Vial Announces Enrollment of the First Patient in the Pivotal Clinical Trial for "OcuCool" Precision Cooling Medical Device, Sponsored by RecensMedical, Inc.

2023-07-19

临床研究

SAN FRANCISCO, July 19, 2023 /PRNewswire/ -- Vial, a leading global contract research organization (CRO) providing next-generation clinical trial management services, announced the enrollment of the first patient in the pivotal clinical trial, "COOL-3s", evaluating the OcuCool system, developed by RecensMedical, Inc. ("RecensMedical"), a distinguished medical device company based in South Korea. The OcuCool system encompasses a state-of-the-art precision cooling medical device designed to deliver rapid cooling anesthesia for painless intravitreal injection therapy.

"We are delighted to learn that Vial has successfully enrolled the first patient in the pivotal clinical trial of our OcuCool system. The collaboration with Vial brings us great confidence in the efficient and high-quality execution of this study," said RecensMedical CEO, Gun-Ho Kim. "Together, we aim to expedite the completion of the COOL-3s trial to provide retina specialists with a safe and efficient tool for administering intravitreal injections. We look forward to the outcomes of this study and its potential to transform the field."

The OcuCool system is a novel medical device that precisely and rapidly cools the eye's surface, achieving a temperature ranging from -5 to -15 degrees Celsius, similar to that of a cold ice cube. As a result, it provides non-invasive anesthesia without pharmacologic anesthetic in just 10 seconds and therefore has comparative advantages in safety profile and workflow efficiency compared to the current methods of ophthalmic anesthesia. This technology holds tremendous value in terms of enhanced patient comfort, as well as improved efficiency and workflow for retina specialists administering intravitreal injections.

Extensive safety studies involving animals, as well as pilot human trials, have been conducted using this device. Thus far, it has exhibited no significant adverse effects and has demonstrated anesthetic efficacy comparable to the current standard of care. The objective of this clinical study is to assess the long-term safety and efficacy of applying cooling anesthesia to the eye for intravitreal injection using this novel cooling anesthesia device.

"With the enrollment of the first patient in the COOL-3s trial, we are excited to advance the development of this innovative precision cooling device. This trial represents a significant milestone in our mission to enhance patient comfort and improve the delivery of intravitreal injection therapy," said Wendy Pinson, Director of Clinical Operations at Vial.

Leveraging Vial CRO's electronic data capture (EDC), an intuitive and highly responsive platform known for its consumer-grade experience and eClinical software performance, patient screening and enrollment for the COOL-3s trial is progressing seamlessly. Screening for the first patient was completed by the site team at Texas Retina Associates in Dallas, Texas, run by principal investigator, Dr. Timothy Fuller. Texas Retina Associates has a dedicated focus on the diagnosis, medical, and surgical management of diseases of the retina and vitreous and is one of the largest experienced ophthalmology practices in Texas.

About Vial: Vial is a next-generation CRO powered by technology that promises faster and more efficient trial execution for less cost. The Vial Contract Research Organization (CRO) delivers on the promise of more efficient trials through its innovative technology platform that powers trials end-to-end from site startup to database lock. Vial's technology platform combines modern, intuitive eSource, EDC, and ePRO into one connected system, streamlining site processes and enabling considerable efficiencies. Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO). Vial is a San Francisco, California-based company with over 100+ employees.

About RecensMedical, Inc.: RecensMedical is a pioneering medical device company based in South Korea. RecensMedical specializes in the development of cutting-edge cooling technologies for various medical applications. At the forefront of its portfolio is a revolutionary handheld precision cooling device designed to provide instant ocular anesthesia for intravitreal injections (IVT). This proprietary device is tailored to enhance physician workflow and optimize patient comfort, ensuring a seamless experience during the administration of IVT procedures. With a commitment to innovation and advancing medical practices, RecensMedical is dedicated to transforming the landscape of medicine through its breakthrough cooling technologies.

SOURCE Vial