NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Treace Medical Concepts, Inc. (NASDAQ: TMCI). Shareholders who purchased shares of TMCI during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/treace-medical-concepts-inc-loss-submission-form-2/?id=151932&from=3 ...

Deal Overview - Medtronic plc announced its intent to spin off its Diabetes business into a standalone entity, referred to as the New Diabetes Company, to streamline its portfolio and focus on high-margin growth areas [2][3] - The separation is expected to be completed within 18 months, primarily through a capital markets transaction, with a preferred path of an initial public offering (IPO) [3] Company Focus Post Spin-Off - Post spin-off, Medtronic will concentrate on its core franchises in cardiovascular, neuroscience, surgical, and medical-surgical technologies, which together account for over 90% of its total revenues [3][6] - The company aims to accelerate growth through innovation in areas such as pulsed field ablation, renal denervation, soft tissue robotics, and neuromodulation [3] Financial Implications - The transaction is anticipated to be accretive to Medtronic's gross and operating margins, and earnings per share, while enabling the NewCo to pursue focused innovation and growth strategies tailored to the diabetes market [4] - Medtronic expects its dividend per share to remain unchanged pre- and post-transaction, with no change to its dividend policy [4] Diabetes Segment Performance - The Diabetes segment contributed approximately $2.5 billion in FY25, about 8% of Medtronic's total revenue of $32.4 billion, but has underperformed with a revenue CAGR of just ~1.4% compared to Medtronic's overall ~2.9% CAGR [7][6] - The segment's operating margin has declined significantly from 30.9% in FY19 to 15.8% in FY25, indicating challenges in profitability [7] Market Challenges - The Diabetes segment has faced multiple headwinds, including FDA regulatory setbacks and increasing competition from agile players like Dexcom and Abbott [8] - Despite a recent rebound with a growth of ~10.7% YoY in FY25, the improvement is insufficient to offset structural challenges [9] Strategic Goals for New Diabetes Company - The New Diabetes Company will focus on creating a complete ecosystem for intensive insulin management, including insulin pumps, continuous glucose monitoring, and digital health solutions [3][33] - The separation is expected to unlock value for Medtronic and its shareholders, creating a shareholder base more aligned with the financial profile of the New Diabetes Company [12] Company Overview - Medtronic plc is a global healthcare technology leader, operating in over 150 countries and focusing on improving patient outcomes through innovation in various medical technologies [13][32] - The company operates through four primary segments: Cardiovascular, Neuroscience, Medical Surgical, and Diabetes, addressing a wide range of health conditions [32]

Company Overview - BioSig Technologies, Inc. has acquired Streamex Exchange Corporation as a wholly owned subsidiary in May 2025 [1] - BioSig is focused on redefining cardiac care through advanced signal processing and digital solutions, with its flagship product being the PUREEP™ Platform [8] - Streamex specializes in real-world asset (RWA) tokenization, particularly in the commodities space, aiming to revolutionize commodity finance [9][10] Strategic Appointments - Trevor Bacon and Kellan Grenier, co-founders of Parcl, have been appointed as Strategic Advisors to BioSig and Streamex [1] - Their expertise lies in decentralized finance, synthetic asset creation, and real-world asset tokenization, which aligns with BioSig and Streamex's mission [1][5] Parcl Overview - Parcl is a blockchain-native platform that allows users to speculate on real estate price movements through synthetic, perpetual trading without owning physical properties [2] - The platform is built on Solana and has become a leading protocol in bridging real estate and decentralized finance [2] Advisory Board Composition - The advisory board now includes notable figures such as Frank Giustra, Sean Roosen, and Mathew August, alongside Trevor Bacon and Kellan Grenier [6][7] - Each advisor brings significant experience from various sectors, including commodities, mining, and capital markets [7] Future Vision - BioSig and Streamex aim to scale their infrastructure for tokenizing and trading real-world assets, particularly in illiquid and fragmented markets [5] - The tokenization of real-world assets is expected to transform access and investment opportunities for institutions and individuals [5]

