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] 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, or follow the company on LinkedIn, X (formerly 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. 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.

###

[1] European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202

Attachment

• David and Raynita

GLOBENEWSWIRE (Distribution ID 9116301)

Marlton, NJ, Feb. 14, 2024 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it raised $136 million in financing to accelerate investment in global commercialization, technology, product innovation, and further development of clinical evidence. The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare. This substantial investment reflects investor confidence in, and commitment to, the company’s vision and expansion.

“This round of funding will accelerate our business, both commercially and with our pipeline of advanced technology innovation,” said Jason Spees, CEO of Impulse Dynamics. “We continue to make commercial progress globally with more than 9,000 heart failure patients implanted with CCM^® therapy and millions more who can benefit. 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 Optimizer^® Integra CCM–D^® System. Most patients who currently receive a standard ICD get lifesaving benefits from the defibrillator but still struggle with HF symptoms. With CCM–D, these patients will be able to get the lifesaving benefits of a defibrillator combined with HF symptom relief from CCM in one device.”

The funding will fuel commercialization efforts, develop future product pipelines, and support groundbreaking clinical trials such as the INTEGRA–D and AIM HIGHer clinical trials. The INTEGRA–D trial is a multicenter study evaluating the combination of CCM and ICD therapy in a single device – the Optimizer Integra CCM–D System. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM therapy in patients with symptomatic HF with an ejection fraction (EF) of 40 to 60 percent (inclusive). The trial is currently in its initial enrollment phase and has generated significant attention, feedback, and excitement among experts in HF.

“We are thrilled by the ongoing support from top–tier investment groups for Impulse Dynamics,” said Shlomi Nachman, Chairman of the Board. “Those investments will accelerate the cadence of innovation and market awareness in CCM therapy. I am extremely confident in Impulse Dynamics’ strong leadership and their excellent teams to enhance even further the developments and commercial activities of CCM therapy for the benefit of millions of HF patients worldwide.”

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] 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.

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 9,000 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, or follow the company on LinkedIn, X (formerly Twitter), and Facebook.

[1] European Journal of Heart Failure (2021) doi:10.1002/ejhf.2202

GLOBENEWSWIRE (Distribution ID 9036957)

MARLTON, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole–body MRI–conditional approval for the Optimizer Smart Mini system from the United States Food and Drug Administration (FDA). The Optimizer Smart Mini system delivers the company's proprietary CCM therapy. This conditional approval expands the product labeling to allow for full–body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full–body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.

"We are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment," said Jason Spees, CEO of Impulse Dynamics. "This furthers our commitment to supporting the heart failure patients who benefit from important and life–changing CCM therapy with the Optimizer Smart Mini system."

"Full body MRI capability is part of our promise to deliver an ongoing pace of innovation," said David Prutchi, Ph.D., Chief Technology Officer, Impulse Dynamics. "This advance will ensure that patients who can benefit from our CCM therapy are able to pursue the option without limiting important future diagnostic options."

The Optimizer Smart Mini 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.

The Optimizer Smart Mini incorporates a rechargeable battery with 20–year battery life, offering HF diagnostic monitoring that provides important clinical insights to providers to assist in managing their patients with heart failure. This latest generation also offers internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.

Reference

1 Kuschyk J, Falk P, Demming T, et al. Long"term clinical experience with cardiac contractility modulation therapy delivered by the optimizer smart system. European Journal of Heart Failure. 2021;23(7):1160–1169. doi:10.1002/ejhf.2202

# # #

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 heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 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 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. 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.

ID–A358–US

Attachments

• Optimizer® Smart Mini System
• Optimizer® Smart Mini System With Leads Into the Heart

GLOBENEWSWIRE (Distribution ID 8968472)

MARLTON, N.J., May 18, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced the completion of the first implantation for the INTEGRA–D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined "" CCM and an implantable cardioverter defibrillator (ICD) "" in a single device (CCM–D). The Optimizer Integra^TM CCM–D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life–threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.

The journey of a heart failure patient often involves debilitating symptoms and declining quality of life.

