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

Related Links

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

COVID-19 Patients Being Triaged and Assessed Using 2 Minute Breath-Based Gas Test

6 Apr 2020 Medical

ORANGE COUNTY, Calif., April 6, 2020 /PRNewswire/ — Innovative hospitals across North America are responding to the COVID-19 pandemic and the upsurge of patients with a revolutionary breath-based gas test to support faster patient assessment, triage, and treatment decisions. The medical device uses advanced technology and proven medical methods to measure a patient’s degree of respiratory impairment. The new FDA cleared, portable gas exchange monitor, MediPines AGM100®, is effectively helping frontline healthcare workers to quickly triage and make decisions on how to treat COVID-19 patients (video).

“Our doctors and nurses are counting on this quick respiratory test to help them both identify patients that need escalated care, such as who needs to be admitted, and who needs ventilator support, while they wait for COVID-19 diagnostic test results to arrive, which unfortunately are taking days to get,” stated Dr. Oswaldo Ramirez, Emergency Physician at a leading North Eastern hospital.  

The MediPines AGM100® outputs a unique “breathing gas-based” measurement that can provide immediate respiratory data after the patient breathes into a breathing tube for less than two minutes.  Complicated or invasive or procedures are not required. The AGM100 rapidly provides measurements, such as Oxygen Deficit, that help clinicians assess the extent of a patient’s respiratory impairment.  This has proven to be especially beneficial to healthcare workers trying to prioritize limited resources in the context of COVID-19, enabling high-risk patients to receive the appropriate level of care and attention. 

The device uses a disposable breathing circuit with a mouthpiece designed to limit pathogen exposure. These features are highly important to the safety of both patients and frontline healthcare workers in order to prevent the spread of disease.

“The AGM100® is helping our medical team to better diagnose the severity of a patient’s respiratory symptoms in under a few minutes, while minimizing pathogen exposure to our valuable health care workers,” according to Dr. Ramirez.

About MediPines: MediPines is a California based manufacturer of portable respiratory monitoring devices designed to provide real-time, clinically actionable data. MediPines has released a statement of guidance on the use of the MediPines AGM100® during the COVID-19 pandemic: https://www.medipines.com/resources/.

MediPines Releases COVID-19 Statement of Guidance for Pulmonary Gas Exchange Monitoring

MediPines, in Orange County, California, is a medical device manufacturer that focuses on respiratory diagnostics and therapeutic management solutions. MediPines provides medtech solutions for respiratory screening, diagnostics, and management. (PRNewsfoto/MediPines)

NEWS PROVIDED BY MediPines 


ORANGE COUNTY, Calif., March 12, 2020 /PRNewswire/ — MediPines Corporation, in keeping with their mission of advancing respiratory medicine, has released a statement of guidance on the use of the MediPines Gas Exchange Monitor (AGM100®) in the monitoring of patients that have symptoms of suspected COVID-19 or other respiratory infections. The guidance was developed in collaboration with leading respiratory experts, and provides best practices, instructions, and clinical rationale.

The CDC recently outlined emergency warning signs for COVID-19 “including difficulty breathing or shortness of breath, persistent pain or pressure in the chest,” among other potential symptoms. Furthermore, it is estimated that approximately 90% of patients hospitalized with COVID-19 develop pneumonia or other lower respiratory tract complications which results in inefficient pulmonary gas exchange.

The AGM100® is the first and only non-invasive device that allows comprehensive quantification of pulmonary gas exchange deficiencies associated with these types of symptoms, and thus has unique advantages in providing rapid measurements at multiple time periods over the progression of the disease.  The device and guidelines may assist clinicians in the implementation CDC and WHO recommendations, as well as recommendations provided by other health authorities.

About MediPines:

MediPines Corporation, based in Orange County, California is the manufacturer of breakthrough, portable respiratory monitoring devices designed to provide real-time, clinically actionable data.  

SOURCE MediPines

Related Links

https://www.prnewswire.com/news-releases/medipines-releases-covid-19-statement-of-guidance-for-pulmonary-gas-exchange-monitoring-301022611.html

Search

+