The Rise Of Medical Textiles: Navigating Regulatory Challenges And Biocompatibility Testing

Textiles used in the medical industry are subject to rigorous testing and regulation.

Success in global medical textile markets requires an understanding of global regulatory standards and testing protocols.

By Dr. Timo Hammer

Around the world, millions of people a day receive medical care in hospitals and clinics. Most take for granted that the bandages, gowns and other materials they encounter are safe. But what are the criteria that govern those standards?

Advancements in technology and a burgeoning demand for specialized textile applications continues to drive exponential growth in the medical textile industry. From wound care to surgical garments to filtration systems in medical devices such as ventilators, the scope of medical textiles reaches every corner of the healthcare industry. As these products become increasingly vital in hospital and healthcare settings, manufacturers must navigate the complex landscape of global regulations and testing protocols to ensure safety and efficacy.

The Diverse Applications Of Medical Textiles

Medical textiles encompass a wide range of products designed for specific health-related uses. These can be broadly categorized into two types: disposable items, which are often utilized in hospital settings; and reusable items, such as surgical clothing and medical compression stockings.

Disposable products are typically designed for single use, promoting sanitation and reducing the risk of infection. Common examples include surgical drapes and sterile wound dressings. These items are used in operating rooms and during patient care procedures, where hygiene is paramount. The materials used in these textiles must meet stringent regulatory requirements, ensuring they are safe for immediate contact with patients.
In the other category, reusable items like surgical clothing and compression stockings are engineered for repeated use, requiring longevity and comfort as well as rigorous cleaning and sterilization processes. Surgical gowns, for instance, are designed to withstand repeated laundering while maintaining their protective qualities. Medical compression stockings are designed to provide consistent pres-sure, improving circulation in patients with various medical conditions. The durability and efficacy of these products are essential for their continued use in healthcare settings.

The application of textiles in medical settings extends beyond garments — they also play a critical role in filtration systems used in ventilators, blood purification devices and sanitation equipment. Such innovations highlight the transformative power of textiles in enhancing patient care and operational efficiency in healthcare facilities.

A cytotoxicity test plate undergoing testing for protein determination.

Regulatory Frameworks: European Union And The United States

One of the most significant challenges facing medical textile manufacturers centers around the varying regulatory frameworks in the United States and the European Union. While the outcomes are similar, the differing classifications for medical devices can complicate the introduction of products to different markets.

In the European Union, medical devices are classified under the Medical Device Regulation (MDR) 2017/745. This regulation categorizes devices into four classes — Class I, Class IIa, Class IIb, and Class III —based on the level of risk they pose to patients and operators.

  • Class I includes low-risk devices, which are non-invasive and may be sterile or reusable, such as wound dressings and thermometers.
  • Class IIa comprises medium-risk devices like catheters, surgical clamps and hearing aids.
  • Class IIb devices represent middle-to-high risks found in defibrillators and lasers.
  • Class III devices are considered high-risk and require extensive evaluation, including heart valves and joint implants.

For Class I devices, manufacturers can self-declare compliance using the CE marking process, allowing for a streamlined market entry. A CE marking, or “Conformite Europeenne” label, shows that a product meets safety, health and environmental standards set forth by the EU, and is a requirement for many products sold in the European Union.

Class II and higher necessitate verification by a notified body. However, all classes involve assessment and documentation, including the preparation of a Technical File.

The U.S. Food and Drug Administration (FDA) employs a similar risk-based classification system for medical devices. For Class I exempt devices, there is no requirement for independent audits before market release, allowing manufacturers to proceed with a self-declaration process. Most devices require manufacturers to submit a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed device by providing clinical data and other relevant information. Medical devices that are critical (typically Class III) and for which there are no comparator products require a more rigorous premarket approval process (PMA), demanding extensive clinical trial data to establish safety and efficacy.

These regulatory differences high-light the challenges and complexities manufacturers face in ensuring compliance and achieving market access for medical textiles across both regions.

“It can be tricky for medical device manufacturers seeking to participate in multiple markets,” said Ben Mead, managing director at Hohenstein Institute America, Ligonier, Ind. “Learning the differences early on can save time and money.”

Sterile surgical gowns after processing

Medical Textile Testing: A Critical Step

Biocompatibility is a key consideration in the development and marketing of medical textiles, as it determines how materials interact with the human body. Testing typically involves both in vitro — test-tube or culture dish — and in vivo —animal or human — studies, depending on the potential risk associated with the textile.

