Series C Funding To Be Used To Pursue Final FDA Approval
InnFocus, Inc. reports the conclusion of a $32.8 million Series C financing. The Company is developing the InnFocus MicroShunt® glaucoma drainage system to treat all stages of primary open angle glaucoma. The financing includes previous investors Hoya Corporation and Saints Capital Everest, and new investors Santen Pharmaceutical Co., Ltd, and Crown Venture Fund.
The Company is about to enter the final phase of 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.
“The money raised will help the Company complete the Final Phase of our FDA trial,” said Russ Trenary, InnFocus President and CEO. “We are also very pleased that two of our Series C investors are large ophthalmic companies, which we believe is another validation of the potential of our technology.”
The InnFocus MicroShunt® FDA clinical trial is the only prospective randomized study that compares a device to the trabeculectomy procedure, which has been the “gold standard” for treating glaucoma for approximately 50 years. Patients with mild, moderate, and severe glaucoma are included in the study.
Completion of Phase I included over 100 cases performed in the US. Additionally, over 200 patients have now been treated with the InnFocus MicroShunt® device in Canada, France, Japan, the Netherlands, Spain, Switzerland, and the Dominican Republic.
The Company has reported prospective results on mild, moderate, and severe patients treated outside the U.S. with up to three years of follow up. Patients have experienced a mean reduction in Intraocular Pressure (IOP) from approximately 25 mm Hg on full medication to below 15 mm Hg, with the majority of patients completely off glaucoma medication 3 years after their surgery. 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® was developed in collaboration with the University of Miami’s Miller School of Medicine, Bascom Palmer Eye Institute. It provides a quick minimally invasive procedure for shunting aqueous humor from the anterior chamber to the same “gold standard” drainage path used in trabeculectomy for approximately 50 years. The device is made from SIBS, an innovative highly biocompatible material that has been implanted in the body for over 15 years. It was designed to shunt aqueous humor without the need to cut scleral tissue, control suture tension, or utilize patch grafts. It has been implanted alone or in combination with cataract surgery in prospective studies outside the US.
CAUTION: INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.
SOURCE InnFocus, Inc.
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