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Sunshine Heart (SSH) Tops Q3 EPS by 5c; Offers C-Pulse Update

November 11, 2013 6:28 AM EST Send to a Friend
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Sunshine Heart (NASDAQ: SSH) reported Q3 EPS of ($0.39), $0.05 better than the analyst estimate of ($0.44).

CORPORATE UPDATE:

In the third quarter of 2013, Sunshine Heart made significant site progress within its C-Pulse COUNTER HF U.S. pivotal trial. Within the period, three new sites were activated and a total of eight sites have been activated to-date. Sunshine Heart reports a total of 26 centers either activated or committed to joining the trial, up from 17 centers in the second quarter of 2013. The Company is currently waiting to hear from an additional four centers with regard to intention to participate in the COUNTER HF trial. Sunshine Heart expects to have between 11-19 sites activated and approximately 35 sites activated or committed to participate in the trial by year-end. In addition, the Company commenced patient enrollment in the quarter, enrolling two patients in the trial.

U.S. sites continue to average six months from enrollment to activation. Last quarter, the Company announced new initiatives to expedite site presentations and subsequent site activations. This included the hiring of a consultant to supplement in-house patient recruiting, as well as the addition of three new enrollment-related internal positions, including a Chief Medical Officer and VP Clinical Research and a Patient Recruitment Director. As a direct result of this, encouraging progress was made in the third quarter with regard to site commitments.

With regard to reimbursement for C-Pulse, the Company continues to receive feedback from sites with qualifying LVAD programs that they have received regional CMS reimbursement approval for the C-Pulse procedure under established LVAD codes. The Company also submitted an NUB application for reimbursement in Germany in October and expects to receive feedback in February of 2014 as previously indicated.

The Company reported last quarter that it was developing a formal weaning protocol following the successful weaning of two patients from its pilot feasibility study due to improved results. The protocol has now been fully reviewed by clinical advisors and is finalized to include heart failure class and ejection fraction targets, improvement across other objective functions, and reduction in counter-pulsation therapy, ultimately leading to permanent disconnection. The Company expects this full weaning process to require approximately 12 months from time of implant. The decision to wean and the appropriate timing is ultimately the decision of the physician and not the Company. There is no single parameter that indicates recovery, but rather a body of data available to the individual doctor. Encouragingly, none of the patients weaned thus far have been reconnected due to worsening heart failure and have remained off certain pre-operative drugs that were needed for their heart failure condition. At the 2013 Transcatheter Cardiovascular Therapeutics (TCT) conference on October 29, Dr. Andrew Kao presented details of his experience weaning two patients with a third in the later stages of the process. If successful with the third patient, Sunshine Heart will have weaned a total of five patients from the C-Pulse therapy. As previously indicated, Sunshine Heart does not plan to allow patients to be weaned in its ongoing trials as doing so could impact the primary endpoint of the respective trials.

Site activation and patient enrollments also continue to advance in the C-Pulse OPTIONS HF post-market study in the EU with seven total patients implanted to-date, up from four patients at the end of the second quarter of 2013. The Company has eight sites now activated and able to implant, including five in Germany and three in Italy. UK centers continue to progress through the approval process and the Company continues to expect UK site activation by the end of the year.

In addition to trial progress, Sunshine Heart continues to advance its internal R&D. The Company received approval in the U.S. for a driver enhancement program intended to improve physician ease of use, reduce nuisance alarms, and improve signal clarity. Sunshine Heart expects to implement the new program as quickly as possible across U.S. sites. The same program has been submitted for approval in the EU and the Company expects to receive approval in early 2014. With regard to the fully-implantable C-Pulse system, an acute animal trial has been successfully completed, displaying the ability to implant the device and provide comparable support to the existing C-Pulse system in worldwide clinical trials. As previously stated, the Company also plans to evaluate the fully-implantable system in a chronic trial, which will commence in the fourth quarter.

For earnings history and earnings-related data on Sunshine Heart (SSH) click here.




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