News Hub | News Direct

News Release

Tonix Pharmaceuticals begins Phase 1 trial of TNX-1500 in healthy participants

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to announce the company has initiated a Phase 1 clinical study involving TNX-1500 in healthy volunteers, focusing on single ascending dose escalation. The primary objectives of this study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500. TNX-1500 is a pharmaceutical product under development for the prevention of kidney transplant rejection, as well as other potential indications related to transplantation and autoimmune disorders. Lederman highlighted that recent animal studies have shown promising results, indicating that TNX-1500 has the potential to prevent organ rejection and maintain graft function, either as a standalone treatment or when combined with other drugs. The Phase 1 study will involve the evaluation of eligible participants over a 120-day period after dosing, with a target enrollment of 36 participants. The initiation of this Phase 1 study is a crucial step towards supporting the dosing regimen for an upcoming Phase 2 trial involving kidney transplant recipients. Tonix Pharmaceuticals is optimistic about TNX-1500's potential to improve long-term graft survival with reduced toxicity compared to current immunosuppressive treatments. Additionally, the company believes that TNX-1500 could address various indications, including autoimmune diseases beyond transplantation. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 28, 2023 01:13 PM Eastern Daylight Time

Video

Reprise Biomedical’s Miro3D® Wound Matrix Granted Level II HCPCS Code by CMS

Reprise Biomedical

Reprise Biomedical, Inc., a leading innovator in medical biotechnology for wound care, is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) has assigned a Level II Healthcare Common Procedure Coding System (HCPCS) code to its revolutionary Miro3D wound matrix, effective October 1, 2023. Miro3D is a three-dimensional porcine-derived acellular graft designed to create a protective environment for wounds, specifically for use in cases requiring coverage of and conformance to intricate, tunneling, and irregular wound beds. Available in four sizes, Miro3D features a consistent two-centimeter-thick porous sheet scaffolding structure. When hydrated, Miro3D softens slightly, adapting well to various wound bed shapes and can be fixated to surrounding tissue using preferred methods such as sutures or staples. CMS has assigned HCPCS Level II code A2025, ‘Miro3d, per cubic centimeter,’ to Miro3D. This new Level II HCPCS code permits healthcare providers to bill Medicare and other insurance carriers for Miro3D, thereby making Miro3D more accessible to patients across the country. CMS’s acceptance of Reprise Biomedical’s HCPCS application and coding assignment reinforces the company’s commitment to becoming a leading provider of innovative medical technologies devoted to enhancing patient outcomes and quality of life. “At the core of Reprise Biomedical’s product portfolio lies Miro3D—a completely unique three-dimensional wound care solution,” commented Carrie Powers, CEO of Reprise Biomedical. “The three-dimensional sheet scaffolding structure of Miro3D, which can be tailored to fit wound sizes through trimming or cutting, is transforming the treatment landscape for deep and tunneling wounds, diabetic foot ulcers, and other advanced wound conditions,” Ms. Powers added. About Reprise Biomedical, Inc.: Reprise Biomedical, Inc. is focused on creating and delivering innovative solutions for wound care management through its proprietary perfusion decellularization technology. With a dedication to advancing healthcare, Reprise Biomedical aims to reshape the wound care landscape by offering next-generation technologies that significantly elevate patient outcomes. As the company continues to grow its product portfolio, patients and healthcare providers alike can look forward to the positive impact of Reprise Biomedical’s wound healing solutions. To learn more about Reprise Biomedical and its innovative Miro3D product, please visit https://reprisebio.com. Contact Details Contact Carrie Powers, CEO +1 763-284-6780 cpowers@reprisebio.com Company Website https://reprisebio.com

August 28, 2023 08:00 AM Central Daylight Time

Back-to-School Nutrition SOS: Tackling the Uneaten Lunch Dilemma with Smart Nutrition Solutions

