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Study Report Reference number: TF2-SRGM-003

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Bactericide / Bacteriostatic properties GelitaCel® Oxidized Resorbable Cellulose

Source: GelitaMedical Technical File TF2-GM-01.00

Bactericide / Bacteriostatic properties; The pH level in Oxidized Cellulose is considered to be the triggering effect in the coagulation cascade, resulting in haemostasis and at the same time responsible for bactericidal properties. The goal of this study is to obtain information on comparable bactericidal properties between GelitaCel® (Oxidized Resorbable Cellulose and Surgicel® (Oxidized Regenerated Cellulose, Johnson and Johnson) . Resulting from study TF2-SRGM-002 we confirm by means of this study that the low pH value (2.9) of the product results in bactericide/bacteriostatic properties. Due to the acid environment automatically a bactericide and bacteriostatic environment is created, similar as to other competitive products like Oxidized Regenerated Cellulose (Surgicel®, Johnson and Johnson). Therefore GelitaCel® Oxidized Resorbable Cellulose inhibits aerobic & anaerobic

bacteria cell growth & multiplication similar to all other existing competitive products. In-vitro testing performed by an accredited lab have proven this product characteristic.

Note: Lab accreditation: Ongoing perfomance control of staff and management according to ISO 9001 (accredited by Lloyd`s) Medical Contract manufacturing under cleanroom conditions, accredited ISO13485:2003 Validations based on OECD GLP principles Routine microbial quality control according to GCLP

See also the pictures below which clearly show this.

Bactericide properties of GelitaCel® on P. Aeruginosa

Bactericide properties of GelitaCel® on S.Aureus

GELITA MEDICAL BV · Osdorperweg 590, 1067 SZ Amsterdam · P.O. Box 67, 1160 AB Zwanenburg · The Netherlands Telephone +31 (0)20 667 53 30 · Fax +31 (0)20 667 53 41 · www.gelitamedical.com · [email protected] Deutsche Bank AG 265111536-0000EUR000 · IBAN NL56DEUT0265 1115 36 · Swift code DEUTNL2A · Chamber of Commerce Amsterdam 34205178 · VAT NL 812930204B01 · Our standard terms and conditions are applicable on all our transactions, as filed at the Civil Court of Haarlem, The Netherlands, registration 38/2004.

GelitaMedical has initiated similar testing at regular intervals in order to continuously monitor the bactericide and bacteriostatic behaviour and characteristics of GelitaCel® in various types of aerobic & anaerobic bacteria.

See below a listing of bacteria that will be subject to this regular testing;

Staphylococcus aureus Staphylococcus epidermidis Micrococcus luteus Streptococcus pyogenes group A Streptococcus pyogenes group B Streptococcus salivarius Branhamella catarrhalis Escherichia coli Klebsiella aerogenes Lactobacillus spp. Salmonella enteritidis Shigella dysenteriae Serratia marcescens Bacillis subtilis Proteus vulgaris Corynebacterium xerosis Mycobacterium phlei Clostridium tetani Clostridium perfringens Enterococcus spp Enterobacter cloacae Pseudomonas aeruginosa Pseudomonas stutzeri Proteus mirabilis

Results from pending studies will be reported on availability.

GELITA MEDICAL BV · Osdorperweg 590, 1067 SZ Amsterdam · P.O. Box 67, 1160 AB Zwanenburg · The Netherlands Telephone +31 (0)20 667 53 30 · Fax +31 (0)20 667 53 41 · www.gelitamedical.com · [email protected] Deutsche Bank AG 265111536-0000EUR000 · IBAN NL56DEUT0265 1115 36 · Swift code DEUTNL2A · Chamber of Commerce Amsterdam 34205178 · VAT NL 812930204B01 · Our standard terms and conditions are applicable on all our transactions, as filed at the Civil Court of Haarlem, The Netherlands, registration 38/2004.

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