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Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates
Globenewswire· 2025-08-12 12:14
Core Insights - Orchestra BioMed Holdings, Inc. announced financial results for Q2 2025, highlighting significant capital raised and regulatory achievements [1][2][3] Financial Highlights - The company secured over $111 million in proceeds from strategic transactions and equity offerings, including $71 million from Medtronic and Ligand [4][5] - Cash and cash equivalents totaled $33.9 million as of June 30, 2025, with an estimated position of $101 million as of August 12, 2025, after recent financing [11] - Revenue for Q2 2025 was $0.8 million, unchanged from Q2 2024, while net loss increased to $19.4 million, or $0.50 per share, compared to a net loss of $16.0 million, or $0.45 per share, in the prior year [11][20] Regulatory Milestones - The FDA granted Breakthrough Device Designation for AVIM therapy aimed at treating uncontrolled hypertension, which may enhance future regulatory submissions and reimbursement pathways [4][6] - The BACKBEAT study protocol was updated and approved by the FDA, significantly expanding patient enrollment criteria [4][6] - IDE approval was received for the Virtue SAB U.S. pivotal trial, which will compare Virtue SAB with commercially available paclitaxel-coated balloons [4][6] Strategic Collaborations - The company has expanded its collaboration with Medtronic to develop AVIM therapy-enabled leadless pacemakers [5] - Ligand Pharmaceuticals committed $35 million for a tiered revenue interest in future royalties from AVIM therapy and Virtue SAB [5] Product Development - AVIM therapy has shown promising results in pilot studies, demonstrating significant reductions in blood pressure [12] - Virtue SAB is designed to deliver sirolimus effectively, with positive clinical data supporting its use in treating coronary in-stent restenosis [13]
Orchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility
Globenewswire· 2025-08-08 11:00
Core Viewpoint - Orchestra BioMed Holdings, Inc. announced a significant update to the BACKBEAT study protocol, approved by the FDA, which expands patient eligibility criteria for evaluating AVIM therapy in patients with uncontrolled hypertension who require pacemakers [1][5]. Summary by Relevant Sections Patient Eligibility Expansion - The updated protocol increases the eligible patient pool by more than 24-fold compared to the original protocol, supporting the company's target for mid-2026 completion of enrollment [2][5]. - New eligibility criteria include hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements [5][6]. Clinical Implications - The expanded criteria align the study population with the characteristics of the FDA Breakthrough Device Designation for AVIM therapy, potentially representing millions of U.S. patients needing better options for managing elevated systolic blood pressure [3][4]. - AVIM therapy is designed specifically for older, higher-risk hypertensive patients who may also require a pacemaker, reflecting its transformative potential [3][8]. Company Overview - Orchestra BioMed focuses on accelerating high-impact biomedical technologies through partnerships with leading medical device companies, with AVIM therapy as its lead product candidate for uncontrolled hypertension [4]. - The company has received four Breakthrough Device Designations from the FDA for its core programs, indicating significant potential to address unmet needs in cardiovascular care [4].
Ligand(LGND) - 2025 Q2 - Earnings Call Presentation
2025-08-07 12:30
Safe Harbor Statement and Disclaimers • This presentation contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, by Ligand and its partners thatinvolve risks and uncertainties and reflect Ligand's and its partners' judgmentasofthedateofthispresentation.All statements,otherthan statementsof historicalfact, couldbedeemedtobeforward-lookingstatements, includingstatements thatexpress Ligand'sorits partners'opinions, expectations,objectives, assumptions,plans orpro ...
