Health Professionals

SoftScan is an optical molecular imaging device for diagnosing and characterizing breast cancer, and can be used for monitoring treatment. The SoftScan device addresses a critical and unmet need in breast tissue analysis, namely a device that provides functional or physiological information about a lesion, such as tissue perfusion, blood oxygen and water content, and that allows a lesion to be characterized as benign or malignant.

SoftScan: a novel technology platform

The SoftScan optical breast imaging device uses near-infrared light, combined with time domain technology, to obtain 3D images of the breast. A laser sends brief pulses of light into the breast and detectors measure photon migration through the breast. This information is converted into clinically significant, physiological parameters such as scattering, oxy- and deoxy-hemoglobin. SoftScan images characterize tissue on the basis of cellular structure and tissue blood perfusion. The SoftScan device is comprised of an optical acquisition station and a review workstation.

Benefits to health professionals

  • Higher degree of precision in diagnosis and treatment.
  • Ability to image patients as often as necessary without exposure to ionizing radiation.
  • Ability to image patients with radio-dense breast tissue, typical of younger women and those who are on hormonal replacement therapy.
  • Ability to distinguish malignant tumours from benign tumours
  • Ability to monitor breast cancer treatments.
  • Ability to personalize treatment.
  • Ability to monitor neo-adjuvant therapy.

Benefits to patients

  • No painful compression of the breast.
  • No harmful ionizing radiation.
  • Early characterization of anomalies.
  • Improved diagnosis and quality of care.
  • Reduced need for invasive and, in some cases, unnecessary biopsies.

Target market niche

Adjunct to X-ray mammography; treatment monitoring.

Relevant clinical applications

Using optical technology combined with the ability to determine whether lesions are malignant or benign at an earlier stage through functional imaging, the SoftScan device provides a solution to the limitations inherent in other technologies. More targeted clinical applications are anticipated in diagnosing young women who are at increased risk through familial predisposition and women (pre-menopausal or on HRT) with mammo-dense breasts. Also, the SoftScan device may be an effective tool to help monitor the treatment of patients undergoing chemotherapy for breast cancer. Clinical trials to monitor treatment that are currently under way using the SoftScan technology are showing results to treatment in as little as seven days. The trials are evaluating patients who respond to treatment and those who do not. These evaluations are being conducted at the Sunnybrook Health Sciences Centre. The SoftScan device may prove useful in pharmaceutical settings, aiding in the clinical validation phases of developing new drugs or biomarkers.

FDA clearance status

ART is seeking regulatory approval of the SoftScan device as an adjunct to conventional X-ray mammography in the U.S. The company is testing the SoftScan device at five North American centres. These studies are designed to show that diagnoses with the SoftScan imaging device are unequivocal, regardless of the breast tissue’s density. This study data will support the SoftScan system’s Pre-Market Approval (PMA) application to the FDA.

Availability in the U.S.

The SoftScan device will be commercially available in the U.S. upon approval by FDA.

Availability in the rest of the world

The SoftScan device has been approved for sale in Canada and Europe.

Pricing information

Please contact SoftScan Sales.