CCM therapy delivered by the Optimizer System improves quality of life and helps patients feel better. Patients indicated for CCM therapy may also be at a higher risk for arrythmias and sudden cardiac arrest and are therefore often offered an ICD to treat their heart for life–threatening arrythmias, should they occur. The INTEGRA–D trial is the first to evaluate the Optimizer Integra CCM–D System that combines both therapies into a single device, designed to last for many years.

"The first–in–the–world implant of this novel technology has potential to advance treatments for patients living with heart failure," said Niraj Varma, M.D., Ph.D., electrophysiologist at Cleveland Clinic and National Primary Investigator of the INTEGRA–D clinical trial. "The trial aims to study whether this device can protect heart failure patients from the risk of sudden cardiac death while also treating heart failure symptoms."

"We hope combining cardiac contractility modulation therapy and ICD therapy with prolonged battery life will reduce the number of leads and the number of procedures a patient may have to endure," said Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Principal Investigator of the INTEGRA–D trial. "The first implant went well, and we look forward to further studying this device."

The INTEGRA–D trial is a multicenter study of 300 subjects from 75 centers that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM–D System. The study will assess the performance of the CCM–D device in effectively treating episodes of ventricular tachycardia and/or ventricular fibrillation while also providing CCM treatment for heart failure. Patients enrolled in the study will receive the Optimizer Integra CCM–D System, and will be followed for at least two years.

"This clinical study is important in proving the potential benefit of combining CCM therapy, which improves quality of life in patients with heart failure, with gold–standard ICD technology that delivers lifesaving therapy for sudden cardiac death," said Nir Uriel, M.D., Director of Advanced Heart Failure and Cardiac Transplantation at New York–Presbyterian and National Co–Principal Investigator for the INTEGRA–D trial. Dr. Uriel is also a professor of cardiology at Columbia University Vagelos College of Physicians and Surgeons and an Adjunct Professor of Medicine in the Greenberg Division of Cardiology at Weill Cornell Medicine.

"Today's announcement is another example of our commitment to a continuous pace of innovation to build a comprehensive platform in interventional heart failure and help improve the lives of many patients that suffer from this debilitating disease," said Simos Kedikoglou, M.D., Chief Executive Officer of Impulse Dynamics. "We are proud to partner with physicians at leading centers around the world to conduct important research on this first–of–its–kind rechargeable combination device designed to address a major unmet need of a large patient group."

About the Optimizer Integra CCM–D System and CCM Therapy

The Optimizer Integra CCM–D System is an investigational device that combines CCM therapy and ICD therapy into one device. "Investigational" means that the study device is currently being tested. It is not approved by the U.S. Food and Drug Administration (FDA).

Impulse Dynamics currently offers the Optimizer system that is FDA–approved and CE–marked. The Optimizer system delivers CCM therapy "" the company's proprietary technology "" to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart's contraction, allowing more oxygen–rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6–minute hall walk, quality of life, and functional status of NYHA Class III heart failure 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 "" a therapy that delivers non–excitatory electrical pulses from 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, and CCM therapy has been published in more than 120 peer–reviewed journal articles.

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 heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 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, 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 CCM therapy combined with an ICD delivered via a single device (CCM–D), 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 Integra CCM–D System 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.

###

GLOBENEWSWIRE (Distribution ID 8841961)

MARLTON, N.J., May 15, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today a worldwide milestone achievement with the 9,000th patient receiving the Optimizer system for the treatment of moderate HF. The Optimizer system is the only device approved by the U.S. Food and Drug Administration (FDA) in the United States to deliver CCM therapy. Dr. Steven Gubin, a cardiologist and the President of Stern Cardiovascular, is part of the care team that completed the procedure at Baptist Memorial Hospital–Memphis, offering CCM therapy to a patient living with the debilitating effects of HF. This milestone highlights the momentum building globally for CCM therapy, using the Optimizer platform to improve quality of life in HF patients.

