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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.

Lungpacer Diaphragm Pacing Therapy™

In an effort to support, maintain, and strengthen the diaphragm in patients who have failed to wean from Mechanical Ventilator (MV), Lungpacer has developed a temporary, minimally invasive, percutaneously-placed, transvenous phrenic nerve-pacing system intended for use in conjunction with MV. The Lungpacer DPT System™ is designed to operate in conjunction with MV to transvenously stimulate the left and right phrenic nerves and cause unilateral or bilateral diaphragmatic contraction to limit, prevent or reverse the diaphragmatic atrophy and loss of function known as VIDD (ventilator induced diaphragm dysfunction). Lungpacer anticipates that exercising the diaphragm in this manner in patients who have been on MV for several days or weeks, have presumed VIDD, will help rebuild the diaphragm muscle-mass, strength and endurance and will thus improve the ability
to successfully wean patients from MV.

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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Mike Favet
Board Member

Mike Favet, joined KCK as a Managing Director, Medical Technologies in 2016. Prior to joining KCK, he served in senior management positions for a variety of medical technology companies including Advanced Cardiac Therapeutics, Sonitus Medical, Ventus Medical, Boston Scientific and Guidant. KCK Group is a large, single family, evergreen fund that invests in multiple sectors including through a team focused on medical technology.

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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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Guillaume Darnand
Board Member

Guillaume Darnand, is Investment Manager at Valiance, a London based investment firm. Guillaume is responsible for its portfolio of Life Sciences companies, investing growth capital into innovative medical technologies in Europe and in the US. Prior to that, Guillaume had a career in Investment Banking, advising large capitalization corporates on Mergers and Acquisitions and other corporate finance decisions including Capital Markets financing. Guillaume has experience in various sectors including Healthcare but also Consumer, Retail, Telecoms, e-Commerce, Oil & Gas. He graduated from ESSEC Business School in Paris.

Management

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Linda Clark
Global Director of Clinical Affairs
Linda Clark

Linda Clark, Global Director 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
Sr. Director of Research
Matt Gani

Matt Gani, Sr. Director of R&D, 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
Sr. Director of Operations
Viral Thakkar

Viral Thakkar, Sr. Director of Operations, has more than 14 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

  • August 17, 2016
    ATSJournals Publication – Mitigation of Ventilator-Induced Diaphragm Atrophy by Transvenous Phrenic Nerve

    The top-ranked American Journal of Respiratory and Critical Care Medicine has published on-line a pre-clinical research study demonstrating  that the Lungpacer therapy mitigated ventilator-induced diaphragm atrophy in pigs that were sedated and ventilated in ICU-like conditions for 60 hours.

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    ATSJournals Publication – Mitigation of Ventilator-Induced Diaphragm Atrophy by Transvenous Phrenic Nerve

    Mitigation of Ventilator-Induced Diaphragm Atrophy by Transvenous Phrenic Nerve Stimulation
    Steven C Reynolds, Ramasamy Meyyappan, Viral Thakkar, Bao D Tran, Marc-André Nolette, Gautam Sadarangani, Rodrigo A Sandoval, Laura Bruulsema, Brett Hannigan, Jason W Li, Elizabeth Rohrs, Jason Zurba, and Joaquín Andrés Hoffer

    Am J Respir Crit Care Med. First published online August 08, 2016 as doi:10.1164/rccm.201502-0363OC

    Abstract

    Rationale: Ventilator-induced Diaphragm Dysfunction is a significant contributor to weaning difficulty in ventilated critically ill patients. It has been hypothesized that electrically pacing the diaphragm during mechanical ventilation could reduce diaphragm dysfunction.

    Objectives: We tested a novel, central line catheter-based, transvenous phrenic nerve pacing therapy for protecting the diaphragm in sedated and ventilated pigs.

    Methods: Eighteen Yorkshire pigs were studied. Six pigs were sedated and mechanically ventilated for 2.5 days with pacing on alternate breaths at intensities that reduced the ventilator pressure-time-product by 20%-30%. Six matched subjects were similarly sedated and ventilated, but were not paced. Six pigs served as never-ventilated, never-paced controls.

