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In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure new funding, receive FDA Breakthrough Device Designation, appoint new board members, reveal clinical study results, and much more on the road to LSI USA ‘25 in Dana Point, CA (March 17-21).
Commenced enrollment in the A Transseptal Left Atrial System for Treatment of Mitral Regurgitation (ATLAS) trial in the United States and Europe. The ATLAS pivotal trial aims to assess the safety and efficacy of its AltaValve™ System for treating patients with moderate-to-severe or severe mitral regurgitation unsuitable for surgery or edge-to-edge repair.
Received FDA Breakthrough Device Designation for its ECG-based, AI-powered aortic valve stenosis screening software. The software is intended to identify patients with potential aortic valve stenosis, leveraging the millions of ECGs already present in healthcare system electronic health records.
Enrolled the first patient in its NeuroPulse Post-Ablation clinical trial with Mount Sinai Health System. The study is a randomized, sham-controlled, home-based study assessing the company’s closed-loop neuromodulation wearable for improving ablation success rates and reducing post-ablation failures.
Announced IDE application approval from the FDA to initiate its CGUARDIANS II pivotal study. The study is intended to facilitate approval of the use of its CGuard Prime 80cm Carotid Stenting System in an optimized transcarotid artery revascularization (TCAR) version and indication.
Announced the latest results from its FB-CT1 clinical study assessing the usability and efficacy of its FineBirth device in predicting preterm labor risk. Results demonstrated that the FineBirth threatened preterm labor (TPTL) assessment algorithm achieved a sensitivity of 57.2% and a specificity of 95.4%.
Raised a €17.9M Series B funding round co-lead by LSI Alumni investors Panakes Partners, TechWald Next S.p.A, and CDP Venture Capital SGR's Digital Transition Fund. The funds will be used to accelerate the clinical development and validation of its LymphoDrain, a permanent active implant for lymphedema therapy.
Completed enrollment in the Fluid Management of Acute Decompensated Health Failure Subjects Treated with Reprieve System (FASTR) trial. The trial is intended to compare the effectiveness of decongestive therapy administered by the Reprieve System with Optimal Diuretic Therapy (ODT) in patients with acute decompensated heart failure (ADHF).
Secured €2.2M in funding for developing its digital catheter-based device for treating fluid buildup in the body due to late-stage cancers. The company is an early-stage startup focused on developing patient-centered solutions in palliative care.
Appointed LSI Alumni Dave Hickey to its Board of Directors as an independent board member. Hickey’s knowledge in the specimen collection field and experience launching diagnostic solutions will aid the company in expanding its automatic blood-drawing device to the U.S. market.
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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