Clinical Insights

Please read insights, perspectives, and experiences from medical experts renowned for their work in the field of breast cancer and medical imaging.

The interim results from MAESTRO add to the growing body of clinical evidence showing that the Imagio® opto-acoustic diagnostic tool increases physicians’ confidence when differentiating and classifying malignant and benign breast tissue,” said the study’s principal investigator Ruud Pijnappel, MD, PhD, Radiologist, University Medical Center, Utrecht, NL, who presented the interim analysis. “The improved accuracy that is possible with this technology could help women avoid painful biopsy procedures that sometimes follow false-positive diagnoses.”

State Representative Joe Straus, who represents the San Antonio community in the Texas Legislature, said, “Seno’s breakthrough technology promises breast cancer patients will be able to receive better diagnosis and treatment. The State of Texas is pleased to be its partner.”

“Seno’s opto-acoustic technology creates a new diagnosis window. The ability to identify malignant tissues from the non-malignant based on differences in metabolic demand represents a breakthrough technology for the diagnosis of breast cancer with potential applicability to other forms of cancer,” said John Holaday, PhD and member of Seno Medical’s Scientific Advisory Committee.

Arturo Bonilla, M.D., a San Antonio surgeon and member of Seno Medical’s Board of Directors, says he is impressed by the company’s leadership and is encouraged by his fellow physicians’ reactions to the technology. “When I saw the support from worldwide leading experts in medicine, especially radiology and oncology, I knew that we had something very special here,” said Bonilla. “The experience and integrity of this company and the hard work of all its staff has left me with no doubt this breakthrough technology will soon be commonplace. This in turn will save many lives.”

“Given these early results, I believe that opto-acoustics could potentially spare some BI-RADS 4a cases and some BI-RADS 4b cases from needing to undergo biopsies,” said study investigator Kenneth Kist, M.D., Associate Professor of Radiology at UT Health Science Center in San Antonio, Texas, in response to data shared from the feasibility study on Imagio® breast imaging, presented at the 2013 Radiological Society of North America (RSNA) conference, “This could represent a significant advance in the diagnostic path for breast cancer, and I look forward to seeing the results of the ongoing U.S. Pivotal Study.” Results from the feasibility study suggest that information from Imagio®, beyond that available from traditional breast ultrasound, may be helpful in assisting physicians in their decisions whether to recommend biopsies for women with suspicious breast masses.

Thomas Stavros, MD, FACR, FSRU, FRANZCR, one of the world’s leading experts in breast radiology, has been named the company’s Medical Director. “I am excited to join the Seno management team and help the company in its quest to develop and commercialize opto-acoustic imaging, which I believe could become a new standard in cancer diagnosis,” said Dr. Stavros. “I’ve spent my career working to develop safe and effective breast imaging solutions, and I believe opto-acoustic technology has the potential to significantly improve the breast cancer diagnostic and treatment path. The sad reality is that 80% of biopsies ultimately return negative results due to limitations of current imaging modalities. The Imagio® system produces some of the most exciting images depicting angiogenesis and oxygen levels within and around suspicious masses that I’ve seen in my career and could enable us to more precisely diagnose or rule out breast cancer.”

“There is a significant unmet medical need for more accurate diagnostic imaging technologies to help physicians confirm and rule out breast cancer before the patient has to undergo an invasive procedure. More information at the imaging stage could help us make more informed decisions regarding whether we should send the patient for a surgical or needle biopsy,” said Reni Butler, MD, Assistant Professor of Diagnostic Radiology at the Yale School of Medicine in New Haven, Conn. and the co-principal investigator for the U.S.-based PIONEER Pivotal Study of Imagio®.

“Earlier data from a feasibility study of Imagio® led to encouraging results, and we look forward to seeing the outcomes from this U.S.-based PIONEER Pivotal Study. If the results are consistent with the earlier, smaller studies, we believe this could be an important new technology to help improve the diagnosis of breast cancer and allow many women with benign lesions to have short-interval Imagio® follow-up and avoid a biopsy,” said co-principal investigator Erin Neuschler, MD, Northwestern Medicine® Radiologist and Assistant Professor of Radiology at Northwestern University Feinberg School of Medicine in Chicago.