Evidence of neurodegenerative disease has been found in the peripheral nerves of diabetics. Currently more than 50% of diabetic patients develop some form of peripheral nerve disease, which can lead to loss of sensation, tingling, pain, limb amputation, and death.

No FDA-approved treatment exists for diabetic neuropathy, a condition that afflicts over half of the 29 million Americans (over 415 million worldwide) who suffer from diabetes. Although drugs exist to relieve the pain, the goal for those that aim to treat this major unmet clinical need is a therapy that can prevent the onset of nerve damage, and reverse (regrow) damaged nerves and loss of function and quality of life.

There is no disease-modifying or curative treatment approved for diabetic neuropathy. Current approaches at best mitigate the pain or attempt to control the underlying diabetes.

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