The ISO Standard 10993-1 out-lines the necessary evaluations for biocompatibility, focusing on factors such as the type of body contact and the duration of exposure.
Three biological endpoints are standard for biocompatibility assessments in nearly all medical devices:

  • Cytotoxicity: Evaluates the potential of a material to cause cell damage. The in vitro test uses living cells to detect damaging sub-stances (cytotoxins) from a sample, measuring the material hazard potential at the cellular level.
  • Irritation: Assesses whether a material induces a localized inflammatory response. This in vitro test utilizes 3D human skin models, which are composed of different cellular layers that mimic human epidermis. Measuring irritation specific to mucosal damage to the eyes, nose and lungs still requires testing on animals. In vitro alternatives are under development.
  • Sensitization: Determines whether exposure to a material can lead to allergic reactions. There are several types of testing for sensitization, as sequential events lead to a skin sensitizing effect in humans. Although the regulations still require animal testing, the international trend is toward the use and further development of meaningful animal-free methods. In the US, the FDA mandates specific regulations and standards related to bio-compatibility testing, that align with the EU’s required standard, ISO 10993. However, it does not fully recognize all ISO 10993 standards, and manufacturers must provide biocompatibility data with their regulatory submissions for FDA clearance or approval.

A notable challenge in biocompatibility testing arises from the textile supply chain. Manufacturers often lack detailed information about the materials used, complicating the assessment of compatibility. It is prudent to conduct biocompatibility evaluation early in the development process, allowing manufacturers to identify suitable materials before finalizing the product. Additional testing can be done for evaluation on the finished textile device — as well as the packaging for sterile items — to meet ISO 10993-18, the chemical characterization. Failure to adequately assess biocompatibility can lead to adverse patient outcomes and regulatory repercussions.

“Biocompatibility testing can be useful not only to meet regulations, but to protect consumers and reduce litigation risk,” Mead continued. “It is the safest way to prove compliance.”

Cutting a sample of a surgical textile before testing.

Cleanliness & Disinfection

Eliminating microbes and germs is critical to ensuring patient safety and preventing healthcare-associated infections. Both the European Union and the United States have established regulations and guidelines that address the cleanliness and disinfection of medical products, though their approaches and specifics vary.

The MDR emphasizes the importance of biocompatibility and microbial limits, necessitating compliance with standards such as EN ISO 13485, which outlines quality management systems for medical devices. Reprocessing and disinfection protocols are guided by the European Committee for Standardization (CEN) in standards like EN ISO 17664 and EN 14885. EN 13795, which specifies the requirements for the performance of surgical drapes and gowns in terms of cleanliness and microbial barrier properties, focuses on the product performance regarding its application. Likewise, DIN SPEC 13257 specifies requirements for single-use foot bandages and defines cor-responding test procedures.

The FDA regulates medical textiles under a similar framework, but the focus on cleanliness and disinfection is articulated through the Quality System Regulation (QSR) and specific guidance documents. The QSR mandates that manufacturers establish and maintain procedures for ensuring the cleanliness of products throughout their lifecycle, including stringent requirements for cleaning, disinfection and sterilization processes. The FDA also references standards from organizations like the Association for the Advancement of Medical Instrumentation (AAMI), which provides guidelines for the cleaning and disinfection of reusable medical devices.

Manufacturers are responsible for validating cleaning processes, and they must provide detailed information regarding the recommended cleaning and sterilization methods on product labels. Various types of testing, including measurement of biological residues left behind after washing and porousness of packaging, can help manufacturers verify claims and meet the requirements for both regions.

A Proactive Approach

As the demand for medical textiles continues to grow, manufacturers must remain vigilant and adaptable. Understanding the intricacies of the regulatory frameworks in the European Union and the United States is essential for successful market entry and product acceptance.

While it can seem overwhelming, a proactive approach to biocompatibility and microbial testing can help guide product development and innovation and enhance product safety and efficacy. Many medical device manufacturers partner with a testing laboratory already familiar with the labyrinth of global regulations, developing a plan specific to their needs and budget.

“Meeting global testing requirements can be daunting, but there are ways to optimize the process,” counsels Jaime Griggs, Brand Partnership director at Hohenstein. “Not every medical device or textile needs the same approach.”

