FDA grants breakthrough status to Orchestra BioMed’s AVIM therapy

NEW HOPE, Pa. - Orchestra BioMed Holdings, Inc. (NASDAQ: OBIO), in partnership with Medtronic plc (NYSE: MDT), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy. Medtronic, with a market capitalization of $104.91 billion and rated "GOOD" by InvestingPro’s comprehensive health score system, brings substantial industry expertise to this partnership. This designation is aimed at devices that could provide more effective treatment for life-threatening or irreversibly debilitating diseases.

The AVIM therapy, which is delivered through an implantable pacemaker system, targets patients with uncontrolled hypertension and increased atherosclerotic cardiovascular disease risk. The therapy is currently being assessed in the BACKBEAT global pivotal study, focusing on a subset of over 7.7 million U.S. patients who have uncontrolled hypertension despite medication use.

David Hochman, Chairman and CEO of Orchestra BioMed, expressed optimism about the FDA’s recognition of AVIM’s potential to benefit a broad patient population not typically indicated for pacemakers but who suffer from uncontrolled hypertension and elevated cardiovascular risk.

The FDA’s Breakthrough Devices Program facilitates expedited development, assessment, and review of innovative medical technologies. It also provides potential pathways for enhanced reimbursement, which could support provider adoption and patient access.

Medtronic, a leader in cardiac pacing therapies generating $33.2 billion in revenue, is collaborating with Orchestra BioMed to advance AVIM therapy through the BACKBEAT study. The company’s strong financial position is evidenced by its 49-year track record of maintaining dividend payments, currently yielding 3.42%. Dr. Robert C. Kowal, Vice President of Medtronic, highlighted the significance of addressing hypertension in the pacemaker population, citing it as a common comorbidity. For detailed financial analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro.

Orchestra BioMed’s partnership model aims to bring high-impact technologies to patients swiftly by collaborating with leading medical device companies. AVIM therapy is one of the company’s leading candidates, developed to treat hypertension, a major global health risk.

The FDA’s Breakthrough designation is expected to expedite the regulatory process for AVIM therapy and may lead to favorable reimbursement pathways, including eligibility for New Technology Add-on Payments and Transitional Pass-Through Payments under Medicare and Medicaid Services programs.

This news is based on a press release statement and reflects the company’s anticipation of the potential impact of AVIM therapy on hypertension management. According to InvestingPro’s Fair Value analysis, Medtronic currently appears undervalued, suggesting potential upside for investors interested in the healthcare equipment sector. The platform offers 8 additional exclusive ProTips and extensive financial metrics for deeper analysis of Medtronic’s investment potential.

In other recent news, Medtronic, Inc. reported mixed financial results for its fiscal third quarter of 2025, with revenue reaching $8.29 billion, reflecting a 4.1% year-over-year organic growth, which slightly missed the consensus estimate of $8.33 billion. However, the company’s earnings per share of $1.39 exceeded expectations, surpassing the consensus forecast of $1.36. Citi analysts responded by upgrading Medtronic’s stock rating from Neutral to Buy, raising the price target to $104, citing the company’s visible growth drivers, including advancements in Cardiac Ablation Solutions. Meanwhile, Medtronic’s new BrainSense™ Adaptive deep brain stimulation system received FDA approval, representing a significant advancement in personalized treatment for Parkinson’s disease.

Additionally, UBS raised its price target for Medtronic to $95, maintaining a Neutral rating, pointing to potential growth in the Diabetes sector and Cardiac Ablation Solutions. Piper Sandler also maintained a neutral stance, setting a price target of $90, with insights into Medtronic’s renal denervation technology. Stifel analysts held a Hold rating with an $87 target, focusing on Medtronic’s Transcatheter Aortic Valve Replacement technology’s long-term data.

Medtronic is progressing with its Hugo soft tissue surgical robot, planning to submit a urology application to the FDA soon. The company is also awaiting a National Coverage Determination from CMS for its renal denervation technology, which could further influence its growth trajectory. These developments reflect Medtronic’s ongoing efforts to expand its product portfolio and strengthen its position in the medical technology sector.

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