Paresis

5-Year Data from the AMDS DARTS Trial Demonstrates Positive Aortic Remodeling with 94% of Patients Free from Unanticipated Reoperation 30-Day Data from the AMDS PERSEVERE Trial Shows Cerebral Malperfusion Resolution in 90% of Affected Subjects Post-AMDS Implantation 1-Year Data from the NEOS Study Indicate E-vita Open Neo is Safe and Effective in the Treatment of Aortic Arch Pathologies with Low Combined Major Adverse Events Rate ATLANTA, Oct. 10, 2024 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced data from its AMDS DARTS and PERSEVERE trials and E-vita Open Neo study presented in Late-Breaking Science presentations at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Lisbon, Portugal. The presentation regarding the AMDS DARTS trial highlighted 5-year aortic remodeling data that demonstrate positive, durable patient outcomes following AMDS implantation. The presentation on the 30-day AMDS PERSEVERE trial data showed cerebral malperfusion resolution for 90% of affected subjects at 30-days post-AMDS implantation. Additionally, the presentation on the 1-year data from the NEOS study showed E-vita Open Neo is safe and effective for the treatment of acute and chronic aortic arch pathologies with a lower combined major adverse event rate compared to the market leading alternative. "We were thrilled to command such a strong presence at EACTS, with data from our AMDS and E-vita Open Neo clinical trials dominating the aortic focused late-breaking science session," said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. "Artivion remains committed to driving continued innovation in treating aortic disease, and these data further validate our best-in-class portfolio." Late-Breaking 5-Year Data from AMDS DARTS Trial: The abstract titled 5-Year Results on Aortic Remodeling in the Dissected Aorta Repair Through Stent (DARTS) Implantation Trial reports five years of clinical follow-up on the remaining 25 of 46 study participants with acute DeBakey Type I dissection who were treated with a proximal aortic repair and AMDS. The results demonstrate durable benefits out to at least 5 years over the baseline: 94% of patients were free from aortic reoperation compared to existing literature on hemiarch-only outcomes which report freedom from late aortic arch reoperation as low as 76%, 95% of patients were free from total aortic diameter (TAD) growth >5 mm between the 3-year and 5-year follow up periods at aortic zones 2 and 4; and In contrast, existing literature on hemiarch-only outcomes suggest a majority of patients have early TAD growth in the proximal descending aorta. Aortic growth can lead to increased risk of rupture or dissection, and reoperation. Principal investigator Dr. Michael Moon, Division of Cardiac Surgery, University of Alberta, Edmonton, Canada said, "Significant dilation of the ascending aorta, measured by changes to the TAD, increases the risk of spontaneous rupture or dissection of the aorta, a serious medical emergency. These long-term results from the DARTS study demonstrate a large majority of patients experience a stable or decreased TAD following treatment with AMDS, meaning these patients were successfully treated with AMDS and are at decreased risk for further aortic dissection and reoperation as far out as 5-years post implantation." Late-Breaking 30-Day Data from AMDS PERSEVERE Trial: The abstract titled AMDS Hybrid Prosthesis Improves Cerebral Malperfusion in Acute DeBakey Type I Dissection- Early Results of the PERSEVERE Study focuses on cerebral blood flow across the full 93 study participant IDE cohort at 30-days following AMDS implantation. 20% of patients (19 of 93 patients) presented with symptomatic pre-operative cerebral malperfusion including stroke, transient ischemic attack, delirium or other mental status changes. The 30-day data showed resolution of cerebral malperfusion in the vast majority of patients treated with AMDS. More specifically: 90% of patients experienced resolution of their cerebral malperfusion; and 63% of those who presented with cerebral malperfusion had complete resolution, while another 26% had no worsening of stroke symptoms The data compare favorably to hemiarch alone based on data from five articles in the literature, which showed a stroke occurrence rate of 20.9% compared to 10.8% (10 of 93 patients) in the PERSEVERE trial. Senior author, Dr. William Brinkman, Baylor Scott & White, The Heart Hospital Plano, Plano, Texas said, "Cerebral malperfusion, which often leads to stroke, is a devasting complication of Acute DeBakey Type I aortic dissection. The data from the PERSEVERE trial indicating that AMDS markedly reduces 30-day malperfusion and new disabling stroke compared to the baseline, is very encouraging." Late-Breaking 1-Year Data from E-vita Open Neo NEOS Study: The abstract titled E-vita Open Neo in the treatment of acute or chronic aortic pathologies: 1-year results of the European multicenter NEOS study and sub-group analysis includes 161 