Coronary/Structural Heart

Egg Medical Presents CRT 2026 Data Demonstrating a Responsible Path to Light Lead and Lead-Apron Free Protection

Coronary/Structural Heart by 0 comments

WASHINGTON, March 10, 2026 (GLOBE NEWSWIRE) — Egg Medical, a leader in enhanced radiation protection devices (ERPD), today announced the results of a Late-Breaking Trial presented at the Cardiovascular Research Technologies (CRT) 2026 conference. The study, presented by Santiago Garcia, MD, of The Christ Hospital, confirms that the addition of the EggNest™ system reduces levels of scatter radiation to all members of the interventional team to the extent that users could do procedures safely without the use of lead aprons or wear ultralight aprons. “For decades, the interventional community has accepted a trade-off: protect your long-term health from the effects of radiation exposure by wearing heavy lead aprons at the cost of damaging your back and joints,” said Santiago Garcia, MD, the study’s lead presenter. “This data proves that we no longer must choose. By using the EggNest system, we can provide the entire team with protection that is superior to the status quo, by either going apron-free, or while wearing aprons that feel like a light vest. This is about ensuring that the next generation can have healthy careers without the physical toll.”  The Key Study Findings: Annualized collar dose (in mrem) over lead aprons is 25.5 for the primary operator, 9.8 for assistant, and 10.2 for the nurse. When combined with ultralight aprons, total annualized body doses dropped to 1.41 for primary operator, 2.1 for assistant and 1.0 for the nurse.At these levels, a clinician would have to work for an entire career to receive the same radiation dose they currently receive in just one year under the standard of care.The study confirmed that whether clinicians choose to go apron-free, or wear aprons that are 55% lighter than standard lead, the entire team remained below traditional exposure levels using traditional methods. Modern labs are not one-size-fits-all. Under the banner of “Protection Is Personal,” the company is championing a responsible approach that allows clinicians to choose whether they want to go apron free. “Our goal is to give clinicians a choice—but one backed by rigorous, published data,” said Gavin Philipps, Chief Commercial Officer. “Choice isn’t a weakness; it’s how responsible safety programs operate. By providing personalized data through live dosimetry, the EggNest supports apron-free or ultralight apron workflows where approved, rather than forcing a specific behavior.” A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/548c258c-72cd-4a18-a8cb-e5066a8688cc CONTACT: Contact:
Susan Storm
sstorm@eggmedical.com

Continue Reading →

Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results

Coronary/Structural Heart by 0 comments

– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension – – Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension – RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026. “The FDA’s acceptance of our NDA for lorundrostat marks an important milestone in our efforts to address the clinically significant need faced by millions of patients living with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “While the Explore-OSA trial did not demonstrate a reduction in AHI, the blood pressure reductions and safety profile were clinically meaningful, especially for this difficult to control population. We believe lorundrostat has the potential to become an important new treatment option for resistant and uncontrolled hypertension, and we look forward to working with the FDA as we advance toward potential approval.” Explore-OSA Trial Topline Results The Explore-OSA trial was a Phase 2 exploratory trial of lorundrostat in forty-eight participants with an average body mass index (BMI) of 38.2 kg/m2, an average apnea-hypopnea index (AHI) of 48.5 events/hr and an average systolic blood pressure (BP) of 142.3 mmHg (range 131-175 mmHg). After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index (AHI), the primary endpoint. At week four, the trial demonstrated an 11.1 mmHg (p < 0.0001) and a 1.0 mmHg (p = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period. There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis. Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and will be reported in future publications or medical meetings. About Launch-HTN Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure (BP) remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring. About Advance-HTN Advance-HTN (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once daily, lorundrostat 50 mg once daily and an option to titrate to 100 mg once daily at week four based on defined criteria, or placebo. The trial’s primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo. About Explore-OSA The Explore-OSA trial (NCT06785454) was a Phase 2 randomized, double-blind, placebo-controlled, crossover trial. This proof-of-concept trial was designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received 50 mg of oral, once daily (QD) lorundrostat and placebo in sequential treatment periods, with continuous monitoring of BP during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index (AHI) after four weeks of active treatment compared to placebo. The first secondary endpoint was AOBP, and additional endpoints were nighttime BP and sleep and cardiovascular health measures. About Obstructive Sleep Apnea OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate to severe OSA is associated with increased production of aldosterone and increased nighttime BP; standard treatment with positive airway pressure is not sufficient for BP reduction. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2025, untreated OSA is estimated to cost the United States more than $150 billion annually when considering direct medical expenses, productivity losses and accident-related costs. Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension (rHTN). Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke. About Hypertension Having sustained, elevated blood pressure (BP or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed five successful Phase 2/3 clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the timing and results of review of additional endpoints evaluated in the  Explore-OSA clinical trial; the anticipated timing of the FDA’s review of the Company’s accepted NDA and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof; Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following submission of an NDA and the FDA’s review of the same; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies;; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com

Continue Reading →

Late-Breaking Clinical Trial Presentation of the First-Ever US Cohort of Over 4,000 CathWorks FFRangio Patients Demonstrates Similar Clinical Outcomes to Invasive Pressure Wire-Guided PCI through 2 Years

Coronary/Structural Heart by 0 comments

WASHINGTON, March 7, 2026 /PRNewswire/ — Today at the Cardiovascular Research Technologies (CRT) annual conference taking place in Washington, DC, Dr. Christopher Chieh Yang Koo from National University Hospital Singapore, on behalf of investigators from Smith Center for Outcomes…

Continue Reading →

BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT)

