Lungpacer Medical Inc. is developing a novel therapeutic solution for preserving or restoring the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system is designed to activate and exercise the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation catheter that is
Intravenously inserted Lungpacer electrodes are designed to rhythmically activate the diaphragm. In critically ill patients who have failed or would typically fail to wean and become ventilator-dependent, the pacing therapy is expected to prevent or reverse diaphragm muscle-disuse atrophy and maintain diaphragmatic endurance, thus facilitating weaning of patients from MV. In addition, the paced diaphragm is expected to restore negative pressure ventilation, thereby potentially providing a more physiological respiratory pattern and reducing the levels of positive pressure ventilation and its harmful effects on the lungs.
These potentially beneficial effects of transvascular diaphragm pacing are expected to result in faster patient recovery, a shorter stay in intensive care, improved health outcomes and lower hospitalization costs.
CEO of Lungpacer Medical Inc., is a medical device executive with 30 years of industry and public company experience and an inventor/developer of dozens of medical products including the Angio-Seal Vascular Closure Device. Doug was formerly COO and board member of Kensey Nash Corporation (acquired in 2012 by Royal DSM for $360M). He has authored over 175 patents and managed the commercialization of multiple first of their kind products in cardiology, orthopedics, and general surgery.
Karen Long, is Managing Director at KCK Group, a family office focused on high growth medical technologies. Karen has been at KCK since January 2018 when she first joined as Executive in Residence. Karen also serves as board member at several medtech and consumer health companies.
Prior to KCK, Karen was President & CEO of Nuelle, a women’s health company founded at ExploraMed medical device incubator. Nuelle was acquired in 2017 by Aytu Biosciences.
Karen has spent over 20 years in consumer diagnostics and medical devices. She has held a series of key operating roles in companies, ChemTrak, Inverness Medical and at LifeScan, a Johnson & Johnson company. After leaving LifeScan, Karen joined Acclarent as World Wide Vice President of Marketing and led Acclarent’s marketing efforts through rapid growth and ultimately through the acquisition by Johnson & Johnson. Acclarent was also an early spinout from the ExploraMed Incubator.
Joseph Kaufmann, is an Investment Manager at 4CGE LLC, a US based investment group. Joe also serves as the Chairman of the Board of privately held Essential Medical a startup medical device company specializing in large bore vascular closure products.
Former President and CEO of Kensey Nash Corporation (NASDAQ – KNSY) from 1995 to 2012 and CFO from 1989 to 1995. Kensey Nash was a leader in vascular closure, orthopedic/spine devices and resorbable biomaterial products. The company was sold to Royal DSM for $364 million in 2012.
Jose Calle Gordo, is a managing partner at Valiance, a venture growth investment firm in London, chairman at Highlife, a structural heart company, and board member at several med tech companies.
Before that, he served as CEO of Biosensors International, an interventional cardiology company. Previously he held several leadership roles at Abbott Vascular and Guidant in the fields of coronary intervention, structural heart, peripheral vascular and cardiac rhythm management, Jose started his career at Eli Lilly where he held a number of commercial roles with growing responsibility in the field of cardiac devices.
Josh Makower, is a General Partner on NEA’s healthcare team and has led the medtech/healthtech practice since 2015. Josh is also the Founder and Executive Chairman of ExploraMed, a medical device incubator that has created 11 companies over the past 25 years. Josh serves on the board of Setpoint Medical, Foundry Therapeutics 1, Lungpacer, DOTS Technologies, Eargo, Intact Vascular, Vesper, ExploraMed, Intrinsic Therapeutics, Moximed, Willow and Coravin. Josh holds over 300 patents and patent applications. He received an MBA from Columbia University, an MD from the NYU School of Medicine, a bachelor’s degree in Mechanical Engineering from MIT and is a Member of the College of Fellows of The American Institute for Medical and Biological Engineering and was awarded the Coulter Award for Healthcare Innovation by the Biomedical Engineering Society in 2018. He serves on the faculty of the Stanford University Medical School as an Adjunct Professor of Medicine and is Co-Founder of Stanford’s Biodesign Innovation Program (now called the Byers Center for Biodesign).
Robert (Bob) Donohue, is the CEO of WJFS, Inc., a private investment group based in West Chester, PA. Bob also sits on the board of two privately held companies Centinel Spine, AES Clean Technology as well as the nonprofit LOR Foundation.
