Impulse Dynamics – Saudi Mirror http://www.saudimirror.com News On-line Wed, 14 Feb 2024 14:00:00 +0000 en-US hourly 1 https://wordpress.org/?v=5.3.2 Impulse Dynamics Completes $136M Financing Round http://www.saudimirror.com/?p=218210/ Wed, 14 Feb 2024 14:00:00 +0000 http://www.saudimirror.com/?p=218210 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)

]]>
Impulse Dynamics Receives Full-Body MRI-Conditional Approval for Optimizer Smart Mini System http://www.saudimirror.com/impulse-dynamics-receives-full-body-mri-conditional-approval-for-optimizer-smart-mini-system/ Mon, 30 Oct 2023 15:37:46 +0000 http://www.saudimirror.com/?p=217375 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


GLOBENEWSWIRE (Distribution ID 8968472)

]]>
Impulse Dynamics Announces Leadership Changes http://www.saudimirror.com/impulse-dynamics-announces-leadership-changes/ Tue, 19 Sep 2023 11:17:08 +0000 http://www.saudimirror.com/?p=217020 MARLTON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced new leadership appointments, including Jason Spees to Chief Executive Officer, Shlomi Nachman to Chairman of the Board, and John Liddicoat, M.D., as a member of the Board of Directors. Spees was recently President and Chief Commercial Officer at Impulse Dynamics and brings a depth of medical device industry experience from commercial leadership roles. Nachman most recently was the Company Group Chairman at Johnson & Johnson, overseeing the Cardiovascular and Specialty Solutions & Vision Group. Liddicoat most recently served as Executive Vice President and President of the Americas Region and Enterprise Technology & Innovation function at Medtronic.

"I am pleased to lead the Impulse Dynamics team, focusing on a strong commercialization strategy and our commitment to an ongoing pace of innovation to change the course of treatment for patients living with heart failure," said Spees. "We find ourselves in a unique position to capitalize on robust clinical data and a lineup of cutting–edge technologies, exemplified by the Integra–D trial featuring the groundbreaking single device that integrates our CCM technology with implantable cardioverter defibrillator (ICD) technology. I look forward to working closely with the board and the leadership team to optimize the company for its next phase of commercial acceleration."

"I am honored to join the board of an organization that has showcased substantial contributions to the advancement of heart failure treatment," said Shlomi Nachman. "Over 64 million people suffer from heart failure, and many of those treated are not experiencing the higher quality of life they deserve. With CCM therapy and its future product pipeline, we are in the exciting position of being able to help millions of these patients to feel better and lead fuller lives," Nachman added. "I'm looking forward to working with the leadership team and the board to ensure a direct path to ongoing innovation and commercial success."

"I've been watching Impulse Dynamics and its technology from the sidelines for many years, and I am excited to now be able to join the team," said Liddicoat. "I look forward to working with a strong leadership team to lead innovation–driven growth as we aim to enhance the standard of care for heart failure patients across the globe."

Jason Spees joined the company as President and Chief Commercial Officer in July 2021. He brings more than two decades of successful leadership roles in the medical device industry. Spees was most recently Senior Vice President of Sales and Marketing for Biotronik in the areas of cardiac rhythm management, cardiovascular intervention, peripheral vascular intervention, diagnostics, and digital health. Prior to Biotronik, Spees was the Chief Commercial Officer of Preventice Solutions, along with multiple leadership positions, including Vice President of Sales for Boston Scientific. He holds a B.S. in Operations Research and Engineering from the United States Air Force Academy and an M.A. in Public Management – Finance from the University of Maryland.

Shlomi Nachman was the Company Group Chairman of Cardiovascular and Specialty Solutions and Visions Group within Johnson & Johnson's Medical Devices sector. Nachman was a member of the Medical Devices Group Operating Committee, where he led a diverse portfolio of six medical device businesses, including Electrophysiology, Neurovascular Intervention, Ear, Nose & Throat, Breast Aesthetics, Optometry and Ophthalmology. Before that, Nachman had various roles with increased scope and responsibilities, including Worldwide President of Biosense Webster and Cordis. His career at Johnson & Johnson spanned over 27 years, comprising multiple leadership positions with a proven track record of success that has recognized the ability to drive growth, innovation, and architect business turnarounds. Additionally, Nachman has accrued deep knowledge in all aspects of medical devices, such as general management, strategy, L&A, finance, product development, operations, sales and marketing, and research and development. Nachman was born in Israel and holds a B.S. in Management and Economics from the Technion Institute, as well as a diploma in electrical engineering from the Amal Technical School.

