Orchestra BioMed (OBIO, Financial) has achieved a significant regulatory milestone with the U.S. Food and Drug Administration's (FDA) decision to grant Breakthrough Device Designation to its atrioventricular interval modulation (AVIM) therapy. This designation is anticipated to expedite the development and review process, recognizing the novel therapy's potential to address unmet needs in hypertension management.
The AVIM therapy is designed to benefit individuals suffering from high blood pressure, especially those at increased risk of cardiovascular issues and mortality. Orchestra BioMed is currently enrolling patients in the BACKBEAT global pivotal study, focusing on hypertensive patients who require pacemakers, in collaboration with Medtronic.
This recognition by the FDA underscores the potential of AVIM therapy to serve a broader patient demographic, particularly those who do not require pacemakers but still face challenges in managing uncontrolled hypertension. The company is committed to collaborating with key stakeholders, including the FDA and clinical partners, to fully optimize the therapy's impact on patients' cardiovascular health.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 7 analysts, the average target price for Orchestra BioMed Holdings Inc (OBIO, Financial) is $14.86 with a high estimate of $20.00 and a low estimate of $12.00. The average target implies an upside of 423.14% from the current price of $2.84. More detailed estimate data can be found on the Orchestra BioMed Holdings Inc (OBIO) Forecast page.
Based on the consensus recommendation from 7 brokerage firms, Orchestra BioMed Holdings Inc's (OBIO, Financial) average brokerage recommendation is currently 1.7, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
