[Edaily Reporter YU JIN-HEE ] DONGWOON ANATECH CO.,LTD.(094170)has begun full-scale clinical trials to secure product approval for “D-Salife®,” the world’s first saliva-based, non-blood glucose meter. The company plans to accelerate its efforts to secure a leading position in the global non-invasive blood glucose monitoring market by conducting precise clinical trials in accordance with the Ministry of Food and Drug Safety’s new product classification system.

DONGWOON ANATECH CO.,LTD. announced on the 31st that it had submitted an application to the Ministry of Food and Drug Safety (MFDS) for approval of its Investigational New Drug (IND) application for regulatory approval.

The official title of this clinical trial is “A Multicenter, Non-Randomized, Prospective Clinical Performance Study to Evaluate the Clinical Safety and Efficacy of a Personal Salivary Glucose Measurement System (D-Salife® DSLS-201) That Measures Blood Glucose Using Saliva.” The company plans to conduct the clinical trial in two phases in accordance with the MFDS’s classification guidelines for digital medical devices.

The clinical trial will be conducted simultaneously at three major general hospitals, including Asan Medical Center in Seoul and Seoul St. Mary’s Hospital. It will involve a total of 160 to 200 participants, and the company plans to swiftly complete patient enrollment and data collection within one month of the trial’s commencement.

Notably, this clinical trial incorporates a significantly enhanced artificial intelligence (AI) algorithm. The company expects the device to demonstrate substantially improved measurement performance and precision compared to the data from the research trial conducted at Asan Medical Center in Seoul over a two-month period starting last October.

A DONGWOON ANATECH CO.,LTD. official explained, “The results of this clinical trial will serve as highly reliable scientific evidence during the Ministry of Food and Drug Safety’s (MFDS) approval review process,” adding, “This is highly significant as it marks the world’s first initiation of the formal approval process for a saliva-based, non-blood, non-invasive blood glucose meter.” The official continued, “Following approval of the plan by the Ministry of Food and Drug Safety, we will swiftly complete the review by each hospital’s Institutional Review Board (IRB) and then begin recruiting participants.”

The validation process within the global academic community is also proceeding without a hitch. A paper on the Disalife pilot clinical study, jointly conducted by researchers from the University of California, Los Angeles (UCLA) and Seoul National University, will be presented at the “1st International Symposium of the Asian Salivary Gland Research Society (ASGRS)” to be held at Yonsei University on September 3. The findings of this study will be officially presented by Dr. David Wong of UCLA, a world-renowned authority in the field, who will serve as the keynote speaker.