A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: David Prutchi’s Portfolio

Impulse Dynamics Completes $136M Financing Round

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics

Impulse Dynamics, the company where I’m CTO and Executive VP, announced yesterday that it completed a $136M financing round to accelerate its commercial growth and advancing the development of pipeline products.

From the announcement:

“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.

…

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.”

Presenting Keynote “AIMD-based Therapies of Heart Failure” at LASCAS 2024

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, Circulatory Support, David Prutchi's Portfolio, Heart Failure (CHF), Hypertension, My Portfolio, Vagus Nerve Stimulation

LASCAS Keynote

I’ll be presenting the keynote “AIMD-based Therapies of Heart Failure” at the First Workshop on Active Implantable Medical Devices dedicated to understanding the trends and challenges in bioelectronic medicine.

For the complete announcement of the workshop with some great talks by Rikky Muller (UC Berkeley), Pedro Arzuaga (Impulse Dynamics), Marcelo Barú (Biotronik), Federico De Mula (Integer), and Victor Pikov (Medipace) click here:  AIMD Workshop LASCAS 2024 Program.

 

Impulse Dynamics Announced First Implant for Integra CCM-D™ Clinical Trial in May 2023

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio, Tachycardia
Impulse Dynamics OPTIMIZER Integra CCM-D IPG

Image credit: Impulse Dynamics

Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced on May 18, 2023 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.

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Impulse Dynamics Launched Optimizer Smart Mini in April 2022

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio
Impulse Dynamics OPTIMIZER Smart Mini IPG by Impulse Dynamics

Image Credit: Impulse Dynamics

Back on April 29, 2022, Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced both FDA and CE Mark approval and the official commercial launch of the Optimizer® Smart Mini System.

According to the press release:

The Optimizer Smart Mini delivers CCM therapy — Impulse Dynamics’ proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve 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.

The OPTIMIZER Smart Mini offers increased battery longevity of 20 years (compared to 15 years in the previous generation), advanced HF diagnostic monitoring capabilities (e.g., heart rate, heart rate variability, patient posture and position), and remote patient monitoring features that will be activated in the near future.

OT: My New Book on Near-IR Treatment of Brain Disorders is Now Available

Posted on by Posted in Alzheimer's, Brain Stimulation, David Prutchi's Portfolio, Dementia, Depression, Ischemic Stroke, My Portfolio, Opioid Overdose, Stroke

My new book is out and available through Amazon!

High-Power Near-Infrared Light Treatments for Depression, Dementia, and Other Brain Disorders

Light of specific wavelengths and intensities has been shown to repair and protect neurons from damage, opening the possibility of using near-infrared light as a non-invasive treatment of various brain and psychiatric disorders.

This book serves as a practical overview of the scientific fundamentals, technical implementation, and therapeutic applications of transcranial photobiomodulation:

  • Part I provides an accessible explanation of why the irradiation must be done in the near-infrared region of the light spectrum. It presents evidence-based background on the parameters of light important to photobiomodulation, and describes the effects of near-infrared light on cells and tissues.
  • Part II discusses the types of multi-Watt light sources required to non-invasively deliver therapeutic doses of infrared light to the brain. Importantly, this part describes in detail various High-Power Near-Infrared Transcranial Therapy (HIPNITT) medical devices that have been used in clinical trials.
  • Part III presents the potential and challenges of using near-infrared light in the treatment of various brain disorders such as depression, dementia, traumatic brain injury, and Parkinson’s disease.

This book uses straightforward language and offers practical guidance to help readers quickly develop an understanding of the practical aspects of HIPNITT implementation and its therapeutic applications.

CCM Therapy Delivered by the Optimizer System Wins R&D 100 Award

Posted on by Posted in Cardiac Stimulation (other), David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics

Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM® therapy delivered by the Optimizer® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers and their revolutionary ideas in science and technology.

“Winning this award is a tremendous accomplishment for our company as it represents the recognition by fellow scientists and engineers for the enormous effort that has gone into developing this breakthrough technology. The therapy serves a huge unmet need for a very large group of heart failure patients who suffer every day with their symptoms, so it’s great for the technology to receive recognition at this level,” said David Prutchi, Ph.D., Chief Technology Officer and Executive Vice President at Impulse Dynamics. “I am pleased to congratulate all my colleagues that helped evolve what was initially an intriguing electrophysiological discovery into the transformational therapy that it is today.”

