Financing To Support Commercial Acceleration of the Optimizer Smart Mini, Enrollment in the Landmark AIM HIGHer Clinical Trial, and Continued Development of a CCM-D Combination
MARLTON, N.J., May 12, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce today the completion of a $101 million financing round comprised of both equity and debt. Participants include new investors, Alger and Squarepoint Capital LLC; existing investors, Abiomed, Inc. and Kennedy Lewis Investment Management LLC; and private investors from the company’s Board of Directors, including the company’s CEO, Simos Kedikoglou, MD.
“The support of existing and new investors in the current, challenging environment underscores the disruptive potential for CCM therapy, the strength of the global commercial rollout, and the promise of our clinical and product pipeline,” said Dr. Kedikoglou. “We expect this financing will enable us to further accelerate the commercial efforts to drive adoption of our technology, expedite enrollment in the landmark AIM HIGHer clinical trial, and accelerate efforts to realize our next-generation combination device. With the completion of this financing round, we believe we are positioned to provide a proven treatment option that offers hope for quality of life for HF patients around the world.”
The Optimizer® device is commercially available in 44 countries, including the U.S., EU, China, Brazil, and India. The AIM HIGHer trial is a 1,500-patient quadruple-blind, sham-controlled trial that the company has initiated to evaluate the potential of CCM therapy to improve performance and reduce cardiovascular morbidity and mortality in HF patients with left ventricular ejection fraction of 40 to 60 percent. The study is expected to engage up to 150 sites in the U.S. and internationally. The Optimizer Integra, the company’s 7th generation device, is a breakthrough technology that combines traditional CCM with defibrillator functionality, similar to a traditional implantable cardioverter defibrillator (ICD), for appropriate patients. The advanced device is expected to enter clinical trials in the U.S. and elsewhere in the near future.
“We are excited to lead this funding round to support Impulse Dynamics in accelerating the development and commercialization of its breakthrough CCM technology,” said Sanjiv Talwar, MD, PhD, Senior Vice President, Portfolio Manager, and Head of Healthcare at Alger, a New York-based asset manager with a 60-year track record of investing in growth and innovation.
“We have been investors in Impulse Dynamics for some time now, and we are pleased to continue to support the advancement of CCM therapy for the care of heart failure patients globally,” said Rich Gumer, partner with Kennedy Lewis Investment Management LLC, a leading credit manager with a track record of supporting innovative life sciences companies.
About Impulse Dynamics
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company pioneered CCM® therapy, which is delivered by the company’s Optimizer® Smart system, an FDA-approved treatment verified to improve the quality of life for heart failure patients. CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few effective alternatives available to them. To learn more, visit www.impulsedynamics.com, or follow the company on LinkedIn, Twitter, and Facebook.
About the Optimizer Device
The Optimizer device delivers CCM therapy to the heart. CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart’s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.[1] CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA (New York Heart Association) Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT (cardiac resynchronization therapy) and have a left ventricular ejection fraction ranging from 25 to 45 percent
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 our planned use of proceeds from the financing and the potential benefits of our CCM therapy and the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure. 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: our future research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our proprietary CCM therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Optimizer Smart and Optimizer Smart Mini systems or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to expand our indications and develop and commercialize additional products and enhancements to our current products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to expand, manage and maintain our direct sales and marketing organization; our ability to commercialize or obtain regulatory approvals for our CCM therapy and our 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 our ability to establish and maintain intellectual property protection for our CCM therapy and products or avoid claims of infringement. The forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
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[1] European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202
