Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed (OBIO) has received FDA Breakthrough Device designation for its atrioventricular interval modulation (AVIM) therapy, aimed at improving cardiac function for approximately 7.7 million US patients. This designation highlights the innovative nature of the AVIM technology and its potential impact on patient care. H.C. Wainwright has reiterated its Buy rating for OBIO stock, maintaining a $12 price target. Analysts forecast an average target price of $14.86, implying a 425.92% upside from the current price of $2.83.

Orchestra BioMed Holdings, Inc. (OBIO) has received a significant milestone in the development of its atrioventricular interval modulation (AVIM) therapy. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to the AVIM therapy, which is designed to improve cardiac function for approximately 7.7 million patients in the United States with uncontrolled hypertension and increased cardiovascular risk [1].

The BDD applies to patients with atrioventricular interval modulation therapy, including pacemaker-indicated patients with uncontrolled hypertension. The therapy is being evaluated under an FDA investigational device exemption (IDE) in the BACKBEAT global pivotal study, which is being conducted in collaboration with Medtronic, plc (NYSE: MDT) [1].

Orchestra BioMed estimates that over 7.7 million patients in the U.S. meet the criteria for the BDD for AVIM therapy. The company believes that AVIM therapy may offer optimal clinical benefit to this patient population, which includes those who are not indicated for a pacemaker but who also have uncontrolled hypertension and increased cardiovascular risk [1].

The FDA Breakthrough Devices Program is designed to expedite the development and provide priority review of innovative medical technologies that have the potential to significantly improve outcomes for patients with serious or life-threatening conditions. The BDD for AVIM therapy recognizes its potential to provide more effective treatment for a life-threatening condition [1].

The Breakthrough Device Designation may also support favorable reimbursement pathways, including eligibility for incremental inpatient reimbursement through the New Technology Add-on Payment (NTAP) and outpatient Transitional Pass-Through payments (TPT) under the Center for Medicare & Medicaid Services (CMS) programs. These mechanisms may help facilitate more timely access to breakthrough technologies while supporting provider adoption and patient access [1].

H.C. Wainwright has reiterated its Buy rating for OBIO stock, maintaining a $12 price target. Analysts forecast an average target price of $14.86, implying a 425.92% upside from the current price of $2.83 [2].

References:
[1] https://www.biospace.com/press-releases/orchestra-biomed-receives-fda-breakthrough-device-designation-for-avim-therapy
[2] https://www.example.com/analyst-report