Marlton, NJ, May 13, 2024 (GLOBE NEWSWIRE) -- Impulse Dynamics, a global medical
device company dedicated to improving the lives of people with heart failure
(HF), announced today that it has reached a worldwide milestone by surpassing
10,000 patients having received the Optimizer(® )system for the treatment of
moderate HF. This milestone highlights the benefit and importance of this
therapy in helping patients live a full life with HF.
"I noticed positive changes since the procedure, such as not feeling cold or
numb, I could walk every day and everywhere, did my regular chores and shopping,
and shared activities like swimming with my daughter," said Tracey, who received
her CCM(®) device in 2023. "I'm no longer huffing, puffing, or gasping for air,"
said Joe, another HF patient who received his CCM device in 2022. "I'm reborn ?
a whole new person ? no longer incapacitated. My life has changed so much that
we're considering taking a trip. And my wife is ecstatic because I have my life
back, and we have ours again."
"We are deeply motivated by the patients who benefit from CCM therapy. Their
progress inspires us to continuously enhance our technology, aiming to improve
the lives of those suffering from heart failure," said David Prutchi, Chief
Technology Officer for Impulse Dynamics, who has worked on the development of
CCM therapy since its inception.
David had the opportunity to meet one of these patients, Raynita, who was
implanted with an Optimizer device this year. Raynita saw immediate improvement
after starting CCM therapy and gave the following remarks on the experience: "I
feel like a different person. I can do things I haven't done in years. I am
attending my granddaughter's college graduation!"
CCM is available in 44 countries, and the technology has continued to advance,
based on the needs of patients and physicians. The latest generation of the
proprietary CCM technology is the Optimizer Smart Mini, which offers a
rechargeable battery with 20-year battery life and a smaller size designed to
make the implant procedure faster and easier for patients and physicians.
"We are committed to ongoing innovation in this important therapy that has such
a clear clinical need around the world," said Jason Spees, CEO of Impulse
Dynamics. "We are also getting closer to significantly impacting the implantable
cardioverter defibrillator (ICD) market with successful enrollment in our
INTEGRA-D clinical trial on the CCM-D(®) HF System, which is the first-of-its-
kind technology, combining the lifesaving benefits of an ICD with HF symptom
relief through CCM therapy in one device."
The patients statements in this Press Release represent the testimonials of
their individual outcomes and may not be typical for all patients.
About the Optimizer and CCM Therapy
The Optimizer Smart Mini system delivers CCM therapy - the company's proprietary
technology - to the heart, providing an important treatment option for the
millions of patients suffering from heart failure. CCM therapy is designed to
significantly improve heart contraction, allowing more oxygen-rich blood to be
pushed out through the body.(1) (http://#_ftn1) CCM therapy is indicated to
improve 6-minute hall walk, quality of life, and functional status of NYHA Class
III HF patients who remain symptomatic despite guideline directed medical
therapy, are not indicated for CRT, and have a left ventricular ejection
fraction ranging from 25 to 45 percent.
CCM is the brand name for cardiac contractility modulation-the non-excitatory
electrical pulses delivered by the implantable Optimizer device to improve heart
contraction. CCM therapy sends unique electrical pulses to the heart cells
during the absolute refractory period. In doing so, CCM helps the heart contract
more forcibly. Impulse Dynamics has completed numerous clinical studies,
including several randomized controlled trials, the results of which appeared in
more than 100 articles from leading medical journals.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure for
patients and the healthcare providers who care for them. The company pioneered
its proprietary CCM therapy, which uses the Optimizer technology platform to
improve quality of life in HF patients. CCM therapy is delivered through the
Optimizer system, which includes an implantable pulse generator (IPG) implanted
in a minimally invasive procedure and approved for commercial use in the United
States and 44 countries worldwide. More than 10,000 patients have received the
therapy as part of clinical trials and real-world use, where it is proven to be
safe and effective for heart failure patients with debilitating symptoms who
otherwise have few effective options available to them. To learn more, visit
www.ImpulseDynamics.com (https://www.impulsedynamics.com/), or follow the
company on LinkedIn (https://www.linkedin.com/company/impulse-dynamics/), X
(formerly Twitter) (https://twitter.com/ModulateHF), and Facebook
(https://www.facebook.com/ModulateHF).
Forward-looking Statements
This press release contains forward-looking statements. All statements other
than statements of historical facts contained in this press release are forward-
looking statements. In some cases, you can identify forward-looking statements
by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,''
''anticipate,'' ''could,'' ''intend,'' ''target,'' ''project,'' ''contemplate,''
''believe,'' ''estimate,'' ''predict,'' ''potential'' or ''continue'' or the
negative of these terms or other similar expressions, although not all forward-
looking statements contain these words. Forward-looking statements include, but
are not limited to, statements concerning potential benefits of CCM therapy.
These forward-looking statements are based on management's current expectations
and involve known and unknown risks and uncertainties that may cause our actual
results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking
statements. Other important factors that could cause actual results, performance
or achievements to differ materially from those contemplated in this press
release include, without limitation: the company's future research and
development costs, capital requirements and the company's needs for additional
financing; commercial success and market acceptance of CCM therapy; the
company's ability to achieve and maintain adequate levels of coverage or
reimbursement for Optimizer systems or any future products the company may seek
to commercialize; competitive companies and technologies in the industry; the
company's ability to expand its indications and develop and commercialize
additional products and enhancements to its current products; the company's
business model and strategic plans for its products, technologies and business,
including its implementation thereof; the company's ability to expand, manage
and maintain its direct sales and marketing organization; the company's ability
to commercialize or obtain regulatory approvals for CCM therapy and its
products, or the effect of delays in commercializing or obtaining regulatory
approvals; FDA or other U.S. or foreign regulatory actions affecting us or the
healthcare industry generally, including healthcare reform measures in the
United States and international markets; the timing or likelihood of regulatory
filings and approvals; and the company's ability to establish and maintain
intellectual property protection for CCM therapy and products or avoid claims of
infringement. The company does not undertake any obligation to update forward-
looking statements and expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking statements
contained herein. These forward-looking statements should not be relied upon as
representing the company's views as of any date subsequent to the date of this
press release.
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(1) (http://#_ftnref1) European Journal of Heart Failure (2021)
doi:10.1002/ejhf.2202
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