That all hinges on the FDA, however, which must still grant humanitarian use device status to Reducer, which is designed to narrow the coronary sinus, and approve a humanitarian device exemption for treating severe angina that can’t be controlled by other means.
Vancouver-based Neovasc estimated the addressable market at $80 million annually.
“Should the FDA grant the Class IV HUD designation to the Reducer, we expect to be in a position to offer treatment to those patients with CCS Class IV refractory angina in early 2020,” CEO Fred Colen said in prepared remarks. “We view this as a significant market opportunity for Neovasc. Concurrently, we will explore an alternate investigational device exemption clinical study design, in conjunction with our supportive U.S. cardiologists, with the intent of further expanding the patient population to CCS Class III patients and to seek full approval for the CCS Class IV patients over time.”
Although they initially got a 3.6% bump to $4.02 on the July 16 Reducer announcement, NVCN shares are off -1.5% to $3.82 since then.