Anastomotic Leaks

KITCHENER, ON, Sept. 9, 2024 /PRNewswire/ - Building on the success of the Continuous Connected Patient Care (CCPC) project, a consortium of leading Canadian medtech companies, led by FluidAI Medical in collaboration with Medtronic Canada ULC, Excelar Technologies, Providence Health Care Ventures, and the University of Waterloo, has announced the launch of the Postoperative Patient Management Platform (PPMP) project under Canada's Global Innovation Cluster for digital technologies, known as DIGITAL. This initiative aims to revolutionize postoperative care through advanced artificial intelligence (AI) and machine learning technologies. Predictive analytics dashboard (CNW Group/Fluid AI Medical) Postoperative complications pose significant challenges, leading to prolonged hospital stays, increased healthcare costs, and adverse patient outcomes. Studies have found nearly 15% of surgical mortality cases are potentially preventable if caught earlier[1]. Additionally, the associated costs of additional treatments following complications due to prolonged hospital stays and readmissions are estimated to be between 1.5 to 4 times higher than for primary admissions[2, 3]. The PPMP project addresses these issues by developing a sophisticated platform that utilizes in-hospital data to create predictive models for patient risk assessment. This platform will help healthcare providers make timely and informed decisions, enhancing patient care and reducing the burden on healthcare resources. The primary objectives of the PPMP project include the development of advanced predictive analytics to foresee postoperative complications such as anastomotic leaks and respiratory depression. Respiratory depression, often induced by opioids administered during and after surgery, is a significant adverse event that can result in prolonged hospital stays and increased costs—up to $23,000 USD for high-risk patients [4]. Additionally, current diagnostic techniques, such as CT scans, have limited sensitivity in detecting postoperative complications like anastomotic leaks, which often go undetected for an average of 8.5 days, posing severe risks to patient health [5]. By integrating extensive data sets from electronic health records and monitoring devices, the platform will offer actionable insights for surgeons, allowing for quicker and more precise decision-making. The commercialization strategy includes initial deployment at Providence Health Care's St. Paul's Hospital in Vancouver, with plans to expand to other hospitals, leveraging partnerships to distribute the platform across Canada, the US, and global markets. FluidAI Medical is leading the development of predictive models and integrating the Stream™ Platform for remote patient monitoring. Medtronic Canada is providing vital monitoring solutions and collaborating on the development of predictive analytics. Excelar Technologies is enhancing its CareFlow platform to support broader use cases in AI-driven risk prediction. Providence Health Care Ventures is facilitating feasibility trials, validating solutions, and ensuring regulatory compliance. The data governance strategy includes the highest standards of privacy, security, ethics and consent approvals and management. The University of Waterloo is conducting user needs assessments to ensure the platform meets healthcare providers' requirements. Each consortium member brings unique expertise and resources to the project, creating a robust and comprehensive solution for postoperative patient management. By integrating AI and continuous monitoring into the PPMP project, we are developing a platform that not only facilitates earlier detection of complications but also sets a new precedent for proactive, data-driven patient care." Says Youssef Helwa, CEO at FluidAI. "FluidAI is proud to be leading the collaboration of Canadian medical technology pioneers on this project which highlights our collective commitment to innovation and excellence." Rick Sethi, Sr. Director of Research & Technology and Open Innovation at Medtronic AC&M, says, "We are excited to be collaborating with amazing partners such as DIGITAL, FluidAI and our other consortium team members to find ways to reduce length of stay of patients in hospitals. The development of our AI-based Clinical Decision Support technology will help augment patient care by supporting our clinicians." "AI will revolutionize global health care systems by providing greater access and better outcomes for Canadians and for people around the world." said Sue Paish, CEO of DIGITAL. "By uniting industry leaders, innovators, and academic partners, we're building the foundation for tomorrow's breakthroughs and ensuring Canada remains at the cutting-edge of global AI innovation. We're proud to co-invest alongside innovators like FluidAI to build relevant AI solutions that advance human health while building global commercial pathways for Canadian companies." By enhancing patient care through early detection and intervention of postoperative complications, the platform will directly improve patient outcomes. Hospitals will benefit from more efficient patient management, reduced hospital stays, and lower readmission rates, and significant cost savings. The PPMP project is a development project and is not yet licensed by Health Canada. About FluidAI Medical FluidAI (formerly known as NERv Technology Inc.) is a Canadian medical technology company that uses AI to aid with the early detection of postoperative complications. From general to gastrointestinal surgeries, FluidAI's mission is to empower healthcare providers with data-driven solutions that improve patient outcomes and advance postoperative care. To learn more about FluidAI and how the company is transforming postoperative care, please visit . About Medtronic Canada ULC Proud to serve Canadian healthcare for over 50 years, Medtronic Canada ULC is headquartered in Brampton, Ontario, and is a subsidiary of Medtronic PLC. We are the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Our technologies and therapies address 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Visit Medtronic.ca, and follow us on X and LinkedIn. About DIGITAL DIGITAL is Canada's leader in accelerating the development and