The evolving landscape of medical technology continues to bring better, faster solutions for improving patient care. Manufacturers seeking to succeed in global markets must take a big-picture view that includes adhering to multiple standards — not only to ensure that medical textiles meet regulatory standards but also to fulfill their intended purpose: To keep people safe in a vulnerable setting.

Editor’s Note: Dr. Timo Hammer is the CEO of Life Science & Care at Hohenstein Laboratories, a Germany-based global textile testing laboratory that serves brands and manufacturers. He holds a Ph.D. from the University of Stuttgart-Hohenheim and advanced his knowledge of the medical device industry as Product manager and Medical Marketing manager at Germany-based Xenios AG.

2024 Quarterly Issue IV

FPM Buys Core Heytex Group Business

Germany-based Freudenberg Performance Materials (FPM) recently acquired the core business of the Germany-based Heytex Group including three production locations, as well as headquarters-related functions including sales and research and development. The assets, purchased from private equity investor Bencis Capital Partners, employ 400 associates and generated approximately $100 million euros in 2023.

“The acquisition of major parts belonging to the Heytex Group complements our business in coated technical textiles ideally: we are expanding our technology platform, our market exposure and R&D capabilities,” said Dr. Andreas Raps. “… At the same time, we are gaining access to new, attractive product segments and strengthening our capabilities in the field of coated technical textiles.”

In related news, Bondcote® engineered fabrics producer HeyTex USA Inc., Pulaski, Va., was purchased by XFS Global LLC, a service-disabled, veteran-owned fabric shelters and support technologies company. HeyTex USA has been renamed BondCote Performance Textiles LLC and will continue to operate as a separate company under the leadership of XFS Global.

2024 Quarterly Issue IV

Shalag U.S. Invests $16.6 Million In New Plant

Nonwovens manufacturer Shalag U.S. Inc., Oxford, N.C., and parent company Israel-based Shalag Industries Ltd. have announced plans to invest $16.6 million for a new production facility in South Hill, Va. The plant will create 52 jobs. Shalag specializes in through-air bonded and carded thermobonded nonwovens that are used in diapers, feminine hygiene products, air filtration and wipes products, among other applications.

“Shalag US Inc., and ownership are looking forward to adding a nonwovens line in South Hill, Virginia,” said CEO and general manager Rodney Clayton. “When our new line is complete and running at anticipated levels, it will increase our overall production capacity in the U.S. by 25 percent. Some factors in the purchase of the South Hill location are the strategic location, the company’s objective to reach more customers, and the ability to diversify its portfolio.”

2024 Quarterly Issue IV

INDA, EDANA Sign LOI To Explore Alliance

The Association of the Nonwoven Fabrics Industry (INDA), Cary, N.C., recently signed a letter of intent (LOI) with Brussels-based EDANA, the Voice of Nonwovens, to explore a strategic alliance and leverage the combined resources and expertise of the two organizations. The hope is the alliance will enhance scope and value to members, offer joint advocacy and representation, bring operational synergies, and enhance innovation and growth. INDA and EDANA are in a due diligence phase to evaluate the prospect.

“This potential alliance represents an opportunity to combine our strengths while openly engaging on the global issues affecting the industry,” said INDA President and CEO Tony Fragnito. “Better coordination will enhance our ability to serve the industry and our members while retaining our regionally focused support and representation.”

2024 Quarterly Issue IV

DILO Receives Award For MicroPunch Technology

DILO Group, Germany, was bestowed with a 2024 Innovation Award for its MicroPunch nonwoven needling development during the CINTE Techtextil China trade fair held recently in Shanghai. Winners are selected based on the “calibre and contribution potential of their products,” according to event organizer Messe Frankfurt (HK) Ltd.

Dilo’s new MicroPunch intensive needling technology allows a wide variety of lightweight nonwoven fabrics to be produced using only a mechanical process incorporating a needle board containing approximately 45,000 needles per meter per board. According to Dilo, the technology produces a nonwoven with properties similar to those of hydroentangled nonwovens using up to 75-percent less energy compared to other bonding technologies.

2024 Quarterly Issue IV

Trützschler, Texnology Supply Line To O.R.V.

