--- title: Our Pipeline description: Our Pipeline --- # Our Pipeline ## Advancing a multi-asset pipeline of high-impact therapeutic solutions ###### Our pipeline is comprised of innovative therapeutic product candidates we believe have the potential for value creation using our partnership-enabled business model. Target Disease Program Target Population Preclinical Clinical Feasibility Clinical Pivotal Hypertensive Heart Disease **$17 Billion** Annual Global Opportunity Atrioventricular Interval Modulation(AVIM) Therapy Preclinical Clinical Feasibility Clinical Pivotal Hypertension (HTN) & Pacemaker BACKBEAT Global Pivotal Study Enrolling & FDA Breakthrough HTN with Increased CV Risk (Non-pacemaker indicated) FDA Breakthrough HTN & Heart Failure FDA Breakthrough AVIM/Cardiac Neuromodulation Therapy may have additional clinical application in advanced heart failure. Atherosclerotic Artery Disease **$10 Billion** Annual Global Opportunity Virtue® Sirolimus AngioInfusion™ Balloon (SAB) Preclinical Clinical Feasibility Clinical Pivotal Coronary In-Stent Restenosis (ISR) IDE Approved & FDA Breakthough Coronary Small Vessel (SV) FDA Breakthough Below-the-Knee (BTK) FDA Breakthough Other Coronary & Peripheral Indications SirolimusEFR™ may have potential clinical application in a variety of non-vascular indications. --- ###### Our flagship product candidates, AVIM Therapy and Virtue SAB, exemplify key criteria that characterize innovations optimized for strategic partnerships: ###### Target mature therapeutic device markets with significant unmet needs ###### Provide high-impact procedure-based solutions with rapid adoption potential ###### Offer strategic and financial benefits to a commercial partner and Orchestra BioMed * Plan to leverage existing coronary in-stent restenosis (ISR) data to support potential Pivotal Study; Virtue SAB has received Breakthrough Device Designation for: 1. The balloon dilation of the stenotic portion (up to 26 mm in length) of a stented coronary artery that is 2.25 to 4.0 mm in diameter, for the purpose of improving lumen diameter. 2. The balloon dilation of the de novo stenotic portion (up to 28 mm in lesion length) of a native coronary artery of 2.0 mm to 2.5 mm in diameter (small coronary arteries), for the purpose of improving lumen diameter. 3. The balloon dilation of the stenotic portion (up to 18 mm in length) of an infrapopliteal artery (P-3 segment or distal, below the knee) with a reference vessel diameter (RVD) of 2.25 to 4.0 mm, for the purpose of improving lumen diameter. Virtue® SAB is investigational and not commercially approved. AVIM therapy is investigational and not commercially approved.