The market has turned very hostile toward high-risk small-cap med-tech companies, and Sunshine Heart (NASDAQ:SSH) has long struggled to deliver the sort of progress that would make it easy to argue that the market is being unfair. Although the company has resolved a clinical hold, enrollment rates have been an ongoing long-term disappointment and the company's targets for reimbursed procedures have proven much too optimistic. With that, that company's prospects for finishing its pivotal COUNTER HF trial, let alone advancing a better, fully implantable, version of its technology without exceptionally dilutive/expensive financing has basically vanished.
The company's C-Pulse device does seem to provide benefits and quality of life improvements to the majority of patients who get it, but the ongoing issues with site and patient enrollment would seem to speak to more significant problems at the management and strategic level. At this point, these shares look more like a lottery ticket - there are paths by which these shares could succeed from here (including both buyout and go-it-alone strategies), but between the financing and operational issues, it's also quite possible that further losses are in store for shareholders.
It Seems To Work …
I've written about Sunshine before and I don't want to spend too much time rehashing the basics of the product (the C-Pulse) and technology (counterpulsation). The device consists of a cuff placed around the ascending aorta, sensing leads, a driveline, and an external power source. The sensing leads monitor the heart rate and trigger the cuff to inflate between beats, sending extra blood to the heart muscle and reducing the workload of the heart.
The C-Pulse offers an alternative to products like LVADs, which come into contact with the bloodstream, and implanted cardiac resynchronization devices that have shown a very mixed record of clinical efficacy.
While the
