BackBeat Cardiac Neuromodulation Therapy (CNT) for Immediate, Substantial and Sustained Lowering of Blood Pressure. Daniel Burkhoff MD PhD

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1 BackBeat Cardiac Neuromodulation Therapy (CNT) for Immediate, Substantial and Sustained Lowering of Blood Pressure Daniel Burkhoff MD PhD Director Heart Failure, Hemodynamics and Mechanical Support Research Cardiovascular Research Foundation

2 Disclosure Statement of Financial Interest I, Daniel Burkhoff, MD PHD have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. AFFILIATION/FINANCIAL RELATIONSHIP Consultant COMPANY BackBeat Medical/Orchestra BioMed, Inc

BackBeat Cardiac Neuromodulation Therapy (CNT) Overview Bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating Autonomic

3 BackBeat Cardiac Neuromodulation Therapy (CNT) Overview Bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating Autonomic Nervous System (ANS) Mimics effects of multiple medications by reducing preload, afterload and sympathetic tone Can be delivered using standard rhythm management device hardware (such as dual chamber pacemakers) Applicable to wide range of hypertensive patients including Isolated Systolic Hypertension Hypertensive patients who are also indicated for a pacemaker Over 70% of pacemaker patients have hypertension Uncontrolled hypertensive patients 1

4 BackBeat CNT Clinical Benefits Programmable: Blood Pressure reduction is adjustable Immediate response Substantial reduction in Blood Pressure Sustained effect High responder rate Broad applicability All subgroups including ISH Wide range of initial blood pressure Pacemaker and non-pacemaker population 2

5 Change in Sistolic BP (mmhg) BackBeat CNT is Programmable and Adjustable Reduction in Blood Pressure Can be Titrated by Modifying Therapy Parameters as Needed Changes in Systolic Blood Pressure Set 1 Set 2 Set 3 Set 4 * * * * * P< 0.01 Acute clinical study (N=18) treated with 4 different sets of BackBeat CNT parameters demonstrates control of the reduction in blood pressure 3

6 BackBeat CNT MODERATO I Study Design Patients with Persistent Hypertension (office BP > 150mmHg) despite 2 or more anti-hypertensive medications and an indication for a Pacemaker One-month pacemaker only run-in phase Primary safety and efficacy evaluation at 3 months post BackBeat CNT activation; follow-up to 2 years Informed Consent Pacemaker Treatment Phase BackBeat CNT Efficacy Evaluation Screening & Baseline N=35 YES Activate BackBeat CNT Therapy 3 Months Follow Up BP criteria? Avg > 150 mmhg YES One month with pacing only BP criteria? Avg >140mmHg N=27 NO Withdraw from Study Moderato system Implant NO Optional Activation of CNT Therapy N=8 YES NO 3 Months Follow up Withdraw from Study 4

7 Immediate & Substantial Reduction in BP Ambulatory Blood Pressure Decreased Significantly Immediately After Activation and Remained Lowered by 14.2 mmhg After 3 Months of Therapy The Effect of BackBeat CNT on Ambulatory Blood Pressure -14.2±9.8 p< Immediate and Substantial Effect of BackBeat CNT on Ambulatory Blood Pressure Run-In BackBeat CNT Petr Neuzil, et. al. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017; Dec 23;6(12): e DOI: /JAHA

8 BP Reduction Sustained Through 2 Years BackBeat CNT Maintains Significant Reduction in Office Systolic BP over 2 years The Effect of BackBeat CNT on Office Systolic Blood Pressure -23.4±20.5 mmhg * P <

3 month change in ambulatory blood pressure (mmhg) High Responder Rate in Challenging Patient Population Baseline AMB systolic pressure: 137 mmhg Average reduction of 14.

9 3 month change in ambulatory blood pressure (mmhg) High Responder Rate in Challenging Patient Population Baseline AMB systolic pressure: 137 mmhg Average reduction of 14.2 mmhg 78% of patients had Isolated Systolic Hypertension (ISH) Responder Rate: 85% SBP reduced > 5mmHg 74% SBP reduced > 10mmHg BackBeat CNT Therapy BP Increase n=2 (7%) BP Decrease n=25 (93%) * * Patient 76 YO on 5 HTN drugs, non responder to RDN therapy (baseline office BP 168/80); After re-optimization of stimulation parameters 24H AMB BP reduced by 14.3 mmhg and office BP by 33/9 mmhg Petr Neuzil, et. al. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017; Dec 23;6(12): e DOI: /JAHA

10 ESV (ml) EDV (ml) HR (bpm) EF (%) BackBeat CNT 2 Year Safety Results 2 Year Safety Consistent with Expected Mechanism of Action Reduction in Heart Rate is indicative of reduced sympathetic activity Reduction in volumes with no change in EF suggests improvement of cardiac function Heart Rate Ejection Fraction Pre-act 24 months Pre-act 24 months End Systolic Volume Pre-act 24 months End Diastolic Volume Pre-act 24 months * P<0.05 8

11 MODERATO II: Randomized, Controlled Study Prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy Patient population: Uncontrolled blood pressure (office Systolic > 140, Day AMB BP > 130 mmhg) treated with at least one anti hypertension medication that are indicated for a dual chamber pacemaker Primary Effectiveness Endpoint: Mean reduction in 24 hour systolic ambulatory blood pressure following 6 months of therapy Primary Safety Endpoint: rate of MACE at 6 month between the treatment and control Informed Consent Screening Pacemaker Treatment Phase N=50 Moderato HTN Efficacy Evaluation Treatment Arm Activate BackBeat CNT 6 Months Follow Up BP criteria: Avg Day SYS AMB 130 mmhg & Office BP 140mmHg NO Withdraw from Study YES One month with pacing only Moderato system Implant BP criteria: Avg Day SYS AMB 125mmHg NO Withdraw from study YES Control Arm: BackBeat CNT Turned Off 6 Months Follow up Activate PHC Cohort I: European initial cohort (~50 patients) results expected Q Cohort II: Global, multicenter cohort (170 patients) enrollment starts in Q

12 BackBeat CNT Program Update BackBeat CNT enables immediate, substantial and sustained lowering of blood pressure 2-year data from European MODERATO I study demonstrates significant and sustained efficacy of BackBeat CNT Study met the safety endpoint. In addition, the safety data suggests improvement in cardiac function BackBeat CNT and Moderato IPG submitted for CE mark Randomized, double-blind MODERATO II study to further substantiate benefit of therapy: Cohort I: European initial cohort (~50 patients) results expected Q Cohort II: Global, multicenter cohort (170 patients) enrollment starts in Q

13 THANK YOU!

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