The Weekly Recap 7/4/25: 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 secure new funds, secure FDA clearances, appoint new board members, and much more on the road to LSI Europe ‘25 in London (September 7-11).

Acutus Medical

Announced the acquisition of its AcQMap™ platform assets by EnChannel Medical to accelerate the development of next-generation non-contact mapping technologies for atrial fibrillation. The deal integrates key IP into EnChannel’s electrophysiology ecosystem, strengthening its mission to deliver precision, patient-specific AF treatment.

Atmo Biosciences

Received FDA 510(k) clearance for its Atmo Gas Capsule System, enabling U.S. commercialization of the company’s ingestible gas-sensing capsule for assessing gut motility. The system offers a radiation-free, clinically validated alternative for diagnosing conditions like gastroparesis and slow transit constipation.

Cognito Therapeutics

Completed enrollment in the pivotal HOPE study evaluating the safety and efficacy of Spectris, Cognito Therapeutics’ non-invasive neuromodulation system for Alzheimer’s disease. With 670 participants across 70 U.S. sites, it is the largest medical device pilot trial to date focused exclusively on Alzheimer’s.

CroíValve

Was selected alongside Lios as one of two Ireland-backed, women-led startups to share €18.75M in European Innovation Council Accelerator funding. CroíValve will use its portion to expand clinical validation of the Duo Tricuspid Coaptation Valve System, a minimally invasive device designed to treat tricuspid regurgitation in patients who are not candidates for surgery.

Ebenbuild

Secured €2.3M in non-dilutive funding from the European Innovation Council to support the launch of its Twinhale digital twin platform for pulmonary drug delivery. Ebenbuild also announced potential equity support of up to €10M to accelerate its broader respiratory health strategy, including future tools for critical care.

Field Medical

Raised $35M in an oversubscribed Series B co-led by BioStar Capital and Cue Growth to support the pivotal VERITAS trial and accelerate development of the FieldForce™ pulsed field ablation platform. Field Medical’s physician-led team is targeting a major unmet need in ventricular tachycardia with breakthrough technology designed for speed and precision.

ImmersiveTouch

Announced a strategic majority investment from HealthpointCapital to scale its FDA-cleared XR surgical planning platform, ImmersiveView™, already used in over 3,500 cases. The deal also marks a leadership transition, with Co-Founder Jay Banerjee stepping down as CEO and joining the board as the company enters its next phase of growth.

Inner Cosmos

Added Intuitive Surgical co-founder John Freund to its board of directors and named Greg Schulte advisory CTO as it advances clinical trials for its minimally invasive “Digital Pill” brain-computer interface. The company is conducting the first FDA-approved IDE trial for a neurotech device targeting depression in nearly 20 years, aiming to bring at-home therapy to patients with treatment-resistant conditions.

Inossia

Received FDA Breakthrough Device Designation for its Inossia^Ⓡ Cement Softener, marking a major regulatory milestone in its path toward 510(k) submission. Designed to reduce the stiffness and strength of PMMA bone cement during percutaneous vertebral augmentation procedures, the device aims to better match the mechanical properties of cancellous bone.

MeThinks AI

Received FDA 510(k) clearance for its non-contrast CT (NCCT) Stroke software, the first tool to detect large vessel occlusions (LVOs) up to the MCA-M2 segment using NCCT. The software also identifies suspended intracranial hemorrhages (ICHs), enabling comprehensive stroke triage.

Moon Surgical

Received its fourth FDA clearance for the Maestro System, adding connectivity capabilities and a Predetermined Change Control Plan (PCCP) to support iterative updates to its ScoPilot AI. This milestone advances Maestro’s role as a Physical AI hub in the OR, enabling scalable intelligence, greater autonomy, and a streamlined regulatory path for AI innovation.

Novadip Biosciences

Reported long-term results from compassionate use of NVD003 in four pediatric patients with Congenital Pseudarthrosis of the Tibia, with all achieving complete fracture healing and no recurrence after four to seven years. The autologous bone graft is now advancing to a Phase 3 trial, targeting market entry in 2027.

Pylon Medical

Appointed Dr. Elad Levy to its medical advisory board to support clinical and regulatory strategy for its direct carotid access platform. His addition comes as the company advances toward first-in-human trials of its minimally invasive in-and-out carotid access technology.

SurgiBox

Formed a strategic distribution partnership with Ondatec Medical to expand access to its portable surgical containment and protection technologies in Türkiye. The collaboration strengthens SurgiBox’s European presence and supports its mission to bring safe, sterile surgery to resource-limited and hard-to-reach healthcare settings.

Vicarious Surgical

Appointed Fuad Ahmad and Joseph Doherty to its board of directors during its 2025 annual meeting of stockholders, strengthening leadership as it advances its V1.0 surgical robot toward FDA submission. The new members bring decades of medtech and financial expertise to support the company’s path to commercialization.

Veris Health

Completed a $2.5M direct equity financing at a $35M pre-money valuation to support the development of its implantable physiological monitor. The funding will help advance the device toward FDA clearance in 2026 and accelerate commercialization.

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.