Spirotome Concept Sales Guide

Version 2012

Click to edit Master title styleSpirotome 8-10-14G• Trocar

• Helix needle

• Cutting cannula

• Release element

FIRST ManualVacuum & Macro

Biopsy System

CE & FDA Approved for 13 different applications

Click to edit Master title styleHow it works?

1.Searching 2.Penetration

3.Cutting 4.Retrieving

Spirotome Technology

Click to edit Master title styleSpirotome Training Program

Identify

Attract

Engage

Ret

ain

Customer RelationshipProduct awarenessProduct Workshop, Application Fields & Procedure Training

Follow Up & Feedback

Define Needs

Training Program

Procedure Support

Spirotome Solution

Define Needs: Radiologist is team player

Click to edit Master title styleSpirotomePhysician • Full control during the procedure. NO shooting or ballistic effect, avoiding vital or impenetrable organs to

be accidentally touched (for example lungs, vascular vessels or bones )• High visibility for an improved targeted navigation • Single insertion biopsy technique• No collateral damage and lower complication rates • High quality sample with a maximal tissue / needle ratio (up to 300mg)• Easy to handle and to fix into the lesion. Accessible to superficial, deeper and delicate lesions.• No cell spreading by shooting effect• Compatible and highly efficient solution for different imaging techniques (Ultrasound, CT, MRI , Stereotactic

Mammography …)

Pathologist • High quality sample qualified for molecular biology • Complete & adequate information is important for a efficient & reliable diagnose and treatment selection

Patient • More efficient treatment selection thanks to a targeted high quality tissue sample within a shorter delay• Virtually painless, silent and patient friendly procedure• Minor bleeding & minor risk for infections• Reliable diagnosis without surgery (local anesthesia)

Cost-efficiency • Low Overhead Costs : • Procedure can be done virtually everywhere (no Operating Room required)• No assistance or preparation time is needed (Spirotome Biopsy can be done in less than 10min)• High quality tissue sample with exact targeting, avoids false negatives

• Low Material Cost : • Only manually operated (vacuum-assisted) macro biopsy device• Full reimbursment for Breast Diagnosis (RIZIV code 688472)• Can avoid surgical intervention in delicate procedures. • No accessories are needed, in contrast to other vacuum assisted biopsy systems

Click to edit Master title styleSpirotome Concept Stakeholders

Radiologist/interventionist Pathologist Oncologist Purchasing Dept

- Product - technical advantages- Clinical advanatages- Patient comfort- Pricing / reimbursement

- TISSUE is the ISSUE-Superior tissue sample quality- opening gates to molecular biology- personalized diagnostics

-More efficient treatment selection- increase success-rate of targeted treatments- personalized therapy

-Pricing - reimbursed vs non-reimbursed indications- added value of Spirotome concept in the diagnostic & therapeutic process-- Spirotome is a universal product in various fields

The Spirotome

CLINICAL EVIDENCE

European Journal of Cancer Prevention, Vol 13, Issue 6, pp 491-498, 2004

Dr. Melcior Sentis (Barcelona)

SPIROTOME ON STEREOTACTIC TABLE

MRI CONDITIONAL Certified testing on Tesla 3:

◦ ASTM F2052 for displacement force

◦ ASTM F2213 for induced torque

◦ ASTM F2182 for induced heating

◦ ASTM F2119 for image artifact

Clinical tests show no interference nor safety issues.

Image artifact lower with Teflon trocar

Solved problems of the needle point

1 cm before the receiving space

0.5 to 0.7 cm ø System 3 cm under the skin Lateral uptake: out of target

= > 6 to 24 samples

Microcalcifications

Harries R, Lawson S, Bruckers Liesbeth. Assessment of microcalcifications with limited number of high-precision macrobiopsies. Eur J Cancer Prev 2010; 19: 374-8.

EXTREME CONDITIONS

Small breasts and peripheral tumors

Subcutaneous areas Subareolar disease Tumors close to bony or

delicate structures

Health Care System

No capital investment On the average 1

macrobiopsy per week ? Affordable biopsies = more

experience = broadening of indications

Indication:BIRADS 4 LESIONS

CONVINCING ?

