Uterine Prolapse

TORONTO--( BUSINESS WIRE )--Cosm Medical proudly announces FDA clearance for Gynethotics™ Pessaries, marking it as the first personalized pessary available to patients. This milestone follows a recent Health Canada clearance and marks a significant advancement in pelvic care, emphasizing Cosm’s commitment to enhancing patient outcomes and revolutionizing treatment options for women worldwide. Gynethotics™ are the first pessary to be FDA cleared in about 5 years with almost 10 million pessary configurations that clinicians can conveniently order online. That is compared to about 100 configurations that are offered by other commercially available pessaries. The benefits of personalized Gynethotics™ Pessaries were demonstrated in a pilot study completed at Sinai Health Systems and published in Urogynecology, the Journal of the American Urogynecology Society, in 2023. “Our vision is to become the world leader in precision gynecological devices for unique bodies and needs.” said Derek Sham, Founder & CEO of Cosm Medical. “With our first FDA clearance, we are one step closer to realizing this vision and making a meaningful impact on the lives of over a million patients by 2030. This will set a new standard of care in gynecology like the established billion-dollar markets of custom orthotics, dental and hearing.” Half of all women will experience a pelvic floor disorder such as prolapse and incontinence in their lifetime. “Aging and women’s health are both severely underserved markets with high clinical unmet needs, demonstrated by the fact that Femtech and Agetech are both projected to be growing at over 15% CAGR.” said Ivneet Bhullar, Investment Partner at Fusion Fund and Cosm Board Member. “It’s been great supporting Cosm over the past 2 years as they’ve achieved major milestones towards driving precision care into gynecology.” Beyond pessaries, Cosm has signed a strategic partnership with the University of Alabama at Birmingham to work with Holly E. Richter, Ph.D., M.D. and Max Cadena, M.D. on a novel design and indication for Gynethotics. “We look forward to improving surgical outcomes and are currently completing Phase 1 of a clinical study with the goal of implementing a new paradigm for impacting post-operative healing,” Richter said. “This is especially important as there are limited evidence-based options for augmenting vaginal native tissue repairs.” About Cosm Medical Based in Toronto, Canada, Cosm Medical is personalizing gynecological devices for precision care because every woman is different. Cosm’s digital gynecology platform leverages novel diagnostics, AI, cloud software, and 3D printing to create patient-specific gynecological devices for unique bodies and needs. For more information, visit: www.cosm.care About Fusion Fund Based in Palo Alto, California, Fusion Fund is a venture capital firm that focuses on backing early-stage entrepreneurs in building forward-thinking companies with technical and data advantages. Since 2015, Fusion Fund has invested in over 80 portfolio companies across the US and Canada in the healthcare, enterprise AI, and industrial automation sectors. For more information, visit: www.fusionfund.com

Increasing prevalence of infectious, cardiovascular and respiratory diseases, growing adoption of ECMO in lung transplantation procedures, growth in the number of ECMO centers, increasing survival rates with ECMO and increasing strategic initiatives such as product launch or collaboration are key factors contributing to high CAGR of Extracorporeal Membrane Oxygenation (ECMO) Market during forecast period. According to the current analysis of Reports and Data, the global Extracorporeal Membrane Oxygenation (ECMO) market was valued at USD 290.2 Million in 2020 and is expected to reach USD 385.9 Million by the year 2028, at a CAGR of 3.6%. Extracorporeal membrane oxygenation is a treatment provided for COVID-19, cardiac and respiratory diseases. Increasing the prevalence of target diseases (such as COVID-19, cardiovascular diseases and respiratory diseases), technological advancements, and increasing extracorporeal membrane oxygenation centers across the globe are some of the factors driving the market growth. It is estimated that in the U.S., approximately 1,055,000 individuals will have coronary diseases, including 720,000 new and 335,000 recurrent coronary events. The number of artificial respiration via the help of the device in a developed nation such as the U.S. from the past decade is