While the field of 3D bioprinting is catching on in medicine and the drug discovery market is growing year over year, there are a few factors that we need to be mindful of while growing VoxCell.
Scientific Validation and Quantifiable Data:
Our first exciting challenge is validating our tissue models, and therefore our bioink and 3D bioprinter. We have started in house experiments for cytotoxicity testing using two main cancer drugs (Doxorubicin and Paclitaxel) and are on track to finish those tests by the end of 2021. We then plan to partner with academic institutions and small research groups, providing them our tissues so that they can provide third-party testing, generating quantifiable data that speak to the efficacy of our technologies (how much time is saved, what is the increase in translatable data, etc). In conjunction with third-party validation and gathering quantifiable data, these partnerships should generate scientific publications for VoxCell and further validate us as a trusted brand.
Deeply Cemented Drug Discovery Process:
The drug discovery process has not changed in decades due to a lack of truly biomimetic innovations in this area. We believe that change is possible, and the industry is ripe for innovation on the heels of the COVID-19 pandemic. Our solutions do not aim to replace any current steps in drug development, but rather provide a more reliable in vitrotesting model after cell monolayers, before the drugs are tested in mice. Our tissue models will provide a bridge between the lack of complexity in 2D cell monolayers and the animal models. Researchers will be able to quickly eliminate therapies that would have otherwise clogged the pipeline and ultimately not be approved, saving time and resources. Since VoxCell is not aiming to replace any steps in the current drug development process, we do not need to have FDA approval for our tissues.
Capital Intensive Technology and Personnel:
Developing deep-tech hardware is expensive and building a team of brilliant scientists to make it happen also comes at a high price. We are selecting the most talented people to work at VoxCell, with all the complementary skills (tissue engineering, manufacturing, business, software development) to make this company a success and impact the lives of people around the world.
Our 3D bioprinter utilizes world-class lasers and optical components that need to be assembled by hand. We have a list of vendors that are prepared and resourced to create a large volume for us when we are ready for manufacturing.
In terms of our capital strategy, we intend to stay lean with the size of our team and operations as long as possible. We will be releasing our consumables while continuing work on the 3D bioprinter hardware, and we are planning to assemble the alpha prototypes and the first few final versions of the bioprinter in-house.
We have explored the regulatory path in-depth and are continuing to speak with the FDA to define our exact regulatory recommendations prior to taking our products to market. Our bioprinter and bioink are not regulated by the FDA with regards to in vitro testing, but we must demonstrate the efficacy and consistency of the tissue products produced by our technology in order to decrease the market entry barrier.
As a laser product, the 3D bioprinter is classified based on the highest level of laser exposure and will be de-risked through design by restricting laser access and exposure with fail-safe interlocks. Our bioinks will be sold dry and, therefore, treated as a dry standard chemical product.
In the case of our tissues, even though we do not require formal FDA approval, we still plan to complete the required tests such as normal tissue control, histology, cytotoxicity, and expression of cancer molecules to demonstrate that our tissue models are comparable to (and better than) standard in vitro and in vivo methods.