Author: Tricol Biomedical

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Tricol Biomedical Expands IP Protection with First New Patent for Gastrointestinal Hemostasis

[February 21, 2023: Portland, OR] The US Patent and Trademark Office has granted Tricol Biomedical, a global leader in innovating hemostasis and wound care solutions, a new patent (#11,564,673) for the company’s modified chitosan dressing and its through-the-scope delivery in the gastrointestinal (GI) tract to quickly control serious bleeding for up to 96 hours.

The patent – the first of its kind for Tricol Biomedical – will protect intellectual property surrounding this modified chitosan dressing designed to provide easy delivery with prolonged safe and effective use within the GI tract. Tricol’s proprietary chitosan-based hemorrhage control platform, branded as Chito+™, has been demonstrated to control serious bleeding quickly and safely, with excellent maintenance of bleeding control.

“Prolonged bleeding in the upper gastrointestinal tract is a significant problem in the emergency room and in acute care settings,” commented Christopher Rowland, President and CEO of Tricol Biomedical. “This patent, the first in a family of patents, protects a powerful new tool for use in GI hemostasis.”

Recently recognized as a 2022 Top 10 Wound Care Solutions Company, Tricol has been a world leader in advanced acute wound care innovation for more than 20 years and is dedicated to expanding technologies, platforms, and applications to improve and save lives around the world. Through a strong scientific background, highly skilled team, and significant emphasis on research and development, Tricol has established itself as a global hemostasis devices company that continues to innovate and deliver on its mission to achieve zero preventable deaths due to blood loss. The company holds over 60 patents with its technology documented in over 30 clinical publications. Tricol manufacturers its life-saving Chito+™ hemostatic gauze and bandage families but is also focused on future implantable offerings with controlled dissolution, meaning they effectively control bleeding but then are dissolved sufficiently for the body to pass.

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Tricol Biomedical Expands Product Lines with Group Purchasing Organizations
Salvin Dental Specialties Is Now Tricol’s Exclusive U.S. Dental Distributor

New Product Offerings with Strategic Partners Will Expand Access for End Users

[December 13: Portland, OR] Tricol Biomedical, a global leader in innovating hemostasis and wound care solutions, has expanded its GPO agreements to include the OneStop™ Vascular line of procedural care products. In addition, the company has developed an exclusive U.S. distribution agreement with Salvin Dental Specialties for the company’s HemCon® Dental Dressing PRO product line.

Tricol’s agreements with these and others are part of the company’s strategic vision to provide safe, effective hemostasis solutions for medical interventions in the pre-hospital, trauma, acute care, and non-acute care settings.

The company has added new hemostatic devices to its GPO contracts. Both serve as hospital purchasing partners within the United States for their procedural care product lines. Their agreements will now include the OneStop™ Vascular line (1.5 in, 2 in, and pre-slit) to provide unique, non-invasive solutions to control bleeding quickly and safely in both planned and emergent medical procedures.

Tricol’s agreement with Salvin Dental Specialties enables the distributor to sell – exclusively – Tricol’s HemCon® Dental Dressing PRO product line, an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue wounds and to provide pain relief to patients.

“Tricol is constantly innovating with our partners to improve the flow of new product offerings, opening the door with these expanded agreements,” said Christopher Rowland, Tricol’s President and CEO. “At Tricol, it’s all about access to our products — whether online, through our direct sales entities, or through our distribution partnerships. With Tricol’s proprietary chitosan platform, marketed as Chito+™, our sales, purchasing, and distribution partners all enjoy carrying medical devices with the highest level of quality and innovation for hemostasis management.”

Recently recognized as a 2022 Top 10 Wound Care Solutions Company, Tricol has been a world leader in advanced acute wound care innovation for more than 20 years and is dedicated to expanding technologies, platforms, and applications to improve and save lives around the world. Through a strong scientific background, highly skilled team, and significant emphasis on research and development, Tricol has established itself as a global hemostasis devices company that continues to innovate and deliver on its mission to achieve zero preventable deaths due to blood loss. The company holds over 60 patents with its technology documented in over 30 clinical publications. Tricol manufacturers its life-saving Chito+™ hemostatic gauze and bandage families but is also focused on future implantable offerings with controlled dissolution, meaning they effectively control bleeding but then are dissolved sufficiently for the body to pass.

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Tricol Biomedical Recognized as Top Wound Care Solutions Provider

Tricol’s Chito+™ Has the Power to Address Hemostasis In and Out of the Hospital

[October 25, 2022: Portland, OR] MedTech Outlook has recognized Tricol Biomedical as a Top Wound Care Solutions provider in its annual Wound Care Solutions issue. The publication, which includes a profile of Tricol, highlights the top ten companies that are advancing the standard of wound care with specialized products that deliver top-quality solutions to patients around the world.

“We are honored to be included on this prestigious list with other groundbreaking companies in the wound care space,” commented Christopher Rowland, Tricol’s President and CEO. “Innovative technologies like Chito+™ – Tricol’s proprietary version of chitosan made from shrimp shells – can be applied to patients in numerous situations when bleeding is an issue – in and out of the hospital – and we are proud to advance patient care globally.”

