Shockwave Medical to Acquire Neovasc

January 17, 2023—Shockwave Medical, Inc. and Neovasc Inc. separately announced that the companies have entered into a definitive, binding agreement, whereby Shockwave has agreed to acquire all of the issued and outstanding common shares of Neovasc. Shockwave, based in Santa Clara, California, is a developer of intravascular lithotripsy to treat severely calcified cardiovascular disease. Neovasc is a Vancouver, Canada-based developer of minimally invasive cardiovascular devices.

According to the companies’ press releases, the upfront transaction is valued at US$27.25 per common share (approximately $100 million). The agreement includes additional milestone payments of up to $47 million contingent upon the final FDA premarket approval of the Neovasc Reducer in the United States for the treatment of refractory angina. The transaction, which is subject to court approval in Canada, customary closing conditions, and Neovasc shareholder approval, is expected to be completed in the first half of 2023. Further details of the transaction are available in the announcement on the Neovasc website and the announcement on the Shockwave website.

Neovasc’s Reducer is under clinical investigation in the United States. The device has received CE Mark approval and has been commercially available in Europe since 2015. The company’s Tiara device for the transcatheter treatment of mitral valve disease is under clinical investigation in the United States, Canada, Israel, and Europe but activity on Tiara has been indefinitely paused. Neovasc remains committed to the ongoing follow-up of patients in Tiara clinical trials and has paused all other Tiara activities, noted Neovasc’s press release.

“Today’s announcement is good news for our stakeholders and the Reducer program,” stated Fred Colen, Neovasc’s President and Chief Executive Officer, in the company’s press release. “We have made tremendous strides building accelerating revenue, clinical data, commercial reimbursement, and a fantastic team, and now it’s time to take the next step to accelerate Reducer adoption globally. The team at Shockwave has demonstrated an extraordinary ability to scale novel technologies and build value for patients, customers, and investors, and we are thrilled to become a part of their organization.”

Gregg W. Stone, MD, who is principal investigator of the COSIRA-II randomized clinical trial that is being conducted under an investigational device exemption to support FDA approval of the Neovasc Reducer for patients with coronary obstructive refractory angina, commented in Shockwave’s press release, “Refractory angina is a debilitating condition without an effective therapy that impacts millions of patients. The ongoing COSIRA-II randomized 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.”

Doug Godshall, President and Chief Executive Officer of Shockwave, stated in the company’s press release, “Our team at Shockwave has proven that we excel at developing products and markets for large, underserved patient populations and commercializing 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. The timing is ideal as there will be no distraction to our United States sales organization in the near term and, as we did with C², our coronary device, we expect to refine our commercialization approach and begin the development of international markets in advance of United States 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.” Mr. Godshall further discusses the acquisition online in a Shockwave blog post, here.