February 05, 2015
Cognoptix CEO Paul Hartung Says Company is Preparing for a Pivotal Phase 3 Clinical Trial of SAPPHIRE Eye Scan Being Developed to Aid in the Early Detection of Alzheimer's Disease
"Our vision is to change the course of Alzheimer's disease."
ACTON, Mass. -- Cognoptix Chairman, CEO and President Paul Hartung disclosed last evening to a group of medtech industry executives and neurodegenerative disease specialists that his Company is focused on changing the course of Alzheimer's disease by enabling earlydiagnosis with an eye test at the point of care, and that "We are preparing for a pivotal Phase 3 clinical study."
Mr. Hartung made his remarks as moderator from the podium at an Alzheimer's Disease-focused forum hosted by Medical Development Group. Other AD experts who presented included James Wessler, President and CEO, Massachusetts and New Hampshire Chapter, Alzheimer's Association; and Anil K. Nair, MD, Director, Alzheimer's Disease Center, Quincy, Mass.
"Every 67 seconds, another American develops AD," said Mr. Wessler. "It is time that we step up to address the impact of this disease."
"The need of the hour is for a test that will not only improve the specificity of diagnosis but also be less expensive than PET brain imaging," said Dr. Nair.
Mr. Hartung explained that, by detecting a specific fluorescent signature of ligand-marked A-beta in the supranucleus region of the human lens, the Cognoptix SAPPHIRE II eye test achieved a sensitivity of 85% and a specificity of 95% in differentiating 20 patients who were clinically diagnosed with probable AD from a group of 20 age-matched healthy volunteers in a Phase II clinical trial. In addition, the SAPPHIRE II test showed superior correlation to PET (positron emission tomography) amyloid brain imaging, with 95% specificity for SAPPHIRE II versus 80% for PET brain imaging.
"We fully expect 2015 to bring us further significant progress toward commercialization of our non-invasive diagnostic eye test for AD, designed to allow treatment to start before significant neuronal loss and irreversible brain damage occur," Mr. Hartung concluded.
Cognoptix, a privately held medical technology company headquartered in Acton, Mass., is focused on developing and commercializing an in-office, drug/device diagnostic system—SAPPHIRE II—as an aid in the early detection of Alzheimer's Disease (AD). Investors are Alopexx Enterprises, Inventages Venture Capital and Launchpad Venture Group.
NOTE: The SAPPHIRE II system is approved for investigational use only in the United States.
# # #