By Industry News
Sydney, Australia – Monday, April 26, 2021 – Next Science Limited is pleased to announce that it has received a section 510(k) clearance from the Food and Drug Administration (FDA) for the sale of XPERIENCETM No Rinse Antimicrobial Solution as a medical device in the United States. Sales of XPERIENCETM in the US will commence immediately.
XPERIENCETM enters 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.
XPERIENCETM is designed for use in virtually every open surgery case, with our initial focus on:
Managing Director, Judith Mitchell commented, “With market leading performance in pathogen reduction, where bacteria like MRSA (“Golden Staph”) can be eliminated so that less than 1 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). With an estimated 234 million surgical procedures undertaken globally per annum1, XPERIENCETM provides 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 mortality across the world.2 The use of XPERIENCETM No 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 health care.3
Next Science’s initial sales focus will be the US orthopaedic market of 5.3M surgeries per year in 20104, a market opportunity of over US$1B per annum.
The potential global market for XPERIENCETM is greater than US$15B per annum.
Key clinical trials to provide additional evidence for Next Science to drive widespread adoption in the surgical community are commencing.
XPERIENCETM will be sold in the US through 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.5 6
About Next Science
Next Science develops innovative technologies to address the problem of bacterial biofilms. BlastX™ is exclusively distributed by 3M. For BlastX™ inquiries, contact 3M at 1-800-228-3957.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.