[Edaily Reporter KIM SAE-MI ] Lee Ye-ha VUNO, Inc.(338220), CEO of Vuno, is facing his biggest challenge 12 years after founding the company. This comes as Vuno, having shifted its business focus to “DeepCARS”—an AI-powered medical device that predicts cardiac arrest—is preparing to navigate the hurdles of domestic new medical technology evaluation and U.S. Food and Drug Administration (FDA) approval, and has decided to conduct a 31.4 billion won rights offering.

On the 28th of last month, VUNO, Inc. decided to issue 6.3 million common shares—equivalent to 44.99% of its existing issued shares—through a shareholder allocation followed by a public offering of unsubscribed shares. The total amount raised will be 31.4 billion won, of which 20 billion won will be used primarily to repay perpetual convertible bonds, while the remainder will be allocated to research and development, overseas regulatory approvals, and sales and marketing.

CEO Lee is an engineer who earned his bachelor’s and doctoral degrees in computer engineering from Pohang University of Science and Technology (POSTECH) and conducted AI research at the SamsungElectronics Advanced Technology Institute. He co-founded VUNO, Inc. with Kim Hyun-jun and Jeong Kyu-hwan in 2014 and served as CEO until 2020. He subsequently served as Chairman of the Board and oversaw the biosignal business before returning to the forefront of management as Chief Executive Officer (CEO) in 2022.

Since CEO Lee’s return, VUNO, Inc. has pursued a strategy of “selection and focus.” Rather than expanding into a wide range of products centered on diagnostic imaging, VUNO, Inc. concentrated its management resources on the biosignals business, including “DeepCARS,” an AI system for predicting cardiac arrest. In fact, after DeepCARS was designated as an “advanced medical technology” in 2022, its adoption by hospitals expanded. Conversely, non-core businesses such as LungCT and BonAge were successively divested. As a result, since CEO Lee’s return, VUNO, Inc. has effectively transformed from a “company with a diverse portfolio of medical AI products” into a “company whose financial performance is driven by DeepCARS.”

This has proven to be a double-edged sword. As the business was reorganized around DeepCas, revenue from prognosis and prediction solutions in the first half of this year rose to 10.4 billion won, accounting for 85.8% of total revenue of 12.2 billion won. In contrast, revenue from diagnostic solutions amounted to only 400 million won, or 3.3%. This reflects an increased dependence on DeepCas.

DeepCas’s evaluation deferral period ended last March, and the company is currently undergoing a new medical technology evaluation. The number of hospitals adopting the system has increased from 10 in 2022 to 154 in the first half of this year; however, if it fails to pass the evaluation, its use in clinical settings will be prohibited, and related revenue will cease. Warnings have also been issued that if DeepCAS sales are suspended—which would affect 85.8% of revenue in the first half of 2026—it would constitute a “major business suspension,” potentially subjecting the company to a substantive review of its eligibility for listing.

The company’s expansion into the U.S. market is also falling behind schedule. Although VUNO, Inc. received FDA Breakthrough Device designation for DeepCAS in 2023, it received a “Not Substantially Equivalent” (NSE) determination on April 30 during the 510(k) review, meaning the device was not recognized as substantially equivalent to existing approved products. The company is preparing to resubmit an application by the end of the year by redefining the intended use and appointing a regulatory consulting firm, but it remains uncertain whether approval will be granted or when it might occur.

Financial pressures also underlie the decision to conduct a rights offering. VUNO, Inc.’s cash flow from operating activities was negative (-) 15.6 billion won in 2023, -10.9 billion won in 2024, and -4.7 billion won in 2025, and it recorded -7.1 billion won in the first half of this year as well. The net loss for the first half expanded to 9.4 billion won. If the return to profitability is delayed and external fundraising becomes difficult in the future, the company is expected to face significant constraints in continuing its business operations.

The extent of CEO Lee’s participation in the rights offering is also a matter of interest. It is reported that CEO Lee plans to subscribe for approximately 7% of his allocated shares, taking into account his current financial circumstances. If CEO Lee were to subscribe for the full 969,199 new shares, he would need approximately 4.8 billion won based on the planned issue price of 4,980 won per share. Currently, CEO Lee and his related parties hold a 15.59% stake; if he subscribes for only about 7%, this stake is expected to drop to 11.09% after the rights offering.

Accordingly, during the shareholder meeting on the 4th, calls were made to increase CEO Lee’s subscription rate. It was reported that CEO Lee stated, “This participation rate has not been finalized,” and added, “I am considering various ways to participate responsibly.” This shareholder meeting focused on explaining to shareholders the background and process behind the decision to conduct the rights offering.

Ultimately, the success or failure of the “selection and concentration” strategy CEO Lee has pursued over the past few years hinges on Deepcas. The company must pass the domestic evaluation of new medical technologies to secure its revenue base and secure a breakthrough for entry into the U.S. market through a resubmission to the FDA. Even if the 31.4 billion won capital increase buys time, the need for additional fundraising may recur if the company fails to generate cash from its core business. Whether CEO Lee’s strategic gamble—divesting non-core businesses and betting on DeepCars—will pay off is expected to be determined in the fourth quarter of this year.

◇ Profile of Lee Ye-ha, CEO of VUNO, Inc.
△Born in 1978
△Graduated from the Department of Computer Engineering at Pohang University of Science and Technology (POSTECH) in 2005
△2012: Ph.D. in Computer Engineering, POSTECH Graduate School
△ 2012: Researcher at SamsungElectronics’ Advanced Technology Research Institute
△2014: Co-founded VUNO, Inc. and served as CEO
△2020: Chairman of the Board and Head of the Biosignal Group at VUNO, Inc.
△2022–present: Chief Executive Officer (CEO) and Chairman of the Board at VUNO, Inc.