UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

FORM 8-K

 

Current Report Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 9, 2017

 

SUNSHINE HEART, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware

 

001-35312

 

68-0533453

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

12988 Valley View Road

Eden Prairie, Minnesota  55344

(Address of principal executive offices)  (Zip Code)

 

(952) 345-4200

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o                             Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o                             Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o                             Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o                             Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 8.01.  Other Events.

 

Sunshine Heart, Inc. (the “Company”) issued a press release on February 10, 2017 to announce its receipt of formal notice from The NASDAQ Stock Market LLC on February 9, 2017 that indicated that the Company has evidenced compliance with the minimum $1.00 bid price requirement, as set forth in Nasdaq Listing Rule 5550(a)(2). The Company remains subject to an extension through March 20, 2017 to evidence compliance with the $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market.  A copy of the press release is filed herewith as Exhibit 99.1 hereto and incorporated herein by reference.

 

Item 9.01   Financial Statements and Exhibits.

 

(d)  Exhibits.

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated February 10, 2017.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: February 10, 2017

SUNSHINE HEART, INC.

 

 

 

 

 

 

By:

/S/ CLAUDIA DRAYTON

 

 

Name:

Claudia Drayton

 

 

Title:

Chief Financial Officer and Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

99.1

 

Press release dated February 10, 2017.

 

4


Exhibit 99.1

 

 

Sunshine Heart Compliant with Nasdaq Bid Price Requirement

 

EDEN PRAIRIE, Minn., Feb. 10, 2017 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (NASDAQ: SSH) announced today that on February 9, 2017, the Company received formal notice from The NASDAQ Stock Market LLC indicating that the Company has evidenced compliance with the minimum $1.00 bid price requirement, as set forth in Nasdaq Listing Rule 5550(a)(2). Shares of the Company’s common stock closed Thursday at $5.59 per share. The Company remains subject to an extension through March 20, 2017 to evidence compliance with Nasdaq’s $2.5 million stockholders’ equity requirement.

 

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.  The Company’s main commercial product, the Aquadex system, is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. 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, potentially competitive product offerings and the Company’s ability to achieve compliance with Nasdaq’s minimum stockholders’ equity requirement. 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

 

Investor Relations

Chief Financial Officer

 

Sunshine Heart Inc.

Sunshine Heart, Inc.

 

ir@sunshineheart.com

T: +1-952-345-4205