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DiscGenics Announces FDA RMAT Designation

January 26, 2023
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The FDA granted RMAT designation to DiscGenics’ Injectable Disc Cell Therapy for degenerative disc disease.

Key Highlights

  • RMAT Designation is a program to expedite development of regenerative biologics to address unmet medical needs.
  • DiscGenics’ IDCT is the first spine product to receive RMAT designation.

Signed into law on December 13, 2016, the 21st Century Cures Act was designed to accelerate the innovation of new devices and medicines for patients that need them. As part of the Cures Act, the Regenerative Medicine Advanced Therapy designation, or RMAT, is targeted towards cell and tissue therapies intended to treat unmet medical needs for serious or life-threatening conditions. Since its inception, less than 100 products have received RMAT designation; as such, being granted one is a high mark of confidence for any company’s product.

DiscGenics, Inc.’s Injectable Disc Cell Therapy (IDCT), rebonuputemcel, is an injectable cell therapy for treatment of symptomatic lumbar degenerative disc disease (DDD). DDD is a very common lower back condition in the middle-aged and especially elderly populations. Some figures estimate 40% of people in their 40s have DDD, going up to 80% for those 80 or older. DiscGenics’ process utilizes “a manufactured live progenitor cell population derived from donated adult human intervertebral disc tissue” to provide long-term pain relief and restore function to patients impacted by lumbar DDD. The RMAT designation will provide IDCT increased guidance and review for additional research and development.

Read the full Press Release here.

Medical Metrics, Inc. is an ISO 9001:2015-certified provider of independent imaging core lab services and the leading core lab for spine clinical trials. We assist sponsors with designing, implementing, and executing the imaging strategy of their global trials through our responsive trial management team, robust operating infrastructure, and world-class imaging expertise. Learn more about our Spine expertise.

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