John Liddicoat brings a history of transformational leadership focused on execution. He spent 16 years at Medtronic, driving the strategic direction and global operations of increasing size and scope, including the Structural Heart, Cardiac Rhythm, and Heart Failure businesses. In his most recent role as Executive Vice President and President of the Americas region and the Enterprise Innovation and Technology function, he was responsible for designing and implementing go–to–market strategies to deliver above–market growth across North and South America. Liddicoat graduated medical school from the University of Chicago, completed a residency in general and cardiothoracic surgery at Johns Hopkins Hospital, and served on the faculty of Harvard Medical School. An innovator and entrepreneur, he has also served as a consultant to venture capital firms and early–stage medical device companies.

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. This device is being used in an FDA–approved Investigational Device Exemption (IDE) study and is not available for sale in the United States.

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 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 therapy delivers non–excitatory electrical pulses from the implantable Optimizer device in a manner designed to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during their absolute refractory period. 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 8924737)

]]>
Impulse Dynamics Announces First Implant for CCM-D™ Clinical Trial http://www.saudimirror.com/impulse-dynamics-announces-first-implant-for-ccm-d-clinical-trial/ Thu, 18 May 2023 11:30:00 +0000 http://www.saudimirror.com/?p=216133 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 IntegraTM 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)

]]>
Impulse Dynamics Announces 9,000th Patient Milestone Achieved With CCM® Therapy for Heart Failure http://www.saudimirror.com/impulse-dynamics-announces-9000th-patient-milestone-achieved-with-ccm-therapy-for-heart-failure/ Mon, 15 May 2023 18:09:26 +0000 http://www.saudimirror.com/?p=216102 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)

]]>
Impulse Dynamics Announces 100th Implant Milestone in China for CCM® Therapy http://www.saudimirror.com/impulse-dynamics-announces-100th-implant-milestone-in-china-for-ccm-therapy/ Wed, 16 Nov 2022 21:14:43 +0000 http://www.saudimirror.com/?p=214769 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


GLOBENEWSWIRE (Distribution ID 8698682)

]]>
Impulse Dynamics Announces 100th Implant Milestone in China for CCM® Therapy http://www.saudimirror.com/impulse-dynamics-announces-100th-implant-milestone-in-china-for-ccm-therapy/ Wed, 16 Nov 2022 21:14:43 +0000 http://www.saudimirror.com/?p=214768 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


GLOBENEWSWIRE (Distribution ID 8698682)

]]>
Impulse Dynamics Announces First International Implants of the Optimizer Smart Mini System in Italy http://www.saudimirror.com/impulse-dynamics-announces-first-international-implants-of-the-optimizer-smart-mini-system-in-italy/ Tue, 14 Jun 2022 08:00:00 +0000 http://www.saudimirror.com/?p=214670 MARLTON, N.J., June 14, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a commercial–stage medical device company focused on delivering our CCM therapy to people with heart failure, announced that the first implants in Europe for the newly launched Optimizer Smart Mini device were recently completed in Italy. The company announced the launch of the new technology on April 29, 2022, and the first U.S. implants on May 10, 2022.

Dr. Stefano Guarracini, Head of Cardiology at the Synergo Casa di Cura Pierangeli Hospital in Pescara, Italy, described his experience with CCM therapy and his outlook for the Optimizer Smart Mini system after the first implant. "Starting in 2019, we had the opportunity to implant Optimizer devices in several patients with heart failure. We believe in the technology and consider CCM therapy to be the only option for many patients suffering from heart failure. We are excited now to be affiliated with the first European institution to have implanted the new Optimizer Smart Mini device and look forward to the simple but more advanced patient management experiences during implants and follow–ups going forward."

Dr. Giovani Bisignani, with the Ospedale di Castrovillari, who completed his first implant almost simultaneously in the southern Italian province of Cosenza, said, "CCM therapy is a powerful weapon against heart failure. The cutting–edge technology of the new Optimizer Smart Mini along with its smaller, physiological shape allowed us to achieve efficient implantation and initiation of CCM therapy in even less time."

In March 2022, the company announced that its quality management system received certification under the new European Union Medical Device Regulation. We believe that the launch of the Optimizer Smart Mini system is an example of the importance of a global infrastructure to support ongoing technology innovation and access. The new components of the Optimizer Smart Mini system are equally important across international markets, including a rechargeable battery with a 20–year life and new internal technology with improved programming and potential for remote monitoring in a smaller design to make the implant procedure easier for patients and physicians.

"The pace of this international rollout is a reflection of our commitment to delivering innovation that is relevant to patients worldwide," said Mateusz Zelewski, MD, Impulse Dynamics' Vice President International, "It is exciting to see how quickly we can increase access to new and better technology that offers hope for more patients living with heart failure."

