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MediPines is Revolutionizing Respiratory Medicine with their Non-Invasive AGM100™ that Provides Instant Pulmonary Gas Exchange Measurements Using a Simple Patient Breathing Method


Steve Lee

CEO & Founder


MediPines

www.medipines.com


Contact:
slee@medipines.com

(949) 398-4670

Interview conducted by:

Bud Wayne, Editorial Executive

CEOCFO Magazine

Published – March 28, 2021


CEOCFO: Mr. Lee, you are systems engineer, tech entrepreneur, CEO of MediPines and co-inventor of the AGM100™. Before we discuss your product offering, what led you to develop the AGM100 and MediPines? How long has MediPines been around?

Mr. Lee: My interest in respiratory physiology was sparked when a family member experienced a debilitating respiratory illness. To me, respiratory impairment detection was sort of like a “black box,” where with the traditional tools that were available, they (physicians and clinicians) had to go through a long process of elimination, which is a very painful experience for patients and families. I felt like there was no objective way for physicians to precisely determine respiratory impairment, so I set out to design and build a device that would take the guesswork out of respiratory medicine. This personal journey led to meeting Dr. John B. West, who became an invaluable contributor to the creation of the AGM100.


Dr. West is a world-renowned respiratory physician. He spent his lifetime as a researcher and educator of respiratory physiology with over 500 peer reviewed publications to his name. I co-invented the AGM100™ technology with Dr. West to offer a respiratory solution to the medical community. It is an advanced engineered system built on years of clinical research and physiology principles outlined in Dr. West’s classic textbooks including, “Respiratory Physiology: The Essentials,” which is largely considered the gold standard in respiratory physiology in medical schools.  


The AGM100 is the world’s first FDA cleared respiratory system that non-invasively provides pulmonary gas exchange measurements using a simple patient breathing method. It is a portable system that can be used at the bedside. I view it as a portable pulmonary lab in a box. In 2015, I launched MediPines with outside investment from prominent Silicon Valley investors. The founding mission of MediPines is to advance respiratory medicine. AGM100 was commercially released five years later in 2020 and it is rapidly being adopted across the country in many leading hospitals, today.


CEOCFO: Why the focus on respiratory medicine?

Mr. Lee: Even before the COVID-19 pandemic hit, the world was facing a tsunami of respiratory diseases. The WHO (World Health Organization) recently estimated that about 1 billion individuals world-wide suffer from respiratory illnesses; that’s 1 out of 8 people worldwide, so respiratory illness is a massive global problem.


This rising tide of respiratory diseases was, in part, due to the pre-existing prevalence of respiratory diseases like COPD and asthma, combined with different factors like the aging population, occupational exposure, and air pollution. Now that the COVID-19 pandemic is here, the world is even more aware of the risks from respiratory-related illnesses.


So, we believe that innovation in respiratory science and technology is paramount in medicine today. That is why MediPines was started, to help advance respiratory medicine.  


CEOCFO: Has the COVID-19 pandemic increased interest in your products? Can the AGM100 help define the immediate need of a patient, and maybe even reduce the number of patients placed on a respirator?

Mr. Lee: Yes, the COVID-19 pandemic has significantly increased interest in our product. Doctors and other caregivers were desperately seeking ways to understand which COVID patient was at greatest risk, and our product provided an easy, non-invasive way to do that. So our AGM100 is playing a crucial role in respiratory assessment and treatment in many hospitals across the nation. Hospital providers that leveraged the AGM100 have reported dramatic results, such as reduced ICU admission rates. According to one Midwest provider, the hospitalized COVID-19 patient death rates plummeted after adoption of the AGM100. Because, for the first time, they were given a fast, precise tool that directly measures the core of lung function and, as a result, were able to intervene early and appropriately, avoiding unnecessary, invasive procedures while reserving limited ventilators for serious, critical patients. This resulted in major patient outcome improvements. Evaluating gas exchange efficiency of COVID-19 patients or any other respiratory disease that exhibits gas exchange abnormality can be extremely useful for clinicians.


CEOCFO: Would you tell us about your AGM100 gas exchange monitor and how it works?

Mr. Lee: The AGM100 was designed to rapidly detect gas exchange efficiency, which is the primary function of the lungs. It offers comprehensive gas exchange analysis information through a simple 90-second breath test. Our technology combines data from the patient’s breath and blood oxygenation with a proprietary algorithm to provide accurate and useful measurements on the patient’s gas exchange.  


It helps provide answers to essential respiratory questions. What is the patient’s blood oxygen level? Is ventilation adequate? Is gas transport from the lungs to the blood efficient? And what is the source of impairment? These are hard questions a clinical team needs answers to, right away, when they are faced with time-sensitive, imminent respiratory failure, or fast-declining patient cases in front of them.