YourUpdateTV

When it comes to parenting, ensuring your child's nutrition is a top priority. But what do you do when lunchboxes come home virtually untouched? Recently, Childhood Nutrition Expert Dr. Nicole Avena participated in a satellite media tour campaign to share insights on how to conquer the lunchtime challenge and ensure your kids are getting the nutrients they need. A video accompanying this announcement is available at: https://youtu.be/ybOpf0vrJvc During back-to-school season, a major concern among parents is whether their child is getting enough nutrients, especially when they come home with a full lunch box. SmartyPants Vitamins are the perfect addition to your family’s routine. As the preferred vitamin brand for parents of picky eaters, SmartyPants is industry-leading in the comprehensiveness of its formulations, its transparency, and advocacy, with 40+ Clean Label Project® certified products rid of GMOs and synthetic colors. Their Kids Formula and Kids Formula & Fiber are made with Vitamin D3 for immune support, and their Kids Prebiotic & Probiotic Immunity Formula is made with two strains of probiotics to support digestive health and the immune system. Additionally, SmartyPants’ Vitamins will appeal to even the pickiest eaters with their great taste (like Strawberry Crème for the Prebiotic & Probiotic Immunity Formula and Lemon, Orange, and Strawberry Banana for the Kids Formula) in a delicious gummy they’ll actually enjoy taking day after day. What's more - SmartyPants also offers a premium Women's Formula to help mom to stay on her A game during this busy, stressful time frame. SmartyPants Vitamins are available nationwide in-store and online at dozens of major retailers and on Amazon. For more information about SmartyPants visit smartypantsvitamins.com ------------------------------------------------------ *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. DR. NICOLE AVENA BIO As a member of SmartyPants Vitamins' Scientific Advisory Board, Dr. Nicole Avena is a research neuroscientist and expert in the fields of childhood nutrition, diet during pregnancy, and food addiction. She received a Ph.D. in Psychology and Neuroscience from Princeton University, completed her postdoctoral fellowship at Rockefeller University, and is presently Assistant Professor of Neuroscience at Icahn School of Medicine at Mount Sinai in New York City and a Visiting Professor in Health Psychology at Princeton University. In addition to a number of best-selling books, including What to Eat When You Want to Get Pregnant, and over 90 scholarly journal articles, she regularly appears on a variety of television and radio programs. ABOUT SMARTYPANTS VITAMINS Founded in 2011, SmartyPants Vitamins is a purpose-led supplement brand on a mission to simplify health for families without sacrificing quality. As the best vitamin brand for kids and families, SmartyPants supplements are formulated with premium nutrients and high-quality ingredients—and a delicious taste and texture that appeals to picky eaters. All SmartyPants supplements are third-party lab tested for purity, potency and safety. From its inception, SmartyPants has generated life-changing nutrient donations for women and children in the U.S. and globally via the brand’s partnership with Vitamin Angels. To learn more, visit smartypantsvitamins.com or check out @smartypants on Instagram. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

