Prehypertension

Leveraging the Company's 4 x 6.7 mm System-on-a-Chip (SoC), the clinical study results are a significant step forward in commercializing a cuffless, radio frequency (RF)-enabled blood pressure device PLEASANTON, Calif., Oct. 31, 2023 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, today announced the results of its Institutional Review Board (IRB)-approved blood pressure clinical study. Movano Health's prototype, which incorporated its SoC, demonstrated a level of accuracy within the standards recognized by the FDA for blood pressure monitoring devices. The Company's algorithm for blood pressure monitoring utilized data from its prototype system combined with the subject's demographic information and a recent blood pressure reading. The prototype achieved an overall mean absolute difference (MAD) of 5.9 mmHg, which is below the 7 mmHg MAD required per a standard for wearable, cuffless blood pressure measuring devices (IEEE1708a-2019). The Company is also evaluating AI-based individual calibration methods to further enhance the future performance of the device. The 44-participant study, conducted at the Movano Health Clinical Lab, assessed the accuracy of its wrist-worn wearable prototype compared to a hospital-grade FDA-cleared blood pressure monitor. The study measured the blood pressure of each participant multiple times, including while under stress, which resulted in an average participant systolic blood pressure range of 25 mmHg and a total study range of 85 - 171 mmHg. The Company's 4 x 6.7 mm SoC combines multiple antennas and a variety of frequencies in the smallest ever RF-enabled integrated circuit designed specifically for blood pressure and glucose monitoring. After shrinking its multi-chip architecture from four chips into one in mid-2022, Movano Health began using the patented SoC in clinical studies this year, which has materially improved the accuracy of its blood pressure measurements as seen by the results of this most recent study. In its current form factor, Movano Health's wearable prototype represents one of the smallest and most accessible ways to measure blood pressure. "After multiple iterations of optimizing our IC, antennas, and AI algorithms, our SoC produced much cleaner signals with significantly less noise in this study than our multiple chip solution did previously," said Michael Leabman, CTO and founder of Movano Health. "Most importantly, we learned that our machine learning models hold across a broader range of blood pressure values than in prior studies, which is crucial for our pursuit of commercializing an FDA cleared cuffless blood pressure wearable." Hypertension has reached epidemic proportions in the United States and is often labeled the silent killer as many don't know they are affected. According to the American Heart Association, high blood pressure affects half of Americans ages 20 years and older – or more than 122 million people – and 59 million Americans have prehypertension. Movano Health's cutting-edge RF technology has the potential to empower individuals and their clinicians to better monitor and manage their high blood pressure on a daily basis. "Our goal is to deliver a more accurate, flexible and cost-effective wearable blood pressure solution, and this study reveals the initial payoff of our investment in propriety mmWave sensor technology. We are extremely encouraged with the performance of our SoC, and the next step is to confirm the calibration holds in longer studies, which would open a pathway to implementing the SoC in future iterations of the Evie Ring and other form factors," said John Mastrototaro, CEO of Movano Health. Movano Health is planning to execute a multi-week study to determine whether periodic calibration is required and refine its AI models on an individual patient basis beginning in the fourth quarter of 2023. Following the completion of this longitudinal study, the Company intends to conduct a clinical trial for its 510(k) submission to the FDA. About Movano Health Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade, high-quality data to the forefront of consumer health devices. Featuring modern form factors, Movano Health's devices capture a comprehensive picture of a person's vital health information and uniquely translate the data into personalized and intelligent insights that empower consumers to live healthier and more balanced lives. Movano Health's end-to-end solutions will soon enable consumers and their healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage health outcomes. For more information on Movano Health, visit . Forward Looking Statements This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding plans with respect to commercial launch of the Evie Ring, anticipated FDA clearance for the Evie Ring and other products in development, expected future operating results; product development and features, product releases, clinical trial, and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. SOURCE Movano