Coronary/Structural Heart by 0 comments

Echocardiography outcomes show treated patients having reduced negative remodeling of heart volumesSUNNYVALE, Calif., March 03, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported late breaking echocardiography results from its Phase III clinical trial for ischemic heart failure of reduced ejection fraction (HFrEF), which affects millions of patients in the United States.    The clinical results were presented by Dr. Amish Raval, M.D., Professor of Medicine at University of Wisconsin School of Medicine and Public Health and CardiAMP HF Trial National Co-Principal Investigator, in the late breaking clinical trial oral presentation session of the Technology and Heart Failure Therapeutics (THT) on behalf of the CardiAMP HF Investigators. The presentation was titled: Autologous Cell Therapy May Curb Pathological Ventricular Remodeling in Chronic Ischemic HFrEF Patients Selected for Favorable Cell Characteristics – Late Breaking Echocardiography Results from the CardiAMP HF Trial. Dr. Raval reported that patients receiving the autologous CardiAMP cell therapy under investigation demonstrated positive evidence of decreased pathological left ventricular remodeling over time compared to patients not receiving the treatment. These results correlated to findings for the trial primary and key secondary endpoints of reduced fatal and non-fatal major adverse cardiovascular events and improved quality of life measures for treated patients. Echocardiography outcomes were measured by the blinded echo cardiography core laboratory at the Yale University Cardiovascular Research Group. The Yale core laboratory measured both left ventricular end diastolic volume, when the heart ventricle is fully dilated (p = 0.06), and left ventricular end systolic volume, when the heart is fully contracted (p=0.09). For the prespecified subgroup of patients having elevated biomarkers of heart stress, the differences between the treated and control patients were both clinically meaningful ( >20ml/m2 and 15 ml/m2, respectively) and statistically significant (p = 0.02 and p = 0.01, respectively). “In patients with baseline elevated NTproBNP levels, a biomarker of myocardial stress, CardiAMP treatment is associated with less adverse cardiac remodeling according to core-lab measured left ventricular volumes,” said Wilson Tang, MD, Professor of Medicine, Research Director of Heart Failure and Transplant, at Cleveland Clinic in Cleveland Ohio, and member of the Executive Steering Committee for the CardiAMP HF trials. “The burden of heart failure continues to grow, cardiac ischemia dominates the cause, and the impact of current pharmaceuticals remains limited,” said Carl Pepine, MD, MACC, Professor of Medicine at University of Florida at Gainesville, and Co-National Principal Investigator for the CardiAMP HF trial. Today’s results from the CardiAMP-HF cell therapy trial are promising and show the potential of optimally targeting subgroups for treatment.” BioCardia believes these results provide additional evidence in support of benefit for the CardiAMP Cell Therapy for patients with ischemic heart failure of reduced ejection fraction. Reduced ventricular size in ischemic heart failure has long been recognized as highly prognostic for more positive long-term outcomes for patients.1, 2 Today’s presentation is available on the BioCardia website: THT2026 CardiAMP HF About CardiAMP Autologous Cell TherapyGranted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use.  About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. References Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE. Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach. J Am Coll Cardiol. 2010 Jul 27;56(5):392-406. doi: 10.1016/j.jacc.2010.05.011. PMID: 20650361; PMCID: PMC4523221.Ito K, Li S, Homma S, Thompson JLP, Buchsbaum R, Matsumoto K, Anker SD, Qian M, Di Tullio MR; WARCEF Investigators. Left ventricular dimensions and cardiovascular outcomes in systolic heart failure: the WARCEF trial. ESC Heart Fail. 2021 Dec;8(6):4997-5009. doi: 10.1002/ehf2.13560. Epub 2021 Sep 20. PMID: 34545701; PMCID: PMC8712869. Forward Looking Statements  This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.   Media Contact:Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact:David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120

Continue Reading →

Orchestra BioMed Announces Presentations Highlighting AVIM Therapy Potential Impact on Hypertensive Heart Disease and Heart Failure at THT and CRT

Coronary/Structural Heart by 0 comments

NEW HOPE, Pa., March 03, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced two presentations that will be given at the Technology Heart Failure and Therapeutics (“THT”) and Cardiovascular Research Technologies (“CRT”) 2026 Meetings highlighting the potential for the Company’s Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) program in hypertensive heart disease and heart failure patients. Presentation at THT 2026Atrioventricular Interval Modulation Therapy: A Device-Based Therapy for Hypertension and Diastolic Heart Failure (Tuesday, March 3, 2026, at 10:20am ET) Presenter: David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Co-Principal Investigator for the BACKBEAT global pivotal study (“BACKBEAT Study”)Dr. Kandzari will present mechanistic and clinical data highlighting the potential application of AVIM Therapy to treat diastolic dysfunction, a precursor of heart failure with preserved ejection fraction (“HFpEF”). The presentation will highlight pilot study data demonstrating sustained systolic blood pressure reductions associated with delivery of AVIM Therapy alongside improvements in cardiac hemodynamics, ventricular remodeling, and echocardiographic measures of diastolic function. Dr. Kandzari commented, “AVIM Therapy has the potential to offer a new treatment paradigm that leverages active implantable devices with a long, established clinical history. The BACKBEAT Study, which continues to accelerate and build momentum, is focused on evaluating the potentially compelling benefit of this novel, always-on therapy for hypertension in pacemaker-indicated patients. In parallel, pilot study clinical and mechanistic results demonstrate that modulation of the atrioventricular interval drives hemodynamic and autonomic nervous system function impact that could help patients with HFpEF, a population with limited therapeutic options. Together, the presentations at the THT and CRT meetings underscore that AVIM Therapy has the future potential to benefit both hypertensive heart disease and heart failure patients.” Presentation at CRT 2026Update on AVIM Therapy: A Pacemaker-Based Treatment for Hypertension (Sunday, March 8, 2026, at 9:18am ET) Presenter: Dan Burkhoff, MD, PhD, Director, Heart Failure, Hemodynamics and MCS Research, Cardiovascular Research FoundationDr. Burkhoff will summarize the robust body of pilot study clinical evidence demonstrating sustained and reproducible systolic blood pressure reductions associated with delivery of AVIM Therapy, along with improvements in hemodynamics, ventricular remodeling, and stable long-term outcomes in pacemaker-indicated patients with hypertension. Dr. Burkhoff added, “In pilot studies, AVIM Therapy demonstrated an immediate reduction in systolic blood pressure that starts upon treatment activation and persists through nearly four years of follow-up. Long-term washout pilot study data demonstrating reproducible blood pressure reduction without evidence of disease progression further highlight the unique potential clinical utility of this therapy. Sustained blood pressure control in higher risk, older, comorbid patients that does not require additional patient adherence to daily medications can have important clinical impact in a population where blood pressure management is essential to reducing the risk of stroke, myocardial infarction, and heart failure.” About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted Breakthrough Device Designation by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company’s ongoing pivotal trials, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com

