Sectra receives FDA clearance for MicroDose Mammography modality

Sectra receives FDA clearance for MicroDose Mammography modality

First-of-its-kind technology enables women to benefit from significant
reduction of radiation exposure

Women in the US will now have the same opportunity as million of
European women already have; to undergo mammography with significantly
lower radiation dose. This is the result of FDA's (Food and Drug
Administration) clearance of the Swedish IT and medical technology
company Sectra's digital mammography system, Sectra MicroDose
Mammography (http://www.sectra.com/medical/mammography/solutions/microdo
se/index.html). Achieving best-in-class cancer
detection (http://newsroom.sectra.com/2011/03/webcasts-from-the-ecr-mamm
ography-symposium/#more-642), the Sectra MicroDose photon
counting (http://www.sectra.com/photon-counting) technology reduces the
radiation dose by half of that used by other digital or film based
systems.

“The advantages of a yearly mammography examination clearly outweigh the
risks. But a woman undergoing regular mammography examinations is
exposed to radiation every time she is screened, and so it is important
to minimize radiation dose,” says Stamatia Destounis, MD, managing
partner, Elizabeth Wende Breast Care, LLC.

Sectra MicroDose has already been contributing to a significant
reduction of radiation dose in most major European mammography screening
programs. It has been used for more than seven years and is operational
in countries throughout Europe, Australia, New Zealand and Japan.
Recently, the system was also approved in Canada and Russia.

“Until now, digital mammography systems in the US have managed to reduce
the radiation dose slightly below those of film-based systems,” says Dr.
Jesper Söderqvist, president of Sectra's mammography operations. “Sectra
MicroDose enables mammography service providers to reduce the radiation
dose by half, which is a significant benefit to women,” adds Dr.
Söderqvist.

Key to the very high image quality at significantly reduced radiation
dose, is Sectra's revolutionary photon counting detector technology.
Sectra MicroDose is the first imaging modality based on a photon
counting detector technology to receive FDA clearance.

Improving cancer detection with photon counting technology
Sectra MicroDose Mammography is based on the company's proprietary
photon counting technology. A multi-vendor comparison
study (http://newsroom.sectra.com/?p=642) presented at a European
radiology congress in March 2011 indicates better cancer detection for
Sectra MicroDose compared to other mammography systems available in the
U.S.

“Ongoing research shows great promise for further improvements in breast
cancer detection with our unique photon counting technology,” explains
Dr. Söderqvist. “Our technology is also the cornerstone in a large
European research project for developing and evaluating new
revolutionary breast cancer detection methods,” adds Dr. Söderqvist.

Unlike traditional analog and digital mammography modalities, which
require a higher dose of radiation to ensure image quality; Sectra
MicroDose Mammography detects x-ray photons individually. Thereby the
Sectra MicroDose detector makes it possible to reduce the radiation dose
by half from that used by other digital or film based systems, while
still obtaining as high or higher image quality. Images are delivered
with 25 megapixles, which is two to four times higher resolution than
that of other digital systems. The high resolution of the images aids
detection of early changes that occur with breast cancer.

 

The information in this press release is such that Sectra AB (publ) is
obligated to disclose in compliance with the Swedish Securities and
Clearing Operations Act and/or the Financial Instruments Trading Act.
The information was submitted for publication on May 4, 2011, at 08:00
am (CET).

For further information, please contact:
Dr. Torbjörn Kronander, President, Sectra Imtec AB, 46 705 23 52 27
Dr. Jan-Olof Brüer, CEO and President, Sectra AB, 46 13 23 52 09