Orchestra BioMed Receives Second Breakthrough Device Designation from FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 30 2026
0mins
Orchestra BioMed (OBIO) announced that the FDA has granted a second breakthrough device designation, or BDD, for AVIM therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker. Together, the two BDDs for AVIM therapy cover indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT trial, which Orchestra BioMed is conducting in collaboration with Medtronic (MDT).
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Analyst Views on OBIO
Wall Street analysts forecast OBIO stock price to rise
4 Analyst Rating
4 Buy
0 Hold
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Strong Buy
Current: 3.930
Low
10.00
Averages
14.25
High
20.00
Current: 3.930
Low
10.00
Averages
14.25
High
20.00
About OBIO
Orchestra BioMed Holdings, Inc. is a biomedical innovation company. The Company’s lead product candidates include Atrioventricular Interval Modulation (AVIM) therapy for the treatment of hypertension (HTN), the leading risk factor for death worldwide and the Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. The Company develops bioelectronic therapies based on patented Cardiac Neuromodulation Therapy (CNT) technology. The AVIM is a bioelectronic therapy candidate designed to substantially and persistently lower blood pressure. Its Virtue SAB is a proprietary drug/device combination product candidate for the treatment of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus (SirolimusEFR) to the vessel wall during balloon angioplasty without the need for balloon coating or a permanent implant.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Orchestra BioMed Secures FDA Breakthrough Device Designation for AVIM Therapy
- FDA Breakthrough Designation: Orchestra BioMed has received a second Breakthrough Device Designation from the FDA for AVIM Therapy, covering over 7.7 million adults with uncontrolled hypertension despite medication, marking a significant advancement in cardiovascular treatment.
- Clinical Trial Support: This designation aligns with the ongoing BACKBEAT global pivotal trial aimed at evaluating the safety and efficacy of AVIM Therapy in hypertensive patients, further strengthening the strategic partnership with Medtronic.
- Reimbursement Pathway Optimization: The Breakthrough Device Designation supports favorable reimbursement pathways, including New Technology Add-on Payment (NTAP) and Transitional Pass-Through (TPT) payments, which will facilitate timely patient access and provider adoption.
- Significant Market Potential: As a bioelectronic treatment designed to substantially lower blood pressure in hypertensive patients, AVIM Therapy is expected to generate multi-billion-dollar market opportunities for Orchestra BioMed, further solidifying its leadership position in the medical device market.
See More
AVIM Therapy Shows Significant Blood Pressure Reduction
- Immediate Blood Pressure Reduction: The MODERATO II trial demonstrated that AVIM Therapy activation resulted in an average reduction of 13.2 mmHg in office systolic blood pressure (oSBP), with 97% of patients achieving a reduction greater than 5 mmHg, highlighting its potential in hypertension management.
- Sustained Control Effects: At the 6-month follow-up, 89% of patients had an ambulatory systolic blood pressure (aSBP) below 140 mmHg, and 58% below 130 mmHg, indicating that AVIM Therapy effectively maintains blood pressure control in line with European and U.S. treatment goals.
- Long-Term Efficacy Validation: Sustained reductions in blood pressure were observed over 3.6 years in a sub-cohort of patients, further validating the long-term application value of AVIM Therapy, potentially offering new treatment options for high-risk patients.
- Strategic Collaboration Outlook: Orchestra BioMed's strategic collaboration with Medtronic is ongoing, with the BACKBEAT global pivotal trial set to evaluate the safety and efficacy of AVIM Therapy in uncontrolled hypertension patients, which is expected to create significant market opportunities for the company.
See More
Orchestra BioMed and Medtronic Collaborate on AVIM Therapy Development for Hypertension
- Strategic Collaboration: Orchestra BioMed's partnership with Medtronic aims to develop AVIM Therapy, which has received FDA Breakthrough Device Designation, potentially offering a new treatment option for 7.7 million U.S. patients with uncontrolled hypertension, significantly enhancing patient quality of life.
- Clinical Trial Progress: The MODERATO II study demonstrated that AVIM Therapy reduced 24-hour ambulatory systolic blood pressure by an average of 8.1 mmHg over six months, indicating its effectiveness in hypertension management and potentially opening up multi-billion-dollar market opportunities for the company.
- Innovative Product: The Virtue® Sirolimus AngioInfusion™ Balloon, as the first non-coated drug delivery system, has also received FDA Breakthrough Device Designation, aimed at treating coronary in-stent restenosis, which is expected to transform the treatment landscape for cardiovascular diseases.
- Market Potential: The successful development of AVIM Therapy and Virtue SAB will position Orchestra BioMed prominently in the global cardiovascular market, particularly in hypertension and atherosclerosis, driving long-term growth for the company.
