Shares of Sunshine Heart (SSH) were flying during the morning hours on Wednesday after the company announced pre-market news that it had received CE Mark approval in Europe for the C-Pulse Heart Assist system in the treatment of Class III and ambulatory Class IV heart failure. Earlier this week the company had reached another milestone, announcing that it had conducted a two-year review of the first patient treated with C-Pulse in the North American feasibility trial.
Sunshine shares had already exploded earlier this month, running from roughly three dollars to over seventeen at one point, as encouraging news regarding the potential of C-Pulse to quickly become the standard-of-care in treating heart failure made the rounds, but had since retreated to the ten dollar price level as the swing, momentum and day traders exited with huge profits.
The drop, however, offered investors a second chance to take a look at the company and its potential, and Wednesday's news proves that Sunshine is for real.
With the European approval now in the bag, Sunshine can move ahead with plans to register its first commercial sales later this year. That potential catalyst should line up nicely with the initiation of a decisive trial in the United States that, should results continue to prove successful, would position the company to seek approval with the US FDA.
As noted earlier this week, results from the feasibility trial have been thus far encouraging and expectations are high that C-Pulse is being positioned to set the standard for the next generation of heart failure treatment.
Already a hot stock to watch, Sunshine is one to keep at or near the top of the list right now. While running heard during Wednesday's AM, investors may look for opportunities to get in during any potential future dips.
Disclosure: No position.
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