In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, launch partnerships, achieve clinical milestones, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Welcomed LSI Alumni Jeff Cambra to its Board of Directors. Cambra brings extensive experience across the medical device and therapeutics industry, with leadership roles spanning general management, sales, marketing, and product development, along with experience supporting commercialization strategy, portfolio management, and strategic transactions.
Announced 12-month follow-up clinical data outside the U.S. for its proprietary radiofrequency vapor ablation platform, highlighting the potential of its proximal intestinal mucosal ablation procedure as a durable treatment for type 2 diabetes. Results showed up to a 2.6% reduction in HbA1c, 100% elimination of exogenous insulin in treated patients, 80% remaining insulin-free without additional medications, and a favorable safety profile for the approximately 60-minute outpatient procedure.
Treated the first patient in the FREEDOM trial, evaluating 400mg progesterone CallavidⓇ in women with luteal phase insufficiency, a condition associated with infertility and recurrent miscarriage. Callavid is being developed as a first-in-class women’s health innovation, with the potential to become the world’s first drug-device combination product for threatened miscarriage prevention, as well as supporting luteal phase support in IVF.
Appointed Ray Baker, M.D., to its Board of Directors. Dr. Baker brings more than 30 years of experience across interventional pain, spine care, and medtech innovation, and will support the company in a fractional Chief Medical Officer capacity to support clinical, regulatory, and market-access strategy.
Received FDA clearance for new enhancements to its Hepatoscope5Ⓡ platform, including a dedicated Spleen Exam workflow that expands the system’s utility in the non-invasive assessment of cirrhosis complications. The updated platform features optimized acquisition parameters, including adjusted vibration frequency and a spleen-specific region of interest, to improve reliability when measuring high stiffness values.
Announced a partnership with LovellⓇ Government Services to serve federal healthcare systems, including the Veterans Health Administration, Military Health System, and Indian Health Service. Under the partnership, Lovell will serve as GraMedica’s Service-Disabled Veteran-Owned Small Business vendor of record to help expand access to the company’s HyProCureⓇ.
LSI Alumni Gwen Watanabe has co-founded Blackwell Health Partners, a new healthcare-focused private equity fund. The fund aims to unite deep healthcare and buyout expertise to accelerate the transformation of promising healthcare companies.
Announced a strategic platform partnership with ProVoyance to explore and develop integrated robotic navigation capabilities. The partnership brings together two FDA-cleared platforms, Interventional Systems’ Micromate™ miniature robot and ProVoyance’s AI-enabled preoperative planning software, into a collaboration framework to deliver seamless, end-to-end solutions for OEM partners and the surgeons and patients they serve.
Appointed LSI Alumni Alex Joseph as its CEO. Joseph will help lead the company as it moves from product development to clinical deployment, focusing on generating clinical evidence and supporting the adoption of robotic supermicrosurgery.
Completed the first robotic-assisted procedure in REMIND, its U.S. IDE Study evaluating the SymaniⓇ Surgical System to perform microsurgical techniques in the region of the neck for treatment of Alzheimer’s disease. The procedure, performed using Symani, explores whether restoring lymphatic drainage pathways in the deep cervical lymph nodes may support improved clearance of harmful neurotoxins that scientific researchers believe contribute to the progression of Alzheimer’s disease.
Entered into a definitive merger agreement to be acquired by Resmed for $340M. The company developed and manufactures Nidra, a novel non-invasive, wearable therapy to treat drug-refractory restless legs syndrome.
Welcomed LSI Alumni Andrew Morris as a Strategic Advisor. Morris brings an extensive background in business development and commercial strategy in the medtech industry, and currently serves as the CCO of MY01.
Achieved ISO 13485:2016 certification, the internationally recognised quality management standard for the medical device industry. The certification is a comprehensive framework specifically designed for the medical device industry to ensure every product is safe, effective, and consistent, and places a heavy emphasis on risk management, evaluation, and traceability.
Launched EPIOS, a new U.S. clinical study evaluating the safety and performance of Quantum Surgical’s EpioneⓇ robotic platform for the treatment of bone tumors and metastases to support the expansion of Epione’s market approvals in the U.S. Epione allows physicians to treat inoperable tumors that are particularly difficult to reach, due to their size or their location, at an early stage, in a simple and effective way.
Published the results of the CLOT OUT first‑in‑human study in the Journal of NeuroInterventional Surgery. The study showed that the company’s ClotildⓇ Smart Guidewire System can differentiate clot from surrounding tissue and reveal true clot boudaries during mechanical thrombectomy.
Initiated enrollment in a pilot clinical study evaluating the SetPoint SystemⓇ as a potential pro-remyelination therapy for adults with relapsing-remitting multiple sclerosis following FDA IDE approval. The company’s proprietary neuroimmune modulation device has also received FDA Breakthrough Device Designation and was accepted into the agency’s Total Product Life Cycle Advisory Program (TAP).
Received FDA BDD for its first-in-class Solaris DE™ drug-eluting covered stent indicated for use in hemodialysis patients for the treatment of stenosis within the dialysis outflow circuit at the venous anastomosis of a synthetic arteriovenous graft (AVG) in the veins of the arm. The device combines a self-expanding nitinol scaffold, an impermeable electrospun PTFE barrier, and a targeted sirolimus-eluting coating at the stent edges to inhibit neointimal hyperplasia and improve long-term vessel patency.
LSI Alumni Tanya Ridding founded TMR Executive Search, a specialist search firm focused on the medtech sector, working with founders, CEOs, and Boards on the critical leadership hires that change the trajectory of the business. The firm’s work will span early-stage and venture-backed companies through to established businesses navigating succession, scale, or geographic expansion.
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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