July, 2012 has been a banner month for medical device company Sunshine Heart Inc. (SSH: Quote) (SHC.AX), with the shares of the company rallying over 220 percent thus far in the month. As further catalysts are expected in the coming months, it might be worth keeping an eye on this stock.
For readers who are new to Sunshine Heart, here's a brief overview of the company's pipeline and the upcoming events to watch out for...
Sunshine Heart is engaged in developing innovative technologies for cardiac and coronary disease, and its lead product candidate is C-Pulse heart assist device for heart failure.
The company received full Investigational Device Exemption, or IDE, approval to commence a 20-person, North American, feasibility study with the C-Pulse Heart Assist System in November 2008. Patient enrollment in the trial began in April of 2009, and by March 31, 2011, 20 patients were enrolled in the study.
Last November, Sunshine Heart announced results of its C-Pulse feasibility trial, which demonstrated that patients implanted with C-Pulse heart assist device had statistically significant improvement in the New York Heart Association functional class, quality of life and left ventricular ejection fraction. Note that the New York Heart Association, or NYHA, classification grades the severity of heart failure symptoms as one of four functional classes.
The FDA completed review of Sunshine Heart's C-Pulse feasibility trial data in March of this year, and has given green signal to the company to go-ahead with Investigational Device Exemption application for its pivotal trial.
According to a S-1 filing dated July 17, 2012, the IDE application for approval to initiate the pivotal trial with C-Pulse Heart Assist System is expected to be filed by the company in the second-half of this year. Enrollment of the trial is expected to be completed by the end of 2015 and the company does not anticipate marketing the device in the United States before 2017.
The company submitted a CE Mark application for C-Pulse Heart Assist System in Europe last December, and is expected to gain approval in the second half of 2012.
Sunshine Heart's C-Pulse System targets Class III and ambulatory Class IV patients as defined by the NYHA. About 1.5 million heart failure patients in the United States and 3.7 million patients in Europe are estimated to fall into the classification range targeted by the C-Pulse System.
In the U.S., pharmacological therapies and pacing devices are the current available treatments for Class III heart failure patients while circulatory assist devices, specifically left ventricular assist devices, or LVADs, are used to treat Class IV patients.
A quick look at the company's balance sheet...
Sunshine Heart, which was founded in November 1999, has incurred significant losses since inception. As of March 31, 2012, the company's accumulated deficit was $69.3 million, and cash in hand was $3.83 million.
Historically, revenue has been generated solely from sales of the C-Pulse System to hospitals and clinics pursuant to research arrangements and with appropriate regulatory approvals for sales in conjunction with feasibility clinical trial. Since enrollment in the feasibility trial was completed in early 2011, the company did not sell any C-Pulse Heart System device in the three month periods ended March 31, 2012 or 2011, and therefore no revenue was generated in the said periods.
The company will start generating revenue when it begins enrolling patients in the pivotal clinical trial of C-Pulse heart assist device and initiate trials in select countries in Europe.
Sunshine Heart's common stock has been listed on the Australian Securities Exchange in the form of Chess Depositary Instruments since 2004. A 1-for-200 reverse stock split was effected for the CDIs trading on the ASX on January 24, 2012.
The stock began trading on the Nasdaq Capital Market on February 16, 2012.
On the Nasdaq, SSH has thus far hit a low of $2.50 and a high of $22.90. The stock gained 3.5% on Monday to close at $10.55, on a volume of 380,700, which is 2.5 times its average over the past three months.
On the ASX, SHC.AX has thus far hit a 52-week low of A$0.02 and 52-week high of A$0.06. The stock closed Monday's trading at A$0.04, up 17% on a volume of 2.5 million shares.
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by RTT Staff Writer
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