participants treated with E-vita Open Neo in Europe. The 1-year data suggests E-vita Open Neo is safe and effective in the treatment of aortic arch pathologies and compares favorably to the IDE study results of the current market leading device: The 1-year mortality rate observed for E-vita Open Neo (9.9%) compared favorably to current market leading device (10.8%); and Lower 1 year combined major adverse events rate of mortality, stroke, and paraplegia/ paraparesis occurring after treatment with E-vita Open Neo (17% vs 23.1% for current market leading device). Professor Martin Grabenwöger, Head, Department of Cardiovascular Surgery, Hietzing Hospital, Vienna, Austria said, "These exciting results from the NEOS study demonstrate the clinical benefits of E-vita Open Neo compare favorably to currently available options for treatment of aortic arch pathologies. This study is a major step forward in improving care for patients suffering from this life-threatening disease." About the AMDS DARTS Trial The AMDS DARTS (Dissected Aorta Repair Through Stent Implantation) trial is a prospective, multicenter, nonrandomized, single-arm trial of 47 patients evaluating the safety and efficacy of the AMDS Hybrid Prosthesis for the treatment of Acute DeBakey Type I (ADTI) dissection. Trial results supported regulatory approvals for AMDS in Canada, Europe, and other countries around the world. About the AMDS PERSEVERE Trial The AMDS PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with ADTI dissection can be treated safely and effectively using the AMDS Hybrid Prosthesis. The trial is designed to support the company's forthcoming application to the U.S. Food and Drug Administration (FDA) for premarket approval of the AMDS. The trial consists of 93 participants in the U.S., who have experienced an ADTI dissection. Each participant will be followed for up to 5 years. The combined 30-day safety and primary efficacy endpoints were used to determine the impact of the AMDS Hybrid Prosthesis on DANE prevention, reducing mortality, new disabling stroke, new onset renal failure requiring dialysis, and myocardial infarction, as well as remodeling of the aorta. Full 30-day IDE data from the PERSEVERE trial presented at the Society of Thoracic Surgeons in January 2024, demonstrated statistically significant reduction in all-cause mortality and primary major adverse events (MAEs) at 30 days with use of AMDS in ADTI dissections complicated by malperfusion. Data from the trial also demonstrated a 72% reduction in all-cause mortality and 54% reduction in primary major MAEs when compared to the current standard of care hemiarch procedure. Data presented from the PERSEVERE trial at the 104th American Association for Thoracic Surgery (AATS) Annual Meeting April 2024, showed positive aortic remodeling at 30-days after treatment with AMDS, as well as no occurrence of distal anastomotic new entry (DANE) tears. More specifically, at 30 days, the majority of patients demonstrated favorable remodeling with over 80% showing either stable or decreased total aortic diameter (TAD). About the E-vita Open Neo NEOS Study The E-vita Open Neo NEOS study is an observational, multicenter study to determine the safety and clinical performance of E-vita Open Neo Stent Graft System in the treatment of acute and chronic aneurysm and dissection in the ascending aorta, aortic arch and descending thoracic aorta. The observational study consists of 161 patients with acute or subacute type A aortic dissection, chronic type A aortic dissection or thoracic aortic aneurysm enrolled at 12 centers in Europe and Asia December 2020 to March 2022. The primary end point was the rate of all-cause mortality at 30 days. The secondary end points included further clinical and safety data that are reported up to 3–6 months postoperatively. About Artivion, Inc. Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion markets and sells products in more than 100 countries worldwide. For additional information about Artivion, visit our website, . Contacts: SOURCE Artivion, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Study marks the first time these side effects were reported in children PHILADELPHIA, Sept. 26, 2024 /PRNewswire/ -- Researchers at Children's Hospital of Philadelphia (CHOP) revealed for the first time that children, adolescents and young adults may experience very rare neurological issues of paraparesis and quadriparesis following chimeric antigen receptor T-cell (CAR-T) therapy, a type of immunotherapy used to treat B-cell Acute Lymphoblastic Leukemia (B-ALL). Additionally, these complications occurred without the type of inflammation typically seen in adults. The findings were published today in the journal Blood. Continue Reading Dr. Caroline Diorio Researchers previously reported that CAR-T may lead to complications known as immune effector cell-associated neurotoxicity syndrome (ICANS), which can present with a range of neurological symptoms from mild confusion to