ECMO*

INSPIRA ART System

ECMO is a salvage therapy

VV-ECMO¹ is used when all other forms of lung support have failed for critically ill patients

INSPIRA ART has the potential to prevent invasive mechanical
ventilation and its associated long-term damages

INSPIRA ART might be applied in (1) patient prior invasive mechanical ventilation, to avoid MV, and (2) in addition to MV to decrease MV duration and subsequent ventilator associated lung injury

There is no “plan B ”when a patient is not improving with
ECMO

VV-ECMO is considered a “bridge to nowhere ”if a patient
doesn’t improve. The daily costs per patient are very high,
and patient cannot be taken-off the device in such a scenario

INSPIRA ART is designed to allow for early intervention

In the case patient deteriorates while receiving INSPIRA ART
treatment2
,alternative treatments can be applied (mechanical
ventilation)

ECMO*

INSPIRA ART System

A high flow device is not designed to support low flow treatment

ECMO treatment cessation, is characterized by short duration of low blood flow during weaning process

In many ECMO centers ,low flow duration (as part of ECMO weaning process) is minimal ,as clinicians assume the probability for clotting events increases dramatically¹,²

Cannuals, pump, pump head and oxygenator utilized with regular ECMO, are less suitable for low flow treatment and may put the patient in danger

INSPIRA ART is designed to optimize the effectiveness profile of low flow extracoporeal treatment

How do we aim to increase the devices ’safety profile?

• Reduce hemolysis
• Reduce thrombosis (Less anticoagulants )

Hemolysis –breakdown or destruction of red blood cells so that the contained oxygen carrying pigment hemoglobin is freed into the surrounding medium
Thrombosis – formation of a blood clot in the hart or in a blood vessel

ECMO*

INSPIRA ART System

Patients are sedated and paralyzed

Patients are mechanically ventilated, sedated and paralyzed when ECMO is first administered

“Awake ECMO ”is an off-lable, non prevalent event as clinicians wish to prevent cannulas dislocation which might result in massive bleeding & death

• Cannulas must be large enough to maintain the blood
  flow of 5 liters

Patients are awake and spontaneously breathing

• Delirium can be prevented
• Muscle mass loss can be prevented
• Patient can eat and drink
• Patient can communicate their symptoms and needs
  to the medical staff
• Patient can communicate with family and friends

ECMO*

INSPIRA ART System

Ventilator induced lung injury is highly prevalent

Patients are mechanically ventilated prior to ECMO administration, as well as during ECMO treatment period

Patients may be awake and spontaneously breathing

INSPIRA ART may potentially prevent MV

Prevention of:

• ventilator induced lung injury
• ventilator associated pneumonia
• ventilator induced diaphragmatic dysfunction          

INSPIRA ART may be added to mechanically ventilated patients to shorten ventilation duration and reduce MV damage to the lung

INSPIRA ART may potentially reduce the duration of MV .

Significant reduction of:

• ventilator induced lung injury
• ventilator associated pneumonia
• ventilator induced diaphragmatic dysfunction

ECMO*

INSPIRA ART System

ECMO treatment is limited to hospitals with relevant know how and accumulated experience:

ICU physicians, perfusionist and trained ICU nurses must operate and monitor a patient treated with ECMO.

ECMO cannot be operated in the absence of a perfusionist

Perfusionist – operates a heart-lung machine (extracorporeal respiratory system), which is an artificial blood pump, which propels oxygenated blood to the patient’s tissues

INSPIRA ART design will may potentially eliminate the need for a perfusionist and facilitate its everyday use.

1. Innovative automatic auto-priming system, eliminates the need for perfusionists, and prevents air embolism
2. Disposable Cartridge is a one unit, no need to connect the different disposable element prior to use
3. Disposable cartridge is entered into the device in a plugand-play easy to use manner

INSPIRA ART would potentially be used in any ICU, with or without prior ECMO experience.

For that reason, the device commercial potential is significantly larger than ECMO’s

ECMO*

INSPIRA ART System

The number of patients treated with ECMO is limited:

1. ECMO is a salvage treatment
2. High rate of bleeding and infection complications
3. Expensive

ECMO’s limited patient population, combined with its high complication rate and its significant financial burden to providers, limit its use

INSPIRA ART market size may resemble the invasive mechanical ventilation market:

1. INSPIRA ART may potentially prevent MV, when used prior to MV.
2. INSPIRA ART may potentially reduce the duration of MV, when added to MV.
3. High volume manufacturing , would allow competitive pricing.

INSPIRA ART’s potential patient population includes all patients considered candidates for MV .INSPIRA ART will potentially allow for an extracorporeal intervention aimed to prevent MV and offer a cost-benefit solution from a payor perspective