Study Finds MediPines’ Breakthrough Non-invasive Gas Exchange Method Highly Precise: Ideal for Covid Response

1 Feb 2021 Medical

MediPines AGM100®’s detection of pulmonary gas exchange impairment is comparable with traditional blood gas method (A-a gradient)

ORANGE COUNTY, Calif., February 1, 2020 – A recent clinical study published by medical researchers from UC San Diego School of Medicine has established that an expired breath sampling method is comparable to the long-established blood-based method (ABG) of measuring pulmonary gas exchange efficiency.

Published in the American Journal of Physiology Lung Cellular and Molecular Physiology, the study, entitled “Measuring the Efficiency of Pulmonary Gas Exchange Using Expired Gas Instead of Arterial Blood: Comparing the “Ideal” PO2 of Riley with End-Tidal PO2,” demonstrates the reliability and validity of a non-invasive breath-based method of determining A-a gradient (Oxygen Deficit), a standard in respiratory medicine to determine gas exchange efficiency, and previously only available through an invasive arterial blood sampling method.

Using the MediPines AGM100®, a respiratory medical device,researchers were able to demonstrate that the new breath-based measurement of gas exchange efficiency has very low variability and is highly correlated with established blood-sampling methods.

In the new non-invasive method of measuring gas exchange efficiency, concerns of variability in expired breath samples have been addressed. The variability of gas concentrations throughout the respiratory cycle can range dramatically; however, when steady state end-tidal gas samples are used, gas concentration is remarkably constant. The current study found the very low variability of end tidal gas measurements within subjects of 1.3% or 1.4 mmHg for oxygen and 1.8% or 0.7 mmHg for carbon dioxide. The traditional method (Riley Method) does not directly measure the lung alveolar gas level but estimates the alveolar level from a calculation that uses arterial blood gas values and a number of assumptions. 

In the age of respiratory diseases like Covid-19, where stability and repeatability of patient measurements matter, this study’s conclusion is a breakthrough finding for quicker, non-invasive methods that are ideally suited for the hospital. A breath-based gas exchange analysis using the AGM100® is easy to obtain for both practitioner and patient. The gas exchange analysis provided by the AGM100® requires the patient to simply breath into a mouthpiece and can be completed within two minutes.

“This study demonstrates the merits of a breath-sampling based approach, given the low variability, which allows for high reproducibility and reliability in clinical practice. This is consistent with our previous study that demonstrated a very high correlation and low measurement bias of directly measured arterial PO2, with that estimated non-invasively from the AGM100 in a range of different physiological states,” said Dr. Phil Ainslie, Canada Research Chair and Co-Director of the Centre for Heart lung and Vascular Health, School of Health and Exercise Sciences at the University of British Columbia.

This finding further supports a clinical validation study published in 2020 by researchers from the University of British Columbia and Duke University Medical Center, demonstrating the high precision of the new expired breath sampling method.

MediPines AGM100®

MediPines AGM100® is the world’s first non-invasive gas exchange analyzer. This advanced respiratory monitoring system was designed to rapidly detect respiratory impairment caused by conditions such as COVID-19, chronic obstructive pulmonary disease (COPD), pneumonia, ARDS, pulmonary edema, and pulmonary embolism. The device is FDA cleared and approved for Health Canada COVID-19 Emergency Use. It provides a comprehensive panel of respiratory measurements including blood oxygen levels, Oxygen Deficit (A-a gradient), P/F ratio, and alveolar oxygen and carbon dioxide levels.

About MediPines

MediPines Corporation, based in California, is a market leader in respiratory assessment and monitoring of pulmonary gas exchange. The company mission is to advance respiratory medicine by providing physiology-based respiratory devices that enhance clinical effectiveness and achieve better patient outcomes.

MediPines.com

MediPines Recognized as a Top 10 Patient Monitoring Solution Provider in 2020

29 Dec 2020 Medical

Covid-19 respiratory monitoring with MediPines AGM100®

ORANGE COUNTY, Calif., Dec. 29, 2020 /PRNewswire/ — MD Tech Review, a premier medical innovation magazine, has voted MediPines as a 2020 Top Ten Patient Monitoring Solution Provider.

MediPines’ innovative respiratory technology, AGM100®, is making a positive impact in hospitals battling Covid-19. This industry recognition came about as MediPines introduced the AGM100®, an advanced respiratory monitoring system, commercially in the US and Canada earlier this year.  

