“Mr. Gibbs’s firm has upwards of 40 FDA-specialist lawyers. Also, Hyman, Phelps & McNamara works closely with other Washing-ton-area consultant firms in the FDA sphere. They can work together with us to help our medical devices achieve FDA approval.”
Indian Wells, CA (PRWEB) August 10, 2016
The Eye Machine, LLC (TEM) announced today the appointment of Jeffrey N. Gibbs as its new Director of Regulatory Affairs.
As a director with the Washington, D.C.-based firm Hyman, Phelps & McNamara, Mr. Gibbs has extensive experience in “FDA law,” working with the Food and Drug Administration in the areas of product approvals and enforcement actions. In recent years, his practice has focused primarily on advising companies developing medical devices, including TEM. Mr. Gibbs previously worked for the FDA as Associate General Counsel for Enforcement, where he received an Award of Merit. Earlier in his career, he was Special Assistant U.S. Attorney for the District of Columbia.
In 2015 and again this year, Mr. Gibbs was named among the “Top FDA Lawyers,” by the Washington Post. He has also twice been listed as among “The Best Lawyers in America.”
Mr. Gibbs replaces Morris Waxler as TEM’s Director of Regulatory Affairs. In the nearly two years Dr. Waxler was with the company, he was instrumental in helping guide TEM through the FDA regulatory application process, and preparing the company for future clinical trials of its medical devices. TEM’s Chief Operating Officer, Walter O’Rourke, praised Dr. Waxler for his contribution, but said a different approach was needed for the company to gain FDA approval to compete in the marketplace.
“To move the approval process forward, we need to partner with a firm that has more resources than a single consultant,” he said. “Mr. Gibbs’s firm has upwards of 40 FDA-specialist lawyers. Also, Hyman, Phelps & McNamara works closely with other Washing-ton-area consultant firms in the FDA sphere. They can work together with us to help our medical devices achieve FDA approval.”
Mr. Gibbs has already assumed his duties and together with his colleagues has begun the work of formulating a plan to that will help TEM realize its goal of market commercialization.
About The Eye Machine:
The Eye Machine, LLC was formed to develop, manufacture, and lease to medical professionals an electrotherapeutic medical device to treat visual disease, providing a pulsed micro-current output delivered to the retina by way of a closed eyelid. This treatment method can help mitigate the effects of age-related macular degeneration and diabetic retinopathy.
The Eye Machine’s pulsed micro-current therapy represents a new, non-invasive treatment for all forms of macular degeneration. The device output signal is structured to provide a range and pattern of frequencies to stimulate the desired physiologic response at the retinal level. This low current has been shown by studies to stimulate the production of the active transport enzyme, adenosine triphosphate (“ATP”), which facilitates the movement of nutrition from the blood to the cell.
According to recent studies, this treatment improves permeability of the blood vessel membranes and cells, allows better oxygen and nutrition delivery to the cells, metabolism, and removal of by-products from the cells. Through these mechanisms, pulsed micro-current therapy improves retinal pigment epithelium (“RPE”) efficiency and in so doing may restore and/or improve retinal function.
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