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Clinical Data for Improved Outcomes

The BioHealx® Anal Fistula Device safely delivers extraluminal compression closure of all 3 fistula segments, while reducing lengthy and costly repeat procedures and diminishing the incidence of incontinence.

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Clinical Results 

A multi-center, prospective, single-arm, European trial of 32 subjects was completed.*

The study objective was to evaluate the safety and effectiveness of the BioHealx device for use in the treatment of anal fistulas. The subjects were followed for a minimum of 12 months.

*Harsányi L, et al. Int J Colorectal Dis. 2025 May 6;40(1):110.

Safety

There were no device-related adverse events including no migration, abscess, nor infection. Patients experienced an improved quality of life after the procedure. The learning curve for the surgeon is minimal.

0%

Device
Migration

0%

Device-Related
Adverse Events

Improved Quality of Life

Short
Learning Curve

Effectiveness 

The effectiveness data showed safe and successful healing of the fistula tract, with 84.4% healing at 12 + months. 

84.4%

Fistula
Healing

96.8%

Stable/Improved
Continence

Comparison to Other Surgical Procedures 

Fistula surgery is challenging with various techniques being used today with mixed results and frequently repeat attempts at cure. There is an opportunity for improved initial outcomes and reduced need for multiple procedures in patients with fistula-in-ano. Successful fistula healing is defined as initial healing without recurrence.

BAFT = BioHealx Assisted Fistula Treatment 

Efficacy: BioHealx vs Open Surgical Procedure Outcomes

Published Meta Analyses Stellingwerf ME, et al. BJS Open. 2019 Jan 21;3(3):231-241; Khamar J, et al. Tech Coloproctol. 2023 Dec 13;28(1):12. ; Iqbal N, et al. Colorectal Dis. 2021 Dec;23(12):3073-3089.; Mishra A, et al. J Clin Diagn Res. 2013 May;7(5):876-9;O’Riordan JM, et al.  Dis Colon Rectum. 2012 Mar;55(3):351-8. Erguder et al. Colorectal Disease. 2025;27:e70199.
Harsányi L, et al.  Int J Colorectal Dis. 2025 May 6;40(1):110.

BioHealx vs. Fistulotomy/Sphincter Repair (FIPS)

Success = Initial primary healing without recurrence

Sorensen ( 2025 )

  • Initial healing 44/55 (76%)
  • Recurrence 13/42 (19%)
  • Success 29/55 (52%)

Anguilar-Martinez ( 2021 )

  • Initial healing 90/107 (84%)
  • Recurrence 15/90 (17%)
  • Success 75/107 (70%)

Sørensen KM, et al. Surg Endosc. 2025 Mar;39(3):2073-2079.
Aguilar-Martínez MDM,  et al. Dis Colon Rectum. 2021 Nov 1;64(11):1374-1384.

BioHealx vs. LIFT

Success = Initial primary healing without recurrence

Erguder (2025)

  • Initial Healing 39/129 (30%)
  • Success 39/129 (30%)

Madboulay (2014/2021)

  • Initial healing 64/81 (79%)
  • Recurrence 11/64 (17%)
  • Success 53/81 (65%)

Wallin (2012)

  • Initial healing 61/93 (66%)
  • Recurrence 24/61  (39%)
  • Success  37/93 (40%)

Malakorn (2017)

  • Initial Healing 138/155 (89%)
  • Recurrence 31/ 138 (22%)
  • Success 107/155 (69%)

Madbouly KM, Emile SH, Issa YA, Omar W. Surgery. 2021 Jul;170(1):61-66.
Madbouly KM, El Shazly W, Abbas KS, Hussein AM. Dis Colon Rectum. 2014 Oct;57(10):1202-
Wallin UG, Mellgren AF, Madoff RD, Goldberg SM. Dis Colon Rectum. 2012 Nov;55(11):1173-8 Malakorn S, Sammour T, Khomvilai S, Chowchankit I, et al. Dis Colon Rectum. 2017 Oct;60(10):1065-1070.
Erguder et al. Colorectal Disease. 2025;27:e70199.

BioHealx vs. Endoanal Flap

Success = Initial primary healing without recurrence

Madboulay (2014)

  • Initial healing 32/35 (91%)
  • Recurrence 9/32 (28%)
  • Success 23/35 (66%)

Schwandner (2010)

  • Initial Healing 30/39 (77%)
  • Recurrence 9/39 (23%)
  • Success 21/39 (54%)

Seifarth (2021)

  • Initial healing  86/100 (86%)
  • Recurrence  26/86 (30%)
  • Success 60/100 (60%)
Bar chart showing Signum Surgical FIPS outcomes: Initial Healing (81), Recurrence (21), FLAP Success (54), and BAFT Success (84). BAFT Success is highlighted with a green-dotted box. Statistical significance is p < 0.00001.

Madbouly KM, EL ShazlyW, Abbas KS, Hussein AM. Dis Colon Rectum 2014; 57: 1202–120,
Schwandner T, Thieme A, Scherer R, et al.  Int J Surg Open. 2018;15:25–31.
Seifarth et al. BMC Surg (2021) 21:283

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