"In the U.S., for Class III heart failure there are about 1.5 million patients," Sunshine Heart CEO David Rosa told MassDevice.com in an exclusive podcast interview. "That’s about 7 times the Class IV market, which is traditionally where LVADs participate."
And that’s the market Sunshine Heart is targeting with its flagship C-Pulse cardiac assist system, an outside-the-bloodstream heart pump designed for patients with Class III or early Class IV heart failure.
The device reduces the amount of pumping burden on a patient’s heart, providing some relief for common symptoms of heart failure, which include shortness of breath and reduced mobility.
Unlike traditional left ventricular assist devices, C-Pulse sits outside the bloodstream. Because the device has no contact with the blood, patients can reduce or in some cases eliminate their reliance on blood-thinning drugs.
It also means that patients can disconnect the device for short durations in order to shower, drive a car or engage in other activities that heart failure device patients are generally cautioned against.
In the recently released results of a feasibility trial, patients with Sunshine Heart’s C-Pulse system had no reported strokes or other neurological events. More than 85% of patients reported an improved quality of life, and 2 patients improved enough that they were able to disconnect their devices for prolonged periods of time without their symptoms reappearing.
"One patient in particular has been disconnected coming up on a year and a half now without any additional recurrent heart failure symptoms," Rosa told us. "That was unexpected, but quite exciting for us."
In the last year, Sunshine Heart completed a feasibility trial for its fully implantable C-Pulse system, completed 5 research & development programs and began listing SSH shares on the NASDAQ stock exchange.
The company has its sights set on CE Mark approval in the European Union in the 2nd quarter and the launch of a pivotal trial of the C-Pulse device in the 3rd quarter this year.
Although the cardiac rhythm management market has been a tough one in recent years, Rosa remains ever optimistic, especially after an FDA advisory panel recommended approval for HeartWare International‘s (NSDQ:HTWR) HVAD implantable heart pump for people with end-stage heart failure.
"Any person that’s CEO for an early-stage company will probably tell you something similar. The major challenges are really capital and being able to get capital to really achieve all the objectives that you have," he said. "What’s really encouraging, and why I’m so encouraged, is that I believe the recent approval of HeartWare’s device, or the recommendation by the panel to approve the device, is so important in that it gives investors additional confidence that the FDA is willing to approve and looking to approve devices in this space."
In an exclusive podcast interview with MassDevice.com, Rosa told us about the company’s beginnings, his optimism for the still-sluggish cardiac rhythm management market and the road ahead for Sunshine Heart.