AirMid's Convertible Ventilator is Postured to Advance Safety by Decades

AIRMID'S CONVERTIBLE VENTILATOR PROMISES TO BRING MANUAL HAND-OPERATED ARTIFICAL VENTILATION INTO THE 21st CENTURY

It targets a 1950's-era designed device that, despite being antiquated, still remains in use today and which we now know contributes to 190,600 cases of lung injury and more than 74,500 U.S. deaths each year

The original 1956 "Ambu" bag

Current manual ventilators do not have any governing mechanisms to prevent inadvertent over-inflation of patients' lungs, putting millions of patients at risk

Because of their age, manual ventilators were grandfathered by the FDA in 1976. 

Those vulnerable to ongoing 1950's-era standards include...

Newborns

Patients having surgery

Those suffering emergencies

AirMid's Guideline Compliant Convertible Ventilator

AirMid's Convertible Ventilator will be the first manual ventilator able to deliver guideline-compliant breath sizes

Because breath size can be "dialed in" to match the guideline-prescribed amount tailored to each individual patient, this means AirMid's Convertible Ventilator provides an opportunity to advance a standard that has waited over sixty years without improvement

Upon FDA clearance, AirMid's technology will singularly enable hospitals to comply with existing safety guidelines to protect patients from lung injury, and in so doing help decrease complications by 61.8%, patient deaths by 42%, and contribute to as much as $12.4 billion in cost savings per year in the U.S. alone

To understand how AirMid will achieve this, an introduction to the attributes of Acute Lung Injury (ALI) and existing clinical evidence providing these figures are needed

ACUTE LUNG INJURY KILLS TENS OF THOUSANDS

Acute Lung Injury (ALI), also called Adult Respiratory Distress Syndrome (ARDS) or Ventilator-Induced Lung Injury (VILI), is a deadly condition where the lungs become swollen and inflamed

Lung inflammation decreases the ability of the lungs to oxygenate the blood, starving the brain and other organs, often leading to death

Studies show approximately 75,000 patients in the U.S. die each year from ALI – more than breast and prostate cancers combined

Cancer Type

Breast (Female - Male)

Prostrate

TOTAL

Estimated Deaths

 

40,920 - 480

29,430

70,830

NATIONAL

CANCER

INSTITUTE

The NEW ENGLAND

JOURNAL of  MEDICINE

“Acute Lung Injury has an incidence of 86 cases per 100,000 person-years and a mortality rate of 39%.  In the United States, there are an estimated 190,600 cases annually, leading to 74,500 deaths …”

CHEST JOURNAL

“Acute Lung Injury (ALI) is responsible for up to 75,000 deaths in the United States per year…”

ACUTE LUNG INJURY MAY BE WORSE THAN GETTING SHOT

A recent landmark study (called “LUNG SAFE”) in the Journal of the American Medical Association (JAMA) quantified the mortal danger of ALI with more accuracy

JAMA

“The Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE) was an international, multicenter, prospective cohort study …”

AJPH

In fact, research suggests ALI is more than twice as lethal than being shot in the chest or abdomen

A study of 11,744 consecutive gunshot wound patients in Chicago was conducted

 “Overall mortality was 18.8%, with 64% of those deaths coded as DOA or dead in the emergency department without interventions provided.”

“Hospital mortality was 34.9% for those with mild, 40.3% for those with moderate, and 46.1% for those with severe ARDS.”

OVER-INFLATION CAUSES ACUTE LUNG INJURY

ALI has historically – and until recently - been regarded as a largely idiopathic condition that mysteriously arises on a proportion of patients

Respiratory and

Critical Care Medicine

“High-volume ventilation may overstretch both normal and diseased alveoli and thus directly produce lung injury.”

Over-inflating delicate air sacs of the lung (called alveoli) causes tearing injuries that are not immediately obvious to the provider delivering ventilation

Only recently has guideline non-compliant, uncontrolled lung over-inflation that causes lung tearing been shown to be a direct cause of ALI

NORMAL LUNGS

INFLAMED LUNGS AFTER ONLY 20 MINUTES OF LUNG HYPERINFLATION

PROBLEM – INADVERTENT LUNG INJURY OF NEWBORN BABIES

Every year approximately 5% of newborns worldwide (about 7 million) require positive pressure ventilation (PPV) to help them start breathing on their own

This is most often provided by a 1950s-era manual ventilator (or “self-inflating bag”)

Research shows medical care givers of all skill levels – even doctors – inadvertently over-inflate in 73.8% of cases, putting newborns at risk of Acute Lung Injury

PEDIATRICS

“Approximately … 3% [of babies born at term] will initiate respirations after positive-pressure ventilation (PPV), 2% will be intubated to support respiratory function, and 0.1% will require chest compressions and/or epinephrine to achieve this transition.”

