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NanoViricides progressing well with new Covid study

NanoViricides

Proactive research analyst John Savin speaks to Thomas Warner after publishing a research note about the latest Covid trial from development-stage antiviral company NanoViricides (NYSE-A:NNVC). The ongoing NV-CoV-2 Phase Ia clinical study is a key milestone in the development of Nanoviricides' (NV) novel and innovative anti-virus therapy, NV-CoV-2 uses a sophisticated polymer (NV-387) as the active ingredient to trap and disrupt viruses in the blood. The polymer is integrated into the product which has now entered a clinical trial in India. With 26 out of 36 non-COVID volunteers completing the single dose stage and 17 advancing to the multi-dose phase, the trial has achieved a significant milestone. The absence of safety concerns is noteworthy. The trial examines two administration routes: a gummy and a syrup. Crucially, the trial aims to determine blood levels and safety, laying the foundation for potential efficacy. A subsequent trial will involve 36 mild-to-moderate COVID-19 patients. Despite the emergence of new virus strains, NanoViricides remains optimistic, as the env 387 polymer may enhance binding effectiveness. Click the provided link to access John Savin's comprehensive research on this exciting development. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 31, 2023 08:00 AM Eastern Daylight Time

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hVIVO announces move to "good facility at a very good price"

hVIVO PLC

hVIVO PLC (AIM:HVO) chief executive Mo Khan speaks to Thomas Warner from Proactive after the specialist contract research organisation announced plans for a new state-of-the-art consolidated challenge trial facility at the life sciences hub in Canary Wharf, London. The expansion, largely funded by hVIVO clients, reflects a growing order book and increasing demand for its human challenge trial services, the company said in a statement. The move involves bringing together quarantine beds, laboratories, and corporate offices into one facility. Notably, the new space will accommodate up to 70 quarantine beds, a significant increase from the previous capacity. The enhanced laboratory space will enable more concurrent studies, fostering revenue growth. He notes that hVIVO's "hugely successful screening facilities in Plumbers Row in East London and in Manchester will remain at their current locations, but the rest of the company will be consolidating into one facility." The phased move is expected to be completed in Q2 of the coming year and promises expanded capabilities, operational efficiency, and sustained growth for hVIVO. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 31, 2023 05:48 AM Eastern Daylight Time

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Willow Bioscience shifts focus to opportunity with BioOxi bio-oxidation platform

Willow Biosciences Inc.

Willow Bioscience CEO Dr Chris Savile joined Steve Darling from Proactive to share news the company has embarked on a major strategic shift, focusing its commercial efforts on the BioOxi platform. To assist in this transition, Willow Biosciences has engaged an advisor to explore and evaluate potential opportunities. This move is part of a broader strategy that also encompasses a collaborative venture with a Nasdaq-listed biopharmaceutical company. Together, they are working to establish sustainable manufacturing routes for key intermediates and active pharmaceutical ingredients. Savile highlighted the company's achievements in executing successful commercial programs. Notably, four new programs linked to the BioOxi bio-oxidation platform technology were launched in April 2023. Willow Biosciences is now concentrating on partner-funded enzyme engineering engagements, a strategic shift aimed at enhancing cost efficiency and optimizing the pathway to revenue growth. This refocusing strategy aligns with the company's commitment to unlocking nearer-term and potentially larger revenue opportunities, particularly compared to its legacy strain engineering business. Furthermore, Savile shared insights into the company's operational evolution. Willow Biosciences has completed a seamless transition, consolidating its operations into a single, cost-efficient facility located in Sunnyvale, California. This facility not only caters to the present needs of the company but also accommodates future growth prospects. With ample laboratory space, Willow Biosciences can continue to expand its collaborative efforts while maintaining a financially prudent approach, in contrast to previous locations. bolstered by cost-effective operations and a focused commercial approach. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 29, 2023 01:39 PM Eastern Daylight Time

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FNIH and PathAI Forge Partnership to Advance Mucosal Healing in Ulcerative Colitis Research

PathAI

PathAI, a leading provider of AI-powered pathology tools to advance precision medicine, is pleased to announce that the Foundation for the National Institute of Health's (FNIH) Biomarkers Consortium - Mucosal Healing in Ulcerative Colitis project team has selected PathAI to be its technology partner to further the study of mucosal healing, bring AI-assisted precision to disease assessment, and drive cutting-edge research to facilitate the development of new therapies for ulcerative colitis (UC), a disease affecting 1 to 2 million in the US alone. 1, 2 “Ulcerative colitis is an increasingly prevalent chronic disease. The lack of standardized measurement and definition of mucosal healing poses a significant challenge for UC drug development, limiting treatment options for patients,” said James O’Leary, Director, Inflammation and Immunity at the FNIH. Though nearly 200 active clinical trials support on-going development of new treatments and therapies, 3 no standard histological measure exists. “Through this collaborative project with PathAI, together we aim to establish a reproducible methodology for histological measurement of mucosal healing in UC treatment.” PathAI’s groundbreaking AI product, AIM-HI UC (AI-based Measurement of Histological Index for Ulcerative Colitis), will serve as the exclusive platform for automated Geboes-based disease assessment for the consortium. This innovative approach will provide invaluable insights into mucosal healing, enabling better capture of true drug effect/signal-to-noise ratio for UC treatments. Furthermore, this partnership holds the potential to fuel biomarker development by unraveling the inflammatory microenvironment of ulcerative colitis. The FNIH Biomarkers Consortium brings together eight prominent biopharmaceutical companies, two prominent disease area foundations, academic partners, and the FDA in an unprecedented effort to standardize and enhance disease assessment in the field of ulcerative colitis. By selecting PathAI as its technology partner, the consortium aims to leverage PathAI’s expertise in AI algorithms to achieve a more accurate and reproducible scoring of mucosal healing and provide improved prediction of long-term patient outcomes. The project will culminate in a common protocol and white paper that will be submitted to the FDA to influence regulatory guidance for future UC clinical trials. "PathAI's algorithms will elevate our ability to investigate novel relationships, signatures, and biomarkers in UC" said Andy Beck, CEO of PathAI. "By embracing an AI-driven standardized approach, we increase accuracy and reduce scoring variability for therapeutic response assessment. We are excited to be part of this groundbreaking project, with the ultimate goal of accurately predicting long-term patient outcomes and driving industry-wide consensus." One distinguishing feature of AIM-HI UC is that it is built on exhaustive WSI tissue segmentation and cell classification models, providing a quantitative and objective basis for a normally subjective assessment. Compared to traditional pathologist scoring, AIM-HI UC has demonstrated higher accuracy in measuring critical Geboes metrics essential to histological healing, including GS2A, GS2B, and GS3. AIM-HI UC is intended for research use only, not for use in diagnostic procedures, serving as a secondary and/or exploratory endpoint in clinical trials. It enables the identification of histologic remission (GS<2) and histologic improvement (GS≤3.1). Additionally, it facilitates translational research and retrospective deployment. To learn more about AIM-HI UC and the underlying algorithm driving this groundbreaking research, please visit www.pathai.com/aim-hiuc or contact PathAI. Footnotes 1 https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/multimedia/vid-20522485 2 https://www.asge.org/home/for-patients/patient-information/understanding-ulcerative-colitis 3 https://www.clinicaltrials.gov About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. About FNIH The Foundation for the National Institute of Health (FNIH) is a non-profit organization that provides critical support to the National Institutes of Health (NIH). FNIH works to advance biomedical research by fostering public-private partnerships and collaborations that accelerate the development of new treatments and therapies. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 29, 2023 10:00 AM Eastern Daylight Time

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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

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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

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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

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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

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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

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