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Week 26 – Half Way Home!

Hope everyone is doing well and is safe and healthy. We finally made it to the halfway point of the year. It has been a challenging 6 months but here we are. The new “normal,” which will be this way for some time to come, has begun to take hold (well, at least for most people in Massachusetts – still a few hold-outs that will hopefully get the gist that this is a real issue). It reminds me when the seat belt law was implemented in Massachusetts. It was very hard to get adjusted at first, but then as time went on, it felt odd when you didn’t buckle up. Today, I could not imagine driving without my seat belt. Wearing a mask now at work is the norm and it feels odd when you start to leave your desk without it. Our team and visitors to the company have adjusted to the changes and we continue to work hard to move various aspects of our technology forward.

Before I provide you an overview of how our technology progressed this week, I want to let you know that July is going to be a month of announcements and new beginnings. We are beginning to edit our first webcast. While I do not have a face for Hollywood (and that is an understatement), I am excited to share some great insights into hemodialysis access from leaders in space (who are also great people). The webcast will be loaded onto our website in early July.

We are also working on a press release and possible other social media releases that should hit in July. To provide a small teaser, this release is related to our ongoing work with investigators at the National Institutes of Health (NIH) focused on developing cell culture plates that have our Bio-Spun™ materials. We are excited to share this information as soon as we are able to. Since we are working with a large company, we need to make sure it goes through the proper channels so everyone is in agreement. We are fortunate that we can review different opportunities and have the nimbleness to quickly execute. With bureaucracy existing in most large companies, we need to provide adequate time to review. This is fairly standard with most of the large companies that we’ve had the chance to work with. This news will position the company to provide various options for Transwell cell culture plates such as different materials, thicknesses, fiber alignment, and combination properties for the NIH and customers interested in using our technology for their research.

Our team continues to mostly focus on developing technology around the NIH program. We are getting close to testing our GMP manufacturing electrospinning unit built by our manufacturing team specifically used to produce electrospun materials for this program. Our summer interns are working on different aspects of this program, from evaluating how different sized proteins and dye penetrate through the Bio-Spun™ materials through developing a camera apparatus to catalogue images and a puncture unit to test adhesive strength. It always amazes me how fast the summer interns pick up what we are working on and start to contribute. I do think our team does a great job of really working with them so they get a good understanding of what we do so that they have a vision of what we are trying to accomplish. We are also examining how cells interact with these materials under different sterilization procedures. It is truly a team effort.

We made progress on providing information to Takeda as they continue to evaluate the Bio-Spun™ fistula plug opportunity. We have other R&D proposals that are also under evaluation. While several of these opportunities are promising, nothing is guaranteed until it is fully executed. We had several virtual meetings and extended emails with different players performing the due diligence. A leading gastrointestinal doctor assessed the medical need for the device and a regulatory expert evaluated our proposed regulatory path. Additionally, a leading scientist evaluated using this device in combination with another Takeda technology and set up a pathology review of our preclinical data. These meetings were very productive, but we still have more to do to finalize all the information required. We are getting ready on several fronts on the electrospinning side in the event we are given the green light by Takeda.

Continue to stay vigilant and keep social distancing, wear a mask where social distancing is not possible to protect yourself and those around you and frequently wash your hands. Continue to support your local businesses as they continue to try to work through these challenging times.

There will be no blog next week in observance of July 4th weekend. Try not to miss us too much (J). Hope everyone has a great upcoming week and safe 4th! There will be much to discuss when we come back on July 10th.


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