What is your idea?
At Signum Surgical we are developing an implant to encourage healing in a colorectal condition called perianal fistula. The implant is designed to be easy to deliver, to prevent reinfection and to promote healing.
What problem are you solving and what is innovative about your approach?
Our device looks to improve the treatment of perianal fistula, a condition that can arise following an infection of a gland in the rectum.
The resulting abscess and infection burrow through the anal sphincter complex, exiting at the skin of the buttocks, and the fistula track is inherently difficult to heal in this challenging area. Patients can suffer recurrent infection.
There is currently no single gold-standard technique to effectively cure a perianal fistula, and patients are often treated with a ‘seton’, a rubber band that allows the tract to drain and prevent the abscess occurring again. More than 2,000 years ago, Hippocrates described a similar treatment using horse hair as a seton material. So this area is crying out for innovation!
If the seton is not effective, the surgical procedure that is used to heal the tract (a fistulotomy) has a high risk of rendering the patient incontinent.
Our innovation, Signum Surgical technology, is a small implant that closes the internal opening of the fistula tract. This prevents re-infection and promotes healing of the fistula tract while maintaining the continence of the patient. Our delivery mechanism also minimises the surgical skill required to treat this condition.
What’s the backstory here and how did you get involved?
Signum Surgical emerged from the Enterprise Ireland-sponsored BioInnovate programme at NUI Galway in 2014, which encourages teams to observe clinical procedures to identify innovations for the benefit of patients.
In the clinic we saw patients undergoing surgery for perianal fistula - including one patient who had required 10 surgeries in the previous twelve months due to tract refistulisation - and we thought there had to be a better way.
Through BioInnovate, the Signum Surgical team developed the idea for the new implantable device and looked at the clinical and commercial feasibility.
With Commercialisation Fund support from Enterprise Ireland, the development of the technology has progressed at NUI Galway with intellectual property protection filed in May 2015. The device has been proven in an acute pre-clinical model and is currently being assessed in a longer term chronic pre-clinical model.
The Signum Surgical team is led by myself, Eoin Bambury, an engineer by training with more than 15 years of experience in medical device new product development in Ireland and the United States, and by Moshe Zilversmit, an international medical device entrepreneur who has more than 10 years of experience developing medical devices. We are both graduates of the 2014 Bioinnovate programme.
How is this idea commercially attractive?
Approximately 146,000 perianal fistula procedures are carried out in the United States and Western Europe each year. The cost of perianal fistula surgery for each patient ranges between US$4,800 and US$14,500.
To bring our implantable device to the clinic, we will initially target the US market where we are already in contact with key opinion leaders in high-volume centres carrying out perianal fistula procedures.
We believe that a relatively low level of investment will allow us to bring the Signum Surgical device to early clinical use and revenue.
What are you looking for at the Big Ideas event?
We are looking for investment to bring the Signum Surgical technology through regulatory approval and into initial clinical trials, so that we can get this innovative solution to market in order to benefit patients as soon as possible.