This PFI: AIR Research Alliance project focuses on the translation and transfer of bone and soft tissue regeneration technologies to new products for musculoskeletal repair. Autograft and allograft based products are currently used for repair purposes and have several limitations including suboptimal strength, possible negative immune effects and risks of disease transmission. The new technologies and proposed products overcome the drawbacks posed by autografts and allografts. These new product technologies are potentially stronger, bioactive, more biocompatible and completely degradable while being ideally suited for load-bearing bone healing and soft tissue repair and regeneration applications. There are estimated to be over 1 million bone graft implants performed each year throughout the world. Production costs for the proposed technologies will be in the range of $500 per implant, yielding a $2000 net profit per implant. Our objective in the first 3 years is to achieve a 2% market share of bone grafts (20,000 grafts) which would provide $40 million in revenue per year. Every year, 400,000 rotator cuff repair procedures performed in the US require the use of a tendon augmentation device. Production costs are $1,000 per implant, yielding a $4000 profit per implant. We conservatively believe that 30% of repair operations would benefit from our soft tissue regeneration system (120,000 repairs) and that a 10% market share would be 12,000 repairs. This translates to a profit of 48 million per year.
In order to move these technologies to commercialization, we have categorized different products into short-term, mid-term and long-term time frames spanning 1 to 5 years. Short-term products include grafts fabricated from the materials alone without inclusion of any biologics. The short-term products, classified as devices or implants, create a short route to 510k FDA clearance (approval). An ample financial base from the aforementioned products will allow re-investment of R & D efforts toward the commercialization of subsequent products or to pursue an out-license or acquisition exit after subsequent 510k approvals. The strong patent portfolio and constant revenue from the initial product commercialization will create a self-sustainable academic centered innovation ecosystem. All these activities will ensure workforce development, create new jobs and businesses, and foster economic development.
Third party partnerships engaged to transfer the technologies to the market domain include technology niche analysis, business plan development, and initiation of new startup ventures for existing products and new products. The potential economic impact is expected to approximate 100 million per year in the next 2 to 3 years which will contribute to the U.S. competitiveness in the orthopaedic device fixation, repair, and regeneration market.
Societal impact short term, the proposed devices successfully address issues and drawbacks related to biological grafts currently used and will improve treatment efficiency/cost, enhance patient compliance and contribute to a better quality of life. The developed products will be used as alternatives to current grafts. Identified material compositions and designs may find application in the delivery of growth factors, antibiotics and pain medications for treating a variety of musculoskeletal ailments in the long term. This proposed project has immense economic potential as well as a broad impact in education by bridging the interfaces of chemistry, biology, medicine and materials science.
Educationally, the proposed research will focus on the recruitment and training of underrepresented minorities at the undergraduate and graduate levels, thus ensuring a competitive and diverse dissemination of scientific knowledge. Students and fellows will be engaged in business plan development and encouraged to complete an internship with the third party investors to enhance their entrepreneurial skill sets.