Germany-based Trützschler Nonwovens and Italy-based Texnology S.r.l. are partnering to provide a complete needlepunching and thermobonding line to Peruzzo Productions Group company O.R.V. Manufacturing S.p.A., Italy. The production line will be used to manufacture filter media, among other products.

O.R.V. selected the machinery after customer trials conducted at Trützschler’s Nonwoven Customer Testing Center in Germany. “With Trützschler Nonwovens and Texnology, we are pleased to have found two partners with whom we can realize this major project based on the shared values of a family-owned business,” said O.R.V. Manufacturing CEO Gabriele Zanella.

“We strive to set new industry standards while implementing environmentally conscious solutions,” added Nicola Olivo, co-owner, Texnology. “Together, we leverage the unique strengths of each company and transform these values into high-quality products.”

2024 Quarterly Issue IV

Where Leather Goes To Dye

Modern Meadow’s BIO-VERA® material can be used to make items traditionally made using leather such as handbags and pouches.

Under intense scrutiny for its ecological footprint, the textile industry is developing ways to combine material science and existing manufacturing processes to pave the way for a more sustainable future.

By Dr. David Williamson

For nearly as long as humans have lived, they have dyed materials. Early craftsmen discovered that natural dyes found in the bodies of insects, mollusks and plants could be isolated and used to transform common textiles into culturally defining works of art. Tyrian purple, for example, was so difficult and costly to produce that few in the ancient world could afford it, and so the color purple became an iconic symbol of Roman royalty. To this day, the significance of color as a medium for personal and cultural expression has not faded. Whether it’s the deep indigo of Japanese textiles or the vibrant reds of ancient Peruvian fabrics, color tells stories — of status, geography, and tradition — that words often cannot.

What began as a niche art has since evolved into a multi-billion-dollar global industry. Modern dyeing practices, powered by synthetic chemicals and large-scale production facilities, allow manufacturers to dye materials at a rate and scale unimaginable to the dyers of antiquity. Yet, this growth has come at a significant environmental cost. The global textile industry is now under intense scrutiny for its ecological footprint. The apparel and footwear sectors alone are responsible for up to 8 percent of the world’s greenhouse gas (GHG) emissions and significant amounts of water used and effluent produced, creating stress on regions given how water is already a diminishing resource. The demand for color has become entangled with some of the most pressing sustain-ability challenges of our time.

Next-generation materials have emerged as a potential solution for the industry. These advanced materials, many created through biomanufacturing, are designed to both reduce the environmental cost of textile production and decrease contribution to landfills. Though there are many exciting applications for next-generation materials, one noteworthy opportunity lies in leather production, where there is opportunity to reduce its environmental footprint and not many alternate solutions exist.

The leather tanning process relies heavily on water- and chemical-intensive processes to achieve the richly dyed hides that are so often associated with luxury. Consumer demand for animal-free, responsibly produced leather has steadily risen, causing many to look to next-generation materials. However, leather is an ancient material that has been crafted by artisans for millennia. The material’s charm comes not from its resilience and water-resistant properties, but from its distinct look and feel.

A viable alternative to leather will thus have to be more than just ecologically friendly, it will have to inspire reverence among consumers, becoming a material that’s worth showing off. Next-generation materials have largely failed to achieve this, in part because the look of leather is so hard to replicate. But where others have failed, Modern Meadow is poised to succeed. Using a protein-based material known as Bio-Alloy® as a starting point, Modern Meadow has developed a leather-like material that not only matches many of leather’s tensile properties but allows tanners to tell their ancient and colorful stories on a new canvas.

Modern Meadow’s BIO-VERA® material matches many of leather’s tensile properties and allows tanners to tell their ancient and colorful stories on a new canvas.

Dyeing: A Dance Between Proteins and Pigments

To appreciate the significance of Bio-Alloy, it’s important to first understand how leather gets its color. The final color of any material is determined by many factors, including the quantity and arrangement of dye molecules that have bound the material, as well as the overall structure of the material.

Leather is rich in type 1 collagen proteins, which provide a unique canvas for dye binding. Collagen’s triple-helix structure, along with the various functional groups present on its amino acid backbone, create ample opportunities for interaction between dye and protein. If this interaction is strong, the dye molecules will be retained in the material and contribute to its final color.

