SYDNEY--(BUSINESS WIRE)--Next Science Limited (ASX:NXS) (Next Science / Company) is pleased to announce that it has received a section 510(k) clearance from the Food and Drug Administration (FDA) for the sale of XPERIENCE No Rinse Antimicrobial Solution as a medical device in the United States. Sales of XPERIENCE in the US will commence immediately.
XPERIENCE 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.
XPERIENCE is designed for use in virtually every open surgery case, with our initial focus on:
- Shoulder
- Hip
- Knee
- Trauma
- Podiatry
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 healthcare.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 XPERIENCE 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.
XPERIENCE 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
Approved and authorised for release by Next Science’s Board of Directors.
About Next Science
Next Science is a medical technology company headquartered in Sydney, Australia, with a research and development centre in Florida, USA. Established in 2012, the Company’s primary focus is on the development and continued commercialisation of its proprietary Xbio technology to reduce the impact of biofilm based infections in human health. Xbio is a unique, non-toxic technology with proven efficacy in eradicating both biofilm based and free-floating bacteria. Next Science owns 100% of the patent protected intellectual property relating to its Xbio technology. For further information visit: www.nextscience.com.
Forward looking statements
This announcement may contain forward looking statements which may be identified by words such as “believes”, “considers”, “could”, “estimates”, “expects”, “intends”, “may”, and other similar words that involve risks and uncertainties. Such statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of Next Science or its Directors and management, and could cause Next Science’s actual results and circumstances to differ materially from the results and circumstances expressed or anticipated in these statements. The Directors cannot and do not give any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this announcement will actually occur and investors are cautioned not to place undue reliance on these forward-looking statements.
1https://www.who.int/surgery/global_volume_surgery.pdf
2https/www.centerfortransforminghealthcare.org/improvement-topics/surgical-site-infections/
5https://blog.definitivehc.com/how-many-ascs-are-in-the-us
6https://www.aha.org/statistics/fast-facts-us-hospitals
