2025

FIRST-IN-HUMAN CLINICAL STUDY TO ASSESS THE SAFETY OF MICROPOROUS ANNEALED PARTICLE (MAP) WOUND MATRIX IN PATIENTS WITH CLEAN WOUNDS AFTER MOHS MICROGRAPHIC SURGERY (MMS) FOR SKIN CANCER
Stephanie Deshayes^*1, Donald Griffin^1,2, Andrea Quach¹, Stephanie Martin³, C. William Hanke⁴, Jennifer Hau⁵, Westbrook Weaver^1
1Tempo Therapeutics, San Diego, CA; ²University of Virginia, Charlotsville, VA; ³Cal Coast Dermatology, Encino, CA; ⁴Laser and Skin Surgery Center of Indiana, Carmel, IN; ⁵Cypress Dermatology, Cypress, TX

Basal Cell Carcinomas (BCC) or Squamous Cell Carcinomas (SCC) affect over 5 million patients every year in the US alone. Acute surgical oncology resection sites of BCCs and SCCs are frequently addressed with Mohs micrographic surgery (MMS). A significant number of these patients require surgical resection that exposes bone, muscle, or fascia. The recovery of these surgical sites is challenging, costly, and requires careful management to optimize healing and minimize complications. The most prevalent complications of post-operative wound management following MMS are infection and scarring from dermal atrophy and scar contracture. Currently, there is neither a one-size-fits-all approach nor a single standard treatment to post-Mohs wound care.
MAP Wound Matrix is a flowable biomaterial that conforms to the wound shape and uses cell-scale networks of pores to physically integrate with the tissue for a single treatment approach to tissue regeneration. The purpose of this first-in-human clinical study is to evaluate the safety of MAP Wound Matrix when used in the treatment of clean wounds after MMS compared to a standard hydrocolloid dressing.
Subjects underwent skin cancer surgery via MMS in the clinic. Post-surgery, subjects were randomly assigned to investigational (MAP Wound Matrix) or control (hydrocolloid dressing) treatment in a 2:1 ratio. Uniquely, the study design does not exclude patients with complex wounds or that are suffering from immunodeficiency. MAP Wound Matrix is applied only once after surgery, while the control is reapplied following standard of care (i.e., every 3-4 days for the first two weeks). Subjects were followed through multiple follow-up visits, either in clinic or virtual for up to six months. The primary endpoint is the incidence of serious adverse device effects (SADE) in subjects treated with MAP Wound Matrix, compared to the control treatment group. Secondary assessments include standard clinical wound assessment, wound imaging, device assessment, and pain.
As of November 22^nd 2024, 25 subjects were enrolled, and no SADEs have been reported. Surgical wound images have been captured and clinical wound assessments have been collected for all patients over the course of healing. Clinical assessment data thus far indicate no inhibition of wound healing for MAP Wound Matrix treated subjects, and early tissue integration. The number of wound dressing changes was reduced for the MAP Wound Matrix arm compared to the control arm.
Study results thus far indicate the MAP Wound Matrix can be applied to clean wound after MMS without SADEs. In addition, these interim data suggest that MAP Wound Matrix has the potential to affect wound healing after cancer resection via a single treatment. The potential of a product to improve tissue formation over bone, cartilage, or fascia while reducing complications of scar contracture and dermal atrophy would address a significant unmet medical need for patients undergoing skin cancer surgery.