    Measurements and Main Results: Cumulative duration of pacing therapy ranged from 19.7 to 35.7 hours. Diaphragm thickness assessed by ultrasound and normalized to initial value showed a significant decline in ventilated-not paced but not in ventilated-paced subjects (0.84, IQR=0.78-0.89 vs. 1.10, IQR=1.02-1.24; P=0.001). Compared to Controls (24.6 µm2/kg, IQR=21.6-26.1), median myofiber cross-sectional areas normalized to weight and sarcomere length were significantly smaller in ventilated-not paced (17.8 µm2/kg, Interquartile Range=15.3-23.7; P=0.001) but not in the ventilated-paced group (24.9 µm2/kg, Interquartile Range =16.6-27.3; P=0.189). After 60 hours of mechanical ventilation all 6 ventilated-paced subjects tolerated 8 minutes of intense phrenic stimulation whereas 3 of 6 ventilated-not paced subjects did not (P=0.055). There was a non-significant decrease in diaphragm tetanic force production over the course of the experiment in the ventilated-paced and ventilated-not paced groups.

    Conclusions: These results suggest that early transvenous phrenic nerve pacing may mitigate Ventilator-induced Diaphragm Dysfunction.

    http://www.atsjournals.org/doi/pdf/10.1164/rccm.201502-0363OC

  • May 18, 2016
    Steven Reynolds, MD to Present Data on the PACER Trial for Lungpacer Medical’s Diaphragm Pacing Catheter in Mechanically Ventilated Patients

    BURNABY, British Columbia, May 18, 2016 /PRNewswire/ — Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that Steven Reynolds, MD will be presenting data related to the recently completed Phrenic Activation for Enhanced Respiration (PACER) feasibility trial at the American Thoracic Society Meeting in San Francisco, California on Wednesday, May 18, 2016. 

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    Steven Reynolds, MD to Present Data on the PACER Trial for Lungpacer Medical’s Diaphragm Pacing Catheter in Mechanically Ventilated Patients

    BURNABY, British Columbia, May 18, 2016 /PRNewswire/ — Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that Steven Reynolds, MD will be presenting data related to the recently completed Phrenic Activation for Enhanced Respiration (PACER) feasibility trial at the American Thoracic Society Meeting in San Francisco, California on Wednesday, May 18, 2016.  The company enrolled 24 mechanically ventilated patients.

    The PACER feasibility study was designed to determine initial safety, early feasibility, and functionality of Lungpacer’s IntraVenous Electrode (LIVE) Catheter and prototype stimulation system. The results are encouraging as the clinical trial demonstrated the ease and safety of LIVE Catheter insertion and removal, and success at pacing the target phrenic nerves. The study also confirmed the ability to reduce the harmful positive pressure produced by a mechanical ventilator to deliver breaths to the patients, consistent with the company’s preclinical data.

    “The Lungpacer LIVE Catheter was easily placed and shown to be effective at stimulating the diaphragm muscle in synchrony with the mechanical ventilator. No adverse events were observed. We look forward to measuring the therapeutic benefits of the Lungpacer technology in the next phase of clinical studies,” commented Steven Reynolds, MD.

    “We are excited to present data from the PACER feasibility study, which indicates the potential for our novel therapy to help critically ill patients that are susceptible to ventilator-induced diaphragm dysfunction and ventilator induced lung injury,” saidDoug Evans, Lungpacer’s President and CEO.

    About Ventilator-induced Diaphragm Atrophy and Lung Injury

    Mechanical ventilation (MV) can be life-saving for many critically ill patients. However, MV can also be harmful to the patient as continued MV and sedation interrupt the normal activation of the diaphragm muscle, which then atrophies rapidly and profoundly (known as Ventilator-induced Diaphragm Dysfunction (VIDD)). In addition, positive-pressure invasive ventilation can damage the lungs (Ventilator-Induced Lung Injury, (VILI)) and is associated with Ventilator-Associated Pneumonia (VAP).

    VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator. About 31% of patients on MV are categorized as ‘difficult to wean’ and approximately 10% require prolonged weaning periods greater than seven days. These patients alone account for 40% of total ICU patient-days and become the most expensive in-patients in North American hospitals. When a critically ill patient becomes ventilator-dependent, the risk of dying in the ICU increases seven-fold.

    About Lungpacer Medical, Inc.

