CoapTech, Inc.

BALTIMORE--(BUSINESS WIRE)-- Protaryx Medical, a pioneer in medical device innovation, today announced the appointment of David Mester, MBA as its new chief executive officer (CEO). With a career spanning over 33 years in the structural heart medical device industry, Mester brings a wealth of experience and expertise to guide Protaryx into a new era of growth and innovation. The company also announced the appointment of Peter Boyd, J.D., MBA to its board of directors. Protaryx Medical is known for its Protaryx Transseptal Access Device, a cutting-edge technology for transseptal procedures that provides streamlined access to the left side of the heart through the fossa ovalis. What sets the Protaryx device apart is its unique integration of access and transseptal crossing functions into a single device that can be used independently or integrated with another therapy device. This approach was designed to optimize workflow efficiency. Prior to joining Protaryx Medical, Mester held pivotal senior business and technical leadership roles at Sequoia Medical, Xeltis, Gore Medical, CarboMedics, and ViVitro Labs. His career has been dedicated to advancing innovative materials and delivery systems for heart valve applications. He led the acquisition of new technologies and played an instrumental role in forming a new business unit at Gore Medical to explore novel heart valve technology. In addition, Mester has overseen first-in-human and early feasibility studies for emerging technologies and led successful regulatory submissions for cardiovascular products. Mester earned a bachelor’s degree from St. Edward’s University in business and applied science and an MBA from Louisiana State University. David's leadership prowess extends to overseeing first-in-human and early feasibility studies for emerging technologies, as well as leading numerous successful regulatory submissions for cardiovascular products. He is a respected figure in the industry, with active participation in ISO and FDA regulatory-sponsored working groups and a longstanding membership with the Association for the Advancement of Medical Instrumentation (AAMI). "David Mester's exceptional track record in driving innovation and leading transformative initiatives in the structural heart medical device industry makes him the perfect fit to lead Protaryx Medical into its next phase of growth," said Jim Gammie, M.D., founder and officer of Protaryx. "His extensive experience in business leadership, technical expertise, and commitment to advancing innovation to improve patient care align seamlessly with our mission to redefine procedural outcomes." To further strengthen the Protaryx leadership team, Protaryx has also appointed Peter Boyd to its board of directors. Boyd is a healthcare entrepreneur with a background in business, science and law. He co-founded Harpoon Medical, where he negotiated and managed all aspects of a complex structured financing and the company’s subsequent acquisition by Edwards Lifesciences. Boyd has also worked as an associate at Latham & Watkins in Silicon Valley in the emerging company and M&A practice groups and co-founded startups including ReGeleTec Inc., Sonnest Inc., and Wheelhouse Ventures. He currently serves as an advisor to startups including CoapTech and NeoProgen. Boyd earned his J.D. and MBA from the University of Virginia and a bachelor’s degree from the University of North Carolina. About