Orchestra BioMed Holdings Inc Stock Price, News & Analysis

Orchestra BioMed presented key insights on AVIM (atrioventricular interval modulation) therapy at CSI Frankfurt 2025, highlighting its potential for treating hypertensive heart disease. Dr. Daniel Burkhoff showcased AVIM as a device-based blood pressure management solution specifically designed for high-risk patients with indicators of diastolic dysfunction and progression to HFpEF. The therapy targets over 7.7 million U.S. patients with hypertensive heart disease, recently receiving FDA Breakthrough Device Designation. AVIM therapy works by reducing cardiac preload and modulating autonomic nervous system responses to improve cardiovascular function. The company is currently conducting the BACKBEAT global pivotal study in collaboration with Medtronic, enrolling patients with uncontrolled hypertension who need dual-chamber pacemakers.

Orchestra BioMed (NASDAQ: OBIO) reported Q1 2025 financial results and significant regulatory milestones. The company received FDA Breakthrough Device Designation for its AVIM therapy targeting uncontrolled hypertension and cardiovascular risk. Additionally, the FDA approved an IDE for the Virtue SAB U.S. pivotal trial, comparing their sirolimus-based technology against a paclitaxel-coated balloon. Financial highlights include: cash position of $49.9 million, revenue of $0.9 million (up from $0.6M in Q1 2024), and a net loss of $18.8 million ($0.49 per share). R&D expenses increased to $13.5 million (from $9.1M), primarily due to the BACKBEAT global pivotal study costs. The company's AVIM therapy patent portfolio expanded to 137 issued patents worldwide.

Orchestra BioMed (NASDAQ: OBIO) has significantly expanded its intellectual property portfolio for AVIM therapy, securing 10 new patents for hypertension treatment in the past 12 months. The company's global patent estate now totals 137 issued patents, including 120 patents for hypertension and 17 for heart failure treatment, comprising over 2,100 claims. The portfolio includes 46 U.S. patents and 91 international patents across key markets including Europe, Japan, and China.

AVIM therapy recently received FDA Breakthrough Device Designation for treating uncontrolled hypertension in high-risk cardiovascular patients. The therapy is currently being evaluated in the BACKBEAT global pivotal study for treating uncontrolled hypertension in patients with pacemaker indications, targeting a condition that is the leading global risk factor for death and affects millions worldwide.

Orchestra BioMed has received FDA approval for its IDE to start a pivotal U.S. trial of Virtue SAB, its first-in-class Sirolimus-AngioInfusion Balloon. The trial will compare Virtue SAB head-to-head with Boston Scientific's AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis.

Key highlights:

• Virtue SAB is the only non-coated drug-eluting balloon system under clinical investigation worldwide
• The device has received multiple FDA Breakthrough Device Designations
• Trial will involve 740 patients across 75 U.S. centers
• Previous SABRE pilot study showed promising results with 12-month target lesion failure of 2.8%

The trial is set to begin in second half of 2025. Orchestra BioMed aims to tap into a multibillion-dollar U.S. market for coronary drug delivery balloons, with Virtue SAB positioned as a potential new standard of care in interventional cardiology.

Orchestra BioMed (Nasdaq: OBIO) has announced its upcoming participation in several major investor conferences, showcasing its commitment to engaging with institutional investors and sharing company developments.

Key conference appearances include:

• Chardan Capital Conference (April 29, 2025) - CEO David Hochman will join a virtual fireside chat at 10:30am ET discussing "Data & Regulatory Catalysts"
• Jefferies Global Healthcare Conference (June 5, 2025) - Management team will conduct a live fireside chat at 3:45pm ET in New York
• H.C. Wainwright BioConnect Conference (May 20, 2025) - Company will deliver a presentation and host one-on-one investor meetings

All virtual events will be accessible through live webcasts and will remain available on Orchestra BioMed's Investor Relations website after the events. The company, which focuses on accelerating high-impact technologies through risk-reward sharing partnerships, will also offer one-on-one meetings with investors at selected conferences.

Orchestra BioMed (NASDAQ: OBIO) announced a satellite symposium at the HRS 2025 Annual Meeting focusing on their atrioventricular interval modulation (AVIM) therapy program. The FDA recently granted Breakthrough Device Designation for AVIM therapy, targeting patients with uncontrolled hypertension and increased cardiovascular risk.

The symposium, scheduled for April 25, 2025, in San Diego, will feature presentations from leading experts discussing clinical results showing AVIM therapy's effectiveness in reducing systolic blood pressure and improving cardiac function. Orchestra BioMed estimates over 7.7 million U.S. patients meet the criteria for AVIM therapy.

The company is currently enrolling patients in the BACKBEAT global pivotal study in collaboration with Medtronic (NYSE: MDT), evaluating AVIM therapy for uncontrolled hypertension in patients with dual-chamber pacemakers.

Vivasure Medical has received CE Mark approval for its PerQseal Elite vascular closure system, a pioneering fully absorbable and sutureless large-bore vessel closure device. The product will be launched in select European markets this summer.

The PerQseal Elite system is specifically designed for closure following large-bore percutaneous cardiovascular procedures like TAVR and EVAR. It stands out as the first fully bioresorbable device in this category and requires no pre-procedure steps, offering improved procedural efficiency.

The device is placed from inside the vessel, providing simpler and more controlled deployment compared to conventional techniques. It restores the vessel to its natural state without leaving behind materials such as collagen, metal implants, or sutures.

Orchestra BioMed (Nasdaq: OBIO) has received FDA Breakthrough Device Designation (BDD) for its atrioventricular interval modulation (AVIM) therapy. The designation applies to an estimated 7.7 million U.S. patients with uncontrolled hypertension and increased cardiovascular risk.

The AVIM therapy, delivered through an implantable pacemaker system, is designed for patients with preserved left ventricular systolic function and uncontrolled hypertension, despite using anti-hypertensive medications. The company is currently conducting the BACKBEAT global pivotal study in collaboration with Medtronic (NYSE: MDT).

The BDD status provides accelerated FDA engagement and reviews, while potentially supporting higher reimbursement for AVIM-enabled devices through Medicare's New Technology Add-on Payment and Transitional Pass-Through payments programs.

Orchestra BioMed (NASDAQ: OBIO) has reported its full year 2024 financial results, showing a revenue of $2.6 million, down from $2.8 million in 2023. The company's net loss widened to $61.0 million ($1.66 per share) compared to $49.1 million in 2023.

Key financial metrics include cash and marketable securities of $66.8 million as of December 31, 2024. R&D expenses increased to $42.8 million from $33.8 million, primarily due to the BACKBEAT global pivotal study costs. The company raised approximately $30 million through stock sales and credit facility.

Notable developments include continued progress on the BACKBEAT study with Medtronic, submission of a revised design for the Virtue ISR-US pivotal study, and entering mediation with Terumo for partnership restructuring. The company also strengthened its leadership with three new independent directors and appointed Mark Pomeranz as EVP & General Manager of Interventional Therapies.