UniversitätsSpital Zürich

BAAR, Switzerland--( BUSINESS WIRE )-- CorFlow Therapeutics AG (CorFlow) announced today that it has raised €44 million in Series B funding, co-led by Broadview Ventures and Panakes Partners with strong continued support from 415 Capital , CorFlow's initial VC investor and largest shareholder. Merieux Equity Partners , Laerdal Million Lives Fund , Wellington Partners , M&L Investments , Unorthodox Ventures , KOFA Healthcare and Monte Carlo Capital participated in the multinational syndicate . Concurrent with the financing, David Prim of Broadview Ventures, Barbara Castellano of Panakes Partners, Yoann Bonnamour of Merieux Equity Partners, and Rhiya Pau of Laerdal Million Lives Fund have joined the CorFlow Board of Directors. The Series B will fund the MOCA II ( M V O with C oFI TM System A ssessment II) pivotal study intended to gain US market clearance. The trial will run in the US and Europe and aims to validate CorFlow’s CoFl system to diagnose MVO in heart attack patients immediately following stent implantation. Additionally, it will fund an adaptive platform therapy study evaluating treatment effects of therapeutic agents delivered locally through the CoFl system on heart attack patients diagnosed with MVO. MVO affects more than half of all patients who suffer an acute heart attack and is an independent predictor for heart failure and mortality. Currently not routinely diagnosed MVO remains largely untreated, leading to poor patient outcomes, and contributing to high health care costs associated with cardiovascular disease. CorFlow’s CoFl system is being developed to provide timely, accurate and consistent detection of MVO while patients are still in the catheter laboratory (cath lab) immediately following the reopening of the larger epicardial arteries with a stent. Uniquely, the technology has been designed to also enable localized delivery of therapeutics to the microvasculature upon MVO diagnosis. CoFl also seamlessly integrates into standard workflows utilizing existing guide catheter and wire access. "We are thrilled to have closed on this significant round of financing, backed by a top-tier global syndicate of medical technology investors," commented Paul Mead, President and Chief Executive Officer of CorFlow. "Recent data from over 70 patients in our MOCA I first in human trial and from our extensive preclinical program support our collective confidence that we can improve outcomes in patients who suffer heart attacks, specifically those patients whose microvascular disease goes undiagnosed and untreated today. There is overwhelming evidence now that microvascular conditions are a significant root cause of adverse outcomes in heart attack patients and other cardiovascular conditions. I am grateful that our new investors have the vision to see 'where the puck is going' in this rapidly emerging field." The MOCA II IDE trial is designed to confirm the CoFl system’s accuracy in diagnosing MVO in high-risk heart attack patients. Led by Principal Investigator Dr. Tim Henry of The Christ Hospital in Cincinnati, Ohio, the trial will recruit several hundred patients undergoing stent implantation due to ST-Elevation Myocardial Infarction (STEMI) and will compare CoFl's proprietary dynamic diagnostic measurement of MVO to post-procedure Contrast Enhanced Cardiac Magnetic Resonance Imaging (CMRI), the current gold standard for detecting MVO. The MOCA II trial leverages the learnings from the company’s First-In-Human MOCA I trial conducted in Switzerland, Latvia and the UK. "There is increasing awareness of the impact of MVO on patient outcomes following coronary revascularization. CorFlow has the potential to be the next significant breakthrough in treating coronary artery disease, and Broadview is delighted to be supporting this impressive team and technology,” states David Prim of Broadview Ventures. "CorFlow's breakthrough technology has been designed by clinicians for clinicians and we are excited to support CorFlow's mission to generate robust clinical data in order to get this much needed therapy to the patient as quickly as possible." adds Barbara Castellano of Panakes Partners. "We also are committed to supporting the emerging field of microvascular disease in general, and this oversubscribed funding round gives us options to apply the technology in new ways, and in new geographies, where patients can benefit.” The funding will also support a novel adaptive platform therapy trial in Europe evaluating whether localized delivery of therapeutics to the microvasculature immediately following stent implantation can improve outcomes in patients diagnosed with MVO. Led by Dr. Giovanni Luigi De Maria (Oxford University Hospitals Trust, UK) and Professor Colin Berry (University of Glasgow and NHS Golden Jubilee National Hospital, UK), this European RCT will assess the effects of several therapeutic agents with both clinical and imaging measures up to six months. "The improvement in outcomes for heart attack patients has stagnated over many years now and we believe that real-time diagnosis and targeted therapy for MVO has the potential to save the lives of countless patients in the future." Comments Frederik Groenewegen of 415 Capital. "We have long been believers in the CorFlow technology and team, and with the support of this first-class investor syndicate we now have the opportunity to collect the clinical data required to establish a new standard of heart attack care." About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with offices in Italy, and founded in 2016 by Dr. Rob Schwartz, Dr. Martin Rothman and Jon Hoem. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications in and beyond the heart. About Microvascular Obstruction (MVO): Often described as the "last frontier" in the treatment of acute heart attacks, MVO is characterized by blockages in the microvascular coronary arteries, which vary in size down to the circumference of a human hair. Previous research has identified that MVO is one of the most powerful prognostic indicators for future adverse outcomes - for every 1% increase in MVO, there’s a corresponding 14% increase in one-year mortality risk and 8% increase in hospitalization due to heart failure.

