LONDON (ShareCast) - (Sharecast News) - Tissue-healing technology specialist Advanced Medical Solutions Group has filed its pre-market approval (PMA) application for 'LiquiBandFix8' to the US Food and Drug Administration (FDA), which subsequently accepted it, it announced on Monday.
The AIM-traded company said it expected that United States approval for the product would be granted around the end of 2023.

It said LiquiBandFix8 uses drops of cyanoacrylate adhesive instead of sharp tacks to fix hernia mesh to tissue inside the body.

The approval of the PMA would herald a "significant step forward" in the treatment of hernias in the US, benefiting surgeons and patients through its ease of use, less invasive application versus tacks, and the resulting potential to reduce pain and improve recovery time, the firm explained.

It said the PMA application included clinical data from 160 patients followed up for 12 months to demonstrate the effective use of the product.

Those patients were the first cohort of a larger clinical trial of 284 patients which completed in December last year, and whose 12-month follow up would conclude this December.

AMS said the clinical study was conducted across 10 US sites, comparing the direct performance of LiquiBandFix8 with a "market-leading tacker device", the data from which would be used to market the product.

The PMA application covered a laparoscopic and open version of the device.

AMS said it was currently evaluating a number of potential commercialisation strategies in the US for LiquiBandFix8, and a US launch would present the group with a "significant opportunity" to access a large new addressable market, estimated to be greater than $250m.

LiquiBandFix8 is already being commercialised in Europe and other non-US markets, and AMS recently reported "encouraging growth" in the first half of 2022 as volumes of hernia repair procedures continued to recover from the Covid-19 pandemic.

"I am pleased to be able to confirm that the PMA for LiquiBandFix8 has been accepted by the FDA," said chief executive officer Chris Meredith.

"To have reached this milestone is a credit to the drive and energy of the research and development, clinical and regulatory teams at AMS."

Meredith said LiquiBandFix8 is "one of a number" of "significant new technologies" being developed within the group, that it expected to augment its product offering over the coming 12 to 24 months.

"Today's news further validates our strategy and commitment to increased research and development investment, enabling us to launch innovative products which we believe will drive significant, long-term revenue growth for the business."

At 1112 GMT, shares in Advanced Medical Solutions Group were down 0.56% at 266.5p.

Reporting by Josh White for Sharecast.com.

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