In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni achieve regulatory clearances, secure over $99.2M in new funds, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).
Secured new growth financing led by Concord Health Partners to accelerate commercial expansion and pipeline development for its expandable spinal implant technologies. The company also appointed industry veteran Bernie Haffey as Chairman of its Board of Directors to guide the next phase of strategic growth.
Announced the successful utilization of the Intilume™ System to perform robotic-assisted en bloc resection of bladder tumors (ERBT) in its first-in-human clinical trial at Prince of Wales Hospital in Hong Kong. The flexible endoscopic system demonstrated enhanced precision and safety, supporting the broader adoption of minimally invasive ERBT for bladder cancer.
Presented new clinical evidence at ESOC 2025, demonstrating that the use of its Brainomix 360 Stroke platform significantly increased access to mechanical thrombectomy, especially in primary stroke centers. The company continues to aid in cutting-edge research with its next-generation imaging biomarkers.
Completed enrollment in its first-in-human clinical study just seven months after the first patient implantations—ahead of schedule and with promising early results. The company plans to present initial findings at upcoming ASPN and NASS conferences as it advances innovation in interventional spine care.
Received FDA 510(k) clearance for adult cholecystectomy using the DEXTERⓇ Robotic Surgery System, expanding U.S. indications alongside inguinal hernia repair. The approval strengthens DEXTER’s position as a purpose-built robotic solution for outpatient settings like ASCs and HOPDs.
Secured commitments for a fully underwritten institutional placement to raise $36.1M to support the commercialization of its WiSE CRT system, the world’s only FDA-approved wireless cardiac pacing device for heart failure. The financing positions the company to begin limited market release in 2025 and ramp U.S. distribution in 2026.
Merged with Matrix Requirements to form a new entity, Matrix One, expanding capabilities across connected medical device cloud and quality systems. As part of the transition, the Galen Cloud product becomes Matrix Connect, continuing its mission to simplify secure, compliant connectivity for medtech innovators.
Completed its pre-market clinical study of b.Spine for posterolateral spinal fusion, with 100% of patients achieving successful fusion at 1-year follow-up. Supporting data has been submitted for MDR CE Mark approval, advancing the company’s mission to bring next-generation bone regeneration solutions to more patients.
Oversubscribed its $1M bridge round, raising $2.2M to accelerate commercialization of the OsteoPearl™ implant for vertebral compression fractures. The company also completed its 200th surgical procedure using the allograft implant, underscoring strong clinical adoption and growing market momentum.
Initiated patient treatment in a new randomized controlled trial comparing the MISHAⓇ Knee System to non-surgical treatment for medial knee osteoarthritis. The trial reinforces the company’s leadership in joint unloading therapies and builds on the growing clinical adoption of its FDA-cleared implantable shock absorber.
Was awarded a $900K supplemental grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to advance clinical validation of its minimally invasive, image-guided Prana System for lung cancer. The funding supports continued development, team expansion, and innovation efforts in Texas.
Received CE Mark approval for the HYDRAFILⓇ System, a percutaneous hydrogel implant for treating chronic low back pain due to degenerative disc disease. Backed by 2-year clinical data showing >80% improvement in disability scores, the approval clears a path to commercialize HYDRAFIL in Europe and supports enrollment in the ongoing U.S. pivotal trial.
Secured $60M in Series B funding led by Innovation Industries to complete clinical development and prepare for the commercial launch of MySalvia Therapy, a breakthrough neuromodulation treatment for chronic migraine. The funding supports regulatory pathways in the United States, Europe, and Australia, advancing Salvia’s mission to transform care for millions living with chronic migraine.
Completed enrollment in its first-in-human INSPECT study evaluating a real-time tumor detection system for use during transbronchial lung biopsies. The microsensor-enabled technology is designed to guide bronchoscopists in accurately identifying cancerous tissue, aiming to accelerate diagnosis and improve outcomes in lung cancer 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.
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