Advanced Medical Solutions gets CE-mark for Seal-G MIST
Surgical and advanced wound care-focussed Advanced Medical Solutions has received CE-mark approval for its laparoscopic gastrointestinal sealant device ‘Seal-G MIST’, it announced on Tuesday.
The AIM-traded firm said that the existing CE-mark for the ‘Seal-G’ open device had also been extended to include a blue colourant, to aid 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, with a small number of patient procedures and successful follow-ups already complete.
The 160-patient study would also recruit patients in the UK and Italy, with final study results expected in early 2022.
Advanced Medical Solutions said the open-label trial would 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 Europe launch, planned for 2022.
In 2020, the company completed commercial research activity with ‘key opinion leaders’ in Europe for both products.
Positive feedback was received, including recognition that the device was a “potential solution” to the unmet need for an effective gastrointestinal sealant.
“Having invested in these innovative products since acquiring Sealantis in January 2019, we are busy preparing to enter the global $1bn internal sealants market with a differentiated commercial product range,” said chief executive officer Chris Meredith.
“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.”
At 0953 BST, shares in Advanced Medical Solutions Group were up 1.1% at 275p.