    Lungpacer Medical is a clinical stage medical device company pioneering the development of neurostimulation systems designed to exercise and strengthen the diaphragm muscle and reduce complications in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system is designed to activate the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation approach that is expected to restore diaphragm strength and endurance in patients who have failed to wean from MV after their diaphragm muscle atrophied as a consequence of VIDD, thus saving many lives, improving patient outcomes, and greatly reducing hospital care costs. The Lungpacer Diaphragm Pacing System is at this time an investigational device only and is not for sale in any country.

    This press release contains “forward-looking statements” concerning the development of Lungpacer’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Lungpacer undertakes no obligation to update any forward-looking statements for any reason.

  • May 11, 2016
    Lungpacer Medical, Inc. Receives Expedited Access Pathway Designation from FDA for the Lungpacer Diaphragm Pacing System

    Burnaby, British Columbia, Canada – May 11, 2016 – Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that it has received Expedited Access Pathway (EAP) designation from the U.S. Food and Drug Administration (FDA).

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    Lungpacer Medical, Inc. Receives Expedited Access Pathway Designation from FDA for the Lungpacer Diaphragm Pacing System

    Burnaby, British Columbia, Canada – May 11, 2016 – Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that it has received Expedited Access Pathway (EAP) designation from the U.S. Food and Drug Administration (FDA). The EAP was granted for the Lungpacer Diaphragm Pacing System (DPS) for treating patients who have been unable to wean from mechanical ventilation.

    The EAP is a new FDA program aimed to facilitate more rapid patient access to breakthrough technologies. The EAP status was granted for the Lungpacer DPS because the FDA agrees that it is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition; that it may represent a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology; and that the availability of the device may be in the best interest of patients because it addresses an unmet medical need.

    “Our team is thrilled that the Lungpacer DPS was granted EAP status. This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most rapid path to commercialization in order to help our patients. Mechanically ventilated patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to helping these individuals regain the ability to breathe independently faster,” commented Doug Evans, President and CEO.

    With EAP designation, the FDA works with device manufacturers to try to reduce the time and cost from the start of product development to marketing approval, without changing the FDA’s approval standards. Components of the program, on the part of the FDA, include priority review, more interactive review, senior management involvement, and assignment of a case manager. Additionally, the program facilitates development of a potentially less burdensome premarket clinical trial, shifting a portion of data collection to the post-market phase, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.

    About Ventilator-induced Diaphragm Atrophy and Lung Injury

    Mechanical ventilation (MV) can be life-saving for many critically ill patients. However, MV can also be harmful to the patient as continued MV and sedation interrupt the normal activation of the diaphragm muscle, which then atrophies rapidly and profoundly (known as Ventilator Induced Diaphragm Dysfunction (VIDD)). In addition, positive-pressure invasive ventilation can damage the lungs (Ventilator Induced Lung Injury, (VILI)) and is associated with Ventilator-Associated Pneumonia (VAP).

    VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator. About 31% of patients on MV are categorized as ‘difficult to wean’ and approximately 10% require prolonged weaning periods greater than seven days. These patients alone account for 40% of total ICU patient-days and become the most expensive in-patients in North American hospitals. When a critically ill patient becomes ventilator-dependent, the risk of dying in the ICU increases seven-fold.

    About Lungpacer Medical, Inc.

    Lungpacer Medical is a clinical stage medical device company pioneering the development of neurostimulation systems designed to exercise and strengthen the diaphragm muscle and reduce complications in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system is designed to activate the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation approach that is expected to restore diaphragm strength and endurance in patients who have failed to wean from MV after their diaphragm muscle atrophied as a consequence of VIDD thus saving many lives, improving patient outcomes, and greatly reducing hospital care costs. The Lungpacer

    Diaphragm Pacing System is at this time an investigational device only and is not for sale in any country.

    This press release contains “forward-looking statements” concerning the development of Lungpacer’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Lungpacer undertakes no obligation to update any forward-looking statements for any reason.

    For additional information about Lungpacer, please visit www. Lungpacer.com.