constantly on rise. With rising technological innovations improved survival rate with extracorporeal membrane oxygenation is another major factor that supports the spread of the adoption of extracorporeal membrane oxygenation in case of medical emergencies such as COVID-19 cases. In South Korea it has been observed that the inpatient with Extracorporeal membrane oxygenation therapy for respiratory failure had improved survival rate from 30.8% to 35.9%. Access Free sample PDF Copy of the Report (To Understand the Complete Structure of this Report [Summary + TOC]) @ According to the Extracorporeal Life Support Organization (ELSO), the number of hospitals offering ECMO services reached 264 in 2020, rising from 108 in 2008. Obesity often leads to poor vascular health and an increased risk of cardiovascular disease (CVD). With advent of COVID pandemic the demand for the device is expected to surge further. . However, stringent regulations in developed nations, and high associated cost of the procedure may hinder market growth in developing nations. Further key findings from the report suggest Recently, Terumo and Marker Therapeutics received FDA approval for a blood purification and oxygenation system in the treatment of COVID-19 infection. Terumo’s Spectra Optia apheresis system works with the Marker Therapeutics’ Depuro D2000 adsorption cartridges. It reduces the number of cytokines and other inflammatory blood proteins that control a cell’s immune response then filter the blood and return it to the patient. According to the FDA the proteins that are removed are typically elevated during infections, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death. Various organizations and research institutes are engaged in clinical trials of the extracorporeal membrane oxygenation for cardiac and respiratory diseases. For instance, NHS ECMO completed the study of the ECMO service for adults with respiratory failure. Central Hospital, Nancy, France is engaged in studying the efficacy of Venoarterial Extracorporeal Membrane Oxygenation prior the left ventricular assist device implantation Favorable reimbursement policy such as, Medicare and Medicaid reimburse the patients going through extracorporeal membrane oxygenation procedure based on its mode of cannulation and medical indication is expected to fuel the market growth of the extracorporeal membrane oxygenation market Leading players of the market such as Getinge group recently launched its Cardiohelp System and Cardiosave Market players are focused in developing the advanced technologies in extracorporeal membrane oxygenation. For instance, MC3 Cardiopulmonary received US FDA approval for its Crescent jugular dual lumen catheter in the US for extracorporeal membrane oxygenation. In 2017, CytoSorbents Corporation launched CytoSorb Therapeutic ECMO kit in Austria. The kit combines CytoSorb blood purification cartridge with innovative tubing connector set that provide easy integration in most of the commercial ECMO systems. During 2020-2028, extracorporeal membrane oxygenation market is expected to register a CAGR of 4.8% in Asia Pacific; followed by North America and Europe, with 4.6% and 4.1% CAGR, respectively. High prevalence of severe cardiogenic shock and related diseases across the globe is the major factor driving the market during the forecast period across all regions. The venoarterial device type of extracorporeal membrane oxygenation segment dominates the field with highest market share in the year 2020. It is estimated to grow at a CAGR of 4.4% during the forecast period to reach USD 156.61 million by 2028 Based on end use segment, pediatric is expected to account for the CAGR 3.6% of the global extracorporeal membrane oxygenation market, as growing incidences of birth defect and premature birth across the world and raising public awareness about the technologically advanced respiratory support Asia Pacific is expected to grow at the highest rate. Developing nations such China, and India are likely to witness high growth due to high prevalence of cardiac and pulmonary diseases, increased healthcare expenditure and growing R&D investment High cost of the the procedure and lack of skilled personnel are the key factors likely to hamper growth of the extracorporeal membrane oxygenation market The ongoing pandemic is significantly changing the dynamics of the pharma and healthcare sector. Various countries are facing challenges such as shortage of medicines, vaccines, healthcare devices