atrioventricular interval modulation (AVIM) therapy

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Orchestra BioMed Announces Pricing of $40 Million Public Offering
Globenewswire· 2025-08-01 11:59
Core Viewpoint - Orchestra BioMed Holdings, Inc. announced a public offering of 9,413,637 shares at $2.75 per share, along with pre-funded warrants for 5,136,363 shares at $2.7499 each, aiming to raise approximately $40 million before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 2,182,500 shares at the public offering price [1]. - The expected closing date for the offering is August 4, 2025, subject to customary conditions [1]. Group 2: Use of Proceeds - The net proceeds will fund the atrioventricular interval modulation (AVIM) therapy program, the BACKBEAT study, and the Virtue Sirolimus AngioInfusion Balloon (SAB) program, along with general corporate purposes [2]. Group 3: Company Overview - Orchestra BioMed focuses on high-impact biomedical technologies through partnerships with leading medical device companies [6]. - The company’s lead product candidate, AVIM therapy, targets hypertension, while Virtue SAB addresses atherosclerotic artery disease [6]. - The company has strategic collaborations with Medtronic and Terumo for the development and commercialization of its key therapies [6].
Orchestra BioMed’s AVIM Therapy Global Intellectual Property Estate Reaches 137 Issued Patents for the Treatment of Hypertension and Heart Failure
Globenewswire· 2025-05-07 12:30
Core Insights - Orchestra BioMed is expanding its intellectual property portfolio, securing 10 new patents related to hypertension treatment, bringing the total to 120 patents in this area [2][6] - The company has also increased its patent estate for heart failure treatment to 17 issued patents, enhancing its overall IP platform [2][6] - AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study for treating uncontrolled hypertension in patients indicated for pacemakers, highlighting its potential impact on broader cardiovascular health [2][8] Intellectual Property Expansion - The global intellectual property portfolio for AVIM therapy includes patent protection in key markets such as the United States, Europe, Japan, and China [3] - The hypertension-specific patent estate now consists of 46 issued U.S. patents and 91 patents outside the U.S., collectively comprising over 2100 claims related to hypertension and heart failure [6] Strategic Collaborations - Orchestra BioMed has a strategic collaboration with Medtronic for the development and commercialization of AVIM therapy, focusing on hypertension treatment in pacemaker-indicated patients [4] - The company is also partnered with Terumo for the development of the Virtue Sirolimus AngioInfusion™ Balloon for treating atherosclerotic artery disease [4] Regulatory Designations - AVIM therapy has received Breakthrough Device Designation from the U.S. FDA for treating uncontrolled hypertension with increased cardiovascular risk, which may expedite its development and market access [2][6][9]
Orchestra BioMed to Participate in Upcoming Institutional Investor Conferences
Globenewswire· 2025-04-28 20:30
Core Insights - Orchestra BioMed Holdings, Inc. is actively participating in multiple institutional investor conferences to discuss its innovative biomedical technologies and partnerships [1][2][3] Group 1: Upcoming Conferences - The company will participate in Chardan Capital's Trending Issues in Drug Development Conference on April 29, 2025, featuring a fireside chat with CEO David Hochman [1] - Management will also engage in a live fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, along with one-on-one meetings with investors [2] - Additionally, a live presentation is scheduled for the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, where management will host one-on-one meetings [3] Group 2: Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through risk-reward sharing partnerships with leading medical device companies [4] - The company's lead product candidate is atrioventricular interval modulation (AVIM) therapy for hypertension, a major global health risk [4] - Orchestra BioMed is also developing the Virtue Sirolimus AngioInfusion™ Balloon for atherosclerotic artery disease, which is a leading cause of mortality worldwide [4] - The company has strategic collaborations with Medtronic for AVIM therapy and with Terumo for the Virtue SAB [4]
Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting
Newsfilter· 2025-04-23 13:00
Core Insights - Orchestra BioMed Holdings, Inc. announced an industry-sponsored satellite symposium at the Heart Rhythm Society 2025 Annual Meeting to discuss advancements in its atrioventricular interval modulation (AVIM) therapy program [1][4] - The FDA granted Breakthrough Device Designation to AVIM therapy for treating hypertension in patients with increased cardiovascular risk, highlighting the unmet need in this patient population [2][4] - The BACKBEAT global pivotal study is currently enrolling patients to evaluate the efficacy of AVIM therapy in managing uncontrolled hypertension [2][9] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [7] - The company's lead product candidate is AVIM therapy, aimed at treating hypertension, which is a leading risk factor for death globally [7] - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and Terumo for the Virtue Sirolimus AngioInfusion Balloon [7] Symposium Details - The symposium titled "The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy" will take place on April 25, 2025, at the Hilton San Diego Bayfront Hotel [3] - Presentations will cover clinical results from studies demonstrating AVIM therapy's effectiveness in reducing blood pressure and improving cardiac function [4][5] - Key presentations will include topics on the unmet hypertension need, AVIM therapy's impact on hypertension, and the rationale behind the BACKBEAT study [5][6] Clinical Evidence - AVIM therapy has shown promising results in pilot studies, with reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure and 12.3 mmHg in office systolic blood pressure at six months compared to control patients [9] - The BACKBEAT study aims to further evaluate the safety and efficacy of AVIM therapy in patients with uncontrolled hypertension despite anti-hypertensive medication [9]