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Sunshine Heart dumps counterpulsation for neuromodulation, initial data expected later this quarter

Jul. 11, 2016 7:44 AM ETNuwellis, Inc. (NUWE) StockBy: Douglas W. House, SA News Editor64 Comments
  • Thinly traded nano cap Sunshine Heart (SSH) says apparently had a eureka moment regarding its product development strategy, shifting from counterpulsation to neuromodulation. It says it made the discovery in a feasibility trial that revealed the primary mechanism of action was a neuromodulatory effect due to the C-Pulse System's counterpulsation balloon's placement on the ascending aorta and its activation of the aortic baroreceptors (mechanoreptors in the aortic arch that change the tension in the aortic wall in response to changes in blood pressure) with each expansion.
  • The company says its new focus will enable a more cost effective way to develop a fully-implantable system, a faster path to commercialization and broader access to the NYHA Class III heart failure market.
  • The first step will involve the evaluation sympathic nerve activity in five patients using C-Pulse turned on and off to assess response. Full data should be available later this quarter.
  • A first-in-man study to show hemodynamic response to a proprietary neuromodulation approach in ~20 subjects will follow. It will use an external pulse generator and prototype leads. Enrollment will commence in Q4 with results expected in the same quarter. If all goes well, a clinical trial in ~30 patients will commence in 2017.
  • The company needs to do something. Shares are down almost 93% from early 2015.

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