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Clinica's MedTech Ventures: Freedom Meditech

This article was originally published in Clinica

Executive Summary

Clinica’s MedTech Ventures: Freedom Meditech
Specialty area(s): Diabetes detection, monitoring
Based in: San Diego, California
Founded in: 2006
No. of employees: 11
Total investment received to date: $9.6m
Investors: JumpStart Ventures, angel investors

Diabetes is a growing scourge of the modern world: in the US there are currently around 25.8 million people with diabetes and another estimated 79 million with pre-diabetes. The World Health Organization estimates that 382 million people live with diabetes worldwide today, a number that will more than double by 2030.
Helping to drive this rise is the skyrocketing incidence of obesity, which increases the risk of type 2 diabetes: the most common form of the disease, making up 95% of cases.

However, detecting diabetes with current blood tests such as glycated haemoglobin (HbA1c) and fasting plasma glucose can be hit-and-miss. “All we have in blood testing is cut-points where panels of physicians have determined where a patient may or may not be diabetic in combination with certain risk factors,” explains Keith Ignotz, president and chief operating officer of Freedom Meditech, which has developed a revolutionary eye scanner, ClearPath DS-120, to help detect diabetes early on.

The noninvasive scan carried out on the system takes six seconds so can be done at the point-of-care, with patients receiving their results during the same doctor’s visit. It also has other advantages over conventional blood tests: there are no consumables or biohazard waste, and patients do not need to fast beforehand. And studies have shown that it is more accurate than these conventional tests (more on that later).

The ClearPath DS-120, which is similar in size to devices already used by optometrists, was cleared by the US FDA in January 2013. Freedom has also developed a device to monitor diabetes, called I-SugarX, which is not yet FDA approved.
After clearance of the ClearPath DS-120, Freedom spent the first half of 2013 scaling up manufacturing, before launching the system in the US in September. Since then it has been increasing its international presence, signing up distributors in Germany, Czech Republic, Turkey, Italy, Spain, Mexico, the Middle East, and some South American countries.

The scan works by detecting autofluorescence in the lens of the eye, a marker of elevated blood glucose levels over one’s lifespan. “Any change in glucose in the serum, the glucose presents concurrently in the aqueous of the eye,” Mr Ignotz explains.” The lens uniformly absorbs the glucose, and there’s a chemical process that leads to the formation of advanced glycated end products (AGEs), which fluoresce. It is this signal that is being picked up by the scan.

Normal ageing also results in increased AGEs – but the key is comparing a patient’s level against the normal population. “We have a database of the normal population from age 20-70, and we use that to benchmark patients at a specific age, let’s say 45, to see if they’re within the normal range, or elevated,” says the COO. Those with elevated levels can then be further investigated for diabetes.

So how does Freedom’s technology perform against conventional blood testing? A study published in the Journal of Diabetes Science and Technology in January found a specificity of 94% and sensitivity of 67% with ClearPath DS-120 scanning, versus 79% and 44%, respectively, with HbA1c testing, and 95% and 50%, respectively, with fasting plasma glucose measurement. The lower the sensitivity, the greater the risk of diabetic patients remaining undiagnosed.

As for price, Freedom could also come out on top. HbA1c testing costs $35-40 each time, Mr Ignotz estimates, while “our test, depending on the volume, is a fraction of that.” While the ClearPath DS-120 costs around $35,000, this translates to less, per test, in centers carrying out high volumes, helped by the lack of consumables and technician time.

Another advantage of measuring AGEs is that they are long-lived and accumulate over time. “The proteins in the lens of eye are some of the few in the body that do not turn over. So the fluorescence never goes down, it can only go up or be stabilized through good glucose control.”

This means that, at the point of diagnosis, ”you have a glimpse into how severely compromised patients’ metabolic state has been,” the COO explains. Other techniques have also looked for changes in the eye, such as imaging using a fundus camera or Optos’s retinal imaging devices. However, these only detect complications of a disease that has already been progressing for years. “Studies have found that at diagnosis, with our current problems in detection, 50% of the insulin-producing pancreatic islet cells have been destroyed,” Mr Ignotz says.

In contrast, Freedom has “the opportunity to provide early detection in the course of the disease, which is asymptomatic, and to alert patients so they may be brought under control.” This could reduce the risk of future complications from the disease by allowing earlier treatment.

The COO doesn’t believe there is anything else similar in development. Some companies have tried to develop diabetes tests measuring changes in the skin, but so far with limited success. “The problem with measuring AGEs in the skin is that you have a changing target, because the skin is in flux.”

Freedom, with its novel approach, seems ripe for plucking by firms already in the diabetes space, including blood glucose measuring specialists such as Johnson & Johnson’s LifeScan unit and Roche, as well as insulin pump manufacturers including J&J’s Animas division and Medtronic (which launched its “first-generation artificial pancreas” last year).

“There’s a tie-in [opportunity] with anyone in diabetes,” Mr Ignotz says. “From a branding point of view our technology could build awareness, from the initial encounter with the patient.” He adds that the firm has had and continues to have discussions with all of the major players, “and some you wouldn’t even dream of.”
He concludes: “The unfortunate thing about type 2 diabetes is there’s no silver bullet, and all the current therapies only treat the disease symptomatically, with 30% of type 2 patients going on to need insulin. This represents a tremendous opportunity to save the healthcare system money, ensure better patient outcomes and enhance practice revenues.”

Keith Ignotz, president and COO.
Tel: +1 858 638 1433
Freedom Meditech, Inc., 5090 Shoreham Pl, Suite #109, San Diego, CA 92122, US.



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