In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni get acquired, launch partnerships, achieve regulatory approvals, receive new funding, and much more on the road to LSI Europe ‘26 in Barcelona (September 28 - October 1).
Received a $2M Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to advance the use of its robotic platform for MRI-guided ablative treatment of brain cancer. The SBIR program, often referred to as "America’s Seed Fund," is a highly competitive federal program that supports scientific excellence and technological innovation through the investment of federal research funds in critical American priorities.
Welcomed Dr. Toni Day to the team. Dr. Day has over 20 years of experience in global regulatory and quality strategy, bringing a wealth of expertise in advancing complex and novel medical technologies from development all the way through to market approval.
Reached €500K in its crowdfunding round to support the development of its Artimis® Meniscus Prosthesis, an FDA Breakthrough Device designed to mimic the function of the natural meniscus. The polymer implant is inserted through minimally invasive keyhole surgery and is designed to restore knee mechanics and provide rapid pain relief, as demonstrated in earlier clinical results.
Achieved CE Mark certification for Wave, its AI-powered technology providing rapid, objective insights into newborn brain activity. This opens the door to commercialization across Europe and puts the company a step closer to making expert-level newborn brain assessment available to more clinicians in more hospitals.
Announced a strategic partnership with Medtronic to distribute its Sentire™ surgical system in select markets outside the U.S. where the system is market-approved. The $700M investment from Medtronic will help distribute Sentire alongside Medtronic’s Hugo™ robotic-assisted surgery (RAS) system.
Granted a second FDA Breakthrough Device Designation for its Brain Interchange™ system to include communication. The designation covers non-progressive quadriplegia, giving people with paralysis in all four limbs a way to control a computer cursor through thought alone and establish a direct and independent channel of communication with the digital world.
Received a binding offer from Enovis™ to be acquired and is expected to enter into a definitive agreement following the completion of the information and consultation process. The company has developed the Op.n® platform, bringing surgical navigation and active robotics together in a single architecture.
Raised $55M in an oversubscribed Series D round, with participation from IAG Capital Partners and Elevage Medical Technologies. Proceeds from the financing will be used to accelerate commercial expansion of the company’s comprehensive clinical platform, including FFR-CT, with 510(k) submission currently under FDA review, and Plaque-IQ™.
Signed a collaboration agreement with M20 Genomics. The agreement will bring the two companies together to become an authorized service provider for single-cell sequencing across Southern Europe.
Launched Interlay, a healthcare software platform built on more than a decade of experience developing healthcare software with AI. Interlay aims to bring healthcare-specific knowledge and organizational product context into the AI tools teams already use, while helping product and engineering teams adopt more consistent and effective AI workflows.
Completed enrollment in the TRUST pivotal IDE clinical study evaluating the safety and effectiveness of the Laguna® Thrombectomy System for pulmonary embolism. The study enrolled 107 patients across 17 clinical sites and evaluated the endovascular platform, which combines aspiration and mechanical clot retrieval through the Malibu® Aspiration Catheter System and Laguna Clot Retriever® System.
Appointed GuoMing Chen as its new CEO. Co-founder of the company’s structural heart intervention business, Chen brings more than 15 years of experience in medical device R&D, clinical applications, and supply chain management, with a strong focus on heart valve technologies.
Achieved statistically significant results from its ACCCESS U.S. pivotal study, meeting its co-primary efficacy endpoints for 12-month AHI and Oxygen Desaturation Index responder rates and its safety endpoints in patients with complete concentric collapse (CCC) of the soft palate. The study was designed to support expanding the company’s Genio® system’s U.S. indication to CCC patients, who are currently contraindicated for commercially available unilateral hypoglossal nerve stimulation.
Published its pivotal regulatory evidence in NEJM. The study randomized 264 patients, with a hazard ratio of 0.49 (P=0.006), and reported no major procedural complications or meaningful differences in adverse events during follow-up.
Signed a convertible loan agreement with the European Investment Bank (EIB) for up to €20M. The financing covers half of the company’s €40M financing plan to carry REGENERA™ through CE Mark approval, manufacturing scale-up, and product launch.
Entered into a definitive agreement to be acquired by Stryker. The company has developed the FiberLocker® System, a soft tissue augmentation technology designed to reduce the occurrence of a key clinical failure mode in rotator cuff repair.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in The Weekly Recap, and follow our blog for the latest medical device news and advancements.
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