A name change last month seemed at least to slow the stock plummet for CHF Solutions (NASDAQ: CHFS), formerly Sunshine Heart, and news on Thursday made the early-stage medical device company one of the biggest movers amongst NASDAQ issues.
The catalyst for the Eden Prairie, Minnesota-based company was the U.S. Food and Drug Administration giving an approval to the Stanford University School of Medicine's Department of Pediatrics’ Investigational Device Exemption seeking to begin a clinical trial evaluating CHFS’s Aquadex FlexFlow Aquapheresis System for safety and efficacy in treating diuretic (water pill)-resistant fluid overload in children with acute decompensated heart failure.
The Aquadex FlexFlow system is an extracorporeal ultrafiltration device for the removal of salt and water in patients with hypervolemia, or fluid overload. The system is the only alternative to hypervolemia as a result of congestive heart failure for patients for which diuretic therapy does not work.
The retention of sodium has many negative effects on the body, including lung crackles, peripheral edema, hepatomegaly with ascites and increased cardiac filling pressure, among others.
In the upcoming study being led by Stanford’s Christopher Almond and David Kwiatkowski, Associate and Clinical Associate Professor of Pediatrics (Cardiology), respectively, 45 patients between the ages of six months and 21 years with heart failure and diuretic-resistant fluid overload will be enrolled.
The goal will be to determine whether CHF Solutions’ system is associated with greater weight loss and a non-inferior rate of kidney dysfunction compared to optimal medical therapy. Secondary endpoints include assessing the impact of heart failure symptoms, adverse outcomes and the need for medical management.
After touching an all-time low of 51 cents on May 31, shares of CHFS have edged ahead modestly, including closing at 62 cents on Wednesday. With today’s news, the stock has been invigorated, surging to $1.06 for a gain of 70.3% as the day winds towards the closing bell. That’s the highest level for the stock since April 18.
