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Page 1: mepdef ANG 4/23/02 9:47 AM Page 1 › files › ebib › jaarverslagen › IBA_2001eng.pdf · are restated without the impact of proton therapy, the Group’s EBITDA is seen to rise

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I B A Ann u a l R e p o r t 2001

Dear Shareholders,The year 2001 was a significant year for IBA in which we corroborated the strategy initiated in 1999 by transforming IBAfrom an equipment manufacturer into a multinational Groupexploiting and developing its unique expertise in particle accelerators for sterilization services on the one hand and forthe diagnosis and treatment of cancer on the other.

Increased profitability and new applications for sterilizationIn the area of sterilization services, 2001 saw successful integration achieved for the medical device business with profitability returning to pre-acquisition levels. New treatmentareas were developed for advanced applications (enhance-ment of material characteristics) and in particular, for thedecontamination of mail. Indeed, this new market for mailsanitization led us to put into full-time operation the first service center equipped with IBA’s accelerator technology inBridgeport, New Jersey (USA). In the area of food pasteur-ization, however, the approvals expected from regulatoryauthorities with regard to the processing of certain types offood were not granted and this caused a delay in businessdevelopments for IBA Food Safety.

It was, however, in our solutions to diagnose and cure can-cer that we have seen our most spectacular developmentsin 2001.

A Proton Therapy breakthroughThe year 2001 can be characterized specifically as a break-through year for IBA’s proton therapy technology. We received FDA clearance for our system in July, the first patient treat-ments started at Massachusetts General Hospital (MGH) inNovember, and we sold 2 systems to customers in Chinabefore the end of the year. Success also continued in 2002when we obtained authorization for CE marking of the systemin February, enabling the system to be sold throughout the 15 countries of the European Union.

Since the two Proton Therapy system sales to China came very late in the year, their contribution to the 2001 results isdistinctly lower than in fiscal 2000 which benefitted stronglyfrom the contracts with the Tenet Healthcare company cancelled during 2000. In fact, if the 2000 and 2001 resultsare restated without the impact of proton therapy, the Group’sEBITDA is seen to rise by 31% in 2001 and sales increase by19.7 % instead of 9.1%.

Having said this, we expect these two proton therapy systemsales to China to make a significant contribution to the 2002and 2003 results and to help spread the use of IBA’s techno-logy in other parts of the world since this is today the most precise technology available for the clinical treatment of localized cancer.

Healthy growth in dosimetryIn 2001, the area of dosimetry which consists of positioningdevices and quality assurance systems used in cancer radiationtreatment shows healthy growth with sales up 11% when compared with 2000.

FDG activity doubledThe year 2001 also saw impressive developments in the areaof FDG (F-18 fluorodeoxyglucose), a new tracer with unequalledprecision for the early detection of cancer, produced using acyclotron and representing a high-growth market in which IBAis intending to play a major part. Following their acquisition byIBA in February, Eastern Isotopes have more than doubled theirsales in 2001 compared to 2000, reflecting spectacular market growth. With more and more diagnostic indicationsbeing reimbursed in the US and the first FDG centers equippedwith IBA’s cyclotron technology, we continue to have high expectations for this activity in 2002.

Philippe de Woot

Chairman of the Board of Directors

2

Pierre Mottet

Chief Executive Officer

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3Le t t e r f r om t h e C h a i rman

Preparation of brachytherapy launchStill in the field of cancer treatment, in this case using radio-active implants, IBA continued developing its third-generation linear implant, a patented, FDA-cleared fine helicoidal wire concept designed to treat prostate cancer with potential forother types of cancer.

All these successes in 2001 were no doubt also due to the newmanagement structure which was put into place in 2000 andwhich increased in efficiency in 2001. In this context, we wouldlike to thank Jean-Claude Delobel for his in-depth work on the solidification and organization of the IBA Group. Chief ExecutiveOfficer with IBA from March 2000 to March 2002, Mr Delobel succeeded in creating a world-wide organization based on solidfoundations.

Perspectives 2002At the operational level, in addition to the goal of maintainingand increasing our leadership position in sterilization services,we have set ourselves a two-fold objective for 2002:• to continue improving the profitability of IBA’s activities by

pursuing and, if necessary, increasing optimization and ratio-nalization measures defined and implemented during 2001.

• to continue investing in our most immediately promising high-growth markets, in particular FDG and proton therapytechnology, and to achieve our brachytherapy product launch.

With regard to IBA’s medium-term strategy defined for 1999to 2004, we consider ourselves to be currently on the righttrack towards achieving our objectives although the road hasnot always been smooth and there have been delays. The StockExchange environment in particular is proving a challenge withmarkets seeking short-term orientation.

While Belgian technology is at the heart of IBA, more than 68%of our sales and services are achieved in the USA. The USA istherefore an important market for IBA from both a sales and afinancial point of view. In fact, in the market areas where IBAhas high growth potential, for example, in food pasteurization,we see the need to provide IBA with the same opportunities asits competitors who are listed in the USA.

For this reason, we have decided to list IBA in the USA.Following a first aborted contact with USA financial markets inDecember 2001, we have set ourselves the objective in 2002of preparing for a professional introduction to this market in thebest conditions possible in 2003.

Given the economic situation in 2001, we have booked potential non-values in IBA’s balance sheet, which resulted in anexceptional charge of € 22.2 million for fiscal 2001.

In March of this year, with the perspective of a US listing inmind, we had the pleasure of announcing the nomination of James F. Clouser as Chief Operating Officer. Mr Clouser was the former Chief Executive Officer of SteriGenics Inter-national acquired by IBA on the Stock Exchange in 1999.

Mr Clouser brings to the IBA Group unique expertise gained inthe US financial markets and in the world of sterilization. MrClouser will help us consolidate the cultural complementaritythat exists within the IBA Group which has particle acceleratortechnology at the heart of Europe and markets in the USA.

With more than 1,500 employees today on 3 Continents, IBAis an acknowledged leader in its 3 main poles of activity:Technology & Equipment, Sterilization & Ionization services andthe production & distribution of Radioisotopes. The IBA Grouphas a unique profile based on the solid profitable business ofsterilization services and the extremely high growth possibilitiesoffered by our gold standard cancer detection and cancer radiation treatment technologies. End of 2001, IBA’s sales andservices rose by 9.1% to € 257.6 million and its EBITDAincreased by 31% not including proton therapy.

We would like to take this opportunity to thank all our shareholders for their support particularly in these somewhatturbulent times. It is clear to us that without your support, IBA’sgrowth would not have been possible.

Looking to the future, we are confident about our vision andhigh growth potential. Recent market developments appear toconfirm our strategy even though investments still need to bemade in the coming years.

Our thanks also go to IBA employees across the world who arecommitted to IBA’s mission and values and without whom ourobjectives could not be met.

Pierre Mottet Philippe de Woot

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March 1986 Founded as a spin-off from the Cyclotronresearch laboratories of the CatholicUniversity of Louvain in Belgium.

1986-1990 Development and sale of cyclotrons used forthe production of radioisotopes for medicalimaging.

