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NuVue Therapeutics,Inc.
Medical Devices & Tech
11135 Sedgefield Rd.
Fairfax, VA 22030 USA
phone:(703)-591-1691/477-3000
fax:
Symbol Private
Founded 1999
Employees 6
www.nuvuetherapeutics.com
Research Sector Medical Devices & Tech
Summary Description
Developing ultrasound guided, site-specific, & cryothermally enhanced cancer therapies.
Management
Roger Kolasinski, Founder, President/CEO; Patrick Le Pivert, Vice President of R&D,Director for Cryothermal and Combined Technologies and Director of the Medical Advisory Board; Dennis Morrison, Director for Microencapsulation Research & Development; James Kulinski, Director of Sales; Mark Ehlert, Director of Corporate Development
Keywords
Diagnostics, Cancer, Diagnostic Tissue Acquisition/Biopsy, Biopsy and Therapeutic Tissue Site Markers, drug-delivery systems, fluid delivery device, site-specific cancer therapies, chemotherapy, Cryochemoablation

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Updated: Oct. 27, 2011

Description
NuVue Therapeutics, Inc., (NuVue) is a privately held medical device and therapeutics company founded to develop an array of cost effective, ultrasound-guided handheld disposable devices that create a completely new Discipline of Therapy for both the targeted acquisition of diseased tissues and the site-specific delivery of drugs. This Discipline of Cancer Therapy is designed and adapted to inherently be able to KILL ALL types of Soft Tissue Tumors when delivered through NuVue's proprietary therapeutic delivery devices. With the use of these specially developed interventional devices, along with its newly created regimen of CryoChemoAblative Therapy, the company has now given Oncology a new set of tools and the abilities that will always insure less toxic, superior clinical patient outcomes, while preserving the patient's immune system: NuVue's Silver Bullet Approach
Products / Services
Diagnostics: First, the Company will revolutionize both the fine needle aspiration (FNA), and core needle biopsies with its NuVue ColorMark A and C Needles. These disposable, single-use needles use the Company's enhanced ultrasound guided visualization (UGV) technology to make the needle visible to a color Doppler ultrasound imaging system, cost-effectively creating a remarkably clear and bright image on the screen, in real time, all the time, during any procedure, without having to ever fall back on the use of costly MRI or other CT scans, as is currently the case. With their improved and assured positional accuracy and safety, and their capabilities for use in the physician's office setting with no additional uninsured risks, NuVue's ColorMark needles have for the first time an inordinate opportunity and potential to capture a major portion of physician's office and interventional radiology market share within the large biopsy needle market. The Company next will introduce its third diagnostic product, the NuVue BrightMarkTM Tissue Site Markers. These markers consist of contrast agents encapsulated into, tiny balloons/ microcapsules, using the Company's platform microencapsulation technology licensed from NASA. NuVue's BrightMark line of Tissue Site Markers will meet the unmet clinical need for tissue markers that are easy to use, long lasting, and reliably mark the procedural site, with the assurance of no migration, unlike most other competitors in the market today. Therapeutics: The Company then will introduce a suite of progressively more powerful devices for the local, accurately positioned chemoablative treatment of soft tissue cancers. Each of these products will use NuVue's visualization (UGV) technology to achieve pinpoint site-specific delivery of therapeutic agents. The first, NuVue's ChemoAblator system, will deliver currently-approved chemotherapeutic free fluid drugs to targeted tumors, while assisting with the retention of such free drugs within the desired site-specific tissues; all the while preventing backflow of any of the fluids outside of the desired delivery site targeted by the physician. The second product NuVue's CryoChemoAblatorTM system, will add additional cryothermal effects, to insult and destroy additional tumor tissues and vasculature, while predisposing the diseased tissues to enhanced effects of the delivered chemotherapeutic drugs, ensuring better patient outcomes. The third product, NuVue ChemoTM, will use NuVue's proprietary microencapsulation technologies licensed from NASA. This Microencapsulation, The NuVue ChemoTM process ensures a site-specific, timed release of low (full therapeutic) doses of highly concentrated drugs in a regimen of therapy that can be specifically designed for the therapeutic responsibility needed by the patient. Taken together, the Company's diagnostic and therapeutic product lines comprise NuVue's Site-Specific Discipline of Cancer therapy offering practitioners a new paradigm of diagnosis, treatment, and follow-up of soft-tissue cancers -- NuVue's Silver Bullet Approach.
Technology / Differentiation
The Company realized that in order for its site-specific, Silver Bullet Approach to work, it had to overcome and eliminate all of the deficiencies of the present methods of Chemoablative treatments. NuVue's Silver Bullet Approach in fact has now been able to overcome the five major deficiencies of such older methods and now finds itself being able to insure: (1) the focal and targeted kill of designated diseased tissues , (2) the controlled diffusion of chemotherapeutic agents with free or microencapsulated drug formats, while having eliminated the possibility of any type of blackflow or washout of any therapeutic agents, (3) the creation of a precise kill of the vascular network within and surrounding the capsule of the tumor with the use of its cryothermal abilities, (4) the prolonged retention of such drugs within the targeted tissues, achieving the desired therapeutic result, and (5) all the while, keeping the patient's Immune system active and viable during such treatments do to a lessened level of systemic toxicity. By doing this, NuVue has, in fact, created its special Site-Specific Discipline of CryoChemoAblative Therapies, which have shown an incredible level of therapeutic effect, some four fold kill of tumor tissues, during all of its pre-clinical studies. The Company is now poised to capture rapid market penetration upon the commercialization of its first disposable interventional devices that can be used with any existing and approved drugs, while it also proceeds with the development of its future microencapsulatd therapies.
