The Royal Melbourne Hospital

Led by University Hospitals stroke director Amrou Sarraj, MD, SELECT2 study results in New England Journal of Medicine presented at International Stroke Conference CLEVELAND, Feb. 10, 2023 /PRNewswire/ -- A large international clinical study finds that patients with large strokes had a dramatically better recovery after endovascular thrombectomy plus medical management than patients receiving only standard medical management. Endovascular thrombectomy is mechanical recovery of a clot blocking blood flow in an artery. The study was published Feb. 10 in the New England Journal of Medicine to coincide with its presentation at the International Stroke Conference in Dallas. The SELECT2 study, which involved 31 medical centers in North America, Europe, Australia, and New Zealand, was stopped early because of the successful results seen in patients who received thrombectomy versus medication only. Global Principal Investigator and Lead Author of the study, Amrou Sarraj, MD, said, "We went on to challenge the current practice where patients with large strokes would be precluded from thrombectomy." Dr. Sarraj is the Stroke Center and System Director, the George M. Humphrey II Chair in Neurology at University Hospitals, and Professor of Neurology at Case Western Reserve University School of Medicine. While thrombectomy has proven effective in smaller strokes, patients with large strokes were considered too high risk for the procedure. Size of a stroke is determined by range of damaged brain tissue seen through CT or MRI scans. "These patients are left to receive medical management only, and a significant number of them end up with very poor outcomes; being wheelchair bound, bed ridden, or dead," said Dr. Sarraj. "This is a huge opportunity for improvement at a very large level, especially since these patients account for 20 to 25 percent of all large vessel occlusions and may have huge impact on patients, their family, and society." The study had a target of 560 patients with large artery occlusion causing a large stroke on CT or advanced imaging, but the data and safety monitoring board stopped the trial after enrollment of 352 patients because of the superior outcomes seen with thrombectomy. The patients were randomly assigned to one of two groups: 178 received thrombectomy and 174 received medical management. Patients who were seen prior to 4.5 hours from onset of stroke received clot-buster drugs TPA or TNKase if eligible. "We found that almost 20 percent of the patients who received a thrombectomy ended up with functional independence, going back to their family, to the society as almost normal or not needing support, compared to 7 percent for medical treatment only. We also found that almost 40 percent of the patients end up ambulating independently." said Dr. Sarraj, "This is a huge improvement in these patients with large strokes who are not being offered the treatment at this point." Dr. Sarraj expects the results to change treatment guidelines in the near future. "This will give a large number of patients the opportunity for a chance for improvement," he said. Cathy Sila, MD, Chair of Neurology and the Gilbert W. Humphrey Professor of Neurology at UH and Professor of Neurology at Case Western Resreve, said, "The results of the SELECT2 trial represent another major advancement in acute stroke therapy and brings hope for meaningful recovery to an additional subgroup of patients who previously would have been thought not to benefit. The success of SELECT2 trial is a testament to the dedication and perseverance of Dr. Sarraj, the UH stroke team, and his collaborating coinvestigators across the world. We are proud to be leading the charge towards a brighter future for patients and their families affected by stroke." "The Neurological Institute at UH is a leader in clinical trials involving patients with stroke. This study led by our researchers will dramatically improve the treatment of patients not just in Northeast Ohio but worldwide," said Nicholas Bambakidis, MD, Vice President and Director of the UH Neurological Institute, Chair of the Department of Neurosurgery, and holder of the Harvey Huntington Brown, Jr., Chair in Neurosurgery. He is also Professor of Neurological surgery at Case Western Reserve. "Conducting a trial at this level is not an easy task," Dr. Sarraj added. "First and foremost, I thank our patients and their families for their noble contributions to the trial, my co-investigators worldwide, my research team that was the heart and soul of the trial and University Hospitals which hosted the trial as the global coordinating center in the last two years since I came here." Grace A McComsey, MD, Vice President of Research, Associate Chief Scientific Officer and Director, Clinical Research Center at UH, said, "Research and innovation are vital to our UH mission. This is yet another great example of how well designed clinical trials can challenge the current knowledge to improve life expectancy and quality of life. I am proud of our team, led by Dr. Sarraj, that scientifically challenged the status quo and showed promise in a devastating condition like stroke." Dr. McComsey holds the Rainbow Babies & Children's Foundation John Kennell Chair of Excellence in Pediatrics. The trial was funded through a grant from Stryker Neurovascular to