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 Device

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 is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company is focused on delivering its proprietary CCM therapy, which is delivered by the company’s Optimizer device, the CE-marked, and FDA-approved treatment verified to improve the quality of life for heart failure patients. CCM therapy is a safe, effective, and minimally invasive treatment option for many heart failure patients who otherwise have few effective options available to them.1 To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, Twitter, and Facebook.

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, and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. 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.

 

Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933
www.impulse‐dynamics.com

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/

INVESTOR RELATIONS:

Harriss Currie
CFO
Impulse Dynamics
hcurrie@impulsedynamics.com
856-642-9933

MARKETING OPERATIONS: 

Rohan More
Global Vice President, Marketing
Impulse Dynamics
rmore@impulsedynamics.com
856-642-9933

PUBLIC RELATIONS:  

Ian Segal
Manager, Public Relations
Impulse Dynamics
isegal@impulsedynamics.com
856-642-9933