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Advanced Medical Solutions Group (LON: AMS) said on Tuesday that it has received CE mark approval for its laparoscopic gastrointestinal (GI) sealant device, Seal-G MIST.
The company said it has also extended the existing CE mark for the Seal-G open device to include a blue colourant that aids visibility for the surgeon during product usage.
AMS fees the CE Mark will strengthen its commercial product offering for its range of GI sealants and provides it with a differentiated product “to enter new $1 billion market and fulfil a significant unmet need”.
Patient enrollment for the first human clinical study of Seal-G and Seal-G MIST began in 2021with a small number of patients. The 160 patient study will also recruit patients in the UK and Italy, with final study results expected in early 2022.
Chris Meredith, CEO 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.”
AMS Shares are flat on the day despite the news, priced at 272p per share.
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