The move positions the glaucoma company for domestic and international growth
MIAMI, Oct. 28, 2015 /PRNewswire/ — InnFocus, Inc. reports that Randy Lindholm has been named Executive Chairman of the Board of Directors. The Company is developing the InnFocus MicroShunt® GLAUCOMA DRAINAGE SYSTEM to treat all stages of primary open angle glaucoma.
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"Randy Lindholm's strategic expertise and extensive track record, combined with CEO Russ Trenary's demonstrated ability as a senior ophthalmology executive for over 30 years, provide a potent combination that we believe will drive increased value for our company," said Scott Halsted, InnFocus Board member and major investor.
Mr. Lindholm was appointed InnFocus Board Chairman earlier this year, and has now moved into the Executive Chairman's role, following the close of the company's recent $32.8 million Series C financing. He has served as Chairman, Executive Chairman, or Director with numerous privately held medical device companies including BARRx Medical (acquired by Covidien), Crux Biomedical (acquired by Volcano/Philips Medical), Microvention (acquired by Terumo), Estech (acquired by Atricure), Novasys Medical (acquired by Roper), RITA Medical (acquired by Angiodynamics) and Tibion Bionic Technologies (acquired by Alter G). He also currently serves on the Board of Directors of publicly traded Omnicell.
"I am convinced that InnFocus is poised to become the clear leader in treating all stages of primary open angle glaucoma, from early to late stage. Our promising clinical results abroad, the outstanding safety profile of our lead product, and our unique SIBS material open up many options for the Company," said Lindholm.
The Company is about to enter the final phase of U.S. FDA clinical trials for the InnFocus MicroShunt® system to prove it is a safe, effective, and easy-to-perform alternative for the surgical treatment of glaucoma. Completion of the Phase I FDA study included over 100 cases performed in the US.
Two hundred and forty patients have now been treated with the InnFocus MicroShunt® device in the U.S., Canada, France, Japan, the Netherlands, Spain, Switzerland, and the Dominican Republic, with up to 5 years of postoperative follow-up. Patients outside the United States have experienced a mean reduction in Intraocular Pressure (IOP) from approximately 24 mm Hg on full medication, to below 15 mm Hg with the majority of patients completely off glaucoma medication 3 years after their surgery. These results include patients treated on a stand-alone basis as well as in conjunction with a cataract procedure. Pressures below 15 mm Hg are well-known to reduce a major risk factor for optic nerve damage and subsequent vision loss, which can occur when IOP is too high.
The InnFocus MicroShunt® device is made from SIBS, an innovative highly biocompatible material that has been implanted in the body for over 15 years. The device is designed to shunt aqueous humor without the need to cut scleral tissue, control suture tension, or utilize patch grafts.
The InnFocus MicroShunt® system was developed in collaboration with the University of Miami's Miller School of Medicine, Bascom Palmer Eye Institute. It is distinctly different than the numerous MIGS approaches in that it provides a quick minimally invasive procedure for shunting aqueous humor from the anterior chamber to the same "gold standard" drainage path that has been used in trabeculectomy for approximately 50 years.
CAUTION: INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.
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