Alcresta Therapeutics has received 510(k) clearance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health for its next-generation digestive enzyme cartridge, RELiZORB (iMMOBILIZED LIPASE).
This development marks a significant step in addressing the enteral nutrition needs of a broader patient population with rare diseases.
RELiZORB is designed for children aged two years and older and adults, and is claimed to be the only FDA-cleared product to break down fats in enteral formula. It mimics the role of pancreatic lipase.
It targets fat malabsorption issues common in tube feeding for various disease states.
The device builds on Alcresta's digestive enzyme technology, enhancing its compatibility with a greater range of enteral nutrition formulas.
This includes formulas frequently used by patients with short bowel syndrome (SBS) and extends its use to both continuous and bolus feeding methods.
The improved device now permits a maximum of six cartridges per day, up from two, allowing more patients who rely on enteral feeding, including those with SBS, to benefit from the technology.
Bolus feeding, a prevalent method for SBS patients, is now supported by the next-generation device.
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 updated label for the device includes findings from two pre-clinical studies carried out at Boston Children's Hospital.
These studies, led by Dr Mark Puder and the paediatric surgical research team, assessed the efficacy and safety of the device with both continuous and bolus feeding in paediatric porcine models of SBS.
Dr Puder's team continues to conduct clinical trials with RELiZORB, currently recruiting SBS patients.
Commercial availability of the next-generation RELiZORB is anticipated in the second quarter of 2024. Existing patients are expected to transition to the new device by the end of the summer season.