It’s non-invasive. A patient simply needs to breathe through a specialized mouthpiece that is connected to our analyzer unit. The measurement is not difficult or dependent upon patient effort, the patient just needs to breathe. It is easy for the patient and convenient for the clinician to operate.  


The output parameters are immediately actionable to an attending healthcare team. It is used to rapidly assess patient respiratory status, support triage, titrate interventions, and quickly determine response to therapy.


CEOCFO: Would you give us an idea of the dimensions of the product?

Mr. Lee: The device is portable, and the monitor is about the size of a tablet computer. It is small and typically placed on a rolling stand so that it can be moved across many departments in the hospital. It is a spot-check device, so a single monitor can be used to assess and support treatment of multiple patients.


CEOCFO: How are hospitals and doctors currently checking respiratory measurements? Are there any similar devices available today and if so, what sets the AGM100 apart?

Mr. Lee: The main way that clinicians currently check for similar respiratory measurements is with an invasive blood sampling method – what’s called an “arterial blood gas” (ABG). It does provide what is happening to blood oxygen levels but does not inform you about what is truly going on inside the lungs. On top of that, they require expensive equipment, and a specialized staff to maintain and keep them running in a hospital. Most importantly, it introduces pain to the patient, that often-times can be avoided by using a non-invasive method like ours.


They can also do a lung x-ray/CT scan to assess that, but that’s a time-consuming and expensive process that greatly limits the frequency of how often they can take measurements.


So, while there are invasive or intrusive measures available, there’s not an option that is easy and non-invasive, like our AGM100 – for rapid assessment and treatment effectiveness confirmation.  And we are also unique in the Oxygen Deficit information that we provide.


In terms of the accuracy of blood oxygen levels, studies have been published in medical journals such as CHEST, which show that the blood oxygen level (gPaO2) provided from the AGM100 correlates extremely well with the PaO2 on an arterial blood gas method in a wide range of normal and clinical situations. A number of scientific papers published by a global team of scientists have demonstrated the accuracy of the AGM100 measurements and the near one-to-one relationship with ABG. Therefore, we have proven that a breath-based approach like ours, through a calculated means, has high accuracy and reliability, which is a very exciting development.


CEOCFO: Where is it in use currently, such as hospital emergency rooms or physicians’ offices? Could the current model be used in ambulances, senior care facilities or long-term care facilities?

Mr. Lee: Yes absolutely. If you think about the small portable pulmonary lab in a box concept, the utility is quite broad. Right now, major customers are hospitals and hospital systems, like integrated delivery networks. The first adoptees within the hospitals were typically emergency and respiratory groups, but we are quickly learning that our device is expanding through different areas of the hospital, all the way to the patient discharge space, where right before the patient is discharged, they would take a measurement. There is broad applicability because respiratory medicine cuts across multiple departments within the hospital.


There are also emerging segments like post-COVID clinics, long-term care facilities, and eventually, I think, in ambulances too. It has many features that make it desirable in low-resource and remote locations. The device is small and portable. It can easily be transported and moved into a mobile unit. It is simple to operate, and healthcare professionals can be trained to operate it in under 30 minutes. The technology is cleared for use in all qualified healthcare facilities.


CEOCFO: Is there a pediatric application?

Mr. Lee: Right now, the AGM100 is FDA cleared for use only in adult populations. However, significant potential pediatric applications are being explored because our device is non-invasive and it may allow pediatric populations to be evaluated in a much more non-invasive manner, which reduces the possibility of pain for kids. MediPines won a competitive award last year funded by Children’s National Hospital and the FDA to study the utility of non-invasive pulmonary gas exchange measurement in pediatric populations.


If you think about respiratory issues, it cuts across elderly, as well as children, so we believe the pediatric application will be very important. We are working with Children’s National Hospital in Seattle and UC Davis Children’s Hospital.


CEOCFO: Would you tell us about the Advanced Single Patient Breathing Circuit and how it works with the AGM100?

Mr. Lee: The advanced breathing sampling circuit was specifically designed for optimal patient breathing gas sampling. It was designed to detect the presence of respiratory gases with a high degree of accuracy and reliability, reflecting the full range of possible air flow dynamics in gas sampling of all patients, especially sick patients. Because we take continuous measurements of expired partial pressure of oxygen and carbon dioxide gas, that is PO2 and PCO2, it has to be very comfortable for the patient and convenient for the clinician to operate. Construction-wise it is biocompatible, air-tight, and meets all regulatory requirements for skin-touching devices. Importantly, the circuits have filters built right into them, an important consideration during a pandemic of respiratory disease.  


CEOCFO: Are you currently exploring upgrades, enhancements, or changes to the AGM100? Could there be other models on the horizon? Do you still currently have a heavy R&D spend?

