AMS granted CE mark for laparoscopic GI sealant device

Advanced Medical Solutions Group, the surgical and advanced wound care specialist company, has received CE mark approval for its laparoscopic gastrointestinal (“GI”) sealant device, Seal-G MIST.

Also, the existing CE mark for the Seal-G open device has been extended to include a blue colourant that aids visibility for the surgeon during product usage.

Patient enrolment for the first human clinical study of Seal-G and Seal-G MIST began in Israel in February 2021 with a small number of patient procedures and successful follow-ups already completed. The 160-patient study will also recruit patients in the UK and Italy with final study results expected in early 2022. The open-label trial will collect clinical evidence on the usage, safety, performance and usability of Seal-G and Seal-G MIST. Successful study results would provide additional momentum for the full commercial European launch planned for 2022.

In 2020, AMS completed commercial research activity with European Key Opinion Leaders (“KOLs”) on Seal-G and Seal-G MIST. Positive feedback was received, including recognition that the device is a potential solution to the high unmet need for an effective GI sealant.

Chris Meredith, chief executive officer of Advanced Medical Solutions, said: “Having invested in these innovative products since acquiring Sealantis in January 2019, we are busy preparing to enter the global $1 billion internal sealants market with a differentiated commercial product range. These market approvals and the initiation of patient enrolment are important milestones for the Group as we continue to build our commercial activity through 2021, in anticipation of full commercial launch in 2022."