The Weekly Recap 8/28/26: 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 achieve regulatory approvals, receive new funding, appoint new executives, and much more on the road to LSI Europe ‘26 in Barcelona (September 28 - October 1).

Apreo Health

Treated the first patient in its BREATHE-3 Study at Houston Methodist. The study is evaluating the safety and efficacy of the Apreo BREATHE Airway Scaffold, a bronchoscopically delivered, self-expanding implant designed to relieve emphysema-related lung hyperinflation in patients who continue to have difficulty breathing despite optimal medical management.

AQUAPASS

Appointed LSI Alumni Michael Tajima as COO. Tajima brings 16 years of leadership in medical device organizations spanning product development, medical evidence development, commercialization, globalization, and organizational scaling, most recently leading Strategy at Paragonix Technologies.

Axoft

Introduced Fleuron^® Water Invisible Soft Elastomer (WISE), a UV-curable material engineered to “disappear” in water when submerged by matching water’s refractive index. Ultra-soft, flexible, and impermeable to water, WISE enables dramatically reduced optical aberrations and sharper, higher-resolution imaging for aqueous samples.

Calla Lily Clinical Care

Welcomed Mark Lubkeman to its Board of Directors, bringing 35 years of experience across biopharma and medtech. Lubkeman previously served as COO of IntraBio, leading its U.S. product launch and commercialization, and headed BCG’s Global Biopharma business, advising CEOs and boards on corporate and commercial strategy.

eCential Robotics & Spineart

Received FDA 510(k) clearance for the PERLA^® TL application on the eCential^® Op.n^® Navigation and Robotic-Assisted Platform. This advancement enables surgeons to leverage integrated navigation and robotics technologies to support implant placement accuracy, workflow efficiency, and procedural confidence in both open and minimally invasive spine procedures.

HighLife

Received CE Mark approval for its Clarity Mitral Heart Valve for use with the HighLife Transcatheter Mitral Valve Replacement (TMVR) System. The Clarity Valve represents the next-generation evolution of the company’s TMVR platform, purpose-built to further mitigate left ventricular outflow tract obstruction (LVOTO)-related anatomical concerns while preserving its established transfemoral valve-in-ring architecture.

Lupin Dental

Closed a €15M Series A financing round led by Fynveur, which invested €10M, alongside continued support from existing shareholders and new private investors. The financing is complemented by a loan from Bpifrance and will support the company’s next phase of growth as it works to transform the future of dental care.

Materna Medical

Completed the final close of its oversubscribed Series B3 financing, welcoming new investors Portfolia and Dalton Investments alongside returning investors including GLIN, Harbright Ventures, Women’s Venture Capital Fund, and Houston Angel Network. The final close builds on the momentum from the initial financing announced in June and strengthens the company’s investor base for its next phase of growth as it moves towards its next product launch. 

Noah Medical

Announced that its Galaxy™ System is now fully compatible with GE HealthCare’s premium OEC C-arm portfolio, enabling seamless integration for image-guided, robotic-assisted bronchoscopy and expanding access to minimally invasive lung diagnostics. The updated Galaxy II software supports the GE HealthCare OEC 3D mobile cone-beam CT system, as well as OEC Elite CFD, OEC 9900, and OEC 9800 C-arm systems, providing advanced 2D and 3D imaging capabilities.

Paradromics

Received an FDA approval letter that expands the types of computing devices that can be used with its BCI system. Rather than being tied to a company-provided computer, clinical trial participants and future BCI users will be able to connect to the personal technology devices that are already a part of their daily lives.

Pulnovo Medical

Successfully enrolled the first two patients in its PULSE-LHD clinical trial, conducted under an FDA IDE, at Henry Ford Hospital in Detroit. The study is a multi-center, randomized, placebo-procedure-controlled trial designed to evaluate the safety and efficacy of Pulmonary Artery Denervation (PADN) in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease. 

Qaelon Medical

Appointed Ricardo “Rick” Estape, MD, to its Scientific Advisory Board, bringing extensive expertise in robotic gynecologic surgery. With more than 11,000 robotic procedures performed across benign and oncologic gynecology, Dr. Estape brings valuable clinical insight into the insufflation, visualization, and workflow challenges of robotic gynecologic surgery.

Samay

Received its 23rd patent protecting a core component of Sylvee, its acoustic resonance technology, which interprets changes in lung function from sound patterns in the body. The patent, issued in Canada, will help the company expand into a market where chronic obstructive pulmonary disease exacerbations affect nearly 10% of the population. 

Shape Memory Medical

Closed a $10M convertible note financing led by new investor August Global Partners (AGP), joined by fellow new investor Taiwania Capital. The financing provides capital to support continued clinical development of the company’s aortic portfolio, including patient follow-up and data collection in the AAA-SHAPE Pivotal Trial and advancement of the FLAGSHIP feasibility trial.

Venous Stent

Completed the successful first-in-human implantation of the ALTA^® Venous Stent, marking a significant milestone in the development of its next-generation venous stenting solution. The procedure moves the ALTA stent from preclinical development into clinical use and advances the company toward commercialization of its solution for iliac vein stenting.

Virtual Incision

Granted FDA 510(k) clearance for the use of its MIRA™ Surgical System in benign hysterectomy procedures. The clearance was supported by outcomes from the MIRA Surgical System Hysterectomy IDE Study, a prospective clinical study conducted by five surgeons across three U.S. hospitals that confirmed the system’s safety and performance in benign hysterectomy procedures.

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.