    Media Contact:
    Doug Evans, PE
    Lungpacer Medical
    778-655-2106
    Doug@Lungpacer.com

  • October 21, 2015
    Lungpacer Medical, Inc. Announces Start of First-in-Human Early Feasibility Trial

    BURNABY, British Columbia, Oct. 21, 2015 /PRNewswire/ — Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today the enrollment of the first patients in the Phrenic ACtivation for Enhanced Respiration (PACER) early feasibility trial.

    close modal

    Lungpacer Medical, Inc. Announces Start of First-in-Human Early Feasibility Trial

    BURNABY, British Columbia, Oct. 21, 2015 /PRNewswire/ — Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today the enrollment of the first patients in the Phrenic ACtivation for Enhanced Respiration (PACER) early feasibility trial. To date, five patients have been successfully tested in the company’s First in Human (FiH) feasibility trial.

    The PACER feasibility study was designed to determine initial safety and early feasibility of the Lungpacer IntraVenous Electrode (LIVE) Catheter and the diaphragm pacing method. Initial results are encouraging as the Lungpacer system demonstrated good functionality including the ability to reduce the mechanical ventilator pressure required to deliver breaths to the patients, consistent with the company’s pre-clinical data.

    “We are excited about the initial results from the PACER early feasibility study, which supports the potential for Lungpacer’s novel therapy to help critically ill patients that are susceptible to ventilator induced diaphragm dysfunction and ventilator induced lung injury,” said Dr. Steven Reynolds, MD, Regional Medical Director of Critical Care – Fraser Health Authority.

    “Our team is thrilled with the initial outcomes from our FiH trial. Mechanical ventilator patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to exploring the potential for the LIVE Catheter to help these individuals regain the ability to breathe independently faster,” commented Doug Evans, President and CEO.

    About Ventilator-induced Diaphragm Atrophy and Lung Injury

    Mechanical ventilation (MV) can be life-saving for many critically ill patients. However, MV can also be harmful to the patient as continued MV and sedation interrupt the normal activation of the diaphragm muscle, which then atrophies rapidly and profoundly (known as Ventilator Induced Diaphragm Dysfunction; VIDD). In addition, positive-pressure invasive ventilation can damage the lungs (Ventilator Induced Lung Injury; VILI) and is associated with Ventilator-Associated Pneumonia (VAP).

    VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator. About 31% of patients on MV are categorized as ‘difficult to wean’ and approximately 10% require prolonged weaning periods greater than seven days. These patients alone account for 40% of total ICU patient-days and become the most expensive in-patients in North American hospitals. When a critically ill patient becomes ventilator-dependent, the risk of dying in the ICU increases seven-fold.

    About Lungpacer Medical, Inc.

    Lungpacer Medical is a clinical stage medical device company pioneering the development of neurostimulation systems designed to preserve the integrity and strength of the diaphragm muscle and reduce complications in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system is designed to activate the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation approach that is expected to save many lives, improve patient outcomes and greatly reduce hospital care costs. The Lungpacer Diaphragm Pacing System is at this time an investigational device only and is not for sale in any country.

    This press release contains “forward-looking statements” concerning the development of Lungpacer’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Lungpacer undertakes no obligation to update any forward-looking statements for any reason.

  • May 28, 2015
    Lungpacer Medical, Inc. to Present at Jefferies 2015 Global Healthcare Conference

    Lungpacer Medical, Inc. to Present at Jefferies 2015 Global Healthcare Conference

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    Lungpacer Medical, Inc. to Present at Jefferies 2015 Global Healthcare Conference

  • May 18, 2015
    Steve Reynolds, MD, to Present Encouraging Preclinical Results with Lungpacer Medical’s Catheter-based Diaphragm Pacing System

    Steve Reynolds, MD, to Present Encouraging Preclinical Results with Lungpacer Medical’s Catheter-based Diaphragm Pacing System

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    Steve Reynolds, MD, to Present Encouraging Preclinical Results with Lungpacer Medical’s Catheter-based Diaphragm Pacing System

Get in touch

Corporate Headquarters

Lungpacer Medical Inc.
8602 Commerce Court
Burnaby, B.C. V5A 4N6
Canada

USA

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

Caution: Investigational Device
The Lungpacer Diaphragm Pacing Therapy System is limited by Federal (United States) law to investigational use.The device is not approved for sale in the United States or Europe.Lungpacer®, Weaning Solution®, Lungpacer DPT System™, Lungpacer DPT™, LIVE Catheter® are registered trademarks of Lungpacer Medical.