The Weekly Recap 9/26/25: 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 achieve regulatory milestones, secure new funds, appoint new executives, and much more on the road to LSI USA ‘26 in Dana Point (March 16–20).

52North

Appointed Rebecca Simmons as Chief Operating Officer and Joe Neale as Chief Technology Officer to accelerate regulatory and commercial progress. With deep experience across deep tech, healthcare, and global medtech product development, the hires strengthen 52North’s leadership bench as it works toward commercializing Neutrocheck^Ⓡ at scale.

Aescape

Named Tom Brady as Chief Innovation Officer and secured exclusive rights to his science-backed longevity and pliability protocols. The move marks a strategic push to scale elite athlete recovery practices to the broader consumer market, as Aescape continues expanding its robotic massage platform and presence across wellness, sports, and hospitality sectors.

Axon Therapies

Announced the close of an oversubscribed $32 million Series A financing co-led by new investors Earlybird Venture Capital and Santé Ventures, with participation by existing investor Deerfield Management and new investors CD Capital and KOFA Healthcare. In conjunction with the financing, the company announced that Zoar Engelman, PhD, Axon's co-founder and former Chief Scientific Officer, has been appointed Chief Executive Officer.

BetaGlue Therapeutics

Appointed Alexis Peyroles as Chief Executive Officer to lead the advancement of YntraDose^Ⓡ, its 90-Yttrium-based internal radiotherapy platform for unresectable solid tumors, including locally advanced pancreatic adenocarcinoma. Peyroles brings deep oncology expertise and a proven track record of strategic transactions, positioning the company for clinical progress and future growth.

Biolinq

Received De Novo Classification from the FDA for Biolinq Shine™, the first fully autonomous, needle-free glucose sensor. The biosensor marks a new category in wearable glucose sensors for metabolic health, offering real-time glucose, activity, and sleep tracking without a subcutaneous needle, and is initially intended for people with type 2 diabetes not dependent on insulin.

FluidAI

Received FDA 510(k) clearance for Origin™, a real-time surgical drain monitor that uses sensors and AI to detect post-operative complications by analyzing patient fluid and data. The clearance positions FluidAI to expand into the U.S. market, raise a Series B round, and advance its broader vision for data-driven surgical recovery.

Formus

Entered an exclusive distribution agreement with Zimmer Biomet to bring Formus Hip, its AI-automated 3D pre-operative planning software, to the Japanese market. Building on a five-year partnership in Australia and New Zealand, the collaboration expands Formus’ reach into the world’s second-largest orthopaedic market to support faster, more precise surgical planning at scale.

Intressa Vascular

Enrolled the first patient in Germany for the EXTENSO clinical study evaluating the Allay^Ⓡ Aortic Stent as an adjunctive endovascular treatment to thoracic endovascular repair with stent grafts in Type B aortic dissection. The milestone marks the European launch of the multicenter trial, which aims to demonstrate reduced reintervention rates and improved outcomes for patients.

Interventional Systems

Entered a co-marketing agreement with Siemens Healthineers to promote robotic-assisted image-guided procedures using its Micromate™ platform. The collaboration combines Interventional Systems’ needle-based surgical robotics with Siemens Healthineers’ angiography suite, aiming to increase global access to precision-guided percutaneous interventions.

Kent Imaging

Received CE Marking for SnapshotNIR, enabling commercialization and clinical adoption of its portable, noninvasive tissue oxygenation imaging device across the European market. The regulatory milestone supports Kent Imaging’s global expansion and distributor partnerships as the company accelerates access to NIRS-based wound care, surgical recovery, and vascular assessment.

Materna Medical

Announced the presentation of a new case series at SOGH 2025 showing that complete levator ani muscle avulsions from vaginal delivery did not fully heal over time. The findings reinforce the need for preventive strategies like Materna’s investigational Ellora™ System.

MicroSteer

Was awarded its third consecutive Israel Innovation Authority grant to advance its single-use robotic device for complex colorectal lesion removal. MicroSteer’s add-on system decouples dissection from endoscope manipulation, potentially enabling safer and more accessible endoscopic resections through enhanced precision and control.

Nyxoah

Completed the first successful implant of its Genio^Ⓡ system in Abu Dhabi, marking continued regional expansion of its leadless neuromodulation therapy for obstructive sleep apnea. Nyxoah plans to grow its presence across Dubai, Kuwait, and Abu Dhabi by partnering with leading healthcare institutions to increase access to its patient-centric alternative to CPAP and BiPAP.

Picard Medical

Was awarded a new U.S. patent for the fully implantable, driverless “Emperor” total artificial heart platform. The patent expands Picard Medical’s IP portfolio to 34 claims in the U.S. and supports its mission to develop a next-generation, durable, and patient-friendly alternative for end-stage heart failure patients.

Vena Medical

Was issued a Medical Device Licence by Health Canada for the Vena MicroAngioscope System™, the world’s first intravascular imaging device with a licensed neurovascular indication. The technology has already been used in more than 30 commercial cases across Canada, enabling real-time, full-color direct visualization inside blood vessels to support informed clinical decision-making.

VESTECK

Was awarded an NIH SBIR grant totalling $1.98M to support the pre-market development and clinical validation of the SUTURE-TIGHT™ endovascular suturing device. The funding will help VESTECK advance its AAA repair system toward FDA IDE approval and 510(k) clearance, with the goal of reducing reintervention rates due to endograft migration.

Watershed Therapeutics

Was awarded a Phase I NIH SBIR grant to advance a self-eliminating, intravesical drug delivery platform for the prevention of recurrent urinary tract infections (rUTIs). Watershed’s bladder-retained system delivers amikacin locally over 4–12 weeks, with early human studies showing comfort, durability, and sustained therapeutic levels without obstructing flow.

Xeltis

Reported positive results from its European pivotal trial evaluating the aXess restorative vascular access conduit for hemodialysis treatment. The data showed superior and sustained patency, fewer reinterventions, and high infection resistance, supporting Xeltis’ plan to advance toward commercialization of its PFAS-free, tissue-restoring platform.

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.