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Today we're highlighting another innovative company of which many of our readers have probably never previously heard -- ClearPoint Neuro, Inc. (ticker CLPT)*.
ClearPoint is a medical device company providing real-time visibility for brain surgery procedures.
If you think about it, minimally-invasive surgery has transformed many procedures throughout the body (such as heart-valve replacement which can now be performed by surgeons working through a small incision to access an artery rather than by cutting open the chest as was previously necessary for open-heart surgery) -- but in order to enable minimally-invasive procedures, real-time visibility is necessary so that the surgeon can guide the instruments to the targeted part of the body.
For a variety of reasons, real-time imagery of the brain has been unavailable for brain surgeons, creating an obstacle to the development of true minimally-invasive procedures in brain surgery. The primary obstacle has been the fact that real-time brain imagery uses an MRI (magnetic-resonance imaging) machine, but because an MRI uses a powerful magnet, surgeons could not use any metal instruments on a patient at the same time that they are looking at the patient's brain under the MRI.
Therefore, an MRI would be taken prior to the procedure, and then the surgeons would use that MRI to guide them during a procedure -- knowing that the imagery itself was not real-time (it was taken in the past) and that the brain might have shifted slightly in the interim, thus preventing the levels of precision and sub-millimeter accuracy that could be possible with real-time imagery, and which could make all the difference in such delicate procedures.
ClearPoint has developed the ClearPoint Neuro Navigation System, which is a platform that consists of both hardware and software which enables MRI-guided, minimally-invasive brain neurosurgery procedures, including deep-brain stimulation (used for Parkinson's patients), laser ablation procedures (including laser interstitial thermal therapy, or LITT, used for some epilepsy and tumor-related treatments), and for drug delivery to parts of the brain using inserted cannulas (there are presently a number of bio-pharma and gene-based treatments moving through trials). ClearPoint markets a SmartFlow cannula which enables real-time imagery for more accurate placement and delivery of therapeutics to treat serious neurological disorders).
The ClearPoint's neurosurgery navigation business (approved for use in the US and the EU and in countries that follow the lead of those two) follows the well-known "razor and blade" business model, in which healthcare sites purchase capital equipment (the system itself) and then disposable components which are used for each procedure (the "blades" that must be replaced, in the razor-and-blade analogy).
ClearPoint has their capital equipment in use at about sixty hospitals or functional neurosurgery centers in the US, Canada, and the EU at present, although they estimate that the total number of hospitals with MRIs which perform the types of procedures for which ClearPoint's neurosurgery navigation products would be appropriate may be around 400 to 500.
ClearPoint presently has commercial relationships with approximately 25 biologics and drug delivery companies who are either evaluating or using ClearPoint products for the delivery of their therapies. These therapies are in varying stages of development, from preclinical research all the way to late-stage regulatory trials.
It is important to note that developing therapies to treat the brain is especially challenging due to the "blood-brain barrier," which limits the ability to deliver compounds through the bloodstream and have it reach the brain. Therefore, new biotech or even gene-therapy treatments which are being designed to treat serious neurological disease in the brain must be delivered directly to the brain (such as through a cannula), and that's why ClearPoint's real-time guidance capabilities are so critical to the new therapies being tested today. We believe that ClearPoint's capabilities may well prove to be essential for the delivery of new therapies based on revolutionary discoveries such as gene therapy, which are already beginning to transform treatment in other areas of healthcare outside of the brain.
ClearPoint generally has arrangements which involve "milestone payments" as treatments progress pass various milestones during the research and clinical testing process. Also, the ClearPoint products are used during the testing process and would likely be used in the delivery of any therapies which make it past clinical trials into commercial use (and in fact, the clearance of such therapies may mandate the use of the same delivery methodology after approval that was used during the trial period).
We believe that ClearPoint is an important company enabling the application of new and promising therapeutic developments to an extremely difficult part of the body -- the brain -- with the potential to help people suffering from some of the most debilitating neurological diseases.
* Disclosure: At the time of publication, the principals of Taylor Frigon Capital owned shares of ClearPoint Neuro (CLPT).
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