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Week 29 – A New Milestone Accomplished!

I hope everyone had a great Thanksgiving and was able to take some time to relax while enjoying family and friends. I always appreciate some down time to recharge the batteries. That being said, as I’ve mentioned before, you are never “off” when you own a company but this is as close as you get. We have been blessed with the opportunity and never lose sight of that fact. We have so many people rooting for us to succeed. We are so humbled when people come up to us, friends and even people we are meeting for the first time, telling us that they are following the company, are really excited about what we are doing and wish us continued success. Every one of these kind words keeps us going when things get tough, when we get frustrated, or when we get tired from the grind. Thank you from the bottom of our hearts!

We are excited to share with you that our NuSpun™ Vascular Graft has reached a major milestone. If you remember some time ago in our blog, we discussed that we had begun a preclinical study to see how our graft would perform after implantation for 3 and 6 months. Believe it or not, 6 months is upon us. I am excited to say that our first graft has made it to 6 months! From a person that has evaluated different vascular grafts over his 30-year career, I can tell you firsthand that this is no easy feat. We were excited about our first 3 grafts making it out to 3 months but this takes it to another level. So many things can go wrong, from graft design and problems with implantation to complications like infection and blood clotting. Unlike many other products, there are many things that go against success.

Not only did it make it to 6 months, but initial visual inspection looked excellent. Blood was flowing freely through the device and the inner surface was a nice white color, indicating that cells are on the blood contacting surface. This healing pattern was not seen in the control graft implanted alongside of this device, which showed some blood clot on the surface with no cells. We will evaluate the device using specific markers that will allow us to look at the different type of cells, how the body’s immune system responds and how the blood/material surface looks. We will be looking to assess healing in the form of new small arteries (capillaries) formed within the wall of our devices. Using specific stains, we are seeing that cells that make up a blood vessel (endothelial cells) are present in the NuSpun™ wall as indicated by red stain uptake. We will continue to share a brief summary of this data as it becomes available.

This is not just an exciting time for Tina and me, but for every single person that has been part of this process over the last 16 years. This includes all members of our current team (both internal and external) and to those who have moved on to other opportunities in their career paths. Additionally, this achievement would not be here without the financial support that we have received over the years, especially our current investors who have been so supportive in this endeavor, understanding and accepting the risks of developing such a device. Our NuSpun™ Vascular Graft has seen a lot of changes over this time leading up to the graft we are evaluating today. We have made many different changes; from polymer composition and structural design (adding in the crimp to allow the device to bend freely) to electrospinning and surgical implantation procedures. Each change, both large and small, have continued to improve the graft. This seems like it was just an easy and simple process but it is really far from that. There has been frustration and setbacks over this time, but nothing changed our determination to bring this device forward.

There was nothing more personally satisfying for me to celebrate this success with our longtime collaborator and friend Dr. Mauricio Contreras. I have had the pleasure of working with Mauricio for over 30 years. We have had our share of dealing with negative results over that time period for various studies. So much time and thought are put into this process that when you get negative results, it personally affects you. It does not deter you but each result affects you. It has to because you need to learn from each result. Mauricio is on the front line of these studies so it is even more personal to him. After explanting the NuSpun™ Vascular Graft and the control Teflon graft and doing our first cursory look inside, I could sense his excitement. Being a surgeon, he is not prone to get excited until all things have been assessed. After all was completed, we discussed the visual results and shared a high-five. That high-five will stick with me forever. That was a 30-year high five in the making, from a person who has been in the trenches with me the whole time. No better feeling!

Have a great weekend!


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