The designation was issued by the FDA's Office of Orphan Products Development pursuant to Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb). Oxaliplatin is an approved and commonly used chemotherapy.

As RenovoRx continues to advance its therapeutic pipeline, it is simultaneously expanding commercialization of RenovoCath as a stand-alone device, driving adoption at leading cancer centers and building strategic and clinical collaborations that can support future revenue growth and broader platform use. RenovoCath, a patented FDA-cleared device, employs a dual-balloon infusion catheter for targeted delivery of therapeutic agents directly near a tumor. 

This is RenovoRx's second ODD in pancreatic cancer, and third designation in total, reflecting the Company's differentiated approach to targeted intra-arterial drug-delivery using RenovoCath. RenovoRx previously received ODD for intra-arterial gemcitabine delivered via RenovoCath (known as IAG) in locally advanced pancreatic cancer (LAPC) and bile duct cancer. This designation for oxaliplatin, a platinum-based chemotherapy widely used in pancreatic cancer treatment, further supports the versatility of RenovoRx's novel approach to delivering multiple therapeutic agents directly near the tumor site.

ODD carries meaningful regulatory and financial benefits, including:

  • Seven years of market exclusivity: Upon FDA approval of the designated indication (in this case, intra-arterial oxaliplatin for pancreatic cancer via RenovoCath), RenovoRx would be entitled to seven years of exclusive marketing rights, during which the FDA cannot approve the same drug for the same orphan indication by another sponsor.

     
  • Federal tax credit: A 25% tax credit on qualified clinical research expenses incurred in connection with the designated drug.

     
  • FDA application fee waiver: A waiver of the FDA application filing fee, which currently exceeds several million dollars for applications requiring clinical data.

     
  • Eligibility for orphan product development grants: Access to grant funding from the FDA's Orphan Products Development grants program to support clinical development.