Shockwave Medical Inc. will acquire Neovasc Inc. for just under $108 million, if all terms of the deal are met. Shockwave will pay $27.25 in cash for each of Neovasc’s 2.71 million outstanding shares or approximately $73.78 million at close. Shockwave said the offer corresponds to an enterprise value of $100 million. Neovasc could receive an additional payment of up to $47 million, if the company’s Reducer system for refractory angina obtains U.S. FDA marketing approval within a specified time frame.
Medical devices and diagnostics are patent-dependent items, and companies may be able to avail themselves of extensions of their patents due to the time taken for FDA regulatory review. The U.S. Patent and Trademark Office announced March 8 that it had granted Neovasc Medical Ltd. a one-year extension of the term of two patents for the company’s flagship Reducer device, thus giving the company one additional year of market exclusivity to obtain the FDA’s approval for the device.
The U.K. National Institute of Health and Care Excellence (NICE) issued two health technology assessments dated Nov. 24, including one that gives a guarded recommendation for devices used to narrow the coronary sinus as a treatment for refractory angina. Neovasc Inc., of Richmond, British Columbia, touted the news as a positive for its Reducer device, given that this is the first instance in which NICE has lent any support for a device to treat the condition.
Neovasc Inc. has hit pause on its Tiara transfemoral mitral valve replacement (TF) program and is cutting its workforce by more than 40%, citing the additional time and substantial investment required to develop the program and the associated costs. The changes are expected to extend its cash runway from about 18 months to more than three years. The changes were implemented with about 18 months to remain solvent as part of a series of actions to focus on enhancing current shareholder value and focusing investments on near-term value drivers, namely the Reducer stent and the Tiara transapical mitral valve replacement (TA) system.
The PMA for the Neovasc Reducer device for treatment of drug-refractory angina faltered at an Oct. 27 U.S. FDA advisory committee, but it wasn’t for lack of support from star-power cardiologists. Gregg Stone, of the Cardiovascular Research Foundation, gave an impassioned plea for approval, pointing out that these patients have few options if they are poor candidates for bypass grafting or percutaneous coronary intervention. Stone said, “this is really a desperate patient cohort,” adding that a two-class improvement in angina severity “is a robust reduction.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advisory hearing gives Neovasc Reducer poor marks for efficacy; CMS eyes expanded DME coverage of CGMs; APEC launches Vision 2025 for business ethics; Innovation Alliance voices support for Iancu, PTAB changes.
The results of Reducer 1, an international, three-arm observational study of an initial 241 patients with refractory angina were remarkable, Neovasc COO Bill Little told BioWorld.
Neovasc Inc., of Richmond, British Columbia, has submitted a premarket approval application to the U.S. FDA for its Neovasc Reducer. The minimally invasive stent, which was granted breakthrough status in October 2018, is used to treat refractory angina.
