Kaiser Permanente, Inc.

Expansion comes after IntelliSep® helped reduce the risk-adjusted sepsis mortality index by 30% in first hospital deployment SAN FRANCISCO, Oct. 30, 2024 /PRNewswire/ -- Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced that Franciscan Missionaries of Our Lady (FMOL) Health System has expanded access to the IntelliSep® rapid sepsis detection technology for patients at St. Dominic's Hospital in Jackson, Miss.; St. Francis Medical Center in Monroe, La.; and Our Lady of Lourdes Health, in Acadiana, La. "After years of research at Our Lady of the Lake Regional Medical Center (OLOLRMC), we are excited to be the first health system in the country to bring the IntelliSep diagnostic to our emergency departments across every market we serve," said E.J. Kuiper, President and CEO of Franciscan Missionaries of Our Lady Health. "This groundbreaking advancement underscores our commitment to pioneering innovative healthcare solutions and improving patient outcomes. Together, we are setting a new standard in early sepsis detection, ultimately saving lives and improving the quality of care we provide." IntelliSep is the first and only U.S. Food and Drug Administration (FDA)-cleared cellular host diagnostic indicated for use in the emergency department (ED), where over 80% of sepsis cases present. The FMOL Health System was the first in the nation to deploy the technology last August at Our Lady of the Lake Regional Medical Center in Baton Rouge, La., the busiest emergency department in Louisiana. Over the last year, the hospital reported marked improvements in patient care and outcomes, including: Lives saved: Reduced the overall risk-adjusted mortality index by 30% for sepsis patients. Faster triage: Patients deemed at risk for sepsis were triaged more quickly from the ED and treated 60 to 70 minutes faster. Less time in the hospital: Patients tested with IntelliSep, who were subsequently admitted, spent 1.28 fewer days in the hospital. Cost savings: Hospital realized an average of $1,429 savings per patient tested. Reduced blood cultures: Blood culture utilization was reduced by approximately 30% post implementation of IntelliSep, decreasing monthly blood culture counts by 200 to 300. This translated into 23 to 30 hours of nursing time saved per month, which could be reallocated to bedside patient care. The IntelliSep test exemplifies the health system's commitment to delivering high-quality, efficient care by enabling early and accurate detection of sepsis. After demonstrating these strong care improvements at OLOLRMC, the health system is now announcing expanded access to the technology to communities across Louisiana and Mississippi. "Franciscan Missionaries of Our Lady Health System has been a key partner in developing ED protocols for IntelliSep and their continued investment in this life-saving technology demonstrates their commitment to offering the highest level of patient care across their health system," said Ajay Shah, CEO of Cytovale. About Cytovale® Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, IntelliSep®, leverages machine learning and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep measures the dysregulated immune system response to infection that would indicate sepsis and generates results in about eight minutes using a standard blood draw. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit and follow Cytovale on LinkedIn and X. SOURCE Cytovale WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MENLO PARK, Calif., Oct. 21, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the appointment of Sarah Krevans to its Board of Directors, effective immediately. Ms. Krevans will also serve as a member of the Board's Audit Committee, Compensation Committee, and Nominating and Governance Committee. Following the appointment of Ms. Krevans, the Board will be composed of five directors, four of whom are independent. Continue Reading CEO Sutter Health Ms. Krevans served as president and CEO of Sutter Health, a Northern California based not-for-profit health system in one of the most diverse and innovative regions in the nation, from 2016 to 2022. She was responsible for Sutter Health's integrated network of 14,000 clinicians, 24 hospitals, outpatient services, research facilities, and home health and hospice care. Under her leadership, Ms. Krevans advanced clinical programs, innovation, and digital health to make healthcare more accessible for patients. "Sarah is a highly accomplished healthcare leader with extensive experience in a dynamic and diverse environment," said Bob Ragusa, CEO of GRAIL. "I am confident that her experience will bring immense value to GRAIL as we move toward establishing a new standard of care for multi-cancer early detection for patients." Previously, Ms. Krevans served as chief operating officer, and regional executive officer and president of the Sutter Health Sacramento Sierra Region. She also held executive roles at Kaiser Permanente and served as deputy director of Maine's Bureau of Medical Services and acting director of Medicaid, health planning and licensure programs. Ms. Krevans' experience as a board member includes serving on many not-for-profit boards and as Chair of the California Association of Hospitals. She currently serves on the board of the Acacium Group and is the incoming Chair of CaringBridge. Ms. Krevans earned master's degrees in business administration and in public health from the University of California, Berkeley, and a bachelor's degree from Boston University. She has been named as one of the "Top 25 Women Leaders" by Modern Healthcare and included on Modern Healthcare's list of the "100 Most Influential People in Healthcare." About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. For more information, visit grail.com. SOURCE GRAIL, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

-- LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy— -- Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 -- DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. “This approval represents an important milestone for the narcolepsy community, specifically for younger narcolepsy patients and their caregivers who face significant challenges associated with waking up in the middle of the night to complete treatment regimens. With this label expansion, pediatric patients 7 years and older living with narcolepsy now have the same option that adult patients with narcolepsy have – to choose a once-nightly treatment option that does not disrupt sleep for a middle of the night dose,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “In less than two years, Avadel has made great strides in establishing our commitment to the development of transformative medicines for sleep disorders. This includes successfully launching LUMRYZ for the adult narcolepsy population, initiating a Phase 3 pivotal trial evaluating LUMRYZ for the treatment of idiopathic hypersomnia, and now the expansion of LUMRYZ into the pediatric narcolepsy population.” "I have been prescribing sodium oxybate for children and adolescents with narcolepsy for years as I have seen how effective this medication is and can safely be used," said Anne Marie Morse, DO, a board-certified and fellowship-trained pediatric neurologist and sleep medicine specialist at Geisinger Health System. “And before this, although numerous families have also witnessed the transformation in their children's lives, I have also had many families turn down the medication, or discontinue after starting, because of the challenge experienced or feared to experience with a forced awakening causing a purposeful nightly disruption, many times met with an exhausting fight, to take the second dose of first-generation oxybates. The expanded FDA approval for LUMRYZ allows me to now share with my patients and their families that there is an FDA-approved treatment that offers a single bedtime dose of medication, provided in a pre-filled packet. I can now offer more options to more patients which allows me to continue my role as a partner in my patients' journeys." Narcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. The condition affects approximately 1 in 2,000 people in the United States, where roughly 5% of patients are under the age of 18. Symptoms of narcolepsy are EDS and may also include a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), disrupted nighttime sleep, sleep paralysis and hallucinations when falling asleep or waking up. LUMRYZ is a once-at-bedtime formulation extended-release sodium oxybate and was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy. LUMRYZ was approved by the FDA for use in the treatment of cataplexy or EDS in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity through October 16, 2031. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined in a trial of adults with narcolepsy were nausea, dizziness, enuresis, headache, and vomiting. Similarly, in a trial of pediatric narcolepsy patients receiving immediate-release sodium oxybate, the most commonly observed adverse reactions (incidence ≥5%) were nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. About LUMRYZ™ (sodium oxybate) for extended-release oral suspensionLUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.  On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in patients 7 years of age and older with narcolepsy.  The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.   With its approval in May 2023, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. About Avadel Pharmaceuticals plc Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in both adults and pediatrics with narcolepsy. For more information, please visit www.avadel.com. INDICATIONSLUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy: sudden onset of weak or paralyzed muscles (cataplexy)excessive daytime sleepiness (EDS) IMPORTANT SAFETY INFORMATION WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death.The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects.Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. Do not take LUMRYZ if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency. Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you. Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized. LUMRYZ can cause serious side effects, including the following: Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking. Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full Prescribing Information, including BOXED Warning. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the safety and potential therapeutic benefit of, and market and prescriber preference for, LUMRYZ in treating cataplexy and EDS in patients 7 years of age and older with narcolepsy; and the pediatric Orphan Drug Exclusivity for LUMRYZ and potential benefits resulting from such exclusivity. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable). The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, and subsequent SEC filings.Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Investor Contact:Courtney MogerleyPrecision AQCourtney.Mogerley@precisionaq.com(212) 698-8687 Media Contact:Lesley StanleyReal Chemistrylestanley@realchemistry.com(609) 273-3162