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Press Release

iSchemaView's Rapid Adopted by More Than 700 Stroke Centers Over 100 Percent Growth This Year

More Than 2,000 Cases Weekly on RAPID’s Advanced Imaging Platform, the Imaging Standard for Stroke Centers Redwood City, Calif. – October 29, 2018 — Today, on World Stroke Day, iSchemaView, the worldwide leader in advanced imaging for stroke, announced that adoption of its RAPID advanced imaging platform has grown more than 100 percent year-to-date. Over 700 stroke centers around the world have now contracted to use the RAPID platform commercially, and over 300 sites are installing RAPID for clinical research, including multinational trials. “On a day dedicated to stroke awareness, we are proud to play a growing role in helping stroke patients globally,” said Don Listwin, CEO of iSchemaView. “With stroke centers now delivering over 100,000 RAPID cases a year, dramatically more patients are receiving treatment than ever before.” RAPID has quickly become the ubiquitous standard in the analysis of brain images using automated tools for CT ASPECTS, CT angiography, CT perfusion and MR diffusion and perfusion. Developed by leading stroke experts, RAPID combines unmatched expert feature extraction, proprietary algorithms and machine learning to deliver the best-in-class platform, one that has quickly become the standard in three quarters of U.S. comprehensive stroke centers. “This is an amazing moment in stroke medicine, and with the backdrop of World Stroke Day, it is the ideal time to celebrate the landmark research that has recently opened new treatment windows for so many more patients,” said Dr. Greg Albers, Professor of Neurology at Stanford University, Director of the Stanford Stroke Center and cofounder of iSchemaView. “We are incredibly gratified that the RAPID platform, built on clinical data and deep stroke expertise, is helping researchers drive this transformation in the treatment of stroke.” RAPID, the worldwide imaging platform of choice for stroke research, was chosen as the imaging solution for patient selection in five groundbreaking clinical trials. These include SWIFT PRIME, EXTEND IA, DAWN, DEFUSE 3 and, most recently, EXTEND. In addition to transforming selection for thrombectomy procedures, the positive results of the EXTEND trial that were recently presented at the World Stroke Congress, demonstrate that RAPID may now allow primary stroke centers to potentially provide effective treatment for patients who present beyond the traditional time window for intravenous tPA therapy. “I would like to congratulate the EXTEND investigators for this landmark achievement,” continued Dr. Albers. “For the last two decades, numerous investigators have attempted to expand the window for intravenous tPA therapy. The results of the EXTEND study will dramatically increase the number of patients who can benefit from intravenous thrombolysis.” Under IRB approval, the RAPID platform was also used to select patients for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that successfully treated patients up to twenty-four hours after onset. RAPID was the exclusive imaging tool used to aid in patient selection in both studies. The results of the studies helped change the American Heart Association and American Stroke Association’s stroke guidelines to include CT perfusion and MR perfusion. The prior treatment window for mechanical thrombectomy was up to six hours. Starting in 2018, select patients with salvageable brain tissue identified through advanced imaging are now eligible for treatment up to twenty-four hours after they were last seen well.
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Press Release

