"The scientific team at InnFocus is very impressive, and I believe that the sustained IOP reductions with the vast majority of pressures being below 14 mmHg represent ground breaking results," said Trenary. "These pressures in the low teens differentiate the InnFocus MicroShunt from the other glaucoma devices currently in clinical trials (known as the "MIGS" devices) that tend to achieve more modest IOP reductions. We are eager to complete the Phase I FDA trials, and continue work outside of the United States to establish the InnFocus MicroShunt as the premier offering in the minimally-invasive glaucoma arena."
"We are at the perfect juncture in our company's history to bring in an accomplished, experienced veteran like Russ Trenary," said company founder Len Pinchuk, "His demonstrated leadership in developing and launching ophthalmic devices and his broad network of relationships with leading eye surgeons are a perfect blend. We look forward to having him guide us through the FDA and overseas clinical processes."
InnFocus has been testing several generations of its glaucoma shunt in France and the Dominican Republic for over six years. Its current generation product, now in its third-year of testing in the Dominican Republic, is demonstrating an excellent success rate of achieving sustained IOP reductions of over 50% with final pressures residing in the 10 to 12 mmHg range. Over 90% of the eyes that have received the MicroShunt have IOPs less than 14 mmHg with no long-term adverse events and with approximately 90% of the patients completely off of glaucoma medication. This level of reduced IOP is believed to be required to stop the progression of glaucoma.
|SOURCE InnFocus, Inc.|
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