Business Context and Reporting Period
This Form 8-K was filed by Sunshine Heart, Inc. on September 16, 2014. The filing serves as a Regulation FD disclosure regarding upcoming clinical data presentations. The company is developing the C-Pulse Heart Assist System, a mechanical circulatory support device.
Key Financial Metrics
The filing text does not provide specific financial data such as revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on clinical trial updates and investor communications.
Material Changes
No material financial changes are reported in this document. The primary event is the announcement of follow-up data from six patients implanted with the C-Pulse Heart Assist System at St. Luke's Hospital as part of an FDA-approved North American Feasibility Trial.
Guidance, Outlook, and Management Commentary
- Clinical Updates: Dr. Sanjeev Aggarwal will present case studies and an update on the COUNTER HF study at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) Conference.
- Investor Event: An analyst and investor breakfast was held on September 16, 2014, at the Grand Hyatt Washington. Presenters included Dr. Aggarwal, Dr. Christopher Bowles (Royal Brompton and Harefield NHS Foundation Trust), and Dr. William E. Cohn (Texas Heart Institute).
- Availability: Presentations are available on the company's investor relations website.
- Regulatory Note: The information is furnished pursuant to Item 7.01 and is not deemed "filed" for liability purposes under Section 18 of the Securities Exchange Act of 1934.
Investor Verification Checklist
- Verify the clinical outcomes of the six patients in the North American Feasibility Trial presented at the TCT Conference.
- Review the specific data points regarding the COUNTER HF study update.
- Access the full presentations (Exhibits 99.2, 99.3, and 99.4) on the Sunshine Heart investor relations website for detailed clinical metrics.
- Confirm the status of the OPTIONS HF European Post-Market Study mentioned in the press release exhibit.