510(K) approval for LiquiBand
For immediate release: 15 April 2010
Advanced Medical Solutions Group plc
(“AMS” or the “Group”)
510(k) clearance for LiquiBand® tissue adhesive
aimed at closure of surgical wounds in the Operating Room
Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS.L), the global medical technology company, today announces that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a topical skin adhesive which is aimed at the closure and protection of surgical incisions in the Operating Room as an alternative to sutures and staples.
Containing a strong, fast setting, cyanoacrylate adhesive, the product has a dual applicator which allows initial closure of the surgical incision followed by the application of an adhesive film to help protect the wound site from infection or breakdown.
As part of the LiquiBand® Topical Skin Adhesive range, this product is aimed at the closure and protection of surgical wounds and is particularly suited for laparoscopic procedures.
Together with the two products launched into the US in December 2009, this approval now provides AMS with a broad range of topical tissue adhesives for closure of trauma wounds and surgical incisions for the US Acute Care and Alternate Site market segments.
Commenting on this announcement, Dr. Don Evans, Chief Executive Officer of Advanced Medical Solutions commented:
“This latest 510(K) will increase our coverage of the US tissue adhesives market from what we believe to be around 70% to some 90%. It will also increase our penetration into the important US Operating Room segment.
“Our LiquiBand® range is already well proven and successful in Europe. Together with the strong marketing and distribution partners we are putting in place, this latest FDA approval further increases our ability to penetrate the US market, which is currently estimated at US$200 million and growing at around 15%.
“The first few months of our US marketing activity has been very encouraging and we are confident that this new dual applicator product will underpin the momentum we are already seeing.”
For further information, please visit www.admedsol.comor contact:
Advanced Medical Solutions Group plc
Don Evans, Chief Executive Officer Tel: +44 (0) 1606 545508
Mary Tavener, Finance Director
Chris Meredith, Chief Operating Officer
John West / Chris Munden Tel: +44 (0) 20 7920 3150
Investec Bank plc
Gary Clarence / Daniel Adams Tel: +44 (0) 20 7597 5970
Notes to Editors:
Advanced Medical Solutions Group plc (AIM: AMS.L) designs, develops, manufactures and sells products for the $15 billion global woundcare market. AMS products are sold globally, either directly or through strategic partners and distributors.
AMS advanced woundcare products are based on an extensive range of technologies including alginates, silver alginates and hydrophilic polurethane foam. These and other products pioneer the concept of moist wound healing, allowing wounds to heal faster and with less pain and scarring. They protect the wound, deal with tissue fluids and provide an optimal environment for healing to occur. The inclusion of silver adds a proven effectiveness against antibiotic resistant bacteria.
AMS wound closure and sealants products are based on cyanoacrylate adhesive (“superglue”) technology developed for medical applications. Tissue adhesives offer significant benefits over conventional ways of closing wounds following trauma or surgical incision. They are simple to use, non-invasive, help to reduce the risk of infection, minimise trauma to the patient and provide good clinical and cosmetic outcomes. The technology is also ideally suited to protecting skin from breakdown or for use as a skin sealant to help prevent infection of surgical sites.
AMS employs 240 people in three locations (Winsford, Plymouth and the Netherlands). The business is debt free, profitable, cash generative and the Board recently announced that its intention is to recommend a maiden dividend for the year ended 31st December 2010.
In 2009, AMS delivered a 19% increase in revenues, a 51% increase in operating profit before exceptionals, and a strong, debt-free, year-end balance sheet. The business has an experienced management team, whose stated aim is to grow the business both organically and by exploring selective acquisition opportunities.
This information is provided by RNS