Protaryx Medical Protaryx Medical is an innovative medical device company focused on advancing access and procedural efficiency in structural heart interventions. The company's flagship product, the Protaryx Transseptal Access Device, represents a breakthrough in transseptal procedures, streamlining access to the left side of the heart and optimizing workflow efficiency. Protaryx Medical is dedicated to driving innovation and improving patient care in the field of structural heart medical devices. The company is headquartered in Baltimore, Maryland, with engineering operations in Minneapolis, Minnesota. For more information, please visit protaryx.com.

呼吸，是维持生命的基本生理活动。随着人类生存环境的变化、空气污染的加重以及呼吸系统传染病的大流行，呼吸系统疾病的患病率直线上升。据2020年柳叶刀子刊发布数据，2017年，全球估计有5.449亿人（95% UI 5.069亿-5.849亿）患有慢性呼吸系统疾病，比1990年的3.897亿增加了39.8%。慢性呼吸系统疾病所致的死亡占全因死亡总数的7.0%，为2017年全球死亡的第三大原因，仅次于心血管疾病（31.8%）和肿瘤（17.1%）。呼吸系统疾病主要病变在气管、支气管、肺部及胸腔，轻者多咳嗽、胸痛、呼吸受到影响，重者呼吸困难、缺氧，甚至呼吸衰竭而死。呼吸系统疾病发病率高、死亡率高、负担高，随着新冠肺炎的大流行，已经成为全球共同关注的卫生问题。呼吸机已经成为患者的另一个“肺”，是人工替代自主通气的有效手段，已经普遍用于各种原因导致的呼吸衰竭、大手术期间的麻醉呼吸管理、呼吸支持治疗和急救复苏中，在现代医学领域占据十分重要的位置。据西南证券报告，2020年全球家用无创呼吸机市场规模为27亿美元，2016~2020年复合增速12.2%，预计随着中国等新兴市场渗透率提升，全球家用无创呼吸机市场将在2025年达到55.8亿美元，复合增速15.5%。我国疫情发生前，国内呼吸机产业市场容量（按出厂价计算）在120亿元左右，医用呼吸机需求量达到1.69万台，同比增长15.2%。呼吸机种类繁多，按照工作原理可区分为有创呼吸机和无创呼吸机。有创呼吸机通常应用于重症呼吸衰竭患者，无创呼吸机则可以通过口鼻面罩、鼻罩、全面罩等方式进行无创正压通气（NIPPV）治疗，缓解轻中度呼吸衰竭患者症状。2018年，FDA制定了一项新的规定，指定将HI-VNI技术（高速鼻腔吹气）作为无创正压通气（NIPPV）有吸引力的替代方案。HI-VNI技术专利正是来自于一家叫VAPOTHERM呼吸器械公司VAPOTHERM。   超1250家医院、300万患者采用VAPOTHERM是一家创办于1999年的医疗器械公司，总部位于美国新罕布什尔州。VAPOTHERM专注于为慢性或急性呼吸窘迫患者提供呼吸支持的无创技术，围绕其专利技术HI-VNI开发出适用于不同场景和疾病的多种系统设备。2018年，VAPOTHERM在纽交所上市，市值超过10亿美元。Bill Niland是VAPOTHERM的创始人兼首席商务官，毕业于美国罗文大学。Bill是一个连续医疗保健领域创业者，成功创办并退出了四家医疗保健公司。2014年，他加入Harpoon Medical担任总裁兼首席执行官，此后以预付1亿美元和总价格将公司出售给Edwards Lifesciences，总价格高达两亿五千万美元。Bill在医疗保健领域拥有超过25年经历，担任ReGelTec、Sonavex、CoapTech多家公司的首席执行官或董事会成员，拥有22项专利，其中12项为医疗器械领域专利。从VAPOTHERM创办以来，由其专利技术HI-VNI带来的高流量鼻导管疗法，已经被1250多家医院采用，服务超过300万患者。美国之外，在英国、巴西、西班牙、德国、日本印度尼西亚均有业务展开。无口罩、高流量、鼻导管对于呼吸窘迫（包括缺氧、高碳酸血症和呼吸困难）患者来说，NIPPV一直是活跃在临床的一线治疗方法。作为有创呼吸方法的替代品，NIPPV在舒适度和临床可用性方面都取得了质的飞跃。NIPPV采用口鼻面罩、鼻罩、全面罩的方式帮助患者实现低流量无创正压通气，能够减少患者气管插管率和病死率。近年来高流量鼻导管HFNC成为了较NIPPV更为广泛接受的工具，在预防再插管、预防或解决拔管后急性呼吸窘迫方面具有NIPPV同样的功效。有研究表明，超过30%的患者不能忍受口罩的压迫感，造成焦虑或不适应。基于对NIPPV和HFNC的技术研究，VAPOTHERM将二者相结合起来开发出无口罩、高流量的鼻导管治疗方案Mask free-NIV。 呼吸衰竭治疗 来源：VAPOTHERM官网Mask free-NIV并不是依靠传统的正压通气方法，而是通过使用加热加湿的空气高速流动来帮助呼吸，这种方法就是HI-VNI。HI-VNI是一种新兴的氧合技术，也称为高速鼻腔吹气，允许通过专门的高流量鼻导管以高达40l/min的输送加湿加热氧气。目前，FDA已经批准了HI-VNI的更新版本，出台新的分类法规，将HI-VNI指定为无创正压通气（NIPPV）有吸引力的替代方案。围绕Mask free-NIV产品和HI-VNI技术，VAPOTHERM开发出适用于不同范围的多种配套产品。● HVT 2.0 SystemHVT 2.0 System包括HVT 2.0 Mask free-NIV和一次性患者电路仪。HVT 2.0配套Mask free-NIV和可移动触摸屏及组件，能够在5分钟以内快速启动。相关数据证明，比较NIPPV，HVT 2.0能够降低患者的ICU住院率，患者在佩戴时改善患者行走能力，缩短住院时间而降低护理费用。HVT 2.0可同时适用于成人和儿童，流量范围5-45l/min，电量持续支持30天连续使用。● Precision Flow SystemPrecision Flow System是HI-VNI技术更新版本名录下的推出的唯一一款产品。产品包括Precision Flow Mask free-NIV、患者电路仪和Precision Flow Heliox氦氧混合输送仪器。该系统蒸汽加湿与常规不同，使用专门仪器混合气体产生医用级蒸汽，通过消除冷凝水使医用气体状态保持稳定，维持氧气湿度和温度。同时提供两种流量范围供给新生儿或儿童及成人使用，新生儿1-8l/min，儿童/成人5-40l/min。为了能够使仪器适用于急诊或重症状况，该系统还提供氦氧混合气体输送。按照医生处方要求，Precision Flow Heliox能够按比例准确混合氦氧两种气体，缓解呼吸窘迫。Precision Flow Heliox提供流量范围为1-40l/min，氦氧混合输入80/20（79%氦气/21%氧气），氧气浓度为21%-100%（以1%为增量调节）。● Capital AccessoriesCapital Accessories包括氧气辅助模块（OAM）、蒸汽输送装置和Q50空压机，是适用于所有场景的辅助器械。OAM能够通过自动控制FiO2（吸入氧浓度百分比）协助医护控制SpO2（血氧饱和度）范围，保证患者SpO2处于正常水平以免产生一些临床后果，如早产儿视网膜病变（ROP），或某些危重成年人群的肺损伤或血管收缩等。Q50空压机可方便地安装在Precision Flow辊架上，最大限度地减少了额外的空间需求，可以辅助Precision Flow System实现护理目标。