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Prevention of Amputation with Rapid Healing of Diabetic Ulcers Using Autologous Microsized Fat Tissue

Award Number: R43DK147508
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2026
PERIOD OF PERFORMANCE END DATE: 09/21/2027

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Prevention of Amputation with Rapid Healing of Diabetic Ulcers Using Autologous Microsized Fat Tissue - PROJECT SUMMARY Diabetic foot ulcers (DFUs) are a serious complication of diabetes and a major cause of nontraumatic lower-extremity amputation. Approximately 11.3% of the U.S. population has diabetes, with prevalence varying across population groups, including American Indian or Alaska Native, Black or African American, Hispanic or Latino, Asian, and White populations. Each year, approximately 1.9% to 4.0% of people with diabetes develop foot ulcers, representing an estimated 708,000 to 1,490,000 cases annually. Once a DFU develops, the risk of amputation ranges from 14% to 24%, and DFUs precede nearly 80% of lower-extremity amputations. Studies have also reported differences in DFU-related outcomes, including major amputation and hospitalization, among American Indian or Alaska Native, Black or African American, Hispanic or Latino, Asian, and White populations. These findings underscore the substantial clinical burden of DFUs and the need for effective preventive and therapeutic strategies that improve wound healing and reduce the risk of serious complications. Treatment of DFUs adds approximately $13 billion to the cost of diabetes care in the United States, further highlighting the need for effective treatment options. The SyntrFuge™ System was developed as a point-of-care approach for treating DFUs through minimal manipulation of autologous adipose tissue. The system enables healthcare providers to harvest and process a patient’s adipose tissue and immediately administer the processed tissue to the wound site. Through microfragmentation, the SyntrFuge System utilizes the inherent structural and supportive properties of adipose tissue to support wound healing in chronic conditions such as DFUs. In this Phase I project, we will prepare a clinical site and conduct an early feasibility clinical study of the SyntrFuge System in participants with DFUs. Specific Aim 1 will establish clinical site readiness, obtain required approvals, manufacture SyntrFuge Systems for clinical use, and recruit study participants. Specific Aim 2 will conduct an early feasibility study to evaluate the safety and preliminary effectiveness of a novel automated point-ofcare device that produces microsized autologous fat grafts for the treatment of DFUs. Successful completion of this project will provide clinical evidence regarding the safety and potential effectiveness of the SyntrFuge System in promoting DFU wound healing and reducing the risk of complications. These results will support continued regulatory and commercial development of the SyntrFuge System, including pursuit of FDA Breakthrough Device designation for the treatment of diabetic foot ulcers.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $313,372 )
2026	2026	SYNTR HEALTH TECHNOLOGIES, INC.	9120 IRVINE CENTER DR STE 200	IRVINE	CA	92618	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/17/2026	NEW	$313,372
														Subtotal = $313,372

Grand Total All Awards = $313,372

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Prevention of Amputation with Rapid Healing of Diabetic Ulcers Using Autologous Microsized Fat Tissue

Award Number: R43DK147508

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/22/2026

PERIOD OF PERFORMANCE END DATE: 09/21/2027

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