Neovasc (NASDAQ:NVCN; TSX:NVC) has begun an initial launch in Europe to introduce its implantable Reducer medical device for the treatment of refractory angina (RA) in advanced-stage cardiovascular patients.
“Our aim is have distributors selling Reducer in Switzerland, Italy and the UK, while in Germany, we’ll use a combination of distributors and our own sales reps,” CEO, Alexei Marko, says in an interview with BioTuesdays.com.
“If the results of the initial rollout are favorable, we’ll explore a full commercial launch in the EU,” he adds.
RA is a debilitating condition involving chronic chest pain. Even simple activities such as standing up or walking a small distance from one room to another can be difficult to perform. RA is caused by inadequate blood flow to areas of heart muscle that cannot be managed through conventional therapy.
Mr. Marko explains that the Reducer device is implanted through a catheter into the coronary sinus, which is a large vein in the heart. The hourglass-shaped device modulates blood flow in the heart to elevate coronary sinus pressure and redistributes blood in the heart muscle, increasing flow to ischemic areas of the endocardium.
“This is a 20-minute catheter-based procedure similar to implanting a coronary stent in a heart patient,” he adds.
According to Mr. Marko, there are an estimated 645,000 annual RA patients in the U.S. and an equivalent number in Europe who are potential candidates for a Reducer treatment and a substantially larger population of recurrent angina patients.
Reducer obtained a CE Mark in Europe in late 2011, but its launch was delayed in order to obtain post-marketing data, which is where Neovasc’s COSIRA study comes in.
Earlier this month, the New England Journal of Medicine published final results from the COSIRA study, assessing the efficacy and safety of the Reducer for treatment of RA.
The data demonstrated that patients treated with Reducer achieved a statistically significant improvement in the Canadian Cardiovascular Society (CCS) angina grading scale, compared with patients in a sham control arm.
In addition, patients treated with Reducer were 2.3 times more likely to see an improvement of two classes or better in their CCS score than patients in the sham control arm. The study also demonstrated a 96.2% technical success rate and a 100% procedural success rate for Reducer implantation.
“Getting published in the New England Journal of Medicine gave the technology and data a great deal of credibility,” Mr. Marko points out. “It’s also indicative of the unmet medical need and overall interest in late-stage RA.”
In the U.S., he says Neovasc plans to file an application for an investigational device exemption (IDE) for Reducer this year and hopes to initiate an IDE study in early 2016 for FDA approval.
Neovasc’s second cardiovascular product is Tiara, a minimally invasive, transcatheter device to treat patients with mitral regurgitation (MR) that are not candidates for conventional surgery. MR is an often severe condition that can lead to heart failure and death.
Mr. Marko explains that the Tiara device is delivered through the apex of the heart to replace the mitral valve while preserving the integrity of the surrounding structures of the heart. “Due to the complexity of the mitral valve anatomy, development of transcatheter treatments for MR has significantly lagged aortic valve replacement devices,” he adds.
The 20-to-30-minute procedure avoids the need for invasive cardiac bypass surgery. “The design of Tiara is specific to mitral anatomy and does not obstruct the left ventricular outflow tract, which connects to theaorta,” he points out.
Doctors at St. Paul’s Hospital in Vancouver, Canada, performed the first implant of Tiara 13 months ago under a compassionate use exemption. Three more patients received the procedure last year under a similar exemption.
“We obtained excellent results with these first cases,” Mr. Marko contends. “There were no procedural complications and patients had complete resolution of their MR.” The initial Tiara implant data were published in the Journal of the American College of Cardiology last year.
Neovasc is currently conducting TIARA-1, a multicenter feasibility study in the U.S., Canada and Europe. The company is aiming to have enrollment of 30 patients completed in mid-year and have 30-day data available by the end of 2015.
“The goal of this study is to build a data set to support a pivotal IDE study in the U.S. next year as well as to use the core data to support a CE Mark application for marketing approval in Europe,” Mr. Marko suggests.
“Our intent is to be on the European market in 2016, and my best guess is that the U.S. will lag Europe by three years,” he figures.
Participating centers in TIARA-1 include: Columbia University Medical Center/New York-Presbyterian Hospital, New York; Lenox Hill Hospital, New York; Cedars-Sinai Medical Center, Los Angeles; St. Paul’s Hospital, Vancouver; and Antwerp Cardiovascular Center/ZNA Middelheim, Belgium.
Mr. Marko says there are an estimated 5.9 million people who suffer from MR in the U.S. and EU, with 40% of patients in the U.S. having severe MR. “A significant percentage of patients with severe MR are not good candidates for conventional surgery,” he adds.
JMP Securities analyst, J.T. Haresco, considers Neovasc to be a front-runner in the race to develop a transcatheter mitral valve replacement.
“Neovasc has one of the most compelling designs for a transcatheter mitral valve (Tiara) in development that potentially offers physicians speed, ease of use, and solid clinical performance,” he wrote in an initiation report last October.
He figures Neovasc’s two cardiovascular products are targeting opportunities valued at some $40-billion in markets with unmet needs, of which Tiara’s transcatheter mitral valve replacement market opportunity could be as high as $30-billion. He rates the stock “outperform,” with a $14 price target. The stock closed at $9.08 on Friday.
Investor interest in Tiara and Reducer helped Neovasc raise almost $75-million earlier this month to support its programs for at least two years.
The company intends to use net proceeds of the offering to complete the TIARA-I feasibility study, initiate an IDE study for Tiara, further develop and refine Tiara, advance commercialization of Reducer in Europe, initiate an IDE study for Reducer and for general corporate purposes.
Neovasc has funded much of the early development of Tiara and Reducer from its biological tissue business. A proprietary process creates implantable tissue from animal pericardium that retains the strength and physical characteristics of natural tissue.
The company’s customers incorporate this pericardial tissue to develop their medical devices, including surgical patches and transcatheter heart values.
Neovasc also provides support to customers at all phases of their programs, from inception through to commercialization.
For the third quarter of 2014, revenue rose 17% to $4.3-million from $3.6-million for the same period in 2013.
