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CENTER VALLEY, Pa., March 19, 2024 /PRNewswire/ -- Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today it applauds the new Obesity Bill of Rights . Continue Reading Olympus applauds the newly launched Obesity Bill of Rights and will support the initiative by working to build awareness and talking to its healthcare customers about this important campaign to counter bias and ageism in obesity care. Olympus will support the initiative by working to build awareness and talking to its healthcare customers about this important campaign to counter bias and ageism in obesity care. The program, spearheaded in January 2024 in the U.S. by the National Consumers League (NCL), a nonprofit consumer advocacy group, in conjunction with the National Council on Aging (NCOA), establishes a set of rights to "assure screening, diagnosis, counseling and effective treatment based on medical treatment guidelines." This ongoing effort to gather support is expected to culminate in a fully implemented Bill of Rights by Dec. 31, 2029. The NCL and NCOA are working at the grassroots, employer, state and federal levels on this effort to ensure equal access to care for all obesity patients. NCL and NCOA worked with health leaders and obesity specialists to draft these Bill of Rights tenets that are intended to change the narrative, such that the healthcare industry more effectively sees obesity as a treatable chronic disease that can be treated with the same "respect, attention and medical care" as other chronic conditions. Statistics regarding obesity are staggering: 108M people in the U.S. are considered obese, only 10% of whom get help from medical professionals and only 2% of whom are treated with new medications. More than 230 conditions are worsened by obesity. Obesity is connected to $1.73 trillion in annual medical costs in the U.S. 400K premature deaths annually are linked to obesity.1 "Olympus provides equipment to the surgical community that helps in the treatment of obesity, and statistics show that not enough people have access to this type of treatment," said Paul Skodny, Executive Director for Health Economics and Market Access at Olympus Corporation. "It is our hope that awareness of treatment options and equitable access and insurance coverage will help address the detrimental health impacts of obesity." Bariatric Surgery as a Solution for Weight Loss Because of recent pharmaceuticals' entry into the market, such as semaglutide-based medications, obesity treatment has been receiving more attention. Surgical treatment which can complement medical management, has a lengthy track record, having been available to patients for decades with favorable long-term outcomes.2 Studies show patients typically lose the most weight one to two years after bariatric surgery and see substantial improvements in obesity-related conditions. Despite the growing number of obesity-related health problems, fewer than 2% of those eligible for bariatric surgery elect to have it.3 Given these statistics, Olympus, maker of technologies for performing minimally invasive bariatric procedures, sought to understand the awareness level and concerns of eligible patients in a survey conducted in 20194: Marginal Awareness around Benefits: A little more than 50% of respondents demonstrated only marginal awareness that bariatric surgery causes hormonal changes that improve weight loss by maintaining or enhancing energy expenditure.5 Worry about Gaining Weight Back: 20% of respondents were avoiding bariatric surgery because of concerns about surgery complications and gaining the weight back. Awareness around Insurance Opportunities: 56% of respondents were aware that insurance covers bariatric surgery in most qualified cases.6 Surgical benefits are real and should be known to more patients. Studies show that: Patients may lose as much as 60% of excess weight six months after surgery, and 77% of excess weight as early as 12 months after surgery. On average, five years after surgery, patients maintain 50% of their excess weight loss.1 The majority of bariatric surgery patients with diabetes, dyslipidemia, hypertension, and obstructive sleep apnea experience remission of these obesity-related diseases.1 Statistically, the risk of death during weight-loss surgery procedures is less than 1 percent. All abdominal operations carry the risks of bleeding, infection in the incision, thrombophlebitis of legs (blood clots), lung problems (pneumonia, pulmonary embolisms), strokes or heart attacks, anesthetic complications and blockage or obstruction of the intestine. These risks are greater in patients with severe obesity.7 To learn more about Olympus' state-of-the-art technologies for performing minimally invasive bariatric surgeries, visit the Bariatrics product page. About Olympus At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals striving to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit medical.olympusamerica.com. _______________________________ 1 Americans now have an Obesity Bill of Rights. NCLnet.org. . Published January 31, 2024. Accessed February 29, 2024. 