next generation ultrasound in europe: evolution in diagnosis and therapy

Next Generation Ultrasound: Evolution in Diagnosis and Therapy

Shri Shanmugham, Senior Research Analyst

Healthcare

March 4, 2010

2

Focus Points

� Ultrasound Overview

� Advancements:

• Elastography

• CEUS

• HIFU

� Conclusion

3

Ultrasound Overview

� Ultrasound equipment is experiencing an innovative phase with advances that include 3D/4D imaging, Elastography, customized probe design, organ specific imaging, and specialized post-processing software

� With safety standards being strictly enforced by regulatory bodies, ultrasound has also emerged to be the major tool for secondary diagnosis

� The potential for ultrasound is on the rise and they are also being employed in surgery, interventional procedure, renal, obstetrical, breast, pelvic, thyroid, scrotal, prostate, transrectal, and musculoskeletal applications.

� Developments in elastography, and dedicated probe design have attracted sales for ultrasound

� 3D and 4D (volumetric) imaging utility is poised for expansion for many ultrasound application, including therapeutic ultrasounds. Obstetrics and gynaecology employ the full application of ultrasound volumetric imaging in Europe.

4

Ultrasound Advancements - Elastography

� Elastography exploits the smaller elasticity profile of malignant tissues to enhance the imaging differences with benign tissues.

� Elastography is effective for estimation of lesion size. Consecutively, biopsy rates in benign lesions are reduced and proving to be more economical for patients.

� Elastography is gaining edge for better detection of thyroid cancer, particularly in nodules with undermined cytology, owing to extensive clinical research.

� Elastography for thyroid and liver will generate the next wave of interest with respect to ultrasound application. However, all equipment manufacturers are trying Elastography on thyroid and liver with varying success.

� Elastography is in a budding stage and will evolve to become a potential and versatile ultrasound application. Currently, Elastography is available with full potential for breast diagnosis from Siemens, Philips and SuperSonic Imagine.

Source: SuperSonic Imagine

5

� www.supersonicimagine.fr

� Total Number of Ultrasound Products: 1

� The company’s USP is its MultiWave ultrasound platform that leverages the innovations and speed in the videogame industry and supports both high quality B-Mode imaging and ShearWave Elastography. ShearWave Elastography enables real-time, quantitative and reproducible tissue elasticity imaging with a color coded elastrography map.

� ShearWave Elastography generates, captures and quantifies the speed of shear wave propagation and using the Young's modulus derives the stiffness of tissue in kilopascals.

� The product – The Aixplorer ultrasound system is clinically dedicated with packages for the breast, abdomen and thyroid with other dedicated applications on the horizon for the future.

� In support of its first application, SuperSonic Imagine has undertaken a large, 2300 patient, worldwide breast clinical trail that will be published in the Spring of 2010.

� In August 2009, Aixplorer received the FDA approval and certification.

YesElastographyNoTherapeutic

Yes

Color

MappingNoSurgery

No3D/4DNoOB/GYN

NoContrast HarmonicNoUrology

NoTriplexYesAbdomen

Yes

M-Mode and

2DYesBreast

Yes

Tissue

HarmonicYes

General

Imaging

Image ModeApplication

SuperSonic Imagine – Company Profile

6

Ultrasound Advancements - HIFU

� High Intensity Focused Ultrasound (HIFU) is an emerging technology for the non-invasive treatment of certain tumors and other pathological conditions. It generates precise tissue necrosis and it hardly affects the neighboring tissue areas.

� HIFU is primarily utilized for the effective treatment for prostrate cancer. New HIFU developments are also taking place for the treatment of hyperparathyroidism. It has also been successful in the treatment of uterine fibroids. HIFU clinical trials are being conducted for treatment of kidney, pancreas, bladder and liver.

� HIFU treatment is not applicable for cancer treatment of brain, lungs, pelvic areas, lymph nodes or skin

� There are no effective standards governing the application of HIFU technology. Many standards have been proposed by researchers executing HIFU clinical trials. However, it is important to note that no single HIFU treatment procedure is regarded as an effective therapeutic option.

