In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, appoint new executives, secure funding, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Announced the initiation and first patient enrolled in its 1000-patient HOSP-HF pivotal study. The study will run across ten centers in Sweden, Denmark, Singapore, and the U.S. during 2026, marking a key step in validating the clinical and economic utility of its non-invasive hemodynamic congestion monitoring platform in real-world hospital settings.
Announced the successful completion of 13 ventricular ablation procedures at leading institutions using the Company’s proprietary Ultra-Low Temperature Ablation (ULTA) technology under Expanded Access authorization from the FDA. The procedures addressed recurrent, symptomatic ventricular tachycardia (VT) or premature ventricular contractions (PVC) in patients who had previously failed ablations with conventional and/or experimental modalities, including radiofrequency (RF), venous ethanol, and pulsed field ablation (PFA), with physicians reporting favorable acute procedural outcomes and effective workflow integration in the electrophysiology lab.
Launched Fleuron™ MFD-USF for microfluidics and organ-on-chip systems. Fleuron enables rapid microfluidic prototyping using standard soft lithography while overcoming key PDMS limitations through negligible small-molecule absorption, compatibility with organic solvents without swelling, and improved material stability for scalable, reliable device manufacturing.
Welcomed LSI Alumni Dr. Lara Zibners as an advisor as the company advances its light-based, non-hormonal women’s health platform. Dr. Zibners, Co-Founder and Chairman of Calla Lily Clinical Care and a long-time advocate for innovation in women’s health, will bring a global lens to commercialization strategy and platform growth.
Welcomed LSI Alumni Liam Burns to its Advisory Board. Burns brings more than 25 years of leadership experience in bringing breakthrough surgical technologies from concept to global commercialization, and has built a career at the intersection of clinical insight and commercial execution.
Announced a collaboration with Ochsner Health, a leading health system serving Louisiana, Mississippi, and the Gulf South, to launch a Brain Health Collaboratory aimed at advancing new approaches to treating cognitive decline and Alzheimer’s disease. The collaboration will combine the company’s investigational Spectris™ technology platform with Ochsner’s expansive clinical network to develop a Brain Health Index, a framework designed to better track cognitive health, disease progression, and treatment response in real-world care settings.
Closed a $50M extension of its Series C financing, bringing the total Series C financing to $138M, with Arboretum Ventures joining as a new lead investor and existing investors also participating. The proceeds from this financing will fund completion of the company’s pivotal ReCET Clinical Study and support the company’s regulatory path to FDA approval.
Announced a strategic collaboration with the Icahn School of Medicine at Mount Sinai in New York to accelerate the joint development and validation of next-generation AI-ECG algorithms, positioning the company to expand from symptom-based cardiac rhythm monitoring into AI-enabled disease assessment and management. The company also announced a commercial partnership with ClearCardio, which will serve as its first commercial customer and plans to make an investment in the company, reflecting strong strategic alignment.
Secured a $40M loan facility, provided by Horizon Technology Finance. The loan facility includes an initial funding of $15M at closing, with the remaining $25M available to support future commercial expansion of its SwoopⓇ System across hospital and office settings, as well as globally.
Welcomed Hashan De Silva to its Board. De Silva, Founder and Managing Partner at KP Rx, brings a combination of clinical, industry, and investment experience that will be invaluable as the company scales the Kitea System, its breakthrough remote monitoring technology.
Received FDA Breakthrough Device Designation for its Noah Labs Vox™, a voice-based AI algorithm for remote monitoring of chronic heart failure, which expedites its upcoming clearance and commercial activities, including the company's upcoming FDA trial. The company was also awarded a €3M ProFIT grant from the Investment Bank of Brandenburg.
Entered into a know-how agreement with Mayo Clinic to apply the company's technology to enhance robotic bronchoscopy with in-situ optical diagnostics and therapy delivery. Planned to begin early in 2026, the agreement will have Mayo Clinic investigators Janani S. Reisenauer, M.D., and Matthew J. Aizpuru, M.D., provide clinical expertise to the company to accelerate development of an innovative solution based on its technology, compatible with robotic-assisted delivery.
Received CE mark approval for Knee+ NexSight, its new Augmented Reality guidance solution for total knee arthroplasty, with the first procedures already performed in Europe. Designed to meet the evolving demands of surgeons and high-throughput operating rooms, Knee+ NexSight projects a virtual screen into the surgeon’s field of view and integrates voice command, and is currently under FDA 510(k) review.
Welcomed LSI Alumni Suzy Engwall as its Sr. Director of Global Business Development & Strategic Growth. Engwall has a deep background in go-to-market strategy and business development, and will identify and build relationships with medical device, diagnostic, and digital health companies navigating the complexities of U.S. commercialization, connecting them with the company’s extensive network.
Welcomed Amrita Sethi and Barham Abu Dayyeh to its Scientific Advisory Board. Dr. Sethi is a nationally recognized leader in advanced endoscopy with expertise in therapeutic endoscopic procedures, including endoscopic submucosal dissection (ESD) and complex GI interventions, while Dr. Abu Dayyeh is a globally recognized leader in advanced endoscopy and endobariatrics with expertise in minimally invasive and organ-sparing GI therapies.
Welcomed LSI Alumni Will Martin to its Board of Directors. Martin brings over 20 years of medical device leadership, including four successful startup exits, most recently serving as the President and CEO of IRRAS.
Announced the closing of its second fund, Futures II, with participation from leading healthcare systems, including Mayo Clinic and Sutter Health. Futures II is anchored by an investment thesis focused on AI-enabled medical robotics and minimally invasive therapies, fueling companies creating entirely new care pathways and business models, and will back companies innovating in these categories to create new standards of care in distributed settings.
Appointed Thurman Ballard as Vice President of Sales to lead the company's U.S. commercial strategy and sales organization, with a focus on expanding surgeon adoption of the EnFix family of demineralized bone fiber implants designed for enthesis repair. Ballard brings more than 35 years of experience commercializing orthopedic and sports medicine technologies with a proven track record of launching disruptive products, building high-performing sales organizations, and leading teams to consistently deliver strong revenue growth.
Executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. Under the agreement, NCI will test and validate the company’s current FDA-cleared instruments and prototypes of instruments for soft tissue biopsy, and co-develop the next generation of image guided instruments for soft tissue biopsy.
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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