Orchestra BioMed Showcases AVIM Therapy as Purpose-Built Solution for Hypertensive Heart Disease at CSI Frankfurt 2025
Globenewswire· 2025-06-18 13:30
Core Insights - Orchestra BioMed Holdings, Inc. presented key clinical insights on AVIM therapy for high-risk hypertension at the CSI 2025 Meeting, emphasizing its potential to address hypertensive heart disease, a significant cardiovascular syndrome affecting an aging population [1][6] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through risk-reward sharing partnerships with leading medical device companies [5] - The company’s lead product candidate is AVIM therapy, designed for hypertension, which is a leading risk factor for mortality worldwide [5][8] AVIM Therapy Insights - AVIM therapy is a novel, device-based approach specifically targeting patients with hypertensive heart disease, who are at increased risk for major adverse cardiac events and currently lack sufficient therapeutic options [2][3] - The therapy aims to reduce cardiac preload and modulate autonomic nervous system responses to lower blood pressure and improve cardiovascular function, representing a potential paradigm shift in blood pressure management [3][4] Clinical Data and Studies - Pilot studies have shown that AVIM therapy resulted in net 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 [10] - The BACKBEAT global pivotal study is currently enrolling patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker, in collaboration with Medtronic [7][10] Market Opportunity - Hypertensive heart disease affects over 7.7 million patients in the U.S., highlighting a significant market opportunity for AVIM therapy, especially given its recent FDA Breakthrough Device Designation [6][10]
Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones
Globenewswire· 2025-05-12 20:28
Core Insights - Orchestra BioMed Holdings, Inc. reported financial results for Q1 2025, highlighting regulatory progress and a strengthening clinical pipeline [1][4] - The company received FDA Breakthrough Device Designation for its AVIM therapy, indicating significant recognition of its potential in treating hypertensive heart disease [3][6] - The company is advancing its clinical trials, including the BACKBEAT global pivotal study in collaboration with Medtronic and the initiation of the Virtue Trial for its Virtue SAB product [3][6] Financial Performance - Revenue for Q1 2025 was $0.9 million, an increase from $0.6 million in Q1 2024, primarily due to partnership revenues from Terumo [12] - Research and development expenses rose to $13.5 million in Q1 2025 from $9.1 million in Q1 2024, driven by costs associated with the BACKBEAT study [12] - The net loss for Q1 2025 was $18.8 million, or $0.49 per share, compared to a net loss of $13.5 million, or $0.38 per share, in Q1 2024 [12][19] Regulatory Developments - The FDA granted Breakthrough Device Designation for AVIM therapy, which aims to improve outcomes for patients with uncontrolled hypertension [6][10] - The company received FDA IDE approval for the Virtue SAB U.S. pivotal trial, which will compare its investigational product against a commercially available drug-coated balloon [6][13] Clinical Advancements - 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 [10] - The Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, demonstrating positive clinical data in coronary in-stent restenosis [11][13] Strategic Partnerships - Orchestra BioMed has strategic collaborations with Medtronic for AVIM therapy and Terumo for Virtue SAB, enhancing its commercialization efforts [8][10] - The company continues to expand its intellectual property portfolio, with 137 issued patents worldwide related to AVIM therapy [6]
Orchestra BioMed Receives FDA Approval of IDE to Initiate U.S. Coronary Pivotal Trial Randomizing First-in-Class Sirolimus-AngioInfusion Balloon, Virtue SAB, Head-to-Head with Paclitaxel-Coated Balloon
Globenewswire· 2025-04-29 13:00
Core Viewpoint - Orchestra BioMed has received FDA approval for an Investigational Device Exemption amendment to initiate the Virtue Trial, which will compare its Sirolimus-AngioInfusion Balloon (Virtue SAB) against the Boston Scientific AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis (ISR) [1][5][6] Company Overview - Orchestra BioMed is a biomedical innovation company focused on accelerating high-impact technologies through partnerships with leading medical device companies [9][10] - The company is developing the Virtue SAB for atherosclerotic artery disease, which is a leading cause of mortality worldwide [10] Product Differentiation - Virtue SAB utilizes a proprietary extended-release formulation of sirolimus (SirolimusEFR™) delivered through a non-coated microporous AngioInfusion™ Balloon, designed to overcome limitations of traditional drug-coated balloons (DCBs) [2][4][8] - The device has been granted multiple FDA Breakthrough Device Designations for various indications, including coronary ISR and small vessel disease [5][8] Clinical Trial Details - The Virtue Trial will be the first U.S. head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon for coronary ISR [5] - The trial aims to enroll 740 patients across up to 75 centers in the U.S., with a primary endpoint of non-inferiority in Target Lesion Failure (TLF) at 12 months [6][5] Market Potential - The U.S. market for coronary drug delivery balloons is estimated to be multibillion-dollar, driven by significant unmet clinical needs and established reimbursement [6] - The company believes that the superior safety and efficacy of sirolimus over paclitaxel will be demonstrated through the performance of Virtue SAB in clinical settings [6]