False-positive breast biopsies in the United States cost the healthcare system more than $2 billion per year, according to findings released from a study in ClinicoEconomics and Outcomes Research, conducted by a team of health outcomes research scientists at IBM Watson Health in collaboration with Seno Medical’s Chief Medical Officer, A. Thomas Stavros, MD. The study authors stressed the critical need for follow-up with patients who present with abnormal results on a screening mammogram. Standards of care and practice guidelines require further imaging studies before an invasive procedure such as breast biopsy is performed, when the screening mammogram uncovers something suspicious.*
"A clinical trial investigating a non-invasive, radiation-free imaging system that has the potential to help doctors more effectively determine which patients need breast biopsies has been completed."
They further recognize the unmet medical need for highly effective diagnostic tools that could eliminate patients whose suspicious breast masses are benign before they are subjected to invasive diagnostic procedures. Seno Medical’s Imagio® OA/US Breast Imaging System and its proprietary artificial intelligence tool, SenoGram™, is helping breast imagers become better at interpreting both ultrasound and opto-acoustic ultrasound (OA/US) images, as seen in recent studies. “The costs to the healthcare system are secondary to the psychological impact on women who are told that their mammogram and ultrasound were inconclusive, and that a biopsy is required to rule out cancer,” says Stavros. “Not only does our technology provide the fusion of opto-acoustics (OA) and ultrasound (US) into a more robust image set (OA/US), but the feature reference keys and training that accompanies our technology further educates imagers on the nuances of ultrasound image characteristics and interpretation in addition to effectively reading opto-acoustics.”
Seno Medical is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Much like predecessor fusion technologies, such as PET/CT or PET/MRI, opto-acoustic/ultrasound (OA/US) provides both anatomic and molecular (functional) information in a fused image set to aid clinicians in more accurate diagnoses, using blood as a natural contrast agent (requiring no contrast agent, radiopharmaceutical or ionizing radiation for the patient).
According to Tom Umbel, CEO of Seno Medical, through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes the Imagio® OA/US breast imaging system is a more effective imaging modality to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. “The Imagio® Breast Imaging System combines laser technology with conventional ultrasound imaging providing a unique color blood map in and around breast masses that is co-registered with grey-scale ultrasound”, adds Tom. “The SenoGram™ artificial intelligence tool is only available with the Imagio® System. This clinical decision support tool acts as a “Digital Assistant” and aids the radiologist’s efficiency by providing image reference keys to facilitate more effective and accurate assignment of ultrasound and OA/US feature scores.”Additionally, the SenoGram™ helps to more objectively and precisely translate Imagio® ultrasound and OA/US feature scores into a Likelihood of Malignancy (LOM) for the beast mass, improving upon what breast imagers can achieve with their existing subjective assignments of LOM alone. This tool handles and appropriately compiles fourteen different feature scores and patient attributes, discordant or otherwise that typically challenge the human mind..
“Seno Medical currently has a CE mark in the European Union and installations in the Netherlands. Our technology is pursuing an FDA Pre-Market Approval (PMA) in the USA,” says Tom. While the commercialization of Seno’s Imagio® breast imaging system is underway today, many other exciting applications lie in the future. “We envision this technology to potentially include screening, diagnostic and treatment devices for other forms of cancer including thyroid, prostate, cervical, ovarian and bladder, in addition to therapeutic monitoring of neoadjuvant therapy,” adds Tom.IE
CEO Seno Medical
Seno Medical’s imaging system uses opto-acoustic technology interleaved with ultrasound (OA/US) to generate functional and anatomical images of the breast. As a new imaging modality, Seno believes that its Imagio® breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancies than current diagnostic imaging approaches, without exposing patients to potentially harmful ionizing radiation (X-rays) or contrast agents, including breast cancer biopsies.