Izotropic Corporation has announced that the United States Patent and Trademark Office has issued U.S. Patent No. 11/913494, entitled “Biopsy Systems For Breast Computed Tomography”. A Notice of Allowance was announced for this patent in February of this year.
The patent covers the use of Izotropic Corporation’s dedicated Breast CT Imaging System for robotic guided biopsy (Izotropic Breast CT Biopsy System), giving physicians the ability to image and obtain samples of suspicious lesions and tumors for pathology testing./p>
To understand the significance of this patent, it is important to understand the common imaging and diagnostic care paths that lead to a breast biopsy procedure and how they are performed.
When a patient presents with a symptomatic breast or an abnormality is detected on a screening mammogram, a diagnostic mammogram is often performed by a radiologist who will take additional 2D images at different viewpoints to assess the shape and structure of the abnormality. If further investigation is required after the diagnostic mammogram, a patient may then have a breast ultrasound to determine if the abnormality is a fluid-filled cyst or a solid tumor, which may or may not be cancerous. After these diagnostic tests, a biopsy may be performed which is often ultrasound guided, though it is also common for patients to have even more imaging tests including additional diagnostic mammography, tomosynthesis or MRI imaging procedures, before that ultrasound guided biopsy is performed. In some cases, an abnormality may be best imaged on an MRI, in which case MRI would be used to guide the biopsy procedure. MRI requires a patient to be submerged 9ft into an imaging tube and this distance means a doctor cannot access the patient to perform a biopsy procedure and the patient must be brought out of the tube and imaged an additional 2-3 times to ensure that 1) the abnormality is properly located, 2) a plastic needle biopsy placeholder has been correctly positioned, and 3) that the needle itself has successfully sampled the suspicious lesion or tumor. The only way to definitively diagnose breast cancer is to perform a biopsy for pathology testing.
A recent study found that the costs of follow-up imaging and diagnostic procedures after screening mammography in the US alone was over $8B USD annually.
The Izotropic Breast CT Biopsy System takes advantage of true 3D imaging capabilities comparable to MRI and would allow a suspicious lesion or tumor to be located in three dimensions during a diagnostic test and then immediately biopsied. This would reduce the timeline to diagnosis and minimize or eliminate additional imaging tests and medical appointments required to diagnose breast cancer. This may also decrease costly follow-up appointments and false-positive biopsy results. These false positives are where a suspicious lesion or tumor found on breast imaging that was thought to be cancerous was then determined to be benign after pathology testing of a biopsy sample.
The same study on follow-up costs cited above provides additional insight into costly false-positives: 71% of breast biopsies in the US are found to be negative and the expenditure associated is estimated to be $2.18B USD annually. It also reported the average amount paid for a breast biopsy procedure to be $1,938 USD, not including the average costs of additional services or billings to complete the diagnostic process: $1,264 for pathology testing of the biopsy sample, $735 for a follow-up office visit, totalling an average of $3,937 USD.
Given the significant financial and time costs associated with the current care pathways to breast biopsy, and the ability of breast CT to routinely detect small tumors in the 3-5mm range (the average size tumor detected with mammography is 11mm), the Company feels meaningful advances are forthcoming in the earlier detection and diagnosis of breast cancers with dedicated Breast CT and breast CT biopsy devices.
The Company also announces the issuance of 150,000 stock options to a consultant at an exercise price of $0.26 per share for a 6-month term, expiring at the close of business on November 6, 2020. The options vest immediately.Back To Top
Izotropic Receives Patent to Use Breast CT for Robotic-guided Biopsy. Appl Radiol.