Vial will be supporting RecensMedical with the phase 3 clinical trial for its Ocu-Cool system.
Vial announced today it has partnered with RecensMedical Inc. on the company’s Phase 3 trial of its Ocu-Cool system.
According to a news release, the Ocu-Cool system, developed by RecensMedical, includes a precision cooling medical device focused on delivering rapid cooling anesthesia for painless intravitreal injection therapy.
The release goes on to state that the Ocu-Cool device aims to be the first medical device from South Korea to receive De Novo clearance from the US FDA. De Novo clearance from the FDA describes market approval requests for new medical devices or technology where there is no comparable predicate device on the market.
Vial is a global tech-enabled Contract Research Organization that provides “next-generation” clinical trial management services. Wendy Pinson, Director of Clinical Operations at Vial, elaborated on Vial’s partnership with RecensMedical in the release.
“At Vial, it’s our mission to enable scientists to cure all human disease. To accomplish this, we must do our part in promoting innovation and enhancing trial outcomes for scientists around the globe,” she said. “We are excited to partner with Recens and work with their team to get COOL-3 approved for the market as the world’s first contact-type precision-cooled eye anesthesia device aimed at de novo,”
“The Vial team provided a thorough and informative pitch to help us run our Phase 3 trial. We are very excited to work with Vial and feel confident they will help us achieve the best results possible,” said RecensMedical CEO, Gun-Ho Kim in the release.
For more information on the Ocu-Cool device by RecensMedical, visit their website.