May 23, 2025

The Weekly Recap 5/23/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

The Weekly Recap 5/23/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

Weekly Recap 16_9 - 05.23.2025

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni achieve regulatory milestones, present promising interim clinical results, secure new funds, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).

Aevice Health

Received FDA 510(k) clearance for pediatric use (ages 3+) of AeviceMD, a smart wearable stethoscope that enables remote monitoring of lung sounds in children with chronic respiratory conditions. The clearance supports Aevice Health’s U.S. commercialization plans and expands access to early intervention tools for vulnerable pediatric patients.

Atia Vision

Received FDA IDE approval to begin a U.S. clinical trial of the OmniVu™ Lens System, a dual-optic intraocular lens designed to restore dynamic vision after cataract surgery. Backed by international data from over 75 treated eyes, the system aims to deliver a continuous visual range while preserving anatomical integrity.

Axena Health

Received federal supply access for the LevaⓇ Pelvic Health System, enabling prescription through VHA, CCN, and MHS providers to support more than two million female veterans. The FDA-cleared device offers convenient, non-invasive pelvic floor muscle training to treat urinary incontinence at home.

Gradient Denervation Technologies

Received FDA Breakthrough Device Designation for its ultrasound-based pulmonary artery denervation system. Gradient Denervation Technologies’ catheter platform is designed to reduce pulmonary pressures in patients with pulmonary hypertension and heart failure.

Hyalex Orthopaedics

Received FDA approval for an IDE supplement to expand the early feasibility study of the Freestyle Knee Implant into a pivotal clinical trial. Hyalex Orthopaedics’ next-generation implant leverages the HYALEXⓇ HYDROSURF materials platform to restore mobility for patients with cartilage damage and early osteoarthritis of the femoral condyle.

illumicell AI

Installed its first U.S.-based LuceDx system at the Harvard Pagliuca Life Lab to begin six clinical investigations focused on biomarker correlation and diagnostic interference. This milestone marks illumicell AI’s U.S. launch and supports its mission to generate real-world data and advance next-gen diagnostic insights.

Inner Cosmos

Reported 36-month interim data showing all three patients in its ongoing clinical study surpassed prior transcranial magnetic stimulation (TMS) outcomes using Inner Cosmos’ minimally invasive psychiatric BCI. The system is designed for at-home neurostimulation with remote psychiatrist oversight.

Nitinotes

Presented interim results from a multicenter study at IFSO-EC 2025 showing EndoZip™ led to 11.4% total body weight loss at 12 months with improvements in blood pressure and HbA1C among patients with obesity, hypertension, and type 2 diabetes. The automated, minimally invasive endoscopic system demonstrated a favorable safety profile and continues to show promise as a potential new option in obesity care.

Orixha

Received €4M in co-funding from France 2030’s “First Factory” program to build an industrial reprocessing plant for its Liquid2Breathe (L2B) fluid, a key component of the Vent2Cool liquid ventilation system. The facility, set to open in 2028, will enable large-scale production and reprocessing of respiratory fluid.

Pulnovo Medical

Received new investment from EQT following CE-MDR certification for its PADN-based pulmonary hypertension treatment system, with continued backing from Qiming Venture Partners. The funding will support Pulnovo Medical’s global expansion across clinical trials, regulatory approvals, and commercialization.

ReGelTec

Received CE Mark approval for the Hydrafil System, a percutaneous hydrogel implant designed to treat chronic low back pain by restoring disc biomechanics and reducing pain. The approval, backed by data showing over 80% improvement in disability and 70% pain reduction, supports ongoing enrollment in ReGelTec’s U.S. pivotal study, HYDRAFIL-D.

Wellumio 

Signed a Memorandum of Understanding with MEYTEC GmbH, a leader in telemedicine solutions, to integrate Wellumio’s portable brain imaging technology with MEYTEC’s advanced tele-stroke systems. The collaboration aims to accelerate stroke diagnosis and expand access to critical care.

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.