VUNO shares surge after FDA innovative medical device designation

Shares of VUNO shot up by around 11 percent on Thursday morning after the company announced that its AI-based cardiac arrest prediction medical device, VUNO Med-DeepCARS, has been designated as an innovative medical device by the U.S. FDA, the first in the Korean medical AI industry.

As of 11:11 a.m. Thursday on the tech-heavy Kosdaq, VUNO shares traded at 26,400 won, up 11 percent from the previous day. 

With the innovative medical device designation, VUNO will accelerate its preparations to enter the U.S. market, it said.

The FDA's Breakthrough Devices Program is designed to help innovative medical technologies that provide effective treatment or diagnosis of life-threatening diseases reach the market more quickly. 

Particularly, VUNO Med-DeepCARS was recognized for its ability to provide a breakthrough diagnostic technology over existing critical illness monitoring tools for life-threatening in-hospital cardiac arrest inpatients.

Accordingly, the device will receive priority review in the FDA approval process alongside close support from the FDA, including flexible clinical study designs and access to specialized review teams.

VUNO Med-DeepCARS analyzes blood pressure, pulse, respiration, and temperature which are registered in electronic medical records (EMR) to provide a score for a patient's risk of cardiac arrest.

This enables proactive response by physicians in general wards where it is difficult to constantly monitor all hospitalized patients. A confirmatory clinical trial study demonstrated its efficacy without any restrictions on patient age, gender, or medical specialty.

VUNO is conducting clinical studies with medical institutions in the U.S. to launch the device in the U.S.

Last month, it completed the registration of a U.S. patent for the product's core technology.

"As the number of hospitals adopting the product in Korea continues to grow and prove its marketability, we will strive to increase overseas sales by actively promoting pre-marketing in preparation for rapid FDA approval," said VUNO CEO Lee Ye-ha.