Knee/elbow joints feature a variety of different cell types such as bone tissue and cartilage tissue. These various cells all grow in a very structured fashion, with different types of cells appearing in precise locations. Tissue engineering (eg. bone-cartilage regeneration) in knee/elbow regions can be especially difficult due to the variety and specificity of cells present in the system. Thus the question arises: How can we get different types of cells to each grow in very specific locations?
Collatrix uses Streptococcal collagen-like protein (Scl1, Scl2), which are prokaryotic proteins native to S. pyogenes. Scl2 in particular can be modified to contain binding motifs. A mammalian cells’ ECM can bind to these binding motifs on the Scl2 protein, with Scl2 acting as an anchor. Each cell type will therefore have a unique gradient of various modified Scl2 proteins to which it will best attach. These scaffolds are completely customizable, biocompatible, and degrade naturally over time, allowing for the body to interact with and eventually fully incorporate the implanted materials.
The system will consist of a bioreactor, which provides an environment for optimal E. coli culturing and Scl2 expression; hydrogel, the physical framework into which mammalian cells will attach and grow in a coordinated environment; and the gradient machine, which is used to generate the unique combinations of Scl2 proteins on the hydrogel. The end product, the generated hydrogel scaffold, will be introduced into the site of joint damage to heal and provide relief to our customers.
Collatrix product begins with the manufacturing of the bioreactor. Doctors in hospitals and orthopedic clinics will then prescribe their patients suffering from joint damage treatment through Collatrix, in which orthopedics will diagnose the location, extent, and nature of the patient’s unique needs. These orders will be conveyed to our production team, who will then construct the hydrogels using the bioreactor. It will then be sent to the respective orthopedic clinic or hospital and will be administered by the medical professional at the site of the patient’s joint damage.
Following approval by the FDA, our team will work with health insurance companies so that the use of Collatrix can be covered and all customers can benefit from its usage. Collatrix will be marketed in a manner that highlights the product’s efficacy for permanently healing joint damage, and the value that it provides compared to other alternatives on the market. The product will be sold primarily through the prescription of orthopedic clinics and hospitals at a price that supports a healthy margin for all key stakeholders, but is still competitive relative to standard industry prices and the value that Collatrix provides its users.
Projecting over a 20-year period, our company has numerous goals and milestones that we strive to achieve at specific times. Most importantly, within the first 10 years of our incorporation, we hope to complete the preclinical and clinical trial phase under the guidance of the FDA. During this time, we will also undergo the patent application and maintenance process in order to ensure that our intellectual property is secured. We will also continue our research and improve our technology over this period so that once the product enters the market, we can immediately start production. At around this 10-12 year mark, we will dive into the manufacturing and optimization of Collatrix, and engage in heavy marketing and advertising to increase customer awareness and market penetration. Once we have established a firm footing in the U.S., we hope to expand internationally, to reach individuals all over the world who struggle with joint damage.
Cornell iGEM will expand Collatrix to produce joint tissue for not only knee and elbow joints, which are single-direction hinge joints, but for more complex joint replacements. Due to each joint having different ranges of motion, Collatrix is currently only focusing on perfecting the comfort and fit for single-axis movement. The next logical step would be to expand the product to all joints in the body.
Besides the product expansion, Cornell iGEM plans to diversify its consumer base to different countries and peoples. Once our team establishes Collatrix in the U.S. as a premier biomedical product concerning the relevant regulations, patents, and quality, we will look into using our product to help others in different areas of the world. As different countries have different biomedical regulations, we will need to research the necessary clearance to market our product in target markets. Parallel to the U.S. business strategy, Collatrix will be placed in hospitals, clinics, and other relevant healthcare providers that can properly utilize it to benefit patients.