Continue Reading →

Chiesi Global Rare Diseases Announces FDA Approval of JUXTAPID® (lomitapide) Capsules for Pediatric Use in Homozygous Familial Hypercholesterolemia (HoFH)

Coronary/Structural Heart by 0 comments

Approval expands indication of JUXTAPID® to include children 2 years of age and older with HoFH This announcement was made during the week of Rare Disease Day, which aims to raise awareness about the impact of rare diseases on patients BOSTON, March 03, 2026 (GLOBE NEWSWIRE) — Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved JUXTAPID® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. JUXTAPID is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. HoFH, an ultra-rare genetic disorder, impacts an estimated 1 in 250,000 to 1 in 360,000 individuals worldwide, including children, who can be born with dangerously high low-density lipoprotein cholesterol (LDL-C) levels.1,2 Without early intervention, those living with this condition face a significantly increased risk of severe atherosclerosis.3,4 “This approval represents more than a regulatory milestone; it’s a meaningful advancement for children and families living with HoFH,” said Mitch Goldman, Senior Vice President, R&D, Chiesi Global Rare Diseases. “By expanding access to JUXTAPID for children 2 years of age and older, we’re enabling very young members of the HoFH community to benefit from the same proven treatment that has already helped adults manage their condition. This achievement reflects our unwavering commitment to bringing safe, effective therapies to those who need them most and to making a lasting difference at every stage of life.” “Children with HoFH face extraordinary challenges from the moment they’re diagnosed,” said Katherine Wilemon, Founder and CEO of Family Heart Foundation. “Their lives are shaped by frequent medical visits and the constant worry of cardiovascular risk at an age when most kids are just learning to ride a bike or play sports. The recent treatment approval for this age group marks a meaningful step forward for young children impacted by HoFH.” The FDA’s approval is grounded on evidence from a Phase 3, open-label, multicenter study (APH-19) evaluating the safety and efficacy of JUXTAPID® in 43 pediatric participants aged 5 to 17 years with HoFH who were receiving standard-of-care lipid-lowering therapy and a low-fat diet.5 Over a 24-week treatment period, JUXTAPID was titrated to each participant’s highest tolerated dose. The study demonstrated a mean 49% reduction in low-density lipoprotein cholesterol (LDL-C) from baseline, accompanied by significant decreases in non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, very low-density lipoprotein cholesterol (VLDL-C), apolipoprotein B, and triglycerides. Adverse events were primarily gastrointestinal or hepatic in nature, consistent with the known safety profile of JUXTAPID. An integrated model-based analysis confirmed that JUXTAPID is safe and efficacious for the treatment of HoFH in pediatric populations and support the dose justification in children > 2 yrs old. Overall, the results showed that JUXTAPID achieved substantial, clinically meaningful reductions in LDL-C in pediatric use for HoFH.6 USE and IMPORTANT SAFETY INFORMATIONJUXTAPID (lomitapide) is a prescription medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 2 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). It is not known if JUXTAPID is safe and effective in people with kidney problems including people with end-stage kidney disease who are not on dialysis. It is not known if JUXTAPID is safe and effective when used in children under the age of 2. IMPORTANT SAFETY INFORMATION What is the most important information I should know about JUXTAPID? JUXTAPID is available only through certified pharmacies that are enrolled in the JUXTAPID REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed JUXTAPID.There is a registry that collects information about the effects of taking JUXTAPID over time. Ask your healthcare provider for more information about this registry or visit www.JUXTAPID.com or call 1-877-902-4099. JUXTAPID may cause serious side effects, including: Liver Problems: JUXTAPID can cause liver problems such as increased liver enzymes or increased fat in the liver. For this reason, your healthcare provider should do blood tests to check your liver before you start JUXTAPID, if your dose is increased, and while you take JUXTAPID. If your tests show signs of liver problems, your doctor may lower your dose of JUXTAPID or stop it altogether.You should tell your doctor if you have had liver problems in the past, including liver problems while taking other medicines.JUXTAPID may cause nausea, vomiting and stomach pain, especially if you do not eat a low-fat diet. These side effects can also be symptoms of liver problems. Tell your healthcare provider right away if you have nausea; vomiting or stomach pain that gets worse, does not go away, or changes; fever; flu-like symptoms; yellowing of your eyes or skin; or are feeling more tired than usual while taking JUXTAPID.Do not drink more than 1 alcoholic drink per day while taking JUXTAPID. Harm to your unborn baby: Do not take JUXTAPID if you are pregnant, think you may be pregnant, or are planning to become pregnant.If you are a female who can get pregnant, you should have a negative pregnancy test result before you start on JUXTAPID. Use effective birth control while taking JUXTAPID and for 2 weeks after your last dose of JUXTAPID. If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your healthcare provider right away. Do not take JUXTAPID if you: Are taking medicines that are