1990-1994 Development and sale of particle accelera-tors for sterilization, functional imaging andcancer treatment.

June 1998 Initial Public Offering (IPO), listing on theBrussels Stock Exchange.

1998-1999 Expansion of original business focus throughselected acquisitions to other types of particle accelerators, and leveraging of IBA’sexperience in irradiation sterilization to othersterilization methods and services (EtO and Cobalt 60). IBA becomes the largest sterilization service company in the world.

November 1999 IBA joins the BEL 20 index (Top 20 BelgianCapitalizations).

September 2000 Listing on EURONEXT, the pan-EuropeanStock Exchange set up by the Paris,Amsterdam and Brussels Stock Exchanges.Part of NEXT 150 index.

2001 IBA’s first Proton Therapy system starts treating patients at Massachusetts GeneralHospital (MGH), Boston, USA.IBA starts FDG distribution for the diagnosisof cancer.

January 2002 Listed on the market segment NextEconomy,EURONEXT.

4 IBA Annu a l R e p o r t 2001

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Compan y P r o f i l e 5

Company Profile 5

IBA today... 6

Highlights 2001-2002 7

Mission & Values 8

IBA in the World 9

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6 IBA Annu a l R e p o r t 2001

IBA today...

Over its 15 years of existence, IBA has relentlessly built itsdevelopment on the expertise it has inherited in the field of particle accelerators and grown into a Group achieving sales of€ 257.6 million last year.

IBA is today active in 3 fields, in which it enjoys a leader-ship position:1. Particle Accelerator Technology and Equipment2. Sterilization and Ionization services3. Radioisotope production and distribution for cancer

diagnosis and treatment.

At the core of the Group is the development of innovative particle accelerator concepts and new applications for particleaccelerators, with a specific focus on cancer detection andtreatment on the one hand and sterilization on the other hand.

This Technology and Equipment activity, accounting for 26.5%of the Group’s revenues, focuses on the development, manu-facturing and sales of particle accelerators and related equip-ment for health and well-being. Proton Therapy is the flagshipactivity in this field.

IBA is then also active in two fields of application for its accelerators: • Sterilization & Ionization • Radioisotopes.

IBA is the world leader in providing Sterilization and Ionizationservices to a large number of customers worldwide. Thebiggest application is the sterilization of single-use medicaldevices on their way from the manufacturer to the hospitals.Besides its own technology, IBA also offers complementarytechnologies (ethylene oxide gas and gamma irradiation steril-ization) to its customers for this application. The use of IBA technology in this field also covers the cold pasteurization offood, treatment of anthrax in mail or the improvement of theproperties of materials (e.g. semi-conductors or polymers).This field represents 65.3% of IBA’s revenues

IBA has strongly developed in 2001 its activity in Radioisotopesfor cancer diagnosis and treatment, which now accounts for 8.2% of revenues. F-18 FDG, a radioisotope produced bycyclotron, is quickly developing as the gold standard in cancerdiagnosis. Leveraging on its own expertise and the acquisitionof Eastern Isotopes in February 2001, IBA is gearing up forplaying a leadership role in this new field. IBA is also developingnew radioactive implant technology using cyclotron-producedPalladium-103 for prostate cancer treatment.

Technology&

Equipment

isotopes

Radio-Ion

ization

Steriliza

tion &

3 Poles of activity

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Compan y P r o f i l e 7

Highlights 2001

January• Agreement signed with AmeriCold Logistics, the largest cold

storage chain in the USA in order to partner for the constructionof food ionization facilities using X-rays.

February• Acquisition of a majority share in Eastern Isotopes, Inc., Sterling,

Virginia, allowing IBA to become a major provider of PET services,in particular production and distribution of FDG in the USA.

• Opening of the extended sterilization facility at Petit-Rechain, nearVerviers, Belgium, doubling service capacity and meeting theincreased demands of medical disposable markets in Europe.

March• Results for financial year 2000 show a sales increase of 67% to

€ 236 million compared to € 142 million end 1999.

April• FDA (Food & Drug Administration) clearance granted for a

petition filed by the Food Safety Division of IBA, allowing the irradiation of pet food.

• Announcement of a 46% equity stake in RadioMed Corporation,Tyngsboro, Massachusetts, USA, offering a patented, FDA-cleared new generation of linear Palladium-103 (Pd-103)implants based on a fine coiled wire design for treatment ofprostate cancer.

May• Contract signed with medical disposable manufacturer Coloplast,

Denmark, to construct IBA’s first electron-beam sterilization facil-ity in Europe scheduled to be operational in July 2003.

• Sale of an IBA Cyclone 30 to AccTecc (Accelerator TechnologiesB.V.), a spin-off company of the University of Eindhoven, TheNetherlands, for the production and distribution of commercialradioisotopes.

June• IBA and SCK-CEN, the Belgian nuclear research center, located

in Mol, Flanders, sign an agreement to design MYRRHA, an innovative accelerator-driven system for medical and industrialapplications of the future, including reducing the long-term toxicity of nuclear waste, the production of radioisotopes,research and development of advanced materials for use in thespace industry, telecommunications and fusion technology.

July• FDA (Food & Drug Administration) clearance is obtained for the

IBA Proton Therapy System less than 5 months after the 510 (k)file was submitted.

October• Contract signed with Ghent University Hospital, Belgium, to con-

struct a center for the commercial production and distribution ofFDG (F-18 fluorodeoxyglucose).

November• Opening of Bridgeport Facility, IBA’s first E-beam/X-ray service

center.• Contract signed with the United States Postal Service (USPS) to

sanitize mail at IBA’s irradiation facility in Bridgeport, New Jersey,a service center entirely dedicated to this purpose and using thelatest IBA state-of-the-art X-ray and electron-beam Rhodotrontechnology.

• First patient treated with IBA’s Proton Therapy System at theNortheast Proton Therapy Center (NPTC) at MassachusettsGeneral Hospital (MGH), Boston, USA.

• Sale of an IBA Proton Therapy System to Wanjie High Tech. Co.Ltd, China.

December• IBA considers offering shares in a private placement to institu-

tional investors in the USA with the objective of preparing a USlisting. In the light of market conditions, the decision was takennot to pursue the placement but to prepare more thoroughly forUS listing in 2003.

• Sale of an IBA Proton Therapy System to Chang An InformationIndustry Group in Xian, Shanxi Province, China, the second ProtonTherapy System sale for IBA in 2001.

Highlights 2002

January• Pierre Mottet, Chairman of the Executive and Strategic

Committee, replaces Jean-Claude Delobel as Chief ExecutiveOfficer.

• IBA, The Titan Corporation and SureBeam Corporation announcethat they have amicably resolved all outstanding litigation betweenthe two companies.

February• Renewal of contract with the USPS (United States Postal Service)

for mail sanitization at the IBA Bridgeport Facility, New Jersey,USA.

• Authorization obtained for CE marking of the IBA Proton TherapySystem, allowing it to be marketed in all 15 countries of theEuropean Union.

