Bagel Labs Applies for Clinical Trial of Sarcopenia DTx 'DEX-2'... "Expanding Muscle Management Platform"

Bagel Labs, a company specializing in digital therapeutics, announced on September 2 that it has applied to the Ministry of Food and Drug Safety for approval to conduct a clinical trial of 'DEX-2', its digital therapeutic device for sarcopenia.

Bagel Labs has developed a research prototype and conducted preliminary studies targeting sarcopenia as an indication. With this application, the company is now entering the formal clinical stage to verify the safety and efficacy of the device in actual patients. Once approved by the Ministry of Food and Drug Safety, the clinical trial will proceed, and the resulting data will serve as a basis for future product approval.

DEX-2 is a digital rehabilitation platform that uses artificial intelligence (AI) video recognition technology to analyze users' joint movements and exercise posture in real-time. It enables users to track exercise repetitions and the accuracy of their posture and provides feedback using only a smartphone camera, without the need for additional sensors or fitness equipment. The exercise difficulty level can be adjusted according to each user's physical ability and performance level, allowing for personalized rehabilitation exercises at home.

Bagel Labs developed the research prototype of DEX-2 with support from the Bio-Industry Technology Development Program of the Ministry of Trade, Industry and Energy. Subsequently, the company collaborated on preliminary research with Professor Kim Kwangil from the Division of Geriatrics and Professors Lim Jaeyoung and Beom Jaewon from the Department of Rehabilitation Medicine at Seoul National University Bundang Hospital.

In the preliminary research, the group that received exercise intervention with DEX-2 showed improvement trends in key indicators of sarcopenia such as the Short Physical Performance Battery (SPPB), gait speed, and phase angle in bioelectrical impedance analysis (BIA), which evaluates qualitative changes in muscle status and body composition. Bagel Labs incorporated the detailed exercise intervention protocol and clinical evaluation indices into the current clinical trial protocol based on these research results.

Bagel Labs is also developing digital therapeutic devices for obesity in parallel with its work on sarcopenia. The obesity digital combination drug 'DEX-1-OB', currently being co-developed with Hanmi Pharmaceutical, aims to integrate drug therapy using Hanmi Pharmaceutical's GLP-1 class obesity drug 'Efeglenatide' with lifestyle management such as dietary habits and exercise through a digital therapeutic device, establishing a unified treatment system.

A pilot study is underway comparing the combination of GLP-1-based obesity drugs and digital therapeutics to drug-only therapy. The study not only analyzes the amount of weight lost, but also examines how much muscle mass is preserved and whether physical function is maintained during the weight loss process. The goal is to develop a digital intervention strategy that can address muscle loss that may occur during obesity treatment.

Suhong Park, CEO of Bagel Labs, stated, "This application signifies that DEX-2 has completed preliminary research and has entered the formal clinical validation phase for product approval. Through the clinical trial, we will objectively confirm improvements in physical function and muscle quality and demonstrate the competitiveness of our product."

He added, "Although sarcopenia and obesity are different diseases, both share the common goal of muscle preservation and physical function improvement. We will link the technology and research outcomes accumulated from DEX-2 and DEX-1-OB to expand our digital therapeutic platform from weight loss to comprehensive muscle management, broadening the scope of its application."

This content was produced with the assistance of AI translation services.