Market / Customers
MARKETS: The Company will operate in large markets regarding diagnosis and the treatment of cancers. Soft-tissue cancers, including cancers of the breast, prostate, lung, liver, thyroid, pancreas, ovary, bladder, and kidney, comprise very large, high-dollar markets with established reimbursement. The potential U.S. market size is estimated at $5.2 billion for cancer diagnostics/therapeutic deliverables, $1.0 billion for Tissue Markers, $4.0 billion for the cancer cryothermal markets, and greater than $8.0 billion for the microencapsulation chemotherapeutic markets. Analysts have estimated the diagnostic markets are growing at 4.0 to 4.5% per year and the therapeutic drug delivery markets at 18 to 24% per year. On a worldwide basis, the market opportunity is estimated by the World Health Organization to be double the size of the U.S. market. Furthermore, within these markets, there are large groups of potential customers who are practitioners in other medical specialties that could benefit from the offerings of the Company's diagnostic and therapeutic products. Practitioners who now refer patients for biopsies could well invest in a Doppler ultrasound in order to recapture business now referred to others. The customer base initially will comprise thought leaders at medical centers, followed by other practitioners on staff or admitted to practice at hospitals offering access to color Doppler ultrasound machines. (i.e. Surgical Oncologist, interventional Radiology, Urology, Anesthesia, Ob/Gyn, Operating room Physicians, etc.) Subsequently, the Company will target practitioners who can make an economic case for procedures to be done in their own offices, as well, using a purchased Doppler ultrasound machine. This opens up a whole new profit center opportunity, since in-office procedures currently are rarely being done due to the lack of a complete, accurate diagnostic and therapeutic system.
Competitors / Substitutes / Alternatives
NuVue competes with device companies such as C.R. Bard, Boston Scientific, Sanarus, and SenoRx for some portion of its technologies. However, none of these companies offers the full complement of therapies that NuVues Site-Specific Regimen of Cancer Therapy provides; hence, the Company does not have a full competitor, and maintains significant competitive advantage, with its Silver Bullet Approach therapeutic regimen of therapies. In addition to its patent protection, the Company has erected barriers to entry including the development of a proprietary line / system of consumables to insure the exact positioning and controlled release of its imageable microencapsulated and free drugs, cryothermally enhancement devices, and biopsy-site biodegradable marker and drug delivery systems.
Strategy
NuVue intends to market its products to both the domestic and international healthcare markets through highly experienced specialty distributor organizations. Each organization will operate under an exclusive distribution agreement, with NuVue overseeing and measuring their efforts through its internal sales management structure. The company will employ dedicated clinical specialists to assist the distributors? sales personnel in the field. This arrangement will provide the Company with the opportunity to become directly identified with each customer account as they adopt NuVue?s technologies.In today?s medical diagnostic and therapeutic arenas, mergers and acquisitions seem to be the most accepted exit strategies. With management?s past experience with mergers/acquisitions and IPOs, it regards such an occurrence as likely, and anticipates that such opportunities might occur after the third year. Ultimately, because of the level of diversification, breadth and depth of NuVue?s Platform Technologies, and their inherent capabilities for use in other medical arenas, there is limited downside risk for NuVue?s Investors
Funding
NuVue Therapeutics is seeking monies through three steps of funding. First, being short term, the Company is looking for an Angel Investor that would be interested in dealing with a 750 to 1 million dollar Bridge Loan that would carry a negotiable interest rate for a period of one year and/or, at the option of the Angel Investor, could be converted into Common Stock, should it be so desired. The Second, and Third steps of raising funds are similar, in that, the Company, in the Second Step, is looking to raise $4.0Mn in equity; and in the Third Step, that being the second raise, at a level of $6.0Mn, will be used to close out all funding. These funds would be used: 1st) To complete NuVue?s first product launch, its ColorMark ? Specialized Ultrasound- Guide [Biopsy and Therapeutic Needles and its Drug Delivery Systems] (Product 1), immediately upon receipt of Bridge Loan; Second Raise of Funds (First 4 million) would complete design, conduct trials and obtain 510(k) for NuVue?s BrightMark? Microencapsulated Biopsy Tissue Markers (Product 2), along with completing NuVue?s Chemo? microencapsulation development, and begin conducting pre-clinical trials for its Microencapsulated Chemotherapeutic Drug Delivery Products, the first of Five (5) drugs (Product 3); Third Raise of Funds (second tranche of 6Mn) would be used to finish the development of NuVue?s ChemoAblator? and CryoChemoAblator? Cancer Treatment Systems (Products 4 & 5),while finishing the FDA responsibilities required to get the NuVue Chemo? ( The Company?s Microencapsulated Drugs) to the open Market ( Product 6) and finally, with a certain amount of monies from each raise, some monies would go towards such things as to continue to build organizational infrastructure, assist with R&D, patents, legal, and operations & manufacturing expenses.