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Week 9 –What Happens in Vegas.....

Hope everyone had a great week! While we have been full speed ahead on several different programs (which I will briefly summarize at the end of the blog), our NuSpun™ Vascular Graft took center stage this week. We have begun to put together data from our preclinical study. This is a large study that is generating a ton of data so it will take a full team effort to process it all. This process starts from creating and organizing excel spreadsheets that will handle the data followed by carefully making sure the data is organized into specific files and accurately enter the data into the spreadsheets (a special thanks to our high school intern Ben for all of his hard work). The data encompasses a wide and varying range of analysis, from something as simple as evaluating various blood work parameters (i.e. platelets, red cells) to more complex analysis of data from the ultrasound and computerized tomography (CT) scans, one of which shows a 3D view of blood flowing through our NuSpun™ Vascular Graft at 180 days. We also have a few more grafts to implant, but the majority of the study is wrapping up. This data will help us determine how our graft is doing, if there are any changes that are needed and what will be the next steps. This week, I also had Dr. Mauricio Contreras, who led our preclinical studies, come out to the business to go over this data. There is nothing I enjoy more than working with the team to analyze our data and hearing their thoughts.

Before we get into this week, we actually have to travel back to last week. Most people know the old saying “What happens in Vegas stays in Vegas.” Well, I would like to change up that saying this week to something like “What happens in Vegas doesn’t necessarily stay in Vegas (and that’s OK).” Last week, I worked closely with Dr. Yael Vin, a transplant surgeon at Beth Israel Deaconess Medical Center whose job solely focuses on creating access for hemodialysis patients, to prepare a slide deck for the American Society of Diagnostic and Interventional Nephrology (ASDIN) meeting held last Saturday. The majority of the people that attend this meeting are doctors who specialize in identifying problems with a patient’s access site and clean out/fix access sites that are struggling to maintain blood flow or have lost flow all together. This presentation focused on data generated from our ongoing NuSpun™ Vascular Graft study as well as initial data from our drug-loaded NuSpun ™ Vascular Graft being developed as a result of the Phase 1 KidneyX program. We are appreciative of Yael’s interest and passion for our technology and her willingness to provide an audience of surgeons and interventional nephrologists an insight into what we are working on. Her dedication to her patients truly inspires me and makes me want to work even harder to bring our technology forward. Yael was asked after her presentation to present an update of this work at the Vascular Access Society of the Americas (VASA) symposium in May. It seems that the NuSpun™ Vascular Graft is gathering some attention. Good stuff!

Last Saturday morning (the fun of being an owner of the company), I was at work sampling drug-loaded materials that were undergoing a wash study. This type of study, which is generating data for the KidneyX program, is conducted to mimic what would happen when these grafts are exposed to flowing blood. As I am beginning to sample the wash solutions, I receive a text and an email from two different people (an interventional nephrologist and vascular surgeon, respectively) that let me know that Yael is beginning her presentation (what was starting in Vegas was not staying there). Both sent me over images of Yael at the podium, which is shown in attached picture. I was proud to see our NuSpun™ Vascular Graft being shown to a large audience. At that moment, I thought about how far we’ve come. We still have a way to go but we are definitely making progress on the current generation of the graft and the next phase of the graft. We have had to overcome a lot of obstacles to get here ranging from limited funding that stalled development to typical developmental changes that occur with these types of devices. I was reminded that it takes work from all different directions and a lot of hard work from a lot of people in conjunction with people believing in your vision to make progress.

In spite of all of this work, we continued to make progress on several fronts as I previously mentioned. Development of our cell culture inserts, while hitting a few bumps with the equipment, continues to progress at a fast pace from developing quality control processes to expediting our electrospinning process. For this program, we had discussions with potential strategic partners. We continue to expand our tissue culture capabilities that will be used for studies related to our work with Takeda and the KidneyX programs. For Takeda, we continue development of our drug-loaded fistula plugs as well as our cell culture chambers. We are also in the process of submitting two patents for these technologies. Once these are submitted, we will be able to share data (very exciting). We also submitted a patent application focused on our fistula cuff device, which received honorable mention recognition by KidneyX. Lastly, we continue to focus on developing an electrospun suture and processes to improve electrospinning.

We have so much to do but are up to the challenge.

Have a great weekend!



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