PR99507

SALT LAKE CITY, Jan. 26, 2023 /PRNewswire=KYODO JBN/ --

DiscGenics, Inc. ( https://www.discgenics.com/ ), a clinical stage

biopharmaceutical company focused on developing cell-based regenerative

therapies that alleviate pain and restore function in patients with

degenerative diseases of the spine, today announced the U.S. Food and Drug

Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT)

designation to Injectable Disc Cell Therapy (IDCT or rebonuputemcel), an

injectable, allogeneic discogenic progenitor cell therapy for the treatment of

symptomatic lumbar degenerative disc disease (DDD).

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"This designation represents a critical validation of our novel approach to

utilizing a manufactured live progenitor cell population derived from donated

adult human intervertebral disc tissue to treat disc degeneration," said Flagg

Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. "As

committed stewards of this technology, we look forward to partnering with the

FDA to expedite our drug development program and to ultimately realizing the

potential of IDCT to address the unmet medical needs of millions of patients

with this painful and debilitating condition."

The RMAT designation is based on positive two-year clinical data from

DiscGenics's first-in-human study of IDCT. As previously reported (

https://c212.net/c/link/?t=0&l=en&o=3766613-1&h=632202302&u=https%3A%2F%2Fwww.discgenics.com%2Fnews-posts%2F2023%2F1%2F23%2Fdiscgenics-announces-positive-two-year-clinical-data-from-study-of-discogenic-progenitor-cell-therapy-for-degenerative-disc-disease&a=previously+reported

), the study demonstrated IDCT's potential to safely increase disc volume and

provide rapid, durable improvements in low back pain, function, quality of

life, and pain medication usage out to two years post-injection in patients

with lumbar DDD.

Established under the 21st Century Cures Act, RMAT designation is a dedicated

program designed to expedite the drug development and review processes for

promising pipeline products, including cell therapies. An investigational cell

therapy is eligible for RMAT designation if it is intended to treat, modify,

reverse, or cure a serious or life-threatening disease or condition, and

preliminary clinical evidence indicates that the drug or therapy has the

potential to address unmet medical needs for that disease or condition. RMAT

designation provides sponsors with intensive FDA guidance on efficient drug

development, including the ability to discuss surrogate or intermediate

endpoints, potential ways to support accelerated approval and satisfy

post-approval requirements, potential priority review of the biologics license

application (BLA), and other opportunities to expedite development and review.

IDCT is the first and only product intended for spine care to receive this

designation.

FDA also granted IDCT Fast Track designation (

https://c212.net/c/link/?t=0&l=en&o=3766613-1&h=2674439596&u=https%3A%2F%2Fwww.discgenics.com%2Fnews-posts%2F2019%2F8%2F26%2Fdiscgenics-receives-fda-fast-track-designation-for-cell-therapy-for-disc-degeneration&a=Fast+Track+designation

) in 2019, making RMAT the second special regulatory designation DiscGenics has

received from the FDA.

About DiscGenics

DiscGenics is a privately held, clinical-stage 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. 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. For more

information, visit discgenics.com.

SOURCE  DiscGenics, Inc.

CONTACT: Lindsey Saxon, lindsey@discgenics.com