Advanced Medical Solutions Group Regulatory News (AMS)

27 May 2009 07:00



RNS REACH

Advanced Medical Solutions Group PLC 

("AMS" or the "Company")

InteguSeal* significantly reduces surgical site infection

in high risk cardiac surgery patients

Winsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global medical technology company, today announces that in two clinical papers presented at a meeting earlier this month of the European Society of Cardiovascular Surgery (ESCVS) in Warsaw, Poland, InteguSeal* microbial sealant was shown to significantly reduce surgical site infection (SSI) after cardiac surgery.

Post-operative infection of the wound site is an important cause of morbidity and mortality in patients undergoing cardiac surgery. The use of InteguSeal* microbial sealant, a product developed by AMS, and marketed worldwide by Kimberly-Clark, was evaluated as a means of reducing SSIs in two studies reported at the recent meeting.

In a study by Dohmen et al from the Department of Cardiovascular Surgery, Charite Hospital, Berlin, Germany, 291 consecutive patients were studied between January 2006 and July 2008. They were divided into two groups comprising a control group of 132 patients receiving standard institutional pre-operative preparation and a group of 159 patients who received InteguSeal* in addition. The clinical end point showed a statistically significant decrease of SSIs in the InteguSeal* group to 2.5% compared with the control group of 7.6%.

The authors concluded that the use of InteguSeal*, in addition to standard pre-operative preparation, provides a statistically significant reduction in the risk of SSIs in high risk patients undergoing cardiac surgery.

In another study reported at the meeting, F. Pekar from the Cardiovascular Institute SUSCCH in Banska Bystrica, Slovakia, observed 684 consecutive cardiac patients operated on between February 2007 and October 2008 with the use of InteguSeal* microbial sealant, and compared this population with 407 patients operated on between January 2006 and January 2007 without InteguSeal*.

The prevalence of SSI in the control group was 4.18% with a mortality due to SSI of 35.3%. In contrast, the prevalence of SSI in the study population using InteguSeal* was reduced to 1.6% and the mortality due to SSI was zero.

The author concluded that adding InteguSeal* to standard peri-operative SSI control techniques reduced the SSI prevalence and resulted in a shift in the type of SSI according to its depth towards less serious forms. Organ space SSI and death due to SSI did not occur at all in the study population.

Commenting on this announcement, Dr. Don Evans, Chief Executive of AMS, stated:

"Surgical site infections are a major source of concern to surgeons and healthcare providers worldwide and clinical evidence showing a statistically significant reduction in SSIs with the use of our InteguSeal* product will open up a major growth opportunity for AMS in the surgical arena.

"Our marketing and distribution partner Kimberly-Clark is conducting a major multi-centre clinical evaluation that is expected to be concluded and published in the second half of 2009. In the meantime, independent studies such as the two reported at ESCVS recently, are clearly starting to demonstrate the effectiveness of InteguSeal* in reducing SSI and in saving lives."

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Notes to Editors:

Advanced Medical Solutions is a leading company in the development and manufacture of products for the $15 billion global woundcare market.

Founded in 1991 and quoted on AIM, Advanced Medical Solutions is focused on the design, development and manufacture of innovative products for advanced woundcare and wound closure.

The advanced woundcare products are based on the moist wound healing principle. AMS uses its in-house technology to provide a vertically integrated 'one stop shop' for all categories of moist wound healing products. The Company has the capability to move a product from design and development through to production and delivery for distribution and sale into customer markets.

The acquisition of a 49.4% stake in Corpura BV in May 2008 strengthened AMS's position in hydrophilic polyurethane foam - the largest and fastest growing segment of the advanced woundcare market.

AMS' technology in cyanoacrylate based tissue adhesives is used for the closure of small cuts and trauma wounds through to large surgical incisions, and also for protecting or sealing skin to prevent breakdown or infection. 

AMS' products which currently serve the majority of the key global markets are sold either direct or through strategic partners and distributors.