In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure funding, receive regulatory approvals, appoint new executives, and much more on the road to LSI USA ‘26 in Dana Point (March 16-20).
Announced the appointment of surgical-robotics pioneer Yulun Wang, PhD, to its Board of Directors, strengthening the company’s strategic leadership and governance as the company advances from first-in-human studies toward regulatory clearance and commercial launch of its stereotactic neurosurgery robot. The company's strategy for advancing its MRI-guided robotic platform emphasizes capital-efficient development, clear regulatory pathways, and alignment with established clinical reimbursement frameworks.
Published a real-world evidence study in Diseases of the Colon & Rectum showing that its Leva Pelvic Health System delivers clinically meaningful improvement in fecal incontinence (FI) symptoms in women. The study enrolled 214 adult women and found that nearly 60% achieved a minimum clinically important difference after just eight weeks of therapy, 73% reported overall symptom improvement, and pelvic floor muscle performance, measured directly by the Leva device, improved meaningfully over the course of the study.
Announced that it has submitted a De Novo 510k application to the FDA seeking marketing clearance for its Breast Cancer Locator (BCL™) System, a patient-specific 3D-printed guide providing surgeons with precise tumor shape, size, and location references during lumpectomy. The company has completed its U.S. pivotal trial, showing that the BCL System enabled breast surgeons to successfully remove breast tumors with negative margins in 94% of patients and safety outcomes comparable to typical breast conserving surgery.
Appointed Thomas Fagan as its Executive Vice President, Alzheimer’s Portfolio, and a member of the company’s Executive Leadership Team. Fagan, who brings more than 25 years of leadership experience across the pharmaceutical, medical device, and diagnostics industries, will lead the company’s Alzheimer’s portfolio, advancing strategic planning and commercial readiness for Spectris™ as the company moves toward key clinical milestones.
Announced a strategic partnership to deliver an integrated AI-enhanced structured reporting workflow that combines Ibex’s market-leading pathology algorithms with mTuitive’s CAP-, RCPath-, and ICCR-compliant synoptic reporting platform. The partnership enables hospitals and pathology laboratories to incorporate real-time AI insights into a streamlined workflow that produces compliant, complete pathology reports, including tumor detection, grading, and breast biomarker quantification.
Announced the issuance of U.S. Patent No. 12,558,123, further strengthening its intellectual property portfolio in robotic-assisted cochlear implantation. The iotaSOFT Insertion System is the first and only FDA-cleared robotic-assisted cochlear implant insertion system that continues to be integrated across leading centers.
Secured a multi‑million‑pound follow-on investment led by BGF alongside the Development Bank of Wales. The funding will be used to support the initial commercial rollout, strengthen manufacturing and supply chain capability, and build a commercial pipeline that can support entry into other markets as well as regulatory work in the U.S.
Was awarded an NIHR i4i FAST Award for the LightScope. The device revolutionizes the detection of heart conditions, offering a faster, more accurate, and more affordable solution because of its ability to gather essential data through clothing and at a distance, uncovering unique biomarkers in less than a minute.
Raised €10M ($11.7M) with participation from current investors, including Sofinnova Partners, Trill Impact, and Bpifrance, as well as new investor Nexpring Health™. The funds will be used to drive completion of its pivotal U.S. IDE trial, REBALANCE, and will also support launch planning in Europe for the company’s Anavi™ System, which received CE Mark certification under the European Union’s Medical Device Regulation in October 2025.
Closed $28M in Series E equity financing, led by InnovaHealth Partners and Birchview Capital, LP, with participation from several new investors, including OSF Ventures, the investment arm of Peoria, Ill.-based OSF HealthCare, and the Colorado University Healthcare Innovation Fund. The financing will support the company’s technology innovation program and other growth initiatives, and the company also announced that it has refinanced its current debt and established a new $35M credit facility with Trinity Capital.
Announced the successful treatment of the first patient in its first-in-human clinical study, marking the first time that a PBH patient has been treated completely extracorporeally. This breakthrough was achieved alongside the clinical team at Rambam Medical Center, who will continue the study with further patient enrollment and follow-up.
Announced the publication of findings from its MATCH 2 study in the journal Respiratory Medicine, which evaluated 3D targeting during RAB procedures using embedded imaging technologies, including digital tomosynthesis (DT) and augmented fluoroscopy (AF). All procedures in the study were performed with Noah Medical’s Galaxy RAB system, and investigators subsequently confirmed successful tool-in-lesion with cone-beam computed tomography (CBCT).
Announced that it secured additional funding, bringing total financing to more than $25M, through a round led by a prominent high-net-worth investment firm, with repeat participation from Draper Associates, Actions Capital (formerly K50 Ventures), and Fong’s Family Foundation. Along with the funding, the company announced that LSI Alumni Dr. Fred Moll has joined the board after participating in the October financing round, signaling momentum as the company advances its new approach to surgery using acoustic liquefaction (a form of histotripsy), AI, and robotics.
Welcomed Sam Murray as its new Head of Regulatory and Quality. Murray brings more than a decade of experience across medical devices, diagnostics, combination products, and software-enabled technologies, and spent time as a medical device investigator with the FDA.
Announced clinical findings demonstrating the durability of its nPulse Vybrance system, with long-term follow-up data from the nPulse Vybrance percutaneous electrode system first-in-human ablation study evaluating the ablation of benign thyroid nodules using nanosecond pulsed field ablation (nsPFA) energy. The follow-up showed significant and sustained volume reduction of treated benign thyroid nodules at 15–22 months, with no tissue regrowth and no serious adverse events reported.
Successfully secured its Seed round, paving the way towards the company’s first-in-human study. The company has also received a grant from the Israel Innovation Authority (IIA), supporting the continued development of its minimally invasive carotid access and closure platform.
Announced that it received FDA breakthrough device designation for its Occular visual cortical prosthesis. This paves the way toward first-in-human clinical trials, with the company planning to conduct a first short-term clinical trial during a scheduled brain surgery in October 2026 and beginning early-stage human clinical trials in blind volunteers as soon as summer 2027, subject to regulatory approvals.
Appointed Jeffrey B. Jump and Jacques Séguin, MD, PhD, to its Board of Directors. Jump and Séguin will strengthen the Board’s expertise in the structural heart and medical device industry and provide strategic guidance as the company advances enrollment in its AMEND™ TS Early Feasibility Study (EFS) and prepares for subsequent clinical trials.
Secured $30M in its Series C financing round, co-led by LSI Alumni Dr. Fred Moll and Crescent Enterprises. The funds will support the effort to bring its endovascular robot to market as it seeks to deliver clinical telerobotic mechanical thrombectomy procedures, and bring the company’s total funding to $92M.
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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