August 24, 2023 12:02 PM Eastern Daylight Time

Video

Headline

G-Medical Innovations Holdings Ltd

G Medical Innovations Holdings Ltd. (OTC: GMVDF) (“G Medical Innovations”), an industry innovator in comprehensive remote patient monitoring solutions, announced yesterday that on August 22, 2023, it received a letter from the staff of The Nasdaq Stock Market (the “Exchange” or “Nasdaq”) notifying the Company that the Nasdaq Hearings Panel has determined to delist the Company’s ordinary shares from the Exchange, based on the Company’s failure to comply with the minimum $2,500,000 stockholders’ equity requirement under Nasdaq Listing Rule 5550(b). The Company’s ordinary shares are expected to be traded on the over-the-counter (OTC) Pink. The Company’s receipt of the letter from Nasdaq does not affect the Company’s business, operations, or reporting requirements with the Securities and Exchange Commission (“SEC”). Dr. Yacov Geva, Chief Executive Officer of G Medical Innovations commented “while we regret the delisting of our shares from Nasdaq, we remain confident in the long term growth and success of the Company. We will work relentlessly to get our shares listed back on a national securities exchange as soon as practicable”, Dr Geva concluded. About G Medical Innovations G Medical Innovations is a health care company engaged in the development of next generation mHealth and telemedicine solutions and monitoring service platforms. The Company’s solutions and services can empower consumers, patients, and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease, pulmonary disease, and diabetes. The Company’s current product lines consist of its Prizma medical device, a clinical-grade device that can transform almost any smartphone into a medical monitoring device, enabling both health care providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators; its Extended Holter and Monitoring Cardiac Telemetry Patch services, utilizing multi-channel patient-worn biosensors with algorithms, to generate real time analysis and transmission that captures electrocardiography data continuously, including QT syndrome prolongation detection. In addition, the Company is developing its wireless vital signs monitoring system, which is expected to provide full, continuous, and real-time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of independent diagnostic testing facility monitoring services and private monitoring services. For more information about G Medical innovations, visit https://gmedinnovations.com/. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, G Medical Innovations is using forward-looking statements when it discusses its intention to quote its shares and warrants on the OTCQB or OTCQX, when it discusses the Company’s long term growth and success, when it discusses working to get the Company’s shares listed back on a national securities exchange as soon as practicable, or when the Company discusses the potential benefits of G Medical Innovations’ technology and products. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of G Medical Innovations could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in G Medical’s Innovations Annual Report on Form 20-F for the year ended December 31, 2022, filed with the SEC on May 16, 2023, and our other filings with the SEC, which are available on the SEC’s website, www.sec.gov. Except as otherwise required by law, G Medical Innovations undertakes no 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. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Investor Relations Contact G Medical Innovations service@gmedinnovations.com G Medical Innovations Holdings Ltd. is a health care company engaged in the development of next generation mHealth and telemedicine solutions and monitoring service platforms. The Company’s solutions and services can empower consumers, patients, and providers to better monitor, manage and improve clinical and personal health outcomes, especially for those who suffer from cardiovascular disease, pulmonary disease, and diabetes. The Company’s current product lines consist of its Prizma medical device, a clinical-grade device that can transform almost any smartphone into a medical monitoring device, enabling both health care providers and individuals to monitor, manage and share a wide range of vital signs and biometric indicators; its Extended Holter and Monitoring Cardiac Telemetry Patch services, utilizing multi-channel patient-worn biosensors with algorithms, to generate real time analysis and transmission that captures electrocardiography data continuously, including QT syndrome prolongation detection. In addition, the Company is developing its wireless vital signs monitoring system, which is expected to provide full, continuous, and real-time monitoring of a wide range of vital signs and biometrics. Its monitoring services include provision of independent diagnostic testing facility monitoring services and private monitoring services. This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, G Medical Innovations is using forward-looking statements when it discusses: revenue growth and profitability in future periods; the launch of the Company’s CLIA lab in Austin, TX, the Company’s online store for its Prizma Monitoring Devices on Amazon Marketplace and the Company’s HTKs business and online stores; potential announcements with large homecare service companies and large distributors for devices and At Home Test Kits; and the Company’s plans to expand its line of monitoring products and services offered to patients, hospitals and clinics. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of G Medical Innovations could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties,, including those discussed under the heading “Risk Factors” in G Medical’s Innovations Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on May 16, 2023, and our other filings with the SEC, which are available on the SEC’s website, www.sec.gov. Except as otherwise required by law, G Medical Innovations undertakes no 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. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Contact Details G Medical Innovations Investor Relation +972 8-958-4777 service@gmedinnovations.com Company Website https://gmedinnovations.com

August 24, 2023 11:30 AM Eastern Daylight Time

Dental Savings Plans Give The 76% Of Seniors Without Dental Insurance A Way To Manage The Costs Of Oral Care

