In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni raise over 170M, receive regulatory clearances, announce acquisitions, and much more on the road to LSI USA ‘25 in Dana Point, CA (March 17-21).
Strengthened its leadership team with the appointments of Prof. Howard Herrmann and Prof. Nicolas Barry Delongchamps as Strategic Chief Medical Officers in structural heart and urology, respectively. Additionally, Federica Azzimonti joined as Director of Clinical Operations, bringing 25 years of experience in managing international clinical studies.
Successfully completed First-In-Vivo of the Intellidrop, an automated, closed-loop brain fluid management system with wearable continuous ICP. The company is modernizing neurocritical care and cerebrospinal fluid management by automating treatment & generating novel data.
LSI Alumni Caresyntax and Pristine Surgical announced a partnership to enhance surgical intelligence for Pristine Surgical’s 4K single-use digital arthroscope and platform. By leveraging real-world data from orthopedic procedures, the collaboration aims to improve surgical efficiency, lower costs, and improve patient outcomes in ambulatory surgical centers.
Received FDA 510(k) clearance for an expanded indication of its IOPS Intra-Operative Positioning System, broadening its use in peripheral, aortic, and aortic side branch vasculature endovascular interventions. This milestone increases the platform’s clinical applications, allowing more surgeons to benefit from its advanced 3D vascular navigation technology.
Acquired Pixyl and Caerus Medical, expanding its AI-powered imaging portfolio to include MRI solutions for neurology and musculoskeletal diagnostics. This strategic move positions Gleamer as the only AI provider covering X-ray, mammography, CT, and MRI, further advancing radiology automation and diagnostic accuracy.
Appointed Dr. Matt Thompson as CEO, leveraging his decades of experience as a vascular surgeon and medtech executive. Dr. Thompson will lead the development and commercialization of the company’s endovascular solutions to prevent Type II endoleaks, a key challenge in aneurysm repair procedures.
Secured its first commercial insurance coverage for EsoGuard Esophageal DNA Test from Highmark Blue Cross Blue Shield. This coverage milestone supports non-invasive screening for esophageal precancer and cancer, setting a precedent for further insurance approvals.
Received FDA IDE approval to initiate the STARI Phase 2 feasibility study, evaluating its AeroNova System for transvenous diaphragm neurostimulation-assisted ventilation in mechanically ventilated patients. The trial will assess the device’s ability to reduce ventilator-induced injuries and improve patient outcomes.
Secured a patent for its bioabsorbable magnesium alloy manufacturing process in Singapore, strengthening its intellectual property portfolio. This innovation enables the customization of implant properties for orthopedic, trauma, and sports medicine applications, optimizing healing and reducing the need for secondary surgeries.
Raised $65M in Series F financing to expand the adoption of its Vivistim Paired VNS Therapy for stroke recovery. Vivistim is the only FDA-approved intervention clinically proven to help chronic ischemic stroke survivors regain two to three times more upper extremity function than high-intensity stroke therapy alone.
Received €11M in funding from the European Innovation Council (EIC) Accelerator, including €2.5M in grants and up to €8.5M in equity investment. The company is developing an AI-based speech analysis platform for early heart failure detection, aiming to revolutionize remote cardiac monitoring.
Closed a $30M funding round to accelerate its meningeal tissue repair technology for brain and spinal cord surgeries. The funds will support R&D expansion and manufacturing scale-up to meet the growing demand for neurosurgical solutions.
Received FDA 510(k) clearance for Zipline Access Catheters and secured €22M in follow-on funding to support U.S. market expansion. The Zipline catheters enhance trackability and clot removal efficiency in acute ischemic stroke treatment, improving procedural success rates.
Closed a $40M Series E equity funding round to drive the commercialization of its InSet Total Shoulder and Reverse Shoulder Arthroplasty Systems. The financing will also support new product development in the shoulder replacement market.
Appointed LSI Alumni Carol Burns as CEO to lead the commercialization of BioHealx, the first bioabsorbable implant for anal fistula repair. With FDA De Novo clearance secured in 2024, the company will focus on U.S. market entry and post-market clinical validation.
Received regulatory approval in Japan for its geko circulation support device, expanding its global footprint. The company also signed a U.S. distribution agreement with SMS Medical to address edema and deep vein thrombosis prevention across lower limb orthopedic procedures.
Synergia Medical’s NAO.VNS™ device successfully met its primary safety endpoint in the AURORA first-in-human study, with no serious adverse events and a 100% implantation success rate over three months. Its NAO.VNS™ platform eliminates metal components for full MRI compatibility, EMI immunity, and enhanced patient safety while offering a long-lasting, fast-recharging battery for more effective therapy in drug-resistant epilepsy.
Shared results from a study conducted at the University of Utah and presented the findings at the 2025 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting. The new study showed that its Klassic Knee universal femoral design delivers comparable outcomes to asymmetrical implants with better patellar tracking.
Received FDA IDE approval to initiate an Early Feasibility Study for its AMEND Trans-Septal System. The study will assess safety and performance in patients with symptomatic moderate-to-severe or severe functional mitral regurgitation.
Unveiled Aletta, the world’s first Autonomous Robotic Phlebotomy Device (ARPD), designed to perform fully automated blood draws with AI-powered precision. Named after Dr. Aletta Jacobs, a pioneer in modern healthcare, Aletta aims to enhance clinical precision and patient experience while addressing growing healthcare staffing shortages.
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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