Artificial intelligence (AI)-based skin regeneration corporations ROKIT Healthcare is keeping up a steep rally.
On the 26th on the KOSDAQ market, the closing price rose 10.87% from the previous day to 75,500 won. During trading, it climbed to 76,400 won, setting a new 52-week high. Its market capitalization topped 1 trillion won.
Over the past month, the share price jumped from the 35,000-won range to the 75,000-won range, more than doubling.
ROKIT Healthcare was founded in 2012 by chief executive Yu Seok-hwan, formerly president of Celltrion Healthcare. In May this year, it listed via a technology exception, pricing its IPO at 11,000 won and recording a first-day market cap of 142.6 billion won.
The corporations's skin regeneration platform is implemented with ▲ lesion auto-modeling software ▲ a 3D bioprinter ▲ a production kit for patient tissue-based bioink (a biomaterial mixing cells and scaffold), among others. The principle is to first make a "new house to fill the empty space" of the damaged area with a 3D printer, then fill that house with the patient's own cells so the wound can grow and heal on its own.
It is drawing attention in particular for application to treatment of diabetic foot ulcers (diabetic foot). Last month, a U.S. tertiary hospital also received public insurance reimbursement. It was classified with a CPT code (the standard code used by U.S. hospitals and medical staff to bill insurers for medical services). Health authorities in countries in the Middle East, Europe, and elsewhere are likely to assess the economic and clinical utility of AI regenerative treatment based on the U.S. CPT code case.
So far, the corporations has completed sales contracts for its technology platforms with 46 countries excluding Korea, and aims to increase the number of commercialization countries to 72 by 2027.
◇ China patent → platform launch → clinical approval… market "focus" on successive positives
The direct catalyst for the stock surge is approval to begin domestic clinical trials for regenerative treatment of diabetic foot. ROKIT Healthcare's technology has been placed on the National Evidence based Healthcare Collaborating Agency (NECA)'s innovative medical technology track, entering preparations for new medical technology evaluation.
The technology approved this time is "wound treatment using autologous micro-fat tissue based on 3D bioprinting," a first in Korea. The corporations plans to conduct large-scale clinical trials and push for National Health Insurance listing as soon as possible.
On the 21st, it drew market interest by launching the tissue regeneration fibrin activation platform "AI-FRESH." This platform works by separating and activating specific components from a patient's blood, then using AI-based imaging and clinical data to find areas of pain and functional decline and administering fibrin activation injections (an injection therapy that promotes tissue remodeling to aid wound healing and pain relief).
Initial application areas are diabetic foot, partial rotator cuff tear, and chronic pain. When used together with the existing skin regeneration platform, it is expected to shorten pre- and postoperative recovery time, leading industry watchers to say, "By building an ecosystem that includes recovery and pain management, the mid- to long-term momentum has been strengthened."
On the 17th, news of the Chinese patent registration for its bioprinting technology sent its market cap past the 1 trillion won level. According to the International Diabetes Federation (IDF), China is the world's largest diabetic foot market, with about 147.98 million people with diabetes.
A company official said, "We have laid the groundwork in China to push not only diabetic foot regeneration patches but also a variety of organ regeneration platform businesses."
ROKIT Healthcare's skin regeneration platform is currently used not only for diabetic foot but also for burns and skin cancer treatment. The corporations is seeking to expand further into cartilage, kidney, and heart treatments. For cartilage, clinical trials began in Korea, the United States, and South America in September. For kidneys, preclinical studies are underway in Korea, and for the heart, on the 13th it announced plans to commence domestic preclinical studies.
Kang Si-on, a researcher at Korea Investment & Securities, said, "The cartilage regeneration kit is expected to have a unit sales price several times higher than diabetic foot," adding, "Upon commercialization, it is expected to drive top-line growth and margin improvement."
◇ As the share price races ahead, "core business strength" is a task… eyes on U.S. private insurance market entry
Although major events have clustered in a short period and the share price has risen quickly, ROKIT Healthcare is still posting operating losses.
However, the scale of the deficit is shrinking. It recorded -13.9 billion won in 2022, -7.4 billion won in 2023, and -5.6 billion won in 2024.
Some cautiously mention the possibility of turning a profit for the full year. That is because it has resolved capital impairment (a state in which net worth is negative), long cited as a factor discounting corporate value, and sales are steadily rising.
ROKIT Healthcare's consolidated total equity turned positive to 8.4 billion won in the first half of this year from -77.5 billion won at the end of the first quarter. Sales were 9.2 billion won in 2022, 12.4 billion won in 2023, and 13.1 billion won in 2024. On a cumulative basis for the third quarter this year, sales were 16.7 billion won and operating loss was 147.44 million won.
The corporations expects annual sales of 23 billion won this year. Next year, it will aim for 40 billion won in sales. It projected platform business sales at 9.68 billion won, more than double last year. The main sales channels for the platform business are bioprinter and kit sales. Related sales expanded from 2.187 billion won in 2023 to 4.508 billion won last year.
However, variables remain, as the situation could change depending on the regulatory environment, reimbursement rates (the level of treatment costs recognized by health insurance), and clinical trial results.
A ROKIT Healthcare official said, "We expect good results in the domestic clinical trials for regenerative treatment of diabetic foot," adding, "We are also actively preparing to enter the U.S. private insurance market."