Our Agreement To Acquire Neovasc: Why We’re Optimistic & Hope You Are Too
Dear Interventional Community,
By now you may have heard the recent news that Shockwave has entered into a definitive agreement to acquire Neovasc, Inc. This will be our first acquisition since Shockwave’s inception.
While we have been busy developing the next applications of IVL, we have also been on the lookout for technologies outside our company that have the potential to solve the unmet clinical needs of your patients. Here is why we think the Neovasc Reducer technology in the hands of the interventional community has the potential to improve the lives of an underserved patient population.
1. A Large Patient Population: Refractory angina (RA) is a painful and debilitating chronic condition which can severely impact a patient’s life. Each year, in the US and EU alone, up to 300,000 new patients with obstructive coronary disease are ineligible for conventional revascularization as a treatment option experience refractory angina (RA), despite guideline-directed medical therapy. In addition, up to another 500,000 new US and EU patients present with angina and non-obstructive coronary artery disease (ANOCA). Globally, millions of patients suffer from RA today without an effective therapy.
2. A Novel Technology: The Neovasc Reducer device is an FDA Breakthrough Designated device that creates a focal narrowing in the coronary sinus, increasing back pressure within the vein and thus redistributing blood into ischemic myocardium. The transvenous procedure is performed via jugular access in a catheter-based intervention that takes about 30 minutes. Neovasc initially conducted the COSIRA study, which was a was a prospective, multicenter, randomized, double-blind, sham-controlled clinical trial. The results of COSIRA were published in the New England Journal of Medicine and showed a significant improvement in symptoms and quality of life in patients with disabling RA who were not candidates for revascularization. The Reducer is CE-marked and available in select European countries.
3. The Right Study: COSIRA II is a sham controlled double-blind randomized IDE trial to evaluate the Reducer System for safety and effectiveness in patients with RA due to obstructive coronary disease that is not amenable to conventional revascularization. COSIRA II is currently enrolling at centers in the US and Canada. Informed by the COSIRA trial, COSIRA II was developed to support approval and will provide the interventional community with scientifically rigorous, high-quality Level I evidence to support the appropriate use of the Reducer System.
We believe Shockwave can bring value to the development and US approval of the Reducer System by drawing upon our experience introducing IVL. By partnering with the interventional community, together we have the potential to create an entirely new treatment paradigm for a patient population in need.
If COSIRA II is successful, we anticipate being able to introduce Reducer to the US market in the coming years. In many respects, this timing is ideal for Shockwave as we have a robust pipeline of both improved and novel devices to introduce over the coming years.
So, while we are very excited about this acquisition, our engineers and field teams will continue to focus on developing improved IVL technology and new applications supported by high-quality service. In other words, it will be “business as usual.”
And while this is Shockwave’s first acquisition, we don’t expect it will be our last – we will continue to evaluate the market for disruptive opportunities, assessing prospects that we believe we can execute to drive value for patients, physicians and shareholders.
We hope you are excited by this news as much as we are, and we look forward to bringing you future updates as we progress.
Chief Executive Officer
Shockwave Medical, Inc.
Forward Looking Statements
This communication contains forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this communication that relate to expectations or predictions of future events, results or performance are forward-looking statements and are based upon our current estimates and various assumptions. Please see our press release for more information.
For more from Shockwave Medical, follow @ShockwaveIVL on Twitter!
Caution: In the United States, Reducer is an investigational device, limited by United States law to investigational use.
Reducer is commercially available in certain countries outside the U.S. Please contact your local representative for specific country availability.