strong or moderate CYP34A inhibitors (for example, certain medicines used to treat bacterial, fungal, or viral infections, and medicines used to treat depression, high blood pressure or chest pain). These medicines may affect how your body breaks down JUXTAPID.Drink grapefruit juice.Have moderate to severe liver problems or active liver disease, including abnormal liver function tests. Before you take JUXTAPID, tell your healthcare provider about all of your medical conditions, including if you have liver problems; have kidney problems; have intestine or bowel problems; drink alcohol; are breastfeeding or plan to breastfeed. It is not known if JUXTAPID passes into your breastmilk. You and your healthcare provider should decide if you will take JUXTAPID or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JUXTAPID may affect the way other medicines work, and other medicines may affect how JUXTAPID works. Other possible side effects of JUXTAPID include: Problems absorbing certain nutrients. JUXTAPID makes it harder for some fat-soluble nutrients, such as vitamin E and fatty acids, to get into your body. Take supplements that contain fat-soluble vitamins each day while you take JUXTAPID.Gastrointestinal symptoms. Diarrhea, nausea, vomiting, and stomach pain or discomfort are very common when taking JUXTAPID. Strictly following a low-fat diet may help lower the chance of having these symptoms. Stop taking JUXTAPID and tell your healthcare provider if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness.Muscle pain, tenderness and weakness (myopathy). This can happen when JUXTAPID is taken with certain doses of simvastatin and lovastatin. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual while taking JUXTAPID.Increased levels of certain blood thinners. JUXTAPID can increase the level of the blood thinner, warfarin. If you take warfarin, your healthcare provider should check your blood clotting times frequently, especially after your dose of JUXTAPID changes. Liver problems caused by certain drugs. Certain medicines can cause liver problems, including isotretinoin, acetaminophen, methotrexate, tetracyclines, and tamoxifen. If you take these medicines with JUXTAPID your healthcare provider may do blood tests more often to check your liver.The most common side effects of JUXTAPID in adults and children 5 years of age and older include: diarrhea, nausea, stomach (abdominal) pain, indigestion, vomiting, and increases in liver enzymes. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of JUXTAPID. For more information, ask your healthcare provider 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. For additional information, please see the Medication Guide and full Prescribing Information, including BOXED WARNING. About HoFHHomozygous familial hypercholesterolemia (HoFH) is a serious, rare genetic disease that impairs the function of the receptor responsible for removing low-density lipoprotein cholesterol (LDL-C) (“bad” cholesterol) from the body. A loss of low-density lipoprotein (LDL) receptor function results in extreme elevation of blood cholesterol levels. Individuals with HoFH often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries. About JUXTAPID® (lomitapide)JUXTAPID (lomitapide) is a prescription medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 2 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). About Chiesi GroupChiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For more information visit www.chiesi.com. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system.  For more information visit www.chiesirarediseases.com.  Follow @ChiesiGlobalRareDiseases on LinkedIn, Facebook, Instagram, X and YouTube.  Chiesi Global Rare Diseases Media ContactSky StriarLifeSci CommunicationsEmail: sstriar@lifescicomms.com References Cuchel, M., Raal, F. J., Hegele, R. A., Al-Rasadi, K., Arca, M., Averna, M., Bruckert, E., Freiberger, T., Gaudet, D., Harada-Shiba, M., Hudgins, L. C., Kayikcioglu, M., Masana, L., Parhofer, K. G., Roeters van Lennep, J. E., Santos, R. D., Stroes, E. S. G., Watts, G. F., Wiegman, A., Stock, J. K., … Ray, K. K. (2023). 2023 Update on European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolaemia: new treatments and clinical guidance. European heart journal, 44(25), 2277–2291. Mainieri, F., Tagi, V. M., & Chiarelli, F. (2022). Recent Advances on Familial Hypercholesterolemia in Children and Adolescents. Biomedicines, 10(5), 1043. Graves, L. E., Horton, A., Alexander, I. E., & Srinivasan, S. (2023). Gene Therapy for Paediatric Homozygous Familial Hypercholesterolaemia. Heart, Lung and Circulation, 32(7), 769-779.Nohara, A., Tada, H., Ogura, M., Okazaki, S., Ono, K., Shimano, H., Daida, H., Dobashi, K., Hayashi, T., Hori, M., Matsuki, K., Minamino, T., Yokoyama, S., & Harada-Shiba, M. (2021). Homozygous Familial Hypercholesterolemia. Journal of Atherosclerosis and Thrombosis, 28(7), 665. Masana L, Zambon A, Schmitt CP, Taylan C, Driemeyer J, Cohen H, Buonuomo PS, Alashwal A, Al-Dubayee M, Kholaif N, Diaz-Diaz JL, Maatouk F, Martinez-Hervas S, Mangal B, Löwe S, Cunningham T. Lomitapide for the treatment of paediatric patients with homozygous familial hypercholesterolaemia (APH-19): results from the efficacy phase of an open-label, multicentre, phase 3 study. Lancet Diabetes Endocrinol. 2024 Dec;12(12):880-889. doi: 10.1016/S2213-8587(24)00233-X. Epub 2024 Oct 16. PMID: 39426393.JUXTAPID (lomitapide) Prescribing Information. Chiesi Farmaceutici S.p.A.; 2026 PP-RA-01435 V1.0

Continue Reading →

CVRx Announces Late-Breaking Data and Scientific Presentations Highlighting Barostim Outcomes at the THT 2026 Annual Meeting

