Orchestra BioMed Demonstrates Strength of Cardiovascular Pipeline with Virtue® SAB and AVIM Therapy Presentations at CRT 2024 Annual Meeting

  • New pharmacokinetic data demonstrate Virtue ® SAB enables extended release of sirolimus above required tissue concentrations in target arterial sites without polymer degradation or detectable remaining polymer within 90 days of balloon delivery
  • AVIM therapy presentation highlighted recent clinical results showing favorable hemodynamic effects and long-term reduction in 24-hour ambulatory systolic blood pressure, as well as the design of the BACKBEAT global pivotal study now enrolling in collaboration with Medtronic, plc (NYSE:MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced two oral presentations were given at the Cardiovascular Research Technologies ("CRT") 2024 Meeting in Washington, D.C. One presentation featured new preclinical pharmacokinetic ("PK") data on Virtue ® Sirolimus AngioInfusion Balloon ("SAB"), a novel drug-eluting balloon angioplasty system designed to deliver a proprietary, extended-release formulation of sirolimus, SirolimusEFR™ to the vessel wall during balloon angioplasty without any coating on the balloon surface. A second presentation featured recently reported clinical data on atrioventricular interval modulation ("AVIM") therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure. The AVIM presentation also outlined the design of the currently enrolling BACKBEAT global pivotal study evaluating AVIM therapy in hypertensive pacemaker patients in collaboration with Medtronic.

Virtue SAB Oral Presentation , presented by Dean Kereiakes, M.D., President and Medical Director of The Christ Hospital Heart and Vascular Institute and Professor of Clinical Medicine at The Ohio State University

Dr. Kereiakes' presentation, focused on the role of drug-coated and drug-eluting balloon angioplasty systems for the treatment of coronary in-stent restenosis ("ISR"), outlined key points of differentiation and potential advantages for Virtue SAB, including:

  • No surface drug coating and, therefore, no drug loss in-transit to a target arterial lesion or creation of large particulates during balloon inflation
  • Focal uptake and extended release of sirolimus at tissue concentrations greater than the 1 ng/mg tissue concentration known to be required for effective control of cellular proliferation through the critical healing period.
    • Supported by published preclinical data of over 750 coronary artery balloon treatments
  • New preclinical PK data demonstrating that Sostenocel TM , the proprietary polymer system enabling Virtue SAB's SirolimusEFR, was shown to be eliminated in SirolimusEFR-treated stented arteries without detectable degradation, which can lead to localized tissue inflammation. Specifically, the presented PK data showed that:
    • Sostenocel was undetectable at 90 days in treated arteries and at 3 days in all non-target tissues
    • Molecular weight of Sostenocel remained unchanged prior to elimination, showing no evidence of in-vivo degradation.

"Virtue SAB represents a therapeutic innovation that may provide a reliable method to deliver the proven benefits of sirolimus, the gold standard therapeutic used in drug-eluting stents, during balloon angioplasty for the treatment of coronary in-stent restenosis without the potential risks associated with a permanent metal implant or a balloon surface coating," commented Dr. Kereiakes. "Realizing the advantages of sirolimus requires a novel solution that enables sufficient drug uptake and extended drug release at necessary tissue concentrations through the 30-day critical healing period post-procedure. The preclinical data presented at CRT demonstrate how the Sostenocel polymer system that enables SirolimusEFR, the proprietary drug formulation used in Virtue SAB, is eliminated prior to degradation, enabling the long-term pharmacokinetics to support sirolimus arterial tissue concentrations that are essential for effective prevention of restenosis without the inflammatory risks associated with polymer degradation."

The U.S. Food and Drug Administration granted Orchestra BioMed a conditional Investigational Device Exemption ("IDE") to initiate the Virtue ISR-US pivotal study evaluating the efficacy and safety of Virtue SAB for the treatment of patients with coronary ISR. Orchestra BioMed and Terumo, the Company's strategic partner for the development and commercialization of Virtue SAB in coronary and peripheral artery disease, are currently working to update operational plans and financial arrangements for execution of this and other pivotal studies in the future.

