected the rare, less aggressive form of the disease when it was still in an early stage. Pancreatic cancer is one of the least survivable forms of the disease. According to the National Institutes of Health (NIH), pancreatic cancer is currently the third leading cause of cancer-related deaths in America. Furthermore, Menounos’s case is part of a disturbing trend. Incidents of pancreatic cancer are increasing, with the number of cases in women under the age of 55 rising at a disproportionate rate compared to men. Pancreatic Cancer Is Difficult To Find And Painful To Treat When it is in the early stages, pancreatic cancer usually offers no clearly-identifiable symptoms. The types of screens suggested for breast cancer or colon cancer don’t exist for pancreatic cancer, and there is no single diagnostic test to detect it. According to Johns Hopkins University, a clear diagnosis typically emerges only after an extensive series of imaging scans, blood tests and biopsies. Since these tests are generally conducted only after symptoms are felt, an initial diagnosis often reveals that the cancer is in an advanced stage that has spread to other organs. As a result, most patients tend to get a relatively aggressive form of chemotherapy. The combination of drugs used can often result in severe side effects. However, that may change as a result of work being conducted in current clinical trials. A Novel Approach To Treat Pancreatic Cancer Holds Promise Rockville, Maryland-based Theriva Biologics (AMEX: TOVX) is currently in a phase 2b trial with patients diagnosed with metastatic pancreatic ductal adenocarcinoma (PDAC). Theriva is a leader in the development of oncolytic virus therapies – treating cancer with viruses that target tumors. Theriva’s lead therapy candidate is VCN-01, a highly differentiated oncolytic adenovirus that replicates and destroys cancer tissue. The trial is studying the use of VCN-01 in combination with two forms of chemotherapy drugs. Oncolytic virus therapies target specific genes or proteins involved in the disease process to block or alter their activity and ultimately halt or reverse disease progression. The goal is to help patients live longer with less severe side effects. Theriva’s trial results so far appear promising. “We believe VCN-01’s differentiated mechanism of action has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the tumor matrix and increasing tumor access,” said Steven Shallcross, Theriva’s CEO. The company’s current clinical trial is studying a combination of VCN-01 with a drug that mimics some of the building blocks of RNA and DNA to disrupt a cancer cell’s ability to make proteins (Gemcitabine) and one that includes a human protein to stop cancer cells from dividing and multiplying (nab-Paclitaxel). The NIH notes that gemcitabine has been the standard first-line treatment for advanced pancreatic cancer for 15 years and is often used in combination with nab-paclitaxel as first-line treatment for pancreatic cancer. Theriva’s Shallcross noted that repeated systemic dosing of VCN-01 with this standard-of-care chemotherapy is feasible from a safety perspective. “We have shown that the combination has an acceptable safety profile, and can now focus on whether the repeated-dose VCN-01 regimen may lead to improved clinical outcomes for patients with PDAC and other solid cancers,” he said. Studying Pancreatic Cancer Offers Challenges, And The Need Is Large According to gastrointestinal oncologist Mridula Krishnan, MBBS, “Pancreatic cancer is not an easy cancer to study and, especially when it comes to gender-related studies, it’s very tough to find answers.” This is part of what makes Theriva’s work so important. The company believes that its oncolytic viruses are particularly well-positioned for use with other therapies to help pancreatic cancer patients achieve improved outcomes with fewer negative side effects. Mr. Shallcross noted that there is a “high unmet need” and that the company is continuing “to build a portfolio of potentially improved therapeutic combinations for PDAC patients.” According to DataBridge Market Research, that high unmet need is estimated to reach more than $6.2 billion by 2029. Theriva Biologics is also exploring the potential of VCN-01 as a possible candidate as part of other chemotherapy combinations to treat pediatric refractory retinoblastoma and adult ovarian cancer. Featured photo by PublicDomainPictures 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

July 09, 2024 08:45 AM Eastern Daylight Time

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Delivra Health CEO Gord Davey discusses Middle East expansion with new Dubai UAE sales territory

Delivra Health Brands Inc.

