Sunshine Heart Inc (NASDAQ:CHFS)
Sunshine Heart Inc (NASDAQ:CHFS) was up by 13.59% in Friday’s trading session days after announcing that researchers at Stanford University School of Medicine have received FDA approval to evaluate safety and effectiveness of its Aquadex FlexFlow Aquapheresis system. The study seeks to ascertain whether the Aquapheresis therapy is associated with greater weight loss and non-inferior rate of renal dysfunction compared to normal medical therapy.
Stanford Aquadex FlexFlow Aquapheresis System Study
The system is indicated for temporary ultrafiltration treatment for patients with fluid overload who have failed diuretic therapy. The device is designed to improve the quality of life for patients with heart failure as well as other related conditions.
The upcoming non-blinded clinical study will be carried out in 45 children of up to 21 years with diuretic-resistant fluid overload and heart failure.
“We are pleased that the researchers have received FDA approval to proceed with this IDE study,” said John Erb, Chairman and CEO of CHF Solutions. Given the limitations of patient unresponsiveness to diuretic therapies over time, our solution represents a potentially transformative future standard of care,” said CEO John Erb.
Separately, Directors of CHF Solutions has approved two equity awards under the company’s New Hire Equity Incentive Plan. In connection to the approval Jim Breidenstein and Gordon Weber are to receive 339,145 and 226,097 shares of the company’s stock respectively. The option awards come with an exercise price of $0.57 a share with a ten-year term and vest over a period of four years.
Audit Firm Changes
CHF Solutions (NASDAQ:CHFS) has confirmed the dismissal of Ernst & Young as the company’s independent registered public accounting firm. However, the company maintains that financial statements prepared by the firm for the year ending December 31, 2016 and December 31, 2015 does not contain any adverse opinion, or disclaimer of opinion. The company also maintains there were no disagreements with the firm on any matter of accounting prior to its dismissal.
Baker Tilly Virchow Krause, LLP takes over as the company’s new independent accounting firm with immediate effect. For the first three months of the year, CHF solutions reported revenues of $901,000 compared to $746 000 for the quarter ended Dec 31, 2016. Net income in the quarter was $940,000.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.