Philips and the University of Zurich developed a new way to display a patient’s vital signs in an effort to reduce anesthesiology-related mistakes due to cognitive overload. By Mark Holger-Konrad, Philips Information overload can impact patient care and safety, particularly in the operating room, where quick and accurate interpretation of a patient’s vital signs is crucial. Time constraints, capacity limitations, and data overload contribute to poor situational awareness, which is the ability of clinicians to understand and effectively respond to the surrounding environment. In fact, poor situational awareness accounts for over 80% of anesthesia-related mistakes. This striking number shows the prevalence of data misinterpretation among clinicians and how it can lead to costly medical errors. To address this challenge, the industry needed a new way to simplify how patient data was presented to anesthesiologists on patient monitors. Philips collaborated with clinical research partners at the University Hospital of Zurich to launch an innovative avatar-based patient monitoring solution designed to reduce the impact of cognitive overload on decision-makers. Informed by clinician feedback and research, the team demonstrated how adding a visual depiction of a patient’s health status improved clinical decision-making and enabled the delivery of quick care and life-saving, timely interventions. The creation process behind this innovation is a testament to the impact of a collaborative approach between designers and end-users to benefit clinicians and allow them to deliver care with confidence. Alleviating cognitive overload through simple visual design While visual representations of anesthesiology data existed, they were often centered around detailed human figures — frequently using a white male figure as the basis — that could be zoomed in to review specific data points. This information is all critical, but this type of visual added complexity to what anesthesiologists were reviewing. Instead, Philips and the University of Zurich set out to create a simple snapshot of a patient’s vitals and overall condition that would guide anesthesiologists’ assessment and allow them to quickly react to changes and focus their attention on the most critical patient information at the moment. The Philips Visual Patient Avatar is represented through a basic silhouette that uses animations, colors, and shapes to demonstrate a patient’s vitals, such as oxygen levels, heart rate, and body temperature. This allows anesthesiologists and nurse anesthetists to recall and process critical data through a glance at the monitor, enabling better care decisions by minimizing distractions and confusion. Using a simplified human shape with a neutral coloring instead of an anatomically correct figure also helps to remove medical assumptions by eliminating sex and race from the visualization. Additionally, the Avatar’s design allows for the universal recognition of the visual cues that represent changes in a patient’s condition. While doctors may be trained to deliver the same type of care, they do not always speak or understand the same language, including written text and even numbers. However, simple designs can be universally identifiable, reducing the need for interpretation and potential errors. A clinical study found 73% of all vital sign information was correctly identified during the first use of the Avatar. Another clinical study found that users of the Avatar recalled almost double the number of vital signs after 3- and 10-second glances at the monitor. There was also an increase in the percentage of perceived vital signs by 57% when viewed for 10 seconds, and the perceived workload for the task decreased by 12%. Cross-industry inspiration and clinical research partnerships for end user-centric solutions When it comes to innovation, research has shown that bringing people from different industries together can be a source of radical novelty. The inspiration behind Visual Patient Avatar came from a source that may surprise you: the aviation industry. In addition to being practicing anesthesiologists, the creators also happened to be pilots who were inspired by the synthetic vision used on a plane’s dashboard, specifically how it gave them more confidence to navigate poor weather and low-visibility situations. Spotting the similarities with the situational awareness challenges in the OR, the creators explored new opportunities and spent five years researching and developing the Avatar. Developing an innovative solution requires collaboration and a willingness to evolve the design to meet the end-user’s needs. In the case of creating Visual Patient Avatar, we relied on a combination of clinical expertise with the right technology partner to bring it to life. As part of the creation process, practicing clinicians were key stakeholders in the design phase as they had a firsthand view of the most pressing care-related problems, knew the challenges at hand and the priority in which they needed to be fixed. Additionally, they were aware of the frustrations in their daily jobs as anesthesiologists and cognizant of the challenging task of convincing other clinicians who rely on patient monitors that this simple visual would be impactful in alleviating cognitive overload. The next stage in creating the avatar was ensuring the correct data was fed into accurate algorithms to deliver precise and actionable data to anesthesiologists. To do so, we had to consider key metrics such as perceptual performance, situational awareness, and qualitative indicators to test the effectiveness of the design. Leveraging patient data and practical clinical experience, we fostered an effective partnership where the objective was the same — to develop an innovative solution that would meet the needs of the end users and their patients. Not only does this ensure that the solution will truly address their needs, but it will also keep patient safety at the forefront of their minds. If we continue to collaborate on technologies created with the patients and end-users in mind, we are doing our part to support healthcare in new and unique ways. Novel ideas that solve some of the most critical problems can sometimes stem from unexpected places. Just like the synthetic vision on planes helped practicing anesthesiologists find a solution to alleviate cognitive overload, technology developers should continue to be inspired by the creations of other industries. In the face of everyday challenges, healthcare technology manufacturers must pair with the right clinical research partners and prioritize creating devices and solutions that will truly benefit the clinician. Ultimately, focusing on patients and how to improve outcomes inspires healthcare innovation. Mark Holger-Konrad is head of medical and clinical hospital patient monitoring at Philips and previously held clinical leadership positions at PULSION Medical Systems SE and Getinge. He was a practicing anesthesiologist for more than 13 years and received his doctorate from Heidelberg University in Germany. How to submit a contribution to MDO The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.