March• Sale of the first IBA PET cyclotron to Latin America, to the Chilean

Commission for Atomic Energy (CCHEN).• Appointment of James F. Clouser as Chief Operating Officer,

formerly Chief Executive Officer of SteriGenics Internationalacquired by IBA in 1999.

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8 IBA Annu a l R e p o r t 2001

IBA’s values

Innovation

Enthusiasm

Striving forexcellence

AdaptabilityGood

citizenship

Team spirit

Integrity

Respect for the individual

Mission & Values

Our objective is to be the leading global provider of innovativetechnological solutions in the field of health and well-being.

We aim to be leader in each of our target markets by focusingon selected applications for our particle accelerator andadvanced physics and chemical technologies, and by leveragingthe competitive advantages provided by our expertise in theseareas.

To reach this objective, we are guided by the following values:

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Compan y P r o f i l e 9

Number of Employees by Geography

IBA in the World

IBA offers customers access to a network of 39 contract service centers based in North America, Europe and Asia andprovides a one-stop shop, being the only company in the worldto offer all three leading methods for commercial sterilizationand ionization (EtO, Cobalt 60, E-beam/X-ray).

IBA sites also include 4 development and manufacturing facilities for Technology & Equipment and 10 sites in our developing network of Radioisotope activities.

Today, IBA has approximately 1,500 employees in 12 countries across Europe, North America and Asia. IBA is a recognized world leader in the areas of its unique expertise:specialized Technology & Equipment, Sterilization & Ionizationservices, Radioisotope production and distribution. Conso-lidated sales rose to € 257.6 million in 2001 and furthergrowth is expected to be not less than 10% in 2002.

IBA Technology & Equipment

IBA Sterilization & Ionization Services

IBA Radioisotope Production & Distribution

Belgium 17.4%USA (1) 60.6%Rest of World 22.0%(1) (Incl. Mexico and Canada)

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10 IBA Annu a l R e p o r t 2001

Production & Distribution of Radioisotopes

A vigorous growth vector over the coming years, this polecombines FDG production and distribution activities withbrachytherapy. In 2001, it contributed € 21.1 million to the Group’s revenues, making up 8.2% of all activities.

Sterilization & Ionization Services

Generating € 168.3 million or 65.3% of the Group's rev-enues in 2001, this pole comprises 3 main activities:Medical Device Sterilization services (84.5%), Food Safety(10.6%) and Advanced Applications (4.9%), includingmaterials processing and mail sanitization.

Technology & Equipment

At the heart of all IBA's activities, this pole comprises particle accelerator technology serving both medical andindustrial applications, including proton therapy as anessential element. In 2001, it contributed € 68.2 million to the Group's revenues, making up 26.5% of the Group's activities.

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Ac t i v i t i e s 11

Technology & Equipment 12

The Particle Accelerator as Core Technology 13

IBA Proton Therapy System 14

Dosimetry Systems 16

Cyclotrons for producing Radioisotopes and related Systems 17

Accelerator Systems for Sterilization & Ionization 18

Innovation & Development 19

Sterilization & Ionization Services 20

Sterilization & Ionization Technologies 22

EtO (Ethylene oxide)

Cobalt 60 (Gamma irradiation)

E-beam/X-ray

Sterilization & Ionization Process 23

Medical Device Sterilization Services 24

Food Safety 26

Advanced Applications 28

Mail Sanitization 29

Production & Distribution of Radioisotopes 30

FDG Distribution 33

IBA Radioisotopes for Brachytherapy 34

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12 IBA

Technology & Equipment

• Rhodotron• Dynamitron• Betaline

• Proton TherapySystem

• Racetrack Microtron• Dosimetry Systems

Equipment

Applications

SPECT/PET Cyclotrons• Cyclone 30• Cyclone 18/9• Cyclone 10/5• Cyclone 3• FDG synthesis module• Chemistry & targetry systems

Pd103 Cyclotron

Cancer Radiation Therapy Sterilization & Ionization• Medical Sterilization• Food Safety• Advanced Applications

Radioisotope Production• FDG for cancer diagnostics

• Pd 103 for brachytherapy• Other imaging & therapy applications

Technology & Equipment

Revenues 68.1EBITDA 8.3EBITA 2.3Capital Expenditures 12.9

(in € million)

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Te c hn o l o g y & E q u i pmen t 13

The Particle Accelerator as Core Technology

First manufactured in the late 1920s, a cyclotron is a devicethat is used to produce beams of charged particles that can bedirected at a specific target.

Through its affiliation with the University of Louvain, one of the first centers to develop a cyclotron in Europe, IBA has inherited a long experience and tradition in the field of particle accelerators.

The design, manufacture, installation and further developmentof particle accelerators is at the very heart of IBA’s growthstrategy.

IBA’s initial mission was to apply its expertise in particle accel-erators to develop new products or new applications with anundisputed competitive advantage over what exists on the market.

Systems from IBA can accelerate either protons or electrons.

IBA proton accelerators (cyclotrons) are used for cancer treatment (proton therapy) and radioisotope production (FDGprimarily for cancer diagnosis and Palladium 103 for prostatecancer implants). Some electron accelerators are also used forcancer treatment. Related ancillary equipment called dosimetryunits are also developed by IBA.

IBA electron accelerators (Rhodotrons, Dynamitrons andBetaline) are used for medical device sterilization, food pasteu-rization and modification of materials.

IBA systems range in price from € 1 million to € 50 million.

The IBA solution approach extends from the design of innova-tive systems to turn-key delivery and maintenance service.

The high-throughput IBA Rhodotron electron accelerator is

used for medical device sterilization, food pasteurization and

improvement of materials.

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14 IBA Annu a l R e p o r t 2001

IBA Proton Therapy System

One person in three is confronted with the diagnosis of cancerin his or her life. Two out of three cancer patients will be treated by radiation, alone or in combination with surgery orchemotherapy. The success rate of the treatment often highlydepends on the possibility to concentrate the radiation treatment in the tumor without affecting the surroundinghealthy tissues.

Because protons have the property of losing all their treatmentenergy in a small volume, Proton Therapy is recognized as thebest clinically available radiation treatment to treat localizedcancer with no or minimal damage to the surrounding healthytissues. In many cases, like cancer of the eye, head and neckor for children with cancer, it is the only possible option as surrounding tissues cannot receive radiation without majordamage being caused.

Proton Therapy was first discovered in huge particle accele-rator research centers and its availability was limited from afew patients to a few hundred patients a year by the size and complexity of the equipment required.

IBA is the first company to have designed a clinical proton therapy system able to treat thousands of patients a year.

Based on the above facts, it is generally accepted that there isa need for one proton therapy center for 10 million people.

Treatment room, Northeast Proton Therapy Center,

Massachusetts General Hospital, Boston (USA).

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Te c hn o l o g y & E q u i pmen t 15

IBA offers a completely equipped Proton Therapy Center, including a 230 MeV cyclotron, gantries (large frame permit-ting extremely precise targeting of the therapeutic beam fromany angle within the patient) and software package providingdoctors with all the information they need to ensure the mostefficient treatment.

