Juvenile Polyposis Syndrome

PARSIPPANY, N.J., Jan. 9, 2025 /PRNewswire/ -- Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, today announced that its revolutionary NanoCept Antibacterial Technology has been used successfully in multiple surgical procedures. NanoCept is a novel antibacterial coating applied to orthopaedic implants to help address intraoperative bacterial contamination. Continue Reading NanoCept™ Antibacterial Technology "Limb salvage and revision procedures are challenging, and the rate of complication is much higher than most index orthopaedic procedures," said Steven Gitelis, MD, Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical. "The risk of implant infection is on my mind every time I take a patient to the operating room, and this is especially true for patients with bone cancer, as they are more susceptible. The NanoCept Technology represents a significant advancement in the preventative measures my colleagues and I use to mitigate the potentially devastating complications related to intraoperative bacterial contamination of implants. It has the potential to create a paradigm shift in implant selection and is a valuable tool surgeons will now have that may help address an unsolved clinical problem." Orthopaedic implant-related infections are clinically challenging and have significant negative effects on patients. Periprosthetic joint infection (PJI) has a lower survival rate than several forms of cancer1 and is expected to cost the U.S. healthcare system up to $1.8 billion dollars by 2030.2 It is estimated that 60-70% of all early and delayed-onset PJI (<3 months and 12-24 months post-surgery) are initiated at the time of the procedure through intraoperative contamination.3 Onkos received De Novo market authorization from the Food and Drug Administration (FDA) in April of 2024 for its NanoCept Antibacterial Technology. Data submitted to support the De Novo application showed that NanoCept has up to a 99.999% (5-log reduction) kill rate in standardized in-vitro testing of bacteria that are commonly found in the operating room environment. The initial FDA authorization for NanoCept was for the Company's ELEOS™ Limb Salvage System, which is a modular total joint system used for patients with bone loss. "The successful completion of these initial surgeries is a key achievement and significant milestone in our strategy to deploy the NanoCept Technology across our portfolio," said Patrick Treacy, Onkos CEO and Co-founder. "We believe NanoCept is a platform technology that will substantially extend our reach and capability in broad orthopaedic markets, and we are actively working to expand regulatory clearances beyond ELEOS to include implants used in orthopaedic reconstruction due to tumor, trauma and other orthopaedic revision procedures." About Onkos Surgical Onkos Surgical is a leader in innovative solutions for complex orthopaedic conditions. With our novel product portfolio, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement more precise reconstructions. Our personalized approach supports improved patient outcomes and experiences using the latest innovations in antibacterial implant coatings, virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 of the leading academic medical institutions in the US choose Onkos for their complex revision and tumor orthopaedic cases. For more information on Onkos Surgical and its products and services, please visit . Forward Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, launch delays and the possibility that post-market clinical results may be inconsistent with the in-vitro preclinical test results. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only on the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law. Media Contacts: Sean P. Curry Chief Commercial Officer Onkos Surgical [email protected] 973.264.5400 Alyssa Paldo Vice-President, Media Relations Specialist FINN Partners [email protected] 847.791.8085References1,2 – Premkumar et.al. Projected economic burden of periprosthetic joint infection of the hip and knee in the United States. The Journal of Arthroplasty. Volume 36, Issue 5 P1484-1489.E3May 20213 - Tande AJ, Patel R. Prosthetic joint infection. Clin Microbiol Rev. 2014 Apr;27(2):302-45. doi: 10.1128/CMR.00111-13. PMID: 24696437; PMCID: PMC3993098. SOURCE Onkos Surgical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Updated guideline establishes guidance based on latest in evidence-based recommendations ROSEMONT, Ill., Dec. 17, 2024 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) issued an updated Clinical Practice Guideline (CPG) for the Prevention of Total Hip and Knee Arthroplasty Periprosthetic Joint Infection (PJI) in Patients Undergoing Dental Procedures, which replaces the previous guideline from 2012. The CPG supports patients who are scheduled for or have undergone total joint arthroplasty (TJA) and may need dental procedures by addressing antibiotic use and the timing of dental procedures before or after joint replacements, such as total knee arthroplasty (TKA) or total hip arthroplasty (THA) to help prevent infection. To view the full guideline, click here. "Dental procedures are believed to possibly allow bacteria to enter the bloodstream and attach themselves to hip or knee implants, potentially causing PJI in a patient," said Yale Fillingham, MD, FAAOS, co-chair of the AAOS' guideline development group. "PJI is one of the most devastating complications for patients following TJA, and we must do everything possible that is supported by evidence to prevent these infections. Given the large number of annual TJA procedures and that most of these patients undergo a dental cleaning at least twice a year, this CPG is relevant to nearly every TJA patient." THA and TKA are two of the most common surgical procedures performed worldwide. In the United States, over 1 million THAs and TKAs are performed each year, and these cases are estimated to increase by 659% and 469%, respectively, by 2060. Unfortunately, PJI is associated with increased mortality (up to 250% greater than patients who do not have PJI, along with the risk of a higher incidence of mental health disorders). The workgroup studied the latest data to provide clinically backed evidence for orthopaedists and dentists aimed at prevention but also weighed it against potential patient harm. The updated guideline includes two limited-strength options and three consensus options. Options are developed when little or no evidence exists on a particular topic. The group issued a limited-strength option stating that routine use of a systemic prophylactic antibiotic before a dental procedure in patients with a hip or knee replacement may not reduce the risk of a subsequent PJI. "The committee took a close look at the data on the administration of antibiotics before a dental procedure after both hip and knee replacement to see if it mitigated the potential risk of a PJI associated with that dental procedure," said Charles Hannon, MD, FAAOS, co-chair of the AAOS' guideline development group. "Based on the best available data, no study found that administering antibiotics before a dental procedure changed a patient's risk of getting a parasitic joint infection. With that said, it is important to recognize there may be other considerations that may lead a provider to prescribe antibiotics for an individual patient. This decision should be made with the patient, and the unique risks and benefits for the patient should be considered." The second limited-strength option states that screening patients