C. R. Bard, Inc.

Expanded PTFE was born out of frustration 57 years ago, and modern medical devices continue to benefit from that serendipitous moment of innovation. During a series of failed experiments in 1969, Robert W. Gore became frustrated and gave a hard yank to a heated rod of the polymer polytetrafluoroethylene (PTFE). The result, reports the Science History Institute (SHI), "revolutionized a range of fields from clothing to defense to medicine and would make his company a household name." Since the mid 1970s, ePTFE's healthcare applications have grown to include surgical patches, medical sutures, wound-care materials, soft-tissue reconstruction, hernia repair meshes, guided tissue and bone reconstruction, and heart valve reconstruction. Image courtesy of Kintek Bob Gore was working at the time as technical and research leader at W.L. Gore & Associates, the company founded in 1957 by his father, Wilbert Lee "Bill" Gore, who is in the Plastics Hall of Fame. (Roy Plunkett, the DuPont chemist who discovered PTFE, also known as Teflon, in 1938, is also a Plastics Hall of Famer.) In the lab that night, the younger Gore, a chemical engineer, was researching a new process for stretching heated PTFE rods into pipe-thread tape, but his efforts were not bearing fruit. Frustrated, he yanked hard on one of the rods with unexpected results. His pressure caused the solid PTFE to stretch by about 800%, transforming the dense polymer into a sponge-like, highly porous structure that was about 70% air. Dubbed ePTFE, the newly formed material retained the moisture resistance, chemical stability, and durability of standard PTFE while gaining breathability. The Gore-Tex membrane consists of millions of microscopic pores, which are 20,000 times smaller than a water droplet and 700 times the size of a water vapor molecule. This size difference allows water vapor (sweat) to escape through the membrane while preventing external moisture from penetrating. Thus was born Gore-Tex fabric, which revolutionized the outdoor apparel industry. W.L. Gore & Associates patented its technology and began discovering other valuable uses for its novel material, including medical implants, electrical cables, and industrial filters. Expanded PTFE textile fibers have also found use in space exploration and in laminated fabrics used for outdoor activities, emergency response, and defense. Finding use in healthcare applications In the mid-1970s, ePTFE was first used commercially in a key medical application as a vascular graft material used to create synthetic blood vessel replacements and bypass grafts. It became a durable, biocompatible alternative for arterial bypass surgery — particularly for larger-diameter vessels and later refined for smaller ones. Since then, ePTFE's healthcare applications have only grown to include surgical patches, medical sutures, wound-care materials, soft-tissue reconstruction, hernia repair meshes, guided tissue and bone reconstruction, and heart valve reconstruction. "The success of ePTFE in medical applications stems from its distinctive microstructure," explains Taanisha Mukhopadhyay, a chemical and metallurgy engineer with Balmer Lawrie and Co. Ltd. in Kolkata, India. "Through a controlled expansion process, PTFE develops an interconnected network of nodes and fibrils, creating a highly porous architecture. This structure allows selective tissue integration while maintaining mechanical strength and resistance to biological degradation. "Unlike many conventional polymers, ePTFE exhibits remarkable resistance to chemical attack, moisture absorption, and microbial colonization. Its biocompatibility minimizes inflammatory responses and reduces the risk of adverse tissue reactions, making it particularly suitable for long-term implantation within the human body. "These characteristics," she says, "have positioned ePTFE as a preferred material for medical device manufacturers seeking reliable solutions for challenging clinical environments." She cites the material's extensive use in cardiovascular applications while also noting how ePTFE has gained acceptance in reconstructive and general surgery. Surgeons frequently employ ePTFE membranes and implants for soft tissue repair, hernia treatment, facial reconstruction, and craniofacial procedures. "The material's microporous structure supports controlled tissue integration while minimizing excessive scar formation," notes Mukhopadhyay. "This balance between stability and biological compatibility makes ePTFE particularly valuable in procedures requiring long-term implant performance." In reconstructive medicine, ePTFE implants have enabled surgeons to restore anatomical structures with improved functional and aesthetic outcomes, benefiting thousands of patients each year. The material also enhances wound care and tissue regeneration and is increasingly being used in implantable medical devices. New uses for new ePTFE composites "Researchers," she adds, "are exploring novel ePTFE-based composites that combine the material's inherent durability with drug-delivery capabilities and bioactive surface modifications. Such innovations may enable future implants to actively promote healing, prevent infection, and improve long-term patient outcomes." Tanner Hargens, vice president of business development at Medical Murray in Brentwood, TN, explains that for most medical device applications, ePTFE is commonly supplied as sheets, tubes, tape, or suture. How the ePTFE is wrapped, including