Monday, June 05, 2023
Advanced Medical Solutions Group plc, a leading company specializing in tissue-healing technologies, is thrilled to announce that it has obtained approval from the US Food and Drug Administration (FDA) for the Pre-Market Approval (PMA) of LiquiBandFix8® for use in hernia surgery. The FDA granted authorization earlier than expected, only seven months after submission, which is a significant accomplishment for AMS as it marks their first successful PMA application. This achievement reflects the exceptional quality of the submission and underscores the numerous benefits that LiquiBandFix8® offers to patients.
LiquiBandFix8® is an innovative solution that replaces sharp tacks with drops of cyanoacrylate adhesive to secure mesh to tissue during hernia surgery. The FDA approval covers two variants of the device: one for open surgery and another for laparoscopic use. These are the first products of their kind in the US and are expected to bring substantial advantages to patients, including reduced post- operative pain and complications. In addition to its use in hernia repair, LiquiBandFix8® has also been approved for closing the peritoneum, the abdominal cavity's surrounding membrane. This expanded application highlights the product's potential to deliver significant clinical benefits. This achievement opens up a substantial commercial opportunity for AMS to enter an estimated $200 million market.
AMS conducted a Randomized Control Trial (RCT) involving 284 patients at five clinical sites across the US. This trial, conducted in collaboration with top hernia surgeons, directly compared the performance of LiquiBandFix8® with a leading tacker device. The clinical data obtained from this trial was included in the PMA application and will be instrumental in marketing the product.
LiquiBandFix8® is already being successfully marketed in Europe and other international markets. AMS experienced strong sales growth in 2022, which was further supported by the endorsement from the UK National Institute for Clinical Excellence (NICE), recommending the use of cyanoacrylate adhesives as an alternative to invasive tackers.
AMS is currently in advanced negotiations with several potential commercial partners in the US and expects to announce its final decision regarding partnerships and marketing strategies in the near future. With this significant approval, the company will now focus on launching the exciting LiquiBandFix8® product range across the US during the second half of 2023.