According to Dr. Ramirez, an emergency physician in Toronto, “By using the device (AGM100), we are sending fewer patients to the Intensive Care Unit, and we have higher confidence that those sent to the ICU really need to be there. Far more patients can be evaluated and treated at much less cost and time.” He is not alone. With ICUs at maximum capacity due to the pandemic, hospitals using the AGM100 have reported a dramatic improvement in triaging patients and efficient allocation of limited ICU resources.

Now, with a push of a button, medical providers know precisely what is happening with oxygen levels in the lungs and the blood with a simple breath test. It allows for medical professionals to rapidly assess the respiratory status of a patient, titrate interventions, and determine response to therapy. Providers do not have to introduce their patients to painful and invasive blood draws or radiation exposure.

This is a momentous development in patient monitoring, as frontline healthcare workers are voicing the need for a more advanced respiratory monitoring solution. The medical community is burdened with  complicated respiratory issues, such as COVID-19, pneumonia, and influenza. These respiratory diseases require a precise determination of gas exchange to detect and treat these illnesses.

“Patient lives are being improved and saved because medical professionals are providing quick personalized care based on the information provided by the AGM100. We are proud to be a part of the needed solution in the management of COVID-19,” stated Steve Lee, MediPines’ CEO and co-inventor of the AGM100 along with Dr. John B. West.

To read the full article visit: https://www.mdtechreview.com/vendor/medipines-advancing-noninvasive-assessment-and-treatment-in-respiratory-care-cid-260-mid-23.html

About MediPines

MediPines Corporation, based in California, is a market leader in respiratory assessment and monitoring of pulmonary gas exchange. The company mission is to advance respiratory medicine by providing physiology-based respiratory devices that enhance clinical effectiveness and achieve better patient outcomes.

MediPines AGM100®

MediPines AGM100® is the world’s first non-invasive gas exchange analyzer. This advanced respiratory monitoring system was designed to rapidly detect respiratory impairment caused by conditions such as COVID-19, chronic obstructive pulmonary disease (COPD), pneumonia, ARDS, pulmonary edema, and pulmonary embolism. The device is FDA cleared and approved for Health Canada COVID-19 Emergency Use. It provides a comprehensive panel of respiratory measurements including blood oxygen levels, Oxygen Deficit (A-a gradient), P/F ratio, and alveolar oxygen and carbon dioxide levels.

Media contact:
Carissa Drews
949-398-4670
info@medipines.com

https://www.prnewswire.com/news-releases/medipines-recognized-as-a-top-10-patient-monitoring-solution-provider-in-2020-301198875.html

Ground-breaking New Medical Device Saving Lives and Resources During Pandemic

8 Dec 2020 Medical

COVID-19 emergency use authorized by Health Canada

https://www.newswire.ca/news-releases/ground-breaking-new-medical-device-saving-lives-and-resources-during-pandemic-895185642.html

TORONTO, Dec. 7, 2020 /CNW/ — A ground-breaking development in the detection of reduced lung function, as seen in COVID-19 patients, is saving lives, time, and resources. It’s thanks to the world’s first non-invasive lung function monitor, the MediPines AGM100®, developed in California, tested at University of British Columbia and Stevenson Memorial Hospital, and approved for use in Canada.

Hospitals are reporting a dramatic decline in ICU admission rates and hospitalized COVID-19 death rates. This is due to the AGM100®‘s quick and accurate measurements of lung function, and faster medical interventions which lead to better treatment.

“The AGM100® could be thought of as a breath test for lung function. In less than two minutes, it allows doctors to assess how well a patient’s lungs are taking oxygen from the air through their lungs into the bloodstream,” says Dr. Oswaldo Ramirez, Emergency Physician, at Stevenson Memorial Hospital, just north of Toronto. “This lifesaving assessment lets us quickly see which patients are in trouble and need to be admitted, and which ones can be released with preventive measures, like home oxygen.”

“This frees up much-needed hospital beds, moves patients out of our Emergency Department, and allows us to focus on the more critically ill without having to wait for the traditional blood test, a process which can take up to an hour,” Dr. Ramirez added.

