Neuraptive Therapeutics’ NTX-001 Gains the US FDA’s Breakthrough Therapy Designation to Treat Peripheral Nerve Injury Requiring Repair
Shots:
- The US FDA has granted BTD to NTX-001 for peripheral nerve injury repair, based on 24wks. results from the P-II (NEUROFUSE) trial and interactions with the FDA. Full 48wks. data are anticipated in the coming wks. and will be shared at future conferences
- Neuraptive is planning to conduct a pivotal P-III study in H1’25 to evaluate the safety and efficacy of NTX-001 vs PBO for treating peripheral nerve injury requiring repair after finalizing the protocol with the US FDA
- NTX-001 is a single-use surgical product that includes an active solution of drug, an isolation chamber, and two sterile solutions. It is used in combination with standard suture neurorrhaphy for repairing severed nerves in patients aged 16-80yrs.
Ref: Neuraptive Therapeutics | Image: Neuraptive Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
