NerveLight
The Manzanita Pharmaceuticals, Inc. core technology is attaching generic, small molecules dyes or drugs to the human forms (recombinant human) of the neurotrophins Nerve Growth Factor (rhNGF) and/or brain-derived neurotrophic factor (rhBDNF).
This has a wide array of clinical applications in various surgeries.
The first product application is a nerve imaging agent: a commercial, generic, small molecule dye in the 800 nanometer region (Near InfraRed, NIR) attached to human NGF (800-rhNGF). The first disease application will be for prostate cancer. In surgery to treat prostate cancer (“radical prostatectomy”), at-risk cavernous nerves surround the prostate, but currently cannot be seen. The urologic surgeon relies on his/her memory of textbooks, memory of the patient’s imaging, and touch (palpation).
Trauma to the cavernous nerves can cause permanent impotence and/or urinary incontinence. That's why the surgeon wants to know where nerves are during surgery on the prostate.
Even though it has been known since 1982 that it is the cavernous nerves that are at-risk in prostate cancer, there is no FDA-approved nerve imaging agent.
Why NerveLight
Attaching an NIR 800 dye, vis-à-vis a lower NIR dye in the 488 region, to rhNGF confers several advantages:
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Using the 800 NIR spectrum avoids the natural autofluorescence of all biological samples
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The Manzanita 800 dye can be detected in the “ICG channel” of imaging systems already purchased and installed in 99% of surgical suites
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The rhNGF part of 800-rhNGF moves the 800 dye into peripheral nerves intraneuronally i.e., 800-rhNGF does not bind extraneuronally to myelin
Roadmap: making surgery better by selectively identifying at-risk nerves
NerveLight is an intra-operative nerve imaging agent that is applied interstially (topically, to the wound bed of the surgical incision, bathes the prostate, “peri-prostatic”).
It is not necessary to ‘peel back tissue’ around the nerves because NerveLight provides a roadmap by illuminating nerves to at least 5cm in depth, sufficient for the surgeon to avoid nerve damage if possible.
NerveLight is applied in a single dose at the beginning of the surgical procedure; the procedure averages about two hours long. It is developed as a surgical guidance tool, to aid cancer surgeons in fluorescence guided surgery.