who have received certain dental procedures before their hip or knee replacement may not reduce the risk of subsequent PJI. However, the workgroup recognizes that patients should be aware of the potential risks of poor oral hygiene. Guidelines At-A-Glance Desk Reference The workgroup also developed a new resource with suggested time intervals between dental procedures and TJA that supports two consensus statements. These statements address whether to delay an arthroplasty after a dental procedure or delay a dental procedure after TKA or THA. "It was important to create an at-a-glance tool for orthopaedic surgeons, dentists and their healthcare teams that provides guidance on the timing of dental procedures before and after TKA and THA. The tool outlines suggested timing based on the risk of transient bacteremia, the occurrence of an invasive surgical procedure that can lead to higher bacterial loads/increased infection risk, or the treatment of an active dental infection," said Dr. Hannon. Highlights from the chart include: Noninvasive dental procedures and minimally invasive dental care procedures such as dental examinations (without probing), oral hygiene procedures, and orthodontic procedures can be performed safely until the day before elective TJA surgery. Oral surgery procedures and dental extractions, which can take up to three weeks to heal, should be completed at least three weeks before elective TJA. The majority of dental procedures should be delayed for up to three months after TJA based on the type of procedure performed. The updated CPG was jointly developed by the AAOS and the American Association of Hip and Knee Surgeons, with contributions from the Infectious Disease Society of America, the Musculoskeletal Infection Society, and the American Dental Association. Intended CPG Use CPGs are not meant to be stand-alone documents but rather serve as a point of reference and educational tool for orthopaedic surgeons and healthcare professionals managing patients presenting with PJI that may be related to TKA and THA. CPGs recommend accepted approaches to treatment and/or diagnosis and are not intended to be a fixed protocol for treatment or diagnosis. Patient care and treatment should always be based on a clinician's independent medical judgment and the individual patient's specific clinical circumstances. The guideline is not intended for use as a benefits determination document. The full Clinical Practice Guideline for the Prevention of Total Hip and Knee Arthroplasty Periprosthetic Joint Infection in Patients Undergoing Dental Procedures is intended for reference by orthopaedic surgeons and dentists and is available through AAOS' OrthoGuidelines website and free mobile app. For more information on the development process for AAOS clinical practice guidelines, please view the Clinical Practice Guideline Methodology. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues; and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, X, LinkedIn and Instagram. SOURCE American Academy of Orthopaedic Surgeons WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

IND2025主会场授课已被预定，大会第一天下午茶歇前授课时间段预定开始，咨询热线：177 0186 0390。点击图片，查看IND2025首批重磅嘉宾 文章参考来源：原理、药明康德 抗微生物药物一直是现代医疗保健的基石之一。然而，当细菌或者其他病原体发生变化，不再对抗微生物药物产生反应时，就会出现所谓的抗微生物药物耐药性（AMR）。几十年来，AMR一直被认为是全球健康的重大威胁。 近日，抗微生物药物耐药性全球研究（GRAM）项目在《柳叶刀》上发表了一项新研究，对AMR随时间变化的趋势进行了首次全面分析。这项具有里程碑意义的新发现突出表明，在1990年到2021年间，AMR的确造成了严重的后果，而更令人忧心的是，这种威胁还在不断升级。   全球性的挑战   2022年，GRAM发表的第一份报告第一次揭示了AMR的真实规模。研究发现，2019年全球与AMR相关的死亡人数比艾滋病毒或者疟疾造成的死亡人数还要多，它直接导致了120万人死亡，还在495万人的死亡中起到了重要作用。 而在新研究中，GRAM对世界各国各年龄段人群中的22种病原体、84种病原体-药物组合和11种感染综合征（包括脑膜炎、血液感染和其他感染）进行了估计。估算结果基于5.2亿份个人记录，这些资料来源广泛，囊括了医院数据、死亡记录以及抗生素使用的情况。 研究结果表明，自1990年以来，AMR每年导致了大约百万人死亡，已经夺去了超过3600万人的生命。从1990年到2021年间，死亡人数也呈上升趋势。其中耐甲氧西林金黄色葡萄球菌（MRSA）导致的死亡在全球范围内增加最多，它在2021年直接导致了13万人死亡，比1990年增加近一倍。 