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Clinical Data for Improved Outcomes

The BioHealx® device safely closes anal fistulas with a bioabsorbable implant that creates tissue apposition for primary healing, reducing complicated, lengthy, and costly repeat procedures while 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. 

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 

Procedure Outcomes

Scatter plot comparing procedures like Signum Surgical, Plug, LIFT, Endoanal Flap, Fistulotomy/Sphincter, and Cutting Seton by success and continence rates; “BioHealx (BAFT)” ranks highest in both categories.

FIBS vs BioHealx

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%)
Bar graph showing four outcomes: Initial Healing (81), Recurrence (21), FIPS Success (63, marked with *), and BioHealx Success (84, highlighted with a green dashed border). Title: “Pooled FIPS Outcomes by Signum Surgical. *p < 0.00001.”.

LIFT vs BioHealx

Success = Initial primary healing without recurrence

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%)
Bar chart titled Pooled FIPS Outcomes from Signum Surgical displays: Initial Healing (81), Recurrence (21), LIFT Success (63), and BAFT Success (84). Note above reads *p < 0.00001.

Endoanal Flap vs BioHealx

Success = Initial primary healing without recurrence

Madboulay (2014)

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

Van der Hagen (2005)

  • Initial healing 13/18 (72%)
  • Recurrence 3/13  (23%)
  • Success  10/18 (56%)

Schwandner (2010)

  • Initial Healing 30/39 (77%)
  • Recurrence 9/39 (23%)
  •  
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.

Fistula Plug vs BioHealx

Success = Initial primary healing without recurrence

Bondi (2017)

  • Initial healing  27/41 (66%)
  • Success 27/41 (34%)

Han (2009)

  • Initial healing 62/114  (54%)
  • Success  61/114 (54%)

Schwandner (2009)

  • Initial Healing 37/60 (62%)
  • Success 37/60 (62%)
Bar graph titled Pooled FIPS Outcomes compares four groups: Initial Healing (59), Recurrence (59*), PLUG Success (59*), and BAFT Success by Signum Surgical (84; highlighted with a green gradient box). Statistical significance p < 0.00001.

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