MIAMI, Feb. 4, 2014 /PRNewswire/ -- InnFocus, Inc., today announced that it will participate in the Glaucoma 360 New Horizons Forum on Friday, February 7(th), 2014 at The Palace Hotel, in San Francisco. The event is presented by the Glaucoma Research Foundation and brings together key clinical, industry, financial and regulatory leaders, in a unique exchange on research innovation and advances in glaucoma treatment.
The InnFocus lead product, called the InnFocus MicroShunt(TM), has demonstrated several years of excellent performance in minimally-invasive glaucoma surgery outside of the United States, and has initiated Phase I trials via IDE clearance by the Food and Drug Administration at 10 centers in the U.S.
InnFocus CEO Russ Trenary, a senior executive in ophthalmology for over 25 years, will update Forum participants on the progress the Company has made in studies outside the U.S., and will also serve as an industry expert on a panel discussing device reimbursement.
"In our studies outside the U.S., we have seen sustained IOP reductions of 50% from baseline, with the vast majority of patients maintaining IOP below 14 mmHg for well over 2 years. We believe this represents ground breaking results, especially since this level of reduced IOP is believed to be required to stop the progression of glaucoma," said Trenary; "the mechanism of action for subconjunctival drainage we rely upon for our device has been the accepted gold standard for decades, and when combined with our unique shunt design and material, the results appear to be compelling. We are looking forward to updating clinical, industry and regulatory leaders about our work and, what we believe, are very exciting future prospects."
InnFocus has been refining its MicroShunt over the past 6 years in clinical trials in France and the Dominican Republic. This effort is aimed at producing results that could dramatically improve the lives of glaucoma patients around the world by producing a device that provides intraocular pressures that are sufficiently low to stop the progression of vision loss. Its current generation product and technique, now in its third-year of testing, is demonstrating an excellent success rate of achieving sustained IOP reductions of over 50%. Over 80% of the eyes that have received the MicroShunt have IOPs less than 14 mmHg, and this level of reduced IOP is believed to be required to stop the progression of glaucoma. There have been no long-term adverse events, and approximately 90% of the patients are completely off glaucoma medication.
InnFocus recently raised over $15 million in a Series B Financing and is concentrating on completing the Phase I FDA trials, as well as continuing its clinical research outside of the United States.
"Our goal is simple," said Trenary. "We plan to establish the InnFocus MicroShunt as the breakthrough technology and approach for surgical treatment of glaucoma."
The Glaucoma 360 Conference is a unique full day meeting that unites medicine, research and industry with one mission--to find a cure for glaucoma. Globally, glaucoma is a leading cause of preventable blindness. Glaucoma 360 was founded by Adrienne Graves, PhD, and Andrew Iwach, MD, both of whom serve on the Glaucoma Research Foundation Board of Directors.
About Glaucoma Research Foundation
Founded in 1978 and headquartered in San Francisco, Glaucoma Research Foundation is America's oldest and most experienced nonprofit dedicated solely to its mission: to prevent vision loss from glaucoma by investing in innovative research, education and support with the ultimate goal of finding a cure. Glaucoma Research Foundation has invested more than $40 million to advance essential research and education programs. More information is available at www.glaucoma.org/about.
About InnFocus MicroShunt(TM)
The InnFocus MicroShunt(TM) (formerly known as the "MIDI Arrow") is a glaucoma drainage implant consisting of a micro-tube about twice the size of an eyelash. It is made from a proprietary biomaterial that demonstrates insignificant inflammation or encapsulation in the eye. It is implanted with the inflow end in the anterior chamber at the angle, and the outflow end under the conjunctiva and Tenon's capsule. The mechanism of action for subconjunctival drainage for the MicroShunt(TM) has been the accepted gold standard for several decades. The product has been implanted alone or in combination with cataract surgery in clinical trials outside of the U.S. in patients ranging from early to late stage glaucoma.
Caution: Investigational device. Limited by Federal Law to Investigational Use.
About InnFocus, Inc.
InnFocus, Inc. is a privately-held company headquartered in Miami, Florida. The Company's scientists and engineers are global leaders in the development of highly biocompatible biomaterials and medical devices. The InnFocus MicroShunt(TM) is the first of what the Company expects to be many medical devices that incorporate these materials in the eye. The InnFocus MicroShunt(TM) was developed in collaboration with the University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute, which has been ranked the number one eye hospital in the U.S. for the 10(th) year in a row by U.S. News & World Report.
SOURCE InnFocus, Inc.