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Week 12 – To Drug or Not to Drug. That is the Question.

Hope all is going well. Hard to believe we are already in the month of June. One sign of this is the arrival of our interns (big welcome to Emily and Emma!). The first week the interns arrive is one of many emotions on both sides. We are excited about them coming onboard because we understand that we have an opportunity to provide them a new set of tools for their toolbox. Based on our previous experiences with interns, the growth that they tend to show over the process is amazing. That being said, the first few weeks can be overwhelming to them because, as you know being readers of this blog, we do a lot of stuff here. Getting to understand the background information can be pretty daunting. While we try to make it as simple as possible, it’s like watching a deer in the headlights at the first meeting. I always tell them to be patient because it will all make sense as they see more. I’m sure they are thinking “Yeah, right!” For us, we need to be on our toes to make sure that we can answer all of their questions. You may think that’s easy but sometimes a simple question can force you to go back many years to answer. I personally enjoy working with them since they are the future of the industry and if we can give back just a little bit to what we’ve been so fortunate to have, that makes me happy. I am grateful that we have a great team that makes my work with them a lot easier. We were debating whether we were going to have interns this year but after thinking about how COVID really hurt their hands-on learning, we felt like we should try to help.

Similar to the last blog, I want to continue to provide some information about the different programs we are working on here. I’ll try to keep it to one topic since more than one could get confusing. Based on my Shakespearean-inspired blog title, the question of incorporating a drug into a medical device is one that is constantly asked. There have been many devices that have arisen from incorporating and subsequently releasing a drug right at the device surface ranging from life-saving devices such as drug-eluting coronary stents for blockages in the heart blood vessels to implantable birth control. Drug-loaded devices can either deliver a drug to the patient over a long period of time or can prevent complications associated with using the device (i.e. preventing cells from overgrowing and blocking blood flow in the device). Sometimes, the issue with including a drug into the device is problems with how it is incorporated. Many devices use a coating containing the drug, with the coating releasing the drug over time. There are several problems with this approach such as the coating holding onto most of the drug, the coating itself having its own complications or the coating blocking the body from healing. So, you can see that there are many things to consider when you are contemplating adding a drug to a device.

One of the benefits of our Bio-Spun™ materials is that we see markedly improved healing as compared to current materials used to make these devices. That being said, even when we see this improvement, there are situations in which our material would be implanted that would be problematic such as an area of the body that gets infected easily or that blood flow is low so blood clotting can occur. I will show you an example of these two different areas:

healing and complications. We are working with a company who is looking to use our Bio-Spun™ material for cardiovascular applications. Like a majority of companies who are in this space, they use woven or knitted polyester (yes – for those of you old like me – this is the material they made leisure suits from in the 70s and for those who are not old enough, be thankful you didn’t have to wear one of these beauties ( Why, you ask do they use it? Because it is relatively inexpensive, durable, been around for many years and engineers can just grab it off the shelf to add to their device. Does it work great? Healing is limited and drug release is not currently available.

This is where Bio-Spun™ materials come into play. The company we are working with wanted to take a look for themselves as to how the material heals compared to the woven polyester they currently use. From the histology assessment, our Bio-Spun™ material with or without an anti-clotting drug, truly integrated into the tissue in their preclinical study as compared to their woven material. In other words, the presence of the drug incorporated and being released from our Bio-Spun™ material did not affect healing. In terms of complications, however, if our non-drug loaded is exposed to blood under static conditions, it behaves the same way as the woven polyester material. However, if we incorporate an anti-clotting drug, the blood does not clot on the surface. So for situations where blood

is not sitting on the surface, you would not need drug but if the material is placed somewhere in the body where blood could be slowly interacting with material, a drug-loaded option would be better. Why do these companies keep using the same old material? Your guess is as good as mine but the data does not lie. This is only one example of how our technology can be applied. I am sure there are other companies out there that could use this.

Please make sure to check out #FactualFriday on June 17th and we’ll see you back here on June24th.



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