Alcresta Therapeutics Announces Commercial Availability of Next-Generation RELiZORB® (iMMOBILIZED LIPASE) Cartridge

Commercial availability of RELiZORB marks important step to supporting more tube-fed patients including those living with short bowel syndrome and other rare diseases.

WALTHAM, Mass., May 13, 2024 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced the commercial availability of the next-generation RELiZORB® (iMMOBILIZED LIPASE) cartridge. The next-generation RELiZORB device was cleared by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) in December 2023. The first commercial shipment will be today, May 13, 2024.

RELiZORB is the only FDA-cleared product indicated to break down fats in enteral formula and is intended for use by tube-fed patients to address fat malabsorption, a condition marked by gastrointestinal symptoms and impacts on growth and development in pediatric patients. The device expands on the predicate RELiZORB device, allowing for broader enteral formula compatibility, use in both continuous and bolus-feeding set ups, and an increase in the maximum number of cartridges a patient can use per day from two to six.

"The commercial availability of the expanded utility device provides an important nutritional tool for tube-fed patients living with high-burden rare diseases, including short bowel syndrome, for whom tube feeding can be a primary source of nutrition," said Jason Weiner, Chief Commercial Officer at Alcresta. "To meet the demand of a broader enteral nutrition addressable market for RELiZORB, we have expanded our sales force from 21 territories in three regions to 27 territories in four regions."

The next-generation RELiZORB device replaces the predicate device on the market. Hospitals can begin ordering the new device immediately and current patients will transition to the newer device by the end of the year. The next-generation cartridge can be visually differentiated by its orange-colored cap, replacing the previous cartridge, which had a purple cap. More information can be found at www.RELiZORB.com.

RELiZORB clinical trials in short bowel syndrome are ongoing at Boston Children's Hospital. For more information about RELiZORB clinical trials now enrolling patients, visit ClinicalTrials.gov NCT03530852 and NCT05635747.

About RELiZORB^® (iMMOBILIZED LIPASE) CARTRIDGE

RELiZORB is indicated for use in pediatric patients (ages 2 and above) and adult patients to hydrolyze fats in enteral formula. RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is developed using Alcresta's proprietary enzyme immobilization technology, iLipase®, which is the digestive enzyme lipase bound to small polymeric bead carriers. RELiZORB connects in-line to enteral feeding systems. As enteral formula passes through RELiZORB, the bound lipase breaks down formula fats into an absorbable form prior to ingestion. RELiZORB was FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. Use was expanded to pediatric patients as young as two years old in August 2023.

About Alcresta Therapeutics, Inc.

Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally-fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and short bowel syndrome, which is marked by significant malabsorption due to limited absorptive area as a result of resection. Alcresta is currently developing a platform application for prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by Linden Capital Partners and HealthQuest Capital. More information can be found at www.alcresta.com.

Internal Media Contact:
Natalie Bronfin
Alcresta Therapeutics, Inc.
[email protected]
617-431-3600

SOURCE Alcresta Therapeutics, Inc.