Published: March 05, 2011
SuperSonic Imagine Reports Validation of Clinical Benefits of ShearWave Elastography, Demonstrating Increased Performance in Breast Cancer Diagnosis
AIX-EN-PROVENCE, France - (BUSINESS WIRE) - SuperSonic Imagine presented yesterday the validation of a world wide
multicentre study, based on European recruitment, confirming the benefit
of ShearWave Elastography when added to ultrasound for improved lesion
classification.
Launched by SuperSonic Imagine in June 2008, the global, multi-centre
study was conducted across 16 American and European sites involving
1,800 patients with breast lesions.
The first major result of this study demonstrated that ShearWave
Elastography is reproducible both quantitatively and qualitatively. This
reproducible technology provides strong assurance of precise tissue
evaluation during diagnosis and is expected to be also useful in
follow-up.
The second important outcome is a statistical model based on 939
lesions, which showed that ShearWave Elastography increases the
performance of ultrasound breast cancer diagnosis. The addition of
ShearWave Elastography features, such as maximum elasticity (stiffness)
or heterogeneity (uniformity) of a lesion, to B-mode ultrasound, would
permit an improvement in the BI-RADS classification
accuracy, (standardization tool for breast lesion classification from
the American College of Radiology) improving breast diagnosis.
European results validate the conclusions of
the model
In Europe, 1,223 lesions have been examined, including 425 cancers
(34.8%). The European study was conducted across four sites in France
(332 lesions), four sites in Germany (585 lesions), one site in Italy
(104 lesions) and one site in United-Kingdom (202 lesions).
The application of the model to this sub-group demonstrates the
importance of the maximum elasticity value. When added to the BI-RADS
score, this value:
-
Maintains the sensitivity* of the ultrasound exam (97.9%)
-
Increases its specificity* by more than 8 per cent (59.9% to 68.2%)
-
Maintains its negative predictive value* above 98%
-
Increases its positive predictive value* by more than 5 per cent
(73.1% to 78.5%)
These results confirm the increase in specificity expected with the
addition of ShearWave Elastography features to BI-RADS
criteria and consequently the reduction of the rate of negative
biopsies. In addition, ShearWave Elastography can assist in diagnosing
cancers that would have otherwise fallen into a follow-up category, thus
earlier intervention and treatment could occur with significant
implications for patient management.
*Note:
Sensitivity = ability to find malignant lesions
Specificity = ability to find benign lesions
Negative predictive value = reliability of the benign test
Positive predictive value = percentage of lesions correctly classified
About SuperSonic Imagine:
Founded in 2005 and based in Aix-en-Provence, France, SuperSonic Imagine
is an innovative, multinational medical imaging company dedicated to
developing a revolutionary ultrasound system: the Aixplorer.
This system leverages a unique MultiWave technology that enables the
user to detect, characterize and, in the future, treat palpable and
non-palpable masses. This unique technology is based on combining two
types of waves: an ultrasound wave that provides exceptional imaging in
B-mode, and a shear wave which measures and displays the stiffness of
tissue in kilopascals (ShearWave Elastography ). Engineers from all
over the world have joined the SuperSonic Imagine team and the company
now has offices in Aix-en- Provence, Seattle, London and Munich. In
addition to a successful direct sales in France, Germany, USA and UK,
SuperSonic Imagine built a strong distribution network worldwide,
including Hologic Inc. (Nasdaq: HOLX) for the breast care market in the
USA as well as dedicated strategic partner Canon in Japan. SuperSonic
Imagine holds the exclusive right, title and interest to 25
international patents and submissions in diagnostic imaging and therapy
applications. SuperSonic Imagine is backed by strong financial,
strategic and industrial investors, including Edmond de Rothschild
Investment Partners (EdRIP), Auriga Partners, Credit Agricole Private
Equity (CAPE), NBGI Ventures, Bioam, Merieux Developpement, Wellington
Partners, Innobio, Canon (NYSE:CAJ), and IXO Private Equity (formerly
known as ICSO Private Equity).
For further information about SuperSonic Imagine please visit our
website: www.supersonicimagine.com
About Aixplorer:
Aixplorer is a next-generation ultrasound imaging system with unique
technology that offers advantages in lesion detection and
characterization. Using a method of imaging called ShearWave
Elastography, Aixplorer can measure true tissue elasticity, in real
time, providing quantifiable*, user- skill independent and reproducible
results. The Aixplorer ultrasound system also provides impeccable images
and sophisticated features all packaged in an ergonomic design, to
assist in the imaging diagnostic process. Based on these innovations,
Aixplorer now has six clinical applications: breast (and 3D breast),
thyroid, abdomen, musculo-skeletal, prostate, and gynaecological
(excluding obstetrics). In parallel to diagnostic imaging, researchers
at SuperSonic Imaging are currently developing a noninvasive ultrasound
therapy method, based on technology from Miroir à Retournement Temporel
developed by Mathias Fink, a co-founder of SuperSonic Imagine. Aixplorer
was named after its birthplace, Aix-en-Provence, in France. The
Aixplorer has both CE mark approval since 2008 and FDA clearance since
2009.
For more information on SuperSonic Imagine and Aixplorer, please visit
these sites:
http://www.supersonicimagine.fr
http://www.youtube.com/watch?v=oF9xZPZai_s
Press contacts SuperSonic Imagine
H&B Communication
Florence
Portejoie, +33 158 18 32 58 or +33 688 84 81 74
f.portejoie@hbcommunication.fr
or
Michele
Debain, +33 442 99 24 32
Global Marketing Director SuperSonic
Imagine
michele.debain@supersonicimagine.fr
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