Glucotrack to present on next-generation continuous blood glucose monitoring technology in Innovation Hub Poster presentation to highlight insights on safety and performance data from direct blood glucose measurement technology RUTHERFORD, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK), a medical device company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced it will present safety and performance data from it ...

Core Insights - BioSig Technologies, Inc. has appointed Sean Roosen as Strategic Advisor to its wholly owned subsidiary, Streamex Exchange Corporation, following its acquisition in May 2025 [1] - Sean Roosen is a prominent figure in the mining industry with over 30 years of experience, having founded and led multiple successful resource ventures [2][3] - Streamex aims to revolutionize commodity markets through real-world asset tokenization, enhancing liquidity and accessibility in the financial sector [6][8] Company Overview - BioSig Technologies, Inc. is a medical device technology company known for its PURE EP™ Platform, which aids electrophysiologists in treating cardiovascular arrhythmias [9] - Streamex focuses on tokenizing real-world assets in the commodities space, developing infrastructure for primary issuance and exchange [6][8] Leadership and Expertise - Sean Roosen has a notable track record, including founding Osisko Development Corp. and leading Osisko Mining Corporation, which developed the Canadian Malartic mine [2][3] - The advisory board of Streamex includes other industry leaders, such as Frank Giustra, who has founded companies with significant market capitalizations [7] Strategic Vision - The company believes in the future of finance being driven by tokenization and decentralized markets, aiming to bridge traditional finance with the digital economy [8] - Roosen expressed enthusiasm about joining Streamex, highlighting the potential of bringing the resource sector into the digital age through tokenized assets [5]

Core Viewpoint - Fresenius Medical Care is advancing its high-volume hemodiafiltration (HVHDF) kidney replacement therapy in the U.S. following FDA clearance for its updated 5008X CAREsystem, marking a significant step in the company's commercialization strategy for 2025 and a full-scale launch in 2026 [1][2][7] Company Developments - The updated 5008X CAREsystem received FDA 510(k) clearance, enabling Fresenius Medical Care to enhance patient care through improved dialysis technology [2][4] - The company plans to deploy the new system in a first wave of Fresenius Kidney Care clinics throughout 2025, with broader implementation expected in 2026 [2][3] - The 5008X CAREsystem features the Fresenius Clinical Data Exchange® (CDX), which allows for direct access to medical information systems at the chairside, optimizing clinic workflows and reducing clutter [2][4] Industry Context - Hemodiafiltration is already the standard treatment in many regions, including Europe, Latin America, and Asia, and the company aims to establish this standard in the U.S. [2] - The CONVINCE study demonstrated a 23% reduction in mortality rates for patients using high-volume hemodiafiltration compared to traditional high-flux hemodialysis, highlighting the potential benefits of this therapy [5][8] Market Potential - There are approximately 160,000 in-center hemodialysis machines in the U.S. that could be replaced with the new standard of care, indicating a significant market opportunity for Fresenius Medical Care [3]

TORONTO, June 04, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, is pleased to announce that it has entered into a consulting agreement with Leonard Wheeler, a former NFL player turned entrepreneur, author, corporate consultant, co-Executive Director of the NFL Legends Community, and more recently, na ...

Core Points - Helius Medical Technologies has demonstrated full compliance with Nasdaq's minimum bid price requirement as of June 3, 2025 [1] - The company is required to regain compliance with the equity requirement by June 30, 2025, as per the extension granted by the Nasdaq Hearings Panel [2] - Helius Medical Technologies focuses on neurologic deficits through its Portable Neuromodulation Stimulator (PoNS) product [3]

Core Insights - Sharps Technology, Inc. has initiated shipments of its SecureGard™ and SoloGard™ smart safety syringes, marking its transition to a commercial-stage, revenue-generating company [1][5] Group 1: Product Shipments and Agreements - The first commercial order of SoloGard was shipped under a $50 million supply agreement with a U.S.-based leader in IV flushing solutions, including customized 10mL SoloGard syringes [2] - The initial purchase order for SoloGard is valued at $400,000 and is part of a five-year contract to supply up to 500 million syringes [2] - A separate shipment of SecureGard smart safety syringes was delivered to a Hungarian vaccine provider under a $100,000 purchase order, reflecting growing global demand [3] - Additionally, 200,000 units of 1mL low dead space syringes were shipped to a Swiss provider for use in specialized injection pens, representing the first tranche of a 1-million-unit order [4] Group 2: Manufacturing and Operational Milestones - The manufacturing of SoloGard is supported by advanced molding and automation technologies, enabling Sharps to meet anticipated demand increases in the second half of 2025 [2] - Significant upgrades to the Hungary-based facility have been made to support high-volume, high-precision production, enhancing production capacity and quality [5] - The company is building inventory and expanding capacity to support current and future purchase commitments under long-term strategic agreements [5] Group 3: Company Vision and Future Outlook - The CEO of Sharps Technology emphasized that these initial shipments represent a key operational milestone and validate years of R&D and strategic planning [5] - The company aims to deepen relationships with partners and drive additional growth in the upcoming quarters [6]

VALENCIA, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a leading therapeutic acute wound care company delivering a portfolio of transformative solutions, today announced that RECELLⓇ, including RECELLⓇ GO, has been recognized as the “Best New Technology Solution – Surgical” in the 2025 MedTech Breakthrough Awards. RECELL, FDA-approved for thermal burn wounds and full-thickness skin defects, has treated over 30,000 patients worldwide. RECELL requires significantly l ...

