FOR IMMEDIATE RELEASE
TeCure Inc. Receives FDA Breakthrough Device Designation for EndoCure™ System for Treatment of Duodenal Mucosal Resurfacing (DMR)
Washington D.C. — August 26, 2025 — TeCure Inc., a clinical-stage medical device company developing novel solutions for the treatment of metabolic disorders, today announced that its proprietary EndoCure™ System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Type 2 Diabetes through Duodenal Mucosal Resurfacing (DMR).
The FDA Breakthrough Device Program is designed to expedite the development and regulatory review of technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The designation recognizes the EndoCure System’s potential to significantly improve clinical outcomes for patients with Type 2 Diabetes, a condition affecting more than 35 million Americans.
“We are honored to receive Breakthrough Device Designation for our EndoCure System,” said Hyun Wook Kang, PhD, CEO of TeCure Inc. “This recognition by the FDA reinforces the clinical need for more innovative and less invasive approaches to treating Type 2 Diabetes. The EndoCure System is designed to safely and precisely resurface the duodenal lining — a target increasingly understood to play a central role in metabolic regulation. This milestone brings us one step closer to delivering a potentially game-changing solution to patients who are not well-controlled on existing therapies.”
The EndoCure System is a novel, catheter-based platform intended to endoscopically treat the duodenal mucosa to restore insulin sensitivity and improve glycemic control in patients with poorly managed Type 2 Diabetes. The technology is designed for minimally invasive access, controlled thermal ablation, and reproducible outcomes, distinguishing it from other metabolic intervention strategies currently under investigation.
With this designation, TeCure will benefit from enhanced FDA interaction and prioritized review, accelerating the pathway to first-in-human studies and potential commercialization.
For more information about TeCure Inc. and the EndoCure System, please visit [www.tecure.com].
About TeCure Inc.
TeCure Inc. is a medical technology company developing innovative, minimally invasive therapies for metabolic and chronic diseases. With a focus on precision endoscopic interventions, TeCure is committed to improving patient outcomes and redefining standards of care for complex conditions such as Type 2 Diabetes and Gastroesophageal Reflux Disease (GERD).
FOR IMMEDIATE RELEASE
TeCure Inc. Receives FDA Breakthrough Device Designation for EndoCure™ System for Treatment of Duodenal Mucosal Resurfacing (DMR)
Washington D.C. — August 26, 2025 — TeCure Inc., a clinical-stage medical device company developing novel solutions for the treatment of metabolic disorders, today announced that its proprietary EndoCure™ System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Type 2 Diabetes through Duodenal Mucosal Resurfacing (DMR).
The FDA Breakthrough Device Program is designed to expedite the development and regulatory review of technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The designation recognizes the EndoCure System’s potential to significantly improve clinical outcomes for patients with Type 2 Diabetes, a condition affecting more than 35 million Americans.
“We are honored to receive Breakthrough Device Designation for our EndoCure System,” said Hyun Wook Kang, PhD, CEO of TeCure Inc. “This recognition by the FDA reinforces the clinical need for more innovative and less invasive approaches to treating Type 2 Diabetes. The EndoCure System is designed to safely and precisely resurface the duodenal lining — a target increasingly understood to play a central role in metabolic regulation. This milestone brings us one step closer to delivering a potentially game-changing solution to patients who are not well-controlled on existing therapies.”
The EndoCure System is a novel, catheter-based platform intended to endoscopically treat the duodenal mucosa to restore insulin sensitivity and improve glycemic control in patients with poorly managed Type 2 Diabetes. The technology is designed for minimally invasive access, controlled thermal ablation, and reproducible outcomes, distinguishing it from other metabolic intervention strategies currently under investigation.
With this designation, TeCure will benefit from enhanced FDA interaction and prioritized review, accelerating the pathway to first-in-human studies and potential commercialization.
For more information about TeCure Inc. and the EndoCure System, please visit [www.tecure.com].
About TeCure Inc.
TeCure Inc. is a medical technology company developing innovative, minimally invasive therapies for metabolic and chronic diseases. With a focus on precision endoscopic interventions, TeCure is committed to improving patient outcomes and redefining standards of care for complex conditions such as Type 2 Diabetes and Gastroesophageal Reflux Disease (GERD).