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Employee Spotlight: MacKayla Carolan

Meet MacKayla Carolan, Research Associate at Tricol. This Q&A gives insight into why MacKayla joined the Tricol team and her involvement with being part of innovative, lifesaving technology.

What is your background, and what led to you joining the Tricol team?

I got my degree in chemistry from Willamette University in Salem, Oregon, in 2019, and started at Tricol shortly after graduation. One of my previous classmates worked here before me, and I took her position when she went to graduate school.

While my university thesis was about the biodegradation of estrogens in the Willamette River using HPLC-MS, I was familiar with chitosan, because a professor at my university worked with chitosan for drug delivery purposes. Now, as a research associate here at Tricol, I work on developing new chitosan-based dressings to stop bleeding in various parts of the body, utilizing organic and analytical chemistry techniques.

While I was familiar with chitosan, I still had a lot to learn when I first came on board. It is incredible to think about how much I have learned and how much I have contributed to our projects along the way. I have also enjoyed learning about the medical device industry and being part of projects as they make their way to market.

We see you in lab coats as you move between Tricol’s two labs. What does a day in the life of MacKayla look like?

I should first say that I get to work with really smart, talented, and energetic people. Working alongside them on a daily basis and collaborating together is such a fun part of my day. We spend a lot of time together.

We have two labs here at Tricol. One is in our downtown Portland office, and the other is at the cleanroom facility we share with OHSU. We use the downtown lab for in-vitro testing of new prototypes and routine testing to make sure our products are up to standard, while the cleanroom facility serves as our wet lab. All the wet chemistry, synthesis, and lyophilization of our chitosan prototypes happen at our cleanroom facility.

My days vary depending on the projects we are focusing on at the moment. Some days we will be doing an organic synthesis, so I am in our cleanroom lab working on reagent addition, dialysis, lyophilization, or some other activity for the synthesis. Other days, we are testing the prototypes we just finished, so I will be in downtown Portland doing in-vitro testing or data analysis to determine whether a certain formulation meets our acceptance criteria.

I really enjoy the variety in my day-to-day activities. It is nice to have multiple projects to work on and other fun people to work with.

What are some of the projects you are currently working on?

We currently have two major projects in the works. I wish I could share all the details about what I’m working on, but a lot of what I do is proprietary and confidential, as we are continuously innovating and bringing new products to market. We are determined to develop devices that will address bleeding anywhere on or in the human body.

If one uses their natural curiosity about how, why, and when bleeding occurs, there are many applications of our technology that can save lives and be a game changer for clinicians in many disciplines.

Our goal in medical procedures is to shorten time to hemostasis, reduce blood loss and enable wound healing.

In general, my day is never boring. I have lots of freedom to experiment and innovate. There are always new and exciting ideas, and it is really fulfilling to see these projects come to fruition.

How does it make you feel knowing you are working on innovative, lifesaving technology?

It is a privilege to be part of such a talented team working on our technology, and it motivates me and the entire innovation team to make sure we are creating quality products. We have spent a lot of time on these devices, perfecting the formulation to make sure they surpass the current standard of care. We want to make sure our devices make it easier for doctors to do their jobs and possibly save someone’s life.

I am very early in my career, but I am proud to have a significant impact on projects that will result in a device that could save someone’s life one day.

 

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HemCon Chitosan Hemostatic Devices and the Body’s Clotting Cascade

In our final article of our first of many educational series, we are going to review the body’s natural clotting cascade and how HemCon’s hemostatic devices do not rely on this process to control bleeding.  We often talk about how our products work “outside of the clotting cascade” but what does that really mean? What is the clotting cascade and why does it matter that HemCon products work outside of it?  First, we must understand the clotting cascade.  By quickly glancing at the diagram below, it will make perfect sense…. Well, perhaps an explanation is necessary. The human body is full of complex processes that are truly amazing, and the clotting cascade is certainly one of them.

