In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive secure funding, regulatory approvals, launch partnerships, and much more on the road to LSI Asia ‘26 in Singapore (June 30 - July 2).
Closed an $80M Series C round led by existing investor StepStone Group, with additional participation from Benchmark, Redpoint Ventures, ICONIQ, and Atreides Management. The funding will help elevate its AcuityAI platform with advanced AI capabilities, now available in open beta, and drive the company’s mission of accelerating the adoption of medical technology.
Closed a £7M funding round led by IW Capital with support from existing shareholders IP Group and Mercia Ventures. The company’s proprietary Ultravision platform uses electrostatic precipitation to actively remove surgical smoke at the source, and its first-generation system has been used in over 50,000 laparoscopic and robotic procedures across Europe, the U.S., and Japan, with studies showing smoke removal up to 225 times faster than competing technologies.
Appointed Martin Reid as its Senior Vice President, Sales, as the company accelerates commercial growth across the U.S. Reid brings more than two decades of senior commercial leadership experience in U.S. medical devices, with a track record of building high-performing sales organizations, launching novel technologies, and expanding institutional access through IDN and GPO partnerships.
Secured a $50M growth capital investment from Trinity Capital to support the expansion of its neuromodulation therapy for tremor management, accelerating commercialization and product innovation for its FDA-cleared Cala kIQ™ wearable and newly cleared Cala kIQ® Plus system for Parkinson’s disease and essential tremor. The funding will help scale the adoption of its personalized, at-home therapy designed to reduce hand tremors and improve daily function.
Announced an exclusive partnership to jointly develop next-generation smart spinal cages integrating Canary Medical’s implantable sensing technology with NanoHive’s Hive™ Soft Titanium® spinal implant design capabilities, uniting both companies’ focus on advancing spine care through intelligent implant technology. The collaboration aims to embed sensing into spinal interbody fusion cages to provide objective, actionable data on patient recovery, biomechanics, and fusion progression.
Received FDA 510(k) clearance for its next-generation hybrid imaging system, designed to deliver a more complete assessment of coronary anatomy within a single workflow. The system integrates intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single platform, enabling real-time visualization of both deep vessel structures and high-resolution surface detail to support physician decision-making and streamline workflows.
Accepted to the FDA Total Product Life Cycle Advisory Program (TAP). The company also announced a third patient who has been successfully implanted at Harborview Medical Center in Seattle, with the first implanted system having been operated stably for more than nine months.
Closed an oversubscribed $5.6M Series A financing round and promoted Lou Fuqua to Chief Operating Officer. The proceeds will fuel the commercial launch of Deep Blue's biosynthetic absorbable T-Line® Mesh, support expansion into aesthetic and breast applications, and deepen already extensive relationships with key opinion leaders and hospital systems.
Announced long-term results from the first 40 patients treated with the Efemoral Vascular Scaffold System (EVSS), showing strong durability in femoropopliteal disease and reinforcing its potential to set a new standard in endovascular treatment. At three years, the bioresorbable scaffold demonstrated 97% primary patency and 97% freedom from target lesion revascularization, along with sustained improvements in ankle-brachial index, Rutherford-Becker classification, and walking tolerance.
Received FDA 510(k) clearance for its HYALEX Slalom™ MTP Hemiarthroplasty System, the company's first cleared commercial product and formal entry into the high-growth U.S. foot and ankle market. The company designed this implant as a joint-preserving treatment of hallux rigidus and other degenerative conditions of the first metatarsophalangeal joint, and the company is initiating a limited U.S. market release with targeted surgeon training and channel buildout, with full commercial launch planned for later this year.
Completed patient recruitment in a first-in-human BCI study evaluating its graphene cortical interface technology, enrolling 10 patients with eight treated surgically. Investigators saw no perioperative device failures, complete datasets from all eight treated patients, and a favorable safety profile through discharge with a 90-day post-operative monitoring endpoint.
Announced the 12-month results from its pilot clinical study of the InVera Infusion Device, designed to treat chronic venous disease (CVD), with 90% of patients demonstrating durable GSV closure. Patients showed statistically significant improvements, including a 74% reduction in HASTI symptom scores and a 38% improvement in rVCSS at 12 months.
Received FDA clearance for Luminoah Flow™, an enteral feeding system designed to improve the experience of patients who rely on tube feeding. The system combines portability, precision, and connected technology to provide real-time data access, streamline clinical workflows, and support greater patient mobility and independence.
Announced the first closing of Lumira Ventures V, a new healthcare venture fund focused on building transformative biotech and medtech companies across North America, which has already completed its first investment and builds on a track record of more than 25 exits and over 40 product approvals. Also announced the appointments of Gerry Brunk as Managing Partner and Peter van der Velden as Executive Chairman, along with the promotion of Isabelle Harris to Associate.
Achieved ISO 27001 certification and strengthened its security ecosystem for clinical data. With this new certification, the company completes a robust security ecosystem with its ENS certification and operates in full compliance with GDPR and HIPAA, shaping a comprehensive framework that safeguards medical data and supports safe operations inside hospitals and healthcare institutions.
Announced the closing of its previously announced private placement with institutional investors, raising gross proceeds of €40.6M. The new shares issued under the private placement are now admitted to listing and trading on Euronext Brussels, Euronext Amsterdam, and Euronext Paris.
Granted patent for its P-ScopE, the company’s portable, single-use laparoscopic platform for bedside abdominal visualization. Following earlier grants in India and Australia, this strengthens its global IP footprint as the company heads into pilot launches.
Completed an oversubscribed $100M strategic financing round led by Medtronic, with continued support from existing investors including EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed, and Lilly Asia Ventures, and new participation from HSG and other global investors. Separately, Medtronic and the company entered into a commercial agreement to explore future commercialization opportunities by leveraging its innovation and Medtronic’s extensive global capabilities.
Published the results of its first-in-human study in the Journal of Inherited Metabolic Disease. This study marks the clinical validation of the company’s first prototype for at-home monitoring in phenylketonuria, an inborn metabolic disorder where frequent testing is critical, but still centralized and slow.
Raised €11.9M in new funding from existing investors, including Insight Partners and Siemens Healthineers. The company also secured €1.7M in non-dilutive research grants, plans to drive product innovation, expand into international markets, and strengthen its position in advancing the future of breast cancer diagnosis and care.
Announced a strategic partnership with Lovell® Government Services to provide access to the Setpoint System® for treatment of rheumatoid arthritis across federal healthcare systems, including the Veterans Health Administration (VHA), Military Health System (MHS), and Indian Health Service (IHS). Under the agreement, Lovell will serve as SetPoint Medical’s Service-Disabled Veteran Owned Small Business (SDVOSB) vendor, enabling streamlined access to the company’s innovative therapeutic platform through established federal contracting channels.
Received CE mark for aXess™, its restorative vascular access conduit for hemodialysis treatment. Designed to reduce long-term catheter dependence and access issues, aXess leverages Restorex™ materials, which trigger the body’s natural healing response to transform into the patient’s own tissue to form a living vessel for reliable vascular access.
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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