Creative Medical Technology’s CELZ-201-DDT Receives FDA Fast Track for Degenerative Disc Disease

PHOENIX, August 13, 2025 — Leads & Copy — Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) announced that the FDA has granted Fast Track designation to CELZ-201-DDT for treating degenerative disc disease (DDD). This allows the company to benefit from accelerated FDA interactions, rolling Biologics License Application (BLA) submissions, and eligibility for priority review.

CELZ-201-DDT, from the AlloStem® platform, is an allogeneic perinatal cell therapy. The designation was based on clinical data demonstrating safety and early efficacy signs. Timothy Warbington, President and CEO, said the designation validates their scientific approach.

DDD affects millions globally, with current options limited. The company’s approach aims to restore function and improve life quality. The global spinal disorders treatment market is projected to surpass $20 billion by 2030.

Creative Medical Technology will post its expanded access policy for CELZ-201-DDT within 15 days of this announcement.

Contact: Devin Sullivan, Managing Director, The Equity Group Inc., dsullivan@equityny.com, 1-407-644-4256; Dave Gentry, RedChip Companies, CELZ@redchip.com; Conor Rodriguez, Associate, crodriguez@equityny.com; Paul Kuntz, Communications Director, RedChip Companies, paul@redchip.com, 412-708-4590

Creative Medical Technology Holdings, Inc. is advancing cell and immune therapies targeting unmet needs in neurology, urology, orthopedics, and autoimmune diseases.

Source: Creative Medical Technology Holdings, Inc.

×

Welcome!

BiotechReporter.news is a Leads & Copy Publication

Leads & Copy is a Media “news tip” source, providing Industry Reporters story Leads, written as Publishable CP-style Copy.

By Subscribing you will receive Daily Biotech Story Leads via email 10:30 am Mon-Fri.