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

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.

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

 

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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.

 

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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

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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.

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

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

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

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

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Lungpacer Medical Inc participating at Innovations in Neuromodulation

External Link: Neuromodulation Innovation – and Reimbursement, A Leadership Summit on the Development of Emerging Therapies

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Lungpacer named a “2015 Ready to Rocket Life Science Company”

Lungpacer named a “2015 Ready to Rocket Life Science Company”

Ready to Rocket is a unique business recognition list that profiles British Columbia technology companies with the greatest potential for revenue growth. Each year, based on analysis of trends that will drive growth in the information technology sector, Rocket Builders identifies the top private companies that are best positioned to capitalize on the trends for growth. This selection methodology has been an accurate predictor of growth and investment milestones.

Ready to Rocket is a unique business recognition list that profiles British Columbia technology companies with the greatest potential for revenue growth. Each year, based on analysis of trends that will drive growth in the information technology sector, Rocket Builders identifies the top private companies that are best positioned to capitalize on the trends for growth. This selection methodology has been an accurate predictor of growth and investment milestones.

“Ready to Rocket” companies, on average, have exceeded a 50% annual growth revenue growth rate and have significantly increased their employee headcount each year.

“Ready to Rocket” companies are more likely to raise investment capital and each year many of the profiled “Ready to Rocket” companies are acquired.

Since 2003, 15 companies that have been featured on our recognition lists were acquired in the year they were featured on the list.

“Ready to Rocket” is a trademark of Rocket Builders, a respected management consulting firm servicing the technology industry.

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Lungpacer expands into new location

SFU spinout Lungpacer Medical Inc. welcomed nearly 100 guests on Dec. 11 to its new 6,500-sq.-ft. Burnaby premises, which are 3 1/2 times larger than the SFU Neurokinesiology Laboratory location where the company originated.

Since its establishment in 2009, Lungpacer has grown from seven engineers and six students to 25 employees—including 11 SFU grads and interns—led by an impressive international management team. Along the way, the company has garnered seven industry awards, eight government grants and several key patents.

“This new location is exactly what we need to take the company to the next level,” says company founder Andy Hoffer. The SFU biomedical physiology and kinesiology professor is a world-leading expert on implantable neural interfaces and the inventor of Lungpacer’s transvascular nerve-stimulation electrode.

Lungpacer electrodes will be intravenously placed in patients on mechanical ventilators to rhythmically activate their diaphragms and prevent muscle-disuse atrophy. Diaphragm pacing is expected to result in faster patient recovery, shorter stays in intensive care, lower hospitalization costs and greater patient access to scarce mechanical ventilators during flu outbreaks. It should also reduce the secondary infections and irreversible lung damage commonly related to ventilator use.

Currently, more than 30 per cent of patients cannot wean from the ventilator and die in hospital, which is what happened to Hoffer’s mother following weeks on a ventilator in his native Uruguay, inspiring him to create the Lungpacer.

The company has completed a key series pre-clinical studies demonstrating the safety and efficacy of its therapeutic medical device and is getting ready to carry out pilot human clinical trials in 2016.

“We are building a vital collaboration with Fraser Health and particularly Dr. Steve Reynolds, program medical director and regional department head of critical care at Fraser Health,  who along with his respiratory technologists from Royal Columbian Hospital did an extraordinary job with our pre-clinical studies,” says Hoffer. Reynolds will also be in charge of the pilot human clinical trials, which will lead to multi-centre pivotal trials.

The new Lungpacer facility features:

  • A quality-control lab and controlled inventory storage facility.
  • A clean room, which is a highly specialized controlled environment where engineers and technicians will fabricate the catheters to be used during clinical trials.
  • A catheter R&D lab where scientists and engineers will test the performance of devices.
  • A temperature- and humidity-controlled environmental chamber for accelerated aging studies.
  • A negative-pressure decontamination room with HEPA filtration system for testing potentially bio-hazardous catheter samples removed after patient use.
  • An electrical lab with electro-static dissipative flooring for building and testing circuit boards.
  • Administrative offices and meeting rooms.
  • A warehouse and a basic machine shop.

External Link: Read more on SFU Research News

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CIHR Proof-of-Principle Grant for First-in-Human Trials at Royal Columbian Hospital

CIHR GrantDr. Steve Reynolds, head of Critical Care and infectious diseases specialist at Royal Columbian Hospital, and Dr. Andy Hoffer, founder of Lungpacer Medical Inc., are collaborating to improve how intensive care units provide respiratory support for their sickest patients.

A $160,000 proof-of-principle Phase I grant from the Canadian Institutes for Health Research (CIHR) will fund their trial of a transvenous diaphragm pacing system (DPS).

The device, developed at SFU, is designed to protect the diaphragm muscle from rapid atrophy, or wasting, in mechanically ventilated, critically ill patients. The goal is to make respiratory support safer and more effective than existing respiratory therapies.

The Lungpacer DPS technology consists of a minimally invasive, temporary intravenous catheter that electrically activates the diaphragm to keep it strong while a patient remains on the mechanical ventilator.

Currently 30 per cent of ICU patients fail to wean from the ventilator and are at high risk of acquiring ventilator-induced lung injury, pneumonia and infections.

Hoffer says the Lungpacer approach aims to significantly improve patient-care outcomes and dramatically reduce health care costs by improving the patient’s chance of re-establishing diaphragm strength for a faster return to unassisted breathing.
Phase I clinical trials are the first in-human trials and will be monitored by the institutional research ethics boards and Health Canada.

“This work has a very real possibility of changing the way we conceptualize mechanical ventilation, the cornerstone of the modern critical care unit,” says Reynolds.

“We value the opportunity to work together. Andy has extensive knowledge in biomedical physiology, running a lab and developing medical devices. My work as a clinician keeps me grounded in the day-to-day running of a critical care unit, and helps to ensure that the development of the device and the research in general has a real world capability.”

The ongoing collaboration between Reynolds and Hoffer is strengthening the developing research community involving investigators from both Fraser Health and SFU, and is a potential model for future partnerships.

External Link: CIHR funds Lungpacer collaboration

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