Prior to WJFS, Bob held the position of CFO of Synthes, Inc. where he was responsible for the Company’s financial reporting, internal controls, M&A, and related issues. He also held the position of President, Synthes Canada, Ltd from 1997 until the sale of the company in mid – 2012. Bob remained with the company, to assist with integration, for 18 months after its sale to J&J in 2012 ($20 Billion). Bob started with Synthes in 1990 as Corporate Controller. Prior to joining the Synthes, he served in several financial positions, including corporate controller and plant controller with several major U.S. corporations.
Education: B.Sc. in Economics, West Chester University; MBA, Widener University. Certified Public Accountant (inactive).
Matt Gani, Vice President of Research, has over 25 years of experience leading medical product development projects involving electrical stimulation, pacemaker, and defibrillator devices. Matt previously served as the VP of Product Development for Northstar Neuroscience, a developer of cortical stimulation therapies, as the Senior Director for Biotronik, and as PM for Telectronics Pacing Systems, acquired by St. Jude Medical.
Viral Thakkar, Vice President of Operations, has more than 15 years of prior experience in managing and execution of all phases of Medical Device Design and Development from market definition through production and release. Viral has worked in medical device companies, internationally, in projects involving power-actuated surgical stapling devices, cardiovascular and peripheral stents, stent delivery systems, embolic protection devices, catheter based intra-vascular temperature management devices. Previously, Viral has served in leadership roles for ZOLL, Boston Scientific, Radiant Medical, SMTPL & Power Medical Interventions.
Rosemarie, CPA, MBA, Vice President of Finance, has twenty-five years of accounting and finance experience. Ms. Dhavale previously was the Vice President of Finance at Delta Dental of Minnesota and was Senior Director of Finance at Kensey Nash Corporation, a medical device company (acquired by Royal DSM). She has been actively involved in analyzing new technologies and businesses throughout her career and lead accounting and finance teams in FP&A, implementations of systems and strategic initiatives.
Judy Ways, PhD, Vice President of Regulatory Affairs, has over 25 years of regulatory experience across medical devices, biologics and drug products in the areas of neurology, psychiatry, immunology, gene therapy, and blood products. She has managed the regulatory activities for multiple medical devices in the US, Europe and other international markets and has a strong track record for worldwide approvals for first-in-kind devices. Judy has also built regulatory, compliance, and quality systems from the ground up for several start-up companies. She worked at and was on the founding team of medical device start-ups Neuronetics and Neuron Therapeutics. Earlier in her career, she worked at MedImmune, Aventis Behring (Centeon) and Glaxo. Judy obtained her PhD. in Immunology and Cancer Biology from Stanford University.
Greifswald University Hospital tests new method (Lungpacer® System) for weaning of respiratory patients Constanze Steinke Pressearbeit Universität Greifswald 07/10/2020 08:54 Department B for Internal Medicine of the University Medical Center Greifswald successfully used, within an international multi-center trial, a special diaphragmatic stimulation therapy to treat a COVID-19 patient as the first clinical site in Europe. “The first patient treated in this trial happened to be a woman who survived COVID-19 but was not able to be weaned from mechanical ventilation,” said Prof. Dr. Ralf Ewert, the head of the Pneumology, Infection Disease and Weaning Centre at the University Medical School of Greifswald. “With the new procedure, we were able to treat this patient, who is over 65 years old and has already spent 38 days on ventilator and enabled her return to independent breathing. In total we have now included four patients into the study and are pleased to contribute to this promising technology with our results,” says the Greifswald pneumologist and mechanical ventilation specialist. The Lungpacer® System by Lungpacer Medical Inc., a Canadian medical device company, is a novel technology that stimulates the phrenic nerves during mechanical ventilation and thus strengthens the weakened diaphragm muscle to assist in..
Greifswald University Hospital tests new method (Lungpacer® System) for weaning of respiratory patients
Constanze Steinke Pressearbeit Universität Greifswald
07/10/2020 08:54
Department B for Internal Medicine of the University Medical Center Greifswald successfully used, within an international multi-center trial, a special diaphragmatic stimulation therapy to treat a COVID-19 patient as the first clinical site in Europe.
“The first patient treated in this trial happened to be a woman who survived COVID-19 but was not able to be weaned from mechanical ventilation,” said Prof. Dr. Ralf Ewert, the head of the Pneumology, Infection Disease and Weaning Centre at the University Medical School of Greifswald. “With the new procedure, we were able to treat this patient, who is over 65 years old and has already spent 38 days on ventilator and enabled her return to independent breathing. In total we have now included four patients into the study and are pleased to contribute to this promising technology with our results,” says the Greifswald pneumologist and mechanical ventilation specialist.