Coronary/Structural Heart by 0 comments

MINNEAPOLIS, March 02, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, announced today the schedule of scientific presentations reviewing the science and outcomes of Barostim therapy at the Technology and Heart Failure Therapeutics 2026 (THT) meeting. THT, the annual conference organized by the Cardiovascular Research Foundation® (CRF®), will be held March 2-4, 2026, in Boston, Massachusetts. The presentations include late-breaking clinical data, oral sessions and posters highlighting real-world outcomes, cardiac energetics, hospitalization impact, left ventricular ejection fraction (LVEF) improvements and changes in advanced hemodynamic, respectively.  Late-Breaking REBALANCE Registry Data In a late-breaking presentation on Monday, March 2, Dr. Dmitry Yaranov will share, for the first time, data from the REBALANCE Registry, a post-market observational study designed to evaluate real-world data on the safety and benefit of Barostim therapy in the commercial setting. Dr. Yaranov will present the six-month outcomes in over 400 patients enrolled in the registry. Scientific Presentations Featuring Barostim Monday, March 2: Late-Breaking Clinical Science Session 1: Initial Six-Month Outcomes with Baroreflex Activation Therapy from the REBALANCE Registry (Dr. Dmitry Yaranov)Unmasking the Energetic Response Following Acute Titration of Baroreflex Activation Therapy Through Patient-Specific Modeling and Simulation (Dr. Rohan Goswami)Impact of Baroreflex Activation Therapy on Hospitalizations: A Single Center Retrospective Analysis (Dr. Joel Joseph) Tuesday, March 3: Electrical Therapies for Heart Failure: Barostimulation for HFrEF (Dr. Philip Adamson)Abstract Session 8: Heart Failure Reduced Ejection Fraction I Real-World Outcomes of Barostim Baroreflex Activation Therapy in Heart Failure: Analysis of a Large Multi-Institutional Database (Dr. Arvind Bhimaraj)LVEF and Functional Improvement Observed in a Post-Market Registry of Barostim Baroreflex Activation Therapy (Dr. Dmitry Yaranov) CVRx Sponsored Satellite Program CVRx will also host a satellite program on Tuesday, March 3 from 12:15-1:30 p.m. ET in Ensemble CD South, which will include the following presentations: Advances in Evidence with Baroreflex Activation Therapy (Dr. Philip Adamson)Outcomes from the REBALANCE Registry (Dr. Dmitry Yaranov)BREATHE-HF: Impact of Barostim Therapy on Cardiac Hemodynamics (Dr. Gabriel T. Sayer)BENEFIT-HF: Broadening Access to Barostim Therapy (Dr. Farooq Sheikh) During the satellite program, faculty will provide updates on the REBALANCE Registry, the BREATHE-HF trial, and the BENEFIT-HF trial. BREATHE-HF, a large physician-initiated study, is evaluating the impact of Barostim on cardiac hemodynamics. In January, CVRx announced the initiation of the BENEFIT-HF trial, a landmark randomized study supported by CMS Category B IDE coverage. The trial is designed to evaluate the impact of Barostim in a significantly expanded heart failure population, with the primary endpoint as a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. “We are excited by the new data supporting Barostim being featured at THT 2026,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are encouraged by the increasing adoption of Barostim by the heart failure community. The accelerating cadence of publications evaluating Barostim’s impact is proof of the positive patient impact and increasing acceptance of Barostim in the heart failure treatment continuum.” About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the expected enrollment of the BENEFIT-HF clinical trial and anticipated benefits of Barostim therapy. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment, the resulting impact of our addressable market and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.comMedia Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com

Continue Reading →

Picard Medical / SynCardia Showcases Leadership in Total Artificial Heart Therapy at Technology and Heart Failure Therapeutics Conference

Coronary/Structural Heart by 0 comments

New data highlight additional benefits beyond survival with the SynCardia Total Artificial Heart and preclinical progress for the next-generation Emperor system New data highlight additional benefits beyond survival with the SynCardia Total Artificial Heart and preclinical progress for the next-generation Emperor system

Continue Reading →

Herz P1 Smart Band 2026: What It Tracks, How It Works, and What Consumers Should Know Before Buying