Doctors can use the AGM100® to continue to monitor lung function at a micro level without having to perform blood tests. This allows for better therapies and reduced dependence on hospital labs. Patients wear a small clip on their nose while breathing normally into a disposable mouthpiece that is connected to a monitor. The device can be delivered to Canada in a few days.

“This portable device, while doing complex things, is simple to operate,” Dr. Ramirez says. “It can be used by doctors, nurses, paramedics, and others. In Canada, that’s particularly important in remote areas of the country that don’t have easy access to blood labs. Given its speed, the AGM100® works well in high volume emergency departments.”

Early intervention made possible by using the AGM100® leads to better outcomes for patients by preventing the need for ventilators and other more critical and invasive forms of treatment. “By using the device, we are sending fewer patients to the Intensive Care Unit. Far more patients can be evaluated and treated at much less cost and time,” Dr. Ramirez said.

While Stevenson Memorial Hospital is currently the first Canadian hospital using the AGM100®, thousands of patients are being assessed and treated at leading hospitals across the United States. Every hospital in Canada would benefit from the improved patient outcomes, healthcare efficiencies, and clarity in clinical decision making the device provides. Given its simple operation, the AGM100®, is particularly effective in long-term care facilities where no labs are present.

The AGM100® has been tested at the University of British Columbia (UBC) since 2018. Dr. Philip Ainslie, Professor and Canada Research Chair, and Co-Director for the Centre of Heart, Lung, & Vascular Health at UBC says, “Over the past two years, in 10 experimental studies with MediPines, we have extensively used and validated the AGM100® in a broad range of physiological and clinical scenarios. It provides a safe, reproducible and valid measure of non-invasive pulmonary gas exchange. Also, AGM100 compares extremely well with directly measured arterial blood gases.” Health Canada authorized the emergency importation and sale of the monitoring system earlier this year.

“To ensure that healthcare workers have the tools they need to combat this life-threatening pandemic, we have ramped up production,” explains Steve Lee, CEO of MediPines, who co-invented the AGM100® with world-renowned respiratory physician scientist Dr. John B. West.

While extremely useful during the COVID-19 pandemic, the AGM100® was designed to assess lung function for patients suffering from ailments like Chronic Obstructive Pulmonary Disease and pneumonia. AGM100® will continue to have that ongoing use during and post-pandemic.

About MediPines
MediPines Corporation, based in California, is a market leader in respiratory assessment and monitoring of pulmonary gas exchange. The company mission is to advance respiratory medicine by providing physiology-based respiratory devices that enhance clinical effectiveness and achieve better patient outcomes. 

MediPines AGM100® 
MediPines AGM100® is the world’s first non-invasive gas exchange monitor. This advanced respiratory monitoring system was designed to rapidly detect respiratory impairment caused by conditions such as COVID-19, Chronic Obstructive Pulmonary Disease (COPD), pneumonia, pulmonary edema, and pulmonary embolism. The device is FDA cleared and approved for Health Canada COVID-19 Emergency Use. It provides a comprehensive panel of respiratory measurements including blood oxygen levels, Oxygen Deficit (A-a gradient), P/F ratio, and alveolar oxygen and carbon dioxide levels.

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Freeman Lung Institute First in Region to Provide MediPines AGM100® Advanced Respiratory Monitoring System

27 Oct 2020 Medical

https://www.prnewswire.com/news-releases/freeman-lung-institute-first-in-region-to-provide-medipines-agm100-advanced-respiratory-monitoring-system-301160147.html?tc=eml_cleartime

ORANGE COUNTY, Calif., Oct. 27, 2020 /PRNewswire/ — Freeman Lung Clinic, in Joplin, Missouri, has partnered with MediPines, a respiratory medical device company, to provide patients and medical staff with a new innovative way of evaluating lung function. The MediPines respiratory monitoring system, AGM100®, provides direct respiratory measurements allowing the medical team to better understand how well their patients’ lungs are functioning. This critical knowledge is essential in improving the outcomes of those who suffer from respiratory conditions such as COPD, lung cancer, and other respiratory diseases.

According to Dr. Philip Slocum, Medical Director, and pulmonologist for Freeman Lung Institute, “Having the ability to get painless, precise measurements and calculations of pulmonary gas exchange, in addition to the testing capabilities we already have, allows us to rapidly obtain a high level of detail and understanding about respiratory conditions not previously possible in the pulmonary clinic.”

