Author: Tricol Biomedical

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Global Partnerships Make It a Smaller, Healthier World

Tricol Biomedical’s far-reaching hemostatic solutions benefit worldwide healthcare, impacting the approximate 40 percent of trauma-related deaths that result from bleeding and helping to control bleeding in hospitals due to surgery or other clinical procedures.

Tricol’s proprietary muco-adhesive chitosan formulation, Chito+™, on its vast portfolio of medical devices, supplies distribution partners with its lifesaving products on a global scale.

Here are locations where Tricol is advancing the standard-of-care in hemostatic and wound management. As they evolve, they proudly anticipate sharing their medical technology in new markets.

Italy
For half a century, opens in a new windowSEDA SpA has provided Italian healthcare professionals with innovative medical devices that improve and save lives. As a result, they are a top-trusted, well-known distributor in Italy. Through partnership with SEDA, Tricol has significantly accelerated expansion in Europe.

With an excellent reputation across diverse specialties, SEDA is an ideal partner to represent Triocol’s diverse portfolio of procedural and trauma devices. Together, they quickly have accommodated the critical need for advanced hemostatic devices in Italy while setting a higher standard for patient care.

Spain & Portugal
For over 20 years, opens in a new windowWorld Medica has been dedicated to improving patient outcomes in Spain and Portugal. Tricol enhanced World Medica’s carefully curated portfolio of medical devices with Chito+™ hemostatic solutions. Together, they uncovered and addressed critical supply needs.

Through participation in key national and international congresses, combined with strong KOL relationships, World Medica is a highly trusted medical device distributor in Europe and a perfect partner for Tricol in this region.

The Nordics
By partnering with opens in a new windowMermaid Medical Group since 2011, Tricol has improved patient outcomes across Denmark, Norway, Sweden, Finland, and Iceland.  Mermaid Medical focuses on solutions for diseases of the vascular system as well as devices used in interventional radiology. They succeed through strong, trustworthy partnerships. Tricol is one such partner. Together, they provide safe, effective solutions.

For additional distribution in the Nordics, Tricol partners with opens in a new windowAP Services A/S, a company whose mission is bleeding control. Since 2006, partnership with this distributor has allowed Tricol to further their vision of achieving zero preventable deaths from blood loss.

Perhaps most noteworthy, their impressive partnership allowed Tricol’s lifesaving hemostatic devices to quickly aid our allies in the Ukraine. Originating to help soldiers with traumatic wound injuries, Tricol has been a pioneer in battlefield and pre-hospital hemostasis. Chito+™ hemostatic solutions continue to save lives for those who serve and protect.

South Africa
Johannesburg-based opens in a new windowCossni Medical helps stop the bleed in South Africa. A well-respected distributor in procedural and trauma markets, Cossni has established relationships with South Africa’s major private healthcare groups. They have a stellar reputation for providing carefully selected devices that address critical needs, making them ideal to represent Tricol’s extensive product line. Together, Tricol and Cossni continue to drive improved patient outcomes.

Taiwan
Since 2005, opens in a new windowWinChamp Medical Co., Ltd. has been developing and introducing medical technology throughout Taiwan. Through partnership with WinChamp, Tricol has developed a remarkable presence in Taiwan’s healthcare arena. Together, their customer base, portfolio, and lifesaving abilities keep growing.

Japan
 opens in a new windowZeria is one of the largest pharmaceutical/medical device companies in Japan. Tricol’s partnership with them began in 2010 and has led to a strong presence of Chito+™ devices in Japan. Together, they continuously benefit patients throughout the country.

Empowering the World with Chito+™
Hemorrhage is the most common cause of preventable death in trauma situations and anemia is a critical complication for ICU patients. Through exemplary distributor partnerships, Tricol’s reach across sites of care is expansive and saves lives around the globe.

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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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Fully Stocked so “The Blood Stops Here”—for Patients and Practitioners

In 2022, Tricol Biomedical completed its strongest production year. This is remarkable considering supply chain issues and the lingering pandemic, which continue to cause worldwide disruption. Supply chain leaders in healthcare are using lessons learned during these unprecedented times to ensure a more stable future. Many of their initiatives align with Tricol’s ongoing best practices.

A Collaborative Effort

According to Brian Clare, Ph.D., Tricol’s Vice President of Business Operations, “collaboration with science, compliance, and production” is at our core. “This triad is the backbone of any life sciences company. It allowed us to quickly react to supply chain shortages and emerge from 2022 stronger than ever,” says Dr. Clare.

Their advanced hemostatic devices, Chito+™ (chitosan based), rely on the science of biomedical materials. These proprietary hemostatic products are USA manufactured at Tricol’s innovation labs, providing for immediacy of information and efficient, superior production.

Tricol maintains a diverse distribution strategy. Strong US manufacturing supply chain partners have helped them sustain product inventory throughout. During the past two years, Tricol has solidified partnerships and executed distribution agreements. As a result, the process from manufacturing to end user was streamlined.