IBA is the only company that has received both FDA-clearanceand the certificate authorizing CE marking of its proton therapysystem. The first IBA Proton Therapy System is in operation atthe Northeast Proton Therapy Center, Massachusetts GeneralHospital (MGH), Boston, USA and has been used successfullyto treat cancer patients since mid-November 2001.

Proton Therapy is reimbursed in the United States, making acenter a viable and profitable proposition even for investmentsranging from $ 50 to 100 million for a complete center withone to four treatment rooms. Reimbursement is currentlyunder review in other countries.

Although a handful of other companies are in the process ofdeveloping competitive systems, more specifically in Japan, IBAis confident that it will continue to prevail thanks to its techno-logical advance and R&D efforts. IBA’s success has been reiterated in 2001 with the sale of 2 Proton Therapy systemsto China.

Perspectives

IBA’s revenues in 2002 are expected at least to double, justfrom the manufacturing of the current order book for ProtonTherapy systems. IBA intends to book at least 2 more ProtonTherapy system sales in the next 3 years.

The high-precision IBA Proton Therapy System eliminates some of the most undesirable side effects of cancer radiation therapy. In particular, this improves the quality of life for patients suffering from difficult types of cancer, such as eye, neck and headcancer or sensitive patients such as young children.

Model of a Proton Therapy Center equipped with an IBA Proton

Therapy System consisting of four treatment rooms.

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16 IBA Annu a l R e p o r t 2001

Dosimetry Systems

Dosimetry systems are used for quality assurance in radiationtherapy of cancer or medical imaging, or to optimize patientpositioning in these two fields.

In radiotherapy dosimetry, IBA is clearly market leader withproducts placed in more than 1,500 radiation oncology centersand serving the needs of around 16,000 radiologists. Our mainmarkets are the USA, Western Europe and Asia.

In radiation diagnostics, IBA has more than 15 years’ experi-ence and offers a full range of quality assurance and dose monitoring devices which help radiologists obtain the bestresults with the exact documentation of patient exposureaccording to international standards.

Both product lines help achieve better precision in the diagnosis and treatment of cancer by radiation.

Achievements & Perspectives

IBA dosimetry systems have enjoyed a healthy 11% growth in 2001, driven by the continued expansion of their target applications and a similar growth is expected for 2002.

The new KermaX instrument allows patient dose monitoring in

complete conformity with government regulations.

The “Blue Phantom” is used to characterize the beam trace

from a linear accelerator employed in cancer treatment.

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Te c hn o l o g y & E q u i pmen t 17

Cyclotrons for producingRadioisotopes & related Systems

IBA’s first cyclotron (Cyclone 30) was developed for the production of radioisotopes used in nuclear medicine. Nuclearmedicine is unique in the field of medical imaging in that itshows organ metabolism, in other words how organs functioninside the body, and not organ morphology. This technology isreadily used to diagnose disease in the thyroid, the brain or theheart, for example. The IBA Cyclone 30, of which one moresystem was sold in 2001, still enjoys an undisputed leadershipposition and has only one competitor in Canada.

IBA then went on to develop a line of smaller cyclotrons withrelated automated chemistry systems for Positron EmissionTomography (PET), the latest technique in the field of nuclearmedicine, which has shown significant benefits in the earlydiagnosis of cancer. These cyclotrons are either sold to hospitals for in-house production of radioisotopes or to FDGdistribution centers like the ones operated by IBA itself. In thisfield, IBA has had a very good year in 2001 with 8 systemssold and generally enjoys a market share similar to that of itstwo major competitors: General Electric and CTI, a Siemensaffiliate.

IBA has also developed high-power cyclotrons for the produc-tion of Palladium 103, required to manufacture brachytherapyimplant devices for the treatment of prostate cancer. Virtuallyall the cyclotron-produced Palladium103 in the world today hasbeen produced by an IBA cyclotron. IBA has also started todevelop a new cyclotron for this application in 2001.

Although more difficult to predict, sales in this field in 2002are expected to remain at a level similar to that of 2001.

Designed to produce PET radioisotopes in large quantities,

this IBA Cyclone 18/9 is the ideal solution for FDG distribution

centers, large hospitals and research centers.

Radioisotopes produced by an IBA cyclotron are converted into

a radiopharmaceutical then injected into the patient to give this

type of metabolic image used by the doctor to diagnose dis-

ease and monitor the treatment prescribed.

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18 IBA Annu a l R e p o r t 2001

Accelerator Systems for Sterilization& Ionization

IBA offers a complete line of electron accelerators with different energies and power ranges for use in the area of sterilization and ionization. Electron beams can be convertedinto X-rays for better penetration of dense or thick products.

IBA has by far the most complete product range and thelargest installed base in the market but faces competition onselected application niches. IBA systems can cover all needsfrom dedicated high-throughput stand-alone service centers, as operated by IBA itself, to small, self-shielded systems allowing in-line processing.

These IBA accelerators are used to sterilize medical devices,pasteurize food, improve materials such as semi-conductors orpolymers and as of last year, treat anthrax in the mail.

The IBA Betaline is a compact self-shielded linear accelerator

system that can be rapidly installed in an existing location for

on-line processing of materials.

IBA accelerators can be used to improve the strength, heat and

abrasion resistance of the plastic sheathing on wires and cables.

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Te c hn o l o g y & E q u i pmen t

Innovation & Development

Innovation is a way of life for IBA.

It spans throughout the whole Group and all our technologiesincluding FDG production, implant devices or EtO gas andgamma sterilization. And it certainly has an even strongerreach in particle accelerators. Indeed, a total of 50 people arededicated to the development and configuration of IBA systems.

IBA’s innovative technology teams form the indispensable linkbetween design, production, and field work. As such, they arecontinually attentive to customers’ concerns so that they canprovide the required improvements and new designs.

In order to ensure more precise follow-up of projectdevelopment, IBA has high-level coordination methodsand quality control procedures including concept anddesign reviews.

Achievements & Perspectives

Major achievements in 2001 include:• finalization and start-up of the Proton Therapy System at

Massachusetts General Hospital (MGH), Boston, and devel-opment of the next generation of software for proton therapy

• development of a new kind of high power cyclotron for theproduction of Palladium 103

• further development of the Betaline, the IBA in-line steriliza-tion system

• manufacturing of the TT1000 prototype, a higher powerelectron beam system

• design work for a full pallet irradiation system to be used insterilization applications

• conceptual work in collaboration with the Nuclear ResearchCenter in Mol concerning the MYRRHA project, an acceler-ator driven sub-critical reactor capable of incineratingnuclear waste with a long life span.

All these programs will be extended in 2002.

19

The new IBA higher power TT1000

accelerator will be able to treat

products at a greater throughput

than ever before.

Concept and design reviews take the form of interactive,

multi-disciplinary meetings and enable project leaders to

keep a close eye on all work under their responsibility.

