GIE Medical Announces First Patient Enrolled in PATENT-B Benign Bowel Stricture Treatment Study

The large, multicenter randomized controlled clinical trial is evaluating the safety and efficacy of the ProTractX3™ TTS drug coated balloon for the treatment of benign bowel strictures

MINNEAPOLIS, April 18, 2024 /PRNewswire/ -- GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, announced today that enrollment has begun in its Paclitaxel Coated Balloon for the Treatment of Chronic Benign Stricture - Bowel (PATENT-B) study. The study is evaluating the safety and efficacy of the first of its kind ProTractX3™ TTS drug coated balloon (DCB), and the first patient was enrolled at Allegheny Health Network (AHN) in Pittsburgh, Pa.

"Advancements in endoscopic stricturotomy, such as balloon dilation to open strictures in the bowel or esophagus, have been key to the minimally invasive management of strictures which develop in the bowel or esophagus. The ProTractX3™ TTS DCB – which releases medication into the stricture following dilation – stands to further advance this endoscopic treatment by helping to prevent stricture reformation and ultimately improve outcomes for patients," said Dr. Gursiman S. Kochhar, division chief of AHN Gastroenterology, Hepatology and Nutrition. "As a national leader in the field of advanced endoscopy for the treatment of inflammatory bowel disease (IBD), we are extremely pleased to enroll the first patient in this study and look forward to the impact this device might have for patients managing bowel strictures." 

In 2023, the Food and Drug Administration Center for Devices and Radiological Health (CDRH) granted GIE Medical the Breakthrough Device Designation to expedite development of its ProTractX3 TTS DCB for patient access because it has a reasonable chance of providing more effective treatment of life-threatening or irreversibly debilitating human disease or conditions than the current standard of care.

"By starting to enroll the randomized cohorts in PATENT-B, our treatment for bowel stricture IDE study, we are one step closer to being able to potentially provide a new treatment solution for certain patients suffering from benign bowel strictures," said GIE Medical Vice President Drew McClure.

People who may qualify to participate in the PATENT-B study:

• Are 22 years of age or older
• Diagnosis of symptomatic benign bowel stricture with at least two previous dilations
• Stricture length ≤5 cm   

GIE Medical's ProTractX3 3-Stage TTS DCB is a balloon coated with the anti-restenotic agent paclitaxel. It is an investigational device in the U.S. The company is also evaluating the safety and efficacy of the ProTractX3 3-Stage TTS DCB for the treatment of benign esophageal strictures in its PATENT-E clinical trial.

ABOUT GIE MEDICAL 
GIE Medical is a clinical stage company conducting trials in the U.S. to help patients suffering from benign stricture(s) of the esophagus or bowel (small intestine, colon, and rectum).

The ProTractX3™ Through the Scope Drug Coated Balloon could offer a new solution for treating GI strictures, potentially creating sustained long-term patency and reducing the number of treatments. For more information, visit www.GIEMedical.com.

Media Contact:
Hyedi Nelson
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SOURCE GIE Medical