另外，VAPOTHERM还开发出了多种一次性组件，包括ProSoft鼻插管、气管切开适配器，供给雾化药物输送的两种方案（气溶胶一次性患者回路ADPC和气雾剂适配器AAA-1） 以及一氧化氮输送方法等。慢性呼吸系统疾病与AI计划2022年3月，VAPOTHERM宣布与人工智能研究机构卡内基梅隆大学建立战略合作伙伴关系，旨在利用卡内基梅隆大学的AI专业知识为VAPOTHERM员工提供相关培训，开发适用AI来提供更好的护理，提高生活质量，减少慢性呼吸系统疾病的影响，同时降低客户的医疗成本。根据VAPOTHERM发布的2022年第三季度财报，第三季度总收入为1350万美元，比2022年第二季度增长4.4%。呼吸器械与氦气、雾化药物以及AI相结合，未来的呼吸机或许有想象之外的发展潜力。中国呼吸机行业整体技术与国际先进水平至少差距20年以上，国内头部企业成人呼吸机吸气端依然在采用已经被国际主流产品淘汰了的“热丝式”流量传感器，新生儿常频、高频等高技术机型处于“空白”状态。技术落后使得国内呼吸机仍处于中低端水平，国内高端的呼吸机市场由德国和美国行业巨头垄断市场份额的80-90%。而在出口端，尽管受新冠疫情影响呼吸机出口量上升，但在2020年以前，国内的头部企业生命支持系统部门出口产品以麻醉机和心电监护为主，呼吸机国际市场销量惨淡。从行业整体前景看，与美国、德国、法国、英国等发达国家相比，我国人均呼吸机数量仍处于较低水平，每百万人呼吸机数量为57台，行业渗透率可提升空间大。机遇与挑战并存，“新冠”疫情这一偶发因素带来的行业大发展，尽管并没有从根本上改变中国呼吸机行业整体技术的劣势地位，在后疫情时代的常态化市场竞争中依然面临着严峻而紧迫的考验与挑战。但在市场需求呼唤下，一方面走国际技术引进、学习消化，再追赶提高的技术发展路径；一方面实现国内医疗、计算机软件、机械电子等行业力量整合，下大力气联合攻关攻克难题。最终实现技术跨越，走出国产呼吸机的进阶之路。左右滑动查看更多近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

The minimally invasive procedure is simple, quick, and decreases risks for patients in need of a feeding tube MIAMI, Oct. 25, 2022 /PRNewswire/ -- Jackson Memorial Hospital is the first healthcare facility in Florida to launch a new innovative procedure to support feeding patients in its intensive care units (ICU). In August, Jackson started performing percutaneous ultrasound gastrostomies (PUG), a new technique launched by medical device company CoapTech that allows ultrasound-trained providers to place gastrostomy tubes (G-tubes) in a patient using only ultrasound guidance with CoapTech's PUMA-G device. Since its launch, Jackson Memorial has been able to successfully implement this minimally invasive approach in at least 10 patients in its ICU and intermediate ICU. Traditionally, when a patient is unable to eat or swallow long-term, a G-tube is placed by a gastroenterologist using endoscopy or in an operating room. Using the PUG procedure eliminates the need for a specialist consult. "Patients in need of a feeding tube now experience a safe, quick, and simple process with the PUG procedure," said Hamilton Clark, Jackson Memorial's senior vice president and chief executive officer. "It offers less waiting time for the patients, and our nurses and support staff can provide efficient care for patients in need of nutrition." This new approach lets more healthcare workers, such as intermediate and critical care staff, care for patients when the need for adequate nutrition is greatest. "The benefit of this is that it is enabling a whole new group of providers to perform gastrostomies safely, without having to move the patients out of the comfort of their rooms or wait for consultant services to perform the procedure," said Douglas Houghton, DNP, APRN, ANCPC, CCRN, FAANP, associate chief of clinical operations at Jackson Memorial. "We perform this procedure with equipment that we already have and already know how to use, which is great for our patients and hospital teams." Jackson Memorial's goal is to continue growing the number of caregivers who can provide this service, so that it can be done in all of its ICUs. "I applaud the Jackson Memorial team for their commitment to innovation and better patient care," said Howard Carolan, president and CEO of CoapTech. "They are leading the way in Florida as they utilize PUMA-G to decrease length of stay, reduce costs, and provide better patient care." Jackson Memorial Hospital 1611 N.W. 12th Ave., Miami, FL 33136 SOURCE CoapTech; Jackson Memorial Hospital