See More
Orchestra BioMed and Medtronic Collaborate on AVIM Therapy Development
- Strategic Collaboration Highlight: Orchestra BioMed's partnership with Medtronic aims to develop AVIM Therapy, which has received FDA Breakthrough Device Designation, potentially offering new treatment options for 7.7 million U.S. patients with uncontrolled hypertension, significantly enhancing patient quality of life.
- Clinical Trial Progress: In the MODERATO II trial, AVIM Therapy demonstrated an average reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure over six months, showcasing its efficacy in hypertension management and potentially transforming treatment paradigms.
- Innovative Product Introduction: Virtue SAB, as the first non-coated drug delivery system, has also received FDA Breakthrough Device Designation for treating coronary in-stent restenosis, highlighting its potential in cardiovascular disease treatment and opening new market opportunities.
- Industry Impact: The three presentations at the Innovation in Cardiology Intervention meeting in Israel underscore Orchestra BioMed's leadership in biomedical innovation, further solidifying its strategic collaboration with Medtronic and advancing the commercialization of high-impact technologies.
See More
Orchestra BioMed Grants 151,250 Stock Options to 12 New Employees
- Employee Incentive Program: On November 24, 2025, Orchestra BioMed granted a total of 151,250 stock options to 12 new employees under the 2025 New Hire Inducement Plan, aimed at attracting talent and enhancing the company's competitive edge in the biomedical sector.
- Vesting Structure: Each new employee will have 25% of their options vest on their first anniversary, with the remainder vesting quarterly over the next three years, which not only incentivizes long-term retention but also enhances team stability and execution capabilities.
- Strategic Partnership Context: Orchestra BioMed's collaboration with Medtronic, a global medical device leader, accelerates the development of its AVIM therapy, expected to provide innovative solutions for uncontrolled hypertension patients, representing a multi-billion-dollar market opportunity.
- Product Innovation Outlook: The company's Virtue SAB balloon system has received FDA Breakthrough Device Designation for treating atherosclerotic artery disease, highlighting its significance in the global medical market and the potential to significantly improve patient outcomes.
See More
Orchestra BioMed to Attend Upcoming Conferences for Institutional Investors
Upcoming Investor Conferences: Orchestra BioMed will participate in the 2025 Jefferies London Healthcare Conference from November 17-20 and the Piper 37th Annual Healthcare Conference from December 2-4, hosting one-on-one meetings and a live fireside chat.
Company Overview: Orchestra BioMed focuses on accelerating high-impact biomedical technologies through partnerships with leading medical device companies, with flagship products AVIM Therapy and Virtue® Sirolimus AngioInfusion™ Balloon currently in pivotal clinical trials.
AVIM Therapy Details: AVIM Therapy is a bioelectronic treatment for hypertension, designed to be delivered via a firmware upgrade to pacemakers, and has received FDA Breakthrough Device Designation for patients with uncontrolled hypertension.
Virtue SAB Overview: The Virtue SAB is a novel drug delivery angioplasty balloon system aimed at treating atherosclerotic artery disease, also granted Breakthrough Device Designation by the FDA for specific coronary and peripheral artery conditions.
See More
Orchestra BioMed Secures FDA Breakthrough Device Designation for AVIM Therapy
- FDA Breakthrough Designation: Orchestra BioMed has received a second Breakthrough Device Designation from the FDA for AVIM Therapy, covering over 7.7 million adults with uncontrolled hypertension despite medication, marking a significant advancement in cardiovascular treatment.
- Clinical Trial Support: This designation aligns with the ongoing BACKBEAT global pivotal trial aimed at evaluating the safety and efficacy of AVIM Therapy in hypertensive patients, further strengthening the strategic partnership with Medtronic.
- Reimbursement Pathway Optimization: The Breakthrough Device Designation supports favorable reimbursement pathways, including New Technology Add-on Payment (NTAP) and Transitional Pass-Through (TPT) payments, which will facilitate timely patient access and provider adoption.
- Significant Market Potential: As a bioelectronic treatment designed to substantially lower blood pressure in hypertensive patients, AVIM Therapy is expected to generate multi-billion-dollar market opportunities for Orchestra BioMed, further solidifying its leadership position in the medical device market.
See More
AVIM Therapy Shows Significant Blood Pressure Reduction
- Immediate Blood Pressure Reduction: The MODERATO II trial demonstrated that AVIM Therapy activation resulted in an average reduction of 13.2 mmHg in office systolic blood pressure (oSBP), with 97% of patients achieving a reduction greater than 5 mmHg, highlighting its potential in hypertension management.
- Sustained Control Effects: At the 6-month follow-up, 89% of patients had an ambulatory systolic blood pressure (aSBP) below 140 mmHg, and 58% below 130 mmHg, indicating that AVIM Therapy effectively maintains blood pressure control in line with European and U.S. treatment goals.