Core Insights - AVITA Medical, Inc. has been recognized for its RECELLⓇ technology, winning the "Best New Technology Solution – Surgical" at the 2025 MedTech Breakthrough Awards, highlighting its innovative approach in acute wound care [1][4] Company Overview - AVITA Medical is a leading therapeutic acute wound care company focused on delivering transformative solutions, with its flagship product being the RECELL System, which is FDA-approved for treating thermal burn wounds and full-thickness skin defects [6][7] - The RECELL System utilizes a patient's own skin to create Spray-On Skin™ Cells, optimizing wound healing and accelerating recovery times [6] Product Benefits - RECELL has treated over 30,000 patients globally and requires significantly less donor skin compared to traditional grafting methods, which reduces donor-site pain and accelerates healing [2][4] - The introduction of RECELL GO enhances procedural consistency and surgical team coordination, making it suitable for high-volume burn and trauma centers [3] Recognition and Awards - In addition to the MedTech Breakthrough Award, Dr. Katie Bush, Senior Vice President of Scientific & Medical Affairs at AVITA Medical, received the 2025 Emerald Pinnacle Healthcare Award for her contributions to innovation and leadership in the medical device sector [5] Market Approvals - The RECELL System is approved for various applications in international markets, including burns and vitiligo, and has received regulatory approvals in Australia, Europe, and Japan [7]

Summary of TransMedics Group (TMDX) FY Conference June 03, 2025 Company Overview - **Company**: TransMedics Group (TMDX) - **Industry**: Organ transplantation technology and services Core Points and Arguments 1. **Unique Position in Organ Transplantation**: TransMedics operates in a unique space within organ transplantation, which is considered the gold standard for treating end-stage organ failure due to its long life expectancy and quality of life benefits for patients [7][8] 2. **Challenges in Organ Transplantation**: The industry faces significant challenges, including a shortage of available organs and the need for improved post-transplant clinical outcomes [8][9] 3. **Innovation in Organ Preservation**: TransMedics has developed the Organ Care System (OCS), which addresses the critical issue of organ preservation, a previously neglected area in organ transplantation technology [11][16] 4. **Market Opportunity**: The company identified a vast opportunity in the underutilization of donor organs, with a significant portion of the donor pool going unused each year [15][23] 5. **National OCS Program (NOP)**: The NOP is a national network that integrates logistics and clinical services to enhance organ transplantation efficiency, operating out of 17 hubs across the U.S. [24][28] 6. **Logistics and Transportation**: TransMedics Logistics provides dedicated air and ground transportation for transplant missions, significantly improving the efficiency of organ transport [29][30] 7. **Successful Transplant Outcomes**: Over the last two years, the NOP model has facilitated more than 9,000 successful transplants, contributing to a double-digit growth in heart and liver transplants [36][37] 8. **Future Growth Catalysts**: The company plans to launch new technologies and expand its services, including kidney transplantation, which could add 30,000 procedures annually in the U.S. alone [22][42] 9. **Cost Efficiency**: TransMedics offers a zero-cost model for transplant programs if an organ is not transplanted, alongside significant cost reductions in logistics, enhancing its value proposition [49][50] Additional Important Content 1. **Technological Advancements**: The OCS technology allows for continuous perfusion of organs, maintaining their viability outside the human body, which is a significant advancement over traditional preservation methods [19][21] 2. **Integration with Clinical Operations**: The NOP Logistics Command Center coordinates all aspects of organ transport and transplantation, ensuring real-time visibility and efficiency [31][34] 3. **Regulatory Engagement**: The company is actively engaged with the FDA for new technology approvals, aiming for launches in late 2025 [43] 4. **Long-term Vision**: TransMedics aims to transform from a preservation technology company to an organ enhancement company, focusing on improving transplant outcomes and increasing the volume of organ transplants [41][43] 5. **Market Positioning**: The company emphasizes its competitive advantage through its unique service model and logistics integration, which are not matched by competitors in the organ transplantation space [47]

Precision oncology specialist Guardant Health (GH 8.53%) was something of a stock market star on Tuesday. On the back of very positive news in the regulatory sphere, the company's shares jumped almost 9% higher today. This made it quite the outperformer on the exchange, as the bellwether S&P 500 index's gain was a relatively modest 0.6%.A new designationThis morning before market open, Guardant announced that the U.S. Food and Drug Administration (FDA) had granted the healthcare company's Shield multi-cance ...