Hope everyone is enjoying their summer so far. Unfortunately, it tends to fly by too quick. In a medical device-based company, this is especially true. Everything we do seems to require us to monitor time in some form or fashion, from running experiments and performing specific benchtop tests to evaluating our devices in preclinical studies. It always feels like “hurry up and wait.” Sometimes, the wait is well worth it.
As I relayed to you in my previous blogs, we are putting our NuSpun Vascular Graft through many different types of tests (e.g. benchtop and preclinical) that are required before implantation into a patient. These studies require various skill sets, from engineers and scientists to surgeons and surgical technicians. The necessity for performing this extensive amount of testing is to make sure our graft will be safe and effective when a patient requires an access site to initiate hemodialysis. While we do
everything possible at the benchtop to understand how our NuSpun Vascular Graft will perform when implanted, nothing can replicate the intricate and complex responses generated by the body to a “foreign” device. Therefore, implantation of our graft into a preclinical model gives us that initial snapshot of how the device may perform over a period of time when put into a patient.
It seems like we hurry to initiate these studies and then have to wait to see the results. I am glad to be able to share some of these early results. This initial data really get us excited about potential future results. After our surgeon implants the NuSpun Vascular Graft along with a standard clinical graft (ePTFE; also known as Teflon) on the opposite side of the body to see how our device compares under the same conditions. There are limited techniques that can be used to see if blood is flowing through our device, if there are any changes to the inside size of the device due to the body’s response and how fast blood is flowing through the device. To see how the devices are doing, we performed Duplex Ultrasound analysis at specific time periods. This machine uses sound waves to create images from inside the body such as arteries, veins, heart valves, babies, etc. An important feature of this technology is that it is non-invasive, meaning that no surgery is required to see what is going on within the body. Ultrasound allows us to evaluate all of these parameters from outside of the body. Really cool stuff!
If a picture is worth a thousand words, a video has to be worth a lot more. Using ultrasound, we are able to evaluate our device in real time right after implantation and at different time points thereafter. We are already 30 days out from the surgery for four of these devices and started our fifth today. A lot can happen in that time frame. There is nothing more nerve-racking than waiting to see if the graft is working. After waiting for what feels like forever, we see this great sight from the ultrasound of blood flowing through the grafts (brighter the color, the more intense the flow). You then hear the pulse through the graft (our lead preclinical surgeon thinks it sounds like the word “wow” repeating – you decide). It is such a sweet sound!
Our goal is to evaluate our NuSpun Vascular Graft for 90 and 180 days. These time periods are required by the Food and Drug Administration (FDA) as a prerequisite to clinical trials. We are on our way! That being said, as one of our close advisers who is not a scientist likes to say, “It’s biology, which is unpredictable.” He is right on target. We have a way to go but a great start indeed. A great team effort all around! Nothing makes me prouder.
Have a great weekend!