Source: Theraclion

7

� www.theraclion.com

� Total Number of Ultrasound Products: 1

� Founded in 2004, Theraclion is a specialist for the non-invasive treatment of head and neck pathologies using High Intensity Focused Ultrasound (HIFU)

� The company is supported by internal scientific committees composed of surgeons and interventional radiologists.

� The product Thyros is dedicated to the treatment of hyperparathyroidism (primary and secondary)

� A limited market launch of Thyros will occur in Q1 2010 in UK, Germany and Italy, followed by the rest of Europe.

� The product is CE marked and its FDA approval is pending.

Theraclion – Company Profile

NoElastographyYesTherapeutic

NoColor MappingNoSurgery

No3D/4DNoOB/GYN

NoContrast HarmonicNoUrology

NoTriplexNoAbdomen

NoM-Mode and 2DNoBreast

NoTissue HarmonicNoGeneral Imaging

Image ModesApplication

8

Ultrasound Advancements - CEUS

� Contrast Enhanced Ultrasound (CEUS) is a technology where contrast agents such as gas filled micro bubbles are injected into the circulatory system with the objective of improving image quality. High echogenicity differences that exist between the gas filled micro bubbles and tissues enable a highly contrasted image

� CEUS is also expected to ascertain better diagnosis of prostate cancer. This is because the sensitivity of prostate cancer diagnosis increases significantly by performing targeted biopsy of the prostate with CEUS.

� The biggest growth area for CEUS is in the assessment of joint damage rheumatoid arthritis (RA) and osteo arthritis. With the advent of regenerative medicine, the objective is to track therapy response accurately.

� In the long-term future, contrast agents will become optimized for a desired set of harmonic characteristics. In other words, contrast agents will be specifically developed for a specific application (such as tissue perfusion for example).

Source: GE Healthcare

9

Conclusion

� HIFU and CEUS is poised for the greatest growth potential in the next decade. It is premature to estimate the market size and growth rate for these two sectors at the moment because HIFU and CEUS are experiencing extensive clinical trials. The results of such trials yield varying success rates. However, it is imperative that more clinical trials would follow, given the government initiatives to promote non-radiological safety standards.

� HIFU requires extensive clinical validation by both controlled and uncontrolled methods. There is not an independent company in Europe for HIFU for clinical testing and HIFU product development. All HIFU companies have strategic partnerships with other HIFU companies and research clinics. Unlike diagnostic requirement, HIFU is eminently organ specific.

� Elastography will create a niche segment of opportunity within the ultrasound spectrum. The general ultrasound market is essentially saturated and revenues for vendors are generated by replacements. However, the technological edge that elastography offers for enhanced diagnosis, clients would be more compelled to invest in ultrasound equipment that has this feature.

10

Major Vendors in the Ultrasound Segment

11

Next Steps

� Request a strategic approach document for a Growth Partnership Service or Growth Consulting Service to support you and your team to accelerate the growth of your company. ([email protected]) +44 (0)20 7343 8383

� Join us at our annual Growth, Innovation and Leadership 2010: A Frost & Sullivan Global Congress on Corporate Growth London, United Kingdom

(www.gil-global.com)

� Register for the next Chairman’s Series on Growth: Growth Acceleration System: Leveraging the Growth Diagnostic Blueprint

17 March 2010 10:00 AM GMT (www.frost.com/growthEU)

� Register for Frost & Sullivan’s Growth Opportunity Newsletter and keep abreast of innovative growth opportunities (www.frost.com/news)

12

Your Feedback is Important to Us

Growth Forecasts?

Competitive Structure?

Emerging Trends?

Strategic Recommendations?

Other?

Please inform us by taking our survey.

What would you like to see from Frost & Sullivan?

13

For Additional Information

Katja Feick

Corporate Communications

Healthcare

0049 (0) 69 7703343

[email protected]

Noel Anderson

European Vice President

New Business Development

+44 (0)207 343 8389

[email protected]

Siddharth Saha

Director of Research

Healthcare

+ 44 (0) 207 343 8374

[email protected]