Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed”
or the “Company”), a biomedical innovation company accelerating
high-impact technologies to patients through risk-reward sharing
partnerships, today announced two presentations at the 2024
Innovation in Cardiology Intervention (“ICI”) meeting in Tel Aviv,
Israel. The presentations will provide insights on the ongoing
BACKBEAT global pivotal study, as well as an overview of the novel
mechanism of action of AVIM therapy and supporting clinical
evidence for the treatment of uncontrolled hypertension in patients
indicated for a dual-chamber pacemaker. The presentations will be
part of a broad scientific program of important developments in
cardiology, in a session focused on “Device-Based Hypertension
Treatment.”
Insights into the BACKBEAT IDE
Study, presented by Avi Fischer, M.D., Senior Vice
President of Medical Affairs and Innovation, Orchestra Biomed
(December 9, 2024; 14:12 JST / 07:12 AM EST)
- Dr. Fischer's
presentation will focus on the unmet medical need in patients who
are indicated for a pacemaker and also have uncontrolled
hypertension despite the use of antihypertensive medication. This
group of patients is the target population for the BACKBEAT global
pivotal study, which reflects the increased risks associated with
elevated systolic blood pressure in older comorbid patients.
AVIM Mechanism of Action &
Supporting Clinical Evidence, presented by Andrea Russo,
M.D., FACC, FHRS, FAHA, Professor of Medicine, Cooper Medical
School of Rowan University, Academic Chief, Division of Cardiology,
Director, Electrophysiology and Arrhythmia Services, Cooper
University Hospital, and Co-Principal Investigator of the BACKBEAT
study (December 9, 2024; 15:00 JST / 08:00 AM EST)
- Dr. Russo's
session will delve into the unique mechanism of action of the AVIM
therapy and robust body of supporting clinical data. Dr. Russo will
detail how AVIM therapy is designed to modulate the autonomic
nervous system to immediately, substantially and persistently
reduce blood pressure, as demonstrated in the MODERATO I and II
pilot studies.
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company
accelerating high-impact technologies to patients through
risk-reward sharing partnerships with leading medical device
companies. Orchestra BioMed’s partnership-enabled business model
focuses on forging strategic collaborations with leading medical
device companies to drive successful global commercialization of
products it develops. Orchestra BioMed’s lead product candidate is
atrioventricular interval modulation (AVIM) therapy (also known as
BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment
of hypertension, a significant risk factor for death worldwide.
Orchestra BioMed is also developing the Virtue® Sirolimus
AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic
artery disease, the leading cause of mortality worldwide. Orchestra
BioMed has a strategic collaboration with Medtronic, one of the
largest medical device companies in the world, for development and
commercialization of AVIM therapy for the treatment of hypertension
in pacemaker-indicated patients, and a strategic partnership with
Terumo, a global leader in medical technology, for development and
commercialization of Virtue SAB for the treatment of artery
disease. For further information about Orchestra BioMed, please
visit www.orchestrabiomed.com, and follow us
on LinkedIn.
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About AVIM Therapy
AVIM therapy, also known as BackBeat CNT™, is an
investigational therapy compatible with standard dual-chamber
pacemakers designed to substantially and persistently lower blood
pressure. It has been evaluated in pilot studies in patients with
hypertension who are also indicated for a pacemaker. MODERATO II, a
double-blind, randomized, pilot study, showed that patients treated
with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour
ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office
systolic blood pressure (oSBP) at six months when compared to
control patients. The BACKBEAT (BradycArdia paCemaKer with
atrioventricular interval modulation for Blood prEssure treAtmenT)
global pivotal study will further evaluate the safety and efficacy
of AVIM therapy in lowering blood pressure in a similar target
population of patients who have been indicated for, and recently
implanted with, a dual-chamber cardiac pacemaker.
Forward-Looking Statements
Certain statements included in this press
release that are not historical facts are forward-looking
statements for purposes of the safe harbor provisions under the
United States Private Securities Litigation Reform Act of 1995.
Forward-looking statements generally are accompanied by words such
as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “should,” “would,” “plan,” “predict,”
“potential,” “seem,” “seek,” “future,” “outlook” and similar
expressions that predict or indicate future events or trends or
that are not statements of historical matters. These
forward-looking statements include, but are not limited to,
statements relating to the implementation of the Company’s ongoing
BACKBEAT global pivotal study, the potential safety and efficacy of
the Company’s product candidates, and the ability of the Company’s
partnerships to accelerate clinical development. These statements
are based on various assumptions, whether or not identified in this
press release, and on the current expectations of the Company’s
management and are not predictions of actual performance. These
forward-looking statements are provided for illustrative purposes
only and are not intended to serve as and must not be relied on as
a guarantee, an assurance, a prediction, or a definitive statement
of fact or probability. Actual events and circumstances are
difficult or impossible to predict and may differ from assumptions.
Many actual events and circumstances are beyond the control of the
Company. These forward-looking statements are subject to a number
of risks and uncertainties, including changes in domestic and
foreign business, market, financial, political, and legal
conditions; risks related to regulatory approval of the Company’s
commercial product candidates and ongoing regulation of the
Company’s product candidates, if approved; the timing of, and the
Company’s ability to achieve expected regulatory and business
milestones; the impact of competitive products and product
candidates; and the risk factors discussed under the heading “Item
1A. Risk Factors” in the Company’s annual report on Form 10-K for
the year ended December 31, 2023, which was filed with the
Securities and Exchange Commission (“SEC”) on March 27, 2024 , and
under the heading “Item1A. Risk Factors” in Part II of the
Company’s quarterly report on Form 10-Q for the quarter ended
September 30, 2024, filed with the SEC on November 12, 2024.
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, which
only speak as of the date of this press release. The Company does
not plan and undertakes no obligation to update any of the
forward-looking statements made herein, except as required by
law.
Contact:Kelsey
Kirk-EllisOrchestra
BioMed484-682-4892Kkirkellis@orchestrabiomed.com
Orchestra BioMed (NASDAQ:OBIO)
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