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JenaValve Appoints Dave Haan as Vice President of Clinical Affairs

IRVINE, Calif., May 12, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Dave Haan as Vice President of Clinical Affairs. Dave will lead the company’s clinical affairs strategy, overseeing the continued execution of JenaValve’s clinical programs — including the ARTIST randomized controlled trial and the JENA-VAD Registry. His appointment strengthens the company’s clinical leadership during a pivotal period of organizational growth and commercial expansion following the recent FDA approval of the Trilogy THV System for symptomatic, severe aortic regurgitation (ssAR).

Orchestra BioMed Targeting BACKBEAT Trial Enrollment Completion By End of Q3 2026 and Data Presentation in Q2 2027

Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026 Orchestra BioMed and Medtronic plc. (NYSE: MDT, “Medtronic”), the Company’s strategic collaborator for the BACKBEAT Trial, intend to submit primary endpoint results for consideration as a late-breaker at a major cardiology conference in Q2 2027Medtronic plans to submit AVIM Therapy-related marketing application for FDA approval after primary endpoint data analyses and reports are complete and pursue subsequent global regulatory approvals, assuming primary safety and efficacy endpoints are met NEW HOPE, Pa., May 12, 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 an update to the overall clinical and regulatory timeline for the BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled hypertension despite medications. The Company is targeting completion of enrollment by the end of the third quarter of 2026. Further, the Company and Medtronic, its strategic collaborator for the BACKBEAT Trial and the commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, plan to submit the primary endpoint data for a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Lastly, assuming primary safety and efficacy endpoints are met, Medtronic plans to submit a marketing application for FDA approval after primary endpoint data analyses and reports are complete, and subsequently to pursue global regulatory approvals. The updated BACKBEAT Trial timeline is supported by FDA approval of a reduction in the sample size for the clinical trial to a target total of 284 evaluable randomized subjects with the total enrollment target of 316 patients accounting for potential loss to follow up. The primary efficacy endpoint (between-group difference in 24-hour ambulatory systolic blood pressure “aSBP” at 3-month follow up) and primary safety endpoint (freedom from unanticipated serious adverse device events in the AVIM Therapy arm at 3-month follow up) remain robustly powered ( >90% statistical power) at the revised sample size for the trial.  The sample size is designed to detect a between group difference of at least 5 mmHg in aSBP. The change in sample size reflects collaboration among Orchestra BioMed, Medtronic and the FDA under the Breakthrough Devices program, and follows FDA approval of an amendment to the BACKBEAT Trial protocol received on May 8, 2026 by Orchestra BioMed. David Hochman, Chairman, Chief Executive Officer of Orchestra BioMed, commented, “We are delighted to provide clarity on the anticipated overall timeline for the BACKBEAT Trial, which reflects ongoing global enrollment momentum and FDA alignment with a streamlined sample size that remains highly powered to assess AVIM Therapy’s efficacy and safety at the 3-month primary endpoints. We believe BACKBEAT has the potential to be a landmark pivotal trial that can open up an entirely new therapeutic modality for patients at increased risk from high blood pressure and hypertensive heart disease.” Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Cardiac Rhythm Management operating unit, stated, “For decades, cardiac pacing has been foundational in the management of rhythm disorders. With the BACKBEAT Trial, Medtronic and Orchestra BioMed are investigating whether AVIM Therapy can extend the benefits of pacing to the field of hypertension management in high-risk patients. This update reflects our shared confidence in progress toward the completion of enrollment, the submission of data to the FDA, and the presentation of clinical evidence.” 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 by 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 and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations 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 TherapyAVIM 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 is evaluating 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 two Breakthrough Device Designations 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 enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of regulatory submissions, realizing the clinical and commercial value of the Company’s product candidates, 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, 2025, which was filed with the SEC on March 12, 2026. 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 KirkOrchestra BioMedkkirkellis@orchestrabiomed.com

Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress

LAGUNA HILLS, Calif.–(BUSINESS WIRE)—- $ADGM #ARRHYTHMIA–Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced financial results for the first quarter ended March 31, 2026. Recent Business Highlights: Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026 – the first large-scale, rigorously executed pivotal trial in patients with bot

NeuWire Medical Appoints Ramin Mousavi as Executive Chairman Following Stroke Journal Publication.