2 Story of Obesity Surgery. asmbs.org. . Published 2023. Accessed February 29, 2024. 3 . February 27, 2020. Accessed February 29, 2024. 4 The Olympus-commissioned online survey was conducted mid-December 2019. 5 Public Education Committee. Benefits of Bariatric Surgery: ASMBS. American Society for Metabolic and Bariatric Surgery. . Accessed February 29, 2024. 6 Manning S. How to get your health insurer to pay for your weight-loss surgery. Insure.com. . Published September 24, 2020. Accessed February 29, 2024. 7 Available Procedures. Yale New Haven Health. . Accessed March 15, 2024. SOURCE Olympus Corporation of the Americas

Company also elevates Jeff O’Donnell, Sr. to executive chairman and moves polymer processing in-house to new local manufacturing facility as it reaches critical inflection point PITTSBURGH--(BUSINESS WIRE)-- PECA Labs, a medical device company reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices designed to fit, grow, and last, has received an additional CE Mark for its exGraft family of vascular grafts, expanding its on-label use. exGraft vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased or injured vessels, and with the new clearance, exGraft now includes instructions for post-operative expansion up to 140 percent with the use of oversized balloon catheters. The exGraft is a synthetic vascular graft built on PECA Labs’ proprietary polymer processing platform that can be permanently expanded. Post-operative expansion is designed to allow for increasing graft diameter, which may enable the graft to match growth in pediatric populations or help to avoid restenosis (narrowing) in adults. Pre-operatively, the controlled dilation may help address unique anatomies. The exGraft’s capability to be balloon-expanded in the cath lab provides cardiac care teams greater flexibility in treating patients. To help navigate the unique anatomy of each patient, exGraft also includes radiopaque markers, which help ensure accurate identification of the graft in the post-implantation period. The markers are useful during procedures in the cath lab, as well as for following patients using X-rays. The exGraft received initial CE Mark clearance and 510(k) clearance from the U.S. Food & Drug Administration (FDA) in 2019 for use as a vascular prosthesis and has gained traction within pediatrics, being employed in more than 20 U.S. pediatric hospital centers. It has been implanted in more than 2,000 pediatric patients to date. “This CE Mark clearance, which results in an expanded label within the exGraft family of vascular grafts, is extremely significant. Not only does it validate the potential of our controllably-expandable polymer conduit, but it also means the world to patients seeking options for a number of cardiovascular diseases and conditions,” said Doug Bernstein, CEO, PECA Labs. “Pre-operatively, exGraft expansion is designed to allow for customizable geometries to address complex anatomies, and improve outcomes of some procedures. Post-operatively, expansion via a minimally-invasive procedure is designed to provide growth potential and reduce the risk of restenosis, which is key to reducing the need for revision surgeries.” As it ramps up commercial operations, PECA opened a new facility for polymeric processing, moving critical manufacturing in-house. With the opening of this site, PECA now has brought a significant portion of the product lifecycle in-house. Located near PECA’s headquarters in the Bloomfield neighborhood of Pittsburgh and in close proximity to University of Pittsburgh Medical Center (UPCMC) Children’s Hospital, the new site will allow PECA greater control of its manufacturing processes and the ability to scale quickly as it grows. As the company reaches a key inflection point, PECA Labs also named Jeffrey O’Donnell, Sr. as executive chairman. Elevating Mr. O’Donnell to the role of executive chairman will help to drive the company’s strategy as it develops and commercializes cardiovascular implants based on its novel tunable polymeric material platform. Mr. O’Donnell brings to PECA Labs more than 25 years of board and chief executive experience at emerging medical device companies. He currently serves as managing director for medtech accelerator Runway Healthcare and as managing partner at Lucius Partners. Mr. O’Donnell founded and served as CEO for Trice Medical, and before that Embrella Cardiovascular, which was acquired by Edwards Lifesciences (NASDAQ: EW). He served as president and