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Overview

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

 

“expected to save many lives, improve surviving patient outcomes and greatly reduce hospital care costs.”

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.

Board of Directors

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Doug Evans
CEO & Board Member.

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.

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Karen Long
Board Member

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.

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Joseph Kaufmann
Board Member
Joseph Kaufmann

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.

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Jose Calle Gordo
Board Member

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.

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Josh Makower, MD
Board Member

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).

Management

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Linda Clark
VP of Clinical Affairs
Linda Clark

Linda Clark, Vice President of Clinical Affairs, has more than 25 years of experience in critical care nursing and early stage start-up companies. She has managed and executed numerous clinical trials for novel devices from FIH to FDA completion and for CE mark approval. Her background includes trials in cardiology, cardiac surgery, neurosurgery and sleep apnea. Linda has held senior management positions for Abiomed Cardiovascular, Cardeon, Innercool, Paracor Medical, Respicardia and most recently LoneStar Heart.

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Matt Gani
VP of Research
Matt Gani

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.

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Viral Thakkar
Vice President of Operations
Viral Thakkar

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.

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Rosemarie Dhavale
VP of Finance
Rosemarie Dhavale

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.

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Judy Ways
VP of Regulatory Affairs
Judy Ways

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.

News

  • April 14, 2020
    Lungpacer Medical, Inc. Announces FDA Approval of Emergency Use Authorization of the Lungpacer Diaphragm Pacing Therapy System to Help Address COVID-19 Pandemic

    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.”

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    Lungpacer Medical, Inc. Announces FDA Approval of Emergency Use Authorization of the Lungpacer Diaphragm Pacing Therapy System to Help Address COVID-19 Pandemic

    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.”

  • March 1, 2020
    Lungpacer Medical, Inc. Presentations at American Thoracic Society Conference, Scheduled for May 2020, Philadelphia, Pennsylvania

    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..

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    Lungpacer Medical, Inc. Presentations at American Thoracic Society Conference, Scheduled for May 2020, Philadelphia, Pennsylvania

    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 Patients Requiring Prolonged Acute Vs. Short-Term Mechanical Ventilation in the US, 2014-2018: Results from a Multicenter Cohort Study, Zilberberg, et al.
    • Early Markers of the Need for Prolonged Acute Vs. Short-Term Mechanical Ventilation in the US, 2014-2018: Results from a Multicenter Cohort Study, Zilberberg, et al.
  • February 2, 2020
    Lungpacer Medical, Inc. Presents Preclinical Results at Society of Critical Care Medicine, February 2020, Orlando, Florida

    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.

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    Lungpacer Medical, Inc. Presents Preclinical Results at Society of Critical Care Medicine, February 2020, Orlando, Florida

    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.
  • February 1, 2020
    Lungpacer Medical, Inc. Presents Preclinical Results at the European Respiratory Society’s Respiratory Failure & Mechanical Ventilation Conference, February 2020, Berlin, Germany

    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.

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    Lungpacer Medical, Inc. Presents Preclinical Results at the European Respiratory Society’s Respiratory Failure & Mechanical Ventilation Conference, February 2020, Berlin, Germany

    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.
  • January 1, 2020
    Lungpacer Medical, Inc. Announces Completion of RESCUE 2 European Clinical Study

    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.

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    Lungpacer Medical, Inc. Announces Completion of RESCUE 2 European Clinical Study

    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.

  • December 1, 2019
    Lungpacer Medical, Inc. Announces Publication of RESCUE 2 Study Design Manuscript

    VANCOUVER, British Columbia, December 2019 Lungpacer Medical, Inc. announced the publication of the RESCUE 2 Study Design Manuscript in the journal Trials. The RESCUE 2 study is a multicenter randomized clinical trial being conducted in France and Germany evaluating the use of the LIVE Catheter and Lungpacer therapy to treat subjects who are difficult to wean from mechanical ventilation.  The study will randomize 110 subjects and the results of the study will be published after study completion. Additional information can be found at Trials 2019; 20(1):60. doi: 10.1186/s13063-018-3171-9 or ClinicalTrials.gov, NCT03096639. Temporary Transvenous Diaphragm Pacing vs. Standard of Care for Weaning from Mechanical Ventilation: Study Protocol for a Randomized Trial: Evans, D., Similowski, T. et al.

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    Lungpacer Medical, Inc. Announces Publication of RESCUE 2 Study Design Manuscript

    VANCOUVER, British Columbia, December 2019

    Lungpacer Medical, Inc. announced the publication of the RESCUE 2 Study Design Manuscript in the journal Trials. The RESCUE 2 study is a multicenter randomized clinical trial being conducted in France and Germany evaluating the use of the LIVE Catheter and Lungpacer therapy to treat subjects who are difficult to wean from mechanical ventilation.  The study will randomize 110 subjects and the results of the study will be published after study completion. Additional information can be found at Trials 2019; 20(1):60. doi: 10.1186/s13063-018-3171-9 or ClinicalTrials.gov, NCT03096639.

    • Temporary Transvenous Diaphragm Pacing vs. Standard of Care for Weaning from Mechanical Ventilation: Study Protocol for a Randomized Trial: Evans, D., Similowski, T. et al.

Get in touch

Corporate Headquarters

Lungpacer Medical Inc.
Suite 130, 601 W Cordova Street
Vancouver, B.C. V6B 1G1
Canada

USA

Lungpacer Medical USA Inc.
260 Sierra Drive, #116
Exton, PA 19341
USA


Emergency Use Indication:

The Lungpacer DPTS has been authorized for emergency use in healthcare settings for treatment of patients on invasive mechanical ventilation who are at high risk of weaning failure, including COVID-19 patients, during the COVID-19 pandemic.


Important Safety and Effectiveness Information:

There are no FDA approved, licensed, or cleared device treatments to assist in weaning patients off of ventilators. Based on bench testing and reported clinical experience, 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 DPTS treatment is for a maximum of 30 days. Device-related serious adverse events reported in clinical trials were single events of pneumothorax and mucus plug liberation.

The LIVE Catheter component of the Lungpacer system has not been evaluated for safety when used with cardiac pacemakers or defibrillators and should be removed prior to Magnetic Resonance (MR) imaging. Duration: The Lungpacer DPTS is available under an Emergency Use Authorization for the duration of the COVID-19 pandemic.

Emergency Use Instructions for Use, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients are available at: http://lungpacer.com/emergency-use-authorization.

For more information visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.



Emergency Use Authorization Information:

This Diaphragmatic Pacing Stimulator has not been FDA cleared or approved.

This Diaphragmatic Pacing Stimulator has been authorized by FDA under an Emergency Use Authorization (EUA).

This Diaphragmatic Pacing Stimulator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Diaphragmatic Pacing Stimulator Systems under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.