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Divs Technology

Early detection and monitoring of diabetic neuropathy

Serbia
Market: Internet and IT, Medicine, Artificial Intelligence
Stage of the project: Prototype or product is ready

Date of last change: 10.03.2021
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Idea

We strive to provide simple, available technology to do preliminary, self screening mechanism that aims to detect neurological disorders and neuropathies in early stage.

Current Status

Divs Technology has developed prototyped that is already tested. We went through the iterations and improvements in UX, SW and ML. Currently, we are preparing non-inferiority trial (bioequality trial)

Market

People with diabetes.
In US alone:
- 34.4 million people with diabetes
- Only 16 000 neurologists
- Up to 13.7 B $ is estimated to be the annual cost of diabetic neuropathy and its complications.

In the developed world, approximately 10% of the population is diagnosed with diabetes disease. During the first years of diabetes, neuropathy will develop in 5-10% of the population. For up to 15 years, diabetic neuropathy will develop for 60% of the population with diabetes types I and II. Approximately 25% of people with diabetes will develop a foot ulcer during their lifetime, which can progress to infection and limb amputation in severe cases. Ninety percent of hospital admissions for diabetic foot ulcers are related to peripheral neuropathy and infection, and diabetes accounts for 83% of all major amputations in the United States.
The annual costs of diabetic neuropathy and its complications in the U.S. were $0.8 billion (type 1 diabetes), $10.1 billion (type 2 diabetes), and $10.9 billion (total). After allowing for uncertainty in the point estimates of complication rates, the range of costs were between $0.3 and $1.0 billion (type 1 diabetes), $4.3b and $12.7 billion (type 2 diabetes), and $4.6 and $13.7 billion (type 1 and type 2 diabetes)

Problem or Opportunity

Addressing diabetic neuropathy problem - it’s later detection and mistreatment of diabetic neuropathy caused by the combination of: number of visits at neurologist needed, costly, invasive procedures and number of patients affected.
Earlier detection of diabetic neuropathy, better glycemic control and slowing down progression of disease in general (with or without pharmacology therapy) consequently leads to less and later disability of patients.
Progress of diabetic neuropathy after some time, inevitably, leads to disability of certain degree - neuropathic pain, anxiety, depression, painless feet injuries, limb amputations, falls, sexual dysfunction - which can be avoided and successfully postponed if diagnosed earlier, treated and monitored correctly.
Multiple clinical studies are showing that up to 85% of diabetic neuropathy complications might be avoided if diabetic neuropathy is discovered and treated early on.

The limitations of current approach that usually requires neurologist involvement and EMNG diagnostic.
EMNG requires highly skilled personnel - as a reference: usually on a team of 4-5 neurologists, only 1 is trained for performing and reading EMNG. Highly discomfort method that requires 30-45min to perform - which in combination with the number of neurologists per diabetes patient leads to lower throughput of conducted examinations. Having in mind recommendations by American Diabetes Association (ADA) to perform 1-2 neurological exams per year in order to diagnose and monitor diabetic neuropathy - failing to meet the standards is directly causing current number of diabetic neuropathy complications.
There are significant scaling limitations with today's approach - hospital throughput, per square feet clinical costs and most importantly, the problem with the number of highly qualified professionals - this means that the number of patients receiving adequate care is limited - the problem is visible and notable. Although diabetic neuropathy is very well known and understood that today’s developed societies reached the sealing in scaling abilities - we can tell by, as an example, 100+K amputations annually caused by diabetic neuropathy in the US alone.

Solution (product or service)

Divs Technology is providing wearable technology for self assessment of neurological health for people with diabetes.
Patients with diabetes will be able to purchase/receive/order a test set at home, where they can perform repeatable tests in order to assess neurological health in 5 minutes. By performing the tests periodically progress of neurological health with focus on diabetic neuropathy can be tracked with higher precision and gives us the ability to tackle the disease as early as possible. The report can be submitted to the general physician, neurologist or healthcare provider of choice - where the neurologist can adapt therapy, propose the change or perform additional checks when and if needed.

- No highly skilled professionals required to perform periodic checks
- Highly scalable solution that can fit unmet needs caused by the number of people with diabetes in regards to number of neurologists.
- Minimal discomfort
- No need for frequent hospital visit

Competitors

Sudoscan
Neuropad
NC-stat
Neuroquick
Vibratip
Monofilament
Steel Ball Bearing
TCD
Biothesiometer

Advantages or differentiators

The majority of approaches uses subjective feel which is not quantitative method.Testing of sural nerve conductivity for sensory-motor neuropathy requires expert training.

Divs approach:
● Detects neurological disorder before vibration sense disorder detection.
● More practical than locating sural nerve
● More sensitive than skin tests for 80% of DPNs
● Includes stability, coordination and cognitive tests
● Fine grained repeatable mechanism ● Exclude MD involvement

Money will be spent on

Money will be spent on further product and SW development and scaling of a system. Preparation and execution of clinical trials needed to set the Divs at the stage for the second round of funding where the second round of funding is needed to bring the class II certification with FDA.

Team or Management

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