Hemastyl™ System
A clinically evaluated system designed to support healing in complex, chronic wounds.
The Hemastyl™ System has been evaluated in patients with long-standing diabetic foot and leg ulcers that failed standard wound care and were frequently diagnosed for amputation. Across feasibility evaluations, use of the Hemastyl™ System was associated with observed microbe reduction, wound closure, and avoidance of amputation in high-risk patients.
Clinical Feasibility Evidence for the Hemastyl™ System
Two prospective feasibility studies evaluated the Hemastyl™ System in patients with chronic diabetic foot and leg ulcers that had failed standard wound care. A total of 39 patients were treated across two cohorts. Many patients presented with long-standing wounds, multiple comorbidities, and prior diagnoses for potential amputation.
Treatment duration ranged from one to forty weeks depending on wound severity. Outcomes assessed included microbe reduction, wound closure, periwound recovery, patient-reported sensory changes, and avoidance of amputation.
Representative Feasibility Cases Using the Hemastyl™ System
Representative cases from the feasibility evaluations illustrate wound progression over time in patients with chronic, non-healing ulcers who had previously failed standard wound care. These cases provide visual context for outcomes observed across the feasibility cohorts.
Key Outcomes Observed
Observed reduction of microbes following treatment initiation
High wound closure rates observed across both feasibility cohorts
Avoidance of amputation in all patients previously diagnosed for potential surgical intervention
Patient-reported improvements in periwound warmth and sensation in select cases
Figure 1. Periwound Sensory Improvement Following Treatment (n = 17 vs n = 22)
*Patient-reported sensory changes were collected as part of feasibility evaluations and were not primary efficacy endpoints.
Figure 2. Partial and Full Restoration of Periwound Sensation by Cohort
*Patient-reported sensory changes were collected as part of feasibility evaluations and were not primary efficacy endpoints.
Feasibility Study Snapshot
The feasibility population represented patients with multiple risk factors and comorbidities known to impair wound healing.
Broad Categories of Both Treatment Groups (n=39)
Preclinical Evidence Supporting Hemastyl™
Preclinical evaluation of Hemastyl™ was conducted as part of product development to assess biological activity relevant to wound management. Findings from these studies support the biological basis of Hemastyl™ and informed subsequent system-level development.
NanoString Evidence Supporting the Hemastyl™ System
NanoString gene expression profiling was conducted as part of evaluation of the Hemastyl™ System. Analysis demonstrated statistically significant modulation of biological pathways associated with inflammation regulation, angiogenesis, extracellular matrix remodeling, and tissue repair.
These molecular findings provide mechanistic support for observations made during human feasibility evaluations of the Hemastyl™ System.
Regulatory Alignment
Hemastyl™ is FDA 510k cleared. The name “Hemastyl System” represents a January 2026 deNovo filing. Information presented on this page reflects completed feasibility evaluations and supporting data intended for the deNovo filing.
Hemastyl™ Indication for Use
Rx: Under the supervision of a healthcare professional, Hemastyl™ Wound Dressing is indicated for the management of 1st degree burns and 2nd degree superficial burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: Hemastyl™ is indicated for the management of minor abrasions, minor cuts, minor lacerations, and minor scalds.