Hernia

SAN LUIS OBISPO, Calif., Oct. 15, 2024 /PRNewswire/ -- FzioMed, Inc. ("FzioMed" or the "Company"), a recognized global leader in post-surgical adhesion prevention, today announced it will attend the European Society of Gynecological Endoscopy (ESGE) 33rd annual congress October 27-30 in Marseille, France. The Company will showcase its innovative Oxiplex/IU® and Oxiplex/AP® adhesion barrier gels designed to reduce the formation of adhesions following intrauterine and abdominal/pelvic related surgical procedures. Since its foundation, ESGE has aimed to encourage the exchange of clinical experience, scientific thought and investigation among gynecological practitioners in minimally invasive techniques. FzioMed's synthetic adhesion barrier products, based on the Company's patented dual-polymer technology and more than 20 years of clinical use, provide a temporary physical barrier between tissues helping prevent the formation of adhesions, reducing the incidence of postoperative pain and other complications. For intrauterine and abdominal/pelvic related surgical procedures, Oxiplex/IU and Oxiplex/AP gels and their unique applicators offer ease of use combined with proven safety and clinical efficacy. Patrick Bellelis, MD, PhD, endometriosis specialist and minimally invasive gynecologic surgeon at the University of Sao Paolo, Brazil, will be presenting two video lectures on Tuesday, October 29 starting at 15:00 CET (UTC+01:00) titled: "Challenging Case of Deep Endometriosis with Significant Involvement of the Rectovaginal Septum" and "Postoperative Endometriosis Second Look after Application of Anti-Adhesion Viscoelastic Gel." Prof. Bellelis will also be available at FzioMed's exhibitor booth (Booth #A4) periodically throughout the congress to speak about his clinical experience with the Oxiplex family of adhesion barrier gels. "Even with the best surgical technique, postoperative adhesions can form following abdominal, pelvic, and gynecological procedures – from hernia and bariatric procedures to hysterectomy, endometriosis, and other tubal and ovarian surgeries," stated Stephanie Cortese, Senior Vice President of Science and Technology. "These adhesions can cause a variety of complications including chronic pelvic pain, small bowel obstructions, infertility, and scarring that can complicate future surgery." FzioMed's Adhesion Barrier Gels are provided sterile and ready to use with specialized applicators for hysteroscopic or laparoscopic use that allow for ease of application while the clear gel formula maintains local visibility. No special storage, refrigeration, mixing, or handling is required. Oxiplex/IU and Oxiplex/AP gels do not migrate after application as their unique viscosity is flowable yet remains where applied. FzioMed's portfolio of adhesion barrier products have been available since 2002 and have been used in nearly 1 million procedures worldwide. About FzioMed, Inc. Pioneering biomaterials since 1996, FzioMed is a vertically integrated medical device company focused exclusively on preserving surgical excellence in spine, orthopedic, abdominal/pelvic and gynecological procedures. FzioMed develops, manufactures, and commercializes surgical biomaterials used by clinicians as adhesion barriers to improve surgical outcomes and is a recognized global leader in post-surgical adhesion prevention. FzioMed's synthetic, absorbable gel formulations are based on the Company's patented dual-polymer technology platform that provide a temporary, mechanical separation of tissues during the body's natural healing process – reducing adhesion formation. FzioMed's portfolio of adhesion barrier products are marketed in more than 70 countries under various brand names and have been used clinically since 2002 in nearly 1 million procedures worldwide. Visit fziomed.com to learn more about FzioMed and our industry-leading products. SOURCE FzioMed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Anovo robotic surgical platform is the world's first single port robotics platform approved for ventral hernia repairs in the US TEL AVIV, Israel and FORT LAUDERDALE, Fla., Oct. 15, 2024 /PRNewswire/ -- Momentis Surgical Ltd., a medical device company dedicated to transforming robot-assisted surgery with its proprietary technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) Clearance to its Anovo™ robotic surgical platform for use in single site, abdominal access ventral hernia repair. The FDA clearance announced today complements the system's existing approvals in natural orifice laparoscopic-assisted transvaginal benign gynecology surgical procedures. Continue Reading Anovo's flexible robotic arms Dvir Cohen, CEO and Co-Founder of Momentis Surgical, said, "Leveraging the clinical achievements of our Anovo platform in gynecology and the connections we established with leading medical centers worldwide, we have seized the opportunity to expand to general surgery for our groundbreaking technology. Due to its size and mobility, our system can be used both in hospitals and outpatient settings, where most hernia surgeries can be performed, but are not currently, because of the limitations of existing robotic platforms. Anovo's unique features allow surgeons and patients access to robotic procedures outside the hospital by offering robotic technology to ambulatory surgical centers." Anovo is the world's first single port robotics platform approved by the FDA to perform ventral hernia procedures. Performing procedures through a single port with multiple flexible instruments has the potential to result in less invasive and less traumatic outcomes for the tissue at the point of entry, enabled by the small portable robotic system. The Anovo system is the first and only FDA-authorized surgical robotic platform that features miniature humanoid-shaped robotic arms that provide human level dexterity, multi-planar flexibility and 360 degrees of articulation. The biomimetic instruments are designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow and wrist joints. Multiple instruments can be introduced to the body through a single portal and the 360-degree articulation offers obstacle avoidance