iSchemaView's Rapid Approved for Use in Canada

Patients Suffering Ischemic Stroke in Canada Now Have Access to the Only Clinically Validated, Next-Generation Imaging Platform for Assessing Treatment Redwood City, Calif. – August 16, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced it has received final approval for the use of the RAPID platform in Canada. The RAPID platform is designed to provide physicians with fast, fully automated, elegant and easy-to-interpret imaging that facilitates clinical decision-making around cerebrovascular disease, such as stroke. Canadian approval comes after iSchemaView’s quality system was certified through the Medical Device Single Audit Program (MDSAP) — a global approach to auditing and monitoring the manufacturing of medical devices, in an effort to improve safety and oversight on an international scale. iSchemaView’s RAPID platform was recently used to select patients for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that successfully treated patients up to twenty-four hours after onset. RAPID was the exclusive imaging tool used to aid in patient selection in both studies. The results of the studies helped change the American Heart Association’s and Canadian Heart and Stroke Foundation’s stroke guidelines to include CT perfusion and MR perfusion. The prior treatment window for mechanical thrombectomy was up to six hours. Starting in 2018, select patients with salvageable brain tissue identified through advanced imaging are now eligible for treatment up to twenty-four hours after they were last seen well. “Our research use of RAPID has shown that its speed and accuracy are very helpful in the management of patients with acute stroke,” said Dr. Frank Silver, Medical Director, Toronto West Stroke Network; Medical Director of the Ontario Telestroke Program and Professor of Neurology at the University of Toronto. “RAPID plays an important role in selecting which patients should be urgently transferred to regional stroke centers for endovascular therapy.” RAPID technology assists physicians in the analysis of brain images using automated tools for CT ASPECTS, CT angiography, CT perfusion and MR diffusion and perfusion for more than 85,000 stroke cases per year. RAPID is also currently deployed in six multi-center clinical trials globally — adding 200 hospitals to RAPID’s global reach. The RAPID neuroimaging platform creates high-quality images from non-contrast CT, CT angiography, CT perfusion and MRI diffusion and perfusion studies. The software provides an intuitive and easily interpretable real-time view of brain perfusion, allowing physicians to determine lesion volumes for a wide variety of different thresholds. Also approved for use in Canada is RAPID ASPECTS, a validated solution that assists clinicians in assessing early signs of brain ischemia in stroke. RAPID ASPECTS automatically generates a standardized score — based on clinically validated machine learning algorithms — that enables physicians to easily communicate about the extent of a patient’s ischemic changes and to determine eligibility for thrombectomy (clot removal). In addition, RAPID ASPECTS provides clear visualization of the brain so that clinicians can better scrutinize each region and confirm the automated score. “With approval for RAPID in Canada, we will be able to greatly expand the number of health care facilities that are able to assess stroke patients with the only clinically validated next-generation imaging technology,” said Don Listwin, CEO of iSchemaView. “Over 575 stroke centers in 22 countries around the world have now committed to using the RAPID platform, and we look to increasing that number substantially by the end of the year.” For more information about working with RAPID in Canada, contact Cynthia Yang at +1 (949) 836-7402 or at yang@irapid.com .
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Press Release

iSchemaView Rapid Technology Now Installed in More Than 500 Stroke Centers Up 48% Since April