The MediPines AGM100® is an advanced respiratory monitoring system designed to assess and detect a patient’s gas exchange efficiency and provide a comprehensive respiratory assessment in under two minutes. Measurements of oxygen and carbon dioxide levels from a patient’s expired breath are compared with calculated levels of oxygen in the blood, in real-time, to provide traditional and novel respiratory measurements, previously only available through an invasive arterial blood draw.

The FDA cleared AGM100® accurately provides calculated partial pressure of arterial oxygen (gPaO2), carbon dioxide (PETCO2), and Oxygen Deficit (a non-invasive A-a gradient), among other clinical parameters. These medical grade respiratory measurements provide healthcare workers with the necessary information to better evaluate and treat their patients. These clinical measurements are immediately available from simple patient breathing samples.

“We are very excited to support the innovative Freeman Lung Institute to improve respiratory patient care with our device’s advanced monitoring capabilities,” stated Steve Lee, CEO of MediPines.

About Freeman Health Lung Institute

Freeman Lung Institute is the first and only clinic in the area that gives patients access to screening, diagnosis, treatment, and support of life-threatening lung diseases in one convenient location.

Freeman Lung Institute, a locally owned and not-for-profit clinic, provides comprehensive care for a wide range of pulmonary conditions including:

  • Lung cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Emphysema
  • Asthma
  • Pulmonary hypertension
  • Interstitial lung disease
  • Occupational lung diseases

About Freeman Health System

Freeman Health System includes Freeman Hospital West, Freeman Hospital East, Freeman Neosho Hospital, and Ozark Center, as well as two urgent care clinics, dozens of physician clinics and a variety of specialty services. In 2020, Freeman earned more than 80 individual awards for medical excellence and patient safety from CareChex®, a quality rating system that helps consumers evaluate healthcare providers. Freeman Health System was ranked by U.S. News & World Report as No. 4 in the state of Missouri for the seventh consecutive year for 2016 – 2017. The health system was also given the highest grade possible by The Leapfrog Group possible for the fourth consecutive year in the Spring 2018 Hospital Safety Score.

About MediPines

MediPines Corporation is a market leader in respiratory assessment and monitoring of pulmonary gas exchange. Our mission is to advance respiratory medicine by providing physiology-based devices that empower health care providers to advance the effectiveness and operating efficiency of patient care.  

MediPines AGM100®  
MediPines AGM100® is the world’s first non-invasive gas exchange monitor. The device is FDA cleared and provides a comprehensive respiratory assessment through medical grade measurements such as blood oxygen levels (gPaO2), carbon dioxide levels in the lungs (PETCO2), and the degree of respiratory impairment, Oxygen Deficit, (a non-invasive A-a gradient) from an exhaled gas sampling method. This advanced monitoring system was designed to support medical providers with rapid detection of respiratory impairment.

For more information go to medipines.com or contact:

Carissa Drews
info@medipines.com 
(949) 398-4670

SOURCE MediPines

COVID-19 Respiratory Monitoring with MediPines AGM100® in Long-Term Care Facilities

22 Oct 2020 Medical

https://www.prnewswire.com/news-releases/covid-19-respiratory-monitoring-with-medipines-agm100-in-long-term-care-facilities-301157596.html

ORANGE COUNTY, Calif., Oct. 22, 2020 /PRNewswire/ — Long-term care facilities are facing extraordinary challenges with the devastating and often undetectable presence of COVID-19. Elderly and at-risk residents in retirement homes and assisted living facilities are more likely to suffer with comorbidities which can impact the severity and mortality of those with COVID-19. To meet this growing challenge in the face of rising pandemic, MediPines, a respiratory medical device company, has released a scientific paper on respiratory monitoring in long-term care facilities.

The CDC recommends frequent respiratory monitoring of long-term care residents, who are disproportionally impacted by COVID-19. The use of a portable, non-invasive respiratory monitoring system that detects pulmonary gas exchange impairment, like the MediPines AGM100®, is proving valuable in monitoring the elderly and those who are high-risk.