commercialization of Canadian-made digital technologies that address some of the most pressing needs across our economy and society. DIGITAL's model of collaborative innovation and co-investment advances the success of Canadian businesses through the development, adoption and commercialization of Canadian-made technologies while also growing a workforce that is skilled to fill the jobs of a growing digital economy. DIGITAL brings together businesses, academia, community and government agencies to solve some of industry and society's biggest challenges - better and faster than any single organization can do on its own. Through the powerful model that combines cross-sector collaboration, Canadian IP creation and results-based co-investment, we unlock the potential of Canadian industry to lead and succeed in the digital world. Ahead of the curve starts here. For more information, visit digitalsupercluster.ca About Excelar Technologies Excelar's Careflow platform, comprised of Orchestrator, Timeline, and Insights, will support the project. Orchestrator connects patient data across consortium partners' platforms, AI models, and hospital systems. Timeline offers clinicians patient timeline data visualization. Insights provides observational analytics for AI model evaluation, tuning, and governance, as well as de-identified data for clinical research and quality improvement. To learn more about Careflow, visit . About Providence Health Care Ventures As an expert navigator of the Canadian health care, regulatory, and technology landscape, PHC Ventures provides indispensable support to corporate, institutional and individual innovators seeking to validate and commercialize their products and ideas. PHC Ventures offers a portal to Providence Health Care in Vancouver, Canada, a renowned provincial health organization whose lengthy innovation track record and size make it an ideal incubator to validate and scale innovations. PHC Ventures actively co-develops health solutions, forges unconventional partnerships, facilitates consulting relationships with PHC clinicians, and invests in health start-ups. For more, visit About the University of Waterloo University of Waterloo is a leading global innovation hub that drives economic and social prosperity for Canada and the world. With more than 41,000 students, we are home to the world's largest co-op education talent pipeline, to game-changing research and technology, and to an unmatched entrepreneurial culture. Together, these create partnerships and solutions to tackle today's and tomorrow's challenges. Find out more at uwaterloo.ca SOURCE Fluid AI Medical

OR YEHUDA, Israel, May 29, 2024 /PRNewswire/ -- There has been a robust start of Exero Medical's new, international, pivotal, multi-center study of its xBar system. xBar is an FDA breakthrough designated medical device, implementing a novel post-surgical tissue monitoring technology. It is designed to provide timely and accurate data on patients' postoperative healing, to personalize care and expedite the detection of potential life-threatening complications following GI surgery. Continue Reading Exero’s xBar Device The study, initiated 8 weeks ago in Israel and the US, has already enrolled and has used the device to monitor more than 20 patients recovering from colorectal surgery. Ten clinical sites, in the US and Israel, will collectively enroll approximately 190 eligible subjects undergoing colorectal surgery with anastomosis. Thus far, Kaplan Medical Center, Rabin Medical Center and Soroka Medical Center in Israel and Weill Cornell/ New York-Presbyterian Hospital in the US have collectively enrolled 23 patients. "Anastomotic leaks are probably the most fretted complication that patients and their clinical team may encounter. Delays in diagnosis can lead to mortality, worsening oncological and functional outcomes and long prolonged hospitalization. Previous studies have shown the great promise this technology holds in providing advanced notice of pending complications and supporting clinical decision making, and we are looking forward to the results of the study and a potentially new gold standard in post-surgical diagnostics," said Mehraneh Dorna Jafari, MD, Associate Professor of Surgery at Weill Cornell Medical College, Chief of Colorectal Surgery at New York-Presbyterian Brooklyn Methodist Hospital and Exero Principal Investigator. xBar collects and analyzes data from the surgical site using a sensor seamlessly embedded in a standard surgical drain. The system's analysis software is designed to alert surgeons if the gastrointestinal tissue is not healing properly and a risk of anastomotic leak is likely to occur. Data from an interim clinical study with 50 patients showed that xBar was able to detect pending leaks, typically two-three days faster than the current standards of care. Exero Medical CEO Dr. Erez Shor said, "xBar is based on solid physiological working concepts and our excitement continues to grow as we collect data from this study, revealing the real-life performance of the system. We hope for a rapid and successful completion of the trial towards implementation of this breakthrough technology, to save lives, improve care and reduce cost." About Exero Medical Exero Medical's goal is to provide high-quality, actionable post-surgery tissue healing monitoring that can save lives, improve prognosis, and reduce costs. The company's flagship product, xBar, addressing a $7B market, received FDA Breakthrough Designation and is in clinical studies towards a commercial launch in 2025. The company, founded in 2018 by MEDX Xelerator, is also backed by the Israeli Innovation Authority, Clalit Health Services, the largest HMO in Israel and Unorthodox Ventures. xBar is not approved for sale in the United States and is limited to investigational use. For more information, please visit Follow Exero Medical on LinkedIn Press Contact: Marjie Hadad General Manager Must Have Communications On behalf of Exero Medical 917-790-1178 [email protected] Photo: SOURCE Exero Medical

