SBIR-STTR Award

Customizable Meniscus Implant Prepared by dielectrophoretic Biofabrication
Award last edited on: 12/28/2023

Sponsored Program
SBIR
Awarding Agency
NSF
Total Award Amount
$1,141,700
Award Phase
2
Solicitation Topic Code
BC
Principal Investigator
Paul Gatenholm

Company Information

BC Genesis LLC

216 Parkway Lane South
Floyd, VA 24091
   (540) 745-3922
   egatenholm@bcgenesis.org
   www.bcgenesis.org
Location: Multiple
Congr. District: 09
County: Floyd

Phase I

Contract Number: 0912617
Start Date: 7/1/2009    Completed: 12/31/2009
Phase I year
2009
Phase I Amount
$100,000
This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). This Small Business Innovation Research (SBIR) Phase I project aims to develop a prototype meniscal implant using bacterial cellulose and a novel biofabrication process, dielectrophoretic microweaving. Nanocellulose networks produced by the bacteria Acetobacter xylinum are biomaterials with unique hydrogel-like properties and biocompatibility that is ideal for cartilage tissue replacement. For applications such as meniscus there is however need to direct the nanofibril orientation. A new biofabrication process has been invented at Virginia Tech in which the precise control of bacterial motion in an electric field is used to control morphology of the nanocellulose network. In this project a microweaver, a device to manufacture customizable meniscus implants based on images from patients will be developed. This will be a major breakthrough in biomaterials for orthopedics applications. The broader impact of this project is technology for inexpensive but high performance, biocompatible materials for health care. Over 15 million people worldwide suffer from knee-joint failure each year. More than 225,000 people annually undergo arthroscopic meniscal repair at an average cost of $25,000 each. There are no satisfactory products on the market today and there is an urgent need for a new biomaterial that mimics properties of natural meniscus. By developing a meniscal implant that can substitute for the injured native meniscus, it may be possible to diminish the prevalence of osteoarthritis and its related economic costs. BC Genesis LLC is a biomedical start-up company working with technology for developing implants and tissue scaffolds by using bacteria to grow cellulose biomaterial

Phase II

Contract Number: 1026421
Start Date: 9/1/2010    Completed: 2/28/2015
Phase II year
2010
(last award dollars: 2013)
Phase II Amount
$1,041,700

This Small Business Innovation Research Phase II project aims to develop a prototype meniscus implant of bacterial cellulose biomaterials fabricated by dielectrophoretic microweaving, an innovative biofabrication process. Nano-cellulose networks produced by the bacteria Acetobacter xylinum are biomaterials with unique hydrogel-like properties and biocompatibility that are ideal for cartilage tissue replacement. This technology is based on a new biofabrication process, in which bacterial motion is precisely controlled in an electric field to form nano-cellulose networks of desired morphology. Earlier feasibility studies have demonstrated bacterial cellulose deposition at the nanoscale during biaxial motion of bacteria in an electric field and the ability to control the assembly of cellulose layers into any desired three-dimensional architecture and control biomechanical properties. This Phase II project will develop a microweaver bioreactor for fabrication of customizable meniscus implants based on radiology images from patients. The structure and biomechanical properties will be evaluated in knee-model and compared with native meniscus. Biocompatibility and long term performance will be evaluated in large animal model studies. The broader/commercial impact of this Phase II project, if successful, is the availability of meniscus implants that mimic the structure of the natural meniscus to address knee-joint failures, estimated to affect 15+ million people worldwide each year. Each year, in the US, more than 1 million people undergo meniscus surgery. Irreparable meniscus injuries often progress and lead to osteoarthritis. Currently, there is no satisfactory solution for irreparable meniscus injuries. The potential market for a meniscus implant is more than $3 billion. By developing a meniscus implant that can substitute for the injured native meniscus, it will be possible to prevent osteoarthritis and its related huge economic costs.