For more than 20 years, Tricol has been a world leader in advanced acute wound care innovation and is dedicated to expanding technologies, platforms, and applications to improve and save lives around the globe. Through strong scientific background, a highly skilled team, and significant emphasis on research and development, Tricol has established itself as a global hemostasis devices company that continues to innovate and deliver on its mission to achieve zero preventable deaths due to blood loss. The company holds over 60 patents with its technology documented in over 30 clinical publications. Tricol manufacturers its life-saving Chito+™ hemostatic gauze and bandage families but is also focused on future implantable offerings with controlled dissolution, meaning they effectively control bleeding, but then are dissolved sufficiently for the body to pass.

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Preclinical Evaluation of Tricol Biomedical’s Absorbable Biocompatible Chitosan (ABC) Wound Dressing Demonstrates Bioabsorption and Biocompatability in Internal Bleeding

The poster presentation at the Military Health System Research Symposium investigated the use of the ABC compound in an animal study.

[September 29, 2022: Portland, OR] A preclinical study presented at the Military Health System Research Symposium (MHSRS) this month demonstrated that the proprietary† Absorbable Biocompatible Chitosan (ABC) investigational product from Tricol Biomedical is both absorbable and biocompatible in an internal bleeding rodent model.

The poster presentation, Development of Bioabsorbable Chitosan Hemostatic Wound Dressing by Hua Xie and others, investigated the bioabsorption kinetics and biocompatibility of the ABC dressing when placed intraperitoneally on an injured liver lobe and subcutaneously in 16 animal subjects.

The authors describe the evaluation: “Exsanguinating hemorrhage is the leading cause of death of soldier in wartime and the second leading cause of death in civilian traumatic injuries. Quickly accessing and stabilizing the wound with effective hemostatic techniques is the key for life saving in these events. Historically, HemCon® chitosan hemostatic dressings (composed of chitosan with degree of deacetylation above 78 percent that is not readily bioabsorbable) were developed to address severe hemorrhage for external applications. In this study an absorbable, biocompatible chitosan (ABC) is prepared with a lower and narrow range of degree of deacetylation to provide a chitosan dressing material with good hemostatic properties that bioabsorbs without biodegradation induced fragmentation, and without adverse cytokine mediated inflammatory responses. The open structure, freeze dried porous matrix ABC dressing of the study is designed to facilitate biodegradation by providing enhanced cellular infiltration and proliferation.”

The results of the preclinical study demonstrated:

  • Desirable bioabsorption properties and biocompatibility of the ABC dressing in both subcutaneous and intraperitoneal implantation models.
  • The ABC dressing implant was 85% absorbed in 28 days and close to fully absorbed within 60 to 90 days at both implantation sites.
  • The ABC chitosan dressing demonstrates absorbable biocompatibility without systemic or local adverse responses.
  • The ABC chitosan dressing does not result in surgical adhesion formation greater than Grade 2 – no surgical adhesions were observed.

“The proof of principle within this preclinical study demonstrates a significant potential to address internal bleeding with our mucoadhesive controlled dissolution product line,” commented Christopher Rowland, Tricol’s President and CEO. “Tricol has a long history of innovation and is committed to further progressing technologies that cut across hospital call points, procedures, and specialties to significantly benefit the health of patients around the world.”

For more than 20 years, Tricol has been a world leader in advanced acute wound care innovation and is dedicated to expanding technologies, platforms, and applications to improve and save lives around the globe. Through strong scientific background, a highly skilled team and significant emphasis on research and development, Tricol has established itself as a global medical products company that continues to innovate its initial foundation of advanced hemostatic solutions. The company holds over 60 patents and 32 clinical publications, manufacturing life-saving Chito+™ hemostatic product families like HemCon® and OneStop®.

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† Protected by US 9547011; US 9846163; US9925310; US 10709817; CZ 3003026; DE 602014050166.4; CN105142399

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Tricol’s Hemostatic Devices Have What It Takes, According to ECRI

ECRI, a well-known and trusted voice in healthcare, focused on quality, safety and cost, across the healthcare spectrum, analyzed hemostasis pads. They identified four key considerations to help choose the best. Tricol Biomedical offers two hemostatic devices for vascular closure; the HemCon® Patch Pro, and the HemCon® OneStopTM Vascular. Tricol Biomedical’s Chief Science Officer, Dr. Simon McCarthy, describes how the HemCon® OneStopTM Vascular Patch meets and even exceeds ECRI’s stringent considerations.

ECRI’s Key Considerations

  • Will the hemostatic agent be effective on a patient whose coagulation is compromised due to systemic anti-coagulation treatment?
  • Does the hemostasis device have a backing?
  • Can the width and length of the hemostasis pad meet the needs of the wound?
  • Can the pad be used for vascular access sites, percutaneous catheters, lacerations, and trauma?