The Optimizer Smart Mini 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. CCM therapy is currently indicated in Europe to reduce hospitalizations and improve physical exercise tolerance, quality of life, and functional status for a large population of patients with systolic heart failure who remain symptomatic despite guideline–directed medical therapy.

To date, CCM therapy has already been used to treat over 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%.

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 Smart 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 Smart Mini 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 Smart and Optimizer Smart Mini 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


GLOBENEWSWIRE (Distribution ID 8571455)

]]>
Late-breaking Results Show Efficacy for CCM in Patients With HFpEF http://www.saudimirror.com/late-breaking-results-show-efficacy-for-ccm-in-patients-with-hfpef/ Mon, 23 May 2022 14:17:39 +0000 http://www.saudimirror.com/?p=213960 MADRID and MARLTON, N.J., May 23, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today a late–breaking presentation of results from the CCM–HFpEF Piloty Study, which is the largest clinical trial to date studying the effects of the company's proprietary CCM therapy to treat HF with preserved ejection fraction (HFpEF). The results presented "" including a substantial 18 point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score "" indicate that, for patients with heart failure and left ventricular ejection fraction (LVEF) 50%, CCM therapy not only offered meaningful improvement in quality of life but also substantially decreased hospitalizations versus the patient's experience prior to the Optimizer implant. The results were presented at the European Society of Cardiology's Heart Failure 2022 Congress.

Patients with HFpEF suffer from debilitating symptoms and have very few therapeutic options. This patient population is a similar size as the one with reduced ejection fraction and has been shown to have similar struggles with quality of life, hospitalizations, and mortality.

Cecilia Linde, MD, Professor and Consultant in Cardiology at the Heart and Vascular Theme of Karolinska University Hospital and the Karolinska Institute in Stockholm, Sweden, who was the co–principal investigator for this investigation, said, "The CCM–HFpEF Pilot Study was conducted to explore the hypothesis that CCM therapy might benefit patients with HFpEF. Our hypothesis was based on evidence of greater benefits in CCM HFrEF studies in those with higher LVEF range and from case reports of HFpEF patients. In our CCM–HFpEF–Pilot Study, we found significant benefits from CCM therapy in patients with preserved LVEF, supporting prior findings. I look forward to following the progress of the recently begun pivotal AIM HIGHer trial to continue this journey further."

Dr. Ishu Rao, Medical Director for Impulse Dynamics, welcomed these results because they confirm the potential for positive results in the company's recently initiated AIM HIGHer trial. "We are also excited to announce that enrollment is well underway for this landmark IDE–approved, multicenter, randomized, and blinded pivotal trial designed not only to confirm Dr. Linde's groundbreaking work presented today but to go further yet by providing the first long term morbidity and mortality results for a modern Optimizer CCM device. While Dr. Linde specifically studied patients with EFs 50%, in AIM HIGHer, we are examining the efficacy of CCM therapy in 1,500 patients with EFs between 40% and 60%. This represents a large cohort of patients who currently have minimal treatment options and are clamoring for help. If AIM HIGHer's results are consistent with Dr. Linde's findings, we may finally begin to close the significant gap in care that exists for millions of patients afflicted with HF and higher EF."

HF affects more than 64 million people worldwide and leads to dramatic declines in a patient's quality of life. Patients are often classified by a measure of cardiac function known as the ejection fraction (EF), which describes the percentage of blood pumped out of the left ventricle with each heartbeat. CCM therapy is currently indicated in Europe for patients that have an EF below 50% and has been proven to reduce hospitalizations. However, HF patients with higher EF have had few therapeutic options thus far to alleviate their symptoms and treat their disease.

The purpose of the AIM HIGHer trial "" the largest randomized, sham–controlled, device–based interventional heart failure trial "" is to further assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients. CCM therapy for HFpEF has already received the FDA's breakthrough device designation. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide more effective treatment or diagnosis of life–threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards consistent with the Agency's mission to protect and promote public health.

The Optimizer Smart Mini delivers CCM therapy which consists of precisely timed electrical pulses sent to the heart. These signals are designed to improve the heart's ability to function properly, allowing more oxygen–rich blood to be pushed out through the body.

About Impulse Dynamics

Impulse Dynamics, based in Marlton, NJ, is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM therapy, which is delivered by the company's Optimizer Smart Mini, an FDA–approved treatment verified to improve the quality of life for certain 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. 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 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 Smart Mini 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 Smart and Optimizer Smart Mini 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 8557987)

]]>