Safe Group announces FDA 510(k) clearance for SpineUp's Frida solution Fleurieux-sur-l’Arbresle - France - June 5, 2025 at 6 p.m. Safe Group, a leading player in the field of medical devices for spine surgery, is pleased to announce that Frida, the innovative cervical plate developed by SpineUp, has received 510(k) clearance from the Food and Drug Administration (FDA). This clearance marks a crucial step in SpineUp's expansion into the North American market, and testifies to its ongoing commitment to provid ...

Summary of Sharps Technology Conference Call Company Overview - **Company**: Sharps Technology (STSS) - **Industry**: Specialized drug delivery systems, focusing on safety syringes and prefilled syringes [4][5] Key Points and Arguments - **IPO and Funding**: Sharps Technology went public in April 2022, raising approximately $16 million to acquire a facility in Hungary and commercialize its products [5] - **Acquisition of Safeguard Medical Facility**: The acquisition of a syringe operation in Hungary provided Sharps with its own intellectual property and advanced technology [5][6] - **Sales Agreements**: - A significant $50 million revenue agreement for specialized Sologuard products with a US contract filler in Texas was secured, marking a transformational opportunity for the business [7][20] - Ongoing negotiations for prefilled syringes in South Carolina, although facing some challenges [6][7] - **Manufacturing Plans**: - Plans to scale up manufacturing capabilities in Hungary and South Carolina, with new equipment expected to be operational by Q4 [8][10][22] - The facility in Hungary is fully operational and capable of scaling up to 100,000 square feet, supporting both smart safety syringe technology and prefilled syringe technology [9][10][15] - **Product Development**: - Focus on SecurGuard and Sologuard products, which include advanced safety features and low waste capabilities [11][19] - Prefilled syringes made from copolymer materials are positioned as a high-growth area, offering advantages over traditional glass syringes [12][13][27] - **Market Trends**: - The syringe market is experiencing significant growth, with a shift from glass vials to prefilled syringes, driven by pharmaceutical companies' investments [24][25] - The prefilled syringe market is expected to overtake disposable syringes in the long term [25] - **Competitive Advantage**: - Sharps Technology's products feature low waste technology, which minimizes drug loss during administration, and reuse prevention capabilities, addressing safety concerns [50][51] - The company aims to carve out a niche in the specialty syringe market by leveraging relationships with healthcare providers [42][43] Additional Important Information - **Financial Position**: The company reported a strong cash position of over $11 million with no debt, and a market cap of $6 million [37] - **Future Plans**: Sharps is committed to expanding its prefilled syringe capabilities, with potential announcements expected by the end of the year [36] - **Industry Context**: Competitors like Eli Lilly and Schott are making significant investments in drug filling capabilities, indicating a growing demand for specialized packaging solutions [29][30] This summary encapsulates the key insights from the Sharps Technology conference call, highlighting the company's strategic direction, market opportunities, and competitive positioning within the specialized drug delivery industry.

Core Viewpoint - Sharps Technology, Inc. is transitioning to revenue-generating operations with its first commercial deliveries of smart safety syringe products, marking a significant milestone for the company [2][4]. Company Overview - Sharps Technology is a medical device and pharmaceutical packaging company that specializes in patented smart safety syringe products designed for the healthcare industry [4]. - The company focuses on ultra-low waste capabilities and incorporates both passive and active safety features in its syringe technologies [4]. - Sharps has a manufacturing facility in Hungary that has undergone significant upgrades to support high-volume production [2][4]. Recent Developments - The company has commenced shipments under three customer orders linked to previously announced purchase agreements, representing its first commercial deliveries [2]. - CEO Robert Hayes will present at the Life Sciences Virtual Investor Forum on June 12, 2025, providing an opportunity for real-time investor engagement [1][6]. Event Details - The Life Sciences Virtual Investor Forum will be an interactive online event where investors can ask questions in real-time [3]. - An archived webcast will be available for those unable to attend the live event [3].

