The Weekly Recap 9/19/25: 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 funding, announce regulatory clearances, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

AccurKardia

Announced the launch of a multicenter clinical pilot for AK+ Guard™, its FDA Breakthrough Device Designated AI-powered technology for detecting hyperkalemia using Lead I ECG. The study will evaluate over 150 patients across care settings and aims to validate the platform’s ability to deliver real-time, remote monitoring through consumer and clinical wearables.

Amber Implants

Received FDA 510(k) clearance for its VCFix^Ⓡ Spinal System, a minimally invasive vertebral augmentation device designed to treat vertebral compression fractures. One-year follow-up data from initial clinical trials showed sustained pain reduction and faster recovery, supporting Amber’s plan to begin its U.S. commercial launch with a pilot program in early 2026.

Argá Medtech

Enrolled the first patients in the COHERENT AF IDE clinical trial evaluating its Coherent Sine Burst Electroporation (CSE) System for atrial fibrillation. The study is designed to test the safety and effectiveness of the CSE System in patients with paroxysmal and persistent atrial fibrillation.

Axoft

Was awarded grant funding from Bpifrance through the Bourse French Tech Emergence program to advance preclinical development in Grenoble, France. The funding supports Axoft’s mission to build next-generation brain–computer interfaces for patients with neurological conditions.

Byonyks

Announced the issuance of a U.S. patent supporting its Bloodless Dialysis technology, a needle-free, non-invasive solution for kidney failure treatment. The milestone strengthens Byonyks’ intellectual property portfolio as it advances efforts to expand global access to affordable, at-home dialysis care.

Diality

Announced the first patient treated in the PRESCRIBE Diality Home Hemodialysis Clinical Trial evaluating home use of its Moda-flx™ Hemodialysis System. The system combines an integrated reverse osmosis unit with customizable flow rates up to 600 mL/min, aiming to bridge the gap between in-center and home hemodialysis care.

Drill Surgeries

Appointed J. Dean Zikria as Chairman of the Board and Acting Chief Commercial Officer to support the commercialization of its software-based surgical guidance system. Drill Surgeries’ mixed reality platform uses holographic navigation, without pre-op imaging or radiation, to help surgeons perform intramedullary nailing surgeries with greater speed, accuracy, and confidence.

Exero Medical

Completed enrollment of 222 patients across 12 centers in its pivotal U.S. clinical trial evaluating the xBar system for early detection of anastomotic leaks after colorectal surgery. The real-time monitoring platform, which has FDA Breakthrough Device Designation, collects electrophysiological data from the surgical site to enable earlier intervention and improve post-operative outcomes.

GT Medical Technologies

Announced the publication of new clinical data in the Journal of Neuro-Oncology reinforcing the efficacy of GammaTile^Ⓡ in treating recurrent brain metastases after prior tumor removal and extended beam radiation therapy. The study showed high local control rates with low toxicity, supporting GammaTile’s growing role as a safe and effective salvage therapy.

INBRAIN Neuroelectronics

Entered a know-how collaboration agreement with Mayo Clinic to advance its precision BCI-Tx platform, a graphene-based brain-computer interface for neurological disorders. Alongside the partnership, INBRAIN is expanding into the U.S. with new offices in Boston and on the West Coast to support clinical trials, commercialization, and future therapeutic applications beyond Parkinson’s disease.

InnoTech Precision Medicine

Secured dual SBIR awards from the NIH (Phase II) and NSF (Phase I) to advance its AI-enabled, saliva-based diagnostic platform for head and neck cancers. The company’s multiomics technology detects genotypic and phenotypic biomarkers from a single saliva sample.

InspireMD

Appointed Dan Dearen, former Axonics co-founder, president, and CFO, to its Board of Directors. Dearen joins fellow Axonics co-founder Raymond Cohen on the board, bringing decades of medtech financial leadership as InspireMD advances the U.S. commercial launch of its FDA-approved CGuard Prime carotid stent system.

Jupiter Endovascular

Received FDA 510(k) clearance for the Vertex catheter, the first and only FDA-cleared intravascular device with Transforming Fixation (TFX) technology. Vertex enables on-demand shifts from flexible to firm states, enhancing control and stability during endovascular procedures.

Nalu Medical

Secured up to $50 million in growth funding from Trinity Capital to support the continued commercial expansion of its Neurostimulation System. Nalu’s next-generation, battery-free Therapy Disc is FDA-cleared for Peripheral Nerve Stimulation with whole-body MRI-conditional use, and is backed by robust long-term real-world data.

NZ Technologies

Announced a collaboration with Providence Health Care Ventures to establish a Living Lab for evaluating sterile and touchless interaction technologies in clinical workflows. NZ Technologies’ portfolio includes HoverTap™ and TIPSO AirPad, which enable touchless control of medical equipment to reduce infection risk and improve workflow efficiency in sterile and semi-sterile environments.

ONWARD Medical

Published two landmark studies in Nature and Nature Medicine demonstrating that its ARC^IM system delivers safe, targeted spinal cord stimulation to regulate blood pressure after spinal cord injury. Data from multi-year clinical studies showed rapid, sustained improvements in hemodynamic stability, reduced reliance on traditional interventions, and enhanced quality of life, supporting Onward Medical’s upcoming Empower BP pivotal trial.

OSSIO

Established new U.S. headquarters in Palmetto, Florida, bringing nearly 100 jobs, a surgeon training center, and advanced manufacturing capabilities to the region. The expansion supports OSSIO’s continued growth and commercialization of OSSIOfiber implants, which have now been used in over 60,000 orthopedic procedures.

PatenSee

Received FDA Breakthrough Device Designation for its non-contact vascular access management platform for hemodialysis patients. PatenSee’s AI-enabled optical monitoring system supports earlier detection of complications, reduces clinical burden, and is currently being validated in a trial with Henry Ford Health.

Peerbridge Health

Closed a $7M funding round, submitted the next-generation Cor MDx™ cardiac monitoring device for FDA 510(k) clearance, and appointed medtech veteran Dan Reuvers to the Board of Directors. Peerbridge Health also expanded its sales team across three regions to support the upcoming commercial launch and broaden access to affordable, high-quality cardiac diagnostics.

Raydiant Oximetry

Appointed LSI Alumni Michael Nagel as CEO, bringing over 30 years of experience scaling breakthrough medtech innovations across cardiovascular, regenerative, and wound care markets. The company is advancing maternal-fetal safety with two technologies: Lumerah™, a non-invasive fetal pulse oximetry patch, and Daisy™, a vacuum-assisted cervical drain to manage bleeding following various OB-GYN procedures.

Sentante

Received FDA Breakthrough Device Designation for its teleoperated robotic system for endovascular procedures, designed to enable remote stroke intervention. Sentante combines conventional endovascular instruments with proprietary haptic feedback, allowing clinicians to perform procedures from a separate room while maintaining intuitive instrument feel.

True Digital Surgery

Was acquired by B. Braun to advance the Aesculap division’s digital microsurgery capabilities and expand global market share. The acquisition secures True Digital Surgery’s expertise in robotic-assisted 3D surgical microscopy, enabling further development of the Aesculap AEOS^Ⓡ system for neurosurgery, spine, and ENT procedures, while maintaining TDS as a dedicated innovation hub in Goleta, California.

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.