As we enter June, the LSI alumni community is ending the month with another week of breaking medical device news stories. From receiving Breakthrough Device Designation and FDA clearance to pivotal trial results, these top medical device companies are paving the way to LSI Europe '24 in Portugal this September. Here’s a look at the latest updates from LSI alumni making waves in the medtech industry.
Accelus has announced the appointment of Greg Tibbitts as the Interim Chief Financial Officer. This strategic move aligns with the company’s commitment to enhancing surgical procedures and patient outcomes through innovative spinal solutions. With Tibbitts' extensive experience, Accelus is poised to strengthen its financial strategy and drive further innovation in spinal healthcare.
AcuityMD has successfully raised $45 million in Series B funding, led by ICONIQ Growth. This funding will be used to expand AcuityMD's commercial intelligence platform for medical technology manufacturers. With over 200 companies already utilizing their platform, AcuityMD helps the commercial medtech industry identify target markets, surface top opportunities, and grow their businesses effectively.
Axena Health has closed an additional $9.4 million in its Series A funding round. This round saw participation from Cross-Border Impact Ventures (CBIV) alongside existing investors AXA IM Alts, KOFA Healthcare, and Avestria Ventures. Axena Health’s flagship product, the Leva® Pelvic Health System, is designed to be a novel and effective first-line treatment for urinary incontinence and chronic fecal incontinence, highlighting the company’s commitment to innovative pelvic health solutions.
Boulder Sterilization, a division of Boulder iQ, has expanded its chlorine dioxide sterilization capacity for medical devices. Boulder iQ is a contract firm specializing in regulatory affairs, quality assurance, design, engineering, and manufacturing. This expansion demonstrates Boulder iQ's dedication to providing comprehensive services that enable life sciences companies to bring products to market efficiently.
HighLife has received FDA IDE approval to initiate a US Pivotal Study with its technology. This study is a single-arm, multicenter, prospective study designed to assess the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation who are unsuitable for surgery or transcatheter repair treatment. This approval marks a significant step forward in addressing a critical need in cardiovascular care.
MedTechVets, a non-profit organization dedicated to helping military veterans transition into careers in the medtech sector, has appointed LSI alumni Joe Mullings to its Board of Directors. Mullings' expertise and leadership are expected to enhance MedTechVets' mission of supporting veterans in their career transitions and strengthening the medtech workforce.
Moon Surgical has achieved a second FDA clearance for its commercial Maestro™ Robotic Surgery System. Designed to support surgeons, operating room staff, and patients, Maestro aims to enhance the efficiency of the 18.8 million annual soft tissue surgical procedures that are not currently supported by available telerobotic systems.
NLC Health Ventures has received a €6 million investment from Dutch health insurer VGZ. Based in Amsterdam, NLC Health Ventures is one of the most active health technology investors in Europe and one of the world’s largest healthtech venture builder. This investment will support NLC Health Ventures' ongoing efforts to drive health technology innovation and development.
Osteal Therapeutics has raised an oversubscribed $50 million Series D preferred stock equity financing. This round was led by Zimmer Biomet and included returning investors Johnson & Johnson Innovation – JJDC, Inc., Gideon Strategic Partners, and HM Capital. Osteal Therapeutics focuses on treating musculoskeletal infections with locally delivered antimicrobials, aiming to minimize off-target tissue exposure and associated adverse effects.
restor3d has closed a $55 million Series A funding round led by private investors including Summers Value Partners, alongside an additional $15 million in debt financing led by Trinity Capital. A leader in 3D-printed patient-specific musculoskeletal implants, restor3d is driven by the belief that every patient deserves personalized care. This funding will support their mission to innovate and expand their product offerings.
Single Pass has announced the completion of the first Kronos Biopsy Closure Device procedures in the US. This device aims to offer a breakthrough solution for patients undergoing percutaneous biopsy who are at high risk of bleeding complications.
Zeto has received FDA 510(k) clearance for its next-generation EEG brain monitoring product, ONE. The ONE system features a user-friendly headset with 21 soft-tip electrodes positioned according to the commonly followed 10-20 EEG system, accompanied by intuitive LED feedback for easy adjustments. This product aims to simplify EEG monitoring and improve the diagnostic process.
Stay tuned for more updates as medical technology companies, investors, and more firms like these continue to innovate and lead the way in the medtech industry.
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