providing patients with rapid, effective anesthesia during ocular injections
Intravitreal Injection Therapy (IVT – giving a shot of medicine into the eye) has transformed the treatment landscape of a number of previously blinding diseases, resulting in a dramatic increase in the number of ocular injections given every year. But the primary limitations of IVT are patient discomfort, ocular surface bleeding, and the time constraints of treating the high volume of patients requiring anesthesia prior to injection therapy.
The University of Michigan has developed the Cryo-Anesthesia Device is a handheld instrument that utilizes thermoelectric cooling to provide rapid, precisely controlled cooling to the eye’s surface, which helps greatly reduce the discomfort associated with ocular injections. It is designed to improve patient comfort, reduce side effects, and increase physician efficiency during IVT delivery.
In contrast to current anesthesia methods that are time consuming with uncomfortable side effects, the Cryo-Anesthesia Device provides rapid anesthesia, improves patient comfort and physician efficiency, and significantly reduces the overall IVT time.
The Cryo-Anesthesia device uses thermo-electric cooling to provide rapid, precisely controlled cooling to the eye’s surface and provide adequate anesthesia in 30-45 seconds.
- Intellectual Property – Patent application filed in November 2015. Non-provisional patent filed in March 2016.
- Commercialization Strategy – Form start-up company, continue to actively explore applications for this technology in other areas.
- Regulatory Pathway – Completing pre-FDA submission packet, anticipating the device will go through the de novo classification process. Also exploring the possibility of bringing the device to market outside the United States.
- Engage Investors – Seek venture and SBIR funding, received interest from outside investment community.
- Completion of device optimization and manufacturability assessment
- Delivery of 3 finalized devices for use in clinical and preclinical studies
- IRB approval and conduct 2 clinical trials with 40 patients in each trial
- Finish GLP toxicity data that can be presented to the FDA as part of the regulatory approval process
- Work to form start-up company
- Q316 Update: CryoEye (startup)