Impulse Dynamics’ website: www.impulse-dynamics.com

Impulse Dynamics Secures $80.25M Funding from Major Investors Including Amzac, Wellington, and Zoll

Posted on by Posted in Abiomed, AIMD Business, Cardiac Contractility Modulation, David Prutchi's Portfolio, Edwards, Heart Failure (CHF), My Portfolio, Zoll

Impulse Dynamics (where I’m Executive VP of Product Development) announced today the completion of an $80.25 Million Series D financing round with major new investors, including strategics.  According to the press release:

“Impulse Dynamics, developer of Optimizer® Smart System for delivering CCM™ therapy, announced the completion of an $80.25 million Series D financing with new investors. The proceeds will be used primarily to facilitate U.S. commercialization of the Optimizer Smart, an FDA-approved implantable device for treating chronic heart failure that has been proven to strengthen the heart and help it beat more forcibly. Led by well-respected medical technology investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings Limited; strategic investors Zoll Medical Corporation, Abiomed and one additional corporate investor; and the company’s chief executive and chief financial officers.”

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First U.S. Commercial Implant of Impulse Dynamics’ OPTIMIZER Smart System

Posted on by Posted in Cardiac Contractility Modulation, David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, My Portfolio

Impulse Dynamics – the company for which I work – announced during HRS that a first patient received the Optimizer® Smart System for delivering CCM™ therapy since the device was approved by the U.S. Food and Drug Administration. The implant was performed on May 6, 2019 at The Ohio State University Wexner Medical Center.

The start of commercial implants in the U.S. is a major milestone for the Company.  It makes me very proud that the technology on which I have worked for over 21 years is now available to make a dramatic change to the lives of heart failure patients across the U.S.

 

FDA Approves breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics

I have led the development of devices to deliver CCM™ therapy from the very beginning, so it is with great pleasure and pride that I share with you the exciting news that Impulse Dynamics just received approval from the United States Food and Drug Administration (FDA) for our Optimizer® Smart System for heart failure patients!  An official FDA announcement was made through the publication of a press release that you can find here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm.

Impulse Dynamics’ press release is as follows:

Impulse Dynamics receives FDA approval for breakthrough Optimizer® Smart System delivering CCM™ therapy for treatment of heart failure

Orangeburg, New York, March 21, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System.

Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first breakthrough device to go before the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a 12-0 vote on the benefit-to-risk ratio of the device.

“With the FDA’s approval of the Optimizer System for the delivery of CCM, we finally have available in the US an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,” said Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. “The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.”

The Optimizer Smart System is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have an LVEF ranging from 25% to 45%. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.

“FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm,” commented Dr. Daniel Burkhoff, Impulse Dynamics’ Medical Advisor. “We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.”

CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.

Dr. Simos Kedikoglou, Impulse Dynamics’ CEO, announced that the Company will launch the device in the US later this year.  “We are extremely excited that the Optimizer Smart System with CCM therapy is now available in the United States,” he said. “We look forward to growing our commercial presence in the US and globally.”

About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 papers in leading medical journals.

About Impulse Dynamics
Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.

Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962

Welcome to implantable-device.com!

Posted on by Posted in Administrative, David Prutchi's Portfolio

Welcome to implantable-device.com, a blog dedicated to professionals interested in the fascinating world of active implantable medical devices!

Let me tell you a bit about myself: I have thirty years of experience in the design of Medical Electronic Instrumentation, most of it developing active implantable medical devices. In addition to over 40 papers and 80 patents on implantable medical devices, I am the lead author of the books “Design and Development of Medical Electronic Instrumentation”, “Exploring Quantum Physics Through Hands-On Projects,” “Exploring Ultraviolet Photography – Bee Vision, Forensic Imaging, and Other Adventures in Ultraviolet Photography,” and “High-Power Near-Infrared Light Treatments for Depression, Dementia, and Other Brain Disorders.” (All of my books are available on Amazon #CommissionsEarned).

Please contact me if you would like to contribute to the blog, correct information that you find in these pages, make a news release, or if you have a picture of an implantable device that you would like to share with everyone else.

I hope that you enjoy reading this blog!

David Prutchi, Ph.D.

#CommissionsEarned. As an Amazon Associate, I earn from qualifying purchases.