Releases Details

New Hope, PA – Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced upcoming presentations at the Innovation in Cardiovascular Interventions (ICI) Meeting in Tel-Aviv, Israel, taking place December 8-10, 2019 and the CSI Focus D-HF Congress in Paris taking place December 13-14, 2019.

The oral presentations will feature the Virtue^® Sirolimus-Eluting Balloon which has Breakthrough Device Designation from the U.S Food and Drug Administration for the treatment of below-the-knee disease and coronary in-stent restenosis, for which the Company has a global strategic partnership with Terumo Corporation. The presentations will also feature BackBeat™ Cardiac Neuromodulation Therapy for which recently presented double-blind, randomized clinical results demonstrated a statistically significant reduction of 24-hour ambulatory systolic blood pressure.

Additional conference details can be found below.

ICI Meeting 2019

Title: Virtue^® Sirolimus-Eluting Balloon: A Promising Breakthrough for Coronary In-Stent Restenosis and Beyond
Date/Time: December 10, 2019 at 9:10 AM IST
Session: Technology Parade
Presenter: Daniel Burkhoff, M.D., Ph.D.
Location: Hall J, David InterContinental Hotel

Title: Bioelectronic Hypertension Treatment Targeting Pacemaker Patients: Results of Moderato II randomized Study with BackBeat Cardiac Neuromodulation Therapy
Date/Time: December 10, 2019 at 4:12 PM IST
Session: Electrophysiology IV - Startup Companies
Presenter: Daniel Burkhoff, M.D., Ph.D.
Location: Hall I, David InterContinental Hotel

CSI Focus D-HF Congress

Title: Backbeat Cardiac Neuromodulation Therapy
Date/Time: December 13, 2019 at 1:40 PM CET
Session: Neuromodulation in the management of heart failure and its comorbidities: diabetes, sleep apnea and hypertension
Presenter: Prof. Felix Mahfoud
Location: Amphitheatre ABC

About Virtue^® SEB

Virtue SEB is a novel, first-in-class drug/device combination product that delivers sustained-release bioabsorbable encapsulated sirolimus, a proven drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating. Virtue SEB’s ability to reliably deliver sirolimus via bioabsorbable sub-micron particles with a drug elution profile comparable to commercially available drug-eluting stents has been demonstrated in extensive preclinical studies published in a peer-reviewed journal. Virtue SEB is the first and only non-coated sirolimus-eluting angioplasty balloon system to receive FDA Breakthrough Designation for below-the-knee stenosis as well as for coronary in-stent restenosis (ISR), another challenging indication for which the product has shown promising 3-year core-lab adjudicated efficacy and safety clinical results in the SABRE trial. Orchestra BioMed and Terumo plan to execute a global clinical program to gain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications including coronary ISR and below-the-knee stenosis.

About BackBeat CNT^™

BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system delivers BackBeat CNT while also providing standard pacemaker functions. BackBeat CNT mimics the effects of multi-drug hypertension therapy by targeting preload, afterload and sympathetic tone. BackBeat CNT’s initial target are patients with uncontrolled hypertension who are also indicated for a pacemaker.

About Orchestra BioMed^™

Orchestra BioMed is a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine. The Company partners with established market leaders to drive global commercialization of its products, establishing multiple long-term potential revenue streams and supporting further product development. Its current product pipeline was organically developed and features Virtue® Sirolimus-Eluting Balloon (SEB) for the treatment of artery disease, the leading cause of death worldwide, and BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension, the leading contributing risk factor for death worldwide. The Company has a global strategic partnership with Terumo Corporation, one of the world’s largest medical device companies, for the development and commercialization of Virtue SEB. Orchestra BioMed’s business model optimizes capital efficiency and cash flow by developing therapies with a high probability of success that fulfill a specific need, fit within current clinical workflow and deliver health-economic value. Orchestra BioMed is led by a multi-disciplinary team with a long track record of successful product development.

Forward-Looking Statements

Some of the statements made herein constitute forward-looking statements. These statements relate to future financial and other performance or anticipated plans and are identified by words such as “may,” “will,” “should,” “expect,” “could,” “scheduled,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “potential,” “propose” and “continue” or negative variants of such terms. These and similar forward-looking statements discuss the Company’s future expectations and plans. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements. These statements are only estimates of future performance. Actual performance or events may not meet such expectations or estimates and may, in fact, differ materially.

Although the Company believes that the expectations reflected in the forward-looking statements made herein are reasonable, the Company cannot and does not guarantee future results, levels of activity, performance or achievements. Moreover, the Company does not assume any responsibility for the accuracy and completeness of such forward-looking statements in the future. The Company does not plan and, subject to applicable law, undertakes no obligation to update any of the forward-looking statements made herein after the date hereof in order to conform such statements to actual results.

Investor Contact:

Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com

Media Contact:

Gloria Gasaatura
LifeSci Public Relations
646-970-4688
ggasaatura@lifescipublicrelations.com