Explosive Growth of the De Facto Standard for Advanced Cerebrovascular Imaging Redwood City, Calif. – August 14, 2018 — iSchemaView, the leader in cerebrovascular imaging analysis, today announced accelerated adoption of the RAPID advanced imaging platform. Over 575 stroke centers in 22 countries around the world have now committed to using the RAPID platform, with 520 currently installed. RAPID technology assists physicians in the analysis of brain images using automated tools for CT ASPECTS, CT angiography, CT perfusion, MR diffusion and perfusion for more than 85,000 stroke cases per year. RAPID is also currently deployed in six multi-center clinical trials globally — adding 200 hospitals to RAPID’s global reach. “Stroke centers want the very best technology to improve patient outcomes, and RAPID’s reputation as the platform of choice for stroke research has accelerated the pace of our growth tremendously,” said Don Listwin, CEO of iSchemaView. “The fast growth of the RAPID platform — the only next-generation imaging platform validated in multiple clinical trials — means a substantial increase in the number of addressable patients who have suffered ischemic stroke.” Under IRB approval, iSchemaView’s RAPID platform was recently used to select patients for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that successfully treated patients up to twenty-four hours after onset. RAPID was the exclusive imaging tool used to aid in patient selection in both studies. The results of the studies helped change the American Heart Association and American Stroke Association’s stroke guidelines to include CT perfusion and MR perfusion. The prior treatment window for mechanical thrombectomy was up to six hours. Starting in 2018, select patients with salvageable brain tissue identified through advanced imaging are now eligible for treatment up to twenty-four hours after they were last seen well. “In addition to individual stroke centers, iSchemaView’s RAPID platform has recently been adopted by several large hospital systems, including 17 hospitals of Baylor Scott & White Health,” said Anil Singhal, MD, Senior Vice President for iSchemaView. “By deploying RAPID through large hospital systems in a hub and spoke model, more patients will be able to get the right treatment at the most appropriate facility, vastly improving patient care and at the same time increasing hospital efficiency.” The RAPID neuroimaging platform creates high-quality images from non-contrast CT, CT angiography, CT perfusion and MRI diffusion and perfusion studies. The software provides an intuitive and easily interpretable real-time view of brain perfusion, allowing physicians to determine lesion volumes for a wide variety of different thresholds. The platform includes four different imaging products, tailored to the particular needs of each facility: RAPID MRI provides fully automated, easy-to-interpret diffusion and perfusion maps that identify brain areas with low ADC values, as well as delayed contrast arrival. RAPID MRI perfusion automatically quantifies regions of reduced cerebral blood flow, volume and transit time that exceed pre-specified thresholds. RAPID CTP provides perfusion maps that automatically quantify regions of reduced cerebral blood flow, volume and transit time that exceed pre-specified thresholds. Regions are color coded, and the volumes of interest are automatically measured. Maps (including mismatch maps) of the severity of Tmax delays are provided using a four-color-coded scale. RAPID CTA automatically provides clear, easy-to-interpret CTA maps which include a colored overlay to identify brain regions with reduced blood vessel density. The severity of reduction can be readily visualized by a simple fourcolor-coded scale. Additionally, a 3D reconstruction of the vasculature allows physicians to rotate the image for optimal viewing of the vessels from multiple angles. RAPID ASPECTS automatically generates a standardized score — based on clinically validated machine learning algorithms — that enables physicians to easily communicate about the extent of a patient’s ischemic changes and to determine eligibility for thrombectomy (clot removal). In addition, RAPID ASPECTS provides clear visualization of the brain so that clinicians can better scrutinize each region and confirm the automated score. RAPID ASPECTS is CE Marked.
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Press Release

iSchemaView Completes MDSAP Audit, Moves to Expand Worldwide Adoption of Rapid Imaging Platform

Critical International Audit Paves Way for Regulatory Application and Approvals Around the World. Canadian Representative Launched. Redwood City, Calif. – June 5, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced that the company has completed the Medical Device Single Audit Program (MDSAP), with coming certification. iSchemaView is now applying for clearances and approvals of the RAPID imaging platform in all participating countries around the world. In 2014, the International Medical Device Regulators Forum (IMDRF) launched a global approach to auditing and monitoring the manufacturing of medical devices, in an effort to improve safety and oversight on an international scale. The result was the creation of the MDSAP, a regulatory audit that serves as a critical step in satisfying the relevant requirements of international regulatory authorities. MDSAP participating countries include Australia, Brazil, Canada, Japan and the United States, with the World Health Organization and European Union among official observers. “With dozens of new stroke centers installing RAPID’s automated CTP, MR, CTA and ASPECTS solutions each month, we are seeing accelerating adoption this year,” said Don Listwin, CEO of iSchemaView. “Now that we have completed the MDSAP we are looking to ensure that patients to our North, and around the world, can take advantage of our unmatched imaging solutions. Our mission is to help health care systems address and treat more stroke patients than ever before, and this news moves us ever more swiftly down the path of success.” With MDSAP complete, iSchemaview will be pursuing approval for RAPID in all participating countries, with estimated clearance in Canada expected this summer. In lock-step with the process, iSchemaview is also announcing that Kevin Talmage of Yocan Medical Systems will partner with the company as a Canadian region representative. Talmage brings with him over twenty years of successful medical device marketing and sales experience across Canada. For more information about working with RAPID in Canada, contact Kevin Talmage at (647) 271- 2516 or at kevin.talmage@yocanmedical.ca .
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iSchemaView Introduces Rapid ASPECTS

