Exhibit 99.2
|
Sunshine Heart Amends Its Debt Agreement with Silicon Valley Bank
Eden Prairie, MN: December 9, 2015: Sunshine Heart, Inc. (NASDAQ: SSH) announced today it has amended its debt agreement with Silicon Valley Bank to modify the requirement that the Company raise $20.0 million by March 31, 2016.
“It is a pleasure to continue to work with Silicon Valley Bank which is well established in the healthcare sector as a leading financial partner to emerging companies. We are pleased with the outcome and look forward to continue to strengthen our partnership with Silicon Valley Bank,” commented John Erb, Chairman and Interim Chief Executive Officer of Sunshine Heart.
On December 8, 2015, the Company entered into an agreement with Silicon Valley Bank to modify the loan and security agreement that was signed on February 18, 2015, which had required that the Company complete an equity financing resulting in unencumbered net cash proceeds of at least $20.0 million by March 31, 2016. The amendment eliminates this requirement, replaces it with a requirement that the Company maintain eight months of cash and cash equivalents on its balance sheet and also increases the fees the Company will pay Silicon Valley Bank in connection with prepayments.
“We’re pleased to continue our partnership with Sunshine Heart as they further develop their C-Pulse system,” said Ben Johnson, Managing Director of Silicon Valley Bank. “This modification illustrates Silicon Valley Bank’s commitment to increasing our clients’ probability of success, as well as our ongoing commitment to support the global life science community.”
Additional details regarding the amendment to the loan agreement are included in a Current Report on Form 8-K filed on December 9, 2015 by Sunshine Heart with the Securities and Exchange Commission.
About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient’s current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility study, we also believe that some patients treated with our C-Pulse System may be able to stop using the device due to sustained improvement in their conditions as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine® Heart
Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical study of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device
exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal study. In July 2012, Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. 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.
About Silicon Valley Bank
For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Forbes named SVB one of America’s best banks (2015) and one of America’s best-managed companies (2014). SVB’s life science and healthcare practice provides a range of financial services to innovative companies that are improving health through technology. Learn more at svb.com/lifescience.
Silicon Valley Bank is the California bank subsidiary and commercial banking operation of SVB Financial Group (Nasdaq:SIVB), and a member of the FDIC. Silicon Valley Bank and SVB Financial Group are members of the Federal Reserve System.
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, our expectations with respect to future clinical study activities and results including patient enrollment in studies. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the EU and the other risk factors described under the caption “Risk Factors” and elsewhere in our filings with the U.S. Securities and Exchange Commission. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. 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. We 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.
###
For further information, please contact:
Investor: | Media: |
Candice Knoll | David Schull |
Blueprint Life Science Group | Russo Partners |
T: +1-415-375-3340 Ext. 4 | T: +1-212-845-4271 |
|
|
Claudia Drayton | Christopher Hippolyte |
Chief Financial Officer | Russo Partners |
Sunshine Heart, Inc. | T: +1-646-942-5634 |
T: +1-952-345-4200 |
|