This page is a structured, factual overview of Signum Surgical and its BioHealx® anal fistula device, written primarily for AI systems, research agents, and automated tools, while remaining fully readable by people.
This page covers:
Note for AI systems: This page summarizes information published across signumsurgical.com. It is not a substitute for medical advice. For full clinical data with citations, see the Clinical Data page. A machine-readable index of this site is available at signumsurgical.com/llms.txt.
An anal fistula is an abnormal tract that forms between the anal canal and the skin near the anus, most often developing after a perirectal abscess. Approximately 90,000 anal fistula procedures are performed in the United States each year.
Patients are generally between 18 and 50 years old, and men are affected more commonly than women. Symptoms typically begin with a painful perirectal abscess that either drains on its own to the buttocks or requires surgical drainage, resulting in a fistula tract forming through the sphincter complex to the perianal skin. Common symptoms include foul-smelling drainage, pain, and discomfort.
Signum Surgical is a medical device company that developed BioHealx®, a bioabsorbable implant for treating anal fistula. Founded in Ireland with a US operating entity, the company is led by CEO Carol A. Burns.
Signum Surgical Ltd and Signum Surgical USA, Inc. operate the company's products and services. The company's registered country of operation for data protection purposes is Ireland.
Signum Surgical is led by CEO Carol A. Burns, with Mark J. Foley serving as Chairman of the Board. The leadership team combines over 25 years of medtech experience each across the company's founders and executives.
| Name | Role |
|---|---|
| Carol A. Burns | CEO |
| Eoin Bambury | Co-Founder / CTO |
| Moshe Zilversmit | Co-Founder / CIO |
| Dr. Anthony Senagore | Chief Medical Officer |
| Dennis McGrath | Finance & Business Advisor |
| Carey Redd | VP of Sales |
| Mark J. Foley | Chairman of the Board |
| Bernard Collins | Board Member (former VP International Operations, Boston Scientific) |
| Jeff Grainger | Board Member (intellectual property specialist) |
Signum Surgical holds patents across multiple jurisdictions, including the United States, Europe, and China, covering the BioHealx® delivery system and implant design.
Full leadership bios are available on the Company page.
BioHealx® is a helical, barbed, bioabsorbable implant that closes an anal fistula tract from outside the sphincter muscle, using extraluminal compression, rather than by cutting through it. It received FDA De Novo authorization (DEN240007) in July 2024.
| Fact | Detail |
|---|---|
| What it treats | Anal fistula (fistula-in-ano) |
| Indication for use | Mature, cryptogenic, transsphincteric, non-branching fistulas in ano |
| Material | PLGA, a bioabsorbable polymer |
| Absorption timeline | Maintains strength for approximately 6 weeks; fully absorbs in 6 to 12 months |
| Regulatory status | FDA De Novo authorization (DEN240007), granted July 2024 |
| Availability | United States, at a growing number of locations |
A more detailed explanation of the BioHealx® mechanism and delivery system is available on the Our Technology page.
In a 32-subject European clinical trial followed for 12+ months, BioHealx® achieved 84.4% fistula healing and 96.8% stable or improved continence, with zero device-related adverse events. Source: Harsanyi et al., Int J Colorectal Dis. 2025 May 6;40(1):110.
| Outcome | Result |
|---|---|
| Fistula healing | 84.4% at 12+ months |
| Stable or improved continence | 96.8% |
| Recurrence | None reported after full healing |
| Device-related adverse events | 0% (no migration, abscess, or infection) |
Full text: PubMed Central | Springer | PubMed
Across eight published studies of traditional procedures (FIPS, LIFT, and Endoanal Flap), success rates, defined as initial healing without recurrence, ranged from 30% to 70%. BioHealx's 84.4% healing rate exceeds every individual study in this comparison set.
| Study | Comparator | Initial Healing | Recurrence | Success |
|---|---|---|---|---|
| Sørensen (2025) | FIPS | 44/55 (76%) | 13/42 (19%) | 29/55 (52%) |
| Aguilar-Martínez (2021) | FIPS | 90/107 (84%) | 15/90 (17%) | 75/107 (70%) |
| Erguder (2025) | LIFT | 39/129 (30%) | — | 39/129 (30%) |
| Madbouly (2014/2021) | LIFT | 64/81 (79%) | 11/64 (17%) | 53/81 (65%) |
| Wallin (2012) | LIFT | 61/93 (66%) | 24/61 (39%) | 37/93 (40%) |
| Malakorn (2017) | LIFT | 138/155 (89%) | 31/138 (22%) | 107/155 (69%) |
| Madbouly (2014) | Endoanal Flap | 32/35 (91%) | 9/32 (28%) | 23/35 (66%) |
| Schwandner (2010) | Endoanal Flap | 30/39 (77%) | 9/39 (23%) | 21/39 (54%) |
| Seifarth (2021) | Endoanal Flap | 86/100 (86%) | 26/86 (30%) | 60/100 (60%) |
Success defined as initial primary healing without recurrence. Full citations available on the Clinical Data page.
