SBIR Phase I: A novel 3D printed biodegradable mesh delivering active pharmaceutical ingredients in a sustained and localized manner

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The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to establish a proof-of-concept for an oncological medical device that will be used as an adjunct treatment for pancreatic cancer (PC). PC is one of the lethal forms of cancer and is the second leading cause of cancer-related death in the US. Chemotherapy is the first-line standard treatment for cancer therapy. The medications used during chemotherapy are administered through an intravenous infusion (IV), pill, or injection. Once these medications enter the bloodstream, they destroy the cancerous cells and the healthy cells. The most common side effects for patients are nausea, vomiting, hair loss, and decreased immunity leading to a low quality of life. Our prototype aims to reduce chemotherapy side effects and the need for in-hospital chemotherapy administration, significantly reducing healthcare costs. The proposed innovative technology offers an alternative to direct surgical resection in the sensitive areas surrounding the pancreas. This treatment will extend the number of patients who can benefit from surgery and increase the overall success of surgeries primarily by preventing local relapse. This Small Business Innovation Research Phase I project will lay the essential foundation for understanding the medical device product's physical and chemical characteristics. Pancreatic cancer (PC) is a "silent" disease because it is diagnosed at a much later stage when cancer has already metastasized. One of the significant challenges associated with PC treatment is the standard administration techniques (e.g., intravenous injection, oral administration) cannot efficiently deliver a therapeutic concentration of the drug to the tumor site because of the pancreas' anatomy. The innovative technology used in this prototype device will render it as an implantable, biodegradable, drug-eluting product allowing for spatio-temporal control and delivery of various active pharmaceutical ingredients (APIs) directly to the tumor site. Further, reductions in global toxicity and access to traditionally unresectable areas may enable higher concentrations of chemotherapeutic agents than could be tolerated by systemic administration, significantly altering the treatment landscape. This project will address the following four technical challenges related to the formulation and physical characteristics of the prototype, which will determine its release profile and the 3D printing mechanism, and its impact on the device's quality. The research and development routes that are being pursued include (1) assessment of prototype mechanical profile, starting with one API of interest (2) assessment of different polymer compositions and how they impact the flow of the printing material and resolution; (3) testing the use of fluorophores during the formulation of the prototype (4) assessment of different properties of the print material (e.g., pressure, print-head type, temperature, and viscosity) on the quality of the prototype.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.