I founded the company in October 2016, and I started researching ophthalmic rapid cooling technology earlier, in 2014, during my time at the University of Michigan. We received U.S. Food and Drug Administration (FDA) approval at the end of September this year, so it took a full 10 years.

Professor Kim Geon-ho of Ulsan National Institute of Science and Technology (UNIST) founded Recens Medical, which received the FDA's De Novo approval for its ophthalmic cooling anesthesia device, OcuCool, at the end of September, becoming the first among domestic medical device corporations to do so. The De Novo is an FDA approval system applied to new medical technologies that lack similar precedents. While domestic medical device corporations typically obtain a 510(k) approval through a relatively simple verification process compared to similar technologies, the De Novo applies to unprecedented technologies, requiring much more complex animal testing and clinical trials.

Kim Geon-ho, CEO of Recens Medical and a professor at Ulsan National Institute of Science and Technology, obtains the de novo approval from the U.S. Food and Drug Administration (FDA) for the ophthalmic rapid anesthetic device OcuCool at the end of September. This is the first time that a domestic medical device corporation receives de novo approval./Courtesy of Recens Medical

Kim noted, "To gain De Novo approval, we have to prove the new technology and also find new uses, which is much more difficult. Overall, about 10 approvals per year are granted, so it's not easy even in the U.S."

Interestingly, Kim's major is in mechanical engineering. Given that it is a medical device corporation, one might easily think that the founder's field of study should be medicine or biology, but Kim specialized in mechanical engineering. How did a mechanical engineering professor manage to overcome the FDA's hurdles with an ophthalmic cooling anesthesia medical device?

Kim met with Chosun Biz at the Recens Medical office in Hwaseong, Gyeonggi Province, on the 12th, and said, "Mechanical engineering is the field that deals with heat. Moving heat elsewhere is essentially cooling technology, and I saw it as entirely possible to use the cooling function of thermoelectric devices to rapidly cool the eye, leading to the development of this technology." Thermoelectric devices change temperature when electricity flows through them and, conversely, produce electricity when subjected to a temperature change.

The OcuCool developed by Kim over a decade is a technology that rapidly anesthetizes simply by coming into contact with the eye. When performing intravitreal injection (IVT) procedures for treating ocular diseases such as macular degeneration and diabetic retinopathy, anesthetics were previously applied or injected. It took about 5 to 10 minutes to feel the actual effect of the anesthesia after receiving the injection, and patients felt discomfort from prolonged exposure to disinfectants like Betadine for antibacterial purposes.

The OcuCool from Recens Medical provides cooling anesthesia by instantaneously lowering the temperature to minus 15 degrees Celsius just through contact with the eye, rather than using anesthetics. It allows for precise anesthetic application to the treatment area, taking just 10 seconds. This significantly reduces procedure time from the usual 10 to 15 minutes down to 1 to 2 minutes, thereby minimizing exposure to chemicals.

The ophthalmic rapid anesthetic device OcuCool developed by Recens Medical employs a technology that rapidly cools and anesthetizes the eye simply by contact, unlike the previously used intravitreal injection (IVT)./Courtesy of Recens Medical

Kim said, "I was asked by a local clinical physician in the U.S. if I could replace IVT procedure anesthesia with cooling anesthesia, and I believed it to be entirely feasible given my extensive research in the cooling field," adding, "We conducted clinical trials at 10 ophthalmology hospitals in the U.S. from 2018 to 2022 to obtain FDA approval and received positive evaluations in terms of safety, effectiveness, and patient satisfaction."

Dr. Charles Wykoff, a specialist at the Houston Retina Consultants Hospital who participated in the OcuCool clinical trials, explained, "Chemical anesthesia requires time to diffuse through the nerves, while cooling anesthesia is activated through physical cooling, which results in a much quicker onset of anesthesia." He noted that, for various reasons, such as reduced waiting times and faster recovery, patients participating in the clinical trials preferred cooling anesthesia.

In addition to OcuCool, Recens Medical has already generated revenue with a precision cooling device for dermatology called TargetCool. Like OcuCool, TargetCool is a medical device that rapidly cools the treatment area, reducing pain during dermatological procedures using botulinum toxin or fillers to smooth wrinkles and fill in gaps.

Kim is also researching ways to apply rapid cooling technology to drug delivery medical devices. He noted, "The transdermal drug delivery system (TDDS) market is very large, but there is currently no technology that uses cryogenic refrigerants to deliver drugs," explaining, "Using cryogenic refrigerants makes it possible to accelerate drug delivery like a bullet."

Recens Medical is planning to establish 2025 as its first year of growth. It aims to actively open avenues in the U.S. market for OcuCool, which has received FDA approval, while also planning an initial public offering in South Korea next year. Recens Medical has already secured a cumulative investment of 70 billion won. Kim stated, "We have 60 employees in South Korea and 5 in our U.S. branch," adding, "We are currently considering how to establish production plans."