SBIR Phase I: Development of a Novel Mammalian Cell-Based Nano-Biological Coating for Implantable Medical Devices.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to address the critical health and economic burden associated with implant-related infections by reducing or eliminating them with a novel biocompatible and antimicrobial nano-biological coating on implants. Infections related to implanted medical devices are shockingly common, as one million implant-related infections occur each year in the United States.

These infections are usually treated with antibiotics. Unfortunately, overuse of antibiotics can cause multi-drug resistance, leading to more severe infections, making them harder to treat. There is a higher five-year mortality rate for prosthetic joint infections than for breast cancer.

These infections not only present significant treatment challenges due to a biofilm formed by colonizing bacteria, but they also impose a massive financial burden on the healthcare system, costing more than $8.6 billion annually. This proposal addresses this critical issue by creating a novel nano-biological coating designed to inhibit biofilm formation and protect against all types of bacteria, including antibiotic-resistant strains, while ensuring high biocompatibility.

As such, the primary target market for this technology is medical device manufacturers, particularly in the orthopedic implant sector, anticipating $8 million in revenues by the third year of commercialization.

This Small Business Innovation Research (SBIR) Phase I project will focus on the development of a novel mammalian cell-based nano-biological coating when applied to orthopedic implants and demonstrate that the nanoparticles that can limit infection and inflammation while promoting bone growth. Nanoparticles are well known to reduce infection but how they are coated on medical devices remain problematic and undescribed.

This proposal will establish an innovative approach to treat medical devices with nanoparticles to inhibit bacteria via cell stimulation. Several technical challenges that arise from stimulating cells to produce nanoparticles on medical implants, include optimizing nanoparticle synthesis, in vitro characterization and validation, and in vivo proof-of-concept studies.

Commercialization of this technology depends on establishing a controlled production system, scaling up production, obtaining regulatory approvals, and achieving market launch. The specific technical objectives of this SBIR Phase I are: (1) Characterization of nanoparticles produced by different cells on Ti6Al4V and stainless-steel orthopedic implants, (2) Determination of the antibacterial and anti-inflammatory properties of such coated surfaces, (3) Determination of bone and fibroblast cell proliferation on such coated implants, and (4) Determination of the performance of nanoparticles produced by the cells as the active ingredient from such coated surfaces.

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.