My late father-in-law Shorty (his nickname from when he was young man and not me insulting him) used to love to ask me what our most important product was, which always ended up with him saying that “progress is our most important product.” While he liked using this saying, it was General Electric that was the first one to use this as their company slogan back in the 50’s and 60’s. As I looked around the company this week (when I was not running into Boston for our preclinical study), no truer words could be spoken. Progress is being made on all fronts of the company, from manufacturing to research and development (R&D) and regulatory (more to come on this area in an upcoming blog). It is like watching a fine-oiled machine running. Nothing more spectacular!
Let’s start with manufacturing. The prototype manufacturing electrospinning unit is beginning to take shape and look like a finished piece of equipment. A lot of hard work has gone into making this important piece of equipment: evaluating how R&D makes their prototype device, understanding what properties are required from the machine to make the final medical device (in this case, our NuSpun™ Vascular Graft), developing a schematic for the new machine, ordering components, assembling the components, programming the software, running the unit and troubleshooting any issues that arise.
We are also developing new equipment to accurately and reproducibly determine various properties for our NuSpun™ Vascular Graft such as fluid permeation through the graft (see image) and how the graft will respond to pressure via burst strength evaluation. These properties are important to measure prior to testing these devices in preclinical and clinical trials to ensure blood flow is maintained within the graft and that the graft will not burst when exposed to blood pressure. It never ceases to amaze me what these folks can do.
Progress is also being made on several R&D programs. We have started work on our KidneyX program. In our initial studies, we have shown that a fluorescent molecule can be electrospun into a specific layer within a vascular graft (see image). This molecule is a substitute for our target drug to visualize where the drug can be placed. The goal is to locally deliver a drug to an area within the body to prevent complications. Next step is to replace the fluorescent molecule with the drug, detect drug release and assess biologic activity.
We continue to refine and analyze gastrointestinal devices that we are developing for Takeda using benchtop and preclinical studies. Even though these studies are promising, I cannot get into too much detail since we will be submitting this data for patent protection (meaning we cannot publicly disclose data). Once the patent submission process is complete, we will provide you insight into what we’ve been working on.
Lastly, our Bio-Spun™ materials are being used for in vitro diagnostics (National Institutes of Health and MatTek) and cardiac (Edwards Lifesciences) applications. There is nothing better than having outside groups evaluate our technology and verify the benefits of our electrospun materials. The studies that are ongoing with these materials range from benchtop and tissue culture evaluation through initial preclinical assessment. We will provide specific data from these programs in our upcoming blogs.
Progress has truly been our most important product!
Have a great weekend!