The Weekly Recap 10/31/25: 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, achieve clinical milestones, appoint new executives, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

Avvio Medical

Received FDA Breakthrough Device Designation for its Enhanced Lithotripsy System (ELS), a minimally invasive platform designed to treat kidney stones without general anesthesia, fluoroscopy, or costly capital equipment. The designation accelerates the company’s path to De Novo submission in 2026 and supports its mission to move kidney stone treatments out of the OR and into more accessible outpatient settings.

Earlybird Health

Promoted Dr. Rabab Nasrallah and LSI Alumni Dr. Christoph Massner to Partners at Earlybird Health in recognition of their leadership across biotech, medtech, and data-driven health investments. The promotion reflects their impact on investment strategy and portfolio management, further strengthening Earlybird Health’s commitment to rigorous, future-focused healthcare innovation.

Elixir Medical

Announced new landmark clinical results for the DynamX^Ⓡ bioadaptor coronary implant system. Data presented at the 2025 Transcatheter Cardiovascular Therapeutics conference showed a 48% risk reduction in device-related cardiac events compared to a current-generation drug-eluting stent.

Inner Cosmos

Completed its FDA early feasibility trial for the Digital Pill, a minimally invasive implantable device designed to treat treatment-resistant depression. The system is implanted subdermally and magnetically connects to an external pod, enabling patients to self‑administer transcranial magnetic stimulation‑like therapy at home.

Innitius

Received CE Marking for CerviSense^Ⓡ, an operator-independent diagnostic platform that assesses cervical stiffness for obstetric decision-making. The certification enables European commercialization and supports broader adoption of the technology to improve outcomes in preterm birth management and labor induction.

magAssist

Appointed Steve Motes as Chief Executive Officer for its U.S. operations, bringing 25+ years of leadership experience in the medical device industry and deep expertise across advanced circulatory support and critical-care technologies. His leadership is expected to strengthen the company’s presence in the U.S. cardiovascular market and accelerate its broader global growth strategy.

Onera Health

Was awarded the 2025 SleepTech^Ⓡ Award from the National Sleep Foundation for its FDA-cleared patch-based home polysomnography system. The recognition affirms Onera’s leadership in expanding access to comprehensive sleep diagnostics through patient-applied, wireless sensors.

Orchestra BioMed

Announced first patient enrollments in the U.S. IDE pivotal Virtue Trial, a head-to-head randomized study comparing its Virtue^Ⓡ Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) to the AGENT™ paclitaxel-coated balloon for coronary in-stent restenosis. The company also signed a $30M agreement with Terumo that terminates their prior distribution deal and grants Terumo a right of first refusal to acquire the rights or enter a distribution agreement regarding the Virtue SAB for the treatment of coronary artery disease.

Pleural Dynamics

Announced positive results from a prospective, multicenter study of its ACES (automatic continuous effusion shunt) device, showing a 53% mean reduction in pleural effusion volume at 30 days, a 96% rate of implantation success, and no related adverse events. This evidence, along with the recently issued reimbursement code from CMS, reinforces the company’s plans to expand access to its fully implantable automatic effusion shunt.

Pulse Biosciences

Enrolled the first patient in its NANOCLAMP AF study evaluating the nsPFA Cardiac Surgery System for atrial fibrillation, following FDA IDE approval in September. The milestone marks the start of a multicenter trial for the company’s nonthermal ablation technology, which aims to minimize collateral tissue damage during cardiac surgery.

Recor Medical

Announced results from two clinical studies demonstrating sustained blood pressure reductions and no safety concerns for its Paradise^Ⓡ ultrasound renal denervation (uRDN) system. Findings from both the GPS registry and RADIANCE pooled analysis further validate Paradise as a durable, effective treatment for uncontrolled and resistant hypertension.

Remedy Robotics

Entered a strategic partnership with Mission Thrombectomy to expand global access to endovascular stroke treatment using the N1 System, the world’s first remotely operable endovascular robot. As Mission Thrombectomy’s exclusive robotics partner, Remedy Robotics aims to integrate its telerobotic technology into stroke-thrombectomy workflows.

Solaris Endovascular

Reported positive six-month interim results from the DEScover trial, demonstrating 95% primary patency through six months, 100% procedural success, and zero 30-day device-related adverse events. The company believes that the Solaris DE stent may set a new benchmark for sustained patency in dialysis access and peripheral artery disease.

ViCentra

Announced the appointments of Karen Baxter as SVP Sales, Europe, and Jay Little as VP Strategy & Business Development to accelerate growth following its $85M Series D. The former Dexcom and Medtronic leaders bring nearly 40 years of diabetes device commercialization experience to expand Kaleido’s European footprint and strategic partnerships.

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.