The Lungpacer® System by Lungpacer Medical Inc., a Canadian medical device company, is a novel technology that stimulates the phrenic nerves during mechanical ventilation and thus strengthens the weakened diaphragm muscle to assist in weaning from the ventilator. The University Medicine Greifswald is the first hospital in Germany to participate in the so-called RESCUE-3 study, to provide safety and effectiveness data for the new procedure. In Germany, the system is currently only available as part of clinical studies.
Greifswald University Hospital tests new method (Lungpacer® System) for weaning of respiratory patients. Photo: Manuela Janke/UMG
Via Strengthening the Diaphragm Back to Life During the COVID 19 pandemic, there are more patients in hospitals requiring invasive mechanical ventilation over long periods of time. While mechanical ventilation is live-saving in the case of respiratory failure, it can also be harmful, especially if it is required over a longer period of time. Ventilators use positive pressure to push air into the lungs so that the main respiratory muscle, the diaphragm, is not used. The diaphragm is a plate consisting of muscles and tendons that separates the chest from the abdomen. As a result, mechanical ventilation and artificial immobilization of the patient quickly leads to loss of diaphragmatic strength. This is what doctors refer to as Ventilator-Induced Diaphragmatic Dysfunction.
The Lungpacer® System is designed to be easily integrated into the routine care of patients with invasive mechanical ventilation. The system uses the LIVE Catheter®, which is similar to central venous catheters used in most ventilated patients. The catheter can be used to inject fluids and medications and to stimulate the diaphragm and phrenic nerves to train the diaphragm muscle to assist in weaning. The Lungpacer® Control Unit is a mobile, portable unit used with the catheter and intermediate cable to provide temporary diaphragmatic neurostimulation.
Background RESCUE-3 Study The RESCUE-3 study, which started in 2019, is a randomized, controlled, open, multi-center adaptive clinical trial to investigate the safety and effectiveness of the Lungpacer® Diaphragm Pacing Therapy system for patients who have failed to wean from mechanical ventilation. Patients enrolled into the trial have failed two or more weaning attempts and stayed more than 96 hours (4 days) on mechanical ventilation. The study will enroll up to 376 subjects and will be conducted at up to 80 sites in the US, EU. Further information are available at http://www.lungpacer.com.
Universitätsmedizin Greifswald
Klinik und Poliklinik für Innere Medizin B
Direktor: Prof. Dr. med. Stephan Felix
Ferdinand-Sauerbruch-Straße, 17475 Greifswald
T +49 3834 86-80 500
E InnereB@med.uni-greifswald.de
Studienleiter: Prof. Dr. Ralf Ewert
E ewert@uni-greifswald.de
T +49 3834 86-80 595
Pressesprecher Christian Arns
T +49 3834 86-52 28
E christian.arns@med.uni-greifswald.de
http://www.medizin.uni-greifswald.de
http://www.facebook.com/UnimedizinGreifswald
Instagram/Twitter @UMGreifswald
Contact for scientific information: Studienleiter: Prof. Dr. Ralf Ewert
E ewert@uni-greifswald.de
T +49 3834 86-80 595
VANCOUVER, British Columbia, April 14, 2020 Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA letter, “patients at high risk of weaning failure include COVID-19 patients requiring ventilation and [other] patients being mechanically ventilated for other high-risk conditions including post-cardiac and post-thoracic surgical procedures and medical ICU patients requiring prolonged ventilation.” The approval states that “FDA has concluded that the Lungpacer DPTS may be effective at treating patients during COVID-19 by helping wean patients off ventilators in healthcare settings, thereby reducing their risks of prolonged mechanical ventilation and increasing the availability of ventilators during the COVID-19 pandemic.” Lungpacer CEO, Doug Evans, stated that “this amazing honor provides a unique opportunity to help improve outcomes for many patients affected by this global health crisis.”
VANCOUVER, British Columbia, April 14, 2020
Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA letter, “patients at high risk of weaning failure include COVID-19 patients requiring ventilation and [other] patients being mechanically ventilated for other high-risk conditions including post-cardiac and post-thoracic surgical procedures and medical ICU patients requiring prolonged ventilation.” The approval states that “FDA has concluded that the Lungpacer DPTS may be effective at treating patients during COVID-19 by helping wean patients off ventilators in healthcare settings, thereby reducing their risks of prolonged mechanical ventilation and increasing the availability of ventilators during the COVID-19 pandemic.” Lungpacer CEO, Doug Evans, stated that “this amazing honor provides a unique opportunity to help improve outcomes for many patients affected by this global health crisis.”