DALLAS–(BUSINESS WIRE)–NeuWire Medical, a medical device company advancing the development of a targeted plasticity therapy platform for individuals living with chronic ischemic stroke, today announced the appointment of Ramin Mousavi as Executive Chairman of the Board. His arrival marks an important step in the company’s next phase of growth as NeuWire Medical prepares to advance its clinical, regulatory, and financing strategy. Ramin joins NeuWire Medical following his role as President, Ch

CVRx Reports First Quarter 2026 Financial and Operating Results

MINNEAPOLIS, May 11, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the first quarter of 2026. Recent Highlights Total revenue for the first quarter of 2026 was $14.8 million, an increase of approximately 20% over the prior year quarterU.S. revenue for the first quarter of 2026 was $13.7 million, an increase of 22% over the prior year quarterActive implanting centers in the U.S. grew to 257 as of March 31, 2026, as compared to 227 as of March 31, 2025First site activated and first patient enrolled in BENEFIT-HF clinical trial “We delivered a strong start to 2026, with U.S. revenue growing 22% as the investments we made in our team and programs throughout 2025 begin to translate into results,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are seeing continued progress from our sales organization and the successful activation of the first site and our first patient enrolled in our BENEFIT-HF clinical trial. Together, these developments reinforce our confidence in the path ahead and in our ability to make Barostim more accessible to heart failure patients.” First Quarter 2026 Financial and Operating Results Revenue was $14.8 million for the three months ended March 31, 2026, an increase of $2.4 million, or 20%, over the three months ended March 31, 2025. Revenue generated in the U.S. was $13.7 million for the three months ended March 31, 2026, an increase of $2.4 million, or 22%, over the three months ended March 31, 2025. Revenue units in the U.S. totaled 429 and 359 for the three months ended March 31, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of March 31, 2026, the Company had a total of 257 active implanting centers in the U.S., as compared to 252 as of December 31, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by three to a total of 56 during the three months ended March 31, 2026. Revenue generated in Europe was $1.1 million for the three months ended March 31, 2026, a decrease of $27,000, or 2%, over the three months ended March 31, 2025. Total revenue units in Europe decreased to 56 for the three months ended March 31, 2026 from 59 in the prior year period. The number of sales territories in Europe remained consistent at five for the three months ended March 31, 2026. Gross profit was $12.9 million for the three months ended March 31, 2026, an increase of $2.6 million, or 25%, over the three months ended March 31, 2025. Gross margin was 87% and 84% for the three months ended March 31, 2026 and March 31, 2025, respectively. R&D expenses increased $0.6 million, or 23%, to $3.1 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. This change was driven by a $0.4 million increase in consulting expenses, a $0.3 million increase in compensation expenses, and a $0.1 million increase in non-cash stock-based compensation expenses, partially offset by a $0.2 million decrease in clinical trial expenses. SG&A expenses increased $0.7 million, or 3%, to $22.0 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025. This change was primarily driven by a $1.0 million increase in compensation expenses and a $0.3 million increase in non-cash stock-based compensation expenses, partially offset by a $0.3 million decrease in consulting expenses and a $0.3 million decrease in advertising expenses. Interest expense increased $0.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, driven by the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 and $1.1 million for the three months ended March 31, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $13.1 million, or $0.50 per share, for the three months ended March 31, 2026, compared to a net loss of $13.8 million, or $0.53 per share, for the three months ended March 31, 2025. Net loss per share was based on 26.4 million weighted average shares outstanding for three months ended March 31, 2026 and 25.9 million weighted average shares outstanding for the three months ended March 31, 2025. As of March 31, 2026, cash and cash equivalents were $72.3 million. Net cash used in operating and investing activities was $12.3 million for the three months ended March 31, 2026 as compared to $12.9 million for the three months ended March 31, 2025. BENEFIT-HF Clinical Trial Update On March 31, 2026, the first site was activated in the BENEFIT-HF trial and the first patient was enrolled in the second quarter of 2026. This trial, as previously disclosed, is a landmark randomized controlled trial designed to evaluate Barostim’s impact on all-cause mortality and heart failure decompensation events in an expanded population of heart failure patients with left ventricular ejection fractions up to 50% and NT-proBNP levels up to 5,000 pg/mL. If successful, the BENEFIT-HF trial could expand the indicated patient population for Barostim approximately three times, significantly broadening access to this proven neuromodulation-based approach to heart failure management. Business Outlook For the full year of 2026, the Company maintained its revenue and expense guidance, and updated its guidance range for gross margin, as follows: Total revenue between $63.0 million and $67.0 million;Gross margin between 85% and 87%, compared to prior guidance of 84% and 86%;Operating expenses between $103.0 million and $107.0 million. For the second quarter of 2026, the Company expects to report total revenue between $15.1 million and $16.1 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. 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 Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and second quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. 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 in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; 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.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited)         March 31, December 31,  2026 2025Assets      Current assets:      Cash and cash equivalents $72,303  $75,708 Accounts receivable, net of allowances of $869 and $871, respectively  9,104   10,665 Inventory  12,403   12,205 Prepaid expenses and other current assets  2,940   3,069 Total current assets  96,750   101,647 Property and equipment, net  2,159   2,243 Operating lease right-of-use asset  793   878 Other non-current assets  26   26 Total assets $99,728  $104,794 Liabilities and Stockholders’ Equity      Current liabilities:      Accounts payable $2,998  $3,833 Accrued expenses  6,488   9,484 Total current liabilities  9,486   13,317 Long-term debt  58,490   49,514 Operating lease liability, non-current portion  544   638 Other long-term liabilities  2,099   2,001 Total liabilities  70,619   65,470 Commitments and contingencies      Stockholders’ equity:      Common stock, $0.01 par value, 200,000,000 authorized as of March 31, 2026 and December 31, 2025; 26,428,767 and 26,311,607 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively  264   263 Additional paid-in capital  632,820   629,916 Accumulated deficit  (603,772)  (590,652)Accumulated other comprehensive loss  (203)  (203)Total stockholders’ equity  29,109   39,324 Total liabilities and stockholders’ equity $99,728  $104,794  CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited)         Three months ended  March 31,  2026 2025Revenue $14,769  $12,348 Cost of goods sold  1,888   2,036 Gross profit  12,881   10,312 Operating expenses:      Research and development  3,084   2,517 Selling, general and administrative  21,958   21,232 Total operating expenses  25,042   23,749 Loss from operations  (12,161)  (13,437)Interest expense  (1,551)  (1,457)Other income, net  593   1,123 Loss before income taxes  (13,119)  (13,771)Benefit (provision) for income taxes  (1)  5 Net loss  (13,120)  (13,766)Cumulative translation adjustment  —   — Comprehensive loss $(13,120) $(13,766)Net loss per share, basic and diluted $(0.50) $(0.53)Weighted-average common shares used to compute net loss per share, basic and diluted  26,355,591   25,876,062 