AVIM Therapy Oral Presentation , presented by Dan Burkhoff, M.D., Ph.D., Director, Heart Failure, Hemodynamics, and MCS Research, Cardiovascular Research Foundation

Dr. Burkhoff presented an overview of the AVIM therapy program in hypertensive pacemaker patients, including:

  • The BACKBEAT global pivotal study design
  • Recently reported clinical results from a long-term follow-up study showing sustained reductions of 8.9 mmHg in 24-hour ambulatory systolic blood pressure at a mean of 3.6 years from treatment activation in AVIM-treated patients
  • Results from a new clinical study evaluating the impact of AVIM therapy compared to standard pacing using invasive pressure-volume loop analysis in 16 hypertensive pacemaker-indicated patients. AVIM therapy demonstrated:
    • Consistent favorable hemodynamic effects using both conduction system, as well as traditional right ventricular lead placements.
    • Statistically significant reductions in systolic blood pressure, intra-cardiac volumes, total peripheral resistance and stroke work, with no significant changes in stroke volume or contractility.

"The new data showing the long-term durability of blood pressure reduction in AVIM-treated patients, as well as the clear, favorable hemodynamic impact of AVIM therapy's mechanism of action reinforces my belief in the potential benefit this novel therapy can offer hypertensive patients in the pacemaker population and beyond," said Dr. Burkhoff. "These data combined with previous clinical results from the MODERATO I and II studies are encouraging and bolster my confidence in the potential outcomes of the BACKBEAT global pivotal study, which is a well-designed prospective, double-blind, randomized study evaluating this innovative therapy and currently enrolling hypertensive pacemaker patients in the U.S. and EU."

Orchestra BioMed is actively enrolling patients in the BACKBEAT global pivotal study of AVIM therapy in pacemaker-indicated patients who also have hypertension despite the use of antihypertensive medications.

About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue ® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing and organic development. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .

References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.

Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation and design of the BACKBEAT pivotal study, the potential efficacy and safety of the Company's commercial product candidates, the ability of the Company's partnerships to accelerate clinical development, and the Company's late-stage development programs, strategic partnerships and plans to expand its product pipeline. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company's product candidates and ongoing regulation of the Company's product candidates, if approved; the timing of, and the Company's ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading "Item 1A. Risk Factors" in the Company's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission on May 12, 2023, as updated by any risk factors disclosed under the heading "Item 1A. Risk Factors" in the Company's subsequently filed quarterly reports on Form 10-Q.

The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.

Investor Contact:
Bob Yedid
LifeSci Advisors
(516) 428-8577
Bob@lifesciadvisors.com

Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
(484) 682-4892
kkirkellis@orchestrabiomed.com


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

MDT
The Conversation (0)
Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. (TSX: PNE) ("Pine Cliff" or the "Company") announces its first quarter 2024 financial and operating results, an operational update and information regarding the annual meeting of shareholders.

First Quarter 2024 Results

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Canadian Natural Resources Limited Announces 2024 First Quarter Results

Canadian Natural's (TSX: CNQ) (NYSE: CNQ) President, Scott Stauth, commented on the Company's first quarter results, "Canadian Natural is a world class company and during our 35 years of operations, we've delivered significant value, including recently reaching a position where, commencing in 2024, we are returning 100% of our free cash flow to our shareholders. Crude oil price forecasts have strengthened for the remainder of 2024, including improvements in West Texas Intermediate ("WTI"), Western Canadian Select ("WCS") and Synthetic Crude Oil ("SCO") pricing over those prices experienced in the first quarter of 2024, driving significant targeted free cash flow generation going forward.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. (TSX: PNE) (OTCQX: PIFYF) ("Pine Cliff" or the "Company") is pleased to announce the appointments of Mr. Daniel Keenan P. Eng to the position of Vice President Exploitation and Mr. Austin Nieuwdorp CA, CPA to the position of Vice President Finance and Controller both effective May 1, 2024.