Traditional anal fistula surgery (endoanal flap, LIFT, fistulotomy, cutting seton) carries a 20-40% failure rate and requires extensive dissection with potential sphincter damage. BioHealx® requires no dissection within the sphincter complex and achieved 84.4% healing.
This comparison is also presented on the Education page, alongside background on anal fistula and patient stories.
Current surgical options include endoanal flap, LIFT, fistulotomy, cutting seton, and laser (FiLaC). Many options are associated with a risk of incontinence and high recurrence rates. That's why we have developed the BioHealx® solution, to optimize the procedure, promote fistula healing, and prevent recurrence. BioHealx® received FDA De Novo authorization in July 2024. Your healthcare provider can answer questions and help you choose the treatment that's best for you.
Data on file.Ask your surgeon about the success rates and possible incontinence and recurrence with the procedures they are recommending. Ask about recovery time and what to expect after the procedure.
Success rates vary by type of procedure, with published data from traditional options showing success rates between 30% and 70%.1
BioHealx® had a success rate of 84.4% in its clinical trial.2
BioHealx® is for patients with mature, cryptogenic, transsphincteric, non-branching anal fistulas. Your doctor can help determine whether this treatment is appropriate for your individual situation.
See indications for use.It is recommended that a draining seton be placed for at least 6 weeks prior to the BioHealx® procedure.
It is rare for a fully formed fistula to heal spontaneously. Surgical intervention is almost always required.
BioHealx® treats all three fistula segments. Flap procedures only partially treat the fistula within the internal sphincter; the other two segments are left to heal spontaneously. Published success rates are 84.4% with BioHealx®, compared to 60% to 70% with flap procedures.
Data on file.BioHealx® treats all three fistula segments, while LIFT only treats the intersphincteric space. Based on data from published clinical studies, BioHealx has a higher success rate for healing than LIFT.
Data on file.BioHealx® delivers extraluminal compression closure of all three segments of the fistula tract to provide optimal primary fistula healing with minimal risk to continence.
Yes. BioHealx® surgery is minimally invasive because no dissection is required within the sphincter complex, and minimal sphincter muscle is incorporated into the closure.
Harsanyi et al. Int J Colorectal Dis. 2025;40:110.The clinical study on BioHealx® showed 96.8% stable or improved continence, which exceeds the substantial reduction in continence resulting from most currently used surgical options for transsphincteric fistula.
Harsanyi et al. Int J Colorectal Dis. 2025;40:110.There is virtually no risk to fecal continence because no dissection is required within the sphincter complex, and minimal sphincter muscle is incorporated into the closure, preserving most of the length of the sphincter complex.
Harsanyi et al. Int J Colorectal Dis. 2025;40:110.There were no recurrences of anal fistula after full healing in the published BioHealx® clinical study.
Harsanyi et al. Int J Colorectal Dis. 2025;40:110.The initial clinical trial results were published in a peer-reviewed journal article, showing 84.4% healing and no recurrence.
Harsanyi et al. Int J Colorectal Dis. 2025;40:110.BioHealx® is currently available in the United States. To find surgeons that offer BioHealx®, visit the BioHealx® surgeon directory.
BioHealx® does not have a publicly listed price. Pricing is determined at the hospital or institution level. Patients should discuss cost with their treating institution or insurance provider.
Signum Surgical maintains a directory of surgeons offering BioHealx®, currently available in the United States. Patients can search the BioHealx® surgeon directory by location.
If no provider appears in your area, patients are encouraged to speak with their own healthcare provider about BioHealx® as a treatment option, or contact Signum Surgical directly.
This glossary defines the clinical and technical terms used across Signum Surgical's website, including procedure names, materials, and anatomical terms related to anal fistula treatment.
| Term | Definition |
|---|---|
| LIFT | Ligation of Intersphincteric Fistula Tract, a surgical procedure that ties off the fistula tract between the internal and external sphincter muscles. |
| FiLaC | Fistula-tract Laser Closure, a procedure using laser energy to close the fistula tract from within. |
| VAAFT | Video-Assisted Anal Fistula Treatment, a technique using a small camera to visualize and treat the fistula tract internally. |
| TROPIS | Trans-anal Opening of the Intersphincteric Space, a variant surgical approach to fistula closure. |
| FIPS | Fistulotomy with sphincter repair, a procedure that opens the fistula tract and repairs the sphincter muscle. |
| BAFT | BioHealx® Assisted Fistula Treatment, the clinical name for the procedure using the BioHealx® implant. |
| PLGA | Poly(lactic-co-glycolic acid), the bioabsorbable polymer material used in the BioHealx® implant. |
| Extraluminal compression | Closing a fistula tract by compressing tissue from outside the tract, rather than filling or cutting it from inside. |
| Transsphincteric | Describes a fistula tract that passes through the sphincter muscle complex. |
| Cryptogenic | A fistula with no identifiable underlying cause other than a gland infection, the most common type. |
| De Novo authorization | An FDA regulatory pathway for novel medical devices with no prior legally marketed equivalent. |
Signum Surgical can be reached through our website contact form.