“We were concerned about the practicality of frequent respiratory monitoring in our elderly residents, and the presence of unpredictable conditions like silent hypoxemia. As a result, we committed to using an advanced respiratory monitoring system [AGM100] to obtain residents’ gas exchange measurements. We are monitoring both residents and staff to establish a baseline respiratory measurement. By doing this we will recognize if there is any change in a resident’s or staff’s respiratory status, giving us an early indication of potentially harmful respiratory conditions (e.g., Covid),” stated Jon Howell, Co-Owner of Gracious Living Estates in Pennsylvania.

“Unfortunately, respiratory illnesses like COVID-19, are disproportionally impacting our elderly population. There is an urgent need for frequent respiratory monitoring in this at-risk population,” said Steve Lee, CEO of MediPines. 

In an effort to support long-term care residents and workers, MediPines has released a scientific paper outlining the medical rationale behind proper respiratory monitoring. The discussion outlines the use of a non-invasive respiratory assessment for residents who may not be exhibiting classical symptoms (i.e. low oxygen saturation), but still may be suffering from lung damage due to COVID-19, such as “silent hypoxemia.” The MediPines AGM100® is a respiratory monitoring system that provides rapid non-invasive pulmonary gas exchange measurements, typically in under two minutes.

See MediPines Scientific Series: “The Case for Respiratory Monitoring in Long-Term Care Facilities: COVID-19

MediPines AGM100®  
MediPines AGM100® is an advanced respiratory monitoring system that provides a comprehensive respiratory assessment designed to support medical providers with rapid detection of respiratory impairment. MediPines AGM100® is an FDA cleared technology that non-invasively provides medical grade pulmonary gas exchange measurements. The device has been clinically validated and is FDA cleared and authorized for COVID-19 emergency use by Health Canada.

About MediPines
MediPines Corporation is a market leader in respiratory assessment and monitoring of pulmonary gas exchange.  Our mission is to advance respiratory medicine by providing physiology-based, respiratory devices that empower healthcare providers to advance the effectiveness and operating efficiency of patient care.   

To learn more about MediPines visit: medipines.com

Contact MediPines:
Carissa Drews
(949) 398-4670
info@medipines.com 

SOURCE MediPines

MediPines Wins Prestigious Pediatric Medical Device Competition Focused on COVID-19-Related Technologies

24 Jul 2020 Medical

https://www.prnewswire.com/news-releases/medipines-wins-prestigious-pediatric-medical-device-competition-focused-on-covid-19-related-technologies-301099513.html?tc=eml_cleartime

ORANGE COUNTY, Calif., July 24, 2020 /PRNewswire/ — MediPines, a respiratory medical device company, was selected a winner in the special COVID-19 edition of the “Make Your Medical Device Pitch for Kids!” competition presented by FDA-sponsored National Capital Consortium for Pediatric Device Innovation. The competition focused on innovations in COVID-19-related pediatric medical devices that will improve children’s health care, with 16 finalists competing in a virtual pitch event for a share of $250,000 in total grant awards. MediPines received a grant award as a result of their winning presentation.

The MediPines AGM100®

The MediPines Gas Exchange Monitor, AGM100®, is a respiratory monitoring system used to rapidly and non-invasively assess a patient’s respiratory status. It is the first portable monitoring system of its kind to integrate a comprehensive set of critical parameters and respiratory measurements analyzed from two-minute samples of patient’s normal breathing. Current FDA cleared indications for the AGM100® are limited to adults. MediPines will use the funds to support clinical investigations with collaborators from Seattle Children’s Hospital to support expansion of the indications to include pediatric patients. “We are very excited about the wide range of potential applications in pediatrics,” according to Rob DiBlasi, RRT, Principal Investigator, Seattle Children’s Hospital.

“In children, respiratory decline can be sudden. The ability to rapidly determine respiratory impairment has the potential to make a dramatic impact in pediatric screening and treatment support,” stated Richard Hinds, MS, RRT, Medical Director at MediPines. 

For safety and efficiency, the pitch competition utilized a video conference format. The event was presented by NCC-PDI co-founders Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Hospital and the A. James Clark School of Engineering at the University of Maryland, and powered by nonprofit accelerator and NCC-PDI member, MedTech Innovator.

MediPines was one of eight winners selected by a panel of 75 expert judges from health care, business, investor and regulatory sectors. Winners were chosen based on the clinical significance and commercial feasibility of their COVID-19-related medical devices for children. The competition focused on medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

“Our heartfelt congratulations to MediPines, who was selected from a highly competitive field of worthy devices,” says  Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s National Hospital and principal investigator of NCC-PDI. “COVID-19 is presenting unprecedented challenges and my NCC-PDI colleagues and I know that supporting pediatric innovations will improve care for the patients and families we serve.”

