LensGen has received investigational device exemption (IDE) approval from the FDA to initiate a pivotal study of the company's Juvene IOL for patients with cataracts.

The LensGen Juvene IOL is designed to permanently restore clear and continuous vision at all distances including near and intermediate. The lens is modular and has a fluid optic component that changes shape to adjust focus on demand for today's active lifestyles, from viewing mobile devices and computer screens to high-quality distance vision in a broad range of lighting conditions. The lens is implanted using the same surgical techniques used with traditional IOLs.

"We are proud to achieve this significant milestone for the company, which allows us to move forward with the IDE pivotal trial with the ultimate goal of seeking premarket approval in the largest eye care market in the world," Ramgopal Rao, LensGen Chief Executive Officer, said in a company news release. "Achieving IDE approval of a novel device is a tremendous undertaking and enormous accomplishment for the company, and we are grateful to the FDA for their rigorous and insightful guidance throughout the process."

"Based on the Grail Study clinical data and my direct experience with surgery and observations of the patients implanted with Juvene IOL, LensGen technology has the potential to provide a significant new and superior option to our patients," said Eric Donnenfeld, MD, Clinical Professor in the Department of Ophthalmology at the New York University Grossman School of Medicine and Founding Partner of Ophthalmic Consultants of Long Island.

LensGen is currently in the processing of raising a Series B Financing expected to close in the first half of 2022.