Week 19 – We’ve Got You Covered from Top to Bottom (Literally)
Hope everyone is doing well and is safe and healthy. As I promised at the end of the last week’s blog, I will deviate from most of my discussion focusing on COVID-19-related issues. I know that we are all inundated with a lot of the information being released which can bring some anxiety so I am hoping to bring you a little touch of “normal” business this week. When I thought about the two areas I wanted to discuss this week, a status update on the bioactive masks and one device (a perianal fistula plug) that we are developing for Takeda that is inserted into hollow tracts that form at the patient’s buttocks (a.k.a. rear-end or butt) resulting from complications related to gastrointestinal disease, I thought we are literally providing devices that are covering you from top to bottom.
Before I get going, I want to provide you an update on our bioactive mask production. We have now donated 12 masks with many more to come over the next weeks and months. We continue to perform as much testing as possible, from wear testing (as you can see from our selfie when we used our masks to go for a walk by the ocean) along with evaluating
different lots being made to providing materials for outside testing groups to confirm that our mask will provide comparable properties to a surgical mask. I have been listening to people being interviewed that it is their right not to wear a mask. People need to understand that even though they could be feeling great, they could still be a carrier of COVID-19. You protect yourself and the people around you (those you love and strangers) by donning a mask.
We learned that we can alter our electrospinning parameters to create a filtration membrane that prevents particle penetration even more than a N95, which could have benefits in other areas outside of masks. As mentioned previously, we are not aiming to become a mask producer. Our goal is to produce at least 6-12 masks per week using our Bio-Spun™ polyester material containing silver as the filtration material. We are looking to make a small difference using our technology. For those of you who have received a mask and either have questions or want to learn more, we have added some helpful information under the Advanced Technologies tab on our website (https://www.biosurfaces.us/advanced-applications). If you need a mask, please feel free to reach out to us by email at firstname.lastname@example.org. We will add you to the list and send a mask as quick as possible as we fill each order on a first-come, first-served basis.
I am excited to finally be able to tell you what we have been working on with Takeda over the past 3 years. I will discuss one of the three devices we have developed in this blog. I am able to provide you this overview since we filed a patent application in conjunction with our collaborators at Takeda. If we had provided you any information prior to submission (called public disclosure), it would have started the “clock” and limited our ability to completely protect what we developed. I am sure that the description in the opening paragraph grabbed your attention; a device is inserted into hollow tracts that form at the patient’s buttocks (a.k.a. rear-end or butt) resulting from complications related to
gastrointestinal disease. These hollow tracts called perianal fistulas typically form as a complication from ulcerative colitis and Crohn’s disease, but can also form for other reasons such as pregnancy, radiation, trauma and cancer to name a few. I am providing an illustration of where these tracts form and what they would look like. How many of you have heard of this complication? To be completely honest, I never had heard of this complication prior to speaking with Takeda. However, the more you talk to people, the more you realize that you might know someone who has a perianal fistula. It could be that it is a hidden complication due to the location.
Patients can undergo invasive surgery, which works but it is very painful, may create
incontinence (uncontrolled defecation) and might not work long-term. A less invasive procedure calls for inserting a biomaterial (plug) to fill the hollow tract in the hopes that it will heal. Current devices, which all breakdown in the body, have had limited success since the devices get quickly ejected due to a lack of healing. I have included an illustration on how these plugs are inserted into the tracts. We liked the premise of using a less invasive procedure as did colorectal surgeons who work with these patients. We believe that creating a plug device that would fully heal and integrate into the tissue will be a better option for patients. Using our proprietary electrospinning technology, we developed a new perianal fistula plug called the Bio-Spun™ J Plug. The “J” stands for Jelly since we think it looks like a jellyfish. We were able to show in benchtop and preclinical studies that this plug had superior healing as compared to the current plugs. We were also able to incorporate specific drugs such as antibiotics into the electrospun fibers to prevent infection of the tract.
We are excited about the progress we made to date and are looking to move this device forward toward clinical evaluation.
Please stay safe, keep social distancing, wear a mask where social distancing is not possible to protect yourself and those around you and support your local businesses as safely as possible! We are all in this together and we’ll get through this.