NCC-PDI is one of five members in the FDA’s Pediatric Device Consortia Grant Program created to support the development and commercialization of medical devices for children, which lags significantly behind the progress of adult medical devices. To date, NCC-PDI has mentored over 100 medical device sponsors to help advance their pediatric innovations, with twelve devices having received either their FDA market clearance or CE marking.

“These winners represent some of the most promising emerging medical device innovations in the diagnosis, treatment, and care of children affected by COVID-19,” said Paul Grand, CEO of MedTech Innovator. “I’m thrilled that we were able to work together with NCC-PDI and seventy-five expert industry stakeholders and clinicians to provide support for these innovators on their critical missions to improve and protect the lives of pediatric patients, our most vulnerable population.”

“We are excited about the potential to help save the lives of our precious children impacted by  infectious respiratory diseases using our advanced respiratory monitoring system,” stated Steve Lee, MBA, CEO at MediPines.

About MediPines

MediPines Corporation is focused on innovative devices for respiratory assessment and management. Our mission is to advance respiratory medicine by providing physiology-based, respiratory devices that empower health care providers to modernize and advance the quality and operating efficiency of medical care.

MediPines Releases Scientific Paper on COVID-19 Respiratory Monitoring

15 Jul 2020 Medical

ORANGE COUNTY, Calif., July 15, 2020 /PRNewswire/ — In an effort to support healthcare providers facing massive healthcare burdens due to the current respiratory challenges caused by COVID-19, MediPines has released a timely scientific discussion on oxygen saturation versus pulmonary gas exchange as a respiratory monitoring imperative for COVID-19 patients.

Patients with COVID-19 do not always present with traditional signs and symptoms of respiratory distress, making it difficult for healthcare providers to rely on traditional tools such as pulse oximetry. Pulse oximeters provide a rapid estimate of arterial oxygenation saturation; however, saturation alone is insufficient for the assessment of respiratory impairment as it does not “see” pulmonary gas exchange in patients with chronic lung diseases, such as COPD, or in patients with infectious respiratory diseases like COVID-19.

Amidst this global crisis, innovative hospitals across the United States and Canada are leveraging a new respiratory monitoring system, the MediPines AGM100®. The AGM100 is significantly impacting hospital providers and COVID-19 triage centers as it provides rapid, accurate pulmonary gas exchange measurements. Pulmonary gas exchange is the primary function of the lungs. In time-sensitive respiratory cases, rapid assessment results can have a significant impact on patient care decisions and outcomes.

“Consistent with our founding mission of advancing respiratory medicine, MediPines is committed to sharing our scientific discoveries and medical insights with the medical community, with the latest breakthrough news and advancements in respiratory medicine to improve patient care. There is a need for more and ongoing research and scientific discoveries in the respiratory field,” stated MediPines CEO, Steve Lee.

The MediPines AGM100®
The MediPines Gas Exchange Monitor, AGM100®, is a respiratory monitoring system used to rapidly and non-invasively assess a patient’s respiratory status. It is the first portable monitoring system of its kind to integrate a comprehensive set of critical parameters and respiratory measurements analyzed from a patient’s normal two-minute breathing samples. The device has been clinically validated and is FDA cleared and authorized for COVID-19 emergency use by Health Canada.

About MediPines
MediPines Corporation is focused on innovative devices for respiratory assessment and management. Our mission is to advance respiratory medicine by providing physiology-based, respiratory devices that empower health care providers to modernize and advance the quality and operating efficiency of medical care.

