Next Science Begins U.S. Clinical Trial for XPERIENCE No Rinse Antimicrobial Solution
Highlights
- Clinical trial for XPERIENCE commences after receiving FDA clearance in April
- Randomized, controlled, double-blinded study will evaluate the effects of XPERIENCE in decreasing surgical site infections
- Study will focus on patients undergoing tibial fracture repair
JACKSONVILLE, Fla.–(BUSINESS WIRE)–Next Science Limited (ASX:NXS) (Next Science / Company) is pleased to announce that a clinical trial has been initiated in the U.S. for XPERIENCE TM No Rinse Antimicrobial Solution. Enrollment in the 30-patient, 90-day study is currently underway.
The trial, the TIFRAX (Tibial Fracture) Study, is a randomized, controlled, double-blinded, prospective study to evaluate the efficacy of XPERIENCE in helping decrease wound bioburden and surgical site infections (SSI). It will also evaluate whether XPERIENCE can improve post-operative outcomes when used as adjunct treatment to standard of care in patients undergoing tibial fracture repair.
The study’s primary investigator is Dr. Robert Harris, an orthopaedic trauma surgeon with the Hughston Clinic in Columbus, Georgia. In addition to serving as the director of orthopaedic trauma for the Hughston Clinic, Dr. Harris is a fellow of the American Academy of Orthopaedic Surgeons and a member of several orthopaedic surgery associations, including the American Orthopaedic Association, the Orthopaedic Trauma Association and the Society of Military Orthopaedic Surgeons.
XPERIENCE is a no-rinse solution that is designed to help prevent surgical site and post-operative infections by rinsing away debris and microorganisms. XPERIENCE breaks down biofilms, which are powerful communities of bacteria that function as a single entity with behaviors and defenses that are a leading contributor to SSIs.1 2 Biofilms account for more than 80% of microbial infections in the human body,3 according to the U.S. National Institutes of Health.
“The start of this trial is a significant milestone in the clinical development of XPERIENCE and for the evolution of our company,” said Managing Director Judith Mitchell. “Next Science has a unique opportunity to change the trajectory of the war on infection by providing solutions that eliminate biofilms, and their incumbent bacteria. The results of this clinical trial will help in the global fight against surgical site infections, which in the U.S. alone contribute an additional $3.5 billion annually to the cost of healthcare.4”
In April, Next Science announced it had received 510(k) clearance from the Food and Drug Administration for the sale of XPERIENCE as a medical device in the U.S. XPERIENCE is predominantly used in orthopaedic procedures, including shoulder, hip, knee, trauma and podiatry surgeries. Future studies will look at expanding current indications.
XPERIENCE is the newest innovative product from Next Science, whose mission is to heal patients and save lives by addressing the impact of biofilms on human health. Each of these products is powered by XBIO™ Technology, which disrupts biofilm’s extracellular polymeric substance and makes the bacteria within the biofilm more vulnerable to attack.
About Next Science
Next Science is a medical technology company headquartered in Sydney, Australia, with a research and development center in Florida, USA. Established in 2012, the Company’s primary focus is on the development and continued commercialization of products powered by 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. 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.
1 International Wound Infection Institute (IWII) Wound infection in clinical practice. Wounds International.
2 Hall-Stoodley L, Stoodley P. Evolving concepts in biofilm infections. Cell Microbiol. 2009;11(7):1034-43.
3 Joo HS, Otto M. Molecular basis of in-vivo biofilm formation by bacterial pathogens. Chemistry & Biology. 2012;19(12):1503-1513.
4 Zimlichman, E., et al., “Health Care-Associated Infections. A Meta-analysis of Costs and Financial Impact on the US Health Care System”. JAMA Intern Med, 173(22): (2013): 2039-46.
Contacts
Judith Mitchell
Managing Director, Next Science Limited
Phone: +61 2 9375 7989
Email: investorqueries@nextscience.com
Michael Brown
Pegasus Advisory
Phone: +61 400 248 080
Email: mbrown@pegasusadvisory.com.au
Anthony Priwer
Dalton Agency
Phone: +1 615.515.4891
Email: apriwer@daltonagency.com