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Food Safety

20 IBA

Sterilization & Ionization Services

Medical Sterilization Advanced Applications

• EtO• Cobalt 60• E-beam• X-ray

• Cobalt 60• E-beam• X-ray

• Cobalt 60• E-beam• X-ray

• IBA Rhodotron• Dynamitron• Betaline

Applications

Technology

Equipment

Sterilization & Ionization Services

Revenues 168.3Medical Sterilization 142.2 Food Safety 17.8Advanced Applications,

including Mail Sanitization 8.3EBITDA 50.0EBITA 21.8Capital Expenditures 28.3

for E-beam/X-ray processing

(in € million)Revenues by Region

USA 141.7Rest of World 26.6

(in € million)

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S t e r i l i z a t i o n & I o n i z a t i o n S e r v i c e s 21

IBA’s service centers sterilize medical products, pasteurize food,

improve the characteristics of materials and decontaminate mail.

Sterilization and Ionization Services is IBA’s largest businessachieving € 168.3 million or 65.3% of total revenues in theGroup in 2001. We have built a leading position in the sterilization and ionization markets by focusing on 3 key areas: medical device sterilization and related services, food irradiation(Food Safety Division) and improvement of material character-istics (Advanced Applications). This business is 100% service-based and has been selected by IBA as one of its three key businesses given the solidity of the revenue streamgenerated and the potential for use of IBA accelerator techno-logy in this area.

Most of the revenues derived from this business sector arefrom sterilization & ionization services for medical devices, themajor part of which (84.2%) is realized in the USA. Additional revenues in this sector are derived from irradiation of foodcommodities (e.g. spices), ionization of advanced materials andmore recently, since November 2001, the decontamination ofUS mail from Anthrax.

To satisfy the needs of our customers and provide them withone-stop shopping on a global scale, we largely use traditionaltechnologies like EtO (ethylene oxide) gas and gamma irradiationin addition to Electron beam and X-ray generated by our particle accelerators.

In 2002, the sales revenues for the IBA sterilization & ioniza-tion business in general are anticipated to grow by 5 to 10%.

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22 IBA Annu a l R e p o r t 2001

Sterilization & Ionization Technologies

The easiest and cheapest way to sterilize products is using heat(possibly steam). While this is perfectly applicable for metalproducts and some food products, heat is not an option inmany cases. Products made of polymers (such as syringes andcatheters) or fresh food would be seriously damaged ordestroyed if treated by heat and need other technologies.

IBA provides the full array of industrial technologies for sterilization based on cold or low-temperature processes. The irradiation subgroup of technologies can also be used forthe purpose of improving properties of materials.

EtO (Ethylene oxide)This is one of the oldest sterilization methods in use. It is typically used to

sterilize medical products that cannot be irradiated, such as certain plastic

products, kits and trays. Exposure to the gas destroys an organism’s ability

to reproduce through an alkalization reaction. The EtO process requires that

the humidity, temperature and gas concentration be rigidly controlled and fol-

lowing exposure to the gas, products must undergo an aeration period. It is

used about 45% of the time in medical sterilization applications.

Cobalt 60 (Gamma irradiation) This method exposes the products to the irradiating beams emitted by

Cobalt 60 during its disintegration. The ionizing energy produced by gamma

rays goes through the packaging and is deep penetrating, making it an ideal

solution for products with various densities and product packaging types,

and for sterilization of products in boxes and pallets. Used about 45% of the

time for medical sterilization applications, it is also utilized for food pasteur-

ization and for some limited materials improvement applications.

Electron beam/X-rayThis is the most recent technology used for sterilization and ionization.

Electron beam particle accelerators convert ordinary electricity into a

concentrated stream of high energy electrons. The productivity of the

system is proportional to the power of the accelerator. High-power electron

beams can reduce the sterilization time from as much as 2 weeks with EtO

to as little as a few hours. Electrons have, however, low penetration capa-

bility. IBA’s technology can convert electron beams into deep-penetrating

X-rays, similar to gamma irradiation, providing sterilization centers with

maximum flexibility. Electron beams and X-rays produce no residue.

Currently used to meet 10% of medical sterilization needs, this technology

is meeting with growing interest. Together with X-rays, Electron beam

technology is also expected to become the technology of choice for food

pasteurization. Electron beam is the main technology used for modification

of materials. X-ray is starting commercialization.

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S t e r i l i z a t i o n & I o n i z a t i o n S e r v i c e s 23

Medical Device Manufacturers

Food Processors

US Postal Services

Medical Device Manufacturers

Food Processors

US Postal Services

IBA Sterilization Service Center

(here: E-beam/X-ray)

(1)

(2)

(3)

(4)

Sterilization & Ionization Process

When they leave the factory or the post sorting center, themedical devices, food or US mail are transported to the IBAsterilization & ionization service center. (1)

At the facility, the goods are placed in their original packaginginto totes or trays on a conveyor system, then transported to,around or under the sterilization source depending upon thetechnology used. (2)

The sterilizing gas (EtO) or energy source (Cobalt 60, E-beamor X-ray) penetrates the products at a dose predefined by thecustomer and sterilizes or ionizes the product. The process isdocumented so that sterility can be proven. (3)

The treated product leaves the IBA facility in a sterile conditionand is transported either to a distribution center or to the enduser, that is the hospital in the case of medical devices, the postoffice in the case of US mail or the supermarket in the case offood. (4)

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24 IBA Annu a l R e p o r t 2001

Medical Device Sterilization Services

Sterile products, such as compresses and bandages, are usedby medical staff in hospitals and also by people in the home.Sterilized medical products improve the quality of life and thestandard of healthcare. IBA’s medical sterilization services helpsave, preserve and improve lives.

Single-use medical devices need to be sterilized after packaging and before they reach the hospitals where they willbe used.

Our customers are typically medical device manufacturers andpharmaceutical companies who desire to outsource their sterilization operations and we offer tailor-made, volume-basedpricing, medium to long-term (one to seven years) contracts,increasingly on a global basis. The majority of revenues in thisbusiness come from contracts with terms for more than twoyears. In addition, we offer customers the option to buy oursterilization equipment if they choose to operate their own sterilization facility (see “Technology & Equipment”, pp.13 &18).

Our extensive customer base includes the Who’s Who in medical technology, with clients such as Allegiance HealthcareCorporation, Baxter, Tyco Healthcare Group or AlconLaboratories.

Meeting customer concerns for high-level quality, total cost-effectiveness and lead-time minimalization are critical success factors in this business. IBA offers conformity to thehighest quality and regulatory standards on a worldwide basis,an established network of 39 service centers spread across the USA, Europe and Asia, all 3 main technologies required and made-to-measure innovative solutions to meet new performance requirements.

IBA’s Strategic Position

Current expected world market size: € 750 million, outsourced: € 438 million.IBA Market share: 45%, No. 1 player, twice the size of No. 2High potential in emerging countries.Increasing trend towards outsourcing.

Every day, medical staff in thousands of hospitals worldwide use products which havebeen sterilized to ensure a safe, hygienic hospital environment and prevent harmful

bacterial infections.

