Peer-Reviewed Article Reporting DiscGenics’ Cell Therapy Phase I/II Study Results Receives International Journal of Spine Surgery Best Paper Award

April 10, 2025

Salt Lake City, UT – April 9, 2025 – DiscGenics, Inc., a privately held, late-stage clinical, biopharmaceutical company developing allogeneic, cell-based, regenerative therapies for musculoskeletal degeneration, today announced that the double-blind, peer-reviewed article, “Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration—Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial,” was selected as one of just three of the best and most influential articles published in the International Journal of Spine Surgery (IJSS) in 2024.

The publication reported results from the combined Phase I/II clinical study of allogeneic disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD). The study met the primary safety and efficacy endpoints, showing that a single intradiscal injection of high-dose IDCT (9,000,000 cells/mL) safely increases disc volume and produces statistically significant, clinically meaningful improvements in back pain, disability, and quality of life out to 2 years post-injection in patients with lumbar disc degeneration.

“The patient outcomes from this study are very encouraging, as they show IDCT’s ability to safely and effectively reduce pain and disability associated with DDD while also demonstrating the potential of this treatment to produce a regenerative effect within the degenerating disc,” said Matthew F. Gornet, M.D., Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, lead author, and top enroller in the IDCT study.

Dr. Gornet will present the research at the International Society for the Advancement of Spine Surgery (ISASS) meeting in Miami, Florida, on Friday, April 11.

“We are honored to be recognized by ISASS and the IJSS and would like to thank Dr. Gornet and all of the study authors for their contributions to this article,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “IDCT truly has the potential to change the paradigm of care for patients with DDD, and the momentum provided by this publication has been inspiring as we finalize preparations to initiate Phase III clinical study of this therapy in the U.S.”

DiscGenics previously announced it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with Phase III clinical evaluation of IDCT. Subject enrollment is expected to begin in Q2 2025.

About IDCT

IDCT (injectable disc cell therapy, or rebonuputemcel) is a standalone, single-injection biologic drug treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. The active ingredient (Drug Substance) in IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue. These cells are enriched and expanded into Discogenic Cells through a multistep manufacturing process in a highly controlled environment under current Good Manufacturing Practices (cGMP) that results in significant proliferation and phenotypic changes to the cells. The Discogenic Cells are mixed with a viscous Sodium Hyaluronate Solution and excipients to generate IDCT, the Final Drug Product. At the completion of the manufacturing process, each lot of IDCT is subjected to extensive release testing prior to use, including identity, purity, potency, and safety evaluations. IDCT is cryopreserved and maintained as individual “off-the-shelf” doses for administration via percutaneous injection into the intervertebral disc in an outpatient setting. IDCT has been granted regenerative medicine advanced therapy (RMAT) and Fast Track designations by the U.S. Food and Drug Administration.

Disclaimer: IDCT is an investigational product that is under development by DiscGenics and has not been approved by the FDA or any other regulatory agency for human use.

About DiscGenics

DiscGenics is a privately held, late-stage clinical biopharmaceutical company developing allogeneic, cell-based regenerative therapies for musculoskeletal degeneration. It’s lead product candidate, IDCT (injectable disc cell therapy, or rebonuputemcel), is a standalone, single-injection biologic drug treatment designed to halt progression of lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics is also developing a follow-on allogeneic cell platform to enable new musculoskeletal indications. To further development of these unique therapies, and to maintain control over compliance, cost, and production timelines, DiscGenics has built and validated an in-house scalable, allogeneic cell manufacturing process and cGMP facility at its headquarters in Salt Lake City, Utah. For more information, visit discgenics.com.