Researchers at Northwestern University and Washington University School of Medicine in St. Louis found a new way to use ultrasound to monitor patient health. This first-of-its-kind sticker enables the monitoring of organs and deep tissues through a simple ultrasound device. When attached to an organ, the soft, tiny sticker changes in shape in response to the body’s changing pH levels. This can serve as an early warning sign for post-surgery complications, like anastomotic leaks. Clinicians can view the shape changes in real-time through ultrasound imaging. According to the researchers, no existing methods can reliably and non-invasively detect anastomotic leaks. The sticker they developed can enable earlier interventions than previously possible. Then, when the patient fully recovers, the biocompatible, bioresorbable sticker dissolves, eliminating the need for surgical extraction. The team published data from a study evaluating three different types of stickers made from hydrogel materials. Published in Science, the study spanned small and large animal models, looking at anastomotic leaks from the stomach, small intestine and pancreas. “These leaks can arise from subtle perforations in the tissue, often as imperceptible gaps between two sides of a surgical incision,” said Northwestern Engineering’s John A. Rogers, who led device development with postdoctoral fellow Jiaqi Liu. “These types of defects cannot be seen directly with ultrasound imaging tools. They also escape detection by even the most sophisticated CT and MRI scans. We developed an engineering approach and a set of advanced materials to address this unmet need in patient monitoring. The technology has the potential to eliminate risks, reduce costs and expand accessibility to rapid, non-invasive assessments for improved patient outcomes.” Chet Hammill, who led the clinical evaluation and animal model studies at Washington University with collaborator Matthew MacEwan, an assistant professor of neurosurgery, sought out Rogers to produce improved outcomes for patients with anastomotic leaks. Rogers’ team previously developed bioresorbable electronic devices to serve as temporary implants. “We like to monitor patients for complications for about 30 days,” Hammill said. “Having a device that lasts a month and then disappears sounded ideal.” Improving ultrasound Rogers surmised that the team could enhance current imaging methods rather than develop new imaging systems for this technology. Ultrasound represented an inexpensive, available option that didn’t require large, cumbersome equipment or expose patients to radiation or other risks. The team noted that ultrasound fails to reliably differentiate between bodily fluids, like blood and gastric fluid, for example. “The acoustic properties of the leaking fluids are very similar to those of naturally occurring biofluids and surrounding tissues,” Rogers said. “The clinical need, however, demands chemical specificity, beyond the scope of fundamental mechanisms that create contrast in ultrasound images.” The team’s approach to address this issue utilized tiny sensor devices that are readable by ultrasound. They made their small, tissue-adhesive sticker from a flexible, chemically responsive, soft hydrogel material. Then, they embedded small, paper-thin metal disks into the layers of the hydrogel. When the sticker encounters leaked fluids, it swells. Visualizing the sticker When the sticker swells, the metal disks within it move apart in a way that ultrasound can see. “Because the acoustic properties of the metal disks are much different than those of the surrounding tissue, they provide very strong contrast in ultrasound images,” Rogers said. “In this way, we can essentially ‘tag’ an organ for monitoring.” Because the need for monitoring extends only during a postsurgical recovery, Rogers team designed these stickers with bioresorbable materials. They simply disappear naturally and harmlessly in the body after they are no longer needed. Computational collaborator Yonggang Huang, the Jan and Marcia Achenbach Professorship in Mechanical Engineering and professor of civil and environmental engineering at McCormick, used acoustic and mechanical simulation techniques. These helped to guide optimized choices in materials and device layouts to ensure high visibility in ultrasound images. This applied to stickers located at deep positions within the body as well. “CT and MRI scans just take a picture,” Hammill said. “The fluid might show up in a CT image, but there’s always fluid collections after surgery. We don’t know if it’s actually a leak or normal abdominal fluid. The information that we get from the new patch is much, much more valuable. If we can see that the pH is altered, then we know that something isn’t right.” The team created stickers across a range of sizes, with the largest coming in at 12 mm in diameter and the smallest just 4 mm in diameter. The metal disks within them register at just 1 mm in diameter. Rogers says the small size of the disks means radiologists could have difficulty assessing the images manually. So, the team developed a software that can automatically analyze the images, detecting disk movement with high accuracy. Testing the sticker To evaluate the stickers, Hammill’s team conducted the animal model testing. In the studies, ultrasound imaging consistently detected changes in the shape-shifting sticker, even as deep as 10 cm in the tissues. When exposed to fluids with abnormally high or low pH levels, the sticker’s shape changed within minutes. According to Rogers and Hammill, the researchers feel the device could be implanted after a surgical procedure. Additionally, they envision delivery through a syringe thanks to the small size and flexibility of the sticker. “These tags are so small and thin and soft that surgeons can easily place collections of them at different locations,” Rogers said. “For example, if an incision extends by a few centimeters in length, an array of these tags can be placed along the length of the site to develop a map of pH for precisely locating the position of the leak.” The team believes that next steps could include similar tags that could detect internal bleeding or temperature changes. “Detecting changes in pH is a good starting point,” Rogers said. “But this platform can extend to other types of applications by use of hydrogels that respond to other changes in local chemistry, or to temperature, or other properties of clinical relevance.”