Market Overview and Potential
Nociscan is limited by federal law to investigational use only and is not available or marketed for use. However, the investigational development effort is conducted contextual to its intended future market needs and demographics.
The potential market for Nociscan is substantial, considering initially that there are over ten million MRI’s done each year for spine in the US. Of these, three million are for chronic severe discogenic lower back pain patients that have failed conservative care, are considering major surgery - and are expected to be potential candidates for Nociscan diagnosis in the future. Our initial planned focus, however, is to incorporate Nociscan where provocative discography is otherwise indicated and performed today following MRI. This is estimated to be done nearly 200,000 times each year in the US and nearly 400,000 worldwide, at an average direct reimbursement cost estimated to exceed $1,500 per patient. The discography market in terms of overall direct cost is estimated to exceed $350MM in the US and $700MM world-wide. Additional indirect costs of this current regimen also include 1-3% complication rate of the invasive discogram (e.g. infection), time from work (typically 1-2 days), and potential risks of accelerated degeneration and herniation rates (e.g. that could complicate treatment outcomes, such as in progressive pathologic disease in “negative” control discogram discs adjacent to treated “positive” discogram levels). Due to its highly invasive, painful, potentially risky, and costly nature, discogram even at these adoption rates is done sparingly as a “last resort” for severely disabled back pain patients. The need is clear and urgent for a reliable, non-invasive, non-painful, objective, readily adoptable and cost efficient diagnostic platform that provides additional diagnostic information to supplement this current regimen with more information to assist doctors in diagnosing these patients. The investigational Nociscan platform may in the future, for example, be conducted following MRI exams to provide useful information as a “screen” to help doctors determine whether a needle-based provocative discogram is warranted, and if so to assist them in determining which discs should be examined via discography.
The investigational Nociscan procedure is being developed for future use on high field (e.g. 1-3 tesla or “T”) MR systems – with 3T systems comprising approximately 15-20% of the more than 12,000 high field MR systems installed in the US. We expect that a limited number of these scanners supporting Nociscan in each geographic market may be sufficient to support adjunctive use with most discography patients via referrals to these select installations. In fact, Nocimed estimates that Nociscan could be efficiently incorporated into the future diagnostic regimen of the current 200,000 discography patients per year in the US via only 500 MR systems, or <10% of the high field MR systems in the US.
These forecasted market dynamics around Nocimed’s future plans may potentially create a uniquely beneficial scenario that offers significant benefits to multiple parties. Imaging centers are expected to benefit by Nociscan if its adoption in the future will draw additional revenues to their centers – both via payment for the Nociscan exam itself, and for the MRIs of potentially increased referrals. Payers are also expected to benefit in the future if Nociscan information can help prevent unnecessary or mis-directed discographies, and/or surgeries. Referring physicians are also expected to benefit in the future if they can gather additional, objective data more easily and without increased risk of complications and injury to their patients. Perhaps most importantly, patients are also expected to benefit from these attributes in the future if they will enhance the available care provided to them with additional objective diagnostic evidence of potential sources of their debilitating pain.
CAUTION: Nociscan™ is restricted by Federal Law to investigational use. Nociscan™ is investigational only and not available for sale or use within or outside of the United States.
Nocimed™ and Nociscan™ are both proprietary trademarks of Nocimed, LLC (all rights reserved). Nocimed’s technologies and products are considered proprietary and the subject of multiple patents pending within and outside of the United States.
Physicians interested in possibly becoming an investigator in Nocimed’s investigational research are encouraged to contact the company directly via the contact information provided via link on the company’s website home page.
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