Vivasure Medical Submits PMA Application for PerQseal® Elite and Secures Expanded Venous Indication in Europe
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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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.
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.
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.
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.
Orchestra BioMed Holdings Reports Increased Loss in Q3
Third-Quarter Financial Performance: Orchestra BioMed Holdings, Inc. reported a net loss of $20.8 million or $0.40 per share for the third quarter, an increase from a net loss of $15.4 million or $0.41 per share in the same quarter of 2024.
Revenue Comparison: The company's revenue for the third quarter was $861 thousand, down from $987 thousand in the third quarter of 2024.
Orchestra BioMed announces secondary offering of approximately 8 million shares
Prospectus Filing: Orchestra BioMed filed a prospectus to sell approximately 8.03 million shares by selling stockholders, including shares issued to Covidien Group and Ligand Pharmaceuticals.
Share Breakdown: The prospectus includes about 4.21 million shares from Covidien, 1.81 million from Ligand, and 2 million shares that can be issued upon exercising a warrant with an exercise price of $3.67 per share.
No Proceeds for Company: Orchestra BioMed will not receive any proceeds from the sale of these shares.
Company Updates: The company has seen a rise in stock value as trials for its antihypertensive drug expand, and additional financial information is available through Seeking Alpha’s Quant Rating.
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.
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.
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.
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.
Orchestra BioMed Holdings Reports Increased Loss in Q3
Third-Quarter Financial Performance: Orchestra BioMed Holdings, Inc. reported a net loss of $20.8 million or $0.40 per share for the third quarter, an increase from a net loss of $15.4 million or $0.41 per share in the same quarter of 2024.
Revenue Comparison: The company's revenue for the third quarter was $861 thousand, down from $987 thousand in the third quarter of 2024.
Orchestra BioMed announces secondary offering of approximately 8 million shares
Prospectus Filing: Orchestra BioMed filed a prospectus to sell approximately 8.03 million shares by selling stockholders, including shares issued to Covidien Group and Ligand Pharmaceuticals.
Share Breakdown: The prospectus includes about 4.21 million shares from Covidien, 1.81 million from Ligand, and 2 million shares that can be issued upon exercising a warrant with an exercise price of $3.67 per share.
No Proceeds for Company: Orchestra BioMed will not receive any proceeds from the sale of these shares.
Company Updates: The company has seen a rise in stock value as trials for its antihypertensive drug expand, and additional financial information is available through Seeking Alpha’s Quant Rating.
