The essence of “VELOCITY IMAGING TOMOGRAPHY”
The theory of “Linear Velocity Imaging Tomography” is proprietary and explained in a patent application filed by the company founder, Dr. Avraham Suhami.
The “Traversal time” of an electro-magnetic wave traversing the breast may be measured using directional antennas with very high time accuracy of 3 picoseconds using proprietary traversal-time measuring method; “Velocity” distribution in a slice of the breast of EM wave traversing from multiple directions may be reconstructed mathematically using iterative tomography algorithms. The different “local Velocity aggregates” will indicate the concentration of similar tissue areas, such as normal tissue, glands, fibers and benign or malignant growths; the edges of such similar tissue agglomerations, their “margins” will indicate where malignancy may have infiltrated.
Although the existence of a localized tumor in the breast can be determined by X-rays, such differentiation is limited, as density between normal, benign and malignant tissue, changes by only 20-30%. However “Velocity Imaging Tomography”, that is based on measuring “traversal time” is in principle significantly more accurate, as it measures both
NON-X-RAY full imaging of the pendant breast in less than a minute.
REPETITIVE imaging as often as needed at any age
NO RUSH to SURGERY. “Breast imaging” may be repeated, to watch for “Growth” if any, in sequential examinations.
Benign growths are differentiated from Malignant tumors by imaging their surrounding blood supply (Angiogenesis) characteristic of malignancy.
Reconstructs 3D Volume of Breast tissue extending across consecutive slices, thus enabling to measure quantitatively changes in “size” indicative of TUMOR GROWTH.
Enables to view the “Margins” of excised tumors after surgery.
“structure inhomogeneity” and dielectric contrast εr ,that as explained above may differ up to 300%.
The company is currently running clinical tests, in cooperation with the Medical Imaging division of the Rambam Medical Center in Haifa, measuring traversal times across human tissue samples, following the Helsinki protocol on the human research ethics of the hospital. The tissue samples are surgically excised from live breasts of patients, who agreed in writing, that samples from the excised tissue that are examined by the Pathology department of the hospital, also be used for our medical research.
As per the Helsinki protocol, live samples from the excised tissue sent to the Pathology department for tissue characterization, are also used for measuring “traversal times” across said tissue, by a company operator using our highly accurate (~3 picoseconds) time measuring equipment. The attached figures illustrate measurements that show a great contrast in “traversal times” between breast fat (~10psec/mm) and a benign tumor (fibroadenoma) (~30psec/mm), which is in line with our theoretical predictions for “Linear Velocity Imaging Tomography”.
The measurements will continue during the coming months until more statistics from different tissues are accumulated. Following the “Traversal Velocity” measurements that are going on in Rambam Medical Center, we are also negotiating with CARMEL Medical Center, to repeat the “traversal times” measurements in order to increase the statistical validation of the “Velocity Imaging Tomography”.
In parallel with the clinical measurements for classifying different breast tissues by the propagation time of Radio Frequency beams, we are designing the Breast Tomomograph gantry that consists of a table upon which the patient rests and inserts the breast to be imaged into a round aperture. A circular array of proprietary RF transceivers, turn around the breast and move vertically up and down, in order to scan it from all directions, without compressing the breast. The data obtained by the array of Transceivers is relayed to a powerful computer which, using our proprietary software, forms a 3D volume image of the Breast in the Velocity domain.
2D “surfaces” across the 3D Volume Image may be generated for better visual examination, and the results displayed on monitors.
The entire breast scanning process will take less than a minute, so that the Breast Tomograph Gantry may be used for the next patient.
We plan to install a preliminary Breast Tomograph in Rambam Medical Center by spring 2018 under a Helsinki Protocol for comparative evaluation with current mammography systems.
By mid 2018 we plan to submit a DeNovo application to the FDA that will include the Clinical comparative data obtained during the evaluation process in Rambam Medical Center.
We anticipate, in view of the expected higher velocity contrast and not using X-Ray, to show a revolutionary impact on women’s health worldwide, and to obtain an expedient FDA approval by the RSNA 2018.
To validate the economical value of the “Velocity Imaging Tomograph”, we plan to install by RSNA 2018 a private commercial Tomograph in Tel-Aviv that will be able to perform full Breast imaging without radiation and without compression, in less than a minute. We intend to optimize the service including the paperwork to show that an examination session may be performed in less than 5 minutes. Obviously the economical value of the system will depend on the flow of patients at a specific location.
We intend to start building our sales and service organization in Israel and in the USA in the fall of 2018 in anticipation of the expected FDA approval.