2024 SBIR CONCEPT CLEARANCE AWARD Novel Iontophoretic Drug Delivery Device for Local and Effective Treatment of Oral Cancer

Oral cancer remains a life-threatening disease with 11,580 deaths in the US each year. Surgery provides the best chance of survival and is the preferred treatment option for oral cancer patients. Unfortunately, 60% of oral cancer patients are unable to undergo surgical treatment as their tumors are deemed unresectable (unable to be removed with surgery) due to involvement with surrounding fragile organs that would risk their quality of life if impacted by surgery. This patient group faces five-year survivals less than 10% as alternatives like systemic chemotherapy and radiation treatment suffer from dose-limiting toxicities and low response rates. Focal Medical (FM) has identified a solution of a novel medical drug delivery device that can drive chemotherapy directly into target tumors using a method called iontophoresis. This method of drug delivery can deliver large quantities of chemotherapy directly to the tumor to promote tumor shrinkage and make oral cancer patients eligible for surgical treatments. This work proposes the development of an oral tumor device through in vitro and in vivo systematic testing that will establish the feasibility and safety of our solution. Success of this work has the potential to transform treatment of oral cancer patients with unresectable tumors and increase their survival probability by four times.