Monitoring and treating a case of multiple sclerosis requires reliable and long-term data on how the disease is progressing in the person in question. Fitness trackers and smartphones can supply this data, as a research team has now shown. Multiple sclerosis (MS) is an insidious disease. Patients suffer because their immune system is attacking their own nerve fibres, which inhibits the transmission of nerve signals. People with MS experience mild to severe impairment of their motor function and sensory perception in a variety of ways. These impairments disrupt their daily activities and reduce their overall quality of life. As individual as the symptoms and progression of the disease are, so too is the way it is managed. To monitor the disease progression and be able to recommend effective treatments, physicians ask their patients on a regular basis to describe their symptoms, such as fatigue. Going off memory Patients are thus faced with the tricky task of having to provide information about their state of health and what they have been capable of over the past few weeks and even months from memory. The data gathered in this way can be inaccurate and incomplete because patients might misremember details or tailor their responses to social expectations. And since these responses have a significant impact on how the progression of the disease is recorded, it could be mismanaged. "Physicians would benefit from having access to reliable, frequent and long-term measurements of patients' health parameters that give an accurate and comprehensive view of their state of health," explains Shkurta Gashi. She is lead author of a new study and postdoc in the groups led by ETH Professors Christian Holz and Gunnar Rätsch at the Department of Computer Science as well as a fellow of the ETH AI Center. Together with colleagues from ETH Zurich, the University Hospital Zurich, and the University of Zurich, Gashi has now shown that fitness trackers and smartphones can provide this kind of reliable long-term data with a high temporal resolution. Their study was published in the journal NPJ Digital Medicine. Digital markers for MS The researchers recruited a group of volunteers -- 55 with MS and a further 24 serving as control subjects -- and provided each person with a fitness tracking armband. Over the course of two weeks, the researchers collected data from these wearable devices as well as from participants' smartphones. They then performed statistical tests and a machine learning analysis of this data to identify reliable and clinically useful information. What proved particularly meaningful was the data on physical activity and heart rate, which was collected from participants' wearable devices. The higher the participants' disease severity and fatigue levels, the lower their physical activity and heart rate variability proved to be. Compared to the controls, MS patients took fewer steps per day, engaged in an overall lower level of physical activity and registered more consistent intervals between heartbeats. How often people used their smartphone also delivered important information about their disease severity and fatigue levels: the less often a study participant used their phone, the greater their level of disability and the more severe their level of fatigue. The researchers gained insights into motor function through a game-like smartphone test. Developed at ETH a few years ago, this test requires the user to tap the screen as quickly as possible to make a virtual person move as fast as possible. Monitoring how fast a person taps and how their tapping frequency changes over time allows the researchers to draw conclusions about their motor skills and physical fatigue. "Altogether, the combination of data from the fitness tracker and smartphone lets us distinguish between healthy participants and those with MS with a high degree of accuracy," Gashi says. "Combining information related to several aspects of the disease, including physiological, behavioural, motor performance and sleep information, is crucial for more effective and accurate monitoring of the disease." Reliable approach This new approach gives MS sufferers a straightforward way of collecting reliable and clinically useful long-term data as they go about their day-to-day lives. The researchers expect that this type of data can lead to better treatments and more effective disease management techniques: more comprehensive, precise and reliable data helps experts make better decisions and possibly even propose effective treatments sooner than before. What's more, evaluating this patient data lets the experts verify the effectiveness of different treatments. The researchers have now made their data set available to other scientists. They also point out the need for a larger study and more data to develop reliable and generalizable models for automatic evaluation. In the future, such models could enable MS patients to experience a significant improvement in their lives thanks to data from fitness trackers and smartphones.