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Funding to aid launch of dark adaptometer
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MacuLogix is developing an early-stage diagnostic tool for age-related macular degeneration.
AdaptDx, a dark adaptometer research tool, is not currently cleared for sale as a diagnostic tool by the U.S. Food and Drug Administration.
MacuLogix recently raised $3.6 million in Series A funding to accelerate manufacturing and commercial sales.
John G. Edwards, CEO of MacuLogix, said the funding will be used in the transfer of production and the product launch.
“The main thrust of our funding, at least half of it, is to complete engineering of the final commercial version,” Edwards said in an interview with Ocular Surgery News. “The other half of the funding is to support the product launch.”
Financial support
Before receiving the funding, the AdaptDx went through three generations of prototypes, and 18 devices were sold to early adopters for beta testing.
“The purpose of this financing is called ‘transfer to production’ or ‘transfer to manufacturing.’ This is where you take the developed product and then do one final re-engineering of it to realize the final production version, which is going to be sold commercially,” Edwards said.
The product launch of the AdaptDx as a research tool is scheduled to coincide with the Association for Research in Vision and Ophthalmology meeting in May.
“We’re very excited about the fact that after many years of work, this is finally the year that the product launch is going to happen and we’re going to go commercial,” Edwards said.
The financial support will not be used toward more clinical studies. AdaptDx has been used in 15 completed clinical studies with additional studies ongoing. Studies have been performed at various institutions, including the University of Alabama at Birmingham, the University of Michigan, Penn State College of Medicine and the National Eye Institute.
The funding comes from Berwind Private Equity, Roche Venture Fund, Life Sciences Greenhouse of Central Pennsylvania, and Ben Franklin Technology Partners of Central and Northern Pennsylvania. Ophthalmologists are not among the initial investors, but they show support in focus groups and feedback to the company, according to Edwards.
Product history
The dark adaptometer is based on technology developed by Gregory Jackson, MD, and Cynthia Owsley, MD, at the University of Alabama at Birmingham. MacuLogix has exclusive commercial rights to the developed product.
AdaptDx received FDA 510(k) clearance in February 2011 as a research tool. A second 510(k) clearance application was expected to be submitted in March 2013 for broader labeling claims that include using the AdaptDx as a diagnostic tool for AMD, Edwards said.
“[FDA approval is] very low on the list of worries that keep me up at night as a CEO,” Edwards said. “We’ve done so much clinical testing that this should be very straightforward.”
The product will be manufactured by a third-party contractor with distribution initially handled by a small group of direct salespeople to establish buy-in with the ophthalmology and optometry communities. The company will then convert to distribution partnerships for distribution and sales channels, Edwards said.
AdaptDx is currently used as a research tool for retinal health and by pharmaceutical companies in development of ocular drugs, according to the company website. – by Cheryl DiPietro