Tempo Therapeutics, a San Diego-based regenerative medicine company, has received a Small Business Innovation Research (SBIR) award providing up to $2.25 million from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The funding will support a randomized clinical study of the company’s proprietary Microporous Annealed Particle (MAP) Wound Matrix, a synthetic biomaterial designed to promote healthy tissue formation in complex wounds.
The award provides potential funding over two years, subject to satisfactory progress and the availability of funds. It will support MOSAIC II, a clinical study evaluating whether MAP Wound Matrix can reduce the time required for wounds to become suitable for skin grafting following non-melanoma skin cancer surgery.
The study will be led by Stephanie Deshayes, Ph.D., Vice President of Research and Development at Tempo Therapeutics, who will serve as the grant’s principal investigator.
The funding advances Tempo’s development of synthetic biomaterials intended to improve the body’s ability to regenerate healthy, functional tissue. Its MAP technology addresses limitations of conventional wound management, particularly in cases where tissue loss complicates reconstructive procedures.
Unlike approaches that primarily promote healing from a wound’s edges, MAP supports tissue regeneration throughout the wound’s volume. Its flowable, porous structure provides a scaffold that allows cells and blood vessels to grow into damaged areas.
The company engineered the material to support the body’s regenerative processes while minimizing the persistent inflammatory foreign-body response that can occur with implanted materials.
Tempo aims to promote the formation of healthy, vascularized tissue that can support subsequent reconstructive procedures, including skin grafting.
The newly funded MOSAIC II study will investigate the technology in patients with complex wounds resulting from non-melanoma skin cancer resections involving exposed bone.
These wounds can present additional reconstructive challenges because successful grafting requires a suitable wound bed. The study will evaluate whether MAP can accelerate that process, potentially allowing patients to proceed to reconstruction sooner.
The grant follows Tempo’s recently published first-in-human randomized, controlled, multicenter clinical study involving patients with full-thickness wounds following Mohs surgery for non-melanoma skin cancer.
According to the company, wounds treated with MAP achieved a favorable Wound Bed Score approximately 14 days earlier than control wounds, without delaying overall wound closure.
At approximately six months, MAP-treated wounds also demonstrated significantly improved physician-assessed scar quality and reduced soft tissue volume loss compared with standard-of-care hydrocolloid treatment.
Those findings provide the clinical foundation for MOSAIC II, which will investigate whether the technology’s effects can extend to more challenging wounds requiring subsequent reconstruction.
The new study will focus specifically on reducing the time needed to develop a graft-ready wound bed following complex skin cancer surgery.
Although the earlier trial produced encouraging findings, the new randomized study will establish whether MAP can accelerate graft readiness in wounds involving exposed bone.
Westbrook Weaver, Ph.D., Co-Founder and Chief Technology Officer of Tempo Therapeutics, emphasized the importance of evaluating whether the material can promote tissue formation throughout complex wounds rather than relying primarily on healing from their margins.
Tempo is developing its patented MAP platform for applications across surgical reconstruction and wound healing, with additional potential uses in aesthetic dermatology and regenerative medicine.
The company’s lead product has completed first-in-human clinical evaluation and has been submitted to the U.S. Food and Drug Administration through the De Novo pathway. The announcement did not indicate that the product has received FDA authorization.
The NIH funding will support further clinical evaluation as Tempo works to establish whether its technology can address additional wound indications where existing treatment options remain inadequate.
The National Cancer Institute supports the research under Award Number R44CA314892. The award does not represent NIH endorsement of Tempo’s products or guarantee the study’s clinical outcomes.
KEY QUOTES:
“This award brings Tempo closer to an important value-enhancing milestone.”
Steven Sands, Chairman of Tempo Therapeutics
“This award allows us to evaluate that approach in more challenging wounds.”
Stephanie Deshayes, Ph.D., Vice President of Research and Development at Tempo Therapeutics
