Recens Medical's OcuCool Receives FDA De Novo Approval for Rapid Ophthalmic Anesthesia
核心洞察
Recens Medical (搜索)'s OcuCool (搜索), an ophthalmic cooling anesthesia device, has received FDA De Novo approval, marking a first for domestic medical device corporations.
OcuCool (搜索) rapidly anesthetizes the eye through contact, lowering the temperature to -15 degrees Celsius in 10 seconds, reducing procedure times for treatments like IVT.
Clinical trials in the U.S. demonstrated OcuCool (搜索)'s safety, effectiveness, and patient preference over traditional chemical anesthesia due to faster onset and recovery.
Recens Medical (搜索), founded by Professor Kim Geon-ho of UNIST, has achieved a significant milestone with its OcuCool (搜索) device, securing De Novo approval from the U.S. Food and Drug Administration (FDA) at the end of September. This marks the first time a domestic medical device corporation has received this type of approval, which is reserved for novel technologies lacking existing precedents.
OcuCool: Rapid Cooling Anesthesia
OcuCool (搜索) employs a thermoelectric device to rapidly cool the eye for anesthesia. This technology was developed over a decade, originating from Professor Kim's research at the University of Michigan starting in 2014. The device is designed to provide rapid anesthesia simply through contact with the eye, offering a needle-free alternative to traditional methods.
Addressing Discomfort in Ocular Procedures
Prior to OcuCool (搜索), intravitreal injection (IVT) procedures for ocular diseases like macular degeneration (搜索) and diabetic retinopathy (搜索) involved topical or injected anesthetics, requiring 5-10 minutes for effect and causing patient discomfort due to prolonged exposure to disinfectants. OcuCool addresses these issues by instantaneously cooling the eye to -15 degrees Celsius, allowing for precise anesthetic application in just 10 seconds. This reduces procedure time from 10-15 minutes to just 1-2 minutes, minimizing chemical exposure.
Clinical Trial Success and Patient Preference
Clinical trials conducted at 10 ophthalmology hospitals in the U.S. from 2018 to 2022 demonstrated OcuCool (搜索)'s safety and effectiveness. Dr. Charles Wykoff, a specialist at Houston Retina Consultants Hospital, noted that cooling anesthesia activates through physical cooling, resulting in a much quicker onset compared to chemical anesthesia. Patients in the clinical trials preferred cooling anesthesia due to reduced waiting times and faster recovery.
De Novo Approval Significance
Professor Kim emphasized the difficulty of obtaining De Novo approval, stating that it requires proving the new technology and finding new uses. He noted that only about 10 such approvals are granted per year in the U.S.
Future Plans for Recens Medical
Recens Medical (搜索) is planning to establish 2025 as its first year of growth, focusing on expanding OcuCool (搜索)'s presence in the U.S. market. The company is also planning an initial public offering (IPO) in South Korea next year. Recens Medical has secured a cumulative investment of 70 billion won and is considering production plans to support its growth.
Expanding Cooling Technology Applications
In addition to OcuCool (搜索), Recens Medical (搜索) has generated revenue with TargetCool, a precision cooling device for dermatology. Professor Kim is also researching the application of rapid cooling technology to drug delivery medical devices, aiming to develop a transdermal drug delivery system (TDDS) that uses cryogenic refrigerants to accelerate drug delivery.