Alcresta Therapeutics’ RELiZORB Digestive Enzyme Cartridge Receives the US FDA’s 510(k) Clearance
Shots:
- The US FDA has granted 510(k) clearance to the company’s next-generation RELiZORB (iMMOBILIZED LIPASE) cartridge to cater the enteral nutrition needs of a broader population living with rare diseases
- The expanded label incorporates new data from two pre-clinical studies, investigating the safety and efficacy of utilizing RELiZORB with continuous and bolus enteral feeding in pediatric porcine models of Short Bowel Syndrome (SBS). Ongoing trials of RELiZORB are actively recruiting patients with SBS
- RELiZORB is anticipated to be commercially available in Q2'24, and current users are set to transition to the new device by the end of the summer
Ref: Alcresta Therapeutics | Image: Alcresta Therapeutics
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
