Flagg Flanagan (CEO & Chairman), Chad Falciani (Newly Appointed Board Member), and Bob Wynalek (COO & Board Member)
DiscGenics Announces Independent DSMB Safety Review Supports Continuation of Phase III Study of IDCT Without Modifications
Salt Lake City, Utah – June 9, 2026 – DiscGenics, Inc., a privately held, late-stage clinical biopharmaceutical company developing allogeneic, cell-based, regenerative therapies for musculoskeletal degeneration, today announced that the independent Data Safety Monitoring Board (“DSMB”) for its Phase III clinical study of IDCT, also known as rebonuputemcel, for the treatment of symptomatic lumbar degenerative disc disease (“DDD”), has completed a pre-planned safety review and recommended that the study proceed without any modifications.
The DSMB review was conducted as part of the pre-planned clinical safety oversight process agreed upon with the U.S. Food and Drug Administration (“FDA”). Following its review of available safety data, the DSMB recommended continuation of the study as planned, with no changes to the study protocol.
“This DSMB recommendation marks an important milestone for DiscGenics as we continue advancing IDCT through Phase III clinical development,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “We are pleased that the independent safety review supports continuation of the study without modifications, consistent with the pre-planned oversight framework agreed upon with the FDA. This recommendation further reinforces our confidence in the clinical development path for IDCT and our commitment to bringing forward a potential regenerative treatment option for patients suffering from symptomatic lumbar disc degeneration.”
IDCT is a standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics is evaluating IDCT in a Phase III clinical study designed to assess the safety and efficacy of the investigational therapy in adults with symptomatic lumbar DDD.
“Since the inception of DiscGenics, we have generated a robust body of preclinical and clinical evidence supporting the safety profile and regenerative potential of IDCT,” said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. “The DSMB’s recommendation to proceed without modifications is an encouraging outcome from this pre-planned review and allows us to continue the Phase III study as designed.”
DDD is a chronic and progressive condition where the intervertebral disc breaks down and causes pain and disability. It accounts for nearly 40% of chronic low back pain cases in the U.S., a serious medical condition that affects 12-30% of U.S. adults at a given time and is estimated to cost the U.S. healthcare system over $100 billion each year, creating a considerable burden on the economy and individual patients.
“The ability to continue this Phase III study without modification is an important step as we work to further evaluate IDCT’s potential to change the paradigm of care for patients with DDD,” said Flanagan.
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 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 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 CEO Flagg Flanagan Highlighted Launch of FDA-Approved Phase 3 Program for IDCT (rebonuputemcel) at CG 2026 Musculoskeletal Conference
Salt Lake City, UT — March 4, 2026 — DiscGenics, Inc., a privately held, late-stage clinical biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that Flagg Flanagan, Chief Executive Officer and Chairman of DiscGenics presented at the CG 2026 Musculoskeletal Conference.
CG 2026 Musculoskeletal Conference held in New Orleans, Louisiana.
Title: Revolutionizing Care for Chronic Back Pain
Date: Monday, March 2, 2026
Time: 4:00 PM
Location: New Orleans, Louisiana
During the presentation, Flanagan highlighted DiscGenics’ advancement of IDCT (rebonuputemcel), including the launch of the Company’s FDA-approved Phase 3 clinical program for symptomatic, lumbar degenerative disc disease, and outlined the study design and key milestones supporting DiscGenics’ path toward commercialization.
A public video recording of DiscGenics’ company presentation can be viewed here:
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
DiscGenics’ U.S. Phase III Milestone Recognized on Nasdaq Tower in Times Square
Salt Lake City, UT — January 21, 2026 — DiscGenics, Inc., a privately held, late-stage clinical biopharmaceutical company developing regenerative cell-based therapies for degenerative diseases of the spine, previously announced the treatment of the first patient in its U.S. Phase III clinical trial; today, the company is sharing that Nasdaq recognized the milestone by displaying a congratulatory message on the Nasdaq Tower in Times Square.
“Treating the first patient in our U.S. Phase III clinical trial is a major milestone for DiscGenics and a meaningful step forward in our mission,” said Flagg Flanagan, Chairman and Chief Executive Officer of DiscGenics. “We’re proud to see this moment recognized on the Nasdaq Tower in Times Square, but what matters most is what it represents—the dedication of our team and the possibility of making a real difference for patients. As we advance this Phase III study, we remain focused on executing with rigor and urgency, so we can help bring a meaningful new option to the many patients who may benefit.”
This milestone reflects the company’s clinical momentum and operational readiness, supported by DiscGenics’ vertically integrated manufacturing facility and ability to produce cGMP clinical supply to support the program.
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.
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.
DiscGenics and Collaborators Announce Breakthrough in Tissue-Engineered Intervertebral Disc Research
Peer-Reviewed Article Reporting DiscGenics’ Cell Therapy Phase I/II Study Results Receives International Journal of Spine Surgery Best Paper Award
DiscGenics Announces US FDA Approval to Proceed with Phase III Clinical Evaluation of Allogeneic, Injectable Disc Progenitor Cell Therapy for Symptomatic Lumbar Degenerative Disc Disease
DiscGenics has gained acceptance from the U.S. FDA for the clinical protocols and Chemistry, Manufacturing, and Controls (CMC) clinical development plan for Phase III clinical program of its allogeneic, injectable disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD), allowing the study to proceed.
The International Journal of Spine Surgery Has Published Results from an FDA-Approved Study of an Allogeneic Disc Progenitor Cell Therapy for the Treatment of Adults with Lumbar Disc Degeneration
The International Journal of Spine Surgery publishes results from the combined Phase I/Phase II, first-in-human clinical study of an allogeneic disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease.
DiscGenics to Present at Canaccord Genuity 2024 Musculoskeletal Conference
DiscGenics to Present at Biotech Showcase 2024
DiscGenics Announces Research Collaboration with the U.S. Department of Veterans Affairs for Tissue-Engineered Discs with Discogenic Cells
DiscGenics has announced a basic science Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs (VA) to assess the feasibility of using DiscGenics’ proprietary Discogenic Cells with the VA’s whole, tissue-engineered endplate-modified disc-like angle ply structure (eDAPS).
DiscGenics CEO to Present at Upcoming Industry Conferences
Salt Lake City, UT – September 26, 2023 – DiscGenics, Inc., a privately held, late-stage clinical, biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that Flagg Flanagan, Chief Executive Officer and Chairman of DiscGenics will present at the following conferences:
East-West BioPharma Summit being held October 2-4 in Cambridge, Massachusetts and livestreamed globally.
Format Company Presentation
Date: Wednesday, October 4, 2023
Time: 9:45 AM ET
Location: Salon 5-6 at the Boston Marriott Cambridge
Organized by BioCentury and BayHelix in collaboration with McKinsey & Company, the East-West BioPharma Summit brings together industry leaders and investors to debate global development strategy, and to network with peers from both the East and West.
Virtual attendance is available, which includes access to a recording of DiscGenics’ company presentation. For more information, please visit: https://conferences.biocentury.com/east-west-summit.
2023 Cell & Gene Meeting on the Mesa being held October 10-12 in Carlsbad, California and livestreamed globally.
Format Company Presentation
Date: Tuesday, October 10, 2023
Time: 9:45 AM PT
Location: Ecolab Life Sciences Ballroom at the Park Hyatt Aviara Resort
Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a three-day conference featuring more than 120 dedicated company presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies, as well as over 100 panelists and featured speakers.
Virtual attendance is available, which includes a livestream of DiscGenics’ presentation and the ability to view all conference sessions on-demand. For more information, please visit https://meetingonthemesa.com.
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, mild to moderate 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.
