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FDA Grants RMAT designation for Cook MyoSite’s Investigational Autologous Muscle Derived Cells for Urinary Sphincter Repair

·3 min read

Cook MyoSite, a biotechnology firm based in Pittsburgh, Pennsylvania, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Cook MyoSite’s investigational product, Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), for treatment of women with persistent or recurrent stress urinary incontinence (SUI) following surgical treatment.

Implicit in the RMAT designation is an acknowledgement that SUI meets the FDA's definition of a 'serious condition' in cases where women continue to experience incontinence episodes that have a substantial impact on day-to-day functioning despite having undergone surgical treatment. This acknowledgment represents a major step forward for these patients, many of whom suffer significantly from this life-altering condition with limited treatment options.

"This is a milestone for Cook, for urology, and for regenerative medicine, but most importantly, it’s a victory for the patients who have gotten to the end of the treatment pathway and have no more options," said Ron Jankowski, Vice President of Scientific Affairs at Cook MyoSite. "This particular group of SUI patients for whom the gold standard of care has failed have a recognized unmet medical need with continued symptoms that substantially impact day-to-day functioning and quality of life."

Cook MyoSite’s RMAT application was based on retrospective analyses of two open-label clinical studies and two double-blind, randomized, placebo-controlled clinical studies. The combined analyses evaluated the safety and efficacy of AMDC-USR in the subgroup of women enrolled in these studies continuing to experience symptoms despite receiving prior surgical treatment for incontinence. Preliminary evidence of clinically relevant reduction in stress incontinence episode frequency and improvement in quality of life and symptom severity scores, combined with the favorable safety profile, indicates that AMDC-USR has the potential to address unmet medical needs for these women.

To learn more about RMAT, visit https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation.

About Autologous Muscle Derived Cells (AMDC)

Autologous muscle derived cells, or AMDC, is a personalized, regenerative cell therapy product being investigated by Cook MyoSite, Inc. AMDC is created from muscle progenitor cells that are isolated from human adult muscle and are theorized to engraft into existing dysfunctional or weakened target tissue to improve muscle function.

The AMDC technology is being clinically investigated for female stress urinary incontinence, fecal incontinence, underactive bladder, and tongue dysphagia. To date, more than 600 subjects have participated in the AMDC clinical program. For more information on these studies, visit ClinicalTrials.gov.

About Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR)

AMDC-USR is an investigational product that is injected into the urinary sphincter and is hypothesized to reduce the number of incontinence episodes in women with stress urinary incontinence (SUI). Because SUI may be caused by intrinsic sphincter deficiency, augmenting the urinary sphincter function may serve as a potential durable treatment.

About Cook MyoSite, Inc.

In 2002, Cook MyoSite, Incorporated was formed to guide the Cook Group organization into the expanding world of cellular technologies. Today, Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. Learn more at www.cookmyosite.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201217005162/en/


For media inquiries:
Lindsy Bartoleit
412 923 6277