Coronary/Structural Heart by 0 comments

A 2026 Informational Overview of the Herz P1 Smart Band’s Subscription-Free Health Monitoring Features, Heart Rate and HRV Tracking, Sleep Quality Analysis, Blood Oxygen and SpO2 Sensors, Stress and Temperature Monitoring, 30-Day Battery Life Claims, Companion App Functionality, Pricing Structure, Return Policy Terms, Sensor Technology Explained, Water Resistance Specifications, and What Consumers Should Independently Verify Before Purchasing Any Fitness Tracker or Wearable Health DeviceAkron, OH, Feb. 26, 2026 (GLOBE NEWSWIRE) — This article is for informational purposes only. The Herz P1 Smart Band is a consumer wellness product and is not a medical device. It is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Consumers should consult a qualified healthcare professional before making health decisions based on data from any wearable device. This article contains affiliate links. If you click through and make a purchase, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy or integrity of the information presented. The consumer wearable market continues to expand in 2026, with fitness trackers, smart bands, and health monitoring devices competing for attention across a crowded category. For consumers researching their options, sorting through feature claims, pricing models, and subscription structures can feel overwhelming. The Herz P1 Smart Band is one product that’s entered this space, marketed as a subscription-free wrist-worn health tracker with a long battery life and multi-metric monitoring capabilities. This informational overview examines what the Herz P1 Smart Band offers, how its features are described by the company, what the pricing structure looks like, and what consumers should independently verify before purchasing any fitness wearable in this category. The wearable technology space moves quickly, and product specifications, pricing, and availability can change without notice. Any product details are described as stated by the company and should be verified on the official site and directly with the manufacturer. The Herz P1 Smart Band is a consumer wellness product, not an FDA-cleared or FDA-approved medical device, and health monitoring results are not guaranteed. The information below is compiled from publicly available materials and does not represent clinical evaluation, independent laboratory testing, or editorial endorsement of the product or company. To view the current Herz P1 Smart Band offer (official Herz P1 page), consumers can check the complete product details, pricing, and return policy directly. What the Herz P1 Smart Band Is The Herz P1 Smart Band is a wrist-worn consumer wellness and fitness tracker manufactured by WuzuTech LLC, a company based in Akron, Ohio. The company positions the device as a general wellness tool designed for continuous 24/7 health monitoring. It is not classified as a medical device, and the company’s own health disclaimer states that the product and related services “are for general wellness and fitness purposes only and are not intended to be used as a medical device or to replace professional medical advice, diagnosis, or treatment.” The company states that the Herz P1 Smart Band tracks over 20 health and activity metrics using optical heart rate sensors, motion sensors, and temperature sensors built into the device. Data from the band syncs to the Herz companion app, which is available on both iOS and Android. Per the company’s published materials, the device is a one-time purchase with no recurring subscription fees required to access health data or app features. Wearable products in this category use different pricing and app-access models — some include subscription-based features, while others are offered as one-time purchases. Consumers can verify current access terms on the official product page. Regulatory Classification and General Wellness Wearables In the United States, some consumer wearables are marketed as “general wellness” products. The FDA has published guidance describing its enforcement policy for low-risk general wellness products and how they differ from devices intended for diagnosis or treatment. These products may provide estimates and trend insights related to activity and wellness but aren’t intended to diagnose, treat, cure, or prevent disease. The company markets the Herz P1 Smart Band for general wellness and fitness purposes, and states it is not intended to be used as a medical device or to replace professional medical advice. This means the data it provides — heart rate estimates, sleep pattern approximations, SpO2 readings, and activity metrics — should be understood as trend indicators, not clinical measurements. Consumers should avoid using wearable readings as a substitute for clinical evaluation, especially for medical decisions involving heart conditions, oxygenation concerns, unusual temperature patterns, or sleep disorders. Anyone with specific health concerns should consult a licensed healthcare provider who can recommend appropriate monitoring tools. How the Herz P1 Smart Band Works The company’s materials describe the device as using a combination of sensor technologies to collect biometric and activity data from the wearer’s wrist throughout the day and night. The collected data is transmitted via Bluetooth to the Herz companion app (also referenced as QRing), where it’s organized into reports and insights. Optical Heart Rate Sensors — the company states these continuously monitor heart rate and heart rate variability (HRV), providing data on cardiovascular patterns during both active and resting periods. Motion Sensors — accelerometer technology is described as tracking steps, distance, calories burned, and activity intensity throughout the day. Temperature Sensors — the company’s documentation references continuous skin temperature monitoring, which is described as helping users identify patterns related to recovery and overexertion. Blood Oxygen (SpO2) Monitoring — the device is described as measuring blood oxygen saturation levels, which the company frames as relevant to understanding energy levels and respiratory patterns. Per the company’s website, the band also includes stress tracking capabilities and sleep analysis features that monitor sleep stages and quality metrics overnight. What the Herz P1 Smart Band Tracks Based on publicly available information from the company, the Herz P1 Smart Band is described as monitoring the following categories of health and activity data: Heart Rate and HRV — continuous heart rate monitoring and heart rate variability tracking, which the company describes as useful for understanding recovery and cardiovascular health patterns over time. Sleep Quality and Analysis — the company states the band monitors sleep patterns overnight and provides sleep quality insights through the companion app. Blood Oxygen (SpO2) — the device is described as tracking blood oxygen saturation, with data accessible through the app. Skin Temperature — continuous temperature monitoring is referenced in the company’s feature descriptions. Stress Tracking — the company’s materials describe real-time stress monitoring that shows when the body is under strain and how it recovers. Activity Metrics — steps, distance, and calories burned are described as core tracking features. Women’s Health Insights — the company references menstrual cycle tracking capabilities that provide insights into how the cycle affects energy, sleep, and mood. All tracking capabilities described above come from the manufacturer’s publicly available materials. Wrist-worn consumer wellness devices use sensor technologies that provide estimates and trend data — not clinical measurements. Accuracy can vary based on device fit, skin type, motion, environmental conditions, and individual physiology. Consumers who need medically reliable biometric data should consult with a healthcare provider about appropriate monitoring tools. Pricing and Purchase Structure The Herz P1 Smart Band is sold as a one-time purchase through the company’s official website. Wearable products in this category use different pricing models — some require recurring subscriptions to unlock full feature access, while others include all features with a one-time purchase. The company states the Herz P1 Smart Band doesn’t require a recurring subscription to access its companion app features. According to publicly available information on the official website at the time of publication, pricing