Seno Medical Breast Imaging Technology Receives FDA Pre-Market Approval

By Iris Gonzalez
Image of a woman getting a mammogram. Photo credit: National Cancer Institute.

The commercial pathway for a San Antonio-based medical technology company that began its development over 15 years ago is closing in on the U.S. market. Seno Medical Instruments Inc. has gotten pre-market approval from the U.S. Food & Drug Administration (FDA) Tuesday for its medical imaging tool to diagnose breast cancer.

Seno Medical’s imaging system uses opto-acoustic technology combined with laser optics and conventional ultrasound technology to provide an image of breast tissue in real-time. The company developed its Imagio breast imaging device to give physicians a way to examine breast tissue via images to rule out the need for invasive, expensive biopsies in patients with benign breast masses.

About one in eight women in the United States will develop invasive breast cancer, yet only 20% of these biopsies yield breast cancer diagnosis.

Breast mass identification can be difficult when using current technology, with clinicians often resorting to a needle biopsy for further examination.  Clinical studies have shown how optoacoustic technology fused with ultrasound imaging can improve breast cancer diagnosis by differentiating between benign and malignant breast masses and among subtypes of breast cancer.

“We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the U.S. with this FDA approval,” Seno’s CEO Tom Umbel said. “Our internal team and our faithful investigators and clinical trial sites have worked diligently to bring Imagio to market and improve care for patients and providers with the precise diagnostic capabilities and enhanced decision-making support that our novel OA/US imaging provides.”

The most stringent approval process for medical devices is the FDA’s premarket approval, which is required for a relatively small percentage of deemed the riskiest devices. Securing FDA premarket approval for Seno’s breast imaging technology is required before the company can produce it for the U.S. market. Seno Medical Instruments received European approval for its Imagio technology in 2014.

Seno Medical Instruments, Inc. formed in 2005 in San Antonio to commercialize a cancer screening and diagnostic method called opto-acoustic imaging. Its first clinical application is for use in breast cancer diagnosis.

The company purchased opto-acoustic prototypes and proprietary test equipment, the core patent, and other associated intellectual properties from Dr. Alexander Oraevsky and Fairway Medical Technologies in exchange for equity.  Dr. Oraevsky, the father of medical opto-acoustics, had validated the science through grants from such nationally recognized institutions as the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Department of Defense (DOD). He continues to provide advice and support to Seno for future applications of this technology.

Seno’s Chief Medical Officer, Dr. Thomas Stavros, stated in the company’s announcement how their Imagio system is establishing a better standard for diagnosing breast cancer.

“Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses. Other modalities have reported improvements in specificity, but these have often come at the expense of the desired high ≥98% sensitivity. The data from the PMA study shows that OA/US successfully achieved improved specificity at a fixed sensitivity of 98%, the part of the ROC curve where clinical decisions about whether or not to biopsy a mass are actually made.”

The image is of a woman getting a mammogram. Photo credit: National Cancer Institute.




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