News & Events

Posted on August 16, 2016

EDEN PRAIRIE, Minn., August 16, 2016 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (NASDAQ:SSH) announced today the appointment of Megan Brandt to the position of Vice President of Regulatory Affairs and Quality Assurance. In this capacity, Ms. Brandt will facilitate and manage quality and regulatory affairs for Sunshine Heart.

“Megan brings to the company a specific set of necessary skills to successfully guide us through the regulatory approval process as we push forward in our new clinical strategy,” said John Erb, Chairman and Chief Executive Officer of Sunshine Heart. “Her extensive leadership and experience will be critical for the new strategic direction of the company.”

Prior to joining Sunshine Heart, Ms. Brandt was Vice President of Quality and Regulatory Affairs at Cardiovascular Systems, Inc. (CSI), a company focused on developing and commercializing innovative solutions for treating peripheral and coronary vascular disease. At CSI, she successfully facilitated domestic and international clinical study submissions and secured multiple regulatory approvals including CE mark, 510(k) clearances, and original PMA approval for their peripheral and coronary orbital atherectomy systems.

She currently serves as Co-Chair for Medical Alley’s Regulatory Advisory Board and is actively involved in FDA working groups including Harmonization by Doing and MDEpiNet’s RAPID programs. In 2014, she was nominated by Minnesota Business Magazine as an Emerging Healthcare Leader. Ms. Brandt earned her B.S. in Biochemistry and Microbiology from Minnesota State University-Mankato.

About Sunshine Heart

Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing a product portfolio to treat moderate to severe heart failure and related conditions. Our objective is to improve the quality of life for heart failure patients and halt the disease progression. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.

Forward-Looking Statements

Certain statements in this release are forward-looking statements that are based on management’s beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, clinical and pre-clinical study designs and activities, expected timing for initiation, enrollment and completion of clinical trials, research and development activities, ultimate clinical outcomes and benefits of our products to patients, design and development of future studies, site activations, patient enrollment in studies, timing of regulatory filings and approvals, regulatory acceptance of our filings, our expectations with respect to product development and commercialization efforts, market and physician acceptance of our products, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses and potentially competitive product offerings. The risk factors described in our filings with the SEC could cause actual events to adversely differ from the expectations indicated in these forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Sunshine Heart may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility that regulatory authorities do not accept our application or approve the marketing of our therapy, the possibility we may be unable to raise the funds necessary for the development and commercialization of our therapy and other risks and uncertainties described in our filings with the SEC. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information, please contact:

Claudia Napal Drayton

Chief Financial Officer

Sunshine Heart, Inc.

T: +1-952-345-4205

Investor Relations

Sunshine Heart Inc.

ir@sunshineheart.com