UNANDUP, LLC — Department of Health and Human Services SBIR Phase I: 102

Description

Cancer is thend leading cause of death in the United StatesUSand accounts forof everydeathsMore thanAmericans will die of cancer inwith annual US cancer care expenditures reaching $B byand more thanM cancer related deaths occur annuallyWhile chemotherapy is effectiveseveral cancer subtypesincluding liver cancerare associated with a very lowyear survival rate of less thanIn additiononly a small proportion of cancer patients is eligible for tumor resection and organ transplantHepatocellular carcinoma is the most common form of primary liver cancerwith overnew diagnoses each year and ayear survival rate of less thanIt remains theth most common cancer worldwide and therd most common cause of cancer related deathsUnlike other cancersthe death rate for liver cancer has increased over the lastyearsIn generalchemotherapeutic treatment has shown limited effectivenesswith response rates less thanand survival less than one yearOne of the few options available to those diagnosed with hepatocellular carcinoma is catheter directed trans arterial embolizationwith and without chemoembolizationwhich is the gold standard of care for those diagnosed with intermediatestage carcinomaHoweverdespite the procedure s use for over two decadesit remains largely unstandardizedwith variations in the size and type of embolizing particleschoice and dose of chemotherapeutic agentand the time interval between proceduresThough effectivethe procedure s benefit is modest in that the survival improvement is onlymonthsand the treatment is associated with safety concernsincluding embolization of unintended territoriesThe procedure s efficacy is hampered by the tumor s complex hemodynamics and tortuous vasculatureresulting in regions which cannot be reliably and thoroughly occludedIt is generally believed that patient outcomes would be improved if physicians could more completely embolize the tumor s vascular networkIf this were achievedthe tumor would be better starved of blood flow and chemotherapeutic agents could be more effectively deliveredUNandamp UP has developed a breakthrough technology that allows the physician to directly control and improve the delivery of magnetic embolization beads throughout a tumor s vasculatureBy creating unique magnetic embolization beadswhich will be safe in an MR environmentand leveraging the company s patent pending technology which focuses magnetic fields in a novel waymagnetic embolization beads can be controlled in a way not previously possibleUNandamp UP s objective is to provide a technology to hepatocellular carcinoma patients that results in more effective and safer liver tumor embolizationIn the Phase I effortthe company willbuild the prototype magnet assemblyformulate the prototype magnetic embolization beadsassess in vitro model efficacy and MR safetyandassess in vivo efficacy in a rabbit tumor modelAn FDA meeting in planned is advance of a Phase II proposal Project Narrative UNandamp UP is developing a technology that allows physicians to directly control the delivery of magnetic embolization beads throughout a tumor s vasculature to starve the tumor of its blood supplyand ultimatelyto deliver chemotherapeutic agentsHepatocellular carcinoma is the most common form of primary liver cancer and represents theth most common cancer worldwide and therd most common cause of cancer related deathswith overnew diagnoses each yearBy leveraging its break through technologyUNandamp UP hopes to greatly improve upon the proven benefit of trans arterial embolization and offer a commerciallysuperior therapy for those diagnosed with hepatocellular carcinoma