Sunshine Heart (SSH): C-Pulse Still has Life Left

Stephen L Kanaval  |

Sunshine Heart Inc. (SSH) main growth driver is the C-Pulse and it has serious potential. The C-Pulse is a cuff placed around the ascending aorta and helps the heart pump blood throughout the body.

Sensors and tube are also placed surgically on the heart to help with inflating the cuff, while the passed sensor is then carried in a bag with the patient. The cuff creates a “secondary pulse” strengthening the heart’s function. The company’s recent Counter HF trial has been stopped, but there still could be opportunities down the line for this implantable medtech product. The C-Pulse will help patient by (from company documents):

  • Increase coronary blood flow with more oxygenated blood flowing to the blood vessels and heart muscle
  • Decrease cardiac afterload reducing how hard the heart has to work to pump blood through the body
  • Increase cardiac function with more blood being pumped from the heart to the rest of the body

In addition, The C-Pulse system is also designed to reduce clinical symptoms associated with moderate to severe (Class III/ambulatory Class IV) heart failure. These symptoms include shortness of breath, dizziness, fluid retention, and limited ability to perform and/or engage in normal day-to-day activities.

Many investors will shy away from Sunshine Health because of the low test enrollments, but the company has some of the strongest efficacy data available. Sunshine Health has worked to improve this product time and time against study improved placement and patient responses carefully. Heart disease creates 1 million hospitalizations each year and can be linked to 1 out of every 9 deaths. This is a large market and a product that could have a serious impact. In a call, the company’s Chairman and CEO, John Erb, addressed the way forward:

We have spent considerable time and effort collecting and analyzing the data and researching the most optimal strategic path forward. Based on this work we are moving ahead with the therapeutic strategy does focus on neuromodulation as we temporarily set aside counterpulsation.

The primary reason for driving this change is based on our OPTIONS-HF European post market trial. In that trial the hemodynamic effects observed indicated a mechanism of action not explained solely by the principal of counterpulsation. In our COUNTER-HF study similar effects were observed during C-Pulse programming which led physicians to initiate measurements to assess the neural effects of C-Pulse.

Preliminary data demonstrated the primary mechanism of action from C-Pulse was neuromodulation we believe this is due to the balloon cuff being placed on the ascending aorta. During therapy when the balloon cuff is inflated it stretches the walls of the aorta, we believe this causes mechanical activation of adjacent baroreceptors. This was an extremely important discovery that points us in a better direction compared to our previous clinical strategy.

The company is clearly transitioning, but, according to management, this is not a bad thing. The company still has lots of verifiable data that this technology can save lives. Here are Erb’s words on the issue:

We believe our new direction provide significant benefits including one a more cost effective way to develop a wholly implantable system. Two, a faster path to commercialization and three access to the broader heart failure market and potentially other indications.

For these reasons we believe a neuromodulation based therapy will ultimately be more impactful to both patients and physicians than our original C-Pulse system. We are confident that we are on the right track in fact we believe that the development and ultimate approval of fully implantable neuromodulation device can be achieved and half the time and at half the cost of our original system.

This is certainly a company with risk but the market here approaches 3.7 million patient per year, and with verifiable data and results, Sunshine may still have light left.

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Companies

Symbol Name Price Change % Volume
SSH CHFS Sunshine Heart Inc 390.80 0.00 0.00 0

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