 

Don’t worry about the above diagram. What you need to know is that when you cut yourself and you want the bleeding to stop, or when a physician performs surgery and needs to stop the bleeding post-procedure, there are many things within your bloodstream that need to happen for it to successfully form a clot. In fact, there are 13 “clotting factors”, and each factor has an “inactive” form that gets converted into an “active” form to enable clotting. This conversion is the clotting cascade.

Before we go further, let’s get some common definitions out of the way:

  1. Clotting Factors – any of several substances in blood plasma that are involved in the clotting process, such as calcium, Prothrombin, Fibrogen, and tissue. Each clotting factor is assigned a number 1 through 13.
  2. Collagen – the main structural protein found in the skin and other connective tissues.
  3. Prothrombin – a protein in blood plasma that gets converted into thrombin.
  4. Thrombin – an enzyme in blood plasma which causes the clotting of blood by converting fibrogen into fibrin.
  5. Fibrogen – a soluble protein in blood plasma from which fibrin is produced thanks to the action of thrombin.
  6. Fibrin – an insoluble protein formed from fibrogen during the clotting of blood. It forms a “fibrous” mesh that impedes the flow of blood… the clot!
  7. Platelets – small cells in the blood that help with forming blood clots.

When there is damage to a blood vessel (from an unanticipated cut, or surgical procedure), collagen is exposed to circulating platelets in the blood. These platelets bind directly to collagen and create a platelet plug. This is the first thing that happens, triggering the clotting cascade. We mentioned above that there are 13 factors that need to convert from inactive to active inside the clotting cascade.  These 13 factors are organized in what is referred to as pathways, the intrinsic pathway and the extrinsic pathway. The intrinsic pathway is activated when there is direct damage to the blood vessel.  The extrinsic pathway is activated by direct damage to the blood vessel as well, but also by many other things such as tissue damage outside of the blood vessel, hypoxia, sepsis, malignancy and inflammation. Think of these paths as separate roads, each with different factors with conversion processes that ultimately come together at factor 10 to form one road, starting the common pathway.  And within the common pathway, the 2 most important factors are Thrombin and Fibrin.

Fibrin is factor number 1, the protein that forms a mesh, trapping platelets and ultimately creating the clot. But it cannot happen without Thrombin, factor number 2, which plays a big role in activating many of the other factors, both within the intrinsic and extrinsic pathways (factors 5,7,8,11 and ultimately 13). Factor 13 is the last and final clotting factor number.  When you’ve reached factor 13, your blood has formed a clot!

By now you are an expert at understanding the body’s natural clotting cascade. Maybe not, it can be confusing even for those that are somewhat familiar with it. It is truly amazing that this process takes place every day in all of us when we cut ourselves or have a planned event. And now that you know about it, we can get back to the original question of how the HemCon hemostatic devices work “outside of the clotting cascade”, and why it matters.

If you cut yourself and use a store-bought bandage or piece of gauze, and apply gentle pressure to stop the bleeding, you will need the clotting cascade to kick into gear and allow the process to run its course, ultimately creating a clot (thrombin to fibrogen to fibrin).  Think about all the factors mentioned above! This process works fast in some people, and very slow in others. For patient’s on blood thinners(anti-coagulants) their pace of clotting is slowed by impacting certain factors limiting thrombin’s ability to exercise its power in creating a clot. There are also certain diseases like hemophilia or Von Willebrand disease that hinder the ability of the clotting cascade in affected individuals. The clotting cascade does not always cooperate as it does on paper and charts.  Getting the clotting cascade to work could take a very long time in some cases.

This is where “working outside the clotting cascade” comes into play for the HemCon hemostatic devices.  Our positively charged chitosan devices simply attract the negatively charged platelets and blood cells to create a strong clot at the wound site, meaning, you do not have to worry about all those factors in the clotting cascade running their course.  Of course, they will run their course behind the scenes, but HemCon devices do not rely on them at all. Other hemostatic devices made from other sources work by affecting the extrinsic pathway, speeding up the clotting cascade process, but still must rely on part of the clotting cascade being intact.

