By a News Reporter-Staff News Editor at Clinical Trials Week -- Russ Trenary has been named President and Chief Executive Officer of Miami-based InnFocus, Inc., a privately held medical device company with biomaterials expertise that has developed a patented micro-shunt for treating glaucoma. The Company's main product, called the InnFocus MicroShunt™, has demonstrated several years of excellent performance in minimally-invasive glaucoma surgery outside of the United States. Company founder Leonard Pinchuk, Ph.D. will remain with InnFocus to develop its product pipeline (see also InnFocus, Inc.).
The device is cleared by the U.S Food and Drug Administration to begin Phase I clinical trials. The Company has raised $13.4 million thus far in a Series B financing led by the Hoya Group. Hoya is a world leader in ophthalmology and its investment in InnFocus is believed to be the first by any ophthalmology company in next generation, minimally-invasive glaucoma devices. The Company is in the process of finishing the Series B offering to raise an additional $3 million. The funds will be used to complete the Phase I clinical trials, expand clinical studies in Europe where the device is CE Mark Approved, and to invest in the Company's anticipated growth.
Trenary has spent over 30 years with ophthalmic medical device companies, including Allergan Inc. and Advanced Medical Optics. His achievements include some of the most successful ophthalmic device launches to date.
"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.
Keywords for this news article include: Therapy, InnFocus Inc., Government Agencies, Offices and Entities, Adverse Drug Reaction, Clinical Trials and Studies.
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