neovasc Archives - Medical Design Sourcing

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 developing the Tiara mitral valve repair device in 2020.

Under the terms of the acquisition agreement, Neovasc shareholders will receive $27.25 per common share in cash upfront on completion of the transaction. The deal will have an enterprise value of approximately $100 million plus deferred payments of up to approximately $47 million on the achievement of future regulatory milestones.

“Today’s announcement is good news for our stakeholders and the Reducer program,” Neovasc president and CEO Fred Colen said in a news release. “We have made tremendous strides building a…

New CMS codes for angina detection, tracking benefit Neovasc

The Neovasc Reducer (Image from 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 revision of the International Statistical Classification of Diseases and Related Health Problems Clinical Modification (“ICD-10-CM”). The update will be made effective Oct. 1, 2022.

In total, CMS created nine new refractory angina codes. The primary code (I20.2) includes eight supplemental codes describing the condition in combination with various conditions pertaining to atherosclerosis, or hardening of the heart’s arteries.

Neovasc said the codes will help clinicians identify and accurately diagnose patients with refractory angina. Dr. Tim Henry,…

Neovasc enrolls first patient in refractory angina treatment trial

The Neovasc Reducer (Image from Neovasc)

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 news release, study results will complement existing international safety and effectiveness data and support Neovasc’s premarket approval (PMA) application to the FDA to commercialize the Reducer device in the U.S.

Neovasc designed the Cosira-II trial as a randomized, double-blind, placebo-controlled study that will enroll approximately 380 patients across as many as 50 investigational sites in the U.S. and Canada. The study has a primary endpoint set as the change in exercise tolerance testing time measured at six months via 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 per share any time before Jun 16, 2025, according to a news release.

While the gross proceeds are expected to reach $11.5 million, Neovasc anticipates that it will receive net proceeds of approximately $10.4 million after deducting fees and expenses.

Neovasc intends to use the proceeds for the development and commercialization of its Neovasc Reducer for treating refractory angina, as well as the development of the Tiara mitral valve repair device. Other uses include general corporate and working capital purposes.

H.C. Wainwright & Co. acted as the exclusive placement agent for t…