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Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) is a biomedical innovation company dedicated to bringing high-impact technologies to patients through strategic partnerships. The company's unique business model relies on risk-reward sharing collaborations with leading medical device companies, facilitating global commercialization of its innovative products.
Core Offerings and Innovations
- BackBeat Cardiac Neuromodulation Therapy (CNT): This flagship product targets hypertension, an extensive global health issue. BackBeat CNT uses atrioventricular interval modulation (AVIM) therapy administered through standard dual-chamber pacemakers to significantly and persistently reduce blood pressure.
- Virtue Sirolimus AngioInfusion Balloon (SAB): This product is aimed at treating atherosclerotic artery disease, the leading cause of mortality worldwide. The Virtue SAB is a novel drug-delivery system designed to address the specific needs of patients with this condition.
Recent Achievements
In January 2024, Orchestra BioMed announced the successful randomization of the first patient in the BACKBEAT pivotal study, aimed at assessing the efficacy and safety of AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension. This study is crucial for determining the effectiveness of the BackBeat CNT in reducing blood pressure.
Strategic Partnerships
Orchestra BioMed has formed pivotal partnerships to drive its mission. In July 2022, the company entered a strategic collaboration with Medtronic for the commercialization of AVIM therapy. This partnership will enable Medtronic to exclusively commercialize AVIM-enabled pacing systems globally, with Orchestra BioMed sharing in the resultant revenues. Additionally, a strategic partnership with Terumo focuses on the development and commercialization of Virtue SAB.
Financial Condition and Market Presence
Orchestra BioMed is financially robust and strategically positioned in the biomedical sector, with a clear focus on growing its product pipeline through acquisitions, strategic collaborations, and organic development. This approach ensures sustained innovation and market relevance.
For more detailed information, visit www.orchestrabiomed.com and follow the company on LinkedIn and X (formerly Twitter).
Orchestra BioMed (Nasdaq: OBIO) announced two presentations at the 2024 Innovation in Cardiology Intervention (ICI) meeting in Tel Aviv. The presentations focus on the BACKBEAT global pivotal study and AVIM therapy for treating uncontrolled hypertension in patients requiring dual-chamber pacemakers.
Dr. Avi Fischer will present insights on the unmet medical needs of pacemaker patients with uncontrolled hypertension. Dr. Andrea Russo will discuss AVIM therapy's mechanism of action and clinical evidence, including results from the MODERATO I and II pilot studies, demonstrating how the therapy modulates the autonomic nervous system to reduce blood pressure.
Orchestra BioMed Holdings (Nasdaq: OBIO) announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York, NY from December 3-5, 2024. The company's management will deliver a fireside chat presentation on Wednesday, December 4, 2024, at 3:00 PM EST. The presentation will be available via webcast, with a replay accessible on the Orchestra BioMed website's Events section for 90 days afterward. The company will also be available for one-on-one meetings during the conference.
Orchestra BioMed (NASDAQ: OBIO) reported Q3 2024 financial results with revenue of $1.0 million, up from $0.4 million in Q3 2023. The company posted a net loss of $15.4 million ($0.41 per share). Cash position stood at $66.9 million as of September 30, 2024, with an additional $15 million drawn from Hercules Capital facility in November. R&D expenses increased to $11.6 million due to BACKBEAT study costs. The company continues to advance its BACKBEAT global pivotal study with Medtronic and is preparing for Virtue SAB coronary pivotal studies. Operating runway is expected into second half of 2026.
Orchestra BioMed Holdings (Nasdaq: OBIO) has announced its participation in the upcoming Jefferies London Healthcare Conference, scheduled for November 19-21, 2024, in London, UK. The company will engage in a fireside chat presentation on Tuesday, November 19, 2024, at 1:00 PM GMT.
The presentation will be accessible via webcast, and a replay will remain available on the Orchestra BioMed website's Events section for 90 days afterward. Company management will also be available for one-on-one meetings during the conference.
Orchestra BioMed (Nasdaq: OBIO) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Cash and cash equivalents: $65.2 million as of June 30, 2024
- Revenue: $0.8 million, down from $0.9 million in Q2 2023
- Net loss: $16.0 million ($0.45 per share), compared to $12.0 million ($0.35 per share) in Q2 2023
- R&D expenses: $11.1 million, up from $8.5 million in Q2 2023
The company remains focused on its AVIM therapy for hypertension and Virtue SAB program. The BACKBEAT global pivotal study is ongoing, with updates on the Virtue SAB program expected in H2 2024. Orchestra BioMed anticipates its cash runway to extend into H2 2026.
Orchestra BioMed Holdings (Nasdaq: OBIO) has appointed John Mack to its Board of Directors, effective July 29, 2024. Mack brings over 30 years of experience in medical devices, healthcare technology, and finance. He most recently served as President of Cardiac Surgery at Medtronic, where he led the division to market leadership. His previous roles at Medtronic included Vice President & General Manager of Extracorporeal Therapies and Vice President of Business Development, Strategy & Portfolio Management.
David Hochman, Chairman and CEO of Orchestra BioMed, expressed confidence in Mack's ability to contribute to the company's growth and leverage its partnership-enabled business model. Mack's extensive experience in cardiovascular therapy markets and his industry-wide relationships are expected to be valuable assets to the company.
Orchestra BioMed Holdings (Nasdaq: OBIO) will host an in-person R&D day on June 11, 2024, at the Lotte New York Palace Hotel, focusing on its AVIM therapy for hypertensive pacemaker patients. The event will feature presentations on the unmet need for hypertension treatments, the AVIM therapy's mechanism, and supporting clinical data. Esteemed physicians, including Dr. David Kandzari and Dr. Vivek Reddy, will discuss the BACKBEAT global pivotal study. The day will conclude with a live Q&A session.
Orchestra BioMed (Nasdaq: OBIO), a biomedical company specializing in high-impact technologies through risk-reward sharing partnerships, announced its participation in the Jefferies Global Healthcare Conference.
The event will take place in New York, NY, from June 4-6, 2024. Company management will present at a fireside chat on June 5 at 4:00 PM ET.
The presentation will be webcast and available on the company's website for 90 days.
Orchestra BioMed (Nasdaq: OBIO) announced its Q1 2024 financial results and business updates on May 13, 2024. Highlights include the ongoing BACKBEAT global study on AVIM therapy in collaboration with Medtronic, showing long-term reductions in systolic blood pressure. The company highlighted positive data from various cardiovascular studies and presented future plans, including an R&D day event in June 2024. Financially, the company held $75 million in cash and equivalents, with a net cash outflow of $13.1 million. Revenue decreased to $0.6 million from $1.2 million YoY, while R&D expenses rose to $9.1 million. Net loss widened to $13.5 million, or $0.38 per share, compared to $10.9 million, or $0.40 per share, in Q1 2023.
Orchestra BioMed announced that its AVIM Therapy Global Intellectual Property Estate has reached 110 issued patents worldwide, with 37 in the U.S. and 73 internationally. The patents cover over 1,800 claims related to hypertension treatment. The company is currently studying AVIM therapy in the BACKBEAT global pivotal study with Medtronic. Orchestra BioMed will provide an overview of AVIM therapy and the study on June 11, 2024, at an R&D day in New York City.
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