Next Science Gains FDA 510(k) for Antimicrobial Solution

By Julie A. Vetalice

Next Science Gains FDA 510(k) for Antimicrobial Solution

Next Science was granted FDA 510(k) clearance to market XPERIENCE™ No Rinse Antimicrobial Solution, and will launch sales immediately.

XPERIENCE offers 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. This adjunct is designed to help prevent surgical site and post-operative infections.

Next Science will initially focus XPERIENCE on applications for:

  • Shoulder
  • Hip
  • Knee
  • Trauma
  • Podiatry

XPERIENCE will be sold in the U.S. through a third-party distribution network of over 300 commission agents.

Managing Director Judith Mitchell said, “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. With an estimated 234 million surgical procedures undertaken globally per annum, XPERIENCE provides an enormous opportunity to help reduce infection, antimicrobial resistance and save lives while reducing expenses for health systems arising from post-surgical infections.”

Product Labels: Shoulder Replacement, Hip Replacement, Knee Replacement

Tags: 510(k) Clearance, Regulatory