The HemCon hemostatic devices have been stopping bleeding since 2001 when first introduced with the US Army to control traumatic bleeding. Being able to “work outside of the clotting cascade” played a large role in their decision to supply HemCon products to US Soldiers.

 

 

 

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Chitosan’s Anti-Bacterial Properties

It has been over one year since the world was shut down in response to COVID-19. Since then, the general population has become more in tune with proper health and safety practices such as washing hands and wearing masks. Wearing a mask has become an important practice used to prevent respiratory droplets from reaching others. Face masks have found their place as a simple barrier to aid in the prevention of illness. Shouldn’t it be just as important that your injuries, whether through planned hospital procedures or unexpected events, are provided that same protection?  Many of HemCon’s bleeding control products provide an antibacterial barrier against 24 microorganisms.

As you learned in article 2 of this series Chitosan Performance in the Human Body, the HemCon bandage type dressings provide a technology that adheres tightly to blood and seals the injury site to stop bleeding. Equally important is that this adhesion process also provides an antibacterial barrier, blocking the ability of bacteria to penetrate the wound.

 

 

Proper application and removal of HemCon products play an important role here.  When HemCon Chitosan dressings come in contact with blood, they essentially create an instant clot, adhering to the wound, creating a very tight seal that can’t be penetrated.  The dressing can be left in place on the patient for up to 48 hours providing continuous protection!  However, improper technique could jeopardize this important safety feature.  Lifting up the dressing and peeking underneath to see if bleeding is controlled can break the strong seal and could compromise the dressing’s ability to provide the bacterial barrier. (Note:  Not all HemCon dressings provide this barrier to bacteria.  Check the product descriptions on our website for products that carry this claim.)

The antibacterial barrier of HemCon dressings was investigated using a standardized test method, Evaluation of Antibacterial Finishes, where the dressing was exposed to single strains of Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. HemCon bandages exhibited a >99% reduction in organisms 24 hours after being exposed to the dressing. The most common microorganisms causing surgical site infection are Staphylococcus aureus and enterococcus. (Read the full article here.)

The unique properties of chitosan, the correct delivery matrix for the wound type, and good clinical practice produce a powerful barrier against some of the most prevalent bacteria found in hospitals.

 

 

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Chitosan Performance in the Human Body

Tricol’s chitosan is derived from shrimp shells. Yes! We learned all about this metamorphosis in Article 1 in this series – Chitosan Unleashed!  As you can imagine, there are many complex proprietary steps that happen between the extraction of chitosan from shrimp, and the point of using a finished product to control bleeding wounds in a caregiver’s hands.   Our various products are stopping bleeding all around the world!  You can find them in hospitals, outpatient settings, long-term care facilities, schools, places of work, and homes.  They are trusted by first- responders in our communities and on the battlefields we serve.  Many users want to understand the technology behind our life-saving products.  This stuff works, but how?

If we get into the science just a little, Chitosan is positively charged.  When it comes in contact with blood, it attracts negatively charged red blood cells and platelets that are drawn to the positive charge, creating a very tight seal.  Think of a magnet.  This ionic interaction produces an extremely strong, mucoadhesive (sticky) seal. This supportive seal at the wound surface works quickly to stop bleeding.  Chitosan technology has been proven to work even on individuals suffering from abnormal blood clotting mechanisms, or those on blood thinners.  Our chitosan technology works independently of the body’s clotting system (clotting cascade).  Check back later for an article on bleeding and the clotting cascade!

 

There are many ways in which the human body bleeds.  It could be the result of a traumatic injury, or, as a by-product of a medical procedure or intervention.  Whichever way, chitosan needs to be delivered to the source of bleeding via an appropriate support matrix.  In other words, for different types of bleeding, Tricol chitosan products are delivered in different forms.  Although the forms are different, they have in common the need to be strong, interconnected, and porous which allows them to adhere to blood-wetted surfaces and to resist high pressures from the vascular system.

Tricol products are broadly categorized into two general “family” types that we refer to as the “Bandage Family” and the “Gauze Family”.  Although they are both derived from the same shrimp shells off the pristine coast of Iceland, they treat different types of wounds.

