Sunshine Heart (NASDAQ Capital Markets: SSH), which makes a an implantable, non-blood contacting, cardiac assist device to treat moderate to severe heart failure, has received conditional approval from the U.S. Food and Drug Administration for a component of that device.
The public company, which has been the recipient of a huge amount of interest from investors over the past month, announced Monday that the new device driver comprises a single unit which is “lighter, quieter and approximately half the size of its predecessor and also features a number of software enhancements.”
The new driver can be incorporated in a feasibility trial that Sunshine Heart conducting in the U.S. The same component will later be used in a pivotal trial once the FDA approves the company’s investigational device exemption application.
The C-Pulse assist device uses balloon counter-pulsation technology to help the heart by reducing the workload of the left ventricle. When the balloon is inflated, blood flow to the coronary arteries increases thereby bringing more oxygen critical to a heart that is in moderate to severe failure. When the balloon is deflated, the pumping required by the left ventricle of the heart is reduced. The device allows the balloon’s inflation and deflation to work in sync with the patient’s heartbeat, like a pacemaker.
It has shown promise in a clinical trial.
In late July, the company’s C-Pulse device received approval in Europe and can now be commercialized in parts of Asia and Latin America.
Company executives declined to comment on the approval beyond what is already in the press release because of a “big fund-raising” round that is expected to close in a few days, said Jim Yearick, vice president of marketing and sales.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Between, June 1 and August 3, the company’s stock has been up more than 159 percent. A little before noon, the stock was up roughly 10 percent trading around $9.40.
