Our Technology

The Signum Surgical BioHealx™ Device was developed to meet three key points identified by surgeons as necessary for an ideal solution for the treatment of anal fistula

To close the internal opening reliably and permanently

To keep the sphincter muscle intact and not affect continence

To be a low learning curve for maximum patient access

Intended to promote healing

The BioHealx™ implant is a helical, barbed bioabsorbable implant intended to promote healing by primary intention. The implant is provided sterile, preloaded on the BioHealx™ Delivery Device, and is intended for single use.  The BioHealx™ delivery device is a single-use, disposable delivery device that rotates the implant into the soft tissue surrounding the internal opening of the fistula tract.

The BioHealx™ implant apposes the internal opening of the fistula channel and is held in position by its design geometry. The implant is fully enclosed in the anal sphincter muscle tissue and is not exposed to the ano-rectal canal.

Commitment to Quality

Signum is an ISO 13485 certified company

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