Our Bandage family is essentially freeze-dried chitosan.  It is very soft in its finished form.  This is not the type of bandage you would find on the shelf of your local pharmacy or grocery store.  It is the kind of bandage you would find in the kits of the US Army’s Special Forces Green Beret unit or in the hands of the paramedic that arrives on the scene.  In fact, your cardiologist, trauma surgeon, or local dentist may be using this same battlefield-tested product on you.  It is extremely safe and effective in controlling severe bleeding in minutes.  Great for cuts and lacerations.  This product family used to be available only to professionals but is now available to the civilian population as well.

Our Gauze family of products are flexible, chitosan-coated gauze dressings that come in a variety of different dimensions and lengths.   Whereas our bandage family of products is used to quickly control surface level cuts and/or lacerations, our gauze family of products is typically used for deep penetrating wounds, or when the source of the bleeding is below the surface and not visible.  These dressing are then “stuffed” into the wound to come in contact with the source of bleeding.  These gauze dressings are now also available to the civilian population just like our bandage family.

Tricol specific products in both the bandage and gauze families are now being produced and provided for consumer and home use as well.

Check back here soon for the next article in our Chitosan Unleashed series where we will explore the anti-microbial properties of Chitosan-based bleeding products.

 

 

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Chitosan Unleashed!

Chitosan is the active agent in Tricol Biomedical’s HemCon and OneStop hemostasis products and in order to understand how it works, you should first know about chitin. Chitin is the second most abundant naturally occurring biopolymer, after cellulose. In the natural world, chitin functions as scaffold material that gives structure and strength to insect exoskeletons and crustacean shells, and it is also found in mushrooms. It is often found in association with the mineral calcium carbonate. Our chitin is sourced from shrimp shells of the species Pandalus Borealis. The species naming being a reference to the Aurora Borealis found in the sky above the pristine waters of the North Atlantic Ocean. The shells that are received for processing at Primex  in the very north of Iceland are caught under carefully regulated quota systems that leave a sustainable balance to the marine environment. These quotas are based on scientific criteria for sustainable utilization of natural resources and the dedicated work of the Marine Research Institute.

Once the chitin is extracted from the shells, it undergoes a process called de-acetylation that molecularly transforms the chitin to chitosan. So now that we know where Chitosan comes from, what exactly is it? Chitosan is a natural biopolymer that possesses a positive molecular charge and is the hemostatic component in HemCon bandages and coated gauzes. This positive molecular charge is the basis of chitosan’s medical uses. For bandage and gauze products like ours, the positive charge attracts negatively-charged blood cells like a magnet, rapidly creating a tight seal over an injury.

Often a first reaction to the use of Chitosan in medical devices are concerns with shellfish allergies. Most allergic reactions to shellfish are caused by the protein part of the shellfish, not by the shells. Any residual proteins are eliminated during the conversion of chitin to chitosan. There have been no reported cases of an allergic reaction to our chitosan products in the 20 years we have made them. Keep an eye out for more detailed information to come on the use of chitosan by people with shellfish allergies!

Due to chitosan’s many attractive properties such as its natural origin, abundance, and positive charge reactivity, it has a multitude of real-world applications. You can find chitosan used in the medical field, agriculture, food processing, cosmetics, and water treatment. Chitosan is a prime example of how we can use technology to benefit from naturally occurring materials. And as a bonus, HemCon chitosan is made as a byproduct of the shrimp fishing industry, so our material sourcing helps prevent waste and minimizes our environmental footprint.

Now to answer the question on everyone’s mind: how do you pronounce chitosan? Is it ‘cheeto-san’ or maybe ‘chyto-san’? When you find yourself in a conversation about all the benefits of chitosan, you can confidently pronounce chitosan as ‘kai-tuh-san’.

 

 

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Tricol Biomedical launches sales and marketing agency agreement with NorthStar Sales Alliance

Agreement with NorthStar aims to increase hemostatic portfolio in healthcare alternate sites in US.

