Sydney-based medical technology company Next Science Limited (ASX:NXS) has received clearance from the US Food and Drug Administration (FDA) for the sale of XPerienceNo Rinse Antimicrobial Solution as a medical device in the United States. Sales of XPeriencein the US will commence immediately.
XPerienceenters the market as a single step application where the residual solution remains in the surgical site after closure and continues to help defend against pathogens for several hours, giving surgeons a simple and effective adjunct to help prevent surgical site and post-operative infections.
Managing Director, Judith Mitchell, said the productis designed for use in virtually every open surgery case, with its initial focus being on: Shoulder; Hip; Knee; Traumaand Podiatry.
With market leading performance in pathogen reduction where bacteria like MRSA (Golden Staph) can be eliminated so that less than one bacterium in a hundred million is present, we expect the product will become a first choice in the battle to reduce surgical site infection (SSI),” Ms Mitchell said.
“With an estimated 234 million surgical procedures undertaken globally per annum, XPerienceprovides an enormous opportunity to help reduce infection, antimicrobial resistance and save lives while reducing expenses for health systems arising from postsurgical infections.”
SSI is the second largest cause of hospital acquired infection in the US and a major cause of surgical complications and increased morbidity and mortality across the world.The use of XPerienceNo Rinse Antimicrobial Solution can help prevent costly hospital re-admissions. In the US alone, it is estimated that surgical site infections contribute an additional US$3.5B to US$10B to the cost of healthcare.
Next Science’s initial sales focus will be the US orthopaedic surgery market of 5.3 million surgeries per year in 2010; a market opportunity of over $1B per annum. The potential global market for XPerienceis greater than US$15B per annum.
Key clinical studies to provide additional evidence for Next Science to drive widespread adoption in the surgical community are commencing.
XPerience will be sold in the US using a third-party distribution network of over 300 commission agents managed by Next Science. Next Science’s sales network provides coverage to service more than 90% of the US including the 15,000 Hospitals and Ambulatory Surgery Centres that carry out more than 100 million surgical procedures in the US annually.