Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products,  announced 510(k) clearance of its next-generation RELiZORB® (iMMOBILIZED LIPASE) cartridge by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The next-generation RELiZORB device was developed to address the enteral nutrition needs of a wider population of patients living with rare diseases.

"Tube-fed patients have a wide range of enteral nutrition needs and feeding approaches and this 510(k) clearance represents an important expansion of the use of RELiZORB, enabling more patients to get more out of their enteral nutrition regimens," said Dan Orlando, Chief Executive Officer at Alcresta.

RELiZORB is the only FDA-cleared product indicated to break down fats in enteral formula and is intended to address fat malabsorption associated with tube feeding across a variety of disease states. The next-generation RELiZORB expands on Alcresta's novel digestive enzyme technology and broadens the utility of the device to be compatible with an increased number of enteral nutrition formulas (including many commonly used by patients with short bowel syndrome [SBS]), to allow for use with both continuous and bolus feeding, and to increase the maximum number of cartridges a patient can use per day from two to six. These improvements were developed to allow more enterally fed patients to benefit from the device, including those with SBS, for whom bolus feeding is a common enteral nutrition feeding approach.

The expanded RELiZORB label includes new data from two published pre-clinical studies conducted at Boston Children's Hospital, led by Mark Puder, M.D., PhD and the pediatric surgical research team, that evaluated the safety and efficacy of RELiZORB use with both continuous and bolus enteral feeding in pediatric porcine models of SBS. Dr. Puder and the team at Boston Children's Hospital are conducting ongoing RELiZORB clinical trials, which are currently enrolling for patients with SBS.

"People requiring tube feeding and suffering from fat malabsorption can experience significant consequences ranging from life-affecting gastrointestinal symptoms to an impact on growth and development for pediatric patients," stated Dave Recker, M.D., Acting Chief Medical Officer at Alcresta. "Since its initial clearance in 2015, RELiZORB has supported enterally fed patients by breaking down fats in their enteral formula, making them readily absorbable. The clearance of this next-generation device represents a significant milestone that will allow more patients to benefit from the unique role RELiZORB plays in enteral feeding."

The next-generation RELiZORB is expected to become commercially available in the second quarter of 2024, with existing patients transitioning to the newer device by the end of summer.