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

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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

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

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

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