wrap angle, overlap, and the number of layers, has a big impact on radial strength, flexibility, sealing, and tissue response. Hargens explained how a series of key prosthetic vascular patents, invented by Dr. David Goldfarb and held by C.R. Bard, expired in August 2019. This involved the covering of nitinol metal stents with ePTFE, many of which were used for peripheral and aortic stent grafts. The expiration of patents often leads to a spike in innovation around that technology. Because ePTFE can provide an effective implant covering with very little wall thickness, device manufacturers can often reduce the profile of the catheter-based delivery system. And, notes Hargens, for any implant deployed through a catheter, the smaller the catheter, the more patients you can treat. Material and processing knowledge is vital Even given all of its obvious advantages, ePTFE still has its challenges. Hargens acknowledges that polyester, especially in knit or woven form, may be better at promoting tissue growth than ePTFE. And polyester also may offer more suture pull-out strength if that's an important factor. Expanded PTFE is also not the easiest material to bond to, Hargens said, so it's vital to work with a team that has processing and bonding expertise. But he is also seeing more companies now offering that knowledge. "That's one reason I think you're going to continue to see more adoption" of ePTFE. Mukhopadhyay, meanwhile, concurs, noting that "long-term implant performance depends on careful device design, manufacturing precision, and clinical application. Researchers continue to investigate methods for enhancing tissue integration, reducing thrombosis risk, and improving implant longevity." Further, she said, emerging technologies such as nanostructured coatings, antimicrobial surface treatments, and tissue-engineered scaffolds are expected to further expand the capabilities of ePTFE-based medical products. Additionally, advances in additive manufacturing and precision fabrication may allow customized ePTFE implants tailored to individual patient anatomy. "As medical science moves toward increasingly patient-centered and technologically sophisticated treatments," Mukhopadhyay added, "ePTFE is poised to remain at the forefront of biomaterials research and development. By enabling safer implants, more effective therapies, and improved healing outcomes, this remarkable material continues to transform healthcare and enhance the lives of patients around the globe."

COLLEGE PARK, Md., Sept. 25, 2024 /PRNewswire/ -- Medcura, Inc., a leader in innovative hemostasis solutions that deploy patented biopolymer technologies to control surgical bleeding, is pleased to announce it has received a 2024/2025 Best Technology in Spine Award for LifeGel™ Absorbable Hemostatic Gel. Continue Reading 2024 Orthopedics This Week: Spine technology Awards Medcura will formally accept the award at the North American Spine Society (NASS) meeting in Chicago this week. Presented by Orthopedics This Week, the Best Technology in Spine Award recognizes "inventors, engineers and others who chase the dream of advancing spine surgery — and pay for that dream with marathon engineering sessions and more than a few sleepless nights." The panel that selected LifeGel to receive the award includes outstanding spine surgeons and neurosurgeons such as: Juan Uribe, MD; Kris Radcliff, MD; Isaac Moss, MDCM, MASc, FRCSC; Stephen Hochschuler, MD; Michael Wang, MD, FACS; and Peter Derman, MD, MBA. "The spine surgical bleeding market is ripe for disruption in this $1.1 billion segment of the $2.8 billion market for surgical hemostat agents," said Jim Buck, Chief Executive Officer at Medcura. "Spine surgery needs a transformational hemostatic technology and LifeGel is the first and only surgical hemostatic agent to receive an FDA Breakthrough Device Designation." Matthew Dowling, PhD invented LifeGel, founded Medcura, and now serves as the company's Chief Scientific Officer and Director. Dr. Dowling bioengineered LifeGel to meet the challenges of hemostasis during spinal surgery. LifeGel — a clear, ready-to-use, fully hydrated, flowable hemostatic gel containing a proprietary combination of hydrophobically modified chitosan, cross-linked gelatin granules, inert copolymers and water — achieves hemostasis mechanically by coating the bleeding site via mucoadhesion. Management of intraoperative bleeding during spinal surgery is critically important to preserve the operative field of view and reduce complications such as transfusions and hematomas, which can lead to increased time, cost, and patient risk. Products currently used for intraoperative bleeding during spinal surgery have been associated with deleterious side effects, and innovations are warranted. Current flowable hemostatic agents routinely used in spinal surgery are known to swell. When used in confined anatomical spaces, they can potentially lead to post-operative neurologic deficits or even paralysis. Medcura's LifeGel mitigates these risks because it achieves hemostasis without swelling. Compared with approved flowable hemostatic agents, LifeGel offers additional benefits, including being highly cost-effective, immediately ready-to-use thereby reducing costly wastage, and complete with antimicrobial properties of its base, chemically inert polymer. "Medcura is on a new wave of true innovation impacting hemostasis in a broad array of areas in medicine," said Dr. Dowling. "I am very proud of the Medcura team, which