此外，许多最致命的感染都是由一类耐药性极强的细菌引起的，这就是臭名昭著的革兰氏阴性菌。这类细菌对碳青霉烯类药物具有耐药性，而这类药物是治疗严重感染的常用药物。数据显示，30年来，与耐碳青霉烯类革兰氏阴性菌相关的死亡也翻了一倍多。 其中值得注意的是，在2021年，AMR导致的死亡人数略有下降，从2019年的120多万下降到了114万，这实际上得益于COVID-19大流行期间采取的疾病控制措施。但分析表明，这种死亡人数的下降只是暂时的。   趋势的变化   在过去30年间，一些与年龄有关的趋势发生了重大转变。 从1990年到2021年，五岁以下儿童的AMR死亡率下降了50%。这要归功于成功降低了严重儿童感染的发病率，比如疫苗接种的推广和环境卫生的改善，并非因为AMR发病率降低了。 但由于人口迅速老龄化以及老年人更容易受到感染的情况，70岁及以上人群的死亡人数增加了80%以上。 1990年和2021年AMR导致的以及AMR相关的不同年龄段死亡情况。（图/GRAM，The Lancet） 此外，在撒哈拉以南非洲的西部、拉丁美洲热带地区、北美高收入地区、东南亚和南亚这五个地区，AMR直接导致的死亡人数增加最多。从1990年至2021年，这五个地区每年死亡人数增加了一万多。   预测影响   根据计算得出的历史趋势，团队还预测了从2022年到2050年AMR影响的趋势，评估了最有可能对全球和地区健康造成的影响。 在此后的几十年间，未来死于AMR的人数还将急剧上升，增加近70%，从2021年的每年114万人增加到2050年的每年191万人。详细预测显示，如果没有进一步的政策干预，2025年至2050年间全球死亡人数将达到3900万，相当于每分钟就有3个人丧生。 研究人员利用统计模型估算了可直接归因于AMR的死亡人数，以及AMR相关的死亡人数。与导致的死亡人数一样，AMR相关的死亡人数也会增加。到了2050年，AMR还将导致822万例与AMR相关的死亡，相比于2021年的471万例增加了75%。 研究人员预计，这些趋势将在未来几十年持续下去，到了2050 年，全球五岁以下儿童死于AMR的人数将减少一半，而70岁及以上老年人死于AMR的人数将增加一倍以上。 重要的是，中低收入国家将会面临不成比例的负担。南亚地区（包括印度、巴基斯坦和孟加拉国）的AMR死亡人数最多，在2025年至2050年期间，AMR导致的死亡总人数将达到1180万。模拟还预测，南亚其他一些地区以及撒哈拉以南非洲的死亡率也很高，耐多药（MDR）结核病造成的死亡人数尤甚。 预测还包括另外一些情景，比如新型抗生素的稳定发展，或者医疗质量的广泛提高。研究认为，如果定期发布针对革兰氏阴性病原体的新型药物，就有望避免多达1100万例与AMR相关的死亡。 如果能更广泛地恰当使用抗生素，更好地治疗感染，也可能挽救数千万人的生命。   药物进展   “目前在应对抗微生物药物耐药方面取得了切实进展，尤其是在幼儿年龄组中，但我们的研究结果表明，要抵御这一日益严峻的全球健康威胁，还有更多工作必须要做。到2050年，每年可能有约800万人死于耐药性感染，耐药性感染可能是导致死亡的直接原因，也可能是诱因之一。为防止这种情况成为致命的现实，现在亟需采取新策略，通过疫苗、新药、改进医疗服务、改善现有抗微生物药物可及性，以及开展有关如何最有效地使用抗微生物药物的相关指导工作，来降低出现严重感染的风险。”该研究作者、来自挪威公共卫生研究所（the Norwegian Institute of Public Health）的卫生计量研究所客座教授Dr. Stein Emil Vollset说道。 截至2023年12月31日，当前的临床抗菌药物研发管线在药物数量和适应症覆盖范围方面均取得了显著增长。目前，共有97种针对WHO重点细菌病原体（包括结核分枝杆菌、艰难梭菌和幽门螺杆菌）的新型抗菌药物正在临床开发中，这一数量相比2021年的80种显著增加。 ▲截至2023年12月31日，按临床开发阶段划分的传统和非传统AMR药物数量（图片来源：参考资料[1]） 值得注意的是，2023年的药物研发管线显示，AMR药物在临床适应症方面有所扩展，新增了假体关节感染（PJI）、囊性纤维化（CF）患者感染、幽门螺杆菌感染和志贺菌病等适应症，而这些在2017年的分析中尚未涉及。尤其是CF患者的感染和PJI的治疗，这一扩展得益于越来越多专门针对这些复杂临床综合征的非传统抗菌药物的开发。 ▲按预定治疗适应症划分，2017-2023年处于2期和3期临床开发阶段的AMR药物（图片来源：参考资料[1]） 在对临床阶段的AMR药物进行创新性评估时，可以发现，在针对WHO重点病原体的32种传统抗生素中（不包括结核病药物），有12种符合WHO设定的至少一项创新标准。许多此类药物已进入研发的后期阶段。例如，拓扑异构酶抑制剂zoliflodacin和gepotidacin目前正在进行3期临床试验，展现出令人期待的进展。 ▲截至2023年12月31日，传统AMR药物作用机制的分布（图片来源：参考资料[1]） 近年来，在对抗AMR的战役中，非传统药物也逐渐获得关注。这些药物旨在通过直接或间接抑制细菌生长、抑制毒力、改善抗菌耐药性、增强人体免疫系统以及正向调整或恢复健康的微生物群来预防或治疗细菌感染。目前，共有30款针对WHO重点病原体的非传统抗菌药物正在积极的临床开发中。其中，13种为噬菌体及其衍生酶，7种为抗体，3种为抗毒力剂，2种为免疫调节剂，1种为微生物组调节剂，另有4种属于其他类别的药物。这些药物通过创新机制为抗击AMR提供了新的潜在解决方案。 ▲截至2023年12月31日，处于临床开发阶段的非传统AMR药物的分布（图片来源：参考资料[1]） 临床前AMR管线的现状 截至2023年12月31日，AMR药物的临床前管线展现了全球协作的努力。目前，共有244个AMR药物候选物处于临床前开发阶段，分布在WHO的六大区域内，涵盖29个国家。其中，38%的候选药物采用非传统治疗模式，68%属于全新的化学类别，55%具有全新的作用机制，充分体现了行业在突破性疗法方面的承诺。此外，91个候选药物（占37%）专注于特定病原体，主要目标包括结核分枝杆菌（M. tuberculosis）、铜绿假单胞菌（P. aeruginosa）和金黄色葡萄球菌（S. aureus）。近一半（48%）的候选药物专为应对耐药性而设计，显示了行业对抗耐药性威胁的积极行动。 当前的临床前研发管线涵盖多种治疗手段，包括小分子、肽类、噬菌体、免疫调节剂以及微生物组调节剂，展示了多样化且强有力的应对AMR挑战的策略。这种广泛的创新不仅丰富了开发中的治疗选择，也为未来应对更广泛感染和耐药机制的AMR疗法奠定了坚实基础。 ▲截至2023年12月31日，自2019年以来临床前项目和开发机构的数量（图片来源：参考资料[1]）   更多了解   研究人员表示，目前的研究还有一定局限性，比如一些低收入和中等收入国家的数据缺乏。这表明还需要改进数据收集工作，提高未来预测的准确性。在用于估算的个人记录中，有些可能存在错误或偏差，并且2000年以前的AMR数据报告有限，这也可能影响20世纪90年代历史的估算。 了解AMR死亡趋势随着时间的推移发生了怎样的变化，以及未来可能发生怎样的变化，对于做出明智的决策至关重要。虽然近年来在应对AMR方面取得了一些进展，但这还远远不够，还需要做更多的研究和努力。 #创作团队： 撰文：Takeko 排版：雯雯 #参考来源： [1] 2023 Antibacterial agents in clinical and preclinical development: an overview and analysis. Retrieved October 17, 2024 from https://www-who-int.libproxy1.nus.edu.sg/publications/i/item/9789240094000 https://www.ox.ac.uk/news/2024-09-17-antibiotic-resistance-has-claimed-least-one-million-lives-each-year-1990 https://www.eurekalert.org/news-releases/1057804 https://www-thelancet-com.libproxy1.nus.edu.sg/journals/lancet/article/PIIS0140-6736(24)01867-1/fulltext https://www-nature-com.libproxy1.nus.edu.sg/articles/d41586-024-03033-w #图片来源： 封面图&首图：A., Flickr CC BY-SA END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769