Alcresta Therapeutics Receives 510(k) Clearance For Use of RELiZORB® in Children
RELiZORB, The Only Digestive Enzyme Cartridge for Patients Requiring Supplemental Enteral Nutrition, Now Cleared to Help Children Suffering from Fat Malabsorption
July 20, 2017 08:30 AM Eastern Daylight Time
WARREN, N.J.--(BUSINESS WIRE)--Alcresta Therapeutics, Inc., dedicated to developing products designed to address nutritional challenges faced by patients with Cystic Fibrosis, Chronic Pancreatitis, Pancreatic Cancer, Gastric Cancer, and other serious diseases, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its RELiZORB digestive enzyme cartridge for use in pediatric patients suffering from fat malabsorption. RELiZORB was cleared in 2015 for use in patients 18 years and older. This latest clearance will extend the use in children as young as 5 years old.
Alcresta Therapeutics Announces Positive Results, RELiZORB® Increased Fat Absorption in Both Adult and Pediatric Patients with Cystic Fibrosis Receiving Enteral Nutrition
RELiZORB significantly increased plasma levels of omega-3 fatty acids and patients reported a decrease in the frequency of gastrointestinal symptoms in a Pivotal Clinical Trial
July 31, 2017 08:30 AM Eastern Daylight Time
WARREN, N.J.--(BUSINESS WIRE)--Alcresta Therapeutics, Inc., dedicated to developing products designed to address challenges faced by people living with gastrointestinal disorders and rare diseases, announced publication of data from a pivotal clinical study of their product RELiZORB, a novel in-line digestive enzyme cartridge indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyze fats while receiving enteral nutrition.