Sunshine Hearth has updated its clinical strategy, which it says could benefit an under-served population of patients with Class III heart failure and other related conditions. After months of collecting data and researching an optimal strategic path forward, the company is moving forward with a therapeutic strategy focused on neuromodulation rather than counterpulsation.
A press release reports that in a feasibility trial, Sunshine Heart’s counterpulsation therapy provided greater benefits to patients than would have been expected through the haemodynamic action of the aortic cuff alone. The company believes that the primary mechanism of action providing the clinical benefit was a neuromodulatory effect due to the counterpulsation balloon placement on the ascending aorta and its activation of the aortic baroreceptors with each expansion. Therefore compared with its prior clinical strategy, Sunshine Heart believes its new focus will provide the following benefits: 1) a more cost-effective way to develop a fully-implantable system, 2) a faster path to commercialisation, and 3) broader access to the New York Heart Association Class III heart failure market.
John Erb, Sunshine Heart’s chairman and chief executive office, comments: “We are confident that we are on the right track. A neuromodulation-based therapy will provide greater benefits to patients, physicians, and the market than our original C-Pulse System. Furthermore, we believe that the development and ultimate approval of a fully-implantable neuromodulation device can be achieved in half the time and at half the cost of our original system. Our approach targets easy to find anatomical structures which provide an immediate and measurable response. In addition, the mechanism of action is direct, simple and well understood.”
The company has identified the following clinical steps, comprised of three primary objectives:
The company’s near-term clinical objective includes the evaluation of five patients using the original C-Pulse device. The physician initiated research, approved by their local institutional review board, is evaluating sympathetic nerve activity with C-Pulse therapy turned on and off to assess response. Initial data from the study has been very positive and a full data set should be completed by the end of the third quarter of this year. This data will be targeted for publication within the scientific community to further correlate reduction of sympathetic activity to improved quality of life for heart failure patients.
Acute neuromodulatory first-in-man
The company is pursuing a first-in-man acute study to demonstrate hemodynamic response to a proprietary neuromodulation approach. The study is expected to include approximately 20 patients and will utilize an external pulse generator and prototype leads. Enrolment is estimated to begin in the fourth quarter of 2016 and should be completed by the end of 2016.
Following the completion of the acute neuromodulatory first-in-man study, the company will pursue a clinical study that will use a fully implantable pulse generator and proprietary leads. The purpose of the study will be to establish the chronic benefits of a fully-implantable system. The study will include approximately 30 patients and the clinical endpoints will be based on a six-month follow-up period. The results will be used to support CE Mark approval as well as an IDE/PMA submission with the FDA. Patient enrolment is expected to begin in 2017.