LifeTechLimburg Interregio: Medinvents minimal invasive biopsy

Growing from a local company to a global player in the field of

minimal invasive biopsy

Interregio Network meeting: Internationalisation in life sciences

Diepenbeek (B),October 5th 2011

Click to edit Master title styleMedInvents’ concept

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 Health-tech Institute (2011)

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Anno 2011

Jaak Ph. Janssens New Direct and Frontal Tissue Acquisition Tools for Gene Expression Analysis. Current Pharmacogenomics & Personalized Medicine 2010; 8: 37-48

Powerful weapon

But where is the

ammunition ?

Click to edit Master title styleAbout Medinvents

Medinvents aims to be global leader of innovative products for minimal invasive biopsy. We provide a complete suite of biopsy devices needed to support healthcare providers in giving the best care to their patients. More and more targeted treatments are coming. Molecular biology is gaining importance. “Tissue is the issue ” for personalized diagnostics.

Our products are the solution for this new approach: a minimal invasive large core soft tissue biopsy with the highest level of accuracy and safety. Resulting in a fast and easy procedure with optimal diagnosis and better patient treatment.

Click to edit Master title styleOur Mission

-Input-Feasibility study (technical, medical, economical)-Requirement specification-Concept and alternative concepts-Detailed specification listing-Prototyping-Laboratory testing-Validation-Phase I, II, III, IV

-Patent approval-Raw materials exclusivity deals-Investor negotiations-Bank credits - loans-Social regulations-Manufacturing know-how-ISO certification 9001-2003-ISO certification 14385-National and Intn’l certificates-Research funding- Q3- 2004 Start Medinvents-Training – Audits– management…

- R&D and manufacturing -CE certification-FDA certification-Clinical studies – European – US Key Opinion Leaders-Liability insurance-Internal growth – additional investments – expanding research-Facilities-Legal aspects-Distribution network-Corporate imaging

From idea to concept From concept to product From product to market

2000 2001 2002 2003 2004 2005 2006 2007 2008 Go Live >>>

>>>

-General acceptation by the medical community-Return on investment-Market penetration-Reimbursement-Creation of alliances-OEM – original equipment manufacturing-Production automatization-Improvement of products - packaging-Intended use expansion-International Research Trials-Crossing the chasm- International base of KOL users

-Increase in clinical applications (brain, prostate,....) – Targeted Therapies –Molecular Biology-New diagnostic and therapeutic products with related IP. -Hybrid products, OEM expansion-Participation in robot development and manufacturing projects-Increase in consulting functions -Acquisition of manufacturing facilities-Acquisition of or participation in distribution groups-Increase in licensing agreements- From Local to Global

GOING LIVE The future

>>> Go Live 2009 2010 2011

Click to edit Master title styleMedinvents Product Groups

• Focus: Radiology & surgery• Soft tissue Biopsy Concept for higher quality & efficacy in personalized diagnostics• Manual or full automated systems• All Soft Tissue biopsies within clinical oncology

Spirotome & Coramate Systems

Click to edit Master title styleMedinvents Product GroupsSpirotome BONE & Spirotome SPINE

• Focus: Interventional Radiology & Orthopedics• Hybrid Biopsy Concept for bony & soft tissue structures• Specifically to be used in clinical situations where soft tissue from bony

structures (e.g osteolytic lesions) need a representative and high quality diagnostic biopsy

• From diagnostics to therapeutics trough Spirotome Spine Cross Bracing Vertebroplasty

Click to edit Master title styleMedinvents Product Groups

Spirotome CERIVCORE & Spirotome ENDO

• Focus: Gynecology & Endoscopy

• Colposcopic biopsies• Endoscopic or

laparoscopic staging of invasive cancers

Click to edit Master title styleMedinvents’ 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• Lung

Spirotome Cervicore ™• Cervix• Uterus

Spirotome Easy Punch ™• Skin• Vulva

Spirotome Bone ™• Soft tissues within bone

Spirotome Endo ™• Laparoscopy (type ter Brugge)• Uterus (type Campo) Spirotome Neuro ™

• Brain

Spirotome Spine ™• Soft tissues within bone

Rad

iolo

gy

Gynecology

Orthopedics

Dermatology

Neurology

MedInvents’ technology superiority

1. Innovative technology2. Right in time for the

market3. Safety & Comfort4. Accuracy5. Product portfolio6. Strong science7. Patents & certificate8. Consistency9. Next generation

applications

• Direct & Frontal• Macrobiopsy• All soft tissues• Easy procedure• Less invasive



market3. Safety & Comfort4. Accuracy5. Product portfolio6. Strong science7. Patents & certificates8. Consistency9. Next generation

applications

Jaak Ph. Janssens New Direct and Frontal Tissue Acquisition Tools for Gene Expression Analysis. Current Pharmacogenomics & Personalized Medicine 2010; 8: 37-48

Molecular biology




applications

Ann Cornelis, Marcel Verjans, Thierry Van den Bosch, Katrien Wouters, Johan Van Robaeys, Jaak Ph. Janssens & Working Group on Hormone Dependent Cancers, The European Cancer Prevention Organization. Efficacy and safety of direct and frontal macrobiopsies in breast cancer. Eur J Cancer Prev 2009 ; 18 : 280 – 4.




applications

Gielen JL, De Schepper AM, Blom R, Van Dyck P, Bosmans JML, Creytens DH, Veryser J, Somville J, Parizel PM. Experience with a novel frontal core biopsy device in soft tissue and bone lesions.Skeletal Radiol 2011; 40 In press – Published online.

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




applications




applicationsM, 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 2010; 20:: 140-5.



market3. Safety & Comfort4. Accuracy5. Product portfolio6. Strong science7. Patents & certificate8. Consistency9. Next generation

applications

Ter Brugge H. Laparoscopic staging with a new direct and frontal biopsy instrument. J Gynecologic Surgery 2010; in press.




applications

• Proprietary technology• ISO 9001-2008• ISO 13485• FDA (13 applications)• Reimbursement

• Several applications• Several countries




applications




applications

Click to edit Master title styleMedinvents’ Marketing & SalesSales

Organisation

I n D i r e c t S a l e s

International expansion

Indirect Core

Countries

Indirect Countries

D i r e c t S a l e s

Medinvents Direct Sales

teamBeLux

Medinvents P r o j e c t s -

R & D

Consulting – Clincal Research

OEMR&D &

Manufacturing

Formal agreements in 10 countriesThe business is transferred to independent distributors who are trained and certified by MedInvents during an intensive training program.

The marketing in those countries is done by well chosen distributors supported directly by MedInvents.

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1. Build a concept, not just a product2. Always be 1 step ahead – MedInvents = key to Molecular Biology3. Size doesn’t matter, quality & integrity does4. Direct sales on home markets for direct customer feedback 5. Succeed locally before you act globally6. Step-by-Step Expansion, be prepared7. Unique and extensive clinical liasons through partnerships with

international scientific associations (MSL – Medical Science Liaison)8. International partnerships with strong local networks 9. Continuous Training & Education 10. Be loyal to your Standards

Medinvents’ Tips & Tricks to succeed

Kuringersteenweg 304B-3500 Hasselt

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

BE 0449 067 537

Thank you for your attention !

Medinvents 2011

Olivier WoutersChief Marketing & Sales

www.MedInvents.com

http://www.medinvents.com/

Health & Medicine

LifeTechLimburg Interregio: Medinvents minimal invasive biopsy