NuVue ColorMark™ Needles

NuVue BrightMark™ Tissue Site Markers

NuVue CryoChemoAblation System

The Company's third product system is the NuVue CryoChemoAblation™ System that uses all three of the Company’s Platform Technologies: site-specific delivery of its NuVue Chemo™ microencapsulated chemotherapy; the CryoCoolTM cryothermal cryotherapy of targeted soft-tissue tumors, and the ultrasound guidance of its minimally invasive UGV™ technology.

Unmet Clinical Need

There are significant unmet clinical needs in the local chemoablative treatment of soft-tissue cancers including breast, prostate, lung, liver, thyroid, pancreas, ovary, bladder, and kidney. These include:   

• Toxicity:  Systemic (typically intravenous) delivery of chemotherapy drugs has required high doses, which have had toxic effects on patients’ Immune Systems, including outlier organs such as the heart, bladder, kidney, and ovary.


• Limited Success:  Even with these high systemic doses, the chemotherapy drugs often have not been effective.


• Individualized Need:  One reason for less than desired effectiveness is the uniqueness of response of each patient to the various chemotherapy drugs and regimens. 


• High Cost:  The high-dose, systemic applications of chemotherapy drugs are very costly to purchase and administer.

Efforts to directly deliver site-specific chemotherapy, e.g., chemoembolization, have had limited success, both in getting the drug to the tumor (site-specific delivery) and keeping it there (preventing washout). Conventional chemoablation with current instruments lacks accuracy and efficacy. Tumor ablation via Radio Frequency or other means has not been accurate or complete.  Existing and experimental methods of encapsulating drugs and attaching them to tumor tissue through monoclonal antibodies or other targeting treatments, i.e. nanotechnologies, have not been successful. This is due in part to their fragility, the patient's immune response, and other shortcomings of current systemic or encapsulation techniques. 

There is a continuing need, and pent-up demand, for a site-specific treatment for soft-tissue cancers that is accurate, efficient and assures the preservation of the patient’s Immune System from toxic side effects, while minimizing morbidity. 

The Company addresses these unmet clinical needs through its CryoChemoAblation™ system of site-specific delivery of microencapsulated chemotherapy, while initiating a cryotherapeutic effect within the malignant tissues of soft-tissue tumors. 

System Components:  The CryoChemoAblation™ system consists of two components, utilizing all three of the Company’s proprietary platform technologies:

• The first component is the NuVue Chemo™ dose of microencapsulated chemotherapy drugs.  A therapeutic dose, consisting of a low volume / high concentration chemotherapeutic, is provided ready for use in a syringe, permitting up to ten injections at the targeted site. (This component utilizes the Company’s microencapsulation technology.)


• The second component is the CryoCoolTM system, consisting of a base unit storing and delivering cooling agents to a disposable cooling instrument (“cryoprobe”) that is specially designed for the procedure. (This device will utilize both the Company’s enhanced ultrasound guided visualization technology, as well as its cryotherapeutics technology.)

The integration of these technologies holds great promise to create an effective, comprehensive new treatment for unresectable liver and pancreatic cancer and other deep/soft-tissue cancers.