Core Insights - Envoy Medical's pivotal clinical trial for the fully implanted Acclaim® Cochlear Implant is progressing positively, with all 10 participants completing their one-month follow-up visits successfully [1][2][3] - The device allows participants to hear without externally worn devices, providing continuous hearing capability, and no serious adverse events have been reported [2][3] - The CEO of Envoy Medical expressed optimism about the trial's momentum and the potential for rapid market entry if the device receives approval [3] Company Overview - Envoy Medical, Inc. (NASDAQ: COCH) specializes in innovative hearing health technologies, focusing on fully implanted devices for hearing loss [5] - The company has previously launched the Esteem® active middle ear implant, which has been available in the U.S. since 2010, and is now advancing the Acclaim® cochlear implant [5] - The Acclaim CI is designed for individuals with severe to profound sensorineural hearing loss and has received Breakthrough Device Designation from the FDA [8] Product Details - The Acclaim CI utilizes a sensor that leverages the ear's natural anatomy instead of a microphone, powered by a rechargeable battery [6][7] - The device is intended for adults deemed suitable candidates by qualified physicians and aims to address hearing loss inadequately managed by traditional hearing aids [8] - The Esteem FI-AMEI is highlighted as the only FDA-approved fully implanted hearing device for moderate to severe sensorineural hearing loss, offering 24/7 hearing without external components [9]

CARMEL, Ind., June 10, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ("NeurAxis," or the "Company") (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology has been officially incorporated into newly released clinical practice guidelines issued by the leading pediatric academic society for the treatment ...

TORONTO, June 10, 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 the first commercial benign prostatic hyperplasia ("BPH") treatment utilizing the TULSA-PRO system's new TULSA-AI Volume Reduction Module was successfully conducted yesterday by Naveen Kella, M.D., Founder of ...

CARLSBAD, CALIFORNIA, June 10, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a pioneer in innovative spinal solutions, proudly announces that its proprietary SiLO™ Sacroiliac (SI) Joint Fusion System has been successfully used in over 2,500 procedures across the United States. This major milestone underscores the company’s accelerating growth and increasing adoption of its minimally invasive technology by surgeons nationwide. Aurora’s SiLO™ p ...

Core Viewpoint - A class action securities lawsuit has been filed against Treace Medical Concepts, Inc. alleging securities fraud affecting investors between May 8, 2023, and May 7, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Treace Medical Concepts, Inc. made false statements regarding the impact of competition on the demand for its primary product, the 3D bunion correction system, "Lapiplasty" [2]. - It is alleged that due to competition, Treace Medical's revenue declined, prompting the company to accelerate plans for an alternative product to osteotomy [2]. - The defendants' positive statements about the company's business and prospects were claimed to be materially misleading and lacked a reasonable basis [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until June 10, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4].

Lisa Bedell Clive +44 207 676 7256 lisa.clive@bernsteinsg.com Delphine Le Louet +33 1 42 13 92 93 delphine.le-louet@bernsteinsg.com 6 June 2025 European Consumer Medical Technologies Global Ophthalmology: Laser-focused on procedure growth, mix, and China: A primer on the Refractive market Susannah Ludwig +41 582 723 127 susannah.ludwig@bernsteinsg.com Lee Hambright +1 917 344 8429 lee.hambright@bernsteinsg.com Richard Hombach +44 207 762 1858 richard.hombach@bernsteinsg.com Deeksha Pandey +1 917 344 8447 de ...

Core Insights - Anteris Technologies Global Corp. has appointed Mr. David Roberts and Mr. Gregory Moss to its Board of Directors, enhancing its leadership team as it prepares for the upcoming global pivotal clinical trial for its DurAVRTHV product [1][2][4] - The company is transitioning to a new growth phase following its NASDAQ listing in Q4 2024 and aims for U.S. and EMA licensure of the DurAVRTHV for patients with aortic stenosis [2][4] Leadership Appointments - Mr. David Roberts has extensive experience in the healthcare sector, currently serving as President of LeMaitre Vascular, Inc. since 2007, and has held various leadership roles since joining the company in 1997 [2][3] - Mr. Gregory Moss brings a strong legal and compliance background, having served as Chief Business and Legal Officer at Evommune, Inc., and previously held senior roles at Kadmon, culminating in a $1.9 billion acquisition in 2021 [3] Product Overview - Anteris' lead product, the DurAVR Transcatheter Heart Valve (THV), is designed to treat aortic stenosis and is the first biomimetic valve, aiming to replicate normal aortic blood flow [6] - The DurAVR THV is made from Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years and distributed to over 55,000 patients worldwide [6]