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Week 4 – A Happy, but Tired Soul!

Hope everyone had a great week! For the first time in a while, I have had back to back weeks where I have been able to spend a little quality time in the lab. It was not as much as I like since there are always business-related matters that need to be taken care of, but it was enough to keep my soul happy. It is always fun to challenge yourself, especially when you are learning new techniques or revisiting techniques you haven’t done in a long time. That being said, it seems to get scarier as you get older because doing things that are comfortable and familiar are a lot easier. I guess that’s why we keep pushing forward to grow the business instead of just folding things up and going to work for someone else. Making this change would provide us a more consistent environment. Even though it is scary when you don’t know everything or have every answer, it is exciting and rewarding as you accomplish a task, no matter how big or small.

This week we made progress on several of our ongoing programs as well as initiated development of some new technology. This required our team to learn new skills or recall techniques that we haven’t used in for a period of time. I am always impressed by the younger members of our team who do a great job adapting to change or implementing new technologies. Our team is outstanding at multi-tasking so it is important that each member is willing to try to learn new techniques and not be afraid to fail. This is complicated by the fact that we have many programs going on at once. I think this is the hardest thing for many people in this business to understand; failure is a part of life. We cannot advance our technology if we are not willing to fail, learn from it, be persistent and try again. Not everyone has this type of mentality but it can be learned. Succeeding is driven into us from when we are young, from school where you need perfect grades to sports where failure is not an option. In this business, success will come from perseverance after coming close to banging your head against the wall (not literally, of course).

We have begun to ramp up development of our program for the National Institutes of Health (NIH). As you may recall, we are developing a diagnostic tool that allows investigators to

“print” cells onto our electrospun materials that will be mounted onto the bottom of 96 individual wells in a single device. This brings together material manufacturing, process development and engineering. This complete process will eventually be automated, from taking the material after electrospinning, holding it in place, adhering it to the individual 96 wells on the plate, removing the excess material using a laser cutter and sterilizing the final product prior to shipment. Very easy to describe in this blog but more complex to execute. That being said, we are up to the task. We are already making terrific progress. We purchased our first robotic machine (that is being called “Pico” by us) that will be used to accurately and quickly apply the glue to each well. This will allow mass production of these plates. It will take a decent amount of development to get this process working in a consistent manner, but we are excited about the initial first steps taken. We are in initial discussions with several potential strategic partners that sell these types of diagnostic cell culture products and could benefit from a new product within their portfolio. We will see where these discussions take us. Nice to see the interest.

We continue to move our vascular graft program along, from the ongoing preclinical study for our NuSpun™ Vascular Graft to development of a new drug-loaded vascular graft for the KidneyX award. Again, these programs exemplify the need to be persistent. We have explanted 10 of our NuSpun™ Vascular Grafts, with all grafts having blood flowing through them for either 90 or 180 days. This is a big accomplishment. We have a lot of data to go through and will be learning more about the device, from what worked well to what areas need to be improved on. I can say that there is a lot of positive steps achieved for this graft, with this study being a big step for this technology. For the drug-loaded graft, we have successfully made our prototype device that has drug located in only one portion of the device. To date, there is no graft that has this type of targeted delivery. We will now conduct a full battery of tests, from how strong it is, how it sutures, how flexible it is to how much drug releases from the graft and can the released drug prevent the body’s cells from overgrowing. We will use this data to apply for a Phase II award from KidneyX to expand these studies.

Lastly, we have several areas that we are either diving into as new programs or bringing to the forefront after sitting on the backburner. We also continue to advance our work with Takeda as well. We will get more into these in the upcoming weeks. To give you a high-level view, we are working on developing an electrospun suture, new electrospun materials for the NIH program as well as other potential customers and new drug-loaded materials that would prevent blood from clotting. All good stuff but not enough room to discuss in one blog. Stay tuned!

Have a great weekend!



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