Core Insights - Smith+Nephew has introduced a new medial stabilized insert for its LEGION Total Knee System, reflecting a significant trend in knee arthroplasty procedures, with medial stabilized inserts increasing from 4% in 2018 to 32% in 2023 [1][4] Product Development - The new medial stabilized design allows for use with or without the Posterior Cruciate Ligament (PCL), indicating a shift from Posterior Stabilized (PS) designs to more bone-conservative Cruciate Retaining (CR) femoral designs [2] - The medial stabilized design features a larger anterior medial lip and medial pivot kinematics that mimic the natural knee [3] Market Trends - US registry data shows that one in three total knee replacements now utilize a medial stabilized design, highlighting a growing preference among surgeons for solutions that provide natural kinematics and improved patient satisfaction [4] - The LEGION TKS has over 20 years of clinical success, and the new insert aligns with rapidly growing market trends for advanced knee solutions [6] Strategic Positioning - The LEGION Medial Stabilized TKS is positioned as a leading option in the market, combining advanced kinematics, porous fixation, and integration with technologies like the CORI Surgical System [4][7] - The medial stabilized insert will be available in the US on a limited basis, with a full commercial release planned for 2025 and an introduction in Canada in 2026 [7]

Core Viewpoint - Nuwellis, Inc. has announced a public offering of common stock and warrants to raise capital for working and corporate purposes, including potential acquisitions [1][2]. Group 1: Offering Details - The public offering includes 406,755 shares of common stock priced at $0.30 per share, along with pre-funded warrants for 14,085,998 shares priced at $0.2999 each [2]. - Accompanying the common stock are Series A Warrants for up to 43,478,259 shares and Series B Warrants for up to 14,492,753 shares, both with an exercise price of $0.30 [1][3]. - The offering is expected to close on or about June 10, 2025, subject to customary closing conditions [4]. Group 2: Warrant Details - Each pre-funded warrant has an exercise price of $0.0001 and is immediately exercisable until fully exercised [3]. - Series A and Series B Warrants will be exercisable for five years following stockholder approval, with Series A Warrants including a one-time reset of the exercise price under certain conditions [3]. - Series B Warrants offer a zero cash exercise option, allowing holders to receive shares without additional cash payment [3]. Group 3: Company Overview - Nuwellis, Inc. is a commercial-stage medical device company focused on treating fluid overload patients through innovative therapies [7]. - The company is commercializing the Aquadex SmartFlow system, which is designed for ultrafiltration therapy in patients unresponsive to medical management [8]. - Nuwellis is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [7].

Core Viewpoint - ReShape Lifesciences has announced a public offering of 1,054,604 shares of common stock at a price of $2.50 per share, expecting gross proceeds of approximately $2.6 million before expenses [1]. Group 1: Offering Details - The public offering is being conducted under an effective shelf registration statement filed with the SEC, which was declared effective on May 14, 2025 [3]. - Maxim Group LLC is acting as the sole placement agent for this offering [2]. - The offering is expected to close on or about June 9, 2025, pending customary closing conditions [1]. Group 2: Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of products and services for obesity and metabolic disease management [4]. - The company’s FDA-approved products include the Lap-Band® systems, which provide minimally invasive treatment options for obesity, and the ReShape Diabetes Neuromodulation system, which targets glucose regulation [4]. - The Obalon® balloon technology is another innovative product that offers a non-surgical method for weight loss [4].

