Key Developments: Sunshine Heart Inc (SSH.OQ)

SSH.OQ on NASDAQ Stock Exchange Capital Market

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27 May 2015
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Latest Key Developments (Source: Significant Developments)

Sunshine Heart Inc announces FDA approval to resume enrollment in counter hf US pivotal study for c-pulse heart assist system
Tuesday, 26 May 2015 05:30am EDT 

Sunshine Heart Inc:Says US Food and Drug Administration (FDA) has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System.Says it has already begun the process to provide all pivotal study centers with the information required for their Investigational Review Board to approve the continuation of study enrollment.  Full Article

Sunshine Heart Inc provides update on U.S. Pivotal Study of C-Pulse Heart Assist System
Thursday, 16 Apr 2015 04:54pm EDT 

Sunshine Heart Inc:Announces that the U.S. Food and Drug Administration (FDA) has reviewed the Company's submission regarding the COUNTER HF's U.S. pivotal study pause and requested minor protocol changes be submitted in order to receive approval to resume patient enrollment.FDA did not indicate concerns regarding safety of the device.Says the Data Safety Monitoring Board (DSMB), reviewed COUNTER HF's data and recommended continuing the Study.FDA has reviewed the company's submission regarding the counter HF'S U.S. pivotal study pause.All four of reported patient deaths have been adjudicated by independent clinical events committee as being non-device related.  Full Article

Sunshine Heart, Inc receives FDA approval for interim analysis of U.S pivotal trial of C-Pulse(R) heart assist system
Wednesday, 25 Feb 2015 05:30am EST 

Sunshine Heart, Inc:Receives unconditional approval from FDA to conduct an interim analysis of Counter HF, it's U.S. pivotal study.Says Counter HF study is prospective, randomized, multi-center, controlled study that evaluates safety and efficacy of C-Pulse system for treatment of NYHA Class III and ambulatory Class IV heart failure.Integral to Counter HF study is assessment of C-Pulse's balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.Purpose of study is to determine whether the C-Pulse System is a safe and effective treatment for heart failure patients who meet key study qualifications.  Full Article

Sunshine Heart appoints Claudia Drayton as Chief Financial Officer
Monday, 5 Jan 2015 05:30am EST 

Sunshine Heart Inc:Appoints Claudia Drayton as its Chief Financial Officer.Says Drayton, who was formerly Chief Financial Officer and Senior Finance Director for Medtronic Inc.'s Integrated Health Solutions Business, replaces Jeff Mathiesen, who will provide consulting services to the Company through the first half of 2015.  Full Article

Sunshine Heart Inc Closes Public Offering Of Common Shares
Tuesday, 24 Sep 2013 11:41am EDT 

Sunshine Heart Inc announced the closing of its previously announced underwritten public offering of 4,381,500 shares of its common stock, which includes the full overallotment of 571,500 shares, at a price to the public of $10.50 per share. The net proceeds from the sale of shares by Sunshine Heart, after underwriting discounts and other offering expenses, total approximately $42.6 million. Piper Jaffray & Co. and Cowen and Company, LLC acted as joint book-running managers and Lazard Capital Markets LLC acted as co-lead manager for the offering. Craig-Hallum Capital Group and Northland Securities, Inc. acted as co-managers for the offering. Sunshine Heart intends to use the net proceeds from the offering for general corporate purposes, including its ongoing U.S. pivotal trial and post-market EU study, initial commercialization of the C-Pulse Heart Assist System, or C-Pulse System, in the EU, and product development activities.  Full Article

Sunshine Heart Inc Prices $40.0 Million Public Offering Of Common Shares
Thursday, 19 Sep 2013 09:46am EDT 

Sunshine Heart Inc announced the pricing of its previously announced offering of 3,810,000 shares of its common stock at a price to the public of $10.50 per share in an underwritten public offering pursuant to its effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission (SEC). Piper Jaffray & Co. and Cowen and Company, LLC are acting as joint book-running managers and Lazard Capital Markets LLC is acting as co-lead manager for the offering. Craig-Hallum Capital Group and Northland Securities, Inc. are acting as co-managers for the offering. In addition, Sunshine Heart has granted the underwriters a 30-day option to purchase up to an additional 571,500 shares solely to cover over-allotments, if any. The offering is expected to close on or about September 24, 2013, subject to customary closing conditions. Sunshine Heart intends to use the net proceeds from the offering for general corporate purposes, including its ongoing U.S. pivotal trial and post-market EU study, initial commercialization of the C-Pulse Heart Assist System, or C-Pulse System, in the EU, and product development activities.  Full Article

Sunshine Heart Inc Announces Proposed Public Offering of Common Shares
Wednesday, 18 Sep 2013 04:01pm EDT 

Sunshine Heart Inc announced that it has commenced an underwritten public offering of its common stock pursuant to its effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission (SEC). Piper Jaffray & Co. and Cowen and Company, LLC are acting as joint book-running managers and Lazard Capital Markets LLC is acting as co-lead manager for the offering. Craig-Hallum Capital Group and Northland Securities, Inc. are acting as co-managers for the offering. In addition, Sunshine Heart expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering solely to cover over-allotments, if any. The offering is subject to customary conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Sunshine Heart currently intends to use the net proceeds from the offering for general corporate purposes, including its ongoing U.S. pivotal trial and post-market EU study, initial commercialization of the C-Pulse Heart Assist System, or C-Pulse System, in the EU, and product development activities.  Full Article

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