(GLOBE NEWSWIRE) — Tricol Biomedical, a privately held medical device company dedicated to saving lives through innovative hemostatic and wound care solutions, today announced a unique sales and marketing agency agreement for the Tricol Biomedical family of hemostatic products with NorthStar Sales Alliance. NorthStar is a healthcare company with broad access into both the acute care and alternate site markets in US. The new agreement takes effect immediately and activates reach via a strong GPO platform and an engaged field team.

Tricol Biomedical is a fully integrated medical device company focused on bleeding control and wound care technology. Tricol is an innovative company, with over 60 patents and 32 clinical publications, manufacturing life-saving hemostatic product families like HemConTM and OneStopTM. Tricol products are successfully used to meet a variety of medical needs—from Trauma Management to Procedural Care to Consumer Care—and the Tricol product portfolio now features over-the-counter advanced wound care products as well.

“This sales and marketing agreement with NorthStar is consistent with our mission to provide access to Tricol Biomedical products across the full spectrum of the healthcare market. Extending our hemostatic solutions into all areas of patient, procedural and consumer care is critical to our mission of saving lives through innovation in Hemostasis.” – Chris Rowland, CEO of Tricol Biomedical

“We are excited to add the Tricol portfolio of bleeding control products, these products have been successfully used in the professional healthcare market for over 20 years and are well recognized for the lifesaving aspects of this technology.” – John Linderman, CEO of NorthStar Sales Alliance.

To learn more about bleeding control products from Tricol Biomedical, please visit www.tricolbiomedical.com

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Distribution Agreement with Medline Industries Represents Significant Revenue Upside for Tricol Biomedical

Agreement with Medline aims to increase hemostatic portfolio reach across North America

Tricol Biomedical, a privately held medical device company dedicated to saving lives through innovative hemostatic and wound care solutions, today announced an exclusive distribution agreement for the Tricol Biomedical family of hemostatic products with Medline Industries, a healthcare company doing business in more than 90 countries worldwide. Innovative hemostatic products, such as Tricol’s ChitoPulse radial band, are being introduced as part of the Tricol-Medline exclusive agreement.

Portland, OR, Feb. 02, 2021 (GLOBE NEWSWIRE) — Tricol Biomedical, a privately held medical device company dedicated to saving lives through innovative hemostatic and wound care solutions, today announced an exclusive distribution agreement for the Tricol Biomedical family of hemostatic products with Medline Industries, a healthcare company doing business in more than 90 countries worldwide. The new distribution agreement takes effect immediately for an initial term of 5 years with annual increases in minimum purchases.

Tricol Biomedical is a fully integrated medical device company focused on bleeding control and wound care technology. Tricol is an innovative company, with over 60 patents and 32 clinical publications, manufacturing life-saving hemostatic product families like HemConTM and OneStopTM. Tricol products are successfully used to meet a variety of medical needs—from Trauma Management to Procedural Care to Consumer Care—and the Tricol product portfolio now features over-the-counter advanced wound care products as well.

“This Distribution Agreement with Medline Industries is consistent with our strategy to drive Tricol Biomedical revenue through large distribution channels that will leverage our expertise in hemostatic technologies” says Chris Rowland, President & CEO of Tricol Biomedical. “Tricol is pleased to add Medline to our growing distribution team, and we are looking forward to broadening our HemConTM and OneStopTM product brands through Medline’s very capable U.S. sales organization. This agreement is an organic extension of the strong relationship we already have with Medline Consumer Products, and we are delighted that they recognize the quality and innovation of our broad family of hemostatic products.”

“We look forward to offering our customers outstanding product solutions from Tricol Biomedical,” said Jared Rosinski, Director of Product Management of Medline. “The addition of the HemConTM and OneStopTM brand of advanced hemostatic products to our portfolio supports our goal of arming our team with cutting-edge products that provide better clinical outcomes and value to our providers and patients.”

To learn more about bleeding control products from Tricol Biomedical, please visit www.tricolbiomedical.com