In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni receive regulatory approvals, secure funding, complete clinical trials, and much more on the road to LSI USA ‘26 in Dana Point (March 16-20).
Closed an $11.75M Series A financing round led by global pharmaceutical leader Octapharma, with strong participation from both existing and new strategic investors connected to the University of Colorado Anschutz. This investment will accelerate the development and clinical advancement toward key clinical milestones and FDA 510(k) clearance for the CoagCare™ platform, a portable diagnostic system designed to provide rapid, precise information about blood coagulation.
Announced the close of a $10.7M Series A funding round led by MedVenture Partners, bringing the company's total funding to $21.7M. The funding will support the company’s pivotal clinical trial SAPPHIRE, which received FDA IDE approval in 2025, and further development of Avisi's pipeline, which includes novel treatments addressing the entire spectrum of glaucomatous disease.
Earned FDA 510(k) clearance for its AdaptosⓇ Fuse Bone Graft, positioning the company to enter the U.S. market and establish a foundation for commercial growth in spine applications. This marks the company’s entry into the U.S. bone graft substitute market, with plans to initiate phased U.S. commercialization in accordance with cleared labeling, focusing on targeted spine segments.
Extended its Series C Financing to $25.4M (£18.8M) to support U.S. expansion as the company advances deployment of its AI imaging platforms, Brainomix 360 Stroke and e-Lung, across multiple hospitals. The extension round was led by existing investors, Parkwalk Advisors and Hostplus via the IP Group Hostplus Innovation Fund, and includes participation from a new U.S.-based investor, Modi Ventures.
Received FDA Breakthrough Device Designation for its OneBreath™ platform, a perioperative risk stratification in adult patients undergoing elective cardiac surgery. The test operates at the molecular level, directly measuring defined chemical species with high analytical specificity, orthogonal validation, and broad linearity, and is designed to aid in perioperative risk stratification and management of adult patients scheduled for elective cardiac surgery by identifying those at elevated risk of developing postoperative pneumonia (POP).
Announced the publication of new clinical data in the Journal of NeuroInterventional Surgery from a single-arm study evaluating the investigational eShuntⓇ System in elderly patients with normal pressure hydrocephalus (NPH). The findings show encouraging safety observations and symptom improvement through 90-day follow-up, and support continued evaluation of the eShunt System in the ongoing STRIDE randomized, controlled pivotal trial.
Welcomed Peter Donato to the executive leadership team to continue advancing dialysis solutions to improve lives for those living with kidney disease. Peter has nearly 35 years of experience in life sciences, guiding organizations through IPOs, strategic growth phases, and successful acquisitions, including Standard Bariatrics’ ~$300M sale to Teleflex and Assurex Health’s $410M acquisition by Myriad.
Was officially launched by LSI Alumni Bryan Lord, alongside partners and co-founders Evan Goldberg and Michael Miniati, with a goal to be The Entrepreneur’s Co-Pilot™. Flightline Partners offers three core services, including corporate advisory, deal advisory, and fund advisory, and has nearly 100 years of startup, transaction, and investment experience with over $5B in sales and transaction volume.
Received a second FDA 510(k) clearance for the Versus™ Catheter, expanding the company's Hemodynamics-Led Thrombolysis (HLT) platform and unlocking a new Interventional physician segment. The Versus Catheter provides real-time pulmonary artery (PA) pressure measurements to empower clinicians to optimize treatment based on each individual patient’s response.
Closed a $10M growth round led by Fulcrum Equity Partners, with participation from existing investors Live Oak Ventures and Stage 2 Capital. Alongside the funding, MedScout is launching Strategies, AI agents that analyze market and account-level referral networks, procedure volumes, payor dynamics, and more to deliver prioritized, ready-to-work territory plans to reps.
Announced the publication of positive results from its randomized controlled trial (RCT) evaluating the NEUROMARKⓇ System in the International Forum of Allergy & Rhinology. The study demonstrated that the NEUROMARK System, an impedance-controlled radiofrequency ablation device indicated for chronic rhinitis, was more effective than sham control in improving nasal symptoms and quality-of-life measures.
Was granted Breakthrough Device Designation by the FDA for its novel Total Meniscus Replacement (TMR) implant. The designation provides prioritized regulatory engagement, helping to streamline the pathway toward clinical adoption and reduce development risk at a critical stage.
Announced the acquisition of NeuWave Medical, a medical device company whose products are used by physicians in over 70% of the top cancer centers in the United States. This acquisition supports Quantum Surgical’s strategy to democratize robotic-assisted tumor ablation treatments to reduce cancer mortality, and the companies will operate as subsidiaries of Precision IO Group, the newly created parent company led by recently appointed CEO Kurt Azarbarzin.
Secured reimbursement in Japan for its ParadiseⓇ Ultrasound Renal Denervation System for treating hypertension, enabling it to better compete with Medtronic’s rival Symplicity Spyral™ system. The news comes more than five months after Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved Paradise and Symplicity Spyral, two systems that are delivered in minimally invasive procedures to denervate the sympathetic nerves surrounding the renal arteries, using ultrasound energy in the Paradise and RF ablation in the Symplicity Spyral.
Announced Masimo founder and LSI Alumni Joe Kiani will lead SMSbiotech’s board of directors as chair to guide corporate strategy, clinical development priorities, and long-term value creation. The company is developing its proprietary Small Mobile Stem (SMS) cell platform, which it describes as “cutting-edge, allogenic, off-the-shelf, adult stem cell technology that aims at providing safe, affordable, and ethically grounded regenerative medicine.”
Has successfully completed enrollment of its 10-patient First Human study using the Total Flow Medical femoral arterial cannula, conducted at Calgary's Foothills Medical Centre by Dr. William Kent and Dr. Corey Adams. In this study, ten procedures were conducted utilizing the cannula to help maintain distal perfusion of the cannulated limb during minimally invasive mitral valve surgery with cardiopulmonary bypass, with no device-related adverse events observed.
Has received regulatory clearance from the FDA for the use of its flagship technology, the Vena MicroAngioscope System™, in the peripheral vasculature, opening the door for international exporting, beginning with entry into the United States. To support this rapid commercial expansion, the company simultaneously celebrated the grand opening of its new $4.5M Manufacturing Centre of Excellence in Kitchener, Ontario, made possible through strategic funding from the Life Sciences Scale-Up Fund.
Announced that implanting clinicians will present two-year follow-up data from the company’s first-in-human experience with the SUTURE-TIGHT™ Endovascular Catheter System, an adjunctive fixation technology designed to enhance long-term durability of endovascular aneurysm repair (EVAR) procedures. The paper will include outcomes from 14 first-in-human patients treated, including no graft migration at two years, nitinol sutures remaining securely in place, no suture fractures, no evidence of suture embolization, and no evidence of endoleaks.
Announced the completion of the company's first-in-human clinical trial at The Royal Melbourne Hospital. This is a major milestone and a significant step forward for AxanaⓇ, a portable, fast, and simple system that uses Pulsed Gradient Free Mapping (PGFM) to accelerate stroke detection and decision-making in time-critical settings.
Announced FDA Clearance of SaberscopeⓇ, the first single-use 5mm articulating laparoscope for enhanced surgical visualization. The device is designed to deliver consistent, high-quality, full HD imaging while improving operating room workflow, reducing fogging, minimizing case delays, lowering hospital costs, and enhancing safety for patients and clinical staff.
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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