Freedom Meditech – 2013 Fierce 15

Freedom Meditech COO Keith Ignotz

Based: San Diego, CA
Founded: 2006
CEO: Craig Misrach

The Scoop: According to World Health Organization (WHO) estimates, there are 220 million people worldwide with diabetes, a number WHO expects to double by 2030. Tapping into this huge and growing market is a parade of med tech outfits with a wide range of devices, including advanced glucose monitors that ensure patients are on top of their treatment regimen. Freedom Meditech is one of those tech companies poised to revolutionize how diabetics keep tabs on and treat the disease--the company's completely noninvasive detection lens is designed to monitor glucose via an eye scan as opposed to current "finger prick" methods.

What Makes It Fierce: Freedom Meditech prides itself on addressing one of the greatest needs in diabetes care: detecting it in the first place and making sure patients know what kind of care they need moving forward. And from a business standpoint, Freedom is wholly committed to its lead devices, the ClearPath DS-120 and the I-SugarX, trusting in its own expertise to provide any future partners with a product worth selling, according to Keith Ignotz, Freedom's president and chief of operations.

ClearPath DS-120--Courtesy of Freedom Meditech

ClearPath is a remarkably simple diagnostic device cleared by the FDA this year after a series of stellar trial results. The biomicroscope is a noninvasive ophthalmic instrument designed to detect autofluorescence of the crystalline lens in the eye. The device shines a blue light on the patient's eye, and after only 8 seconds it can detect early indications of diabetes. Moving the detection process into the optometry realm, this is a few steps beyond the more invasive current standards of care out there today.

"There are an estimated 86 million people with undetected diabetes rattling around in our health care system," Ignotz said. "We have optometrists that see the bulk of patients for eye exams--we see the eye care provider as an excellent candidate to monitor and detect diabetes."

The tech has been put to the test in over 11 clinical trials and 3,000 subjects, Ignotz said.

Bolstering its marketing of ClearPath and hoping to get its ocular glucose monitor I-SugarX to FDA approval, the company pulled in $7 million in August, bringing its total haul to date to $10 million. Although Freedom declined to disclose its individual investors, Ignotz said they were "life science investors in major-name funds familiar with our story."

And the need for such a device is certainly there, offering a sizable chunk of an already sizable market: "There is a substantial opportunity for a noninvasive diabetes screening device to be able to detect diabetic and pre-diabetic conditions well in advance of the onset of complications," the company claims on its website. "With approximately 50% of the world's diabetic population undiagnosed, and significantly more people with potentially reversible pre-diabetic conditions, there is an immediate, unmet need for a convenient, cost-effective and regularly administrable diabetes screening solution."

"We are addressing a very large diabetical need," Ignotz said. "This is shockingly and unexpectedly simple technology that allows us to rethink the market."

What To Look For: Resting in Freedom's pipeline is its I-SugarX, which is designed to offer a personal, point-of-care and noninvasive alternative to the "finger prick" method. The rapid test is used by holding a small handheld device in front of the eye--no biohazards and no pain. It is in the final stages of in vivo efficacy studies and, if approved, would be the first noninvasive ophthalmic-based diabetes detection or glucose monitoring device available for sale in the U.S.

For more:
Freedom Meditech lands $7M for diabetes device

-- Michael Gibney (email | Twitter)

Freedom Meditech – 2013 Fierce 15