- Long-Term Efficacy Validation: Sustained reductions in blood pressure were observed over 3.6 years in a sub-cohort of patients, further validating the long-term application value of AVIM Therapy, potentially offering new treatment options for high-risk patients.
- Strategic Collaboration Outlook: Orchestra BioMed's strategic collaboration with Medtronic is ongoing, with the BACKBEAT global pivotal trial set to evaluate the safety and efficacy of AVIM Therapy in uncontrolled hypertension patients, which is expected to create significant market opportunities for the company.
See More
Orchestra BioMed and Medtronic Collaborate on AVIM Therapy Development for Hypertension
- Strategic Collaboration: Orchestra BioMed's partnership with Medtronic aims to develop AVIM Therapy, which has received FDA Breakthrough Device Designation, potentially offering a new treatment option for 7.7 million U.S. patients with uncontrolled hypertension, significantly enhancing patient quality of life.
- Clinical Trial Progress: The MODERATO II study demonstrated that AVIM Therapy reduced 24-hour ambulatory systolic blood pressure by an average of 8.1 mmHg over six months, indicating its effectiveness in hypertension management and potentially opening up multi-billion-dollar market opportunities for the company.
- Innovative Product: The Virtue® Sirolimus AngioInfusion™ Balloon, as the first non-coated drug delivery system, has also received FDA Breakthrough Device Designation, aimed at treating coronary in-stent restenosis, which is expected to transform the treatment landscape for cardiovascular diseases.
- Market Potential: The successful development of AVIM Therapy and Virtue SAB will position Orchestra BioMed prominently in the global cardiovascular market, particularly in hypertension and atherosclerosis, driving long-term growth for the company.
See More
Orchestra BioMed and Medtronic Collaborate on AVIM Therapy Development
- Strategic Collaboration Highlight: Orchestra BioMed's partnership with Medtronic aims to develop AVIM Therapy, which has received FDA Breakthrough Device Designation, potentially offering new treatment options for 7.7 million U.S. patients with uncontrolled hypertension, significantly enhancing patient quality of life.
- Clinical Trial Progress: In the MODERATO II trial, AVIM Therapy demonstrated an average reduction of 8.1 mmHg in 24-hour ambulatory systolic blood pressure over six months, showcasing its efficacy in hypertension management and potentially transforming treatment paradigms.
- Innovative Product Introduction: Virtue SAB, as the first non-coated drug delivery system, has also received FDA Breakthrough Device Designation for treating coronary in-stent restenosis, highlighting its potential in cardiovascular disease treatment and opening new market opportunities.
- Industry Impact: The three presentations at the Innovation in Cardiology Intervention meeting in Israel underscore Orchestra BioMed's leadership in biomedical innovation, further solidifying its strategic collaboration with Medtronic and advancing the commercialization of high-impact technologies.
See More
Orchestra BioMed Grants 151,250 Stock Options to 12 New Employees
- Employee Incentive Program: On November 24, 2025, Orchestra BioMed granted a total of 151,250 stock options to 12 new employees under the 2025 New Hire Inducement Plan, aimed at attracting talent and enhancing the company's competitive edge in the biomedical sector.
- Vesting Structure: Each new employee will have 25% of their options vest on their first anniversary, with the remainder vesting quarterly over the next three years, which not only incentivizes long-term retention but also enhances team stability and execution capabilities.
- Strategic Partnership Context: Orchestra BioMed's collaboration with Medtronic, a global medical device leader, accelerates the development of its AVIM therapy, expected to provide innovative solutions for uncontrolled hypertension patients, representing a multi-billion-dollar market opportunity.
- Product Innovation Outlook: The company's Virtue SAB balloon system has received FDA Breakthrough Device Designation for treating atherosclerotic artery disease, highlighting its significance in the global medical market and the potential to significantly improve patient outcomes.
See More
Orchestra BioMed to Attend Upcoming Conferences for Institutional Investors
Upcoming Investor Conferences: Orchestra BioMed will participate in the 2025 Jefferies London Healthcare Conference from November 17-20 and the Piper 37th Annual Healthcare Conference from December 2-4, hosting one-on-one meetings and a live fireside chat.
Company Overview: Orchestra BioMed focuses on accelerating high-impact biomedical technologies through partnerships with leading medical device companies, with flagship products AVIM Therapy and Virtue® Sirolimus AngioInfusion™ Balloon currently in pivotal clinical trials.
AVIM Therapy Details: AVIM Therapy is a bioelectronic treatment for hypertension, designed to be delivered via a firmware upgrade to pacemakers, and has received FDA Breakthrough Device Designation for patients with uncontrolled hypertension.
Virtue SAB Overview: The Virtue SAB is a novel drug delivery angioplasty balloon system aimed at treating atherosclerotic artery disease, also granted Breakthrough Device Designation by the FDA for specific coronary and peripheral artery conditions.
See More
