Week 23 – Is It Friday Already?
Hope everyone had a great week. Cannot believe that it is time to write this blog already! This week just flew by. Really, the month of October has been a blur. It has been a very productive month on several fronts. This week was no exception. While we are making progress, it comes at the expense of me not being in the lab. This is hard to deal with because being in the lab is one of the things I enjoy the most, excluding my family and friends. Being a scientist is ingrained in me so it is a challenge that I will need to adjust to for now. Just like everyone on the team, I need to be where I am needed most. My primary focus right now is on moving our NuSpun™ Vascular Graft forward. It will take a team effort to accomplish this and will require each of us to get out of our comfort zone. I hope to lead by example on this (although it is killing me).
The week started out with a day trip to Washington D.C. to meet with reviewers at the Food and Drug Administration or FDA to discuss our plan to bring the NuSpun™ Vascular Graft forward for use in people. The team submitted an extensive draft plan called a presubmission several months ago for this meeting. It is the FDA’s job to evaluate our plan to see if what we are proposing would result in a device that is safe and effective. The people that work at the FDA are experts in their respective areas so needless to say it is a little intimidating. Picture being in a classroom when you were younger and having a room full of teachers asking you questions. Gives me the shakes just thinking about it. Our team, along with our regulatory consultant Dr. Allison Komiyama (AcKnowledge Regulatory – gratuitous plug) worked hard to prepare for this meeting so even though it was a little daunting, I believe we were well-prepared. While no decisions are made at this meeting, we were able to show our graft to the reviewers and have them handle it. We were also able to expand on how we make the device now and how it will be mass produced in the future as well as listen to their thoughts on specific areas of our presentation. It was a long day of travel but it was very productive.
The next day, we evaluated how our NuSpun™ Vascular Grafts were performing in our preclinical studies using Duplex ultrasound (we described this procedure in a previous blog). Using this technique, we were able to show two grafts had blood flowing through them (also called patent, which is pronounced PAY-TENT) at 3 months and two grafts that were patent at 1 month. Several of these devices are also patent over 4 months so the data has been promising. The attached video shows blood flowing through our NuSpun™ Vascular Graft at 3 months. The color shows blood flowing through the device. What is really cool is if you watch the lower part of the blood flow, you will see the graft moving up and down or pulsing. This is similar to what would happen with your own artery.
Thursday had us traveling up north of Ashland to present our technology to a medical device/healthcare company. Our goal is to discuss the possibility of partnering to develop our NuSpun™ Vascular Graft and other opportunities that could be related to other uses of the technology. The conversation was thoroughly enjoyable, informative and productive. I enjoy talking about our technology and when you hear positive feedback, it is all the more rewarding. Looking to raise capital for the company is important to move this technology forward and is my number one priority. Again, while not as enjoyable as being in the lab, I have grown more accustomed to speaking about the business. It has taken a while but it is important to let people know why this technology could be revolutionary. I owe it to the great folks at the company to make sure we are able to fund this endeavor and am putting everything I have into this process. Hopefully, it will be worth the effort.
The final area we needed to tackle this week was converting a portion of our space in preparation for pilot manufacturing. This includes procuring benches and partitions, finalizing the new GMP electrospinning unit and preparing to make a second unit. This is more bull work since we have to move some heavy pieces of equipment and correctly lay out the space. Getting this done is preparing us for the next steps for making materials in a clean setting. We are excited about the progress being made and more is yet to come!
A big thanks to everyone who has reached out to let us know that you are enjoying the blog. It is appreciated and keeps fueling us. Have a great weekend!