Benefits for: Patient Pathologist Oncologist Operator Health Care System

Lung applications

Musceloskeletal applications

JL Gielen, AM De Schepper, M Blom, P Van Dyck, D Creytens, J Veryser, J Somville, PM Parizel.Experience with a novel frontal core biopsy device in soft tissue and bone lesions. Skeletal Radiol 2011; 40:

Head & Neck applicationsStrong demand for macrobiopsies for molecular biology

Thyroid applications

ImicroRNA and Thyroid CancerHoney Reddi, Ph.D., Assistant Professor, Medicine, Mayo Clinic

Thyroid cancer accounts for 96% of endocrine malignancies affecting about 3 million individuals in the U.S.

Pre-operative assessment of thyroid nodules by currently used cytological methods poses a significant clinical challenge due to a 20% non-diagnostic rate.

This results in unnecessary surgical intervention, wherein only 8-17% of cases are malignant, thereby prompting the need for additional methods of detection.

Lymph node applications- Breast cancer: axillary node- Staging of any cancer- Cancer of unknown primary- PET-CT follow-up

Liver biopsyD Nasr, LL Bidot, M Roche, S Paveliu, P Morel, A Naouri, E Odet, P Esquis, F Pilleul, P Bernard. Maladie des complexes de von Meyenburg (micro-harmatomes biliaires) découverte lors d’une chirurgie laparoscopique (Spirotome): à propos de deux observations. Von Meyenburg disease found during laparoscopic surgery (Spirotome): report of two cases. Annales de Chirurgie 131: 468470, 2006.

Liver biopsies

Liver biopsies under ultrasoundDr. Biguet – CHR – Verviers“Spirotome and microbubles the max for liver diagnostics.”

CEUSWith laparoscopic assistance

M, Barbaret V, Chiers K, Duchateau L, Bacci B, Terragni R, Rossi F, Sounders JH. Evaluation of a manual biopsy device («Spirotome ») on fresh canine organs : liver, spleen and kidneys and first clinical experience in animals. Eur J Cancer Prev 2011; 20: 140-5.

Blind

Deeper samoles Deeper samples Deep biopsies Deep biopsies

Gynecologists Gynecologists, oncologists, radiotherapists

Gynecologists, IVF,

Gynecologists

Complete diagnosis

Importance of stromal factors

Importance of transition zone

Importance of deep biopsies

new concepts in gynecology

New concepts in gynecology, less destruction, painfree

New concepts in stromal factors

new concepts in staging laparotomy

Punch Forceps Forceps Forceps

habits habits habits Combination with endoscopes

Uniqueness

Primary call points

Strategy

Opportunity

Predicate device

Challenges

Vulva Cervix Uterus Abdomen

Gynecological applications

VulvaCervixUterusAbdominalTer Brugge

Campo

Gordts

Ter Brugge H. Laparoscopic staging with a new direct and frontal biopsy instrument. J Gynecologic Surgery 2011; in press.

Cervicore: Key to Terra Incognita

Importance of stroma for Cervix

Sahebali S, Van den Eynden G, Murta E, Michelin M, Cusumano P, Petignat P, Bogers J.

Stroma issues in cervical cancer: a review of the role and function of basement membrane, stroma, immune response and angiogenesis in cervical cancer development.

Eur J Cancer Prev 2010; 19: 204-215

Click to edit Master title styleSpirotome Training Program

Identify

Attract

Engage

Ret

ain

Customer RelationshipProduct awareness

Product Workshop & procedure training

Follow Up & Feedback

Define Needs

Training Program

Procedure Support

Spirotome Solution

Click to edit Master title styleCONCLUSION

Personalized Medicine• Cytostatics• Hormones• Growth inhibitors• Monoclonal

antibodies…

Personalized Diagnostics• Pathology• Immuno-

histochemistry• Molecular biology…

Macrobiopsy• Enough tissue• Representative tissue• Fresh

Implementing clinical use of personalized diagnostics can stratify patients, give molecular classification of disease, determine the likelihood of occurrence, and recommend the best course of treatment.  These approaches promise to reduce costs in healthcare,improve treatment, and have the potential to provide consumer-driven access to health information.  But how will we acquire tissue to fulfill all these opportunities ? Cambridge Healthtech Institute

Kuringersteenweg 304B-3500 Hasselt

tel: +32 (0)11 271557fax: +32 (0)11 283677

BE 0449 067 537

Thank you for your attention !