Pregnancy complications such as preeclampsia and gestational diabetes have recently been associated with a higher risk of developing heart disease later in life. But a new study has found obesity before or during pregnancy is the actual root cause of future cardiovascular disease. “We demonstrate, for the first time, that adverse pregnancy outcomes are primarily indicators — and not the root cause — of future heart health,” said corresponding author Dr. Sadiya Khan. “This means that pregnancy just reveals the risk for heart disease that is already there.” This large, multi-center and diverse study is one of the only studies to follow its participants — about half of whom were overweight or had obesity — from the beginning of their first pregnancy through several years postpartum. Pregnancy complications such as preeclampsia and gestational diabetes have recently been associated with a higher risk of developing heart disease later in life. But a new Northwestern Medicine study has found obesity before or during pregnancy is the actual root cause of future cardiovascular disease. Prior to this study, scientists were unsure which factor -- obesity or pregnancy complications -- played a larger role in cardiovascular disease risk years after pregnancy. This large, multi-center and diverse study is the first to disentangle that question, ultimately determining that pre-pregnancy obesity is the true driver of both poor pregnancy outcomes and future cardiovascular disease risk. It is one of the only studies to follow its participants -- about half of whom were overweight or had obesity -- from the beginning of their first pregnancy through several years postpartum. "We demonstrate, for the first time, that adverse pregnancy outcomes are primarily indicators -- and not the root cause -- of future heart health," said corresponding author Dr. Sadiya Khan, the Magerstadt Professor of Cardiovascular Epidemiology at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician. "This means that pregnancy just reveals the risk for heart disease that is already there." The findings will be published Oct. 10 in the journal Circulation Research. The study used data from the nuMoM2b Heart Health Study to prospectively follow 4,216 first-time pregnant individuals from the early stages of their pregnancy to an average of 3.7 years postpartum. At the early-pregnancy first study visit, the average maternal age was 27 years old, and 53% had a normal body mass index (BMI), 25% were overweight and 22% had obesity. Compared to those with a normal BMI in early pregnancy, individuals with overweight or obese BMI had a higher risk of developing hypertensive disorders of pregnancy. 'Pregnancy is a natural stress test for the heart' In the study, the scientists wanted to better understand the associations among maternal obesity, hypertensive disorders of pregnancy and other adverse pregnancy outcomes, and cardiovascular health several years after delivery. "Our hypothesis was that it may be that the pregnancy complications are unmasking these things since, as we know, pregnancy is a natural stress test for the heart," Khan said. "These findings are important because if pre-pregnancy obesity is the culprit or cause of risk, we should be targeting this with interventions. "We don't want to just wait until people have these cardiovascular events; we want to stop them from happening," Khan said. Obesity intervention before pregnancy is key A major throughline of Khan's research is the idea of the "Zero trimester," or pre-pregnancy health. By improving health during this critical time in an individual's life, they can improve outcomes for not only their pregnancy and baby but for their personal long-term health, Khan said. However, it can be difficult to target people before becoming pregnant, Khan said. So, early in the pregnancy may be an opportune time to counsel on heart-healthy habits like diet and exercise when people are more likely to be interacting with clinicians during prenatal visits. "We definitely do not want to recommend weight loss during pregnancy but do want to recommend counseling and monitoring for appropriate gestational weight gain," Khan said. "It is one of the few times in life that you are seeing the doctor frequently while you're healthy." Pregnant individuals can safely limit their weight gain throughout pregnancy by eating healthy and exercising moderately or even vigorously, studies have shown. More about the study Pregnant individuals in the study were seen at eight clinical centers across the U.S., including Northwestern University. Individuals were 18 years or older and did not have any history of pre-pregnancy hypertension or diabetes. Approximately 15% of all participants experienced a complication related to high blood pressure; 11% had a baby with a low birthweight; 8% had a preterm birth; and 4% had gestational diabetes. In the years following pregnancy, those with complications related to high blood pressure were 97% more likely to have high blood pressure, and 31% were more likely to have high cholesterol. For some complications, the researchers found body weight did not factor into risks. For example, people who were overweight or had obesity did not have increased risks for having a preterm birth or a baby with a low birthweight. However, among all participants, those experiencing preterm births had increased risks for having high blood pressure, high blood sugar or high cholesterol after pregnancy. Having a baby born with a low birthweight wasn't found to increase risks.

