GIE MEDICAL NEWS

MINNEAPOLIS – April 18, 2024 - 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. 

iGIE published initial findings from the INGEST Study that examined the development and initial clinical experience with ProTractX3 DCB for the treatment of benign difficult esophageal strictures, finding that drug-coated balloons can be safely applied with clinically relevant increases in esophageal lumen at one year with symptomatic improvement.

​

READ MORE

MINNEAPOLIS – December 7, 2023 - 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 - Esophagus (PATENT-E) 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 the University of North Carolina School of Medicine.

 

“We are excited to be testing this promising new technology,” said Nicholas J. Shaheen, MD, MPH, Chief, Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine. “Our patients with difficult-to-treat strictures need treatment options that are effective and safe. We hope to show that this innovative approach provides a new direction for them.”

 

Earlier this year, 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.

 

“We are pleased to be enrolling the randomized cohorts in PATENT-E, our treatment for esophageal stricture IDE study, and look forward to the results,” said GIE Medical Vice President Drew McClure. “We sincerely thank our clinical partners and internal GIE Medical team for achieving this significant milestone.”

 

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

• Are 22 years of age or older

• Are failing to respond to conventional dilation (have had at least one previous dilation in the past 12 months with diagnosis of stricture recurrence)

​

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.

 

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.

​

[PLYMOUTH, MN – June 6, 2023] GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, was granted designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its ProTractX3™ TTS DCB indicated for dilation of recurrent benign esophageal strictures in adults with obstructive symptoms associated with narrowing of the esophagus.

 

In December 2022, GIE Medical launched two large, multicenter randomized controlled clinical trials in the United States to investigate the company’s first of its kind multi-stage drug-coated balloon (DCB) technology, ProTractX3 TTS DCB.

 

“The care of gastrointestinal strictures has been largely unchanged for decades,” said Nicholas J. Shaheen, MD, MPH, Bozymski-Heizer Distinguished Professor of Medicine and Chief, Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine. “This technology represents a promising way forward in treating those with difficult strictures and could result in less complicated, less costly and less invasive care for these patients.”

 

The FDA 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 or diagnosis of life-threatening or irreversibly debilitating human disease or conditions than the current standard of care.

 

“We are honored to have our drug-coated balloon catheters selected for the FDA's Breakthrough Device Program for esophageal strictures. This may provide U.S. patients faster access to our novel DCB technology, with the potential to provide safer and more effective treatment," said Lixiao Wang, chairman and CEO of GIE Medical. "This designation will give U.S. gastrointestinal physicians exciting new tools to fight GI stenosis."

 

GIE Medical’s ProTractX3 3-Stage TTS DCB is a balloon coated with the chemotherapeutic agent paclitaxel. It is an investigational device in the U.S.

Plymouth, MN, Dec. 13, 2022 (GLOBE NEWSWIRE) -- GIE Medical, a clinical stage company developing solutions for patients suffering from benign stricture(s) of the esophagus or bowel, has launched two large, multicenter randomized controlled clinical trials in the United States to investigate the company’s first of its kind multi-stage drug-coated balloon (DCB) technology, ProTractX3™ TTS DCB.

​

The first trial, PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture - Esophagus (PATENT-E), is a study to evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.  Patients will be randomized to receive the ProTractX3™ DCB or standard-of-care endoscopic dilation. The study will compare the number of patients with improvement of dysphagia symptoms without clinically driven repeat intervention between arms at 6-months post treatment, as well as compare the rate of treatment-related major adverse events through 30-days post treatment.

 

The second, PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture - Bowel (PATENT-B), is a study to evaluate the safety and efficacy of ProTractX3™ DCB for the treatment of benign bowel strictures. Patients will be randomized to receive the ProTractX3™ DCB or standard-of-care endoscopic dilation. The study will compare the rate of anatomic success between arms at 6-months post-treatment, as measured by the ability to pass a pediatric colonoscope through the treated area without significant resistance. The rate of treatment-related major adverse events will be compared between arms at 30-days post treatment. 

​

Several patients have already been treated in these trials, and active enrollment will continue throughout the U.S.

​

Professor Emeritus Dr. Kenneth Wang M.D. with The Mayo Clinic Rochester said of the technology, “We are hopeful that this will represent a new method of providing relief for these patients who have been dealing with chronic difficulty swallowing.”

​

GIE Medical Chief Operating Officer, Peter Barnett said, “This technology could truly impact patient care and quality of life, and our initial use cases mark the first time this groundbreaking technology has been used in the United States.”

​

GIE Medical’s ProTractX3™ 3-Stage TTS DCB is a balloon coated with the chemotherapeutic agent paclitaxel. It is an investigational device in the U.S. 

​

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.

A balloon coated with the anticancer agent paclitaxel appears to hold significant promise for the treatment of patients with complicated esophageal stents.

​

One year after dilatation with the experimental therapy, from GIE Medical, eight of nine patients with benign strictures have yet to experience a recurrence, researchers have found. Although the data are preliminary, experts said the findings, reported at the 2021 Digestive Disease Week (abstract 818), could herald a major advance in the management of esophageal narrowing.

​

READ MORE