"I am excited to have a new therapy option for heart failure patients," said Dr. Gubin, who has been practicing for 30 years. "One of my heart failure patients, Aubretta Bean, who is a cancer survivor, continued to have symptoms despite her compliance with guideline–directed medical therapy for heart failure. She let me know that she felt better almost immediately after receiving the implant and continues to improve daily. It has been extremely rewarding to see such improvement in her quality of life. Her lab work four weeks later showed her BNP (a common test to diagnose heart failure) decreased by 81%, which is consistent with improvement in her heart failure symptoms."

"Before my CCM implant, I could not walk from one room to the other without gasping for air. It was like being underwater and trying to breathe through a straw," said Aubretta Bean. "Heart failure changed my life so quickly. You might think housework is a chore, but when you can't make your bed or do the dishes, you realize how quickly you would love to do that again. Now after my Optimizer implant, I can do all these things! I look forward to planning my days again and not just trying to get through them. I have eight grandkids and two great–grandkids that I can travel to see!"

Drs. Eric Johnson, David Lan, and Chris Ingelmo are all electrophysiologists at Stern Cardiovascular that have treated ten patients at Baptist Memorial Hospital–Memphis with CCM therapy since March 2023. Dr. Chris Ingelmo completed the milestone procedure for the 9,000th patient treated with CCM therapy. The results have been encouraging, with significant improvement in patient symptoms.

"We are inspired by such stories highlighting the potential for clinicians to use CCM therapy to make a positive impact on HF patients' lives," said Simos Kedikoglou, MD, CEO of Impulse Dynamics. "The growing cadence of implants and the emergence of such inspiring stories reinforces our commitment to delivering meaningful advances in CCM technology and clinical data."

CCM therapy is now available in 44 countries, and the technology has continued to advance based on the needs of patients and physicians. The latest generation of Impulse Dynamic's proprietary Optimizer platform 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.

About the Optimizer and CCM Therapy

The Optimizer Smart system delivers CCM therapy "" the company's proprietary technology "" to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve the heart's contraction, allowing more oxygen–rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6–minute hall walk, quality of life, and functional status of NYHA Class III heart failure 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, and CCM therapy has been published in more than 120 peer–reviewed journal articles.

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 platform to improve quality of life in heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. CCM therapy has proven 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 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, the continued momentum for the adoption of CCM therapy and use of the Optimizer Smart system globally; the ability for CCM therapy and our products and technology to fill a significant unmet medical need for patients with heart failure; and the short–term and long–term benefits of the Optimizer system 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; company's ability to expand and grow its business into new geographic markets; commercial success and market acceptance of CCM therapy; the company's ability to achieve and maintain adequate levels of coverage or reimbursement for its 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.

###

GLOBENEWSWIRE (Distribution ID 8839792)

MARLTON, N.J., Nov. 16, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, announced the 100th implant in China, signifying the opportunity for its innovative Optimizer system delivering CCM therapy in markets around the world. Cardiologist Prof. Guo Tao, Executive Director of Internal Medicine, Fuwai Cardiovascular Hospital, Yunnan Province, performed the 100th procedure and emphasized the role of this therapy in providing an option and hope to patients living with the debilitating reality of heart failure.

"It is quite a coincidental milestone for us that the 10th patient implanted in our center also happened to be the 100th patient treated in China. I have paid very close attention to CCM therapy for more than 20 years now, but it wasn't until recently we could clinically apply this technology. Under close clinical observation, our 10 CCM patients have improved even more than we anticipated. All the CCM patients in our center improved both symptomatically and on various objective indicators, which made both us and our patients very happy. Therefore, it seems from our experience that CCM is performing exactly as described in the foreign research "" specifically, by modulating the exchange of calcium ions and thereby enhancing contractility of the myocardium in the acute period, then normalizing the expression of contraction–related proteins, which leads to reverse remodeling of the heart. Based on these results, we are now planning to expand the application of CCM normatively and actively while continuing to closely follow our implanted patients to obtain more clinical evidence of CCM to optimize its application so more Chinese patients can benefit from this latest innovative treatment."

