The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has granted 510(k) clearance to Alcresta Therapeutics for next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge.

RELiZORB is said to be the first-of-its-kind digestive enzyme cartridge designed to resemble pancreatic lipase’s function. It is based on Alcresta’s proprietary enzyme immobilisation technology, iLipase.

It is indicated to break down fats in enteral formula and address fat malabsorption related to tube feeding in different disease states.

The next-generation RELiZORB cartridge is intended to meet the enteral nutrition needs of a larger group of patients with short bowel syndrome (SBS) and other rare diseases.

According to Alcresta, the cartridge widens the use of the device for use with several enteral nutrition formulas.

It will be used with both continuous and bolus feeding and to increase the maximum number of cartridges a patient uses every day from two to six.

The expanded RELiZORB indication consists of new findings from two published pre-clinical studies conducted at Boston Children’s Hospital.

The trials assessed the safety and effectiveness of digestive enzyme cartridge use with both continuous and bolus enteral feeding in paediatric porcine models of SBS.

Additionally, the Boston Children’s Hospital team is conducting ongoing RELiZORB clinical studies, which are recruiting SBS patients.

Alcresta CEO Dan Orlando said: “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.”

The FDA approved the cartridge in 2015 for use in adult patients. In 2017, the cartridge was authorised for use in children as young as five.

In August 2023, the label was extended to paediatric patients as young as two years.

The device is anticipated to go on sale in Q2 of 2024 and the existing patients will be switching to the newer RELiZORB by the end of the summer.