may vary based on promotions, bundles, and inventory conditions. Consumers should check the official Herz P1 page to confirm the most current pricing, shipping costs, and policy terms before making any purchase decision. The company’s materials state that the purchase includes the smart band, charging cable, and straps. Additional color bands may be sold separately. The company references a 90-day return policy on its official page. Consumers should verify eligibility requirements, timelines, and return shipping responsibilities directly in the published policy before purchasing. Battery Life, Build Quality, and Design The company states the Herz P1 Smart Band contains a 175 mAh battery and describes the following performance characteristics: Active Use Battery Life — the company states up to 25–30 days of regular use on a single charge. Standby Battery Life — up to 60 days of standby time is referenced in the company’s materials. Charging Time — the company states the device fully recharges in approximately 1 to 1.5 hours. Regarding build quality, the company’s documentation describes the device as constructed from a lightweight zinc alloy frame with a durable nylon strap. The company states the band is water-resistant and sweat-proof, suitable for workouts and daily wear. The company’s official product page references water resistance but advises against swimming or full submersion. The Herz P1 Smart Band is described as available in five color options: Midnight Black, Frosted White, Green Power, Navy Blue, and Rose Mist. Battery life and water resistance claims come from the manufacturer. Actual performance may vary based on notification settings, sensor sampling frequency, Bluetooth connectivity, display behavior, device fit, and environmental conditions. Consumers should check the complete product specifications on the official site before purchasing. Companion App and Data Access The company states that the Herz P1 Smart Band syncs with a companion app available for both iOS and Android. The app is described as providing detailed health and fitness reports, goal-setting features, and progress tracking over time. Per the company’s materials, the app supports over 30 languages. The band also includes offline data storage. The company states that if Bluetooth is disconnected, the device can store health data locally for several days. Once reconnected, stored data syncs automatically with the companion app. Consumers should verify app compatibility with their specific device and operating system version before purchasing. What Consumers Commonly Verify Before Purchasing Based on common consumer research patterns in the wearable technology category, here are areas that prospective buyers typically investigate before purchasing a fitness tracker: Accuracy Expectations: Consumer wellness wearables vary in accuracy across different metrics. No wrist-worn consumer device provides clinical-level precision. The company states its device tracks various metrics, but consumers seeking medically reliable data should consult a healthcare provider. Return Policy Terms: The company references a 90-day return policy on its official page. Consumers should verify the specific terms, conditions, and process for returns directly on the company’s website before purchasing. Company Background: WuzuTech LLC is listed as the manufacturer, based in Akron, Ohio. Consumers can verify the company’s business registration, customer service responsiveness, and fulfillment track record independently. App Functionality: Checking the companion app’s current version, update frequency, and user feedback in the iOS App Store or Google Play Store before purchasing can provide additional perspective on the overall experience. Comparison Shopping: Consumers often compare wearables based on sensor types, sampling frequency, battery life under real-world settings, return policy clarity, app permissions, and whether full feature access requires ongoing fees. Evaluating multiple products across these criteria helps inform a purchasing decision. Water Resistance vs. Waterproofing: The company describes the device as water-resistant and suitable for sweat and splashes but advises against swimming or full submersion. Consumers should understand the difference between water resistance ratings before wearing any device in water. Key Terminology for the Consumer Wearable Category Heart Rate Variability (HRV): HRV measures the time variation between heartbeats. In consumer wellness contexts, it’s commonly used as an indicator of recovery and stress. HRV readings from consumer wearables are estimates and shouldn’t be used for medical diagnosis. Blood Oxygen Saturation (SpO2): SpO2 refers to the percentage of oxygen-carrying hemoglobin in the blood. Consumer wearable SpO2 readings are approximations and aren’t equivalent to pulse oximeter readings obtained in clinical settings. Photoplethysmography (PPG): PPG is the optical sensor technology commonly used in consumer wearables to detect blood volume changes beneath the skin. It’s the foundational technology behind heart rate and SpO2 monitoring in most fitness trackers and smart bands. General Wellness Device: A category described in FDA guidance for products intended to promote a healthy lifestyle. General wellness devices aren’t intended to diagnose, treat, cure, or prevent disease and don’t follow the same regulatory pathway as medical devices. Subscription-Free Model: In the wearable category, some manufacturers require monthly or annual subscriptions to access full data insights and features. Subscription-free models provide full feature access with a one-time purchase. Fitness Tracker vs. Smartwatch: A fitness tracker or smart band typically focuses on health and activity monitoring with a lighter design and longer battery life. Smartwatches generally offer broader app functionality, larger displays, and shorter battery life. The Herz P1 Smart Band falls into the fitness tracker and smart band category. Consumer Questions About the Herz P1 Smart Band Is the Herz P1 Smart Band a medical device? No. The company explicitly states that the Herz P1 Smart Band is a general wellness and fitness product. It isn’t intended to diagnose, treat, cure, or prevent any disease or medical condition. The company’s health disclaimer directs consumers to consult a qualified healthcare professional for medical advice. Who manufactures the Herz P1 Smart Band? The Herz P1 Smart Band is manufactured by WuzuTech LLC, a company based in Akron, Ohio. Consumers can verify the company’s business details and contact information independently. Does the Herz P1 Smart Band require a monthly subscription? The company states that no subscription is required. All health data and app features are described as accessible with the one-time device purchase. Consumers should verify this on the official website, as company policies can change. What phone compatibility does the Herz P1 Smart Band support? The company states the device works with both iOS and Android devices through a free companion app. Consumers should verify specific operating system version requirements before purchasing. How long does the Herz P1 Smart Band battery last? The company states up to 25–30 days of regular use on a single charge, with up to 60 days of standby time. Actual battery performance may vary based on usage patterns and settings. The company states charging takes approximately 1 to 1.5 hours. Is the Herz P1 Smart Band waterproof? The company describes the device as water-resistant and suitable for sweat, rain, and hand-washing. However, the company advises against swimming or fully submerging the device. Consumers should check the specific water resistance rating on the official product page. What metrics does the Herz P1 Smart Band track? The company states the device tracks over 20 health and activity metrics, including heart rate, HRV, SpO2, temperature, sleep quality, stress levels, steps, distance, and calories burned. All accuracy claims come from the manufacturer. Does the Herz P1 Smart Band store data offline? The company states the device can store health data locally for several days if Bluetooth is disconnected. Stored data syncs automatically once Bluetooth is reconnected. What is the return policy for the Herz P1 Smart Band? The company references a 90-day return policy on its official page. Consumers should verify eligibility requirements, timelines, and return shipping responsibilities directly in the