The Weekly Recap 11/7/25: 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 announce regulatory wins, secure new funds, achieve clinical milestones, appoint new executives, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

Amber Implants

Appointed Vincent Gardès as Chief Executive Officer to lead commercialization of the FDA‑cleared VCFixⓇ Spinal System. The seasoned medtech executive brings decades of global leadership experience, including a successful IPO and exit at Vexim, as the company prepares for U.S. market launch in 2026.

Aqua Medical

Received FDA IDE approval to initiate its pilot clinical trial of the Proximal Intestinal Mucosal Ablation (PIMA) procedure using the company's proprietary radiofrequency vapor ablation (RFVA) system. The system enables a minimally invasive, outpatient procedure designed to replicate the metabolic benefits of gastric bypass without its invasiveness.

Avisi Technologies

Presented positive 12-month data for VisiPlate^Ⓡ at AAO 2025, with nearly half of patients medication-free and no serious adverse events reported. The results from the VITA Trial support VisiPlate’s safety and efficacy in lowering intraocular pressure for patients with open-angle glaucoma.

CLARO Surgical

Rebranded from Drill Surgeries to CLARO Surgical to reflect its expanded vision for the future of orthopedic surgery. The company combines mixed reality and AI to enhance surgical precision, reduce X-rays and operating time, and bring greater clarity and confidence into the OR.

DermaSensor

Announced newly published studies supporting the performance of its FDA-cleared device for evaluating suspicious skin lesions. The AI-powered, spectroscopy-based system demonstrated strong generalizability across care settings, helping physicians non-invasively evaluate lesions with improved performance and confidence.

Enspectra Health

Published positive results from the VISTA Trial in JAMA Dermatology, validating its FDA-cleared handheld imaging system for noninvasive visualization of histologic skin features. The cross-modal device, which combines RCM and MPM, enabled physicians to identify dermal and epidermal structures with over 96% accuracy and demonstrated ease of use in clinical settings.

InkSpace Imaging

Announced a partnership with Strategic Radiology, a national coalition of 47 independent, privately owned radiology practices. The collaboration brings InkSpace’s lightweight, flexible MR coils to practices nationwide, enhancing diagnostic confidence, improving workflow efficiency, and elevating the standard of patient-centered MRI.

InspireMD

Appointed Dr. Peter A. Soukas as Chief Medical Officer to support the U.S. launch of the CGuard^Ⓡ Prime carotid stent system. A leading expert in vascular intervention, Dr. Soukas brings deep clinical, academic, and research experience to help advance InspireMD’s mission to improve stroke prevention and patient outcomes.

Lauxera Capital Partners

Closed its second healthtech growth fund at over €400M, backing European companies with global potential. With a transatlantic team and hands-on operational model, the fund supports innovators like Acandis and Antaros Medical in scaling internationally and navigating U.S. market entry.

LEM Surgical

Announced the successful completion of the first clinical procedures using its Dynamis Robotic Surgical System in the United States. The milestone marks the real-world debut of its multi-arm, navigation-integrated robotics platform for hard tissue surgery, supporting future U.S. commercialization.

Lungpacer Medical

Enrolled the first patients in its STARI trial evaluating the next-generation AeroNova^Ⓡ system for temporary transvenous diaphragm neurostimulation. The study will assess safety and efficacy in mitigating multi-organ ventilator-induced injury in patients suffering from acute hypoxemic respiratory failure (AHRF).

Medical Microinstruments

Received FDA IDE approval for its REMIND feasibility study, the first robotic microsurgical study targeting Alzheimer’s disease. The study will evaluate the safety and effectiveness of using the Symani^Ⓡ Surgical System to restore lymphatic drainage pathways in patients with lymphatic obstruction and Alzheimer’s disease.

Neuronoff

Launched Calm Medical, a wholly owned subsidiary focused on bladder dysfunction, to commercialize minimally invasive neurostimulation therapies. Using the InjectrodeⓇ platform, Calm Medical aims to provide an earlier, less invasive treatment option for patients with neurogenic and overactive bladder.

Nitinotes

Received CE Mark approval for EndoZip™, the first fully automated suturing system for endoscopic sleeve gastroplasty (ESG). This milestone enables the European launch of a simplified, single-physician ESG procedure designed to expand access to minimally invasive obesity treatment.

ONWARD Medical

Appointed Sean Sciara as its new Chief Commercial Officer following his earlier role as VP of Marketing and Market Access. Sciara brings nearly a decade of leadership experience from Boston Scientific and joins as ONWARD expands its U.S. commercial ramp for ARC-EX^Ⓡ, launches ARC-EX therapy in Europe, and prepares to bring ARC-IM to market.

Panda Surgical

Appointed Craig Marshall, CEO of OrganOx, as an independent non-executive director to its Board. Marshall’s 25+ years of medtech leadership will support the company’s mission to commercialize the first dexterous robot for minimally invasive neurosurgery.

Pitango

Raised $300M across two new early-stage funds: Pitango First for disruptive technology startups and Pitango HealthTech for breakthrough life science ventures. The funds have already backed companies in AI, infrastructure, quantum, cybersecurity, and cloud computing.

Raydiant Oximetry

Launched an IDE pilot study at LSU Health Shreveport to advance its fetal pulse oximetry technology, which uses a transvaginal sensor to collect real-time oxygenation data during labor and delivery. The study will support algorithm refinement and product development, with the goal of improving fetal monitoring and reducing unnecessary cesarean deliveries.

Sovato

Closed its Series B round, bringing total funding to $41M to scale the world’s first and only remote robotic surgery and procedure platform. The company’s technology enables healthcare organizations to extend surgical expertise across long distances, addressing global access challenges and laying the groundwork for scalable telesurgery programs.

Synchron

Raised $200M in Series D financing to accelerate commercialization of its first-generation Stentrode™ BCI platform, the world’s first endovascular BCI, designed to translate brain activity into digital commands without open-brain surgery. The funding will support pivotal trials, expansion of engineering and AI operations, and development of next-generation BCI interfaces.

TECHFIT Digital Surgery

Sold key assets to Acumed, advancing the scale and global reach of its patient-tailored craniomaxillofacial technologies. As part of the deal, co-founder and CEO Mauricio Toro will join Acumed to continue driving innovation in personalized surgical planning and implants.

Tulyp Medical

Emerged from stealth and submitted a 510(k) to the FDA following positive results from its initial first-in-human study evaluating its pressure-driven perfusion system. Backed by Sofinnova MD Start, the company’s patented approach maintains natural vascular pressures to optimize oxygen delivery and improve outcomes during vascular procedures.

VeinTech

CEO and Co-Founder Nikhilesh Bappoo was awarded the 2025 Prime Minister's Prize for New Innovators, one of Australia's highest honors in science and technology. This prestigious award recognizes Nikhilesh’s pioneering work in developing technology that transforms vascular access, improving safety, accuracy, and patient outcomes.

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