Prof. Zhang Shu, Chief Physician of Fuwai Hospital of the National Center for Cardiovascular Diseases and the Chinese Academy of Medical Sciences, Honorary Chairman of the Electrocardiology and Pacing Branch of the Chinese Medical Association, Director of the Cardiology Committee of the Chinese Medical Doctor Association, and former President of the Asia–Pacific Heart Rhythm Society further commented "Currently there are almost nine million patients with heart failure in China, and many of them have not been optimally treated. Heart failure has also become the leading cause of death among cardiovascular and other major chronic diseases in China. I believe CCM will bring good news to Chinese patients. These successful initial experiences provide our doctors with good prospects of bringing hope to the patients they care for."

"We are proud to see the growing acceptance of this technology in markets around the world," said Mateusz Zelewski, MD, Impulse Dynamics VP International. "In reaching this milestone, we have connected with physicians, patients, and their families. We are inspired by the benefits of this therapy to our patients and continue to reinforce our commitment to address the immense need for advanced heart failure options for patients around the world."

CCM therapy was approved in China late last year, and the first implant in the country was announced on November 1, 2021. The Optimizer system delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle.

To date, CCM therapy has been used to treat heart failure in more than 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer–reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 "" 60 percent.

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.

###

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

Attachments

• Optimizer® Smart Mini System
• Optimizer® Smart Mini System

GLOBENEWSWIRE (Distribution ID 8698682)

MARLTON, N.J., Nov. 16, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure, announced the 100th implant in China, signifying the opportunity for its innovative Optimizer system delivering CCM therapy in markets around the world. Cardiologist Prof. Guo Tao, Executive Director of Internal Medicine, Fuwai Cardiovascular Hospital, Yunnan Province, performed the 100th procedure and emphasized the role of this therapy in providing an option and hope to patients living with the debilitating reality of heart failure.

"It is quite a coincidental milestone for us that the 10th patient implanted in our center also happened to be the 100th patient treated in China. I have paid very close attention to CCM therapy for more than 20 years now, but it wasn't until recently we could clinically apply this technology. Under close clinical observation, our 10 CCM patients have improved even more than we anticipated. All the CCM patients in our center improved both symptomatically and on various objective indicators, which made both us and our patients very happy. Therefore, it seems from our experience that CCM is performing exactly as described in the foreign research "" specifically, by modulating the exchange of calcium ions and thereby enhancing contractility of the myocardium in the acute period, then normalizing the expression of contraction–related proteins, which leads to reverse remodeling of the heart. Based on these results, we are now planning to expand the application of CCM normatively and actively while continuing to closely follow our implanted patients to obtain more clinical evidence of CCM to optimize its application so more Chinese patients can benefit from this latest innovative treatment."

Prof. Zhang Shu, Chief Physician of Fuwai Hospital of the National Center for Cardiovascular Diseases and the Chinese Academy of Medical Sciences, Honorary Chairman of the Electrocardiology and Pacing Branch of the Chinese Medical Association, Director of the Cardiology Committee of the Chinese Medical Doctor Association, and former President of the Asia–Pacific Heart Rhythm Society further commented "Currently there are almost nine million patients with heart failure in China, and many of them have not been optimally treated. Heart failure has also become the leading cause of death among cardiovascular and other major chronic diseases in China. I believe CCM will bring good news to Chinese patients. These successful initial experiences provide our doctors with good prospects of bringing hope to the patients they care for."

"We are proud to see the growing acceptance of this technology in markets around the world," said Mateusz Zelewski, MD, Impulse Dynamics VP International. "In reaching this milestone, we have connected with physicians, patients, and their families. We are inspired by the benefits of this therapy to our patients and continue to reinforce our commitment to address the immense need for advanced heart failure options for patients around the world."

CCM therapy was approved in China late last year, and the first implant in the country was announced on November 1, 2021. The Optimizer system delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle.

To date, CCM therapy has been used to treat heart failure in more than 7,000 patients worldwide and is available in 44 countries across the globe. The therapy has been studied in almost 2,000 patients and has appeared in more than 100 peer–reviewed journal articles. Ongoing studies are also underway to examine the safety and efficacy of CCM for patients suffering from heart failure with a left ventricular ejection fraction between 40 "" 60 percent.

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.

###

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

Attachments

• Optimizer® Smart Mini System
• Optimizer® Smart Mini System

GLOBENEWSWIRE (Distribution ID 8698682)