The Tricol Standard Isn’t Typical

While many companies participate in the billion-dollar vascular closure market, Tricol Biomedical’s HemCon® product line stands apart. HemCon’s unique chitosan technology was leveraged by the U.S. Army in 2001 with the mission to control severe, traumatic bleeding on the battlefield. Soon thereafter, all US soldiers carried the original HemCon® Bandage in their individual first aid kits. This was advanced breakthrough technology, saving many lives. This same battlefield technology is also offered in acute care settings with HemCon’s OneStopTM Vascular and Patch Pro Devices.

It’s All in a Pad

The HemCon® OneStopTM Vascular meets the stringent requirements as outlined by ECRI, and more…

  • It is cleared for use to control bleeding in all patients, including those on anticoagulation therapy. Criteria #1 met.
  • OneStopTM Vascular has a backing with clear instructions indicating the active side of the patch as well as instructions not to remove. Criteria #2 met.
  • OneStopTM Vascular is 1.5in x 1.5in and is used in a wide range of wound sizes. Criteria #3 met.
  • OneStopTM is indicated for vascular procedure sites and sites involving percutaneous catheters, tubes and pins, and can be used to control bleeding from lacerations and/or trauma. Criteria #4 met.

Meeting ECRI’s criteria outlined above is great, but the HemCon® OneStopTM Vascular Patch provides 2 additional important features that go beyond the criteria set forth by ECRI.

  • Promotes Rapid Control of Bleeding
  • Provides a Barrier to Bacterial Penetration of the Dressing

Tricol also offers a radial balloon compression device with the OneStopTM Vascular patch incorporated into the design of the device. This device is called the OneStopTM ChitoPulse. This product offers the same features and benefits listed above.

Solid Science for Peace of Mind

Tricol’s secret is in the science. (Well, it’s also in “trade secrets,” but we can only share the science.) Unlike other players in the hemostasis field, Tricol’s products have earned support from a plethora of impressive studies on their efficacy.

A combination of well-funded preclinical and clinical data continuously reinforces the remarkable performance of these hemostatic devices. Supported by solid, proven data, clinicians confidently use them for lacerations, trauma wounds, vascular-procedure sites, and sites involving percutaneous catheters. Bleeding is controlled quickly and safely by the power of products strengthened by science and perfected by experts.

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Tricol Biomedical Receives NIH Phase IIB Grant to Continue Development of its Hemostatic Device for the Prostate

Tricol Biomedical, a privately held medical device company dedicated to saving lives through innovative, hemostatic, and wound care solutions, has received an $853,585 grant from the National Institute Of Diabetes And Digestive And Kidney Diseases of the National Institutes of Health’s Small Business Technology Transfer (STTR) Program. The Phase IIB grant will support final development of Tricol’s proprietary hemostatic device to address bleeding in prostate-related procedures for treatment of both benign and malignant prostate conditions.

In the U.S. alone, more than 42 million men over the age 50 suffer from Benign Prostatic Hyperplasia (BPH), and roughly 12 million require medical attention and intervention for the condition, often through minimally-invasive surgical procedures.1 In addition, prostate cancer afflicts 250,000 men in the US each year,2 often requiring radical surgical intervention.

Nearly 250,000 surgical procedures for the prostate are performed in the U.S. annually3 to address both benign and malignant conditions, and for patients requiring intervention, post-operative bleeding remains a major complication, resulting in prolonged hospitalization and increased illness and mortality for patients, and increased overall cost of care.

Tricol’s development of an endoluminal hemostatic device, specifically to treat prostatic bleeding, could address a serious unmet need to provide effective bleeding control post-surgery, reduce related morbidity and mortality, and significantly decrease the overall cost of hospitalization.

“Tricol has a long history of developing and commercializing revolutionary hemostatic solutions that save lives,” commented Christopher Rowland, Tricol’s President and CEO.  “The potential for this new application to control bleeding in the surgical realm of prostate procedures could have a significant impact on the health of patients globally.”

For more than 20 years, Tricol has been a world leader in advanced acute wound care innovation and is dedicated to expanding technologies, platforms, and applications to improve and save lives around the globe. Through strong scientific background, a highly skilled team, and significant emphasis on research and development, Tricol has established itself as a global medical products company that continues to innovate its initial foundation of advanced hemostatic solutions. The company holds over 60 patents and 32 clinical publications, manufacturing life-saving hemostatic product families like HemCon® and OneStopTM.


Research reported in this publication was supported by the National Institute Of Diabetes And Digestive And Kidney Diseases of the National Institutes of Health under Award Number R42DK078400. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

1.NeoTract US Market Model estimates for 2020 based on IQVIA™ data.
2.https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
3.Urology Care Foundation: 150,000 TURP procedures annually. OncLive:  90,000 radical prostatectomy procedures annually.

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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 on this page, 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 fibrinogen into fibrin.
  5. Fibrinogen – a soluble protein in blood plasma from which fibrin is produced thanks to the action of thrombin.
  6. Fibrin – an insoluble protein formed from fibrinogen 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 fibrinogen 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 by the U.S. 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 U.S. 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 faecalis. (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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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  opens in a new windowwww.tricolbiomedical.com