The fastness of the material’s color depends on how the dye-protein interaction is formed, with the strongest occurring through covalent bonds. While leather can be dyed with most types of dye, it is typically done using acid dyes, which carry a net negative charge and are attracted to the positive charge of collagen fibers. This electrostatic force causes the dyes to penetrate far into the material creating an ionic bond and enabling a deep, rich color to be achieved.

This process is a delicate one that requires careful consideration from start to finish. How the hide is treated from the moment it’s received can affect the collagen’s structure and charge, as well as the hide’s permeability — all of which can affect the dye-collagen interaction and subsequent color of the hide. Similarly, contamination of tanning reagents by chelated metals in factory pipes can greatly affect dye properties. Therefore, the quality of the dyeing process — and by extension, the leather — depends on a meticulously designed tanning and post-tanning process.

Enter Next-Generation Materials

In recent years, the textile industry has sought alternative materials that can rival natural leather in performance while improving on its environmental impact. These next-generation materials, often made from bio-based or synthetic components, are designed to minimize animal, water and chemical usage during production. However, creating a truly viable leather alternative is no simple task.

One of the biggest challenges is replicating the structure and look of natural leather. The complex collagen matrix in animal hides doesn’t just dictate how dyes bind to the material; it also affects properties like breathability, water permeability and resilience. To be commercially successful, any alternative material must match or exceed these qualities while achieving the rich look of leather. Simply put, leather’s value is more than skin-deep — it’s a product of its structure.

Many leather-like materials are constructed using synthetic fibers, which possess chemical properties very different from those of collagen. To achieve the desired color, such materials would have to be treated with a significantly different dyeing process that may not be compatible with tannery infrastructure. The infrastructure for dyeing and processing leather has been optimized over centuries, with significant investments in equipment and processes. Introducing a material that requires bespoke manufacturing workflows can be prohibitively expensive for manufacturers, leading to slow market adoption. This has been a stumbling block for many synthetic leather alternatives, which, despite their promise, have failed to penetrate the market on a large scale.

BIO-VERA® offers a wider range of dye options for tanners. It can be dyed using reactive dyes, bringing an entirely new color palette to designers.

Modern Meadow’s Bio-Alloy: A Game-Changer

This is where Modern Meadow’s Bio-Alloy technology comes in.

Bio-Alloy has a molecular blend composed of biopolymers and plant-derived proteins. Modern Meadow has explicitly designed Bio-Alloy to contain a soy protein blend that is enriched with dye-binding sites, enabling the materials that contain Bio-Alloy to achieve deep and fast color properties.

To emulate leather, Bio-Alloy is combined with a nylon meshwork formed from upcycled rubber and consumer waste. The structure provided by the nylon, combined with the protein matrix of Bio-Alloy results in a remarkably hide-like material, known as BIO-VERA® that can be seamlessly dropped into leather tanning workflows at the dyeing stage.

BIO-VERA offers several advantages for tanneries looking to develop a leather alternative.

Firstly, the material is produced without livestock which greatly reduces the amount of GHG emissions associated with material production. Preliminary life cycle assessment studies show significant reductions in green-house gas emissions with approximately 7 kilograms of carbon dioxide equivalents per square meter of material. Additionally, BIO-VERA is drop-in ready, meaning no bespoke infrastructure is needed — it can simply integrate into existing tannery workflows. Notably, because BIO-VERA does not need to be delimed or tanned, it also requires at least 90 percent less water than natural hides.

As discussed, look is a critical feature of leather. BIO-VERA is capable of achieving a highly-leather-like look and feel thanks in large part to Bio-Alloy, whose protein composition is akin to that of leather’s. This means that BIO-VERA can be dyed using the same acid dyes that work on leather. However, BIO-VERA has also been designed to offer a wider range of dye options for tanners. For example, now it can also be dyed using reactive dyes, bringing an entirely new color palette to the leather industry or the bronze metallic sheen that comes with basic dyes.

Put another way, the availability of different binding chemistries in Bio-Alloy opens up a new level of design flexibility for tanners using BIO-VERA.

A Sustainable Future For Leather Dyeing

The leather industry is at a crossroads. On one hand, the demand for sustainable practices is undeniable. On the other, the challenge of developing a viable leather alternative has proven elusive — until now. With BIO-VERA and its underlying Bio-Alloy technology, Modern Meadow has developed a material that not only addresses the environmental concerns of traditional leather but also meets or exceeds its performance characteristics. By enabling manufacturers to use traditional dyeing techniques, while also opening the door to new possibilities, Bio-Alloy represents a breakthrough in the field of next-generation materials.

