The Weekly Recap 6/27/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funds, appoint new executives, announce clinical milestones, receive awards, and much more on the road to LSI Europe ‘25 in London (September 7-11).

Aspira Medical

Announced LSI Alumni Zaffer Syed as CEO and Co-Founder to lead the development of its wearable ultrasound platform for aspiration risk monitoring in the ICU. Syed joins founder Todd Rosengart to advance Aspira Medical’s mission to reduce aspiration pneumonia through proactive, non-invasive critical care.

Avvio Medical

Achieved ISO 13485:2016 certification with zero non-conformities, marking a key milestone as Avvio Medical advances toward global commercialization. The company is redefining kidney stone treatment with a minimally invasive, anesthesia-free platform designed for rapid, stent-free care in outpatient settings.

Biomed Simulation

Appointed Denise Steinbring as CEO to lead Biomed Simulation’s next phase of growth in ECMO simulation, experiential learning, and patient safety. As a seasoned medtech executive and simulation education leader, Steinbring brings decades of expertise from Medtronic and Chief Outsiders to advance the company’s mission.

Brainomix

Announced a new strategic partnership with 3DR Labs to expand access to its FDA-cleared Brainomix 360 Stroke AI platform across the U.S. stroke care market. The collaboration combines Brainomix’s clinically validated imaging algorithms with 3DR’s medical imaging post-processing expertise to streamline stroke workflows and improve intervention rates.

Endovascular Engineering

Completed enrollment in the pivotal ENGULF IDE study evaluating the Hēlo™ PE Thrombectomy System for the treatment of pulmonary embolism. The milestone advances Endovascular Engineering’s mission to improve outcomes in venous thromboembolism with safer, more effective clot removal technologies.

InspireMD

Received FDA PMA approval for the CGuardⓇ Prime Carotid Stent System, following best-in-class evidence in the C-GUARDIANS pivotal trial. The approval enables InspireMD to launch its next-generation stroke prevention technology in the United States.

Materna Medical

Announced the close of a new funding tranche within its $20M Series B2 and introduced Ellora™ as the commercial name for its second product (previously ‘Materna Prep’). The capital supports Materna Medical’s mission to transform women’s pelvic health, with Ellora™ poised for FDA De Novo submission following its EASE trial across 20 leading U.S. hospitals.

Moon Surgical

Expanded its executive team with Jonathan Conta (Chief Marketing Officer), Jeff Semone (Chief Quality and Regulatory Officer), and Jeff Driggs (VP of U.S. Sales) to accelerate commercialization across the U.S. and Europe. The hires support Moon Surgical’s rapid adoption of the Maestro™ System, now used in over 1,600 procedures spanning 60 types of minimally invasive surgeries.

Nitinotes Surgical

Received FDA IDE approval to initiate a pivotal U.S. trial of the EndoZip™ System for endoscopic sleeve gastroplasty. The prospective, multicenter, randomized controlled study will enroll up to 184 patients across 10+ sites to assess safety and efficacy in treating obesity.

OncoLux

Announced the formation of OncoLux through the merger of LSI Alumni, CytoVeris, and Lumeda. The partnership was formed via the merger of two platforms: Lumeda's innovative DigiLum Photodynamic Therapy platform and CytoVeris’ AURORA multispectral imaging system.

Raymond Cohen

Has been appointed Chairman of the Board at Archimedes Vascular, supporting the company’s mission to advance a novel implant for severe hypertension. Cohen’s appointment follows a $2.2M Series A led by Sherpa Healthcare Partners and marks a new chapter for the company as it prepares to navigate clinical and regulatory pathways.

ReGelTec

Treated its first patient in the U.S. IDE trial evaluating the HYDRAFIL System, a hydrogel-based outpatient solution for chronic low back pain caused by degenerative disc disease. The 225-patient, multicenter, single-blinded, randomized, controlled HYDRAFIL-D study follows CE Mark approval and aims to support FDA approval.

Serac Life Sciences

Announced the first clinical use of SeracamⓇ in the United States and the first use of Seracam in the operating room. Posters from Ohio State University and the University of Malaya highlighted Seracam’s ability to deliver hybrid gamma-optical imaging at the bedside and in the OR.

Sinaptica Therapeutics

Announced the publication of a seminal review paper detailing the mechanism of action behind its rTMS therapy for Alzheimer’s disease. Co-authored by Sinaptica’s scientific co-founders and leading Alzheimer’s expert Dr. Harald Hampel, the paper offers a systems-level explanation of how brain stimulation may counter neurodegeneration.

STENTiT

Enrolled the first patient in its VITAL-IT 1 clinical trial evaluating the Resorbable Fibrillated Scaffold (RFS) for chronic limb-threatening ischemia below the knee. STENTiT’s novel microfiber stent combines temporary structural support with regenerative properties to promote vascular tissue growth and long-term vessel restoration.

ThinkSono

Raised $6M in new funding to accelerate European commercial rollout and support U.S. clinical trials for FDA clearance of its AI-powered deep vein thrombosis (DVT) diagnostic platform. ThinkSono Guidance enables non-ultrasound-trained healthcare staff to perform ultrasound scans at the point of care.

Total Flow Medical

Closed an oversubscribed Seed Extension round to advance the development of its clinician-designed technology for cardiopulmonary bypass. Total Flow Medical is focused on improving outcomes and reducing costs for patients who require the use of a heart-lung machine during surgery.

Vessl Prosthetics

Was selected as one of 13 Ontario-based companies to receive funding from the Life Sciences Innovation Fund to accelerate manufacturing of the Kinn™ Automatic Volume Management System. Vessl Prosthetics is advancing user-centered socket technology designed to improve comfort and outcomes for amputees.

Veyond Metaverse

Announced strategic funding to support the commercial launch of its remote care platforms SkyDoc™, MaritimeDoc™, and MilitaryDoc™. Veyond Metaverse is advancing cloud-based solutions that deliver expert medical support in aviation, maritime, and military environments worldwide.

Vitazi.ai

Was recognized among the 2025 Best Tech Startups in New Mexico for its AI-powered oculomics platform that detects early signs of chronic disease. Vitazi.ai is leveraging retinal imaging to enable earlier intervention and improve outcomes across population health.

Vivasure Medical

Submitted a PMA application to the FDA for PerQsealⓇ Elite and secured CE mark expansion for venous indications in Europe. Vivasure Medical’s fully bioresorbable, sutureless vascular closure system now holds regulatory momentum for both arterial and venous large-bore procedures, supporting global growth.

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.