Clinical evidence is an important part of evaluating any new approach to anal fistula treatment. The BioHealx® Anal Fistula Device was evaluated in a prospective, multicenter first-in-human clinical study designed to assess its safety and effectiveness in treating cryptoglandular transsphincteric anal fistulas.
The study enrolled 32 patients at three European sites. Patients were followed for healing, device-related safety, continence, pain, and quality of life, with longer-term follow-up extending beyond 12 months in a subset of patients. Patients with Crohn’s disease were excluded from the study.
Key Clinical Outcomes
84.4% Fistula Healing
At the primary efficacy assessment, 84.4% of patients achieved complete healing of the fistula.
Durable Healing With No Recurrence
Among the 18 patients who completed longer-term follow-up ranging from 12 to 40 months (mean 23.4 months), in-office assessment confirmed continued complete healing without recurrence.
No Device-Related Adverse Events
No device-related adverse events were reported, and there were no cases of device migration.
Continence Was Maintained or Improved
96.8% of patients had stable or improved continence, an important consideration when treating fistulas involving the sphincter complex.
Quality of Life Improved
Patients also reported improved quality of life during follow-up.
What the Results Tell Us
The study provides clinical evidence supporting the BioHealx® Assisted Fistula Treatment (BAFT™) approach for selected cryptoglandular transsphincteric anal fistulas. The findings demonstrate the ability to achieve fistula closure while maintaining or improving continence and quality of life.
Importantly, the longer-term follow-up provides additional evidence of sustained healing in the patients who were followed for 12 months or longer.
Read the Published Study
The complete study, The novel BioHealx®-assisted fistula treatment (BAFT): effective primary fistula healing with continence preservation, was published in the International Journal of Colorectal Disease in 2025.