Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval. The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a […]
Neovasc closes $11.5m offering
Neovasc (NSDQ:NVCN) annunced that it closed a previously announced registered direct offering worth approximately $11.5 million. The offering includes nearly 3.9 million units, consisting of one common share of the company and three-quarters of one warrant to purchase one common share. Each warrant entitles the holder to acquire one common share of the company at $2.88 […]
Neovasc to seek CE Mark for Tiara transapical mitral valve repair device
Neovasc (NSDQ:NVCN) announced that it plans to win CE Mark approval for its TA Tiara under the new European Medical Device Regulation (EU MDR) by 2021 or earlier. The company said it has treated 82 patients to date with the transapical (TA) Tiara mitral valve repair device. After reviewing the clinical data from its Tiara I […]
Neovasc Reducer gains FDA PMA review
Neovasc said it received FDA administrative acceptance review notification for its Reducer device. Reducer is designed to treat refractory angina, which occurs when the coronary arteries deliver an inadequate supply of blood to the heart. “I would like to reiterate my thanks to the entire Neovasc team for their tireless efforts to complete the submission […]
Neovasc closes $10m direct offering
Neovasc (NSDQ:NVCN) announced that has it closed its previously announced registered direct offering for aggregate gross proceeds reaching approximately $10 million. The Vancouver, Canada-based company sold nearly 1.2 million Series A units at $4.1351 per unit and more than 1.2 million Series B units at $4.135 per unit. Each Series A unit includes one common share […]
Peregrine Ventures raises $115m
Peregrine Ventures said today that it has raised $115 million for its fourth medtech fund. The raise brings the Israel-based VC firm’s total managed funds and co-invest capital to $400 million, the company noted. Peregrine 4 will continue to invest in early-stage and late-stage rounds of medical technology startups, the company said in a news […]
Neovasc to pursue PMA this year for Reducer
Neovasc (NSDQ:NVCN) said today that it plans to seek pre-market approval from the FDA for its Reducer angina device by the end of the year. In July, Vancouver-based Neovasc said it hoped the get the device on the U.S. market in early 2020 via a humanitarian device exemption. Reducer is designed to narrow the coronary sinus […]
Neovasc eyes early 2020 for Reducer’s U.S. debut
Neovasc (NSDQ:NVCN) this week said it hopes to get its Reducer device for treating angina on the U.S. market early next year. That all hinges on the FDA, however, which must still grant humanitarian use device status to Reducer, which is designed to narrow the coronary sinus, and approve a humanitarian device exemption for treating […]
Another Neovasc reverse split set for tomorrow
Neovasc (NSDQ:NVCN) is slated to execute a reverse split of its publicly traded stock tomorrow, after a 1-for-100 reverse split last fall. The Vancouver-based medtech firm said the new 1-for-10 split will take its shares from 74.8 million outstanding to 7.5 million shares. Last September’s split took the number of NVCN shares from approximately 1.9 […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. […]
Neovasc surges on two-year Reducer results
Two-year data from a trial of the Reducer anti-angina device made by Neovasc (NSDQ:NVCN), published this week in the International Journal of Cardiology, bore out earlier safety and efficacy results but showed no effect on the progression of coronary artery disease. The study examined angina symptoms, quality of life and adverse events at two years, […]
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