The title of this week’s blog pays homage to one of my favorite shows Seinfeld, in which one character named George Costanza declares that this is going to be the “Summer of George.” While you could say that this has been the “Summer of NuSpun™,” this week has really kicked things into another gear and brings us closer to seeing how this graft is performing. It is exciting and nerve-racking at the same time. It’s not like being a chef and getting instant feedback by looking at the expression of people eating your food and hearing compliments/complaints from the customers. This is a long process, especially on the preclinical and clinical side, in which you could wait days to years without really knowing much. While conducting the benchtop studies gives us an idea how it should handle/work, nothing can replicate intricate workings of the body. No matter what I have learned, I am still always amazed at how the body works. This process really cannot be replicated in any test tube.
This uptick in the graft development really starts with our great group of investors, who believe in the technology and have put resources behind us to start moving this technology forward. As I will continue to mention, we have a lot of exciting and promising technology but without funding, it would not go anywhere. Performing research is not inexpensive (and it is not because scientists make a lot of money. I personally wish that were the reason). For example, our preclinical study alone costs over $380,000. A lot of time, skill and costs are associated with this type of study with the hope (and a lot of planning) that all goes well. We have just passed the 60 day implantation mark with our NuSpun™ Vascular Graft for 4 of the devices and the other 4 are progressing along. Back in May, we were just getting going and here we are with 4 grafts that are patent (technical term for blood flowing through the graft). We are closing in on our first target of 90 days. Every time we go to evaluate the graft for patency and get good news, the whole company is buzzing. So much work goes into this and the feeling is like hitting some money on a scratch ticket. You’re happy for a short period of time, but the bigger prize is still out there.
As this study moves forward, there are so many areas that support this work. We have made the first four NuSpun™ Vascular Grafts on our pilot manufacturing electrospinning machine. These grafts will soon be implanted in our preclinical study. Why is this important you may be asking? This manufacturing machine has to be able to run the same way each and every time when the operator pushes the button. The last thing you would want is 200 grafts made the same way and the 201st graft is not the same. While there are processes to check these grafts after they are made, would you want the 201st implanted into you? Developing this machine takes us one giant step closer to beginning to mass produce these devices the same way all of time and to pick up problems that could occur, making the devices safe for use. This equipment is specific to what we do and will be used to make grafts for clinical trials in the near future. This has been a long road that started over a year ago. Starting with a rough concept of what the electrospinning unit should look like, drawing the planned unit, creating the software used to run the unit and wiring the unit, it is a full undertaking. To get to this point is a huge achievement!
This week also saw us submit our revised plan (pre-submission) to the Food and Drug Administration (FDA), based on their previous suggestions and comments. This is an important step as we look to formalize all of the testing that will be required prior to implantation into people in a clinical trial. The FDA’s job is to bring together a panel of experts that will review your plan and eventually data to make sure that when the device is used, it is safe. The presubmission allows the FDA to have an early view of what you are planning to do and allows them to provide their input such that when the formal submission for approval is made, the FDA can be confident that the company has followed the appropriate testing pathway to ensure that all risks to the patient will be reduced or eliminated.
We have a long way to go and success is never guaranteed. Time is flying by and so far progress is being made on many fronts. Maybe in the end, it will be the “Better Treatment with NuSpun™.” One can dream!
Have a great weekend!