In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni launch products, appoint new executives, secure funding, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).
Appointed Kavi Vyas as Chief Commercial and Clinical Officer, bringing nearly 20 years of experience advancing innovative medical devices and software solutions to market. He will establish the commercialization strategy for the Katana™ Thrombectomy System and lead efforts across QUADRA-PE trial enrollment, podium planning, and KOL engagement as the company prepares for its next phase of growth.
Announced positive findings from a first-in-human study of its Coherent Sine-Burst Electroporation™ (CSE™) pulsed-field ablation system, including 94% overall lesion durability, 100% procedural success, and a strong safety profile. The company also reported reaching 50% enrollment in its FDA IDE study evaluating the CSE system in up to 360 patients across the U.S. and Europe.
Announced new clinical and preclinical data supporting its HOTWIRE™ transseptal access system, including findings from approximately 500 patients showing 100% procedure success and zero adverse events. The data highlighted the system’s safety, performance, and workflow advantages, reinforcing the clinical value of its impedance-guided technology and zero-exchange approach to left-heart access.
Announced preclinical data evaluating its OrganBank KidneyⓇ platform, showing no delayed graft function compared to 40% delayed graft function with hypothermic machine preservation in a porcine kidney auto-transplant model. The findings, presented at the American Society of Transplant Surgeons Winter Symposium, support plans to initiate a clinical trial later this year.
Announced a strategic collaboration with Merck to support the continued development of CallavidⓇ, its intravaginal drug delivery platform designed to improve the self-administration of vaginal therapeutics. The collaboration represents the first industry partnership for Callavid and aims to address unmet needs in women’s health by enhancing treatment experience and drug delivery.
Announced the second successful human implantation of its Brain Interchange brain-computer interface system in an FDA-approved clinical trial in stroke patients at Harborview Medical Center of UW Medicine. The milestone builds on encouraging neurological gains from the first procedure and supports continued enrollment and data collection to evaluate the system’s potential to enhance upper-limb motor recovery through closed-loop cortical stimulation.
Appointed Michel Mayer as Chairman of the Board and Philippe Veran as a Member of the Board to strengthen governance and strategic direction. The leadership additions are expected to help guide Lupin Dental’s growth and innovation strategy as the company continues developing cutting-edge dental robotics solutions.
Raised $74M in an oversubscribed Series C financing led by MVM Partners with significant participation from Sofinnova Partners to accelerate commercial expansion of NEUROMARKⓇ and advance its product and indication pipeline. The financing will support broader clinical evidence generation, continued pipeline development, and expanded patient access to its minimally invasive treatment for chronic rhinitis.
“I first met Brian Shields at LSI in 2020, and we’ve stayed in touch ever since. LSI played a crucial role in helping us build a relationship, which ultimately led to MVM Partners leading Neurent Medical’s $74 million Series C funding round. If we hadn't met at LSI’s event, we likely would not have gotten to today’s investment.” — Kyle Dempsey, Partner, MVM Partners
“I first connected with MVM Partners at LSI several years ago, and LSI USA has remained a consistent forum for sharing progress along the way. That relationship ultimately led to MVM leading our recent $74 million Series C. LSI created the environment for those conversations to start and, just as importantly, to continue over time until the right opportunity came together. The result is an exciting partnership that positions us to accelerate commercial expansion, strengthen our clinical evidence, and advance our product and indication pipeline.” — Brian Shields, CEO, Neurent Medical
Launched Smartbuds, wireless earbuds that use six EEG sensors to measure real-time brain activity and deliver audio stimulation designed to guide users into deeper sleep. The wearable technology aims to close the gap between passive sleep tracking and active intervention, with beta testing showing increased slow-wave activity and nearly half of users reporting “better” or “much better” sleep with improved morning recovery.
Announced the appointment of Eric Tribe as Chief Executive Officer, bringing more than 20 years of experience leading organizations through startup and growth phases. He will focus on accelerating commercialization of the company’s next-generation Radialis PET Medical Imaging System, expanding sales, building global partnerships, and scaling impact across regulated healthcare environments.
Announced the full commercial launch of the Ossera™ AFX Ankle Fusion Cage System, a comprehensive platform engineered to address complex ankle fusion cases. Built on restor3d’s advanced made-to-order engineering and proprietary TIDAL Technology™, Ossera AFX combines optimized, sterile-packaged implant geometries with reusable instrumentation to enable rapid delivery, efficient surgical workflows, and robust osseointegration.
Appointed Daniel Balkcom as Vice President, U.S. Commercial Strategy and Operations. In this role, Balkcom will lead and define the strategic direction of the company’s U.S. activities, shaping its commercial strategy and approach to future market access and adoption of its proprietary MySalvia Therapy.
Announced that the FDA accepted its stroke treatment system into its Total Product Life Cycle Advisory Program (TAP), which provides early and frequent strategic engagement from the FDA, patients, providers, and payors to facilitate rapid development and widespread access to medical devices. Initial engagement under TAP will focus on defining the pathway toward an Investigational Device Exemption (IDE) for remote stroke thrombectomy clinical studies.
Announced that the FDA has granted Fast Track Designation to 99mTc-maraciclatide as a diagnostic SPECT-CT agent for the "visualization of inflammation in the lungs of patients with known and suspected interstitial lung disease." The designation enables more frequent engagement with the FDA and is intended to help accelerate development and review to support earlier diagnosis and improved patient outcomes.
Appointed Matthew McCarty as Chief Commercial Officer, bringing nearly 20 years of experience across life sciences and clinical trials. In this role, he will lead sales, marketing, partnerships, and commercial strategy as the company expands the RESPⓇ Platform from objective cough and lung sound monitoring into a broader ecosystem of respiratory trial solutions.
Announced the successful first U.S. transseptal implantation of its AMEND™ Transcatheter Mitral Valve Repair Annuloplasty System as part of the ongoing AMEND TS Early Feasibility Study. The milestone procedure advances the evaluation of a percutaneous annuloplasty approach designed to mimic surgical mitral valve repair while avoiding the risks and invasiveness of open-heart surgery.
Announced the availability of its Partner APIs, marking a significant milestone in the company’s commercial and integration readiness. The APIs enable surgical robotics and navigation partners to integrate VISIE’s spatial computing and real-time scanning capabilities into existing robotic platforms with minimal integration overhead.
Raised approximately $7.3M to continue development of its AxanaⓇ portable MRI device, designed to rapidly detect acute stroke. The funding will support progress toward its next clinical milestones and the completion of a multi-center Phase 2 clinical trial.
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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