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biolab

Barcelona, 25 of November of 2008

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To whom it may concern SUBJECT: BIOCOMPATIBILITY TESTS FOR ANDROPENIS GOLD The following tables summarize the results of tests conducted on behalf of ANDROMEDICAL S.A. on the test items ANDROPENIS, ANDROPENIS GOLD and ANDRORING by Biolab S.p.A. in the Assay Center nd th of Via B.Buozzi, 2 ­ 20090 Vimodrone Milan (Italy) from the 2 of September of 2005 to the 24 of November of 2008. Details of the analytical methods, samples analyzed and sample preparation, test conditions and procedures are described in the final reports referenced in each table. A copy of those reports is retained in the archives of the Assay Center. Test Item: ANDROPENIS GOLD HEAVY METALS DETERMINATION (EN 71-3:1994/AC:2002) (see report 2008-910-2iSAM) limit EN 713:1994/AC:200 2 (mg/kg) 1000 75 60 90 60 25 60 500 superior plastic support (mg/kg) <100 <7.5 <6 <9 <6 <2.5 <6 <50 <2.5 <2.5 <2.5 <2.5 silicone band (mg/kg) <100 <7.5 <6 <9 <6 <2.5 <6 <50 <2.5 <2.5 <2.5 <2.5

metals Barium Cadmium Chromium Lead Mercury Arsenic Antimony Selenium Copper Nickel Zinc Gold

metal bar (mg/kg) <100 <7.5 <6 10 <6 <2.5 <6 <50 <2.5 96 <2.5 <2.5

axis (mg/kg) <100 <7.5 <6 <9 <6 <2.5 <6 <50 <2.5 <2.5 <2.5 <2.5

andro top (mg/kg) <100 <7.5 <6 <9 <6 <2.5 <6 <50 <2.5 <2.5 <2.5 <2.5

Biolab Española de Análisis e Investigación S.L. Parc Cientific de Barcelona C/ Baldiri Reixac 4-6 E-08028 Barcelona (España)

T +34-93-403 4555 F +34-93-403 4555 [email protected] www.biolab.es

NIF: ES B63 407 902 Inscrita en el Registro Mercantil de Barcelona Tomo 36252 ­ Folio 0198 Hoja 278914

biolab

BIOLOGICAL TESTS (ISO 10993) Model ANDROPENIS Test Cytotoxicity ­ Elution Test (ISO 10993 ­ 5: 1999) Sample PLASTIC FOAM ALLUMINUM ALLOY SILICONE Delayed Type POOL OF THE Hypersensitivity Test COMPONENTS. (PLASTIC, (ISO 10993- 10 : 2002) FOAM, ALLUMINUM ALLOY, SILICONE, METAL Skin Irritation Test (ISO 10993-10: 2002) BAR) Cytotoxicity ­ METAL BAR Elution Test (ISO 10993 ­ 5: 1999) Result Report NOT CYTOTOXIC SAM2817i-1 NOT CYTOTOXIC NOT CYTOTOXIC NOT CYTOTOXIC NOT SAM2817i-2 SENSITIZING NOT IRRITANT SAM2817i-3

ANDROPENIS GOLD

NOT CYTOTOXIC 2008-910-2i SAM

Test Item: ANDRORING BIOLOGICAL TESTS (ISO 10993) Model ANDRORING Test Cytotoxicity ­ Elution Test (ISO 10993 ­ 5: 1999) Sample ANDRORING Result NOT CYTOTOXIC Report SAM3036i-2

Biolab Española SL Luca Salvi Managing Director

Biolab Española de Análisis e Investigación S.L. Parc Cientific de Barcelona C/ Baldiri Reixac 4-6 E-08028 Barcelona (España)

T +34-93-403 4555 F +34-93-403 4555 [email protected] www.biolab.es

NIF: ES B63 407 902 Inscrita en el Registro Mercantil de Barcelona Tomo 36252 ­ Folio 0198 Hoja 278914

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Andropenis Gold Biocompatibility Tests

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