I ett tidigare pressmeddelande (2011-06-30) rapporterade Episurf indikationer på positiva resultat från genomförd 1-årsstudie utifrån röntgenobservationer. Resultaten handlar om implantatens förmåga att växa fast med kringliggande benvävnad (långtida fixering).
Nu har även oberoende resultat från genomförda histologiska analyser (observationer av vävnader på cellnivå) genomförts samt rapporterats till Episurf.
De histologiska observationerna från 1-årsstudien visar att de studerade implantaten är väl integrerade med kringliggande benvävnad och brosk. Inga degenerativa förändringar (nedbrytande processer) i angränsande ledbrosk har kunnat observeras. Inte heller i övrigt har negativa effekter på omgivande vävnader observerats, utom i ett fall som visade en mindre förlust av benmassa i ett litet område under implantathatten. Dock kunde ny benbildning tydligt observeras.
Slutsatsen från de histologiska observationerna är att fortsatt utveckling av Episurfs implantat är motiverad, där nästa steg är implantation i människor.
Peter Schuepbach*, adjungerad Professor, som genomfört de histologiska analyserna, kommenterar:
”The one-year results of six Episurf implants placed in sheep condyles showed very encouraging results. Both the pegs and hats of the implants were firmly osseointegrated. An intimate bonding between the HA-layer and bone was evident. Cartilage integrity was re-established by the implant hat in all specimens. Degenerative changes in the cartilage adjacent to the hat were not observed. No adverse effects on surrounding tissues were evident in five specimens, while one specimen showed minor bone loss in a small area below the hat. No further bone resorption by osteoclasts was present in this area and repair of the defect by new bone formation was evident. These promising results justify further development of this implant type and its first placement in humans.”
Stockholm den 17 oktober 2011
Episurf Medical AB (publ)
Styrelsen
För mer information, vänligen kontakta:
Homan Panahi
IR-ansvarig Episurf Medical AB (publ)
Tel: +46 (0) 763-989 666
E-post: homan@episurf.com
* Peter Schuepbach is Adjunct Professor of Periodontics, University of Pennsylvania, USA. Peter Schupbach studied natural sciences at the Federal Technical High School of Switzerland and did 1979 his degree as Doctor of Science.
He spent over 20 years at the Dental Institute of the University of Zurich as a head of a histological group. He has a PhD in biology and was lecturer at the Faculty of Medicine of the University Zurich for “Oral Biology and Pathophysiology“.
He is member of several international organizations and author of over 50 publications in the fields of implantology, tissue regeneration, and oral microbiology. He is an international lecturer in implantology. He is Adjunct Associate Professor at the School of Dentistry, Medical College of Georgia, Augusta and since 2008 he is Adjunct Professor of Periodontics at the School of Medicine, Robert Schattner Center, University of Pennsylvania, USA. He also runs a Research Center for Implants and Biomaterials in Switzerland.
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