A company that has created a unique new therapy for patients with advanced heart failure is hoping to spread the word about its product in 2014, after a year of clinical trials in both Europe and the United States.
Sunshine Heart, based in Eden Prairie, MN, raised more than $61 million in 2013, after two public offerings. Clinical trials for its C-Pulse device began late in the year. According to CEO David Rosa, the biggest challenge the company faces is making patients and physicians aware of the therapy, which uses a balloon-like device to help the heart pump blood.
“There’s a lot of untapped market potential out there,” Rosa said. “A lot of patients are not aware of these devices. The investment community knows about us; we really need to increase the awareness among patients and doctors.”
The product itself is unique, Rosa said, because it aids the heart in pumping blood without entering the bloodstream. Other heart failure technologies require some part of the device to enter the bloodstream, which can result in clotting that sometimes leads to strokes. Countering the clotting side effect with blood thinners creates its own problems.
The C-Pulse device instead wraps around the aorta and is powered by an external unit carried by the patient. Although the unit currently requires a lead that extends from the patient’s abdominal wall, the lead can be unplugged for activities such as taking a shower, and Sunshine is working on technology to power the device without an external lead.
Early results shows that the device has good results in patients with class three and four heart failure, an advanced disease state that can severely limit the ability of patients to do normal, day-to-day activities.
In a handful of cases, Rosa says, physicians have been able to discontinue the therapy after patients have recovered to the point where they no longer had symptoms.
A recent deal between HeartWare International and CircuLite created headlines about a competing heart failure therapy, but Rosa says he is less concerned with possible competitors than with developing the market. He says his company hasn’t explored a merger, but it does have a large cardiovascular company – which he declined to identify –- as an investor.
“I think there are a number of companies that would like to get into this space, but it’s not as crowded as some other markets,” Rosa says. “There hasn’t been a successful technology in the class three heart failure space. With some of the clinical results that we’re getting, we’re pretty excited, and we think physicians are also going to be excited.”