ChemoAblatorTM
The first therapeutic product, NuVue’s ChemoAblator™ system for chemoablation, will deliver currently-approved chemotherapy drugs in free drug or encapsulated form to targeted tumors, while preventing any backflow of the fluids with NuVue’s cryothermal technologies. (“What goes in, stays in.”)
The system consists of two products: a base unit for storing and supplying cooling agents, and NuVue’s Interstitial (Cool) InjectorTM, a handheld, disposable device for delivery of drug with backflow prevention capabilities.
The ChemoAblator system uses NuVue’s enhanced Ultrasound Guided Visualization (UGV) technology to assure accurate placement of the drug delivery needle.
Washout of drug is prevented by the application of the Company’s patented cryothermal effects. Whereas current treatments such as chemo-embolization try to prevent washout by blocking the vascular drainage chemically, the Company’s chemoablation does so by applying specific cryothermal effects to the surrounding tissues.
Of ultimate importance is the retention of the delivered drugs within the targeted tumorous tissues. The resulting prolongation of therapeutic effect and homogeneous diffusion of drugs within the malignant tissues has been shown in animal tests to enhance the kill of such tissues within the tumor. Furthermore, the system promises the ability to target the tumor with selected doses of different types of formulated drugs.
The NuVue ChemoAblator™, then, promises the practitioner a powerful new tool -- the ability to: (i) inject a full therapeutic dose of approved chemotherapeutic agent into a tumor, (ii) do so accurately under enhanced ultrasound visualization, and (iii) retain the therapeutic agent in the targeted tissue without any backflow of drug(s). The system has been prototyped, and, after completion of design, will be submitted for 510(k) approval.
[Please note that the ChemoAblator™ products are in NuVue's product pipeline; they have not yet been approved by the FDA and are not yet available for sale or use in the U.S.]
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