Core Insights - AVITA Medical's RECELL technology demonstrates significant clinical benefits, including reduced hospital stays for burn patients, as highlighted in a recent study presented at the British Burn Association Annual Meeting [1][3] - The RECELL system utilizes a small sample of a patient's skin to create Spray-On Skin™ Cells, which leads to faster healing and less pain compared to traditional skin grafting methods [2][5] - The analysis of over 6,300 patients indicates a reduction in hospital stay by an average of 6.2 days or 35.7% when treated with RECELL compared to split-thickness autografts, resulting in approximately $300 million in cost savings over five years [8] Company Overview - AVITA Medical is a leader in therapeutic acute wound care, focusing on innovative solutions that enhance wound healing and accelerate patient recovery [5] - The RECELL System is FDA-approved for treating thermal burn wounds and full-thickness skin defects, and it is used in over 130 burn centers across the United States [4][5] - The company also holds exclusive rights to manufacture and distribute other wound care products, including PermeaDerm and Cohealyx™ [5] Market Impact - The RECELL technology is gaining traction in international markets, with approvals in Australia, Europe, and Japan for various skin healing applications [6] - The findings from the national registry analysis provide a clearer understanding of how RECELL influences clinical decisions and patient outcomes, reinforcing its economic value in healthcare [3][8]

Core Insights - IceCure Medical Ltd. has received a Notice of Allowance for its patent application titled 'Cryogen Flow Control', which is expected to enhance the efficiency of cryoablation technology and expand its indications [1][2] - The ProSense® Cryoablation System utilizes liquid nitrogen to destroy tumors through freezing, providing a minimally invasive treatment option for various types of tumors [3][5] - The company is awaiting FDA marketing approval for ProSense® in early-stage breast cancer, which is crucial for its market traction [2][5] Patent and Technology - The 'Cryogen Flow Control' patent, once granted, will be effective until 2045 and is already granted in Japan, with pending approvals in the EU and other major markets [1][2] - This technology aims to optimize cryogenic delivery by using sensor data to regulate cryogen flow, ensuring precise temperature control for effective treatment [2] Product Overview - ProSense® is designed to create large lethal zones for maximum efficacy in tumor destruction, applicable to benign and cancerous lesions in breast, kidney, lung, and liver [3][5] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [4][5] Market Position - IceCure Medical positions itself as a global leader in liquid nitrogen-based cryoablation technology, focusing on innovation and commercial rollout of its systems [2][5]

Company Overview - Catheter Precision, Inc. is a US-based medical device company focused on developing advanced products for the cardiac electrophysiology market [5] - The company aims to improve the treatment of cardiac arrhythmias through innovative technology and collaboration with physicians [5] Recent Developments - Catheter Precision has received its first purchase order for the VIVO product from Sahlgrenska University Hospital, the largest hospital in Sweden [1][2] - Sahlgrenska University Hospital handles approximately 350,000 patients annually and has the largest ventricular ablation program in Scandinavia [2] Product Information - VIVO™ (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps physicians identify the origin of ventricular arrhythmias before procedures, thus streamlining workflow and reducing procedure time [4] - The VIVO product has received marketing clearance from the U.S. FDA and holds the CE Mark, indicating its compliance with European health standards [4] Strategic Partnerships - The partnership with Sahlgrenska University Hospital is significant as it is a teaching hospital, which allows for training new physicians on the VIVO product, potentially leading to future sales opportunities [3]

Core Insights - Aethlon Medical, Inc. is presenting research on the Hemopurifier® device's ability to bind extracellular vesicles (EVs) in Long COVID samples at an upcoming symposium [1][6] - Long COVID affects an estimated 44 to 48 million people in the U.S., with a significant economic burden projected at $2 billion for those experiencing symptoms for a year [2] - The Hemopurifier is designed to remove harmful EVs from the blood, which are implicated in the pathogenesis of Long COVID [4][8] Company Overview - Aethlon Medical focuses on developing the Hemopurifier, an investigational device aimed at treating cancer and life-threatening infectious diseases [8] - The Hemopurifier has shown efficacy in removing life-threatening viruses and harmful EVs in pre-clinical studies [8] - The device has received FDA Breakthrough Device designation for treating advanced or metastatic cancer and life-threatening viruses [10] Research Details - The research presented will evaluate the binding of EVs from Long COVID patients to the Hemopurifier's affinity resin, which targets the sugar mannose [5][6] - The study involves collaboration with the University of California San Francisco Medical Center Long COVID clinic [5] - The poster presentation is scheduled for August 12, 2025, and will be available on Aethlon's corporate website afterward [6][7]