When using a self-inflating bag “… a large discrepancy between the delivered and the current guideline values was observed for all parameters.”  

“Regardless of profession or handling technique, … 73.8% exceeded the recommended range of volume.”

“… an important issue raised in this study is whether or not the self-inflating bag should be used to ventilate a newborn.”

Studies confirm non-compliance...

...increases risk for ALI

Based on CDC data, the #1 cause of death of patients aged 0-15 is trauma, with traumatic brain injury being the primary risk of death in children 0-4 years of age

The treatment for severe traumatic brain injury is medically-induced coma, meaning artificial ventilation is required (and almost always instituted with a non-compliant manual ventilator)

During treatment of brain injury, lung injury is a high-risk complication

“The presence of pulmonary dysfunction after brain injury is well recognized.”

“The 'primarily inflamed' lungs may have decreased tolerance to the subsequent mechanical stress due to mechanical ventilation.”

“… respiratory failure is the most frequent extracranial complication in patients with acute brain injury…”

minerva

aestesiologica

Studies confirm non-compliance …

… increases risk of ALI

PROBLEM - INADVERTENT LUNG INJURY OF ALL AGE

According to two recent landmark studies, patients undergoing general anesthesia for surgery or being treated in ERs are at risk of – and actually develop – ALI 

In all clinical settings, artificial ventilation is almost always initiated with non-compliant manual ventilators

27.5% of patients receiving unprotected (guideline non-compliant) ventilation during surgery developed lung complications

Annals of Emergency Medicine

An International Journal

Ventilation is primarily unprotected (guideline non-compliant) when provided in the ER; about 20% of patients develop downstream lung complications, with 10% developing Acute Lung Injury (ALI)

Studies confirm non-compliance …

… increases risk of ALI

AIRMID’S REMARKABLE TECHNOLOGY IS THE SOLUTION

Currently there are only two options to provide artificial ventilation, each representing a compromise between advantages and disadvantages

AirMid’s Convertible Ventilator incorporates a simple volume-control mechanism in place of the uncontrollable bag on existing products (leaving everything else the same)

This retains convenience factors and familiarity of current devices, while adding ability to protect patients from torn lungs by enabling ventilation within lung-protective guidelines

As a result, AirMid’s Convertible Ventilator utilizes a proprietary mechanism to combine the best attributes of both current modalities to effectively advance manual ventilation to a new standard

WHAT ABOUT COST?


Current manual ventilators are all non-compliant with existing American Heart Association (AHA) guidelines (the AHA is the leading U.S. authority regarding resuscitation practices and standards).  These single-use/disposable products range in pricing from $10 per unit to over $70 per unit for “premium” versions that offer no advantage in operation or patient safety.  

This, in itself, offers a remarkable opportunity which is further enhanced by the fact that the downstream costs associated with lung injuries exceed $20 billion annually in the U.S.

The lifetime cost of care for a patient with ALI … was $106,821 ….”

The NEW ENGLAND
JOURNAL of  MEDICINE

“Acute Lung Injury has an incidence of 86 cases per 100,000 person-years and a mortality rate of 39%. In the United States, there are an estimated 190,600 cases annually, leading to 74,500 deaths and 3.6 million hospital days.”

           $190,600 cases per year

X  $106,823 average cost per year

           $20.4 billion

           total U.S. spending to treat ALI patients

CHEST JOURNAL

RECENT STUDIES HAVE SHOWN THAT IF VENTILATION IS DELIVERED WITHIN LUNG-PROTECTIVE GUIDELINES, MEANING OVER-INFLATION IS PREVENTED AND THE LUNGS ARE NOT EXPOSED TO OVER-STRETCH, THEN COMPLICATIONS AND MORTALITY DECREASE MARKEDLY

Use of lung-protective ventilation during surgery, compared to non-protective ventilation, reduced lung complications by 61.8% and also decreased lenghth of stay by 2.6 days

"We found that treatment with a ventilation approach designed to protect the lungs from excessive stretch resulted in  improvements in several important clinical outcomes..."

Use of lung-protective ventilation in the ER, compared to non-protective ventilation, reduced lung complications by 62% and also decreased mortality by 42.5%

"Even if delivered for comparitvely brief periods, early lung-protective ventilation during vulnerable periods seems to carry subsequent benefit..."

Annuals of Emergency Medicine
An International Journal
The NEW ENGLAND
JOURNAL of  MEDICINE

Accordingly, through its unique ability to enable universal guideline-compliance, the AirMid's Convertible Ventilator could contribute to an estimated U.S. cost savings of $12.6 billion annually

    $20.4 billion per year in current spending to treat      ALI

X  61.8% decrease in ALI via guideline compliance

 $12.6 billion

 total U.S. potential savings by preventing ALI

2020, AirMid Critical Care Products, Inc.