Updated on 6 September 2012
To enable the company to commercialise the CINCOR System in the US, the company is pursuing a 510(k) regulatory pathway for FDA market clearance. The applicability of the 510(k) pathway was determined by the company through communication with the FDA, and is generally considered to be a less demanding and faster approval route than alternative approval pathways for medical devices. In pursuing its 510(k) market clearance, Osprey Medical has applied for and obtained from the FDA, an Investigational Device Exemption (IDE) to conduct a pivotal clinical trial for the CINCOR System.
The company anticipates commencing its US pivotal trial in 2012 and the completion of the trial and receipt of 510(k) FDA clearance is targeted for 2014. It is aiming for the US launch of the CINCOR System in 2014. The company plans to recruit its own direct cardiology sales force in the US and believes that 20-25 sales representatives can successfully access and service the majority of the US market.
Osprey Medical intends to begin a controlled commercial launch of the CINCOR System in Europe in late 2012. The two countries planned for European market launch are Germany and the Netherlands.
"Each of these countries has a good history of adoption and reimbursement for new medical devices and is amongst the European market leaders in cardiology. Germany was also involved in the company's recent trial that successfully led to CE Mark approval," says Mr Mike McCormick, President and CEO, Osprey Medical. The company plans to target select key opinion leading physicians to establish centers of excellence in Germany and the Netherlands. "It is intended that these hospitals and physicians will refine physician training and usage practices, and report and advocate on the patient and economic benefits of using the CINCOR System. The company believes that these key opinion leading physicians will help drive market awareness, initial market adoption and penetration into these focused regions," he adds.