Cytokinetics Announces New Data Related to MYQORZO® (aficamten) at ESC Heart Failure 2026

Multinational Real-world Data Reinforce Favorable Clinical Profile and Long-Term Safety  SOUTH SAN FRANCISCO, Calif., May 11, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the presentation of new data reinforcing the clinical profile of MYQORZO® (aficamten) at the European Society of Cardiology (ESC) Heart Failure 2026 Congress. The presentations include new analyses from SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with oHCM; MAPLE-HCM, the Phase 3 clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM (oHCM); and FOREST-HCM, the open-label extension trial of aficamten. Collectively, the new evidence expands understanding of the effectiveness of cardiac myosin inhibition with aficamten compared directly to metoprolol, a beta blocker, as well as specific safety and durability characteristics of MYQORZO across patient demographics, clinical, and economic subgroups. “The breadth of research being presented at ESC Heart Failure 2026 reflects our commitment to deepening the scientific understanding of oHCM and heart failure,” said Stephen Heitner, M.D., Senior Vice President, Clinical Research and Development, Cytokinetics. “These new insights underscore the strength and consistency of the clinical profile of MYQORZO, adding to the growing body of real-world evidence informing physician treatment decisions.” New Analyses Show MYQORZO Outperforms Metoprolol Across Sex and Doses A dose-dependent analysis from MAPLE-HCM compared aficamten to the beta-blocker metoprolol in patients with symptomatic oHCM. Key findings showed significant improvements in exercise capacity, outflow gradients, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) across all treatment doses. Conversely, metoprolol failed to show improvement in these outcomes regardless of the dose administered (Figure 1). Figure 1 A secondary analysis of sex differences in MAPLE-HCM showed consistent benefits of MYQORZO in women. Despite women entering the trial (42%) with more severe baseline characteristics, MYQORZO delivered nearly identical improvements in peak oxygen consumption (pVO2) for both sexes (+2.2 mL/kg/min). Both groups also saw significant gains in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and reductions in cardiac biomarkers and NT-proBNP. Long-term Data Reinforce Safety and Efficacy Profile of MYQORZO A prospective analysis of 122 patients who had interpretable ambulatory electrocardiogram (ECG) data at screening in the FOREST-HCM showed that long-term treatment with MYQORZO—up to 96 weeks—did not increase the incidence of arrhythmias in patients, including those who underwent withdrawal of beta-blocker therapy. Among 122 patients, the incidence of non-sustained ventricular tachycardia (NSVT) on ambulatory ECG remained stable through 96 weeks compared with baseline, with no increase in atrial fibrillation (AF) episodes and no newly identified subclinical AF. There was also no increase in arrhythmia frequency among a subgroup of 16 patients who discontinued beta-blocker therapy during aficamten treatment. These results represent the first prospective analysis of ambulatory ECG monitoring in patients treated with a cardiac myosin inhibitor and are consistent with the low incidence of clinically detected arrhythmias previously reported for patients with oHCM treated with aficamten. Additionally, an open-label extension study of aficamten in Chinese patients with symptomatic oHCM showed that aficamten was well tolerated using the same dosing strategy of individualized titration as was used globally. Through 48 weeks of treatment with aficamten, patients experienced no serious or severe treatment-emergent adverse events, no occurrences of LVEF

Hengrui Pharma and Braveheart Bio Announce Positive Phase 2 Results with HRS/BHB-1893 in Non-Obstructive Hypertrophic Cardiomyopathy

Results with next-generation cardiac myosin inhibitor suggest a potentially disease-modifying therapy in non-obstructive hypertrophic cardiomyopathy HRS/BHB-1893 treatment resulted in rapid and sustained reductions in key biomarkers, structural remodeling and meaningful improvements in…