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New tissue acquisition tools for gene expression

analysisTissue quality and patient comfort

Prof. Jaak Ph. Janssens MD, PhD

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Molecular biology research◦ PCR, microchips, ◦ Proteomics, genomics,…◦ Mutation research, polymorphisms

Screening◦ Risk biomarkers

Diagnosis◦ Fine tuning and reclassification

Personalized therapy◦ Prognostic markers◦ Pathway analysis – response prediction

Translational Research

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Bench Tissue acquistion BedReimbursementPharmaceutical Industry

BurdenInstitutionTradition…

Obstacles for translational research

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Bench Tissue acquistionRepresentativityPatient comfortCostsAccess

Bed

ReimbursementPharmaceutical Industry

BurdenInstitutionTradition…

Obstacles for translational research

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Tissue quality◦ Representative ◦ One large piece of tissue ◦ No artifacts

Patient comfort◦ No pain, no complication risk = safe

Inexpensive Access

◦ Handsome◦ Fast – minimal personnel◦ No dedicated room

Requirements for tissue acquistion related to translational research

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Tissue acquisition quality problem

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Fine needle aspiration (Cytology)

Microbiopsy (16 to 14 Gauge)

Macrobiopsy (8 to 12 Gauge)

Open biopsy (general anaesthesia)

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Representativity 98 % complete true prediction rate (compared to surgery)

False negative prediction rate < 1 %Transplantation quality150 to 300 mg samples

Patient comfort No pain (compared to mammography)No complications (requiring additional medical interventions)

Reduced scarringCosts Range 10 – 150 Euro (compared to 250 to 350 Euro)

Access Kits ready to start (compared to set-up times of > 30 min)

No decicated rooms

Results from safety and efficacy trials (n = 300 patients)

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Tru-cut D & F VAB SurgeryRepresentativity No Yes Yes YesComfort Yes Yes No NoCosts Yes Yes No NoAccess Yes Yes No Yes

Tissue acquisition for translational research

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Medinvents’ Products

• Automated version • Handheld or stereotactically positioned• Reusable handle controller, disposable

8 – 10 Gauge needles• Vacuum assisted system• Multiple samples without reinserting

• A range of large core soft tissue biopsy needles• Based on NEW double rota-cutting technique• 8 – 14 Gauge• Vacuum system on Single Use

Product portfolio:• Spirotome Single Use/Reusable• Spirotome Cervicore ™• Spirotome MRI ™• Spirotome Bone ™• Spirotome Easy Punch ™

Medinvents’ ApplicationsCoramate ™•Breast•Thyroid•Salivary glands•Thoracic wall•Abdominal wall•Lymph nodes•Muscle

Spirotome™•Breast•Thyroid•Salivary glands•Thoracic wall•Abdominal wall•Lymph nodes•Muscle•Liver

Spirotome Cervicore ™•Cervix•Uterus

Spirotome Easy Punch ™•Skin•Vulva

Spirotome Bone ™•Soft tissues within bone

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Conclusion

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Clinical Study & Advisory GroupRüdiger Shulz-Wendtland Erlangen – GermanyLuc Rotenberg Paris – FrancePino Cusumano Liège – BelgiumRichard Harries Grimsby – UKWoijtek Polkowski Lublin – PolandGaston Mendoza Lima – PeruMelcior Sentis Barcelona – SpainJohannes Bogers Antwerp - Belgium

Thank you.