Many different types of disposable, single-use medical devices and

products are sterilized by IBA such as surgical gloves, syringes,

catheters, and pacemakers, to name but a few.

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S t e r i l i z a t i o n & I o n i z a t i o n S e r v i c e s 25

Along with medical sterilization, we are also involved in labora-tory testing through our three laboratories in the USA (Itasca,Illinois; Ontario, California; Santa Teresa, New Mexico) and our5 laboratories in Europe, the latter being integrated in IBASterilization Service Centers. Laboratory testing consists oftesting various properties of medical devices that have beensterilized. A large number of our tests are linked to our product sterilization services (packaging research andsterility tests, for example).

Customers for laboratory testing are, typically, customers whouse our medical sterilization services. Medical device produc-ers need sterility-related laboratory services to confirm thattheir products are bacteria-free and hence conform to applica-ble regulations.

Achievements 2001

The medical device sterilization business grew by 9.3% in 2001 and has seen EBITDA restored to pre-acquisition levels,providing the Group with a strong cash flow.

In Petit-Rechain, near Verviers, in Belgium, a brand new sterilization facility using EtO was opened to double servicecapacity. Strategically located, the new plant is destined tobecome the biggest of its kind in Europe capable of coping withincreasing volumes of medical sterilization products fromBelgian, Dutch and German customers.

In Europe, a multi-million contract was signed with the ColoplastGroup in Denmark and the first spade struck the ground forconstruction of the first IBA-owned E-beam facility in Europe,scheduled for completion in 2003.

Perspectives 2002

The growth rate for the world medical device sterilization market is estimated to be about 5 to 10%. IBA believes that itcan probably achieve higher growth given the continued trendtowards outsourcing and the potential for new technologies,such as E-beam and X-ray. In the USA, in particular, we will alsocontinue to improve the efficiency and profitability of our servicecenters and technologies.

Storage area for sterilized medical products,

extended EtO facility, Petit-Rechain, Belgium.

IBA laboratory testing confirms that products are

bacteria-free as required by the customer and end user.

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26 IBA Annu a l R e p o r t 2001

Food Safety

According to the USA Center for Disease Control (CDC), food-borne illnesses (mainly from listeria, salmonella and E-coli) cause over 5,000 deaths a year in the USA alone,despite ever increasing enforcement of high levels of hygienepractice throughout the industry. Children and elderly peopleare the first victims of such contaminations when they occur.For products that cannot endure heating, assuring 100%bacterial cleanliness of the products before they leave the fac-tory or at any given point in the process is a problem.

The use of low energy irradiation has been proven for over 50years on a large number of products as the only largely applicable cold process that can ensure bacterial cleanlinessbefore the product leaves the factory, without affecting theproperties of the food, be it taste, texture or nutritional value.Irradiation is widely recommended by the World HealthOrganization and other similar bodies and is systematicallyused when no risks are to be taken, for example in the caseof patients with a weak condition or cosmonauts in space.Food irradiation is easier to perform on cleaner products,providing an incentive to the food industry to continue toimprove on the hygiene of its processes.

Following the numerous cases of food poisoning from redmeat, the Food and Drug Administration (FDA) approved theirradiation of uncooked red meat in 1997. Since thisapproval, the FDA has also approved shell eggs, sprouts andpet food.

Additionally, zero tolerance liability laws on E-coli 0157:H7and listeria monocytogenes as well as increasing litigationrelated to food-borne illnesses are exerting pressure on foodprocessors to meet increasingly demanding food safety standards, most importantly in the United States.

The current market for food irradiation services in the USA isestimated to be around $ 60 million and IBA has a significantportion of the world’s spice and herbs irradiation market. Ourcustomers for food irradiation are mostly food processorsand manufacturers. Contracts for irradiation of non-perish-ables are generally for a shorter period than those for medical sterilization, but have similar terms and conditions.

We primarily process food at 4 centers in the USA and 1 center in Europe with the main development expected fromthe USA as a result of the industry structure, uniform regu-lation and litigation exposure experienced by manufacturers.

IBA Food Safety is committed to saving hundreds of families from the pain and grief associated with catastrophic illnesses resulting from contaminated foods. To achieve this, IBA Food Safety intends to make state-of-the-art irradiation technology – gamma or E-beam andin particular X-ray – available to food producers, offering consumers the choice of opting forbetter food safety.

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S t e r i l i z a t i o n & I o n i z a t i o n S e r v i c e s 27

X-Ray is widely expected to be the technology of choice for foodpasteurization. IBA’s unequalled high throughput X-ray systemswill allow us to benefit from a strong competitive advantage overIBA’s main US competitor when the market takes off.

Due to higher litigation exposure, the market with the largestpotential is, however, the market for processed food which is still embryonic, pending regulatory approval. The potential US market size for food cold pasteurization has been valued by equity researchers such as Meryll Lynch, and CSFB at$ 800-1,000 million. While requested by the industry and currently in the works, the approval for treatment of processedfoods has been delayed and this has impacted IBA’s plans forgrowth.

Achievements 2001

Revenues for IBA Food Safety in 2001 have grown by 5%. In January 2001, the IBA Schaumburg facility was grantedUSDA (United States Department of Agriculture) approval allowing treatment of meat and poultry using gamma irradia-tion. An agreement with AmeriCold Logistics was signed to collaborate for the development of food ionization facilities usingX-rays on AmeriCold sites. In April 2001, the FDA approved apetition filed by IBA Food Safety, allowing the irradiation of petfood, including dry farm animal feeds, birdseeds, fish food andmost importantly dog chews.

During the year, MDS Nordion and IBA partnered to develop anew system called the Palletron designed for X-ray irradiation ofproducts on whole pallets. However, the most expected event,that is the approval of irradiation for processed foods has beendelayed given other priorities to be addressed by the US admin-istration in 2001. We have therefore adapted our investmentplan accordingly.

Perspectives 2002

Approval of processed food irradiation is now expected for theyear 2002 although no assurance can be given considering theunpredictability of government processes.

Because of our experience in the irradiation of spices and herbsand our network of service centers, combined with our high-powered E-beam/X-ray technology, we believe that we are wellpositioned to benefit from this opportunity if and when the market for food irradiation takes off. We will thus continue toprepare for such a take-off by continuing to extend and improvethe efficiency of our existing technology and by looking at privatefunding possibilities in order to be on equal grounds with thecompetition to fund a possible explosive growth.

IBA Food Safety processes more than 80% of the spices irradiated in the USA.

Processed foods are everywhere. Treating them in their final package

with a controlled dose of ionizing energy would virtually

eliminate disease-causing bacteria.

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28 IBA Annu a l R e p o r t 2001

Advanced Applications

Ionization technology including high-powered E-beam accelera-tors are currently used to improve the properties of advancedmaterials, including increasing the resistance of cable sheathsto high temperatures (especially for the automobile and aero-nautic industries and for public buildings), treating semi-con-ductors (electronic industry), modifying standard polymers intoheat-shrink polymers, vulcanizing rubber (tire industry), dryresins and composite materials (naval and aeronautic indus-tries), and pulverizing PolyTetraFluoroEthylene (“PTFE”) polymerfor inks, kitchen utensils and coloring topazes.