As the textile industry continues to evolve, innovations like Bio-Alloy are paving the way for a more sustainable future. By combining the best of both worlds — advanced material science and compatibility with existing manufacturing processes — Modern Meadow’s protein-based technology is set to make a lasting impact on the world of leather dyeing.

Editor’s Note: Dr. David Williamson is CEO of Nutley, N.J.-based sustainable materials company Modern Meadow.

2024 Quarterly Issue IV

Spirit Announces Purchase Agreement With Tex Tech Industries For Intended Sale Of Fiber Materials Inc.(FMI)

WICHITA, Kan. — November 18, 2024 — Spirit AeroSystems Holdings, Inc. has announced a purchase agreement to sell Fiber Materials, Inc (FMI) business based in Biddeford, Maine, and Woonsocket, R.I., to Tex-Tech Industries Inc. for $165,000,000 in cash, subject to customary adjustment.

FMI is an industry leader in high-temperature materials and reinforced composites, with a focus on Carbon/Carbon and related composites. FMI’s applications include thermal protection systems, re-entry vehicle nose tips, and rocket motor throats and nozzles. FMI’s products are installed on critical defense platforms as well as NASA programs such as Stardust, Mars Curiosity, Orion, and Mars 2020. The program employs approximately 400 engineers and production personnel.

“Tex-Tech is excited to add FMI’s unique array of high-performance products to our existing portfolio of offerings for the rapidly growing space and defense industry,” said Scott Burkhart, Tex-Tech CEO. “Our customers demand world-class solutions, and the integration of FMI bolsters our ability to meet those demands.”

Morgan Stanley & Co. LLC is serving as lead financial advisor to Spirit. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to Spirit. Lincoln International LLC is serving as financial advisor and Sheppard Mullin Richter & Hampton LLP is serving as legal advisor to Tex-Tech.

Posted: November 19, 2024

Source: Spirit AeroSystems Inc.

EVŌQ Nano Expands Antimicrobial Medical Device Platform, Demonstrates Efficacy Across Multiple Device Applications

SALT LAKE CITY — November 19, 2024 — EVŌQ Nano, a nanoscience company that engineers novel nanoparticles for the life, material, and textile science industries, today announced its antimicrobial medical device platform is demonstrating success in a range of applications aimed at combating healthcare-associated infections (HAIs) and improving the performance of implantable medical devices.

The company’s proprietary nanoparticle, EVQ-218, is successfully demonstrating antimicrobial efficacy when tested against multiple biofilm and proliferation assays in four unique application methods:

  1. Integrated during the synthesis process of raw materials
  2. Incorporated into polymer pellets for material production
  3. Applied to finished medical devices postproduction
  4. Added to surface modification coatings to enhance performance

“Existing antimicrobial solutions for medical devices have not met critical needs,” said Shaun Rothwell, EVŌQ Nano CEO. “By incorporating EVQ-218 into various phases of the manufacturing process, the next generation of medical devices has the potential to be equipped with antimicrobial protection to safeguard against infections and complications.”

HAIs affect over 1 million hospital patients annually,1 leading to significant morbidity, mortality, and approximately $10 billion in yearly healthcare costs.2 Extensive lab testing on catheters, luers, fittings, and coatings utilizing EVQ-218 shows strong antimicrobial protection with a >4-log reduction (99.99%) against leading pathogens implicated in HAIs. Importantly, the integration of EVQ-218 preserves the original materials’ mechanical and functional properties, ensuring finished products perform as engineered.3

Novel Mechanism of Action

EVQ-218 is the first stable, nonemissive, pure silver nanoparticle, opening opportunity for widespread therapeutic use.4 Unlike conventional nanosilvers that often trigger antimicrobial resistance (AMR) by rupturing bacterial cell walls, EVQ-218 employs a novel mechanism of action that kills bacteria from the inside.4

  • EVQ-218 stops bacterial growth by sequestering sulfur.
  • The sequestration of sulfur inhibits metabolic activity within the bacterial cell without compromising cell structures or lysing the cell wall. This avoids activation of bacterial mutations that contribute to antimicrobial resistance.
  • In contrast, nanoparticles with silver ions rupture cell walls, triggering activation of resistance pathways.

