Frequently Asked Questions
Seno’s opto-acoustic technology is a platform technology with a number of applications.
Seno’s technology produces high-resolution images related to the performance of tissue; this class of imaging technique is known as functional imaging. By comparison, existing technologies such as X-ray and ultrasound produce anatomical images which, only show the structure of tissue. In Seno’s technology, the images are generated based on hemoglobin concentration and its level of oxygenation; the growth of malignant tumors is supported by additional new blood vessels, a process known asangiogenesis, to provide the necessary hemoglobin for that growth. The resulting increased concentration of hemoglobin, especially that which has given up its oxygen to the cancer cells, is a prime indicator of cancer. Seno’s technology shows this type of functional information. Images are generated without using ionizing radiation (X-rays) or injection of contrast agents.
The existing optical and ultrasonic imaging techniques create images by transmitting energy in one form and detecting that energy in the same form, which greatly limits the information that can be captured and reported. Opto-acoustics transmits light energy, but detects sound energy by using multiple colors of laser light, a much broader range of data can be captured which makes the functional images possible.
The Imagio® breast imaging system – opto-acoustic fused with ultrasound (OA/US) – is currently CE marked in Europe with commercial delivery of the product expected mid-2017. The Imagio® OA/US breast imaging system is currently being processed through the U.S. FDA system of approval. That approval is expected early 2018 with sales in the U.S. immediately after approval.
The pathway of approval for sale and use of Seno’s opto-acoustic imaging system is governed by the Food and Drug Administration (FDA) Center for Devices and Radiological Health. The FDA’s Office of Device Evaluation is responsible for ensuring the safety and effectiveness of the medical devices available to U.S. consumers and does so based on documentation collected by the device manufacturer. Although optical and ultrasound devices are both already used clinically, the unique combination of technologies present in Seno’s opto-acoustic tomography system will require a regulatory approval process reserved for new technologies, which is known as a Pre-Market Approval.
The light used by the opto-acoustic tomography system is not harmful to skin and is within acceptable guidelines for maximum permissible exposure. Similarly, induced temperature-rise and pressure-rise parameters are comparable to that seen in other medical devices. No X-rays are used in the production of images.
Patents have been filed for the various aspects of Seno’s opto-acoustic imaging system and its technology. Additionally, because of the nature of the science and engineering on which the technology is based, significant expertise resides within the Seno team.
The basic science of opto-acoustics was first discovered in 1880 by Alexander Graham Bell, but the application of this effect was not made practical until the technology for producing stable laser light was refined in the 1970’s. In the late 1990’s, a PhD biophysicist developed the first successful method of combining laser light with the latest ultrasound detection techniques in a safe and effective way, thus providing the first opto-acoustic images in human tissue. This biophysicist became the lead researcher and inventor of opto-acoustics for clinical use, and he, along with many other Seno scientists and engineers, were instrumental in initiating the first commercial product development. Other than Seno Medical Instruments, no other company has demonstrated such a combination of expertise and motivation towards commercialization.
Seno has recently completed a pivotal study in the US and a post-market surveillance and clinical follow-up study in Europe to evaluate if this non-invasive imaging system (non-ionizing radiation, no injected contrast agents) has the potential to help doctors more effectively determine which patients need biopsies. Please watch this Website for information about future clinical trials and results.