San Diego-based Freedom Meditech, Inc., a privately-held medical device company focused on commercialization of ophthalmic technologies for the detection of disease and management of patient health, last week announced it had secured a $2MM line of credit from Silicon Valley Bank.
The company said funds will be used to ramp up manufacturing and distribution of its ClearPath DS-120 Lens Fluorescence Biomicroscope – a device measuring glucose in the eye and therefore serving as an alternative glucose monitor. ClearPath is currently under regulatory review in the U.S. and European Union.
Terms include an initial disbursement, with additional funds available based on the attainment of certain milestones. The transaction is in anticipation of a Series B financing close by the company, according to the release.
ClearPath DS-120 incorporates the use of proprietary biophotonic spectroscopy to detect autofluorescence of the crystalline lens of the eye. A study published in the March 2011 issue of Journal of Diabetes Science and Technology confirmed that Freedom Meditech technology accurately monitors glucose non-invasively in the eye with light. The study involved directly measuring glucose non-invasively using optical polarimetry. Peer-reviewed published research has shown that glucose in the aqueous of the eye correlates to that of glucose in the blood, according to the company.
The company plans to launch ClearPath in international markets, initially via the CE Mark and CSA Certification Marks. Additionally, in October 2011 the company filed a Premarket Notification 510k application with the FDA.
Freedom Meditech is also in the final stages of development with an in-office diabetes screening system that employs similar technology to identify individuals who may have undiagnosed diabetes or pre-diabetes.
Nearly 800,000 people in the US alone are diagnosed with diabetes each year. The total number of people with diabetes worldwide is projected to rise from 171 million in 2000 to 366 million in 2030, based on a large increase in urban populations in developing countries, and the increase in average lifespan, according to a 2004 study conducted out of the University of Edinburgh. The glucose monitoring market is more than a $10 billion worldwide, and the potential of Freedom Meditech’s in-office screening system at over $1 billion worldwide.