120,000 US peripheral artery disease (PAD) patients each year, the gold
standard of care, autologous grafting (usually of saphenous vein) to create a
bypass, is not an option. Instead, they must receive synthetic polymer grafts.
These grafts often lose patency after prolonged blood contact, with 30% of
synthetic grafts failing within one year. The resultant complications and
surgeries cost the US healthcare system over $2 billion, and over a thousand
lives. InSitu is made of a vastly improved polymer: robust, elastic, and more
biocompatible. But most excitingly of all, InSitu is designed to guide the
body’s own stem cells to generate a natural artery, anatomically and
functionally similar to the body’s other arteries. The polymer gradually
biodegrades during the course of new artery formation, further minimizing
complication risks. Success has been demonstrated in animal trials. InSitu will
initially aim to replace existing synthetic grafts. Once it proves successful
in a wide range of patients, it may ultimately replace autologous grafting too:
harvesting saphenous vein is invasive, painful, and leads to donor site
morbidity. In this scenario, the
potential market size would grow to 750,000 procedures per year in the US alone.
Polymer synthesis is already licensed to Secant Medical; a new partner is being
sought for GLP preclinical testing, GMP scale up, regulatory approval, device
manufacturing, and marketing.