A small Columbus, Ohio, company is hoping to develop a blood glucose monitor for diabetics who are sick of pricking their skin to check their sugar levels.
DIRAmed LLC is one of several companies looking to cash in on what’s certain to be an exploding market for products and services that help people better treat and manage diabetes. In 2030, there are expected to be 366 million diabetics worldwide — more than double the amount in 2000, according to the World Health Organization.
For DIRAmed, opportunity lies in its noninvasive blood glucose monitor, which the company says will greatly increase diabetics’ adherence to tracking their blood sugar.
“We don’t want to draw blood, and we don’t want to break the skin,” said CEO Will Shain, summarizing the company’s vision.
DIRAmed’s technology is based on Raman spectroscopy, which measures the scattering of light to help in molecular analysis. The device works by aiming a laser at a patient’s skin, and then using a camera to collect and analyze light scattered by the molecules in the skin to get a tissue glucose measurement.
The company has received one patent protecting its technology and expects to receive another.
DIRAmed isn’t new, having been founded in 2002, but its CEO is. Shain, a former executive with STERIS Corp. and Covidien PLC, began working with the company in May as a consultant and came on board as full-time CEO last month. DIRAmed has raised about $3 million over its lifetime, primarily from angel investors.
Near the top of Shain’s priority list will be raising $2 million in investment capital. The three-employee company would use the cash to analyze data from an ongoing clinical study, add a few workers and finish designing a prototype of its device for use in hospitals.
“Our device is not ready for prime time,” Shain said. “It’s in an industrial box.”
DIRAmed is off to a good start in fundraising, having pulled in about $300,000 so far this year, according to a regulatory document.
The company’s plan is to develop “table-top” version of the device for use in hospitals, then focus on a smaller device for home use. An early version of the device is being tested in trials at Indiana University – Purdue University Indianapolis. The trial is intended to show that DIRAmed’s technology works across a broad range of glucose values.
To obtain regulatory approval from the Food and Drug Administration, DIRAmed will have to go the more onerous, lengthy route of Premarket Approval, because there’s no predicate device that would enable DIRAmed to obtain 510(k) clearance, Shain said.
Thus, it’ll likely be three or four years before DIRAmed brings a product to market, Shain said. And the company will face no shortage of competitors, in part because the race to develop a noninvasive blood glucose meter stretches back more than a decade.
Cygnus Inc. received approval in 2002 for a wristwatch-like, noninvasive meter called the GlucoWatch G2 Biographer but pulled it from the market several years later, due to poor performance. Nonetheless, that hasn’t stopped several startups — including LighTouch Medical, MIT Spectroscopy Laboratory and Freedom Meditech — from vying to become the next company to commercialize a noninvasive glucose meter.
With a global market that DIRAmed estimates at $9.6 billion and growing, it’s not hard to understand why.