FREEDOM MEDITECH
CEO: Craig Misrach.
Revenue: Pre-revenue.
No. of local employees: Three full-time employees, plus 42 active consultants. Two full-time employees and 20 active consultants are local.
Investors: 40 unnamed investors.
Headquarters: Corporate offices in San Diego with supporting engineering, ancillary research and development activities in Cleveland, Ohio.
Year founded: 2006.
Company description: Medical device developer.
Key factors for success: Regulatory clearance and being well-capitalized.
Freedom Meditech is taking some of the blood work out of diagnosing diabetes by developing a noninvasive method of detecting the chronic disease through an eye scan.
The San Diego-based company has spent the past several years working on the technology behind the ClearPath DS-120 Lens Fluorescence Biomicroscope, a tool designed to evaluate the crystalline lens of the human eye to detect chronic disease.
Freedom Meditech CEO Craig Misrach said studies have shown that autofluorescence may be an indicator of diabetes, and the company’s device allows for the detection of autofluorescence within the crystalline lens. Misrach said the tool measures advanced glycosolated end products, which form on average seven years prior to the typical symptoms of diabetes. Not only is the six-second eye scan quick and avoids a blood draw, it also enables the earlier detection of diabetes.
“People typically get blood draws today when the symptom has arisen, so diabetes is checked too late in the disease progression,” Misrach said. “Eighty percent of diabetes complications can be avoided with early detection. That’s what we’re aiming to do.”
Early Detection Is Important
Misrach said early detection can be important because diabetes is asymptomatic — people often don’t realize they have the disease until there are complications such as cardiovascular disease, eye disease, kidney disease or an amputation.
“It’s many times detected with a complication and that’s when it’s too late,” he said. “So we’ve introduced a tool and mechanism that can facilitate the early detection of diabetes to avoid complications.”
The technology behind measuring fluorescence attributed to advanced glycosolated end products, or AGEs, is based on sugar in the blood flowing in and out of the eye every five minutes. As diabetes progresses, sugar starts binding to proteins in the body, and the ClearPath measures that binding.
Freedom Meditech plans to have the ClearPath utilized in standard eye exams. During a comprehensive eye exam a screening for eye disease is performed with the likes of glaucoma or complications of diabetes. If the individual being tested possesses risk factors for diabetes a clinician would suggest that the ClearPath be deployed and then determine if further evaluation is needed.
Dr. Dan Einhorn, a diabetes and endocrinology specialist at Scripps/XIMED Medical Center in La Jolla, conducted initial studies with the ClearPath on more than 100 patients in late 2010 and again more recently on an additional 50 patients. The goal was to determine whether diabetes could be detected and to measure the length of time the individual had diabetes.
Einhorn said it appears as if the ClearPath technology identified people more often than the standard glucose tolerance test or the HbA1c, which measures how much sugar adheres to red blood cells that live several months in the blood stream enabling the measurement of average blood sugar levels over that time.
Better Diagnosis Than a Blood Sugar Test
“It makes sense because what’s being detected by the ClearPath is always there — what’s being detected are the AGEs,” Einhorn said. “Once they form they stay there and accumulate over the years. As you accumulate a higher number of these you get a sense of how diabetic or prediabetic someone is. With the blood sugar tests you can be thrown off if a person has accidentally eaten or is sick or has something going on that affects the immediate measurement.
“There is logic behind AGEs being able to make a better diagnosis than a blood sugar test,” he added. “Since AGEs form over years, you can get a better handle on the duration of illness than you could do with a single blood sugar test.”
Einhorn said further studies would help to show whether he could use this technology to monitor the progress of his patients with diabetes, but the immediate opportunity is to see whether diabetes and prediabetes can be detected in the nearly 90 million Americans who are at risk.
“There’s an extraordinary need that doctors are not in a position to meet,” he said. “There’s just too many people. Being able to have a broader net in the eye doctor setting really brings in a whole swath of people who could easily be missed otherwise.”
Misrach said there are only 40 million physical exams performed a year but more than 90 million eye exams. He added that the prevalence of diagnosis is in the age range of 35 to 60, and that’s about when people get presbyopia, a diminished ability to focus on near objects.
“You’re in that sweet spot of people you want to be targeting,” said Misrach, who foresees this as having a $3 billion global market potential through the sale of the ClearPath and associated service contracts, including sales support, customer service, maintenance, and warranties. Freedom Meditech plans to provide that level of service to customers both in-house and through third-party distributors and manufacturer representatives.
Waiting for FDA Clearance
For now, Freedom Meditech is waiting for 510(k) clearance, which was filed with the FDA in September of last year. Misrach said the company continues to work with the FDA regarding its potential market clearance and is hopeful of achieving that clearance sometime this year. Although Freedom Meditech has identified a manufacturing partner in Southern California, there is no formal agreement as yet. Manufacturing could begin upon achieving CE Mark Clearance in Europe, which is anticipated this year.
Further behind in development than the ClearPath is Freedom Meditech’s I-SugarX Glucose Monitoring for Diabetes. The device measures glucose levels, replacing the need to prick a finger multiple times a day.
That technology is based on detecting real-time glucose concentrations in the aqueous humour in the eye, located between the cornea and lens of the eye. The technology platform, polarimetry, looks at the rotation of light caused specifically by glucose. If the rotation of light can be calculated, then the concentration of glucose can be measured.
Not currently FDA approved, Freedom Meditech’s website says the patented prototype for the I-SugarX has been validated in animal studies, with accurate and repeatable data obtained and published in the Journal of Diabetes Science and Technology and Diabetes Technology and Therapeutics. Misrach estimates its market potential at $13 billion globally.