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On Thursday, H.C. Wainwright maintained a Buy rating and a $12.00 price target on Orchestra BioMed Inc. (NASDAQ:OBIO) stock. According to InvestingPro data, analyst price targets for OBIO range from $12 to $20, with the stock currently trading at $2.85. This affirmation comes in the wake of the company’s recent announcement on April 22 that the FDA has granted Breakthrough Device designation for its innovative atrioventricular interval modulation (AVIM) therapy. The company maintains strong financial fundamentals with a healthy current ratio of 4.27x and more cash than debt on its balance sheet, as revealed by InvestingPro analysis.
The therapy, which is delivered through an implantable pacemaker system, aims to reduce blood pressure in patients with a heightened ten-year risk of atherosclerotic cardiovascular disease (ASCVD), preserved left ventricular systolic function, and uncontrolled hypertension. This FDA designation is particularly significant as it acknowledges the novelty of AVIM technology and the critical unmet medical need it addresses, potentially impacting an estimated 7.7 million patients in the United States. With an impressive gross profit margin of 92.27%, Orchestra BioMed demonstrates strong operational efficiency in its existing business.
The Breakthrough Device designation is expected to expedite the FDA’s engagement and review process for the AVIM therapy. It also opens up the possibility for more favorable reimbursement options, such as the New Technology Add-on Payment (NTAP) and Transitional Pass-Through payments (TPT) under the Center for Medicare & Medicaid Services (CMS) programs. These benefits could significantly enhance the commercial prospects of the therapy.
Orchestra BioMed’s AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, specifically targeting pacemaker-indicated patients with uncontrolled hypertension. The study’s outcomes are anticipated to further support the therapy’s efficacy and safety profile. With a market capitalization of $109.19 million and significant analyst coverage, investors can access detailed financial analysis and 12 additional ProTips through InvestingPro.
Orchestra BioMed is scheduled to present recent advancements in its AVIM program at a satellite symposium during the Heart Rhythm Society 2025 Annual Meeting on April 25, 2025. This event will provide the company with an opportunity to showcase its progress and engage with key stakeholders in the medical community.
In other recent news, Orchestra BioMed Holdings has received the FDA Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy. This designation is expected to expedite the development and review process for AVIM therapy, which targets reducing blood pressure in patients with uncontrolled hypertension. Orchestra BioMed reported a net loss of $61.0 million for the year 2024, aligning closely with analyst projections, and generated total revenue of $2.6 million. Analysts at H.C. Wainwright have adjusted their price target for the company’s stock to $12.00, down from $14.00, while maintaining a Buy rating. Meanwhile, BTIG analysts have also maintained a $12.00 price target, citing the company’s strategic partnerships and unique business model. The BACKBEAT pivotal study, a key focus for the company, is progressing with patient enrollment expected to complete by the first half of 2026. The trial is testing AVIM therapy in patients with uncontrolled hypertension who have received a Medtronic (NYSE:MDT) dual-chamber cardiac pacemaker. Orchestra BioMed’s collaboration with Medtronic aims to develop and commercialize AVIM therapy for broader use in hypertensive patients.
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