TQURE 'EndoCure', FDA Breakthrough Device Designation

**T.Cure Achieves Major Milestone: 'EndoCure' Designated as a 'Breakthrough Device' by U.S. FDA! Paving the Way for Global Market Expansion** T.Cure, a domestic deep-tech medical company, has achieved a remarkable feat: its innovative medical device, 'EndoCure,' has been designated as a 'Breakthrough Device (Breakthrough Device Designation, BDD)' by the U.S. Food and Drug Administration (FDA), signaling a green light for its entry into the global market. T.Cure, which received initial investment from Busan Federation of Technology Holdings, has, through this designation, etched its unique technological prowess onto the world stage. 'EndoCure' is a non-invasive treatment solution that integrates endoscopy and laser technology to precisely irradiate specific areas inside the human body with lasers, thereby restoring metabolic functions. Particularly, it offers new hope to diabetic patients who struggle with blood sugar control using conventional drug therapies alone, as well as to individuals seeking healthy weight loss. The core of this device lies in its integration of 360-degree light delivery technology into endoscopic treatment. This enables precise treatment even within tubular organs, which were previously difficult to access with conventional laser devices. T.Cure emphasizes that 'EndoCure' is the first laser treatment device to receive FDA Breakthrough Device designation, thereby proving its innovativeness. Specifically, it works by safely removing lesioned areas of the duodenal mucosa to improve insulin resistance and induce metabolic function recovery. This holds the potential to offer a fundamental solution for patients suffering from chronic metabolic diseases. The FDA's 'Breakthrough Device Designation (BDD)' program is a special status granted to medical devices that have the potential to significantly improve clinical outcomes compared to existing treatments. Devices designated as BDD receive multifaceted benefits, including priority review and early consultation with the FDA, as well as discussions for health insurance coverage. This significantly shortens the product commercialization period, securing an advantageous position for market leadership. T.Cure's achievement was made possible by the proactive early investment from Busan Federation of Technology Holdings and approximately 1.5 billion KRW in R&D funding support through the Ministry of SMEs and Startups' Deep Tech TIPS program. Based on this strong support, T.Cure has solidly built the foundation for successful advancement into the global market, alongside its technological sophistication. Currently, riding on this momentum, T.Cure is accelerating its efforts to conduct clinical trials in the U.S., actively pursuing strategic partnership discussions with leading global medical device companies, and securing additional investment, all while dedicating its full efforts to business expansion. Kang Hyun-wook, CEO of T.Cure, stated, "The FDA Breakthrough Device designation for 'EndoCure' is a remarkable achievement that clearly demonstrates the world-class competitiveness of Korea's deep-tech medical technology." He further expressed his ambition, "Based on our unique 360-degree light delivery technology, we will continuously expand innovative laser treatment options applicable to a wide range of internal human diseases."