CEO at both PhotoMedix and Cardiovascular Dynamics, taking the latter public and purchasing Radiance Medical Systems and Endologix (NASDAQ: ELGX). In 2005, Mr. O’Donnell was named LifeSciences CEO of the Year by Price Waterhouse Coopers. In 2011, Jeff was named the Greater Philadelphia Emerging Entrepreneur of The Year by Ernst & Young. He is also currently the Chairman of the Board of Directors for AerWave Medical and Waypoint Medical. He previously served on the AdvaMed Accel Board of Directors and as an observer on the Membership, Ethics and Technology and Regulatory committees of the AdvaMed Board. Previously, Jeff served as Chairman of the Board for Strata Skin Sciences (NASDAQ: SSKN), as well as a Director on the Board at Cardiac Science and Endologix. “This is an exciting time for PECA Labs, with its important work about to be realized on a much larger scale,” said Mr. O’Donnell. “The company shows great promise, with innovative technologies that I believe will be a game-changer in the cardiovascular space, providing a great benefit to patients, surgeons and interventionalists alike.” About PECA Labs PECA Labs is reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices that are designed to fit, grow and last to help patients avoid repeat surgeries and reduce morbidity and mortality. PECA’s proprietary technologies, a controllably-expandable graft and low-thrombosis polymeric membrane, consist of a proprietary tunable polymer material platform that represents a new approach in engineering synthetic materials for greater durability and customization than currently available cardiovascular implants. The company’s grafts and conduits are designed to lead to a longer lifespan compared to currently available products, due to resistance to thrombosis, calcification and immune response, and by providing growth potential, customization, and noninvasive visualization. For more information visit . View source version on businesswire.com: Contacts Source: PECA Labs View this news release online at:

Pictured: FDA signage at its headquarters in Maryland/iStock, hapabapa The FDA on Monday approved Orchard Therapeutics’ autologous gene therapy atidarsagene autotemcel, which will now be marketed as Lenmeldy, for the treatment of metachromatic leukodystrophy in pediatric patients. Lenmeldy is the first authorized gene therapy for children with pre-symptomatic late infantile or early juvenile metachromatic leukodystrophy (MLD), according to the FDA’s press release on the approval. Lenmeldy is also the first approved therapy for early juvenile or early symptomatic forms of the disease. Orchard CEO Bobby Gaspar in a statement said that Lenmeldy’s approval “opens up tremendous new possibilities” for children suffering from these early-onset forms of MLD, “who previously had no treatment options beyond supportive and end-of-life care.” The company on Monday did not provide specific launch details for Lenmeldy but promises to do so within the week. MLD is a rare and heritable metabolic disease that affects one in every 100,000 live births. It is characterized by a pathological build-up of sulfatides in the brain, liver, kidneys, spleen and other body parts, which over time can cause organ damage and neurological issues. Those with MLD often suffer from motor, behavioral and cognitive problems, as well as seizures. Patients also slowly lose the ability to move, talk, swallow and eat. Children with MLD often degenerate to a vegetative state and require round-the-clock care. Most patients die within five years of disease onset. MLD is caused by a mutation in the arylsulfatase-A (ARSA) gene, which under healthy circumstances produces an enzyme that breaks down sulfatides. Orchard’s Lenmeldy is an autologous gene therapy that uses a patient’s own stem cells to deliver a functioning copy of the ARSA gene. This mechanism of action won Lenmeldy the FDA’s Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations. Lenmeldy was also approved by the European Union in December 2020, where it is marketed as Libmeldy. The FDA’s approval of Lenmeldy is backed by data from two single-arm, open-label trials enrolling a total of 37 pediatric MLD patients. Over a median follow-up of 6.76 years, Lenmeldy led to significantly better overall survival compared with natural history data. The gene therapy also preserved motor and cognitive function in late-infantile MLD patients, whereas untreated counterparts had severe impairments. In terms of safety, Lenmeldy’s most common adverse events were febrile neutropenia, stomatitis, respiratory tract infections and rashes. These are reflected in the therapy’s label, which also bears warnings for thrombosis and thromboembolic events, encephalitis and the risk of hypersensitivity reactions. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.