Opthalmic products developer Freedom Meditech Inc. of San Diego plans to use a recently secured $2 million line of credit from Silicon Valley Bank to ramp up manufacturing and distribution of its ClearPath DS-120 Lens Fluorescence Biomicroscope.
The ClearPath DS-120, which is currently under regulatory review in the U.S. and European Union, is designed to evaluate the crystalline lens of the human eye in order to detect chronic disease such as diabetes.
“SVB’s due diligence on our ClearPath DS-120 showed a strong mix of proven technology, market opportunity and just how far we have come in reducing manufacturing, regulatory and marketing risk for the product,” said Craig Misrach, chairman and CEO of Freedom Meditech. “The financing provided by SVB is a springboard to launch this new and exciting product in the global health care marketplace.”
Terms of the credit facility include an initial disbursement with additional funds available upon attaining certain milestones. The transaction comes as the company waits for its Series B financing round to close.
Freedom Meditech said in a statement that it plans to launch the ClearPath in international markets with an initial focus on countries that accept the CE Mark and CSA Certification Mark. The CE Mark is required to sell in the 27 countries that comprise the European Union and is a gateway to other nonregulated markets. CSA certification is required to sell in Canada and is an entrée to certain Latin American markets. The product is also under FDA 510(k) review.
The ClearPath DS-120 incorporates the use of proprietary biophotonic spectroscopy to detect autofluorescence of the crystalline lens of the eye. The ClearPath non-invasively scans blue light into the lens of the eye in less than six seconds and produces a result immediately at the point of care. The company says the test is painless, requires no special preparation such as fasting, and produces no bio-hazardous waste or disposal cost.