By VFC’s Stock House
Sunshine Heart Inc. (NASDAQ:SSH) shares were moving higher on Monday, trading up by five percent after having dropped to near the six dollar mark late last week following the airing of funding concerns on the Seeking Alpha website by an individual investor who held no position in the stock. The concerns, as it turns out, may have been a tad bit overblown as they did not address the fact that the C-Pulse Heart Assist system had already received a CE Mark approval in Europe and is on track to start registering commercial sales as soon as within the current quarter. Additional concerns were raised — and then debunked — regarding competition from other heart-assist devices on the market, specifically those marketed by Heartware International Inc. (NASDAQ:HTWR) and Thoratec Corporation (NASDAQ:THOR), for example, given that the C-Pulse is implanted outside of a patient’s bloodstream, a huge advantage over any purported competition.
Investors digesting this news may have led the SSH rebound charge, but Sunshine is also receiving attention this week by presenting at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Miami, Florida. Data from the already-completed feasibility study will be presented, including a 12-month follow-up of patients utilizing the C-Pulse.
Also of note, Sunshine received Frost & Sullivan’s ’2012 North American Heart Failure Treatment New Product Innovation Award’ for C-Pulse this week, another potential factor in Monday’s share price rise.
C-Pulse, in addition to other supporting factors, received the award due to the device’s “novel” qualities of being implanted outside of the bloodstream. Venkat Rajan, Industry Manager for Medical Devices at Frost & Sullivan, noted in the associated release:
“Capable of delivering treatment without contact of blood, the implantable C-Pulse Heart Assist system represents a truly novel approach into the treatment paradigm for heart failure patient.”
C-Pulse also recently received an Investigational Device Exemption (IDE) by the FDA that clears the way for development in the US. A pivotal trial in the United States is also expected to commence within the current quarter with an eye towards FDA approval. On a funding note, a recent round of financing has positioned the company on sound footing until the mid-way point of this trial, at which time a potential partner could come in and make a move. The idea of a partner coming on board — or the company being outright purchased — may not be so far-fetched, considering that the recent financing deal included a multi-million dollar up-front payment by a “strategic investor” who will also send a member to Sunshine’s board.
Such moves strongly hint at partnership or buyout interest.
Volume was light during Monday’s run, but SSH will be receiving additional attention this week, given the presentations in Florida and the innovation award.
Disclosure: Long SSH
Contact the Author: vfc@vfcsstockhouse.com
VFC’s Stock House offers investing opinions, insight and ideas on a variety of different stocks, options and ETFs, as well as commenting on news that affects the market.