the University Hospitals Cleveland Medical Center and University of Texas Houston McGovern Medical School. Centers in the study were: University Hospital Cleveland Medical Center/Case Western Reserve University, USA; Valley Baptist Medical Center, USA; University of Kansas Medical Center, USA; University of Iowa Hospitals and Clinics, USA; University of Pennsylvania, USA; Cleveland Clinic, USA; Rush University Medical Center, USA; McGovern Medical School at UTHealth, USA; Melbourne Medical School, University of Melbourne, Australia; Thomas Jefferson University Hospital, USA; Ascension Columbia St. Mary's Hospital, USA; Hospital Clínico Universitario Valladolid - University of Valladolid, Spain; Corewell Health, USA; OhioHealth - Riverside Methodist Hospital, USA; Abington Jefferson Health, USA; Melbourne Brain Centre at the Royal Melbourne Hospital - University of Melbourne, Australia; Liverpool Hospital, Australia; University of New South Wales - Liverpool Hospital, Australia; Baptist Medical Center Jacksonville, USA; Christchurch Hospital, New Zealand; Hospital Universitari de Bellvitge, Spain; Hospital Universitari Germans Trias i Pujol, Spain; Toronto Western Hospital, Canada; Hospital Clínic de Barcelona, Spain; Kaiser Permanente Southern California, USA; Dell Medical School at The University of Texas at Austin - Ascension Texas, USA; Westchester Medical Center - NY Medical College, USA; Royal Adelaide Hospital, Australia; Goodman Campbell Brain and Spine, USA; Semmes Murphey Clinic, USA; University of Iowa Hospitals and Clinics, USA; Neuroradiology, University Hospital Basel, Switzerland; University of Alberta, Canada; Stanford University, USA; MAPS Public Benefit Corporation, USA; Boston Medical Center, USA; Icahn School of Medicine at Mount Sinai, USA; Hospitals of University of Pennsylvania, USA; St. Michael's Hospital, Canada; University of Calgary, Canada; Memorial Hermann Hospital, USA; Vall d'Hebrón, Spain; Institute for Neuroscience and Mental Health, Australia About University Hospitals / Cleveland, Ohio Founded in 1866, University Hospitals serves the needs of patients through an integrated network of more than 20 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system's flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University and the Technion Israel Institute of Technology. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org. About Case Western Reserve University Case Western Reserve University is one of the country's leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 5,800 undergraduate and 6,300 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible. This news release was issued on behalf of Newswise(TM). For more information, visit . SOURCE University Hospitals Cleveland Medical Center

Sam Gill to drive growth in evolving sector across Australia and New Zealand SYDNEY, January 30, 2023: Ongoing growth within the life sciences sector has led global workplace strategy, design and construction leader Unispace to make a key new appointment to its Australia and New Zealand team. Sam Gill has been appointed as Unispace’s Head of Life Sciences for the ANZ region, based in the company’s Sydney office. He joins Unispace from Johnstaff, where he was a leading head contractor within the pharmaceutical and healthcare industry in Australia. Mr Gill’s new role will see him working alongside other industry specialists in the Unispace Life Sciences team, including Chris Edwards, based out of Auckland, and Debbie Leyland, based out of Brisbane. “This newly created role bolsters Unispace’s investment in the life sciences sector both in ANZ and globally,” Emma Forster Mitrovski, Unispace CEO, ANZ, said. “Sam has spent most of his professional career working in the life sciences sector, with a particular focus in this area over the last eight years. He specialises in the construction and delivery of research laboratories and pharmaceutical production facilities including clean rooms and biocontainment facilities. “We are thrilled to welcome Sam to our growing team, and we’re excited to see how he can support Unispace’s continued growth in this evolving sector. Unispace brings a unique end-to-end solution to the life sciences sector, we offer our clients a purpose-built model to control risk and cost, while ensuring design and delivery excellence.” Mr Gill’s experience in the life sciences sector across Australia and New Zealand has seen him work with major players such as Baxter Healthcare, Johnson & Johnson, AbCellera and Phebra. Project highlights have included the delivery of the PC3 Ebola Laboratory at the Royal Melbourne Hospital and the award-winning expansion of Phebra’s NSW facility which included manufacturing, packaging, research, laboratory, and administration components. Mr Gill said his new role with Unispace represented an opportunity to “be part of something new and exciting as it grows, but with the security and backing of an established global business”. “Through my background delivering life sciences projects, such as laboratories and clean rooms, I deeply understand our client requirements and drive an effective construction process,” he said. “The Unispace Life Sciences team has an exciting growth projection and being able to help shape that growth was a real driver for me in joining Unispace. “In addition, Unispace’s investment