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Developing a new DFU dressing

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DK133065-01
Agency Tracking Number: R44DK133065
Amount: $1,741,462.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 200
Solicitation Number: PA21-259
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-05-17
Award End Date (Contract End Date): 2024-01-31
Small Business Information
300 E. Market Street
Louisville, KY 40202-1959
United States
DUNS: 968792007
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (502) 593-9196
Business Contact
Phone: (502) 593-9196
Research Institution

ABSTRACTDiabetic foot ulcers (DFUs) are the leading cause of nontraumatic lower extremity
amputations in the United States and are responsible for more hospitalizations than any
other complication of diabetes. Despite thousands of dressings developed in the past
century, none have shown any specific effectiveness as DFU treatments. Currently,
even the best available treatments achieve only a 50% healing rate for these
wounds—and this healing is often temporary, with a 66% chance of recurrence.For the first time in history, we have found an approach that may change the current
dogma. We have developed a technique for intracellular ATP delivery (ATP-vesicles or
VitaSol™). When we use VitaSol™ for wound healing, granulation tissue starts to
appear within 24 hours. This new tissue keeps growing and fills the wound cavity
within a few days, a phenomenon never seen or reported before by any other
techniques. Control dressings, including normal saline, free Mg-ATP, empty lipid
vesicles, and the only FDA-approved prescription growth factor, Regranex, have no
such effects. The final healing time is much shorter than the controls in long-time
diabetic plus ischemic wounds. A preliminary mechanistic study has shown that the
extremely rapid tissue regeneration is the result of very early (5 hours after surgery),
rapid, and massive macrophage accumulation, in situ proliferation, M2 polarization, and
direct collagen production, long before traditional fibroblasts come into play. This type of
healing is totally different from the conventional process known to the wound care
community, where fibrin, platelets, and red blood cells are the main components of the
early provisional matrix, which is gradually replaced by granulation tissue during the
proliferation phase after 3–6 days of lag time. Although the growth seen with VitaSol™
is extremely rapid, it does not display any unusual growth or hypertrophic scar formation
after 2 years in animals and after more than 9 years in limited human volunteers. If this
can be duplicated in humans, it will be a major breakthrough in medicine.Our central hypothesis is that intracellular ATP delivery provides critical energy at
very early time, activates various transcription mechanisms, resulting in extremely early
and rapid tissue regeneration that fills the wound cavity quickly.In this proposal, we will perform a preclinical toxicity study aimed at IND application,
and test the effectiveness of VitaSolTM in a new animal model with long-term diabetes,
ischemia, and neuropathy.Our product for intracellular energy delivery has consistently been viewed as
innovative. The outcome of this project will be the clinical introduction of a highly
effective, inexpensive, and easy-to-use new dressing for DFU treatment. The potential
impact is very high.

* Information listed above is at the time of submission. *

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