Characterized as a new form of silver by the journal of the American Chemical Society, ACS Omega, EVQ-218 is the first and only non-ionic silver nanoparticle with effective antimicrobial action devoid of cytotoxicity.4 The discovery and development of a non-ionic silver nanoparticle represents a pivotal innovation, unlocking the full therapeutic potential of silver without its detrimental trade-offs.

  1. Health Care-Associated Infections. Patient Safety Network. Published September 7, 2019. Updated October 2024. Accessed November 17, 2024.  https://psnet.ahrq.gov/primer/health-care-associated-infections.
  2. Zimlichman E, Henderson D, Tamir O, et al. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013;173(22):2039-2046. doi:10.1001/jamainternmed.2013.9763
  3. Data on file.
  4. Kennon BS, Niedermeyer WH. EVQ-218: Characterization of high-energy nanoparticles that measure up to NIST standards. ACS Omega. 2024;9(7):7891–7903. doi: 10.1021/acsomega.3c07745.

Posted: November 19, 2024

Source: EVOQ Nano

Pendleton Woolen Mills To Enter Swim Category In Licensing Deal With Li & Fung

HONG KONG — November 19, 2024 — Li & Fung Limited (“Li & Fung”), supply chain solutions partner for consumer brands and retailers, today announced a licensing and distribution agreement with Pendleton Woolen Mills, the global lifestyle brand headquartered in Portland, Oregon. Pendleton has signed with Li & Fung to launch the brand’s new line of swim and beachwear, featuring men’s and women’s styles sporting iconic Pendleton patterns and colors. The new line will be available to shop in Pendleton retail stores and catalogs, and at pendleton-usa.com starting in December 2024, and will also be available for wholesale distribution to retailers nationwide.

By drawing on Li & Fung’s global expertise and leadership in swimwear, Pendleton will offer customers a new category of apparel featuring sustainable materials and the brand’s trademark durability and classic American style. The collection will debut a range of items perfect for an active outdoor lifestyle: women’s reversible one-piece suits, strappy maxi dresses, and dolman sleeve kimonos and matching shorts, men’s trunks in 6” and 7” inseams, and unisex hooded rash guards. All styles will be available in multiple colorways, including classic Pendleton patterns such as Century Harding, Fire Legend, Highland Peak, Nehalem, and Wildland Heroes, among other designs. Sizes will range from XS-XXL, and items will be retailed at price points starting at $74.50.

The entry into swimwear adds to Pendleton’s portfolio of licensed products. Beloved by consumers for quality products including blankets, wool shirts, and outerwear, the launch of a swim and beachwear collection will expand Pendleton’s warm weather offerings. The collection is a fitting call-back to Pendleton’s popularity within California surf culture, dating back to The Pendletones, the original band name for the Beach Boys. Inspired by the surf uniform of the day — Pendleton shirts worn over tee shirts with khakis — the band would define surf music while wearing Pendleton plaid shirts on the covers of 45s and LPs throughout the early 1960s.

“We’re excited to partner with Li & Fung on our new swim and beachwear collection,” said Bob Christnacht, EVP of Sales and Marketing at Pendleton. “Li & Fung will help us expertly navigate the waters of this new category as we broaden our offering. Pendleton has a rich connection to surf culture, and we cannot wait to bring a new way of experiencing Pendleton products to the market.”

The partnership with Pendleton also marks the continued expansion of Li & Fung’s licensing division. Building on a decades-durable reputation as a leading private label and branded partner in swimwear, Li & Fung is now rapidly growing a robust portfolio of licensing partners, spanning national brands across varying price points and categories.

“As long-time fans of the brand, we’re honored to partner with Pendleton in pioneering the next chapter of its rich history,” said Mel Limoncelli, Senior Vice President and Divisional Head, Li & Fung Brands and Private Label. “At Li & Fung, we excel in weaving a brand’s DNA into market-leading collections, ensuring each category we develop is an authentic extension of our partners. This new collection will honor Pendleton’s heritage with sustainable styles, ageless fits, and the Pacific Northwest aesthetic that has defined the brand’s iconic legacy.”

Retailers interested in the new Pendleton swim line can contact PenSwimSales@lifung.com to learn more.

Posted: November 19, 2024

Source: Li & Fung

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