Shockwave Medical has entered into a definitive agreement to acquire Neovasc Inc, developer of the Neovasc Reducer system, a percutaneous treatment for refractory angina.
The Neovasc Reducer system has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA), is CE-marked and is currently enrolling patients in the COSIRA-II study, a randomised clinical trial being conducted under an investigation device exemption intended to support US FDA approval for patients with coronary obstructive refractory angina.
“Refractory angina is a debilitating condition without an effective therapy that impacts millions of patients,” said Gregg W Stone (Mount Sinai Hospital, New York, USA), principal investigator of COSIRA-II. “The ongoing COSIRA-II randomised trial has been designed to definitively demonstrate that the Reducer is superior to a sham control for these patients, offering the potential to change the lives of these patients who are desperate for a solution for their refractory angina.”
“Our team at Shockwave has proven that we excel at developing products and markets for large, underserved patient populations and commercialising innovative solutions for these patients. We believe the Reducer is an excellent fit for Shockwave as it enables us to apply our capabilities to address another large, unmet need within cardiology—refractory angina,” said Doug Godshall, president and chief executive officer of Shockwave. “The timing is ideal as there will be no distraction to our US sales organisation in the near term and, as we did with C2, our coronary device, we expect to refine our commercialisation approach and begin the development of international markets in advance of US approval. This transaction supports our commitment to drive growth through innovation and we are excited for the potential to bring even more solutions to our customers and the patients they serve with the Reducer system.”