Many early-stage medical device start-ups seek acquisition to secure the financial and operational resources they need to obtain regulatory approval and secure market access.

Michael Gertner, MD, founder and CEO of Olympic Ophthalmics, took the more difficult path: he developed and began commercialization of iTEAR®100 himself.

His non-invasive neurostimulation device treats all types of dry eye disease, and he wanted to make certain it got into the hands of as many patients as possible — not ignored by a large acquiring eye care company.

To do so, Dr. Gertner assembled a small but mighty team of investors and in 2017 launched Olympic Ophthalmics. iTEAR 100 received FDA clearance under the De Novo path in May 2000. It’s based on technology similar to what’s been used successfully in cardiology, orthopedics, pain management and other therapeutic areas: electrical pulses stimulate the external nasal nerve, which prompts tear production.

Dr. Gertner and team are currently running a post-market study in patients with previously undiagnosed dry eye, using iTEAR 100 as a first-line treatment. The second generation of the device, which he says will be submitted to the FDA “shortly,” connects to a smartphone app, which allows for easier prescription management.

Listen to the podcast today to hear Dr. Gertner and host Paul Karpecki, OD, FAAO, talk in depth about iTEAR 100, its path to clearance, and why he shifted his career from general surgeon to eye care innovator.

Ground they cover includes:

• The hurdles Olympic Ophthalmics faced when obtaining market access, including a 30-day prescription restriction and COVID-19-related supply chain issues.
• Dr. Gertner’s career trajectory, which took him from medicine to medical devices (he is the first inventor on over 200 patents).
• How Allergan’s TruTear device, which it discontinued in 2020, influenced his work.
• His advice for other entrepreneurs on funding and moving through the regulatory process.