RecensMedical Inc., a UNIST-based startup company, has raised 7 billion KRW of investment whereby the success of its international market penetration was ensured. Those who contributed include LB Investment Corp., KB Securities Co. Ltd., BNK Securities Co. Ltd., Hyundai Venture Investment Corp., and Lighthouse Combined Investment Corp.
Founded in 2016 by Professor Gun-Ho Kim (School of Mechanical, Aerospace and Nuclear Engineering) at UNIST, RecensMedical Inc. is a faculty-affiliated startup company, engaged in developing the next generation of medical devices for the dermatological and ophthalmological markets. The company boasts a proprietary technology for its rapid cooling anesthesia for not only the painless intravitreal injection therapy and the standard care for rapidly growing retinal diseases, but also painless laser therapies and needle injections in dermatology.
The company has announced that it has successfully completed the Phase I clinical trial of its rapid cooling anesthesia technology in the United States, and a follow-up Phase II trial is currently underway. To date, two major ophthalmic specialty hospitals in the U.S. have performed 250 and over surgical procedures on 100 patients, which assured the effectiveness and satefy of this method. Besides, there are about 10 other U.S. hospitals for ophthalmology that have expressed their intention to participate in Phase III clinical trials and to purchase the device.
Through the De Novo classification by the FDA, their rapid cooling anesthesia device is expected to receive first ever FDA approval for a cooling anesthesia device within a year. The term De Novo is Latin expression used in English to literally mean “of new”. The De Novo classification process is intended to provide an efficient pathway to ensure the most appropriate classification of a device consistent with the protection of the public health and the statutory scheme for device regulation. It allows a company to fast-track approval of a device by claiming it “substantially equivalent” to a device that has already been approved and marketed. Therefore, it is extremely rare for a local medical device to obtain this classification.
“In a survey of patient satisfaction, more than 90% were completely satisfied, and there also have been calls for the continuing use of our cooling anesthesia system by the patients who partook in clinical trials within the past 8 months,” says Professor Kim. “With the realization of 10-second anesthesia, the overall procedure time has been reduced by more than five times and there has also been a positive and enthusiastic response.”
RecensMedical Inc. has begun a business on medical dermatology products, in parallel with its ophthalmology device targeting the U.S. market. The company, which has GMP-certified manufacturing facilities at UNIST, has recently acquired both the medicinal products and medical devices manufacturing licenses for precision cooling system for dermatology from the Ministry of Food and Drug Safety.
Likewise, RecensMedical Inc. has successfully developed its business in various medical fields both at home and abroad. Thus, by being exempted from military service, the company has recently hired two technical research personnel. Together with medical experts and UNIST’s outstanding faculty and students, Professor Kim hopes to blaze a trail in the field of medicine with its novel precision cooling technique.
Meanwhile, RecensMedical Inc. is the first venture company in Ulsan, supported by TIPS (Accelerator Investment-Driven Tech Incubator Program for Startups) of the Ministry of SMEs and Startups (MSS). In less than 6 months, it has once again been selected as the first U-TECH Valley company, making a new history of venture startups in Ulsan. The company won commendation by the President of Korea Health Industry Development Institute (KHIDI) at the 2019 Health Industry Performance Announcement and Exchange Meeting on October 31, 2019. On the same day, it also won the league championship at the ‘2019 IP Startup Road Day,’ hosted by the Korean Intellectual Property Office (KIPO).