in hospitals. This is expected to open lucrative growth opportunities for market players in the coming years. For Inquiry Before Buying @ Competitive Landscape: The global market comprises various market players operating at regional and global levels. These key players are adopting various strategies such as R&D investments, license agreements, partnerships, merger and acquisitions, collaborations, and joint ventures to gain robust footing in the market. Top Companies Profiled in the Report: Getinge Group (Sweden), Medtronic plc (Ireland), LivaNova PLC (U.K.), XENIOS AG (Germany), Terumo Corporation (Japan), MicroPort Scientific Corporation (China), NIPRO Corporation (Japan), OriGen Biomedical, Inc. (U.S.), ALung Technologies, Inc. (Germany), and EUROSETS S.r.l. (Italy). Browse Full Report Description with Research Methodology, Table of Content and Infographics @ Extracorporeal Membrane Oxygenation Market Segmentation: Type Outlook (Revenue, USD Million; 2020-2028) Venovenous ECMO Venoarterial ECMO Arteriovenous ECMO Component Outlook (Revenue, USD Million; 2020-2028) Pumps Cannula Oxygenators Gas Blender Heat Exchanger Pressure Monitor Bladder Reservoir Controller Gas Cylinder Others Application Outlook (Revenue, USD Million; 2020-2028) Congenital Diaphragmatic Hernia (CDH) Birth Defects of the Heart Meconium Aspiration Syndrome (MAS) Severe Pneumonia Severe Air Leak Problems Severe High Blood Pressure in the Arteries of the Lungs (PPHN) Others Regional Outlook: North America (U.S., Canada, Mexico) Europe (Germany, U.K., Italy, France, BENELUX, Rest of Europe) Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific) Latin America (Brazil, Rest of LATAM) Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa) Ask for Customize Research Report @ This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth. 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Johnson & Johnson Medical and Ethicon faced lawsuits from women who said they suffered pain, urinary problems, bleeding, and other serious injuries from the implants Johnson & Johnson Headquarters in New Brunswick, New Jersey, USA. (Credit: user:ekem/Wikipedia) Australian law firm Shine Lawyers announced that Johnson & Johnson (J&J) has agreed to a $204.9m settlement in two Australian class action suits for selling defective pelvic mesh implants. Pelvic mesh makers J&J Medical and its subsidiary Ethicon faced lawsuits from women who claimed they suffered pain, urinary problems, bleeding, and other serious injuries from the implants. The settlement comes after a federal court judge in Australia found that Ethicon had sold the products to market without conducting adequate testing and had sold the implants without disclosing the risks involved. Shine Lawyers filed two class actions on behalf of women who had difficulties after getting one or more Gynecare prolapse mesh and incontinence tape implants. The first class action was filed in federal court on 15 October 2012, and it took seven months, from July 2017 to February 2018, to get a verdict. Women who had their implants on or after 4 July 2017, and who were unable to join the first class action, filed the second class action in April 2021. Shine Lawyers’ Class Actions Practice leader Rebecca Jancauskas said: “We welcome this settlement which brings the litigation to an end. “If the Federal Court approves the settlement our focus will shift to the important task of distributing the settlement to group members.” Shine Lawyers claims that it is the largest settlement in a product-liability class action in Australian history following multiple court hearings which involved more than 11,000 claimants. The settlement remains subject to the Federal court’s approval. J&J also faced similar lawsuits in the US, Canada, and Europe. In a separate development, Johnson & Johnson Vision Care has introduced a new range of contact lenses to meet the needs of digitally intense lifestyles. The firm announced ACUVUE OASYS MAX 1-DAY contact lenses and ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses for presbyopia. Both lenses are made from TearStable Technology and OptiBlue light filter for crisp, clear vision at all distances and in all lighting conditions plus all-day comfort. TearStable Technology is intended to maximise tear-film stability and lock in moisture for all-day comfort. The company said that the OptiBlue light filter has the highest level blue-violet filter in the industry at 60% to reduce light scatter for better visual clarity.