severe issues such as brain swelling, seizures and coma. However, as CAR-T therapy becomes a more prevalent cancer treatment, new patterns are emerging, revealing complex side effects in younger patients. "Our findings suggest CAR-T induced neurological side effects, while rare, can impact a spectrum of age ranges, from children to young adults. The causes of these complications in young people could be more complex than the exclusive T-cell activation and excessive cytokine production that typically leads to inflammation in adults," said Caroline Diorio, MD, FRCPC, FAAP, an attending physician with CHOP's Cancer Center. "The lack of inflammation points to a host of other underlying culprits, such as metabolic profiles, that require extensive additional research to understand." In this study, Diorio and her team analyzed two children, two teenagers and one young adult who developed severe muscle weakness, either in all four limbs (quadriparesis) or the lower half of their body (paraparesis) after receiving an infusion of either CD19- or CD22-directed CAR-T therapy to treat B-ALL. All but one of the five patients died during the study due to their cancer. The researchers performed detailed examinations on all five patients, such as tests on spinal fluid, and protein analysis to understand the response. They also later performed full autopsies on two of the deceased patients. Overall, they found chronic damage to white matter in the brain, but without the usual inflammatory responses. The children also had lower levels of certain inflammatory chemicals compared to those who did not have severe symptoms. "I can't emphasize enough that for most patients, immunotherapy, such as CAR-T, is a lifesaver," said Diorio, who is also an Assistant Professor of Pediatrics at the University of Pennsylvania Perelman School of Medicine. "However, these study findings empower us to understand the rare instances when it's not effective and take prompt action to address that." The study was supported by the ACC K12 Award, a CIHR Fellowship Award and a CHOP Cell and Gene Therapy Award. The authors would like to gratefully acknowledge the assistance of the Translational and Correlative Studies Laboratory at the University of Pennsylvania. Diorio et al. "Quadriparesis and paraparesis following chimeric antigen receptor T-cell (CAR-T) therapy in children and adolescents." Online September 26, 2024. Blood. DOI: 10.1182/blood.2024023933. About Children's Hospital of Philadelphia: A non-profit, charitable organization, Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, the hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. The institution has a well-established history of providing advanced pediatric care close to home through its CHOP Care Network, which includes more than 50 primary care practices, specialty care and surgical centers, urgent care centers, and community hospital alliances throughout Pennsylvania and New Jersey, as well as the Middleman Family Pavilion and its dedicated pediatric emergency department in King of Prussia. In addition, its unique family-centered care and public service programs have brought Children's Hospital of Philadelphia recognition as a leading advocate for children and adolescents. For more information, visit . Contact: Jennifer Lee Children's Hospital of Philadelphia (267) 426-6084 [email protected] SOURCE Children's Hospital of Philadelphia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOSTON--( BUSINESS WIRE )-- Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, today announced that management will be participating in two investor conferences during the month of September. Paul Gudonis, chairman and chief executive officer, and David Henry, chief financial officer, will present and host one-on-one meetings at the HC Wainwright 26 th Annual Global Investment Conference being held September 9-11, 2024 at the Lotte New York Palace Hotel. Management’s presentation will be available for viewing beginning at 7:00 a.m. ET on September 9 th , and one-on-one meetings with investors will be held virtually on September 9 th and 11 th . Visit www.hcwevents.com/annualconference to register for the conference to view the presentation or request a meeting, David Henry will host one-on-one meetings at the Lake Street 8 th Annual Best Ideas Growth “Big 8” Conference at the Yale Club in New York on September 12, 2024. This conference consists of one-on-one meetings between Company management and investors. Visit https://www.lakestreetcapitalmarkets.com or contact your Lake Street representative to participate in the conference. About Myomo, Inc. Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury or other neuromuscular disease or injury. It is currently the only marketed device in the U.S. that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Boston, Massachusetts, with sales and clinical professionals across the U.S and representatives internationally. For more information, please visit www.myomo.com .