MediPines AGM100® Gas Exchange Measurements Validated Against ABGs (Arterial Blood Gases)

12 May 2020 Medical

Study Published in CHEST Validates MediPines AGM100® Non-invasive Pulmonary Gas Exchange Measurements with Arterial Blood Gases Under Hypoxic Conditions

ORANGE COUNTY, Calif., May 12, 2020 /PRNewswire/ — A collaborative of international researchers, led by Dr. Phil Ainslie of the University of British Colombia (UBC), published the results of extensive research on the reliability of the MediPines AGM100®, a non-invasive pulmonary gas exchange monitor, under various hypoxic conditions of exercise and extreme physiology.  The pivotal study, conducted by  global medical researchers and physicians from the University of British Columbia (Canada), Duke University (US), and Bangor University (UK), was published in the April edition of the leading respiratory journal, CHEST: View Abstract.  https://doi.org/10.1016/j.chest.2020.04.017 

MediPines Summary of Ainslie Study as Published in CHEST

Pulmonary gas exchange measurements provide medical staff with critical information on how well the lungs are functioning.  Traditionally, the most common method of measuring pulmonary gas exchange efficiency is through an arterial blood gas (ABG) and involves comparing those values to an estimate of the lung oxygen level using various assumed lung level values, a process which is both invasive, time consuming, and fraught with logistic challenges.  The new innovative method directly measures the lung’s oxygen and carbon dioxide levels from exhaled gas sampling method and compares them to the calculated blood oxygen level, adjusted for Bohr effect.

The validation of a non-invasive approach to measuring pulmonary gas exchange provides healthcare workers with an important tool that rapidly delivers actionable, point-of-care information about how well a patient’s lungs are functioning.  This is especially important during a respiratory pandemic like COVID-19 which requires rapid and frequent pulmonary assessments to triage patients and titrate therapy.  The medical community and researchers now have an alternative to traditional pulmonary gas exchange measurement methods.

“Given the limitations of the traditional invasive arterial blood gas approach, we used the non-invasive AGM100® to study healthy volunteers at rest and in hypoxia during progressive exercise in order to compare the validity and reliability of the two methods. The design has implications for those exercising in low oxygen tension environments, including those with pre-existing lung or cardiovascular disease,” stated Dr. Phil Ainslie, Canada Research Chair and Co-Director of the Centre for Heart lung and Vascular Health, School of Health and Exercise Sciences at the University of British Columbia, Canada.

The study found very high correlations (R2=0.97; p<0.001) between the MediPines non-invasive arterial blood oxygen level, gPaO2™, and blood gas obtained PaO2, under conditions of rest at room air, hypoxic rest, and hypoxic exercise.  The study also found a strong relationship between PaOat hypoxic rest and exercise (R2=0.68; p<0.001).

“This is a major advance in our understanding and validation of the non-invasive approach to measuring gas exchange efficiency, as built on multiple clinical studies conducted at the UC San Diego School of Medicine,” stated Dr. John B. West, global authority on respiratory physiology and author of numerous papers and textbooks on this topic.

“It is a tremendous milestone in respiratory medicine to have our technology validated by a global team of renowned respiratory scientists and researchers from the University of British Columbia, Duke University, and Bangor University.  Now physicians and clinicians have access to a rapid, noninvasive method to comfortably support their respiratory diagnosis and treatment decisions to improve patient care, especially in light of the current infectious respiratory disease outbreak, when gas exchange measurements are vital in decision making and where healthcare resources are scarce,” said Steve Lee, CEO of MediPines.

The MediPines AGM100®

The MediPines Gas Exchange Monitor, AGM100®, is a portable device used to rapidly assess a patient’s respiratory status, non-invasively. It is the first technology of its kind to integrate a comprehensive set of critical parameters and innovative respiratory measurements analyzed from a patient’s normal breathing sample in a simple, easy-to-administer breathing test, within a few minutes.

About MediPines

MediPines Corporation is focused on innovative devices for respiratory assessment and management. Our mission is to advance respiratory medicine by providing physiology-based, non-invasive respiratory devices that empower health care providers to advance the quality and operating efficiency of medical care.

SOURCE MediPines

Related Links

MediPines AGM100 Authorized for COVID-19 Emergency by Health Canada

28 Apr 2020 Medical

NEWS PROVIDED BYMediPines 

Apr 28, 2020, 13:16 ET


ORANGE COUNTY, Calif., April 28, 2020 /PRNewswire/ — Health Canada, the regulatory agency governing medical devices in Canada, has authorized the emergency importation and sale of the MediPines AGM100®, a pulmonary gas exchange monitor to help combat the COVID-19 pandemic in Canada. 

The MediPines AGM100® is a non-invasive, portable respiratory medical device used to rapidly assess a patient’s respiratory status and impairment. The device helps clinicians to quickly triage a patient’s respiratory impairment, which is critical to both disease management and hospital workflow.