Delivra Health Brands Inc. (TSX-V:DHB) CEO Gord Davey discusses the company’s recent expansion efforts in the Middle East during an interview with Proactive's Stephen Gunnion. Davey highlighted a successful trip to Dubai, where Delivra has partnered to target the United Arab Emirates (UAE) as a new sales territory. This move aligns with the company's strategy to expand its brand presence in the region. Delivra's product, Dream Water, which is already registered as a drug product and widely available in pharmacies across Saudi Arabia, will now be distributed throughout the UAE. Davey acknowledged the challenges faced during the nine-month process of regulatory approvals but credited their local partner’s expertise in navigating these complexities. He emphasized the significant market potential in the UAE, driven by a growing population and widespread sleep issues, which Dream Water aims to address. Looking ahead, Davey mentioned ongoing efforts to expand into additional territories in the Middle East, although he did not specify which countries due to pending regulatory approvals. He assured that the company is committed to global growth and will continue to update shareholders on progress. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 04, 2024 11:01 AM Eastern Daylight Time

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Vivos One Step Closer To Transforming Cancer Treatment With FDA Application To Start Human Trials For Pioneering Injectable Brachytherapy Device

Vivos Inc.

By Meg Flippin, Benzinga In what could prove to be a transformational development in cancer treatment, Vivos (OTCQB: RDGL), the maker of the Radiogel™ Precision Radionuclide Therapy, submitted an application to the U.S. Food and Drug Administration (FDA) to initiate human clinical trials. The Investigational Device Exemption (IDE) application is an amendment addressing the FDA’s comments about the company’s previous application. Once it's granted approval, Vivos can begin testing its therapy on humans to treat solid metastatic tumors, particularly in lymph nodes associated with papillary thyroid cancer. How RadioGel Works RadioGel, a pioneering Yttrium-90-based injectable brachytherapy device, represents what the company says is a groundbreaking approach to cancer treatment. It is designed for patients who are either not eligible for surgery or have chosen not to undergo the procedure, particularly those with non-radioiodine avid disease and limited burden regional nodal disease. The therapy involves directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor. This method allows for a more localized and potent radiation treatment compared to traditional external-beam radiation therapies. First Filing Since Breakthrough Device Designation The application marks Vivos’ first filing with the FDA since being granted FDA Breakthrough Device Designation for the Radiogel ™ Precision Radionuclide Therapy. The Breakthrough Devices Program by the FDA is designed to accelerate the development and review of innovative technologies that show potential for more effective treatment options. The program's support is instrumental in hastening patient access to promising medical advancements like RadioGel. The technology behind RadioGel allows for the safe delivery of higher doses necessary for treating non-resectable and radiation-resistant cancers. The product also boasts a short half-life, delivering over 90% of its therapeutic radiation within ten days. That will be welcome news to cancer sufferers, given other treatments can require up to six weeks for a full course of radiation therapy. Additionally, the outpatient nature of the RadioGel therapy means patients can return home without concerns about radiation exposure to family members. Vivos Is Ready Since receiving that status, Vivos said the communication with the FDA has improved further, which is important to ushering this treatment along. The IDE filing includes reports on two studies – RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. Vivos said the IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, the company repeated underlying testing to strengthen its answers with current data. “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly,” said Dr. Michael Korenko, President and CEO of Vivos. “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.” Vivos, in collaboration with the Mayo Clinic, is working hard to develop treatments to fight challenging cancer types, offering hope and potentially more effective treatment options to people around the globe. The IDE application puts it one step closer to realizing that dream. Featured photo by National Cancer Institute on Unsplash. Vivos Inc. has developed a Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat solid tumors in animals (IsoPet®) and humans (RadioGel™). Using the company's proprietary hydrogel technology, brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michael K. Korenko info@vivosinc.com Company Website http://www.vivosincusa.com

July 02, 2024 09:00 AM Eastern Daylight Time

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