published policy before purchasing. How does the Herz P1 Smart Band compare to smartwatches? Smart bands and smartwatches serve different purposes. Smart bands like the Herz P1 generally focus on health and fitness tracking with lighter designs and longer battery life. Smartwatches typically offer broader app ecosystems, larger displays, notification management, and shorter battery life. The right choice depends on individual priorities and what you’re looking for in a wearable. Where can consumers purchase the Herz P1 Smart Band? The company’s official website is the primary direct purchase channel. The product has also been listed on third-party retail platforms. Consumers should verify they’re purchasing from an authorized source. What colors are available for the Herz P1 Smart Band? The company’s materials reference five color options: Midnight Black, Frosted White, Green Power, Navy Blue, and Rose Mist. Availability may vary. Additional Category Context Consumers researching subscription-free fitness trackers often evaluate several areas beyond any single product’s feature list. Understanding how optical wrist sensors estimate heart rate and SpO2, what app privacy and data permissions look like, how battery life performs under real-world conditions, and what return and warranty terms actually require are all part of informed decision-making in this category. This article focuses on those evaluation areas using publicly available product disclosures from the Herz P1 Smart Band manufacturer. Consumers are encouraged to apply the same research approach across any wearable they’re considering. For additional context on the broader Herz P1 product line, a separate informational overview examines the company’s smart ring offering — including its features, pricing, accuracy context, and what consumers should verify before purchasing. Read the full informational analysis here. A separate informational overview also examines the company’s smart scale product, including its 8-electrode BIA sensor technology, body composition metrics, and what consumers should verify about accuracy claims for any home health measurement device. Read the full informational overview here. Both analyses were published for informational purposes and are not endorsements or recommendations. A Consumer Verification Checklist for Any Health-Tracking Wearable Before purchasing any health-tracking wearable — including the Herz P1 Smart Band — consumers can strengthen their decision-making by independently verifying the following areas. This checklist isn’t specific to any single product. It’s a framework that applies across the entire consumer wearable category. Verify the App Name and Developer: Download and check out the companion app before purchasing the hardware. Look at who developed it, when it was last updated, and what the current user feedback looks like. The Herz P1 Smart Band syncs with an app referenced as the Herz app or QRing, available on iOS and Android. Check App Permissions: Before installing any health-tracking app, look at what data permissions it requests. Common requests include Bluetooth, location, health data access, and notification permissions. Understand what data the app collects and how it’s stored or shared. Confirm Data Export Options: Some consumers want to export their health data to share with healthcare providers or use with other platforms. Check whether the companion app allows data export and in what formats before committing to a device ecosystem. Read the Return Policy in Full: Don’t rely on summary language. Read the actual return policy terms, including who pays return shipping, whether the device must be in original packaging, and how refunds are processed. The company states a return policy is available on the official Herz P1 website. Check Warranty Terms: Look at what the warranty covers, how long it lasts, and what the claims process involves. Manufacturer warranties for consumer electronics vary significantly in scope and responsiveness. Understand Sensor Limitations: Consumer wearables use optical sensors (PPG), accelerometers, and temperature sensors that provide estimates — not clinical measurements. Factors like skin tone, tattoos, wrist fit, motion, and environmental temperature can affect reading accuracy across all consumer wearable brands. Clarify Water Resistance vs. Waterproofing: These terms mean different things. Check the specific rating. The Herz P1 Smart Band is described as water-resistant and suitable for sweat and splashes, but the company advises against swimming or full submersion. Test Customer Support Responsiveness: Before purchasing, consider sending a pre-sale question to the company’s support team. Response time and quality can give you a sense of what post-purchase support looks like. Ask About Firmware Updates: Wearable devices often receive firmware updates that can affect performance, features, and battery life. Check whether the manufacturer has a track record of providing updates and how they’re delivered. Confirm Device Compatibility: Verify that your specific phone model and operating system version are compatible with the companion app before purchasing. Compatibility requirements can change with operating system updates. Summary of Key Considerations The Herz P1 Smart Band enters 2026 as a subscription-free consumer wellness wearable in a crowded fitness tracker category. The company’s advertised feature set — including 20+ health metrics, up to 30-day battery life, and no recurring fees — positions it as one option among many for consumers exploring accessible health monitoring. As with any consumer wellness device, prospective buyers should understand that the Herz P1 Smart Band is not a medical device and shouldn’t be used as a substitute for professional medical advice, diagnosis, or treatment. All feature claims, accuracy statements, and performance specifications referenced in this article come from the manufacturer’s publicly available materials and haven’t been independently verified through clinical testing as part of this overview. Consumers interested in the complete product details, current pricing, and return policy can view the current Herz P1 Smart Band offer (official Herz P1 page) directly. Contact Information WuzuTech LLC 839 E Market St, Ste 106 #165 Akron, OH 44305 United States Email: support@wuzutech.com Phone: (866) 479-1629 Website: https://herzp1.com Disclaimers Content and General Wellness Disclaimer: This article is for informational purposes only and does not constitute medical advice, professional health guidance, or a product endorsement. The Herz P1 Smart Band is a consumer wellness product, not a medical device. Statements regarding the product have not been evaluated by the Food and Drug Administration. The device is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Consumers should consult with a qualified healthcare professional before making health-related decisions based on data from any consumer wearable device. All product descriptions, features, and specifications referenced in this article are based on the manufacturer’s publicly available materials and have not been independently verified through clinical testing. Results, Pricing, and Availability Notice: Individual results and experiences with consumer wellness wearables vary based on usage patterns, device fit, individual physiology, environmental conditions, and other factors. No specific outcomes are guaranteed. Pricing referenced in this article reflects publicly available information at the time of publication and is subject to change without notice. Consumers should verify all current pricing, shipping costs, and return policy terms directly on the company’s official website before purchasing. FTC Affiliate Disclosure and Publisher Responsibility: This article contains affiliate links. If you click through these links and make a purchase, a commission may be earned at no additional cost to you. This affiliate relationship does not influence the informational content, accuracy, or editorial independence of this article. The publisher is not responsible for the accuracy of information provided by the manufacturer, changes to the product or its availability, or the consumer’s individual experience with the product or company. Consumers are encouraged to conduct their own research and due diligence before making any purchase decision. CONTACT: Email: support@wuzutech.com
Phone: (866) 479-1629

Continue Reading →
1 … 10 11 12 13 14 … 436