DevelopmentsWe have a significant amount of News coming our way very soon. If Management and CEO Fred Colen specifically are moving forward with their key strategic area of focus and a turnaround strategy then we should have something to kick start this stock for investors, quotes taken from March 28/17 Earnings Call Transcript, as follows:
A presentation of the clinical results of 48 Tiara patients; 14 in TIARA I, 12 in TIARA II and 22 compassionate use cases by Dr. Anson Cheung at the Zurich Mitral Valve Meeting on February 27.
To present our clinical results at the EuroPCR Conference during May in Paris. Furthermore, Tiara clinical updates will be provided at the ISMICS meeting and the TVT meeting both occurring during June.
The second key strategic area of focus for us in the mitral valve space is the now initiated development of the transfemoral, trans-septal version of the Tiara mitral valve.
We expect to have the first version prototypes available in the next two weeks (Current) and we are currently scheduling the first round of animal and cadaver feasibility studies before June. We will keep you updated on the timeline for this clinical value driver and key Tiara product.
We estimate that the Reducer can address about 160,000 patients with severe refractory angina in Europe and in the United States. We currently do not face any other permanently implanted device competition for the Reducer to treat severe refractory angina.
At current European list prices and other expected prices we believe that this results in a significant market potential for the Reducer with current indications.
We conducted an additional review of our Reducer revenue plan for EMEA and concluded that it is reasonable to improve our 2018 plan to achieving a doubling of implants throughout Europe and the Middle East, including a tripling of Reducer implants in Germany over 2017.
We are also pleased to report that Neovasc has the opportunity to devote a dedicated symposium at the EuroPCR conference in May for the European physicians to present their clinical experience with the Reducer. Furthermore, the Reducer therapy will be presented in April during a symposium at the Mannheim conference in Germany.
We are open to considering strategic alternatives for the Reducer including potential alliances in order to broaden and deepen therapy penetration in Europe and the Middle East, the USA and the rest of the world.
Also in the context of the COSIRA-II IDE study and approximately 380-patient clinical study to be conducted at up to 35 centers in the United States which was approved by the FDA in late 2017 and. Such potential strategic collaborations could dramatically improve the time to market for this device in the U.S..
Our objective would be to make changes that should enable us to attract new longer-term investors to the company.
I look forward to initiating actions in the next few weeks and months, including engagement with the parties who participated in last November’s financing to see if we can address some of the challenges created by our current financial structure which is clearly holding the company back.