Core Viewpoint - Treace Medical Concepts, Inc. is facing a class action securities lawsuit due to alleged securities fraud impacting investors between May 8, 2023, and May 7, 2024 [1] Group 1: Allegations and Impact - The lawsuit claims that Treace Medical's primary product, the 3D bunion correction system "Lapiplasty," faced decreased demand due to competition [2] - As a result of the competition, Treace Medical's revenue declined, prompting the company to expedite plans for an alternative product to osteotomy [2] - Defendants allegedly made misleading positive statements regarding the company's business operations and future prospects [2] Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until June 10, 2025, to request to be appointed 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 has a history of securing significant recoveries for shareholders and has been recognized as a top securities litigation firm in the United States [4]

Electromed (ELMD) Conference June 10, 2025 11:30 AM ET Speaker0 Jim Kneff, and, with me today is Brad Nagle, who's our CFO. We represent Electromed. We are really excited to be here today and share with you our story. We go on to our next slide, Brad. This is, obviously our standard disclosures, which we won't go through. But, just a real quick setup for, ElectroBed and who we are. We're basically a respiratory care company that's focused on airway clearance. And the technology which we have, which I'll spe ...

SI-BONE (SIBN) FY Conference June 10, 2025 11:20 AM ET Speaker0 Excellent. Well, thank you. Good morning, everyone. I think this is the last session that sits between people and lunch. So we'll jump right in here. I'm very pleased to welcome the management team from SI BONE Laura Francis, Chief Executive Officer and Anshul Maheshwari, Chief Financial Officer. Okay. Thank you. Very much appreciate you're making the trip here to Miami and look forward to kind of getting into the story here. I know Anshul and ...

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 ...