The Weekly Recap 6/20/25: 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 over $17M in new funds, achieve regulatory clearances, appoint new executives, and much more on the road to LSI Europe ‘25 in London (September 7-11).

Adialante

Received a $1.18M National Science Foundation SBIR Phase II award to advance the development of its compact, silent, and low-cost MRI technology. The funding brings Adialante’s total raised to nearly $3M as the team works to expand access to high-quality medical imaging worldwide.

Asabys Partners

Promoted Maite Malet and Isabel Jiménez Bernal to Principal in recognition of their leadership and impact across the firm’s healthcare investment strategy. Asabys continues to strengthen its position in health-tech and biopharma by advancing transformative technologies alongside top industry talent.

Berkshire Biomedical

Was awarded Phase I of a two-phase Fast-Track SBIR grant from the National Institutes of Health to evaluate its COPA™ System for take-home methadone management. The grant, totaling up to $2.9M, will support clinical studies aimed at improving treatment retention for patients with opioid use disorder.

Day Zero Diagnostics

Will be acquired by bioMérieux to expand next-gen sequencing capabilities in infectious disease diagnostics. The deal strengthens bioMérieux’s R&D pipeline with rapid, sequencing-based tools to accelerate pathogen ID and resistance profiling—critical for managing sepsis and other life-threatening infections.

EBR Systems

Raised an additional $13M through an oversubscribed security purchase plan to support the commercialization of its WiSE CRT leadless pacing system. Combined with a recent $36.1M institutional placement, the total $49.1M in new funding will back limited market release in 2025 and full commercial distribution in 2026.

FineHeart

Received ANSM authorization to begin a first-in-human clinical trial in France evaluating FlowMakerⓇ, its fully implantable cardiac output accelerator for advanced heart failure. The study marks a major milestone toward clinical validation of this minimally invasive, pulsatile LVAD alternative designed to preserve native cardiac function.

GI Windows Surgical

Received FDA 510(k) clearance for its Flexagon system, a self-forming magnet technology enabling sutureless, staple-free anastomosis. The clearance validates GI Windows’ approach to advancing minimally invasive surgery with faster procedures, fewer complications, and no foreign materials left behind.

Gradient Denervation Technologies

Was accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) to advance its novel ultrasound-based treatment for pulmonary hypertension. The designation follows recent Breakthrough Device status and is expected to accelerate pivotal study planning and future U.S. access for this first-in-class denervation therapy.

Inovus Medical

Released two new high-fidelity laparoscopic training modules—the Mesocolic Dissection Model and Cholecystectomy Model—for its LapAR simulator and Totum simulation platform. The models are designed to enhance hands-on training for general surgery residents performing colorectal resections and gallbladder removal.

InspireMD

Received CE Mark approval under the EU MDR for its CGuard Prime carotid stent system to help prevent stroke in patients with narrowed carotid arteries. The next-generation device builds on InspireMD’s MicroNet mesh technology with improved deliverability and long-term embolic protection.

Levita Magnetics

Received expanded FDA 510(k) clearance for its magnetic-assisted robotic surgery (MARS) system in bariatric and hiatal hernia surgeries, supporting less invasive treatment of obesity-related conditions. The clearance also includes a new magnetic grasper designed to improve visualization and control in patients with high BMI.

Neuspera

Received FDA approval for its integrated sacral neuromodulation (iSNM) system for treating urinary urge incontinence. The miniaturized, battery-free system offers an alternative to traditional SNM, showing strong clinical outcomes and improved quality of life for patients.

Nurami Medical

Achieved ISO 13485 certification following a successful QMS audit by the notified body DQS, advancing its path to CE Mark approval for ArtiFascia. The synthetic, sutureable dural substitute has already been used in over 150 neurosurgical procedures and is cleared for use in the U.S. and Israel.

Orthonika

Appointed Maria Kristina Bartolo as Chief Executive Officer. She previously served as Chief Technology Officer and Senior Biomedical Engineer at the company, bringing deep technical expertise and product leadership to her new role as Orthonika advances its next-generation soft orthopedic implant solutions.

OSSIO

Launched OSSIOfiberⓇ 2.5mm Suture Anchors, expanding its portfolio of bio-integrative, metal-free implants for soft tissue fixation. The new devices offer 55% greater pull-out strength than leading alternatives and are designed to improve outcomes in procedures like Brostrom repair while supporting a familiar surgical workflow.

OSSTEC

Received an Innovate UK grant in partnership with Nexus Additive to advance in situ monitoring and quality assurance for metal 3D printing. The project aims to accelerate orthopedic implant production while improving safety, reliability, and design precision.

Recor Medical

Appointed Dr. Shon Chakrabarti as Chief Medical Officer to lead the medical strategy for the company’s ultrasound-based renal denervation technology. As a board-certified interventional cardiologist with industry leadership experience, Dr. Chakrabarti will help advance Recor’s mission to transform hypertension care.

Serac Life Sciences

Celebrated Scientific Advisor Professor Alan Perkins, who was awarded an MBE in the King’s Birthday Honours for his services to patient care and clinical science. A pioneering figure in nuclear medicine and co-inventor of the SeracamⓇ imaging system, Perkins continues to shape Serac’s mission to bring precision diagnostics to the bedside.

Terapet

Achieved ISO 13485:2016 certification for its Quality Management System, reinforcing its commitment to safe, high-performance imaging solutions in radiation therapy and nuclear medicine. The certification supports the company’s clinical and commercial roadmap for its flagship technologies, Qualγscan and Nuclγscan.

Virtual Incision

Appointed Jim Alecxih as Chief Executive Officer to lead the company’s next phase of innovation and growth. Alecxih—former Intuitive Surgical executive and medtech veteran—will spearhead the development and commercialization of the MIRA Surgical System’s next-generation platform, M2, expanding access to robotic-assisted surgery in more diverse healthcare settings.

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.