Business Description

Our Vision Our vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Our Company We are a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Our business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by our founding team. Our flagship product candidates are Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of hypertension (“HTN”), the leading risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. We have an exclusive license and collaboration agreement with Medtronic, Inc. (an affiliate of Medtronic plc) (“Medtronic”) for the development and commercialization of AVIM Therapy for the treatment of uncontrolled HTN in patients indicated for a cardiac pacemaker (as amended, the “Medtronic Agreement”). We are actively conducting a double-blind, randomized, global pivotal study (the “BACKBEAT study”), enrolling up to 500 patients with uncontrolled hypertension who are indicated for a Medtronic dual-chamber pacemaker, with enrollment completion currently planned for mid-2026. We recently initiated patient enrollments in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (the “Virtue Trial”) for our U.S. investigational device exemption (“IDE”) pivotal study randomizing Virtue SAB vs. Boston Scientific Corporation’s AGENT™ drug-coated balloon. Designed to support regulatory approval of Virtue SAB, the Virtue Trial is expected to enroll 740 patients in the United States with enrollment completion currently planned for mid-2027. Our Flagship Candidates AVIM Therapy AVIM Therapy is a bioelectronic therapy candidate designed to immediately, substantially and sustainably lower blood pressure. AVIM Therapy can be fully integrated as a firmware upgrade to standard cardiac pacemakers. HTN is the most common comorbidity in the pacemaker population affecting over 70% of the pacemaker-indicated patients, making AVIM Therapy a potentially highly attractive therapeutic solution for these patients. AVIM Therapy may offer therapeutic benefits to HTN patients not yet indicated for a pacemaker who have uncontrolled systolic blood pressure despite medical therapy and have high cardiovascular risk factors, such as Isolated System Hypertension (“ISH”), Diastolic Dysfunction (“DD”) and additional serious medical comorbidities including hypertensive patients with heart failure with preserved ejection fraction (“HFpEF”). Although the safety and efficacy profile has not yet been established by any regulatory body, AVIM Therapy previously showed encouraging results in clinical studies conducted by Orchestra BioMed with its Moderato™ device, including the MODERATO II study, a prospective, multi-center, randomized, double-blind pilot study (the “MODERATO II study)” and in the MODERATO I study, a prospective, multi-center, single-arm open label study of patients with uncontrolled HTN and an indication for a pacemaker. We have also published additional clinical study results demonstrating favorable mechanistic and cardiac function effects of AVIM Therapy on patients with blood pressure above target thresholds. ​ 1 Table of Contents ​ On June 30, 2022, we entered into an exclusive license and collaboration agreement with Medtronic, one of the largest medical device companies in the world, for the development of AVIM Therapy for the treatment of HTN in pacemaker-indicated patients (the “Medtronic Collaboration”). The Medtronic Collaboration provides us with development, clinical and regulatory support for the BACKBEAT ( B radyc A rdia pa C ema K er with AVIM for B lood pr E ssure tre A tmen T ) global pivotal study (“BACKBEAT study”). Upon regulatory approval, if received, Medtronic will have the exclusive global rights to commercialize AVIM Therapy for this target population.…