Mr. Keenan became part of Pine Cliff in 2016. He holds a Bachelor of Mechanical Engineering Degree from the University of Victoria obtained in 2001. Throughout his 20-year career, he has taken on increasingly challenging roles in exploitation, production operations and facilities engineering, culminating in his most recent position as Pine Cliff's Manager of Exploitation. Notably, Mr. Keenan has played a pivotal role in identifying and expanding Pine Cliff's asset portfolio and drilling opportunities, showcasing his leadership and strategic vision.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. (TSX: ACO.X) (TSX: ACO.Y)

2024 ATCO AGM (CNW Group/ATCO Ltd.)

ATCO Ltd. (ATCO) will hold its 57th Annual General Meeting of share owners at 10 a.m. MDT on Wednesday , May 15, 2024. In addition to the formal business of the meeting, attendees will hear management's view of ATCO's full year 2023 and first quarter 2024 operational and financial performance.

At this year's meeting, members of the ATCO executive leadership team will also outline growth strategies and goals for ATCO Structures, ATCO EnPower and ATCO Energy Systems.

Attendees will hear from:

  • Nancy Southern , Chair & Chief Executive Officer
  • Katie Patrick , Executive Vice President, Chief Financial & Investment Officer
  • Adam Beattie , President, ATCO Structures
  • Bob Myles , Chief Operating Officer, ATCO EnPower
  • Wayne Stensby , Chief Operating Officer, ATCO Energy Systems

Share owners and interested parties can view the meeting virtually using Microsoft Teams via this link using a web browser (Chrome, Safari, Edge or Firefox) on a smartphone, tablet or computer. Using Internet Explorer is not recommended as it is no longer supported and may not function properly.

Attendees who are share owners or proxyholders wishing to vote their shares should review the information contained in the ATCO Management Proxy Circular dated March 11, 2024 , beginning on page one.

As a global enterprise ATCO Ltd. and its subsidiary and affiliate companies have approximately 20,000 employees and assets of $25 billion . ATCO is committed to future prosperity by working to meet the world's essential energy, housing, security and transportation challenges. ATCO Structures designs, builds and delivers products to service the essential need for housing and shelter around the globe. ATCO Frontec provides operational support services to government, defence and commercial clients. ATCO Energy Systems delivers essential energy for an evolving world through its electricity and natural gas transmission and distribution, and international operations. ATCO EnPower creates sustainable energy solutions in the areas of renewables, energy storage, industrial water and clean fuels. ATCO Australia develops, builds, owns and operates energy and infrastructure assets. ATCOenergy and Rümi provide retail electricity and natural gas services, home maintenance services and professional home advice that bring exceptional comfort, peace of mind and freedom to homeowners and customers. ATCO also has investments in ports and transportation logistics, the processing and marketing of fly ash, retail food services and commercial real estate. More information can be found at www.ATCO.com .

Investor & Analyst Inquiries:  
Colin Jackson
Senior Vice President, Finance, Treasury & Sustainability
Colin.Jackson@atco.com
(403) 808 2636

Media Inquiries:
Kurt Kadatz
Director, Corporate Communications
Kurt.Kadatz@atco.com
(587) 228 4571

SOURCE ATCO Ltd.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/29/c6613.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

PrairieSky Announces First Quarter 2024 Results, Record Oil Royalty Production

-

PrairieSky Royalty Ltd. ("PrairieSky" or the "Company") (TSX: PSK) is pleased to announce its first quarter ("Q1 2024") operating and financial results for the three-month period ended March 31, 2024.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Medtronic to announce financial results for its third quarter of fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its third quarter of fiscal year 2025 on Tuesday, February 18, 2025 . A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's third quarter of fiscal year 2025, which ended on Friday, January 24, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CST on February 18, 2025 , to discuss results for its third quarter of full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Medtronic to announce financial results for its third quarter of fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its third quarter of fiscal year 2025 on Tuesday, February 18, 2025 . A news release will be issued at approximately 5:45 a.m. Central Standard Time (CST) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's third quarter of fiscal year 2025, which ended on Friday, January 24, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CST on February 18, 2025 , to discuss results for its third quarter of full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Orchestra BioMed Announces Appointment of Former Medtronic SVP of Corporate Development Christopher Cleary to Board of Directors

