Orchestra Biomed Holdings, Inc. · NASDAQ:OBIO
Orchestra Biomed — Investor Presentation (September 2023)
11 slides from Orchestra Biomed's investor presentation, September 2023
Slide 1: BACKBEAT Study Overview
Orchestra BioMed BACKBEAT Study Overview: BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT September 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements Certain statements included in this press release that are not historical facts are These forward-looking statements are subject to a number of risks and forward-looking statements for purposes of the safe harbor provisions under the uncertainties, including changes in dom
Slide 3: AVIM Therapy Overview
Strategic collaboration with AVIM Therapy Overview Atrioventricular Interval Modulation (AVIM) therapy (also known as BackBeat CNTTM) is designed to immediately, persistently and substantially reduce blood pressure Unmet Need Innovation Initial Opportunity o Hypertension is the leading global o Bioe
Slide 4: Ideal Collaboration
Ideal Collaboration o Developed BackBeat CNT (AVIM o Global market leader in cardiac pacing therapy) from concept stage; owns therapy: >$1.5B in annual revenues all related IP AVIM Therapy: o Providing leading device plus clinical o Conducted all prior development Patented investigational & regulato
Slide 5: Large Global Opportunity for Treating Hypertension in Target Populations
Large Global Opportunity for Treating Hypertension in Target Populations >$10 Billion Potential Annual Global Market Opportunity* HTN + Pacemaker High Risk HTN 750,000 patients 2,400,000 patients ~70% of pacemaker patients1 ~0.2% of HTN patients >3.1M Addressable HTN Patients >$2 Billion >$8 Billion
Slide 6: Novel Mechanism of Action Designed to Substantially Reduce Blood Pressure
Novel Mechanism of Action Designed to Substantially Reduce Blood Pressure Bioelectronic Control of Ventricular AVIM-Mediated Pressure Patterns Filling Immediately Modulate Autonomic Nervous Reduces Blood Pressure System (ANS) Response Slow increase in BP Pressure overshoot suggesting significant ind
Slide 7: Existing Body of Clinical Data Supporting Efficacy and Safety
Existing Body of Clinical Data Supporting Efficacy and Safety 2012 2016 2019 2021 Feasibility Study in MODERATO I - First MODERATO II – Pilot MODERATO II Canine HTN Model In-Human Implant Study Study two-year and ISH Proof of Concept (POC) Multi-center, Single-arm Prospective, Randomized, results in
Slide 8: MODERATO II Randomized, Double-Blind Results
MODERATO II Randomized, Double-Blind Results -11.1 mmHg Significant Reduction in 24-Hr aSBP and oSBP1,2 in 24-Hour aSBP at 6 months aSBP oSBP BackBeat CNT™️ 0 1 day 6 Months 6 Months 24 Months showed encouraging results -3.1 -0.1 0% P =0.17 in MODERATO II, a -5 -1.5 P = 0.5 P = 0.94 MACE vs. 9.5% pr
Slide 9: BACKBEAT Study Summary
BACKBEAT Study Summary Prospective, multi-center, double-blind study investigating the efficacy and safety of AVIM therapy in patients indicated for a dual-chamber pacemaker who also have uncontrolled hypertension (HTN) despite the use of antihypertensive medications Randomize approximately 500 pati
Slide 10: BACKBEAT Study Design
BACKBEAT Study Design Pre-Screening Run-in Phase Enrollment/ Blinded Study Open-Label Crossover 90 days 4-weeks Randomization 12 months Follow-up Phase Treatment: AVIM therapy + medical therapy Primary Follow-up +3M +12M Hypertensive AVIM therapy patients with Informed Run-In Phase download R +2 yea
Slide 11: Key Takeaways
Key Takeaways Hypertension is the leading global risk factor for death and #1 comorbidity in pacemaker patients Large established pacemaker market and implanting physician community, as well as existing reimbursement Patient population with favorable risk-benefit profile as they already require a pa
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