Vivasure Medical Submits PMA Application for PerQseal® Elite and Secures Expanded Venous Indication in Europe
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 24 2025
0mins
Source: Newsfilter
Regulatory Milestones: Vivasure Medical has submitted a Premarket Approval application to the FDA for its PerQseal Elite vascular closure system and received European CE mark approval for expanded indications, marking significant progress in large-bore vascular closure technology.
Innovative Technology: The PerQseal Elite system offers a fully absorbable, sutureless solution for arterial and venous access closure, simplifying procedures and enhancing safety without leaving behind foreign materials.
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Analyst Views on OBIO
Wall Street analysts forecast OBIO stock price to rise
4 Analyst Rating
4 Buy
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Strong Buy
Current: 3.980
Low
10.00
Averages
14.25
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20.00
Current: 3.980
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 Reports Q1 Earnings with Mixed Results
- Earnings Performance: Orchestra BioMed's Q1 GAAP EPS of -$0.33 exceeded expectations by $0.10, yet revenue of $0.11M fell short by $0.05M, reflecting significant challenges in revenue growth with an 87.4% year-over-year decline.
- Cash Position: As of March 31, 2026, the company reported cash and cash equivalents totaling $94.4 million, indicating a relatively stable liquidity position, although future capital efficiency remains a concern.
- Funding Developments: On May 1, 2026, the company secured $35 million, including $20 million from Medtronic and $15 million from Ligand, which will support operational and R&D activities despite the overall revenue weakness.
- Historical Performance Comparison: Orchestra BioMed's previous GAAP EPS was -$1.11 with revenue of $33.48M, highlighting significant performance volatility over the past year and reflecting uncertainties and challenges in market competition.
See More
Orchestra BioMed Updates BACKBEAT Trial Timeline
- Trial Enrollment Target: Orchestra BioMed aims to complete enrollment for the BACKBEAT trial by the end of Q3 2026, targeting 316 patients to ensure data validity and reliability, thereby laying the groundwork for subsequent FDA approval.
- Data Submission Plan: The company and Medtronic plan to submit primary endpoint data to a major cardiology conference in Q2 2027, which, if successful, will provide strong clinical evidence for the market launch of AVIM Therapy.
- Sample Size Adjustment: The FDA approved a reduction in the trial sample size to 284 evaluable randomized subjects, ensuring the ability to detect at least a 5 mmHg difference in systolic blood pressure at the 3-month follow-up, enhancing the trial's statistical power.
- Strategic Collaboration Outlook: The partnership between Orchestra BioMed and Medtronic aims to promote AVIM Therapy for hypertension patients, which, if successful, could offer new treatment options for millions of patients globally, representing significant market potential.
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 Reports Q1 Earnings with Mixed Results
- Earnings Performance: Orchestra BioMed's Q1 GAAP EPS of -$0.33 exceeded expectations by $0.10, yet revenue of $0.11M fell short by $0.05M, reflecting significant challenges in revenue growth with an 87.4% year-over-year decline.
- Cash Position: As of March 31, 2026, the company reported cash and cash equivalents totaling $94.4 million, indicating a relatively stable liquidity position, although future capital efficiency remains a concern.
- Funding Developments: On May 1, 2026, the company secured $35 million, including $20 million from Medtronic and $15 million from Ligand, which will support operational and R&D activities despite the overall revenue weakness.
- Historical Performance Comparison: Orchestra BioMed's previous GAAP EPS was -$1.11 with revenue of $33.48M, highlighting significant performance volatility over the past year and reflecting uncertainties and challenges in market competition.
See More
Orchestra BioMed Updates BACKBEAT Trial Timeline
- Trial Enrollment Target: Orchestra BioMed aims to complete enrollment for the BACKBEAT trial by the end of Q3 2026, targeting 316 patients to ensure data validity and reliability, thereby laying the groundwork for subsequent FDA approval.
- Data Submission Plan: The company and Medtronic plan to submit primary endpoint data to a major cardiology conference in Q2 2027, which, if successful, will provide strong clinical evidence for the market launch of AVIM Therapy.
- Sample Size Adjustment: The FDA approved a reduction in the trial sample size to 284 evaluable randomized subjects, ensuring the ability to detect at least a 5 mmHg difference in systolic blood pressure at the 3-month follow-up, enhancing the trial's statistical power.
- Strategic Collaboration Outlook: The partnership between Orchestra BioMed and Medtronic aims to promote AVIM Therapy for hypertension patients, which, if successful, could offer new treatment options for millions of patients globally, representing significant market potential.
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