  • Medical device industry veteran brings over three decades of expertise in M&A, as well as structured research and development ("R&D") collaborations aligned with Orchestra BioMed's partnership-enabled business model
  • Mr. Cleary previously served as Senior Vice President ("SVP") of Corporate Development at Medtronic plc (NYSE: MDT) ("Medtronic"), where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for atrioventricular interval modulation ("AVIM") therapy in hypertension with increased cardiovascular risk
  • Eric A. Rose, M.D. to transition from Board Member to Board Member Emeritus and Strategic Advisor, continuing to provide invaluable expertise and guidance to Orchestra BioMed

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of Christopher Cleary to its Board of Directors as an independent member, effective as of January 30, 2025. Mr. Cleary brings over three decades of experience in corporate development, mergers, acquisitions, strategic investments and structured R&D collaborations, having significantly impacted the medical technology industry through his strategic leadership and visionary approach.

"We're thrilled to welcome Chris as an independent member of the Orchestra BioMed Board of Directors, a role in which we expect he will provide invaluable guidance to help us more effectively execute our novel, partnership-enabled business model," said David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. "We got to know Chris well over the last several years as he played a key role in shaping our strategic collaboration with Medtronic. With his extensive experience in global strategy, dealmaking, investing, and partnering, Chris brings knowledge and experience that is directly relevant to our strategy, technologies, and pathways to success. He shares our vision that risk-reward sharing partnerships can be a powerful tool for advancing high-impact medical device innovations like AVIM therapy and Virtue SAB and we are excited to work closely with him on our Board."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Orchestra BioMed Announces Appointment of Former Medtronic SVP of Corporate Development Christopher Cleary to Board of Directors

  • Medical device industry veteran brings over three decades of expertise in M&A, as well as structured research and development ("R&D") collaborations aligned with Orchestra BioMed's partnership-enabled business model
  • Mr. Cleary previously served as Senior Vice President ("SVP") of Corporate Development at Medtronic plc (NYSE: MDT) ("Medtronic"), where he played a key role in establishing the strategic collaboration between Orchestra BioMed and Medtronic for atrioventricular interval modulation ("AVIM") therapy in hypertension with increased cardiovascular risk
  • Eric A. Rose, M.D. to transition from Board Member to Board Member Emeritus and Strategic Advisor, continuing to provide invaluable expertise and guidance to Orchestra BioMed

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of Christopher Cleary to its Board of Directors as an independent member, effective as of January 30, 2025. Mr. Cleary brings over three decades of experience in corporate development, mergers, acquisitions, strategic investments and structured R&D collaborations, having significantly impacted the medical technology industry through his strategic leadership and visionary approach.

"We're thrilled to welcome Chris as an independent member of the Orchestra BioMed Board of Directors, a role in which we expect he will provide invaluable guidance to help us more effectively execute our novel, partnership-enabled business model," said David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. "We got to know Chris well over the last several years as he played a key role in shaping our strategic collaboration with Medtronic. With his extensive experience in global strategy, dealmaking, investing, and partnering, Chris brings knowledge and experience that is directly relevant to our strategy, technologies, and pathways to success. He shares our vision that risk-reward sharing partnerships can be a powerful tool for advancing high-impact medical device innovations like AVIM therapy and Virtue SAB and we are excited to work closely with him on our Board."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Thermo Fisher Scientific Accelerates 100 Percent Renewable Electricity Goal for European Operations with New Solar Power Agreement with X-ELIO

Company leads value chain partners in purchase agreement that adds 118 megawatts (MW) of solar energy to enable decarbonization across the pharmaceutical and healthcare industries

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Thermo Fisher Scientific Accelerates 100 Percent Renewable Electricity Goal for European Operations with New Solar Power Agreement with X-ELIO

Company leads value chain partners in purchase agreement that adds 118 megawatts (MW) of solar energy to enable decarbonization across the pharmaceutical and healthcare industries

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×