(Health Korea News / Yoo Ji-in) Resense Medical recently obtained de novo approval from the U.S. Food and Drug Administration (FDA) for its ophthalmic contact cooling anesthesia device, OcuCool. The company said that OccuCool is the first domestic medical device company to obtain FDA de novo approval.
FDA de novo is an FDA fast-track approval system applied to new medical devices without similar prior technology, and is a procedure to verify the safety and advantages of innovative new medical technologies.
According to the company, OccuCool was highly evaluated during the FDA de novo certification process as an alternative to existing chemical anesthesia that invades the eye. Until now, the procedure of injecting medication into the eye (IVT: Intravitreal Injection), which has been used to treat blindness diseases such as macular degeneration and diabetic retinopathy, takes about 5 to 10 minutes to take effect. Q-Cool utilizes precision cooling technology that safely blocks the transmission of nerve signals, providing an anesthetic effect in just 10 seconds upon contact with the treatment area. Through this, the overall procedure time can be shortened by about 10 times from the existing 10 to 15 minutes to 1 to 2 minutes, and side effects such as redness, stinging, and dryness can be minimized by minimizing exposure to chemical ingredients.
To verify the safety and effectiveness of OccuCool, phase 1, 2, and 3 approval clinical trials were conducted at 10 eye hospitals in the United States for 5 years from 2018 to 2022. Going beyond the safety and effectiveness of cooling anesthesia, It was found that 80% of patients participating in the clinical trial preferred Occu Cool’s cooling anesthesia compared to existing anesthetics.
Dr. Charles Wykoff, a specialist at Houston’s Retina Consultant of America who participated in the initial clinical trial, said, “Pharmacological anesthesia produces an anesthetic effect depending on the time when molecules chemically diffuse into nerve ion channels, whereas cooling “Anesthesia is activated by physical cooling, so the anesthetic effect develops much faster,” he said. “In the COOL-2 clinical trial, there was a great response from patients who participated in the clinical trial for various reasons, including reduced waiting time compared to existing procedures and faster recovery after injection. “I confirmed it myself,” he explained.
As the population ages and the prevalence of diabetes increases, the IVT market where OccuCool is used is expected to grow significantly. According to QY Research, the global IVT market size as of 2020 is about $13.7 billion (about KRW 18.4347 trillion), and will grow at an average annual rate of about 7% to reach about $22 billion (about KRW 29.6 trillion) by 2027. It is a prospect.
Geon-ho Kim, CEO of Resense Medical, said, “We are very happy and proud to have proven Resense Medical’s world-class rapid precision cooling technology through the FDA de novo approval of OccuCool.” He added, “Occool’s innovative technology provides faster and more comfortable procedures for patients with blindness. We hope this will help improve the hospital’s service quality. Furthermore, as a leading company leading innovative technologies, we will publicize the excellence of Korean medical devices and develop products that can contribute to patients and doctors in more fields.”
Meanwhile, Resense Medical was founded in 2016 as an innovative technology company that developed the world’s first rapid precision cooling medical device. Rapid precision cooling technology is a technology that precisely cools and controls cells to the desired temperature within a few seconds by applying thermoelectric technology that exchanges heat energy and electrical energy. In addition to OccuCool, Resense Medical has developed ‘TargetCool®’, a precision cooling device for dermatology, and is currently selling it in 29 countries.
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