RenovoRx is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared local drug delivery device, targeting high unmet medical needs. RenovoRx's novel approach to targeted treatment offers patients with solid tumor cancers the potential for increased safety, tolerance, and improved efficacy. Our mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
Our patented (TAMP) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy's toxicities versus systemic intravenous therapy. TAMP is enabled by the RenovoCath device.
In addition to the RenovoCath device, we are also evaluating our novel combination oncology product candidate, IAG, utilizes RenovoCath. The combination oncology product candidate is currently being evaluated for the treatment of LAPC under a U.S. investigational new drug application that is regulated by the FDA's 21 CFR 312 pathway. The combination product candidate, enabled the RenovoCath device, is currently under investigation and has not been approved for commercial sale.
RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon new drug application approval by the FDA.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, we announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders, including several esteemed, high volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner.
