Updated on 2 November 2012
How important is the latest regulatory milestone that Sunshine Heart has achieved? What are the conditions set by the FDA for providing marketing approval for C-Pulse?
The US market is the largest addressable market for the C-pulse device and obtaining marketing approval for the US is one of the company's primary goals. Conditional approval by the FDA of the IDE application is an important milestone in this process and getting the green light to commence the pivotal trial, which if successful, we believe will be sufficient to obtain marketing approval for the device in the US, is a key step toward this goal.
The conditions the FDA have set involved making minor changes to the informed consent, providing the Charters for the Data Safety Management Committee and Clinical Events Committee, minor revisions to the Investigator agreement, minor labeling updates and a few minor modifications to the study design not affecting the endpoints. Importantly, there were no substantive changes to the clinical trial design structure or endpoints.
Are there any other solutions that Sunshine Heart is offering to deal with heart failures?
The C-pulse device is the company's lead technology however it is also developing a fully implantable version to reduce the risk of exit site infection to the patient, make the device more patient friendly and broaden the market opportunity of the therapeutic device.
What are the future plans of the company?
In the last six months the company has achieved three key milestones, including getting the CE mark, FDA approval of the IDE, and raising of $23 million in capital through US IPO. The company's immediate plans are to execute the market strategies that will enable us to commence and roll out the US pivotal clinical trial and ensure that site engagement and patient recruitment meets our forecast timelines.
We will also begin a structured roll out in Europe, initially in Germany and Italy, and conduct a post marketing clinical trial (of approximately 50 patients) for reimbursement purposes. Largely, the companies resources (both human and financial) will be focused on these two key strategies and markets.