Shockwave Medical (Nasdaq:SWAV) announced today that it completed its $147 million acquisition of Neovasc. In January, Shockwave announced an agreement to acquire all of the issued and outstanding common shares of Neovasc. The company paid $27.25 per share upfront by way of a statutory plan of arrangement. The deal has an enterprise value of approximately […]
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Shockwave Medical to acquire Neovasc for up to $147M
Shockwave Medical (NSDQ:SWAV) today announced it signed an agreement to acquire all of the issued and outstanding common shares of Neovasc (NSDQ:NVCN). Neovasc enrolled its first patient in a clinical trial studying the Neovasc Reducer in January 2022. The company designed the device to reduce angina symptoms in people with refractory angina. It was also reportedly […]
New CMS codes for angina detection, tracking benefit Neovasc
Neovasc (Nasdaq:NVCN) announced today the Centers for Medicare and Medicaid Services (CMS) developed favorable new codes. The new codes cover the diagnosis and tracking of refractory angina. Neovasc develops the Reducer system for reducing angina symptoms in those with refractory angina. According to a news release, the codes will be utilized in the current, 10th […]
Neovasc enrolls first patient in refractory angina treatment trial
Neovasc (NSDQ:NVCN) announced today that it enrolled the first patient in the Cosira-II clinical trial for its Neovasc Reducer. Vancouver, Canada-based Neovasc’s Cosira-II (coronary sinus reducer for the treatment of refractory angina) pivotal trial will study the safety and effectiveness of the Reducer in reducing angina symptoms in those with refractory angina. According to a […]
Neovasc raises $6.1M
Neovasc (NSDQ:NVCN) announced that it entered into agreements for the sale of its common shares worth approximately $6.1 million. Vancouver, Canada-based Neovasc sold an aggregate of more than 6.2 million common shares at a purchase price of 98¢ per share in the registered direct offering, according to a news release. Aggregate proceeds are expected to come […]
FDA panel advises against assurable effectiveness of Neovasc Reducer
Neovasc (NSDQ:NVCN) announced that an FDA advisory panel voted against reasonable assurance of effectiveness for its Reducer system. The FDA’s Circulatory System Devices Advisory Panel voted 1 to 17 “against” on the issue of “a reasonable assurance of effectiveness,” according to a news release. “We would like to thank the FDA, the panel and members of […]
Advisory panel to vote on FDA approval of Neovasc Reducer
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 […]