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Surgical and advanced wound care specialist Advanced Medical Solutions Group (AMS) has announced that its Seal-G MIST laparoscopic gastrointestinal sealant device has been granted a CE mark. Furthermore, the existing CE mark for AMS’s Seal-G open device has been extended and now covers a blue colourant designed to increase surgeon visibility.

Several patient procedures and follow-ups have already been completed after AMS began enrolment for human clinical studies for Seal-G and Seal-G MIST in Israel earlier this year. The study will ultimately expand to include participants in the UK and Italy and is due to return final results in 2022.

The trials will gather clinical data regarding the usage, performance, usability and safety of the devices. If successful, the company is planning to use the results to help drive a planned commercial launch in Europe next year. Commercial research has already reportedly returned positive feedback.

AMS Chief Executive Officer Chris Meredith 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."

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