Mr. Lee: We continue to work on furthering our platform, with a number of enhancements in our R&D pipeline to further advance our technology for better patient care. Another important area is developing what we call “macro-signals” to quickly identify impending respiratory failure, pulmonary edema, pulmonary embolism, influenza-led ARDS, and asymptomatic pneumonia that we typically see in COVID cases. We are fortunate to be working with some leading institutions on these new areas of advancement.


CEOCFO: Is price an issue when it comes to your products? Is it a one-time purchase? Are there consumable, disposable, or single use parts?

Mr. Lee: We have a competitively priced one-time purchase analyzer, along with a single patient, multi-use disposable breathing circuit. Our costs for both the analyzer unit and the breathing circuits are low, so we have been able to offer our products for a very competitive price to the hospitals, while still maintaining best-in-class industry margins that will help us achieve our financial goals.


We have an incredibly innovative solution that is greatly improving current respiratory care, as evidenced by such great hospital adoption. Our analyzer is very affordable to providers with a huge value-add. Unlike a bedside monitor, because respiratory cuts across many areas of the hospital, a single AGM100 could serve multiple departments, so you can assess and treat more patients with far fewer resources.


There is a recurring use case for the single-patient-use breathing circuit. Patient measurements happen continuously, throughout the hospital stay, from the emergency room to respiratory care, and right before patient discharge. I might add that these procedures are reimbursable, so a strong economic value proposition exists for the provider.


CEOCFO: MediPines was recognized as a Top 10 Patient Monitoring Solutions Provider in 2020 by MD Tech Review. What does that mean for you?

Mr. Lee: We are very delighted that we were recognized as a Top-10 Patient Monitoring Solutions Provider last year. We’re working hard to achieve our mission of advancing respiratory medicine, and we take it as recognition for that. The industry is recognizing the importance and the need for respiratory solutions like ours in the patient monitoring space. And going forward, I believe that non-invasive respiratory solutions like ours will play an important role in the patient monitoring industry.


CEOCFO: What is your geographic reach currently; US only or global? Where is your market and do you see that changing?

Mr. Lee: Currently we are cleared for the US market and Health Canada approved us for COVID-19, so we are in North America. Our device is manufactured in Orange County, California in our MDSAP ISO 13485:2016 facility; a global standard for Medical Device manufacturing. We are currently focused on the US and Canada and have a plan to expand to Europe and Asia.


We want to eventually reach every region and every country because respiratory problems are global. We just happen to be focusing on North America because we are a young company.


CEOCFO: How are you reaching out to potential customers? Do you have your own sales staff or work with distributors?

Mr. Lee: Currently we have a direct sales team reaching out to hospital marketplace.  As we grow, we will be exploring various channels of distribution.


CEOCFO: Are you currently funded for growth or will you be reaching out to investors, partners or distributors?

Mr. Lee: We are financially healthy and have strong commitment from our investors. As our business enters the high growth phase, driven by a strong interest and rapid adoption by the medical community, we will be evaluating additional growth financing options. Potential future financing options under consideration include individual and strategic investment as well as bank financing, venture debt, and private credit.


CEOCFO: In closing, why is MediPines important to the future of healthcare and patient care?

Mr. Lee: Respiratory advancement is the key to better human health and managing our future healthcare burden. If we can make improvements in advancing respiratory medicine, this could be one important step to solving a looming healthcare crisis. The success of private sector efforts, like MediPines, could also tell how well we are going to manage our way out of the looming healthcare crisis. Right now, US healthcare consumes 18% of the national GDP. That is $3.8 trillion a year, a staggering number, a substantial economic burden to any society. Medical technology and innovation, I believe, can play an important role in this area. Leveraging the AGM100 can provide 60 times the operating advantage to any hospital provider, compared to the closest alternatives with far fewer resources.


As we provide better care, faster and at lower costs, more patients can be assessed and treated. Providers and society will benefit from the high efficiency achieved, and we can alter the course of healthcare for the better through superior technological innovation. The COVID-19 pandemic has brought respiratory illness to the forefront of medicine. Both the CDC and WHO predict that the current impact of the pandemic will be felt for years to come. The economic burden of the current pandemic is projected to be well over $16 trillion according to recent estimates by Harvard economists. It is expected to continue to increase in the next decade.


There are some great developments on the vaccine front, but respiratory viruses will continually evolve and raise prospects for future pandemics. Therefore, the continuous research and development in the respiratory field is a vitally important topic for all of us. We are hoping that novel and efficient technologies, like the MediPines AGM100, which I believe is a life-saving innovation, can help blunt the effect of future pandemics, while establishing a solid foundation for better respiratory patient care in the context of this emerging respiratory tsunami. We want to help advance respiratory medicine for the patients and for better healthcare for society.


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“Hospital providers that leveraged the AGM100 have reported dramatic results, such as reduced ICU admission rates. According to one Midwest provider, the hospitalized COVID-19 patient death rates plummeted after adoption of the AGM100.”
Steve Lee

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