[Featured Stock] Vuno, Entering the US Market as the 'Second Lunit'... FDA Approvals Expected One After Another

Vuno is showing strong performance. An analysis by securities firms suggesting that three products are likely to receive FDA approval in the U.S. by the end of next year appears to be influencing the stock price. The fact that Lunit surpassed a market capitalization of 2 trillion won, increasing interest in medical AI, was also cited as a factor attracting investor attention. Daishin Securities analyzed that, considering Vuno's relatively small market capitalization due to its primarily domestic sales, concretizing entry into the U.S. market is an important investment point.

At 10:04 a.m. on the 29th, Vuno was trading at 46,300 won, up 14.6% from the previous day.

Researcher Han Song-hyeop of Daishin Securities explained, "Opinions are divided on whether medical AI will end as a mere hype or bring disruptive innovation to the healthcare industry," adding, "There is a consensus that, since medical AI is still in its early stages, the growth potential of pioneering companies is significant."

He continued, "Vuno's strengths lie in high earnings visibility and providing solutions across various fields," and added, "VunoMed DeepCAS adopts a subscription (SaaS) model that adds fixed revenue each time it is installed, leading to explosive growth."

Researcher Han emphasized, "We have completed the installation of DeepCAS in 40 domestic hospitals, which was the target set at the beginning of the year," and "In the third quarter of this year, DeepCAS is scheduled to be installed in five large hospitals."

He predicted, "The company expects to reach the breakeven point by the third quarter of next year," and added, "The breakeven point could be reached earlier."

Researcher Han analyzed, "Currently, the company holds 15 billion won in cash equivalents and can secure an additional approximately 10 billion won," and stated, "There are no separate fundraising plans at present." However, he noted, "The company remains open to fundraising with a 'justifiable' purpose, such as entering the U.S. market," and explained, "It is noteworthy that there is a high possibility of having three products approved by the FDA by the end of next year."

He further expected, "DeepBrain (November 2023), DeepCAS (fall 2024), and LCT (end of 2024) are anticipated to receive FDA approval," and said, "Sales activities in the U.S. will be conducted through partnerships." Additionally, he explained, "Considering the relatively low market capitalization due to primarily domestic sales, concretizing entry into the U.S. market is an important investment point." He also said, "With the currently low foreign ownership ratio, additional stock price increases are expected due to foreign investor inflows through full-scale overseas IR activities."

Vuno expects FDA approval for DeepBrain, a brain MRI-based quantification solution, in November this year. A similar product called NeuroQuant has already been approved and used in the U.S., so there is a high possibility of quickly obtaining FDA approval through equivalence evaluation. The company expects DeepBrain to be a product that promotes 'Vuno' in the U.S. market. DeepCAS, which is expected to be a major revenue source in the U.S., is anticipated to receive FDA approval in the fall of next year. In June, it was designated as a Breakthrough Device (BDD) by the FDA, and a dedicated team was formed. The approval timing is expected to be earlier than the previously anticipated first half of 2025.