State-of-the-art imaging solution provides automated scoring to assess early signs of brain ischemia Gothenburg, Sweden - May 15, 2018 - At the European Stroke Organization Conference, iSchemaView publicly launched RAPID ASPECTS, a digital imaging solution designed to help clinicians assess early signs of brain ischemia in stroke.
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Press Release

iSchemaView Receives FDA Clearance for Rapid CTA

Leader in Advanced Cerebrovascular Imaging First to Meet the Needs of Large and Small Centers and Hospitals with New CTA Support and 3D Imaging Added to Complete Suite of Rapid Offerings Redwood City, Calif. – May 1, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced it has received final clearance from the U.S. Food and Drug Administration (FDA) for RAPID CTA, the company’s 3D imaging solution for Computed Tomography Angiography. RAPID CTA is the newest addition to iSchemaView’s industry leading neuroimaging platform — including RAPID CTP and RAPID MRI — which is designed to provide physicians with fast, fully-automated, elegant and easy-to-interpret imaging that facilitates clinical decision making around cerebrovascular disease, such as stroke. In simplest terms, CTA provides visualization of blood vessels in the brain. Using an injectable contrast agent, high-tech X-ray imaging and sophisticated computer analysis, a CT angiogram provides physicians with detailed and accurate images of the vasculature. However, interpreting standard CTA output is a cumbersome timeconsuming process. RAPID CTA automatically provides clear, easy to interpret CTA maps which include a colored overlay to identify brain regions with reduced blood vessel density. The severity of reduction can be readily visualized by a simple, four-color-coded scale. Additionally, a 3D reconstruction of the vasculature allows physicians to rotate the image for optimal viewing of the vessels from multiple angles. All of this in a few minutes. RAPID CTA is a phenomenal tool for all doctors involved in neurovascular emergencies – from the ER doctor making decisions about patient transfer to the neurointerventionalist getting ready for an incoming thrombectomy procedure. “Our goal is to provide healthcare professionals around the world with the most comprehensive and intuitive suite of imaging solutions possible,” said Don Listwin, CEO of iSchemaView. “With new FDA clearance and the release of RAPID CTA, we are making good on that goal. We ensure physicians can take advantage of RAPID’s power whether they choose plain CT, CT Angiography, CT Perfusion or MR diffusion and perfusion. It’s all about offering them the right imaging solution choice, for the right patient at the right time.” In an effort to save valuable diagnosis and treatment time, RAPID CTA also offers remote viewing for physicians in the hospital, at home or on the road. Image maps are immediately available to doctors for review on any desktop or mobile device. RAPID CTA maps provide an intuitive and easy to interpret view of the brain vessels, helping physicians with: Clinical decision making Patient triage Collaboration between community hospitals and specialists Appropriate patient transfers to specialty centers “Many eligible stroke patients with large vessel occlusions must be quickly transferred to a comprehensive stroke center. The new automated RAPID CTA tool makes it easy for community hospitals to quickly identify potential candidates for treatment and for experts at the comprehensive centers to verify that the patient is appropriate for transfer,” said Greg Albers, Professor of Neurology at Stanford University, Director of the Stanford Stroke Center and cofounder of iSchemaView. “With the addition of CTA to RAPID’s FDA indications, hospitals and clinics of all sizes and locations can now use the platform to immediately review images from wherever they are. That’s powerful.”
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Press Release

iSchemaView Technology RAPIDly Adopted by Over 350 Stroke Centers

RAPID Becoming a New Standard in Advanced Cerebrovascular Imaging Redwood City, Calif. – April 24, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced accelerating adoption of its platform. As of today over 350 stroke centers are now using RAPID advanced imaging technology to assist physicians in the analysis of brain images using automated tools for CT, CT Perfusion, MR diffusion and perfusion. With over 350 stroke centers now using RAPID around the world, regular daily use at the centers is generating over 50,000 scans a year. With 200 or more systems expected to come online in 2018, scan count is projected to approach 100,000 per year. “It is terrific to see the industry respond so dramatically to recent studies and adopt RAPID so quickly,” said Don Listwin, CEO of iSchemaView. “The most important result is that we are getting our complete imaging solution into as many hospitals as possible for the benefit of substantially more addressable patients. We want to put an end to time constrained ‘wait and see’ stroke outcomes, and put RAPID to work for all.” Under IRB approval, iSchemaView’s RAPID platform was recently used to select patients for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that successfully treated patients up to twenty-four hours after onset. RAPID was the exclusive imaging tool used to aid in patient selection in both studies. The results of the studies helped change the AHA stroke guidelines to include CT Perfusion and MR perfusion. The prior treatment window for mechanical thrombectomy was up to six hours. Starting in 2018, select patients with salvageable brain tissue identified through advanced imaging are now eligible for treatment up to twenty-four hours after they were last seen well. "Now there's the potential to treat based on best evidence not just best guess, that’s what RAPID’s perfusion platform affords,” said Christian Ramsey, MD, Neurosurgeon and Surgical Director of Stroke at Baptist Health System. “More patients with more treatment options offers the potential for successful outcomes in patients with historically terrible prognoses.” Today, Gregory W. Albers MD, Stanford University Neurologist and cofounder of iSchemaView, will also be presenting Expanding the Time Window for Thrombectomy: Results of the DEFUSE 3 Study at the Annual Meeting of The American Academy of Neurology in Los Angeles.
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Press Release