When hospitals struggled with supply shortages, Tricol remained a reliable resource. The ultimate goal was achieved: Customer needs were efficiently met to best serve patients.

The healthcare community remains under tremendous stress. Tricol strategizes to lessen its impact. They’re proud to provide the right products, at the right time and place.

Tricol’s response to the war in the Ukraine is especially impressive. Their chitosan-impregnated hemostatic products originated to treat battlefield injuries. Despite supply chain interruptions, Tricol credits strong partnerships with their ability to continuously manufacture and deliver life-saving devices. They quickly doubled production to meet demands of this war-torn country.

Forward-Thinking

To continue saving lives through their hemostatic solutions, Tricol remains committed to being a dependable force. Currently, they are addressing inflation challenges. From investing in new equipment to strengthening their team, they are managing costs without detriment to quality or supply.

Tricol continues to evolve. To combat extensive lead time required to obtain materials, they adjusted their purchasing and inventory tactics. Dr. Clare indicates, “Cost moderation and product availability require an ongoing balancing act. We work hard to keep that balance in favor of our customers.”

Their product lines, including CHITO+™ and m.doc® devices (cellulose based, manufactured abroad), can be found in hospitals, outpatient settings, emergency clinics, and home first-aid kits. And, thanks to Tricol’s supply strategies, they are consistently, conveniently obtainable.

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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®.

opens in a new windowView Posteropens PDF file

† 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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Employee Spotlight: Dr. Simon McCarthy

Meet Dr. Simon McCarthy, Science and Technology Fellow at Tricol. This Q&A gives insight into why Simon joined the Tricol team and the important research he is doing in the field of Hemostasis.

Q: You are certainly a well-known, respected, and published scientist in the field of Hemostasis, no argument there. How did you first get involved in Hemostasis with HemCon?

A: I was hired by Oregon Medical Laser Center (OMLC), Providence Health System (PHS) in November 2000 in their U.S. Army-funded vascular replacement program as a senior scientist specializing in polymeric biomaterials. My main project was chain extension of recombinant human (rH), coacervated tropoelastin to human elastin for vascular replacement. As a side project, I assisted in developing a chitosan-based hemostatic dressing to control hemorrhagic bleeding on the battlefield. As it turned out, the tropoelastin project was stalled for various reasons, so I spent most of my time focused on the chitosan dressing and its testing. The changes I instituted in the chitosan dressing preparation resulted in a dramatic improvement in its overall performance. In quick succession, a new company (HemCon) was set up by Dr. Kenton Gregory & PHS, and I joined HemCon to oversee the development of this new technology.

Q: How has science progressed in your 20 years at HemCon and now Tricol, and how do you stay on top of it?

A: Science never sleeps–there is always some improvement or development occurring every second of every day. An interesting feature of chitosan science and technology is that the emergence of chitosan in medical device use occurred in the mid-1990s. This was driven by demand for an improved supply of pure and well-characterized chitosan from pharmaceutical and nutraceutical companies. It is essential to understand that chitosan is not one material; it is a generic name for thousands of different poly-N-acetyl-glucosamine materials whose properties depend on molecular size, amine functionality, and structure of the chitosan molecule. OMLC, HemCon, and now Tricol have kept pace with rapidly expanding medical use of chitosan materials in three ways:

  1. Early (2000 – 2003) realization of the importance of chitosan characterization & differentiation.
  2. Development & improvement of unique, proprietary HemCon chitosan materials.
  3. Cooperating with best in field scientific and medical institutions interested in exploring HemCon chitosan’s unique biomedical attributes.

Q: HemCon/Tricol has over 60 published pre-clinical and clinical studies. Why is that important in our field of Hemostasis? In other words, why have we done so many studies, and what are we trying to accomplish?

A: Good science applied to achieve significant solutions needs validation. We earn accepted and reliable validation by publishing the science and its outcomes in high-impact, peer-reviewed journals. Regulatory agencies, key opinion leaders, and customers take significant heed of these peer-reviewed publications. In the case of quality publications, it is generally considered the more, the better. Achieving quality publication can be extremely challenging. OMLC/HemCon/Tricol have performed very well over the last 20 years, with close to 3 significant publications per year.

Q: Any advice to young scientists that want to get involved in this industry?

A: Although you may not be paid the same rate as a lawyer or a doctor, there is less stress and plenty of professional satisfaction for the biomedical scientist seeking to make things better. You need to be disciplined and dedicated: the old adage of 99% perspiration for 1% inspiration applies to scientific endeavors. Be sharing and open with your findings. The best solution to any problem is determining the key questions to ask. Be inquisitive; be prepared to be surprised; and be humble as Mother Nature has much to teach. Science is a team endeavor, so do not be slow in asking for help, and be prepared to share any limelight that comes your way. Do not be deterred by failure, which is an essential part of the scientific process. Apply best scientific practice to be safe, effective & efficient. Be involved with local scientific organizations and be ready to volunteer to help others.