DentalPlans.com

By Rachael Green, Benzinga The CDC estimates that 24% of the nation’s population – or 98 million adults – will be 65 or older by 2060. One in five of those older adults will lose all of their teeth. Among the rest, about 68% will have gum disease and 20% will have untreated tooth decay. One of the main barriers is the high cost of dental care, especially for those without insurance. When someone reaches retirement, that often means transitioning out of their employer-sponsored health plan and onto Medicare – which doesn’t cover regular dental care. As a result, just 24% of seniors have dental insurance, compared to 54% of working adults. If they enroll in a Medicare Advantage Plan or meet their states’ eligibility requirements for Medicaid, they may be able to add some dental coverage. But even then the average annual limit is $1,300 and more than half of those who do have dental benefits have an annual maximum of $1,000 or less. Once that limit is reached, beneficiaries have to pay for the rest of their dental care out of pocket. Just one restorative treatment could max out your coverage, leaving you without coverage when you need to see the dentist next, until your plan resets. With so many retirees living on a fixed income, those out-of-pocket costs can pose a high enough burden that many people avoid or delay the care they need. Dental Savings Plans Help Lower The Barriers To Better Oral Health Dental savings plans are an increasingly popular alternative or supplement to dental insurance. These plans work like a membership program where plan members pay a low annual fee to gain access to members-only discounts at any of the 140,000 participating dentists nationwide. Plan members report an average saving of 50%* on their dental care, and plans activate within one to three business days of signing up. Once activated, plan members can enjoy the discounted rates on virtually any procedure with no annual limit or restrictions based on current health conditions. For those with dental insurance through Medicare Advantage or other, a dental savings plan can help lower the out-of-pocket costs once they reach their annual limit by providing discounts on future procedures after you hit your maximum. For those with no insurance at all, a dental savings plan can make preventive, restorative and even emergency dental care affordable, even on a tight budget. To learn more about dental savings plans and see how much you can save, visit DentalPlans.com. Their online tools and resources make it quick and simple to compare plans and get a personalized plan recommendation in minutes. *Discount Health Program consumer & provider surveys indicate average savings of 50%. Sample savings are based on zip code 43614, actual savings may vary by provider, location, and plan. DentalPlans.com, founded in 1999, is a leading online marketplace for dental savings plans in the U.S., helping more than a million people to affordably access quality healthcare services. Our mission is to empower consumers with the tools, information, and services that they need to live happier, healthier lives. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Matthew Wong matthew.wong@wpromote.com Company Website https://www.dentalplans.com/

August 24, 2023 09:45 AM Eastern Daylight Time

News Release

Revolutionizing Healthcare: G Medical Innovations shares future of remote monitoring and home testing

G Medical Innovations Holdings Ltd

G Medical Innovations President Nir Geva joined Steve Darling from Proactive to share significant updates about the company's groundbreaking strides in the realm of mobile health and telemedicine solutions. G Medical Innovations is at the forefront of developing cutting-edge platforms that facilitate the next era of healthcare monitoring services. The company's comprehensive solutions and services are engineered to empower a diverse spectrum of stakeholders, including consumers, patients, and healthcare providers. By offering robust tools for monitoring, managing, and enhancing both clinical and personal health outcomes, G Medical Innovations is shaping the landscape of modern healthcare. Presently, the company is structured around three core revenue-generating verticals. First and foremost is the Vitals Monitoring Business, dedicated to remote patient monitoring. This segment involves harnessing advanced technology to enable the seamless monitoring of patient vitals from a distance. Another crucial aspect is the 31 At Home Tests Kits, which cater to a wide array of diagnostic needs, ranging from minor allergies to more serious conditions like sexually transmitted diseases. The third vertical is a hub of Research and Development activities in Israel, continually striving to forge the next wave of monitoring solutions and algorithms. Moreover, G Medical Innovations unveiled exciting developments in its Home Testing Kit business. The company initiated a wholesale sales consulting agreement with Ideaology 360, exclusively appointing them as the wholesale sales representative in the United States. This collaboration aims to fortify G Medical Innovations' strategic approach for both online and retail sales, enhancing accessibility to their innovative testing kits. These kits have the capacity to diagnose a broad spectrum of ailments and deliver results within a remarkably swift 24-48 hours upon laboratory receipt. The company's forward-looking approach is exemplified by its upcoming product expansions. G Medical Innovations is set to introduce a blood pressure watch and an Oxygen saturation watch that operate in tandem. This combination promises the capability to continually monitor blood pressure during sleep, effectively detecting abrupt fluctuations that could potentially signify the onset of chronic diseases or sleep disorders. This groundbreaking service is anticipated to debut in the fourth quarter of 2023, underscoring G Medical Innovations' commitment to pioneering advancements in healthcare technology. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 23, 2023 01:48 PM Eastern Daylight Time