iSchemaView Names Don Listwin as CEO

Silicon Valley Leader Joins Innovator in Cerebrovascular Imaging to Revolutionize Stroke Care Redwood City, Calif. – April 16, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced that former Cisco and Openwave Systems executive, Don Listwin, has joined the company as Chief Executive Officer (CEO). Listwin comes to iSchemaView with over 30 years of technology management experience, helping dramatically grow both large and emerging brands. “Don stands out as a highly respected leader with an incredible track record of success. He will ensure that iSchemaView capitalizes on its leadership position as the company that provides automated software solutions that aid in the diagnosis of cerebrovascular disease, and are used by many of the world’s leading stroke centers as they work to identify and successfully treat more patients than ever before,” said Gregory W. Albers MD, Stanford University Neurologist and cofounder of iSchemaView. “RAPID is the only imaging software solution used in the studies that selected patients for stroke treatment in the expanded window between six and twenty-four hours. Don will help us not just grow quickly, but also intelligently, as we meet the large demand for clinically proven imaging software in the US and around the world.” iSchemaView’s RAPID platform assists physicians in the analysis of brain images using automated tools for CT, CT Perfusion and MR diffusion and perfusion. Under IRB approval, RAPID was recently used to select patients for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that successfully treated patients up to twenty-four hours after onset. RAPID was the exclusive imaging tool used to aid in patient selection in both studies. The results of the studies have changed the AHA stroke guidelines to include CT Perfusion and MR perfusion. The prior treatment window for mechanical thrombectomy was up to six hours. Starting in 2018, select patients with salvageable brain tissue identified through advanced imaging are now eligible for treatment up to twenty-four hours after they were last seen well. “Greg and his co-founder Doctor Roland Bammer, innovators in the treatment of stroke, had a mission to eliminate the long-term dogma that stroke was untreatable after three to six hours,” said Don Listwin, CEO of iSchemaView. “With an intuitive but novel approach to brain imaging they are achieving their goal. And with a world of healthcare administrators and clinicians interested in taking advantage of new guidelines I look forward to helping iSchemaView achieve business success and more importantly to help physicians effectively diagnose and treat many more afflicted patients than previously thought possible.” Don Listwin spent a decade at Cisco Systems, where he served as executive vice president. During his tenure at Cisco, Don built several multi-billion-dollar lines of business, including the company’s Service Provider line of business that underpins much of today’s global Internet infrastructure. More recently, Listwin served as chief executive officer of both Sana Security and Openwave Systems. In addition, Don founded and holds the role of chief executive officer of the Canary Foundation, a non-profit research organization focused on the early detection of cancer. He also serves as a director on the boards of AwareX, Calix, D-wave, POET Technologies, iSchemaView, Robin Systems and Teradici. Previously, he also served on the boards or was an advisor to JDS Uniphase, PLUMgrid, Redback Networks, E-TEK Dynamics, the Cellular Telecommunications & Internet Association (CTIA) and the Business Development Bank of Canada (BDC). Listwin received a BSEE from the University of Saskatchewan, He is also a consulting professor in the School of Medicine at Stanford University
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