The number of diabetes patients in South Korea aged 30 and older surpassed 6 million in 2020. The number of diabetes patients in the United States stands at 37.3 million. Diabetes is a disease in which the insulin hormone fails to function properly. It does not merely cause an increase in blood sugar but leads to serious complications. Feet may rot and even require amputation. This is known as diabetic foot ulcers, referred to as "diabetic foot." About 3 out of 10 diabetes patients (29%) suffer from diabetic foot complications.
ROKIT Healthcare, a domestic bio corporation, has proposed a new alternative for treating diabetic foot, considered one of the most serious complications of diabetes. This is skin regeneration therapy. Established in 2012, ROKIT Healthcare has developed medical regenerative patches and regenerative medical platform solutions by combining technology that models injured areas using artificial intelligence (AI), medical 3D bioprinting technology, and technologies that create regenerative kits and regenerative bio inks.
Yoo Seok-hwan, chairman of ROKIT Healthcare, noted during a meeting at the company's headquarters in Geumcheon-gu, Seoul, on the afternoon of the 3rd, that "ROKIT Healthcare's regenerative medical platform is an innovative medical solution that can complete all surgical processes within 30 minutes by merging AI and 3D bioprinter technology," adding that "the skin regeneration platform for treating diabetic foot ulcers has already been exported to 22 countries, and as of the end of last year, the number of treatments used on patients surpassed 5,350."
Regenerative medicine utilizes the body’s inherent regeneration capabilities to heal wounds. Fat layers are suctioned from areas such as the abdomen or thighs, and only substances that aid regeneration are filtered to create bio ink. The 3D printer then layers this bio ink to produce cell patches suitable for the injured area. When these patches are attached to the wound, living cells migrate to the injury site, regenerating it.
ROKIT Healthcare's flagship product, "Doctor In Vivo," uses the patient's cells as ink to print regenerative patches and organs for the wounds. When a doctor photographs the wound area with a tablet PC in the operating room, the AI immediately tailors the appropriate shape and outputs the regenerative patch using a 3D bioprinter. This is a regenerative treatment using custom patches made with AI and a 3D bioprinter.
The company has received approvals from major national regulatory agencies, including the Ministry of Food and Drug Safety, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA), successfully commercializing its products. Medical staff from institutions such as Massachusetts General Hospital at Harvard Medical School, Seoul National University Hospital, Asan Medical Center in Seoul, and Seoul St. Mary's Hospital are participating in clinical trials and utilizing the products in medical settings.
Yoo has been with the Daewoo Group from 1979 to 2000. Afterward, he served as the Asia-Pacific president at Tyco, an American security systems company, before entering the bio industry through connections with Seo Jung-jin, chairman of Celltrion Group, who also has a background in Daewoo. He served as president of Celltrion Healthcare from 2007 to 2012 before establishing ROKIT Healthcare. In the early days of the company, business focused on industrial 3D printers, and later expanded technology into the bio field.
Yoo stated, "I believed that the era of mass production systems in traditional manufacturing was coming to an end, and we needed to move toward customizing systems," adding, "I thought we should apply 3D printing technology to the high-value-added bio industry, which is why we developed our business around 3D bioprinting."
He said that ROKIT Healthcare's bio patches and regenerative medical platform could contribute to reducing medical expenses, much like the biosimilars launched by Celltrion. Yoo remarked that "the efficacy of the skin regeneration platform for treating diabetic foot ulcers reaches 90%" and stated that this could reduce the medical costs for diabetic foot patients to one-fourth. This means that medical expenses associated with diabetic foot amputation surgeries and post-operative care can be reduced through skin regeneration therapy.
ROKIT Healthcare's skin regeneration technology is used not only for diabetic foot but also for the treatment of burns and skin cancer. The company is further expanding into cartilage and kidney regeneration. Research on kidney regeneration has been proven effective through preclinical trials and has been selected as a national project. The company is collaborating with Seoul National University Medical School and Asan Medical Center. Yoo stated, "This year, we plan to focus on expanding global sales of the skin regeneration business in the areas of diabetic foot and skin cancer," adding, "We will also strive to achieve R&D results in cartilage and kidney regeneration."
The company is currently pursuing listing on the KOSDAQ. After initially attempting to go public in 2021, it faced setbacks due to receiving a BBB rating in a technical assessment. According to the company, the technology and products had already passed regulatory reviews and were being used in hospitals at the time, but a shortage of evidence papers, which were a key evaluation factor, held them back.
The company subsequently rectified this. It published 15 papers on preclinical and clinical trial results, and 43 papers using 3D bioprinter technology. Last January, it received an A rating from two evaluation agencies in a technical assessment, and in November, it passed the preliminary review for listing from the Korea Exchange (KRX).
ROKIT Healthcare plans to finalize its offering price through demand forecasts for institutional investors from the 14th to the 18th and conduct a public subscription from the 23rd to the 24th. SK Securities is the lead underwriter for the listing. The proposed offering price ranges from 11,000 won to 13,000 won, with the expected amount to be raised between 17.16 billion won and 20.28 billion won. The company stated that it would use the funds raised from this public offering for working capital such as raw material purchases and staffing, as well as for research and development (R&D) expenses and global marketing costs.
Recently, there have been concerns in the market about the company’s capital erosion. In fact, based on the report from the third quarter of last year, the company's capital was 4 billion won, while total assets were in a state of -74.7 billion won, indicating capital erosion. Yoo mentioned that "the current investment funds showing as liabilities on the balance sheet greatly affect this," stating, "The concern over capital erosion can be sufficiently resolved through capital conversion after the listing."
According to the company, ROKIT Healthcare's major investors number around 40, primarily consisting of institutional and overseas investors. Yoo explained that once the existing investors' shares are converted into capital and the public offering funds are received after the listing, the concerns will be alleviated.
Yoo remarked, "Through this listing, ROKIT Healthcare's AI-based ultra-personalized organ regeneration platform will reach an important turning point in expanding into the global market," adding, "We will contribute to improving the quality of life for patients with intractable diseases based on our innovative regenerative medical technology."