It is designed to work by using spectral analysis to “see” into tissue to provide real-time information. Spectral analysis is a well-regarded technology that’s used in many other medical applications and devices. ClariCore’s spectral tissue analysis intends to use spectral biomarkers typically found in prostate tumors and a highly predictive algorithm to instantly distinguish normal versus suspicious tissue.
First, there’s not only a handpiece to collect tissue samples but also a needle in the handpiece that contains an optical fiber. This fiber transmits light of different wavelengths to illuminate the tissue; the light that’s reflected back is sent to the console, where sophisticated software is designed to perform spectral analysis to distinguish normal versus suspicious tissue in real-time.
Secondly, the handpiece is being designed with automatic needle advancement in precise 1mm increments, enabling doctors to get closer to sensitive areas and prostate margins than standard “rapid fire” needle biopsy guns, potentially providing a more complete biopsy.
What can I expect when my doctor uses ClariCore Biopsy System compared to a standard prostate biopsy?
You can expect a very similar experience. Just like a conventional prostate biopsy, your doctor will use a handpiece with a needle to collect tissues samples with guidance from a transrectal ultrasound system. The main difference is that the ClariCore biopsy procedure may take a few minutes longer primarily because the handpiece’s needle advancement feature enables doctors to spend more time exploring potentially suspicious areas.
We expect the cost to patients won’t be substantially different than the out-of-pocket costs associated with the current standard prostate biopsy procedure. The intention is, however, that pathology costs will decrease significantly with ClariCore because its potential ability to provide instant classification of normal prostate tissue should greatly reduce the potential number of tissue samples that are sent out for analysis.
I’ll be undergoing an MRI/fusion-guided biopsy procedure. How could the ClariCore Biopsy System help me?
The intention is that ClariCore will provide an extra level of real-time information by identifying normal tissue areas, ensuring a more accurate needle placement into suspicious tissue and minimizing known errors caused by MRI/fusion systems. This combined accuracy may enable your care team to make faster, and more complete evaluations.