Neovasc Inc. Announces Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2013
Nov 20 13
Neovasc Inc. announced unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2013. For the quarter, the company reported total revenue of CAD 3,633,891 against CAD 2,005,940 a year ago. Operating loss was CAD 1,421,983 against CAD 1,197,136 a year ago. Loss and comprehensive loss was CAD 1,439,826 or CAD 0.03 per basic and diluted share against CAD 1,206,914 or CAD 0.03 per basic and diluted share a year ago. Cash outflow from operating activities was CAD 1,573,872 against CAD 445,147 a year ago. Purchase of property, plant and equipment was CAD 111,150 against CAD 39,872 a year ago.
For the nine months, the company reported total revenue of CAD 8,436,096 against CAD 5,353,539 a year ago. Operating loss was CAD 4,796,491 against CAD 3,973,386 a year ago. Loss and comprehensive loss was CAD 4,538,375 or CAD 0.10 per basic and diluted share against CAD 3,988,560 or CAD 0.09 per basic and diluted share a year ago. Cash flow from operating activities was CAD 3,973,386 against CAD 2,913,016 a year ago. Cash outflow from operating activities was CAD 3,605,021 against CAD 1,673,554 a year ago. Purchase of property, plant and equipment was CAD 1,004,182 against CAD 232,313 a year ago.
Neovasc Inc. Announces Topline Results for its COSIRA Trial Assessing the Efficacy and Safety of the Neovasc ReducerTM
Nov 6 13
OPKO Health Inc. reported that Neovasc Inc., company in which OPKO has made a strategic investment, reported topline results for its COSIRA trial assessing the efficacy and safety of the Neovasc ReducerTM, a novel percutaneous device for the treatment of refractory angina. The data shows that the Reducer achieved its primary endpoint, significantly improving the symptoms and functioning of patients disabled by previously untreatable refractory angina. The COSIRA trial also confirmed that the Reducer is safe and well-tolerated, with no reports of device-related serious adverse events. The safety and efficacy data from the randomized, controlled COSIRA trial is consistent with results seen in previous non-randomized pilot studies of the Reducer. The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow in the heart's venous system, thereby increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and takes approximately 20 minutes. The COSIRA (Coronary Sinus Reducer for treatment of Refractory Angina) trial is a prospective, multicenter, sham-controlled, randomized, double-blinded study assessing the safety and efficacy of the Reducer in 104 patients in the European Union and Canada. Patients were randomized 1:1 between treatment and sham control arms. Its primary endpoint is a two-class improvement six months after implantation in patients' ratings on the Canadian Cardiovascular Society (CCS) angina grading scale, a four-class functional classification that is widely used to characterize the severity of angina symptoms and disability. Only patients with severe angina, CCS Class 3 or 4, were enrolled in the COSIRA trial. The complete results of the COSIRA trial are being submitted as a Late Breaking Clinical Trial presentation at ACC.14, the 63rd Annual Scientific Session & Expo of the American College of Cardiology that will take place in Washington, DC, March 29-31, 2014.
Neovasc Inc. Announces Publication of Positive Tiara Preclinical Data in the Journal JACC: Cardiovascular Interventions
Oct 29 13
Neovasc Inc. announced that a review of results from preclinical studies of its Tiara(TM) valve for the transcatheter treatment of mitral regurgitation has been published in JACC: Cardiovascular Interventions. The review concludes that implantation of the Tiara valve is technically feasible, safe and results in a stable and well-functioning mitral bioprosthesis. Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR), a serious and poorly served condition that requires development of highly specialized devices to address the complex mitral anatomy. Mitral regurgitation is often severe and can lead to heart failure and death. Conventional surgical treatments are only appropriate for a small percentage of the estimated four million patients in the US alone. The preclinical studies included both acute and chronic animal models, as well as human cadavers. Researchers used trans-apical mitral implantation (TAMI), an approach that accesses the mitral valve through the tip (apex) of the left ventricle. Use of TAMI allows the interventional cardiologist easier access to the mitral valve and also avoids potential risks associated with the longer femoral access route. The study results demonstrate that implantation of the Tiara valve in healthy swine and sheep is feasible and safe. The researchers developed a rapid and straightforward implantation procedure resulting in a stable and well-aligned functional bioprosthesis for up to 150 days of follow-up. All of the animals receiving the Tiara device exhibited normal clinical status and behavior without any signs of heart failure. There was no significant mitral regurgitation observed, and left ventricular function was normal in all subjects. The chronic animal experiments confirmed the durability and functionality of the Tiara device in ongoing use, including continuing leaflet pliability, lack of leaflet calcification and good tissue coverage of the device's metal frame.