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Monthly Spin-Off #3 [Future Solution for Treating Fistulas]

Is This a Future Solution for Crohn’s Disease?

What is a Fistula? Can a Fistula Plug be the Answer to Fistula Issues?


A fistula is an abnormal connection between organs anywhere in the body, and can occur due to any number of different reasons. Fistulas can pose a list of problems including pain, discomfort, and other serious complications. When a fistula occurs in the GI tract, however, other, more frustrating problems can arise. Perianal, enterocutaneous and rectovaginal fistulas typically require surgery, and are associated with long recovery and potential incontinence, which can be embarrassing for those who suffer from this complication. People who may be more susceptible to these types of fistulas can also get them due to inflammatory bowel disease, such as Chron’s disease or ulcerative colitis, among others. Anal fistulas are not talked about enough all over the world due to their taboo location, which can greatly affect people of all ages who are desperate for a better treatment.

There are several different ways to treat an anal fistula which all depend upon how the fistula is affecting a person in their particular case. A fistulotomy, flap procedure, and LIFT (ligation of the intersphincteric fistula tract) procedure are more complicated treatments. A fistulotomy involves cutting along the length of the fistula to open it so it can heal as a flat scar. A flap procedure is a type of treatment when the fistula is scraped out and the hole is covered with a flap of tissue. A LIFT procedure involves a cut being made in the skin above the fistula and moving apart the sphincter muscles. The fistula is then sealed at both ends and allows the cut to remain open so it can lie flat and heal. Some of the simpler treatment methods include using medical glue to seal the hole or a seton, which is a piece of surgical thread that is inserted into the tract and allows for the wound to drain and slowly heal. The use of a medical plug is one of the simpler procedures that has a lot of potential in being an effective way to treat anal fistulas, however, there are shortcomings to the currently available plugs. In the image below you can see an animal study that was done using both the industry standard plug vs. our Bio-Spun™ Fistula Plug.

There has been an effort to reduce invasive surgical procedures by insertion of a fistula plug, which are associated with less pain and a quicker recovery. Unfortunately, the success rate of fistula plugs currently in the market, as defined by tract healing, is less than 30%. The primary reasons for the frequent failures include ineffective fistula closure, plug dislocation, or detachment and infection of the implantation site. Therefore, there is a clear need for a next-generation plug that enhances tract healing.

Insert: Bio-Spun™ Fistula Plug

BioSurfaces believes that we have an answer to creating a better treatment for those who suffer from anal fistulas. A novel nondegradable, unibodied fistula plug (Bio-Spun™ fistula plug) has been developed using proprietary

electrospinning technology. The same material that BioSurfaces uses in its other products and devices is used here in the fistula plug, which has a composition that closely resembles the body’s natural scaffold. This helps cells from the body respond much more naturally than their response to other materials, preventing the body from sending an immune response to fight off the implanted plug and inducing scar tissue. The construction of the plug itself provides excellent handling and allows for fitting varying track sizes to better suit patients needs. The plug itself can be used as is, without any changes, or can be surface modified to induce faster healing. The plug can also have targeted drug or stem cell therapy imbedded in the fibers to allow for better treatment. The Bio-Spun™ fistula plug that we offer provides a viable, minimally-invasive solution for anal fistula treatments. Preclinical trials that we have done show that our plug has been able to induce cell migration and tissue ingrowth via mechanosensory contact, prevent fibrosis and rejection, and allow healing to an easily infectious area.

Next Steps

BioSurfaces is looking to bring this device through regulatory approval, which will require additional benchtop, biocompatibility and preclinical testing along with a first-in-human clinical trial. The electrospinning process that we use allows us to create a better, more customizable product to treat a disorder that affects more people than we probably know. Please reach out to BioSurfaces in order to learn more about what we are trying to do to help those who suffer from anal fistulas.

Written By: Nathaniel Long



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