The global advanced materials market is in our estimateapproximately $ 55 million. The market is fragmented and local-ized. The products treated are considered high value added.

IBA currently has a 5 to 10% share of this market. We expectthis market to grow continuously. Today, IBA AdvancedMaterials is focused on the following products: power semiconductors, bulk polymers such as PTFE, formed partssuch as gaskets, seals and hoses, cross-linked medicalcatheters, cross-linked plastic pipe, and composites.

The IBA Advanced Materials Division includes operation of 4 ionization service centers.

Achievements 2001

In 2001, service sales increased 32% when compared with theyear 2000. Blending operations of bulk polymers began at theSalem installation in the USA and commissioning of advancedmaterials treatment began at the new IBA Bridgeport Facility inthe summer of 2001. This facility was then dedicated to mailsanitization starting mid-November following the signing of acontract with the United States Postal Service (USPS).

Perspectives 2002

Growth is expected to continue on a similar basis in 2002.

Electron beam crosslinking of polymers used in thick plastic objects

improves product strength and increases resistance.

Electron beam processing optimizes

the performance of semi-conductors

by adjusting their lifetimes.

New materials play an important role in the improved quality of our lives. Electron beam and gammatechnology are increasingly used to develop new materials with superior properties at lower costs. IBA’s ionization technology impacts us daily, cross-linking catheters for

angioplasty, hardening human artificial joints, improving the fire resistance of wires and cables …

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S t e r i l i z a t i o n & I o n i z a t i o n S e r v i c e s 29

Mail Sanitization

In September and October 2001, five people including 2Washington postal workers died of anthrax in the USA aftercontaminated letters were mailed from New Jersey. More thana dozen other people were infected in New York, New Jersey,Florida and Washington. In addition, there were huge backlogsof mail in both the USPS (United States Postal Service)Brentwood and Trenton facilities due to anthrax contamination.

The USPS turned to IBA to provide them with electron beamirradiation of their mail and X-ray irradiation of their parcels. For the USPS, electron beam irradiation remains the best technology for rendering the mail safe from biohazards in atimely fashion.

While irradiation has been in use for many years, mail sanitiza-tion represents a new application. Thanks to its high-poweredE-beam/X-ray equipment, IBA can offer high volume throughputand rapid processing with guaranteed turnaround time.

Achievements 2001

IBA signed a contract for US mail sanitization with the USPS in November 2001, generating revenues of $ 2.4 million by trimester and dedicating its new Bridgeport E-beam/X-rayfacility entirely to this application.

Since mid-November 2001, the IBA Bridgeport facility has beensuccessfully sanitizing US mail 24 hrs a day, 7 days a week.

Perspectives 2002

Under terms similar to those of the initial contract, the USPSrenewed the mail sanitization contract with IBA in mid February2002. The renewed contract generates further revenues of $ 2.4 million by periods of 3 months.

Mail sanitization is obviously a completely new market for IBA inembryonic form.

September 11, 2001 has certainly changed the way the USAand the world are looking at security in many respects includ-ing the postal services. While it is uncertain whether the USGovernment will proceed with its plan to treat all US mail, a multi-billion dollar investment, it is likely that some form oftreatment of sensitive mail will be maintained for the long term.Whatever the option taken, IBA is one of the leading candidatesto provide a solution.

US mail in boxes placed on trays enter and exit the electron beam

treatment vault, IBA Bridgeport facility, New Jersey (USA).

Since mid-November 2001, IBA’s technology has been successfully sanitizing the US mail atits Bridgeport E-beam/X-ray facility, New Jersey, USA. Hundreds of letters a day passunder the powerful electron beam curtain in order to provide USPS employees and customers with safe mail.

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30 IBA

Radioisotope Production & Distribution

Revenues 21.1EBITDA 2.0EBITA 0.3Capital Expenditures (excl. acquisitions) 16.4

(in € million)

Radioisotope Production & Distribution

SPECT/PET Cyclotrons• Cyclone 30• Cyclone 18/9• Cyclone 10/5• Cyclone 3• FDG synthesis module• Chemistry & targetry systems

Applications

Equipment

Medical Imaging Brachytherapy

Pd 103 Cyclotron

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P r o d u c t i o n & D i s t r i b u t i o n o f R a d i o i s o t o p e s 31

Radioisotopes is the latest of IBA’s activities. It is the secondbusiness based on the use of IBA particle accelerators and hasbeen selected for its very high potential for growth and valuecreation for IBA.

Cyclotrons for the production of radioisotopes were IBA’s business focus when the company was created in 1986, andrepresented 100% of our revenue until 1992. Needless to say,IBA has a unique experience in this field.

Today, IBA not only produces but also distributes radioisotopesfor two basic applications, for use in diagnostic imaging, involving distribution to PET centers primarily in the USA at thecurrent time, and for cancer treatment using Palladium-103(Pd-103) implants (brachytherapy).

End of fiscal year 2001, the production and distribution ofradioisotopes represented € 21.1 million in revenues in 2001or 8.2% of our total turnover.

IBA produces and distributes radioisotopes for use in diagnostic

imaging (left) and cancer treatment using a special wire implant (right).

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Radioisotopes

Isotopes of a given chemical element are atoms with the samenumber of protons but different number of neutrons. Whenthey are unstable, they disintegrate over time and emit radia-tion. They are then called radioisotopes.

Radioisotopes can be naturally occurring or artificially produced. One way to produce radioisotopes is to send a powerful beam of protons accelerated by a cyclotron into a specific target where a nuclear reaction occurs. Such reactionsare limited in power and since the cyclotron is electricity-driven,reactions always stop when the cyclotron is “unplugged”.

Radioisotopes are selected for an application in medical imaging based on the affinity of the chemical element with specific organs or functions, the energy they emit (low enoughto give all treatment dose in the target tissue or high enough togo through the body and be received by a scanner) and theirhalf-life. The half-life is the time over which a radioisotope loseshalf of its radio-activity by disintegration. With a half-life of 2hours, an FDG dose has an effect well limited in time but whichinevitably imposes strong constraints on the distribution logis-tics. Palladium 103, with a half-life of 17 days, allows theimplant to provide a continuous treatment dose to the tumorfor the duration of the treatment, then becomes virtually non-radioactive and can thus be left permanently in the tumor.

32 IBA Annu a l R e p o r t 2001

F-18 FDG functional imaging for cancer detectionSmall doses of F-18 FDG are injected into a person’s bloodstream. FDG is a sugar

and is thus consumed and metabolized by the body. It is now proven, however, that

tumor cells consume more sugar than healthy cells. They thus concentrate higher

doses of this radioactive sugar and the higher concentration of the resulting radio-

activity can be localized by a specific scanner. The scanner will then reconstruct

the source of activity in an image where a “hot” (bright) spot means a high level of

activity. This allows the unique identification of cancer tumors just as small as a

few millimeters. It also allows follow-up and monitoring of the effects of treatment

on the tumor or its possible recurrence.