continues to work towards the advancement of biomaterials science to meaningfully improve how surgeons manage human bleeding in a variety of high-value surgical scenarios." About Medcura Medcura, Inc. is a commercial-stage medical device company developing versatile hemostatic products serving large surgical, medical, and consumer market opportunities. The Company's proprietary technology platform combines the use of safe, inert ingredients with patented chemistries, all aimed at introducing disruptively lower cost products capable of safely and effectively controlling bleeding across a broad spectrum of clinical applications. Medcura has received FDA Breakthrough Device Designations for LifeGel™, which controls surgical bleeding for spine surgeries, and LifeFoam™, a hemostatic agent for traumatic wounds. Learn more about Medcura's growing product line at . Media Contact Shannon Severino [email protected] (412) 608-2393 References LifeGel™ and its application tips are currently in development. All intended uses and/or indications for use for this medical device and its application tips have not been cleared or approved by the FDA. Arista ® AH Absorbable Hemostatic Particles, Instructions for Use,; Warnings. Davol Inc. Subsidiary of C. R. Bard, Inc., Warwick, RI; 2015, Arista-AH Gelfoam ® absorbable gelatin compressed sponge, USP, Instructions for Use; Warnings. Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022 Gelfoam ® absorbable gelatin powder from absorbable gelatin sponge, USP, Instructions for Use; Warnings. Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022 PerClot ® Polysaccharide Hemostatic System, Instructions for Use, Warnings. Starch Medical Inc., San Jose, CA, Uploaded 2019, PerClot-IFU Surgicel ® Powder, Absorbable Hemostatic Powder, Instructions for Use, Contraindications. Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2017 Surgicel ® SNoW Absorbable Hemostatic, Instructions for Use, Contraindications; Adverse Events. Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2013 SurgifloTM Hemostatic Matrix Kit, Essential Product Information, Warnings; Precautions. Ethicon Johnson and Johnson Surgical Technologies; 2022, SURGIFLO-Hemostatic-Matrix-Brochure SurgicelTM Original/ Surgicel NU-KNIT/ Surgicel Fibrillar Absorbable Hemostats, Instructions for Use, Contraindications; Adverse Events. Ethicon, Neuchâtel, Switzerland; 06/2013 SOURCE Medcura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WOONSOCKET, R.I., Jan. 12, 2023 /PRNewswire/ -- CVS Health® (NYSE: CVS) today announced that Sam Khichi will join the company as Executive Vice President, Chief Policy Officer and General Counsel, effective February 13. He will lead the legal, compliance, and government affairs teams who support CVS Health's strategy to make health care more accessible and affordable, leading to better health outcomes for all. "Sam brings diversified experience to many key issues for CVS Health, including geopolitical matters, data privacy, and compliance," said CVS Health President and CEO Karen S. Lynch. "He has an exceptional track record of managing complex health care business and legal strategies." Khichi will become a member of the company's executive leadership team and report to Lynch. Prior to joining CVS Health, he served at Becton Dickinson as Executive Vice President, Corporate Development, Public Policy, Regulatory Affairs and General Counsel. He joined Becton Dickinson through the acquisition of C. R. Bard where he served as Senior Vice President, General Counsel and Secretary, and previously was the Chief Administrative Officer, Senior Vice President and General Counsel at Catalent Pharma Solutions. Khichi has led significant transformations at complex and large-scale health care organizations. "This is an exciting time to join CVS Health and be part of a team whose strategy is redefining how health care is delivered in this country," Khichi said. "I have long admired CVS Health for its innovation and leadership in advancing the consumer health care experience. Achieving transformation of this scale requires changing the way information is shared and technology utilized by consumers, employers, and providers and CVS Health is uniquely positioned to lead this change." Khichi succeeds Tom Moriarty, who plans to retire in April. Moriarty has played a critical role in many significant CVS Health moments, from the company's industry-leading role during the COVID-19 pandemic to helping lead transformative health care acquisitions. About CVS Health CVS Health® is the leading health solutions company, delivering care like no one else can. We reach more people and improve the health of communities across America through our local presence, digital channels and over 300,000 dedicated colleagues – including more than 40,000 physicians, pharmacists, nurses and nurse practitioners. Wherever and whenever people need us, we help them with their health – whether that's managing chronic diseases, staying compliant with their medications or accessing affordable health and wellness services in the most convenient ways. We help people navigate the health care system – and their personal health care – by improving access, lowering costs and being a trusted partner for every meaningful moment of health. And we do it all with heart, each and every day. Follow @CVSHealth on social media. Media contact T.J. Crawford 212-457-0583 [email protected] Investor contact Larry McGrath 800-201-0938 [email protected] SOURCE CVS Health