Advanced Medical Solutions upbeat on US FDA approvals
Tissue-healing technology specialist Advanced Medical Solutions has received approval from the US Food and Drug Administration (FDA) for its ‘LiquiBandFix8’, it announced on Monday, for use in hernia surgery.
The AIM-traded company said the authorisation was granted ahead of schedule.
It said LiquiBandFix8 uses drops of cyanoacrylate adhesive instead of sharp tacks to fix mesh to tissue inside the body.
The FDA approval covered two devices - one for open surgery, and one for laparoscopic use, with both being the first of their kind in the US.
Additionally, LiquiBandFix8 was approved for closing the peritoneum, expanding its application and clinical benefits.
The board said the approval opened up a significant commercial opportunity for AMS, estimated to be worth $200m, as it entered a new addressable market.
“I am delighted to be able to announce the approval of LiquiBandFix8 in the US which represents a significant milestone for AMS, further validating the research and development investment we have made and demonstrating our commitment to develop high-quality, innovative products that satisfy unmet patient needs and provide significant commercial opportunities,” said chief executive officer Chris Meredith.
“The speed of the approval following our PMA application in October 2022, is a testament to the quality of product and the benefits it offers to patients, as well as the strength of our PMA submission.
“Now that we have the FDA approval, I am confident that we can conclude our discussions with potential partners and embark on a successful US launch in H2 2023 and that LiquiBandFix8 in the US will be a meaningful contributor to achieving our stated aim of delivering sustainable double digit organic growth.”
At 1220 BST, shares in Advanced Medical Solutions were up 3.21% at 241.5p.
Reporting by Josh White for Sharecast.com.