In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive new funding, receive regulatory approvals, achieve clinical milestones, and much more on the road to LSI Europe ‘26 in Barcelona (September 28 - October 1).
Granted its first patent, with a PCT patent application already in progress. The company is developing next-generation stentgraft technology designed to reduce catheter sizes by up to 20%, enable individualized implants within days instead of months, and improve device durability.
Received FDA Breakthrough Device Designation for V-Link, the company’s non-invasive, single-use neuromodulation platform designed to reduce cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage in the ICU. The system delivers electrical stimulation to the vagus nerve through the outer ear to help regulate the inflammatory response associated with secondary brain injury following hemorrhagic stroke.
Raised SGD 20M ($15.6M) in a funding round led by ClavystBio, with additional investment from ZIG Ventures. The funding will support global expansion of the company’s robotic-assisted prostate cancer treatment platform and its entry into the U.S. market.
Welcomed Thomas Hanke as a Venture Partner. Hanke has over 25 years of experience in drug discovery and development across therapeutic modalities and indications with a proven track record as a startup investor and board member.
Published the initial results in the Journal of Urology from the VAPOR 2 Study evaluating the Vanquish® Water Vapor Ablation System in men with localized, intermediate-risk prostate cancer. Findings from the study highlight encouraging ablative efficacy across varying tumor locations, a favorable safety profile, with no device-related serious adverse events, and high patient satisfaction.
Listed its CerviSense® in the GE HealthCare Voluson™ Solution Store, the first digital marketplace for women's health ultrasound, in the UK, France, Germany, and the Nordic region. The listing enables OB/GYN clinicians to learn more about CerviSense, a CE-marked intravaginal probe for quantitative cervical tissue stiffness measurement, through GE HealthCare's trusted Voluson™ ultrasound systems.
Received FDA IDE approval for TRIUMPH, the pivotal clinical trial evaluating the company’s transcatheter tricuspid valve replacement (TTVR) system. The device is designed to accommodate a broader range of tricuspid anatomies, and the trial includes both a randomized cohort and a 150-patient registry for patients who are ineligible for commercial TTVR and are suboptimal candidates for transcatheter edge-to-edge repair (TEER).
Completed the first close of its BII Catalyst Fund I for Italy, a fund designed to breathe life into Italian therapeutic startups during their first, crucial steps. The fund brings public (Lazio Innova) and private partners (Novo Holdings) around the same table with a shared goal: to strengthen the Italian life sciences ecosystem, starting from the Lazio region.
Appointed Kristoff Goson as its new CEO to lead the company’s U.S. commercial expansion and global growth strategy. The former Zimmer Biomet executive will help advance the company’s connected ecosystem, which links pre-operative planning, real-time surgical execution, and post-operative outcomes.
Featured its Histolog® Scanner confocal microscopy technology in 13 peer-reviewed clinical papers in a special issue of BJU International. The Histolog Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues, including, but not limited to, the identification of cells, vessels, and their organization or architecture.
Secured MR-conditional labeling in both Europe and the U.S. for its subcutaneous EEG implant, UNEEG SubQ. This advancement offers significant value for patients, eliminating the need for additional surgical procedures prior to MRI scans.
Welcomed Louis-Michel Wong Kee Song, MD, to its Clinical Advisory Board, bringing internationally recognized expertise in advanced therapeutic endoscopy from Mayo Clinic Rochester. His experience in procedures including endoscopic submucosal dissection, endoscopic full-thickness resection, and third-space endoscopy will support the advancement of the company’s ERES™ flexible endoscopic robotic platform in the U.S. and beyond.
Entered into an agreement to acquire Pacira BioSciences’ ioveraº nerve therapy technology for up to $140M, including $70M upfront and up to $70M in revenue-based milestone payments through 2031. The FDA-cleared, drug-free ioveraº system uses cryoneurolysis to temporarily interrupt pain signals by applying focused cold therapy to targeted nerves.
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.
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