in life sciences through the purchase of BioPharma Engineering last year really shows its intention to be a leader in this rapidly evolving sector, and I’m looking forward to being a part of that. Having a global network of experts to bounce ideas off and learn from, particularly across key regions such as Europe and the Americas, was also just too good an opportunity to pass up.” The acquisition of Ireland-based BioPharma Engineering (BPE), which became BPE, A Unispace Life Sciences Company, in 2022 further bolstered Unispace’s technical capabilities to lead additional project types including laboratory, research and manufacturing facilities, and supported the firm's expansion in this sector globally. “The life sciences industry delivers critical solutions from bringing products to market to creating new vaccines, medical devices and other pharmaceutical and biotechnology innovations that help tackle the world’s most urgent challenges,” Ms Forster Mitrovski said. “Never has the importance of life sciences been more visible, especially in the last two-and-a-half years. “This is driving the demand for world-class facilities that support the technical experts and talent and keep companies on the leading edge.” Mr Gill agreed, saying the worldwide focus on biotechnology in recent years had led to a renewed emphasis on the local manufacturing of pharmaceuticals. “Pre-covid, the manufacturing of pharmaceuticals within Australia and New Zealand had slowed, but in recent years there has been a real push from the community for these items to be made locally once again,” he said. “Coupled with the fact that, worldwide, the rapid growth in biotech start-ups has seen tens of billions of dollars invested into the sector, which has resulted in huge demand and competition to attract the best talent, there is now a real push to give the brilliant minds in this sector some really amazing workplaces. “Unispace is in a unique position because we have been in this business for over 10 years, creating workplaces to empower employees and help companies attract and retain top talent. As this becomes a growing focus for companies in the life sciences space, Unispace is perfectly placed to help companies who are looking to change the way they design their research and manufacturing facilities to give their people the best environment to succeed.” ENDS ABOUT UNISPACE Unispace is a global strategy, design, and construction leader creating people-centric spaces for a rapidly changing world. Unispace’s world-class strategists, designers, and project managers work together as one single, unified team. Our goal: to create spaces that spark brilliance, deepen connections, foster a sense of belonging and propel success. For more information Unispace Life Sciences, click here. Media enquiries Laura Phillips +61 (0) 438 952 520 laura.phillips@civicpartners.com.au

JAMA Neurology today published peer-reviewed, long-term safety results involving four people with severe bilateral upper-limb paralysis. Twelve months after having Synchron’s Stentrode implanted inside a blood vessel in the brain, there were no adverse events. In addition, there was no vessel occlusion or device migration. On top of the positive safety results, the Stentrode demonstrated it could work. All four patients’ BCI implants had stable signal strength throughout, with a mean (SD) signal bandwidth of 233 (16) Hz. There was offline decoding of at least five attempted movement types. Plus, each patient learned to successfully control a computer with the BCI. “The SWITCH study is an early demonstration of safety in a low number of participants using a commercial grade brain-computer interface,” Synchron CEO Dr. Tom Oxley said in a news release. “The decoder was simple and robust, meaning that patients didn’t have to train hard to execute switches,” Oxley said. “Our view is that a motor neuroprosthesis should be safe and easy to use.” On top of Synchron, other attention-grabbing BCI companies include Elon Musk’s Neuralink and longtime pioneer Blackrock Neurotech. Millions of Americans live with paralysis that could inhibit their ability to use smartphones and other personal computing devices, according to Synchron. The company estimates that 50 million people in high-income countries could benefit from a BCI by 2025. “This technology holds great promise for people with paralysis who want to maintain a level of independence,” said Dr. Bruce Campbell, the SWITCH study’s co-principal investigator. Campbell is a vascular neurologist from the Royal Melbourne Hospital and the University of Melbourne. “The Stentrode enables a form of motor restoration, with individuals able to use the switches to communicate and engage with their digital world,” Campbell said. Another co-principal investigator in the study was Professor Peter Mitchell, director of neurointervention at Royal Melbourne Hospital. He noted that angiography suites are widely available. So he thinks the Stentrode implant procedure could promote a rapid translation of BCI for people with paralysis. Synchron says enrollment is ongoing for its COMMAND trial. The study is taking place at Carnegie Mellon, the University of Pittsburgh and Mount Sinai Hospital, It will assess the Stentrode’s safety and explore quantified efficacy measures. Researchers have signed up three out of six participants.