REVOLUTIONARY WOUND TREATMENT

WORLD OVERVIEW

The World Health Organization has reported that the estimated number of

patients with diabetes was nearly 425 million in 2017, consequently, increasing

the number of diabetes-related complications.

The global prevalence of diabetic foot ulcers (DFU) varies from 3% to 13%

worldwide, with a global average of 6.4%.

The annual incidence of DFU in diabetic patients is known to be about 2% to

5% and the lifetime risk ranges from 15% to 25%.

More than half of all DFU become infected, and diabetic foot infections (DFIs)

lead to higher amputation rates in the diabetes population.

It is generally known that DFU is a leading cause of non-traumatic lower

extremity amputations.

A recent prospective cohort study followed up the patients with neuropathic

DFU (nDFU) for 14 years to compare the amputation and mortality to patients

without DFU.

It showed that 29.3% patients with nDFU had limb amputations.

The 5- and 10-year mortality was 22% and 71% in the DFU group with a

median survival of 7.72 years compared to 3% and 5% and survival of 12.6

years in nDFU group.

Peripheral arterial disease (PAD) like cardiovascular disease, is a major arterial

disease caused by atherosclerosis, which is associated with a 20-fold higher

prevalence in patients with diabetes and it is known to be a risk factor for the

highest severity of single factors in diabetic patients, the probability of

amputation within one year after the first ulcer is 34.1% and the mortality rate

has been reported to be 5.5%.

The risk of death at 5 years for a patient with a DFU is 2.5 times as high as the

risk for a patient with diabetes who has no foot ulcer.

There were studies reported that the 5-year survival rate in major lower

extremity amputation in the diabetes population is estimated at less than 50%.

Approximately 2 million Americans develop a diabetic foot ulcer each year.

Within 5 years of ulceration, over 50% die and 5% lose a limb.

Diabetic foot ulcers cost the U.S. healthcare system $130 billion annually.

Patients require daily wound care and deal with pain and suffering.

Patients often fear major amputation from diabetic foot ulcers more than

death.

We are developing Version 2.0 of the Topical.

We are using a novel method that allows us to patent the process and the

product.

We are creating a Medical Device, not a drug.

FDA has specific rules for this process.

Required Steps:

-File Patents to protect it.

-Build custom equipment to produce Version 2.0 of the Topical.

-Commission toxicology and animal studies.

-Analyze studies and present reports.

We require a pre-clinical study of toxicology by a Clinical Research

Organization (CRO).

With the toxicology analysis in hand, to market the product to pharmaceutical

companies whereby we believe a pharmaceutical company will buy the

intellectual property from Medex47 for a very significant amount.

The pictures you saw are from testing Version 1.0 of the Topical with desperate

volunteers who were grateful to resolve in just a few weeks a problem that

plagued them for years.