as well as optimal access and working angles. "This FDA authorization represents a significant advancement in the world of robotic surgery by making Anovo a versatile robotics platform for multi-specialty use," said Professor Tim Tollens, MD, Head of Surgery at Imelda Hospital in Bonheiden, Belgium, who performed a series of ventral hernia procedures using the Anovo system. "I have experience with other robotic systems and the Anovo platform is not only potentially better for my patients by reducing the number of incisions, but also incredibly easy for me and my OR staff to use. The average docking time for the robot was under 2 minutes, which is an order of magnitude faster than other robotic systems." Frederic H. Moll, M.D., Momentis board member and founder of Intuitive Surgical and Auris Health, added, "I have spent my career developing groundbreaking surgical robotic technology and I believe the future of soft tissue robotics is flexible instruments. I am very impressed with what the Momentis team has achieved to date. As the company has now created a true robotics platform, this technology is clearly differentiating and will have an immediate impact on the way general surgery is performed as it has in gynecology." "We are thrilled with adding a very high-volume surgical procedure to the approved indications for Anovo," said Maurice R Ferré, MD, Chairman of Momentis Surgical, Chairman and CEO of Insightec and Co-Founder and former CEO of MAKO Surgical. "This is only the beginning of the impact this single port, flexible robotics platform will have on robotic surgery." About Momentis Surgical™ Momentis Surgical is dedicated to transforming the field of robotic surgery by developing innovative small footprint, cost-effective, robotic-assisted technologies and techniques for a growing number of clinical applications. Our goal is to empower surgeons to perform minimally invasive, complex procedures, enabling better patient outcomes, lowering cost of care, and opening access to surgical robotics to more surgeons, patients, hospitals, and surgery centers across the globe. For more information, visit: . Media Contact: Tsipi Haitovsky Global Media Liaison +972-525-989892 [email protected] Photo - SOURCE Momentis Surgical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

No admission of liability or wrongdoing; settlement structured to eliminate uncertainty for all stakeholders related to settled cases. Settlement amount within current product litigation reserve and will be paid out over a multi-year period. Settlement will not change BD's cash flow goals or capital allocation strategy. FRANKLIN LAKES, N.J., Oct. 2, 2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has reached an agreement to resolve the vast majority of its existing hernia litigation. Terms of the settlement agreement, which are confidential, include cases in both the Rhode Island consolidated litigation and the federal multidistrict litigation in Ohio. The aggregate amount payable pursuant to this settlement is within the company's current product litigation reserve for this matter and will be paid out over a multi-year period. As a result, the settlement amount is already recorded as a liability within BD's consolidated balance sheet and the agreement will not result in an incremental charge to the company's consolidated income statement. BD believes this agreement is in the best interest of all parties and is structured to eliminate uncertainty for all stakeholders related to the settled cases. The hernia mass tort litigation represents a large majority of BD's total product litigation reserve. The multi-year payment structure was contemplated as part of the company's cash flow planning process and was included in its previously communicated free cash flow goals and capital allocation strategy. The settlement does not include any admission of liability or wrongdoing, and BD continues to dispute the allegations in these matters. The company will continue to vigorously defend itself in cases not resolved through this agreement. Patient safety and product quality are top priorities at BD. All implantable medical devices carry inherent risks and provide significant clinical benefits. BD is confident in both the design of its products and fulfilling its obligation to provide information about both the risks and the benefits of its products, enabling physicians, in consultation with their patients, to determine whether those benefits outweigh the potential risks in a particular instance. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at , X (formerly Twitter) @BDandCo or Instagram @becton_dickinson. Forward Looking Statements This press release contains forward-looking statements (as defined under Federal securities laws) regarding the hernia mass tort litigation settlement, including statements regarding the potential impact of the settlement on the existing litigation relating to the products that are the subject of the settlement. These statements may be identified by words such as "believes", "will" and other similar expressions. Forward-looking statements are based on management's current expectations, estimates, assumptions, and projections, and are subject to significant uncertainties and other factors, many of which are beyond BD's control. Factors that could cause actual results to differ materially include, but are not limited to, whether the anticipated level of participation by plaintiffs in the settlement will be achieved or will fall below the level that would permit BD to terminate the settlement, the number of claims made by plaintiffs that decline to participate in the settlement, whether the settlement is appealed or challenged, the filing of future claims by plaintiffs that are not covered by the settlement, and the impact or outcome of any pending or future litigation relating to the products that are the subject of the settlement. BD is subject to additional risks and uncertainties as described in BD's latest Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. BD does not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations. 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