BrachytherapyBrachytherapy for prostate cancer consists in the use of implants emitting cura-

tive amounts of radiation over very short distances (a few millimeters) that are

inserted into or close to a cancerous tumor. This minimally invasive procedure tra-

ditionally involves implanting rice-sized radioactive seeds through thin, hollow nee-

dles into or near cancerous tumors, and is currently considered to be the leading

technique to treat prostate cancer. The two types of implants currently available

are one based on the Pd-103 radioisotope and the other on the iodine (I-125)

radioisotope produced in nuclear reactors. IBA has a new-generation Pd-103

implant product, a patented FDA-cleared wire source that is expected to be high-

ly successful in this market (see photo left).

F-18 FDG productionF-18 FDG is produced by cyclotron irradiation. A beam of medium-energy protons

(15 to 18 MeV) is sent into an enriched water target and creates F-18 radioiso-

topes in a water solution. This solution is then processed in an automated chem-

istry system, such as the IBA FDG Module, which will extract and purify the

radioisotope and produce the F-18 FDG. After appropriate quality control by a

radio-pharmacist, the solution is approved for injection.

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P r o d u c t i o n & D i s t r i b u t i o n o f R a d i o i s o t o p e s 33

FDG Distribution

For most cancers, early detection increases exponentially thechance of success for the treatment. When detected earlyenough, while the tumor is still small and localized, cancer canbe cured much more easily. But detecting cancer is not easysince cancer cells cannot be differentiated from healthy cells inconventional medical imaging.

In the past few years, a new diagnosis technique has emergedas a gold standard for cancer detection in many indications.This technique is called Positron Emission Tomography (PET)based on F-18 FDG, an imaging agent produced by cyclotron.

F-18 FDG, after injection into the patient, will concentrate intumor cells and the low level radiation emitted by the imagingagent will then allow a specific scanner to reconstruct an imageof the cancer tumor with high sensitivity and specificity.

These properties of F-18 FDG have formed the basis to grantreimbursement of cancer detection for different applicationsusing F-18 FDG at a fast pace in the past few months in theUSA. The resulting high growth in the use of the technique andthe fact that the scanner base has doubled each year in the lasttwo years require a matching supply of F-18 FDG.

F-18 FDG, however, has a limited usable life and needs to beproduced within a 3 to 6 hours radius from its place of use. Afew large hospitals have purchased their own cyclotron toensure their own supply. Most hospitals, however, prefer to outsource the delivery of the F-18 FDG.

Building on its experience as a cyclotron user and manufactur-er, IBA has decided to take advantage of this high growth oppor-tunity and build a network of FDG production and distributioncenters.

While this initiative was first started by IBA in Europe a coupleof years ago, the fast development of the market in the USAhas led us to change our priorities and accelerate our develop-ment in this field in the USA through the acquisition of an 80% equity interest in Eastern Isotopes in February 2001.Since its acquisition by IBA, Eastern Isotopes has more thandoubled its sales figures and in 2001 FDG revenues represent8% of IBA’s total revenues. A new IBA FDG production and dis-tribution center has opened its doors in January 2002 inFlorida, expected to further support the growth of sales in2002.

Success of FDG in cancer detection also helps its acceptanceand potential reimbursement for neurology and cardiology diseases where it has been proven that F-18 FDG can alsobring unique diagnosis capabilities.

Critical success factors in this business sector include reliable,timely supply of radioisotopes, cost-effectiveness and availabilityof FDG to meet the growing demand. In the USA, IBA has anexcellent track record of reliable on-time deliveries and com-petitive pricing. With a market share of about 30% in the USA,IBA is one of the top three companies developing this market.

Besides the USA, IBA also continues its development of a network of centers in Europe where 3 sites are in preparation,waiting for clearance by the authorities regarding compliancewith the stricter European regulatory requirements.

Every day, doctors in hospitals or imaging centers around the world give hope to hun-dreds of cancer patients thanks to the precise and timely diagnosis of their con-dition or accurate monitoring of their treatment schedule made possible byradioisotopes produced by cyclotron.

IBA’s Strategic Position

US market size: growing from € 51 million (2000) to more than € 445 million (2005) – Foster & SullivanIBA market share in USA: around 30%High potential growth.

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34 IBA Annu a l R e p o r t 2001

IBA Radioisotopes for Brachytherapy

In the recent past, prostate cancer, even when cured, was usually accompanied by very high impotency and incontinencyside effects as the surgery or external radiation treatment oftencaused significant damage to the surrounding nerves.

Brachytherapy, which involves the use of radio-active implants inthe form of small sized “seeds”, has rapidly developed over thelast few years as a result of its ability to concentrate the radia-tion dose in the prostate, leading to a high success rate withvirtually no side effects.

These “seeds” are made of either one or two radioisotopes, oneof which, Palladium 103, is produced by cyclotron.

In the last two years, IBA has identified a technique developedby RadioMed Corporation (Boston, USA) which, when used incombination with a new IBA cyclotron being developed today,would be the basis for a new generation of implants made ofwires and not seeds. This has resulted in the acquisition by IBAof an equity interest in RadioMed (58% at end 2001) with anoption for IBA to buy the remaining shares.

The benefits for the doctor and patient include the definite stability of the implant in the tumor (while seeds have a tendency to be carried away in the bloodstream), the possibili-ty to use thinner, less traumatic needles to insert the implantas well as ultrasound visibility that allows for precise placementof the implant in real time (obviating the need for post-operativeX-ray validation). The manufacturing process is also expected to be ten times more efficient than with the conventional procedures.

RadioMed products are patented and FDA-cleared.

In 2001, the concepts for the new technique have been validated and the equipment required for the manufacturingprocess (including the new cyclotron) have been developed.

Completion of the development of the RadioMed product is expected to take place in 2002. First products are anticipatedto be available on a limited basis by the end of the year.

RadioMed Corporation has an exclusive five-year distributionagreement with Kawasumi Laboratories in the USA for the mar-keting and distribution of RadioMed Corporation’s sources forprostate cancer. Kawasumi is also a syringe manufacturer andhas designed an improved delivery system for the RadioMedCorporation product ensuring less invasive implantation at thetumor site.

IBA and RadioMed are also investigating the use of the newconcept for other applications.

Particle Accelerator

IBA

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P r o d u c t i o n & D i s t r i b u t i o n o f R a d i o i s o t o p e s 35

For men, prostate cancer is the second leading cause of cancer mortality after lungcancer. Thanks to IBA radioisotopes in implants, men with this disease need onlyundergo mild intervention in an outpatient clinic and suffer minimal side effects.IBA’s technology gives them hope that they can overcome their disease andresume a full, active and healthy life as before.

Implant Radiation: Brachytherapy Hospital

Wire Implant Implantation at Tumor Site

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Design & production: arrowdesign.comPhotography: Fotografisch Atelier Paul Delaet, John Horner, Paul Coertens, Sture Ekendahl, Braune Photodesign, Jacky Delorme, Photodisc, TonyStone.Print: Dereume.

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