Health Canada’s decision comes amid an increase in COVID-19 cases in Canada, which require close respiratory monitoring. As of April 28th, Canada reported 49,616 cases of COVID-19 and 2,841 deaths, according to data tracked by Johns Hopkins University. 

“We are currently using the MediPines AGM100® to allow medical staff to quickly get respiratory impairment readings without having to expose patients to more invasive and logistically complicated procedures,” stated Toronto area emergency physician, Dr. Oswaldo Ramirez.

According to Dr. Philip Ainslie, Professor and Canada Research Chair, and Co-Director for the Centre of Heart, Lung, & Vascular Health at the University of British Columbia, “We have extensively used and validated the MediPines AGM100® in numerous physiological and clinical scenarios. It provides a safe, reproducible and valid measure of non-invasive pulmonary gas exchange.”

“We understand the gravity of the situation faced both in the United States and by our Canadian colleagues, and have ramped up production to meet the increasing COVID-19 demand for our non-invasive gas exchange monitors in an effort to ensure that frontline healthcare workers have the tools they need to combat this pandemic,” stated Steve Lee, CEO of MediPines.

The MediPines AGM100®

The MediPines Gas Exchange Monitor, AGM100®, is a portable device used to rapidly assess a patient’s respiratory status, non-invasively. It is the first technology of its kind to integrate a comprehensive set of critical parameters and innovative respiratory measurements analyzed from a patient’s normal breathing sample in a simple, easy-to-administer breathing test, within a few minutes.

For an explanation of use in COVID-19 see the panel discussion video: 

About MediPines

MediPines Corporation is focused on innovative devices for respiratory assessment and management. Our mission is to advance respiratory medicine by providing physiology-based, non-invasive respiratory devices that empower health care providers to advance the quality and operating efficiency of medical care.

For more information contact Carissa Drews at MediPines: (949) 398-4670 or info@medipines.com

SOURCE MediPines

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MediPines Obtains International MDSAP ISO 13485 Medical Device Certification

9 Apr 2020 Medical

ORANGE COUNTY, Calif., April 9, 2020 /PRNewswire/ — MediPines Corporation announces that it received the Medical Device Single Audit Program certification, MDSAP ISO 13485:2016 certification for Medical Device and Quality Management Systems. MediPines Corporation is the manufacturer of portable respiratory monitoring devices designed to provide real-time, clinically actionable data.  

ISO 13485:2016 is an internationally recognized quality standard developed to ensure the consistent design, development, production, installation and sale of medical devices. To be certified, organizations must pass a rigorous audit that demonstrates the company’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

The Medical Device Single Audit Program (MDSAP) was developed as a global initiative to allow third-party auditors to conduct a single audit of a medical device manufacturer that covers ISO 13485:2016 and their respective regulatory requirements. There are currently five countries participating in MDSAP: USA, Canada, Australia, Japan, and Brazil.

Building on top of implementing Good Manufacturing Practices (cGMP), as defined by the US FDA requirements for registered manufacturers, and rigorous requirements set by the California Department of Public Health for medical device manufacturing licenses in 2019, MediPines continues to expand its scope to include global quality standards to provide the highest quality medical devices to the healthcare community.

“Our MDSAP and ISO 13485 certification demonstrates MediPines’ company-wide commitment to the rigorous organizational standards and recognition of our state-of-the-art medical device manufacturing operation.  MediPines is committed to patient safety and product reliability,” stated Steve Lee, CEO of MediPines.

The MediPines AGM100® 

The MediPines Gas Exchange Monitor, AGM100® , is a portable device used to rapidly assess a patient’s respiratory status, non-invasively.  It is the first technology of its kind to integrate a comprehensive set of critical parameters and innovative respiratory measurements analyzed from a patient’s normal breathing sample in a simple, easy-to-administer breathing test, within a few minutes. 

AGM100 is currently being used to triage and assess COVID-19 patients.   

About MediPines

MediPines Corporation is the manufacturer of portable respiratory devices designed to provide real-time, clinically actionable data.  MediPines’ mission is to advance respiratory medicine by providing physiology-based, non-invasive respiratory devices that empower healthcare providers to advance the quality and operating efficiency of medical care.

https://www.prnewswire.com/news-releases/medipines-obtains-international-mdsap-iso-13485-medical-device-certification-301038433.html
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