Video

Graft Polymer eager to push on after signing fresh manufacturing agreement

Graft Polymer (UK) PLC

Graft Polymer (UK) PLC (LSE:GPL) independent non-executive director Alex Brooks speaks to Thomas Warner from Proactive after the polymer modification company announced the signing of a manufacturing agreement with an undisclosed Israeli pharmaceutical partner to produce a patented blood-clotting powder at its GraftBio facility in Slovenia. The product, designed to stimulate blood coagulation, holds versatile applications in wound care and surgical procedures. Brooks explains that Graft Polymer's expertise in polymer knowledge and complex manufacturing processes makes them a natural choice to produce the powder. He expresses optimism that such self-emulsifying nano emulsion products could become a revenue generator. While the main focus remains on their core activities, this segment holds potential strategic importance. Brooks also draws attention to the importance of Graft Polymer's Slovenian manufacturing facility to being able to fulfil orders of this type reliably and at scale. He says that Graft is "excited about the potential to really help our customers really achieve whatever product performance characteristics they're looking for." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 23, 2023 08:00 AM Eastern Daylight Time

Video

Atossa Therapeutics backing Endoxifen in the fight against breast cancer

Atossa Therapeutics Inc

Atossa Therapeutics (NASDAQ:ATOS) President & CEO Dr. Steven Quay joins Thomas Warner from Proactive to speak about the latest developments in his and the clinical-stage biopharma company's fight against breast cancer. Dr. Quay gives an overview of ongoing clinical trials centered around their innovative drug, oral Endoxifen. The drug combines oestrogen receptor degradation, suppression, and PKC beta inhibition to combat breast cancer. The trials are conducted at different stages of breast cancer management. One focus is on breast cancer prevention, specifically targeting high mammographic breast density, a significant risk factor. Dr. Quay emphasises the link between density and cancer risk, noting the potential for changing mammograms' readability and reducing future risk. He goes on to talk about a trial of Endoxifen during what is known as the neoadjuvant window, the period between diagnosis and initial treatment, which is aimed at rapidly reducing tumour activity after diagnosis. These trials, held at Mayo Clinic and UCSF, test the drug's impact on oestrogen-driven cancers, where current treatments often fall short. Additionally, the CEO discussed Atossa's broader motivations, underscoring breast cancer's prevalence and the immense impact it has on individuals and society. He goes on to discuss the company's financial position. with approximately $99.4 million on the balance sheet as of Q2, enabling continued research and development. Dr. Quay also reveals research collaborations at Weill Cornell Medical Centre targeting triple-negative breast cancer, a particularly aggressive form. These efforts seek to transform it into a more treatable type, potentially revolutionising treatment options. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 23, 2023 08:00 AM Eastern Daylight Time

Video

BiVictriX Therapeutics passes "exciting milestone" with US patent for BVX001

BiVictriX Therapeutics PLC

BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) founder and CEO Tiffany Thorn speaks to Thomas Warner from Proactive after announcing that the UK-based drug discovery and development company has been granted a patent for its primary cancer treatment BVX001 by the United States Patent and Trademark Office (USPTO). Thorn describes the granting of the US patent as an "exciting milestone" for the business and explains that the patent marks a significant achievement for the company as it encompasses broad claims, unlike the typical narrow specifications for antibody therapeutics. She highlights that BiVictriX's approach allows for more extensive intellectual property protection. The company's global focus is evident, with patent prosecution spanning eight jurisdictions, including Japan, a pivotal market. A Notice of Allowance has been received from the Japanese patent office that showcases even broader protection than the US grant. Thorn also discusses a recent £2.1mln fundraise and an intensification of business development efforts, including participation in an upcoming partnering conference. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 23, 2023 06:43 AM Eastern Daylight Time

Video