Phase 3 Trial

DiscGenics Launches DDDtrial.com for Patients with Chronic Low Back Pain Associated with Degenerative Disc Disease

SALT LAKE CITY, Utah — April 9, 2026 — DiscGenics, Inc. today announced the launch of DDDtrial.com, a patient-focused website created to help individuals learn more about a Phase 3 clinical research study of IDCT for chronic low back pain associated with degenerative disc disease (DDD) of the lumbar spine. The website offers study information and a convenient pre-screening process for individuals who may be eligible to participate.

IDCT is an investigational injectable disc cell therapy using DiscGenics’ proprietary Discogenic Cells. The Phase 3 study evaluates IDCT as a potential non-surgical treatment for degenerative disc disease of the lower spine.

Individuals may qualify for the study if they are 18 to 75 years old1, have experienced chronic low back pain for at least six months, have lumbar DDD that is diagnosed or suspected, and are able to return for follow-up visits over approximately two years. For qualified participants, no study-related costs are required, compensation may be available, and participants may be assigned a study injection.

“Chronic low back pain can have a significant impact on daily life, and many patients continue to seek non-surgical treatment options,” said Flagg Flanagan, Chairman and CEO of DiscGenics, “With DDDtrial.com, we aim to make it easier for people to learn about this Phase 3 study and determine whether they may be eligible to participate.”

About the Phase 3 Study

The Phase 3 clinical research study is evaluating IDCT as a non-surgical treatment under investigation for degenerative disc disease of the lower spine. The website is intended to support awareness and pre-screening for potential participants.

You May Qualify If You:

  • Are 18–75 years old

  • Have had chronic low back pain for 6 months or longer

  • Have lumbar degenerative disc disease, diagnosed or suspected

  • Are able to return for follow-up visits for about 2 years

To learn more or complete the pre-screen, visit DDDtrial.com.

About IDCT (rebonuputemcel)
IDCT is an Investigational New Drug (IND enabled) allogeneic cell therapy that utilizes Discogenic Cells derived from donated adult intervertebral disc tissue. It is designed to be administered via injection as a non-surgical treatment intended to reduce pain and improve function in patients with lumbar disc degeneration.

About DiscGenics
DiscGenics is a privately held, late-stage clinical, biopharmaceutical company developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics’s first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. IDCT has been granted regenerative medicine advanced therapy (RMAT) and Fast Track designations by the U.S. Food and Drug Administration. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain.

DiscGenics has developed a proprietary, commercial-scale, in-house allogeneic cell manufacturing process and built and qualified a cGMP facility at its Salt Lake City, Utah headquarters.

For more information, visit discgenics.com

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the therapeutic potential, regulatory status, commercialization timing, market opportunity, post-marketing commitments, and future development of IDCT. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including regulatory developments, clinical outcomes, manufacturing readiness, reimbursement decisions, commercialization execution, and other factors. DiscGenics undertakes no obligation to update these statements except as required by law.

DiscGenics Treats First Patient in Phase 3 Clinical Trial of IDCT (Rebonuputemcel) for Symptomatic Mild-to-Moderate Lumbar Degenerative Disc Disease

Salt Lake City, UT — January 12, 2026 — DiscGenics, Inc., a privately held, late-stage clinical biopharmaceutical company developing regenerative cell-based therapies for degenerative diseases of the spine, today announced that the first patient has been treated in their Phase 3 clinical trial evaluating IDCT (injectable disc cell therapy, rebonuputemcel) in subjects with single-level, symptomatic mild-to-moderate lumbar degenerative disc disease (DDD). Site activation is underway across the United States.

“Treating the first patient in our Phase 3 trial marks an important milestone for DiscGenics and for individuals living with lumbar degenerative disc disease,” said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics. “Many patients today face a difficult choice between continuing conservative care that is no longer working or opting for invasive surgery. IDCT is designed to offer an effective alternative that is minimally invasive and requires a single injection in an outpatient setting.  It is a cell-based option that targets the diseased disc itself. With this pivotal trial, we aim to generate the rigorous clinical evidence needed to be able to provide IDCT to patients suffering from symptomatic disc degeneration.”

“In my role as the Principal Investigator at the top enrolling site for the Phase 1/2 trial, we saw promising results. I’m grateful for the opportunity to participate in the current Phase 3 trial to further evaluate what I believe to be a very promising treatment. We were excited to have treated the first study patient in the country,” said Matthew F. Gornet, MD, a spine surgeon at The Orthopedic Center of St. Louis. “Participating in this Phase 3 trial allows us to offer eligible patients access to an investigational therapy that is specifically designed to address the underlying disc pathology. We are pleased to be part of a study that could help expand future treatment options for this challenging condition.”

“This Phase 3 trial has been carefully designed to evaluate both the safety and efficacy of IDCT using a randomized, double-blind, sham-controlled approach,” said Nagy Mekhail, MD, PhD, Cleveland Clinic, and Chief Eligibility Officer for the DGX-A02 pivotal trial. “The rigorous eligibility criteria and standardized assessments are intended to ensure a high-quality data set that can meaningfully inform clinicians, patients, and regulators about the role a targeted, cell-based therapy might play in the management of lumbar degenerative disc disease.”

About the Phase 3 DGX-A02 Trial

DGX-A02 is a prospective, randomized, double-blind, sham-controlled, multicenter Phase 3 clinical trial designed to evaluate the safety and efficacy of IDCT in subjects with single-level, symptomatic mild-to-moderate lumbar (L3–S1) intervertebral disc degeneration. The trial is expected to enroll approximately 162 subjects and includes a 52-week primary period followed by a 52-week follow-up period (total 104 weeks). The trial is registered at ClinicalTrials.gov (NCT07254806).

About IDCT (Injectable Disc Cell Therapy, Rebonuputemcel)

IDCT is an investigational, single-injection biologic treatment designed to halt the progression of lumbar disc degeneration and regenerate the disc from within. The active component of IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, delivered via a viscous carrier. IDCT has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration. IDCT has not been approved by the FDA or any other regulatory authority for any use.

About DiscGenics

DiscGenics is a privately held, late-stage clinical biopharmaceutical company developing allogeneic, cell-based regenerative therapies for musculoskeletal degeneration. Its lead product candidate, IDCT (rebonuputemcel), is a single-injection biologic therapy designed to halt the progression of lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics has developed a proprietary, commercial-scale, in-house allogeneic cell manufacturing process and built a cGMP facility at its Salt Lake City, Utah headquarters.

For more information, visit discgenics.com

This press release contains forward-looking statements, including statements regarding the conduct and progress of DiscGenics’ Phase 3 clinical trial of IDCT (rebonuputemcel), site activation, and the expected enrollment and timing of the study. Actual results may differ materially due to risks and uncertainties inherent in clinical development and regulatory review. DiscGenics undertakes no obligation to update these statements except as required by law.