An average of 14,000 pulmonary, critical care and sleep medicine clinicians and researchers from around the world attend the ATS multidisciplinary conference each year. Unfortunately, due to the COVID-19 global crisis the 2020 meeting has been cancelled. However, Lungpacer Medical, Inc. is pleased to announce that four preclinical abstracts were accepted for poster presentation, and one for podium presentation, all of which will be published. Lungpacer Medical, Inc. also had two abstracts selected for poster presentation on early markers of prolonged MV and economic outcomes at US hospitals. The abstracts are: Increased Hippocampal Apoptotic Index After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. (selected for podium presentation) Temporary Transvenous Phrenic-Nerve-Stimulated Diaphragm Neurostimulation During Mechanical Ventilation Preserves Homogeneity in Non-Injured Lungs, Rohrs, E., et al. Increased Hippocampal Cytokine-Mediated Neuroinflammation After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. Negative Hippocampal Turnover Index After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. Increased Presence of Neural Pro-Inflammatory Cells in the Hippocampus After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. Economic Outcomes Among..
An average of 14,000 pulmonary, critical care and sleep medicine clinicians and researchers from around the world attend the ATS multidisciplinary conference each year. Unfortunately, due to the COVID-19 global crisis the 2020 meeting has been cancelled. However, Lungpacer Medical, Inc. is pleased to announce that four preclinical abstracts were accepted for poster presentation, and one for podium presentation, all of which will be published. Lungpacer Medical, Inc. also had two abstracts selected for poster presentation on early markers of prolonged MV and economic outcomes at US hospitals. The abstracts are:
The Society of Critical Care Medicine (SCCM) is the largest non-profit medical organization dedicated to promoting excellence and consistency in the practice of critical care. With members in more than 100 countries, SCCM is the only organization that represents all professional components of the critical care team. Lungpacer Medical is pleased to announce the presentation of preclinical work on respiratory function at SCCM 2020. Better PaO2/FiO2 with Electrophrenic Transvenous Neurostimulation vs. Mechanical Ventilation Alone, Rohrs, E., et al.
The Society of Critical Care Medicine (SCCM) is the largest non-profit medical organization dedicated to promoting excellence and consistency in the practice of critical care. With members in more than 100 countries, SCCM is the only organization that represents all professional components of the critical care team. Lungpacer Medical is pleased to announce the presentation of preclinical work on respiratory function at SCCM 2020.
The inaugural ERS Respiratory Failure and Mechanical Ventilation conference gathered more than 400 delegates from 60 countries, representing a diverse mix of world-leading respiratory scientists, clinicians and allied healthcare professionals. Delegates witnessed more than 40 scientific sessions and there were over 70 abstracts presented, featuring cutting-edge clinical and scientific presentations, including findings from Lungpacer’s preclinical work. Lungpacer Medical is pleased to announce the presentation of preclinical results related to the use of diaphragm stimulation and respiratory function. Temporary Transvenous Diaphragm Neurostimulation Distributes Tidal Volume in a More Physiological Pattern Versus Mechanical Ventilation Alone, E. Rohrs, et al.
The inaugural ERS Respiratory Failure and Mechanical Ventilation conference gathered more than 400 delegates from 60 countries, representing a diverse mix of world-leading respiratory scientists, clinicians and allied healthcare professionals. Delegates witnessed more than 40 scientific sessions and there were over 70 abstracts presented, featuring cutting-edge clinical and scientific presentations, including findings from Lungpacer’s preclinical work. Lungpacer Medical is pleased to announce the presentation of preclinical results related to the use of diaphragm stimulation and respiratory function.
VANCOUVER, British Columbia, January 2020 Lungpacer Medical, Inc., announced the completion of enrollment and follow up in its RESCUE 2 European CE Mark randomized clinical trial. This is a randomized study that enrolled a total of 110 subjects in France and Germany and evaluated the safety and effectiveness of the Lungpacer Therapy System in subjects who were expected to have ventilator-induced diaphragm dysfunction (VIDD) and be difficult to wean from mechanical ventilation. Results from the study are expected to be presented at a major conference at the end of 2020.
VANCOUVER, British Columbia, January 2020
Lungpacer Medical, Inc., announced the completion of enrollment and follow up in its RESCUE 2 European CE Mark randomized clinical trial. This is a randomized study that enrolled a total of 110 subjects in France and Germany and evaluated the safety and effectiveness of the Lungpacer Therapy System in subjects who were expected to have ventilator-induced diaphragm dysfunction (VIDD) and be difficult to wean from mechanical ventilation. Results from the study are expected to be presented at a major conference at the end of 2020.