Third authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with diseases impacted by anemia Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted full Marketing Authorization for Reblozyl® (luspatercept), a first-in-class therapeutic option, for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia. Reblozyl is currently approved in the European Union (EU), United States and Canada to address anemia associated with transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes. The centralized Marketing Authorization approves use of Reblozyl in all EU member states, as well as Norway, Iceland and Liechtenstein.* “Beta thalassemia is an inherited blood disorder that puts patients at significant risk for long-term clinical complications due to anemia, leaving a substantial need for treatment options, regardless of a patient’s dependence on blood transfusions. This announcement is welcome news for patients with non-transfusion-dependent beta thalassemia associated anemia across the EU who are seeking newer treatment options to reduce these burdens,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “Today’s approval represents the third indication for Reblozyl in Europe, and we look forward to continuing to evaluate this first-in-class therapeutic option across multiple diseases impacted by the burden of anemia in a broad clinical development program.” The EC approval of Reblozyl was based on results from the Phase 2 BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia. Patients were eligible to receive best supportive care, including red blood cell transfusions and iron-chelating agents. Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. *Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales). About BEYOND BEYOND (NCT03342404) is a Phase 2, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept-aamt (ACE-536) versus placebo in adults with non-transfusion-dependent beta thalassemia. The study is divided into the Screening Period, Double-blind Treatment Period (DBTP) and Post-Treatment Follow-up Period (PTFP) and randomized 145 subjects at a 2:1 ratio of Reblozyl versus placebo. All patients were eligible to receive best supportive care, which included red blood cell transfusions; iron-chelating agents; use of antibiotic, antiviral, and antifungal therapy; and/or nutritional support, as needed. The primary endpoint of the study is the proportion of subjects who have an increase from baseline ≥1.0 g/dL in mean of hemoglobin values over a continuous 12-week interval from Week 13 to Week 24 of treatment in the absence of transfusions. Key secondary endpoints include mean change in non-transfusion-dependent beta thalassemia-patient reported outcome (NTDT-PRO) Tiredness and Weakness (TW) domain score and baseline hemoglobin (Hb). Results demonstrated 74 of 96 (77.1%) patients in the Reblozyl treatment arm achieved the study’s primary endpoint, ≥1.0 g/dL mean Hb increase from baseline, versus 0 of 49 (0%) patients in the placebo arm (P In a key secondary endpoint of the study, 47 of 96 patients (49.0%) treated with Reblozyl achieved mean Hb increase of ≥1.5 g/dL compared to baseline from Week 37-48 in the absence of transfusions versus 0 patients (0%) in the placebo arm (PReblozyl arm, 89.6% of patients remained transfusion free at weeks 1-24 versus 67.3% of patients in the placebo arm (P=0.0013). Improvements in patient-reported QoL outcomes (tiredness and weakness) were also observed to correlate with Hb increases. Serious adverse reactions occurred in 11.5% of patients (n=11) who received Reblozyl. The most common adverse reactions occurring in ≥10% of patients treated with Reblozyl were bone pain (36%), headache (30%), arthralgia (29%), back pain (28%), prehypertension (23%), hypertension (20%), cough (18%), diarrhea (17%), influenza-like illness (17%), asthenia (13%), influenza (13%), insomnia (11%) and nausea (10%). About Beta Thalassemia Beta thalassemia is an inherited blood disorder caused by a genetic defect in hemoglobin. It is one of the most common autosomal recessive disorders, and the total annual incidence of symptomatic individuals is estimated at 1 in 100,000 people globally.1 The disease is associated with ineffective erythropoiesis, which results in the production of fewer and less healthy red blood cells (RBCs), often leading to severe anemia—a condition that can be debilitating and can lead to other complications for patients—as well as other serious health issues.2 Treatment options for anemia associated with beta thalassemia are limited, consisting mainly of frequent RBC transfusions that have the potential to contribute to iron overload, which can cause serious complications such as organ damage.1 Non-transfusion-dependent beta thalassemia is a term used to describe patients who do not require lifelong regular transfusions for survival, although they may experience a range of clinical complications and require occasional or even frequent transfusions, usually for defined periods of time.3 About Reblozyl® Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell (RBC) maturation in animal models.1 Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. Reblozyl is currently approved in the U.S. for the treatment of: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. References: 1.Galanello R, Origa R. Beta thalassemia. Orphanet Journal of Rare Diseases. 2010;5(11). Available at: https://ojrd.biomedcentral.com/articles/10.1186/1750-1172-5-11. Accessed February 2022. 2.Rivella, S. (2013). Ineffective erythropoiesis and thalassemias. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703923/pdf/nihms-490109.pdf. Accessed February 2022. 3.Musallam, K. M., Rivella, S., Vichinsky, E., & Rachmilewitz, E. A. (2013). Non-transfusion-dependent thalassemias. Haematologica, 98(6), 833–844. https://doi.org/10.3324/haematol.2012.066845. Accessed February 2022. SOURCE: Bristol Myers Squibb