Inspira Technologies Aims To Become The Tesla Of MedTech – A Glimpse Into Their Pipeline

Inspira Technologies IINN aims to revolutionize acute respiratory care. The company is developing disruptive technologies and product pipelines to offer solutions for treating and monitoring acute respiratory failure patients in order to prevent the need for Invasive Mechanical Ventilation.

The INSPIRA^™ ART, the flagship of the Inspira pipeline, is a disruptive technology being developed that could potentially be a game-changer in the treatment of acute respiratory failure. The system aims to bridge the gap between non-invasive oxygen therapy and invasive mechanical ventilation (IMV). 

Until now, few options have been available for patients with acute respiratory failure, who experience life-threateningly low oxygen levels. Once doctors have exhausted non-invasive treatment options such as oxygen therapy – including oxygen masks, BIPAP, CPAP and high-flow nasal cannulas – the only choice is to jump to more extreme interventions such as IMV, which requires intubation and inducing a coma in the patient. And while these can be lifesaving, the extremely invasive nature of these treatments comes with its own potentially dangerous and even life-threatening consequences such as Ventilator Associated Pneumonia  (bacterial infections resulting from intubation tube positioned in patient airways) and Ventilator Induced Lung Injury (lung damage resulting from ventilator pressure applied).  

The INSPIRA ART system is designed to function as an artificial lung, by providing oxygen directly to the patient's blood while removing carbon dioxide. Even though only a small amount of blood is needed to be treated at a time, the system is being designed to rapidly rebalance oxygen saturation levels within minutes – reducing the burden on the sick lungs and supplying necessary respiratory support for patients. The system aims to prevent the need for invasive mechanical ventilation and avoid ventilator-associated life-threatening complications.

INSPIRA^™ ART: Targeting To Impact Millions of Patients

Acute respiratory failure is a life-threatening condition as the sick lungs cannot provide the body with enough oxygen or remove carbon dioxide properly. In 2017, 3.2 million Americans were hospitalized with respiratory failure. Annually, an estimated 20 million individuals across the globe received IMV.

Invasive Mechanical Ventilation involves placing the patient in a medically induced coma as well as inserting a tube through the nose or mouth (endotracheal intubation) or a surgical opening in the neck and placing the tube into the airway. The tube is connected to a mechanical ventilator which provides oxygen directly to the lungs. 

Despite being the most common procedure used in intensive care, with most patients being ventilated in the first 24 hours after intensive care unit (ICU) admission, IMV is associated with significant risks, complication rates, direct influence on mortality and high costs to the health system. Furthermore, for every day a patient is treated with IMV, they require an additional day to wean off the machine, as the brain “forgets” how to breathe on its own within a few days. This process can be extremely stressful for patients and can be unsuccessful. Apart from literally doubling the treatment time, at least, the process increases patient exposure to further medical risks and costs. 

The substantial risk to patients can result in breathing difficulties due to weakened muscles, possible brain damage through drug side effects, and, in the worst-case scenario, being left in a persistent vegetative state with no guarantee of recovery. IMV can result in deadly complications, including lung injury, pneumonia, collapsed lung, and windpipe collapse while breathing. Endotracheal intubation is also risky and can damage and cause swelling of the larynx. It can also result in paralysis of the vocal cords and narrowing of the windpipe.

INSPIRA ART has the potential to be a groundbreaking technology designed to come into play before patients decline to the point of requiring IMV. It is an innovative way of treating respiratory failure – with potentially up to 50% fewer hospital days. In fact, it is being designed to be administered in awake patients who continue to breathe spontaneously without requiring a medically-induced coma. This aims to extend its use from the ICU into general hospital wards, even in urban or small rural settings. Not only could this mean better patient outcomes, but it may also allow for improved cost savings by reducing the need for specialists and ICU costs. 

By targeting to provide a safe and effective intervention for patients whose condition is getting worse despite non-invasive oxygen therapy, INSPIRA ART could allow doctors to reduce the need for IMV. 

According to Inspira, INSPIRA ART is positioned to become the next gold-standard treatment for acute respiratory failure, marking a bold step forward in treating this complex condition.

Focused On Developing A Robust Pipeline To Support Success

Inspira is currently focused on developing its specialized pipeline by means of clinical studies and interactions with the FDA. 

The company plans pre-submission of the INSPIRA ART system with the FDA for regulatory approval at the end of 2023. 

As building blocks of the INSPIRA ART, the company is developing the ALICE^™ device and non-invasive HYLA^™ blood sensor. 

The ALICE is an extracorporeal (outside the body) blood circulation device designed to provide cardiac and pulmonary support in surgical procedures such as open-heart surgery, with highly intuitive and user-centric features. It is being designed to be compatible with Inspira’s non-invasive HYLA blood sensor. The ALICE is planned for FDA submission via the 510k pathway during the second half of 2023, with regulatory clearance expected to follow within several months 

The non-invasive HYLA is equipped with an optical blood sensor and armed with machine learning-based algorithms, aiming to provide immediate access to key blood parameters continuously and in real-time during extracorporeal procedures (such as open-heart surgery or ICU patients requiring extracorporeal cardiac and pulmonary support). The HYLA is designed to measure and provide an alert for any sudden changes in key blood parameters endangering the patient, enabling prompt medical intervention. A clinical study is currently being conducted at the Sheba Medical Center on patients who are undergoing open-heart surgery.

With a forecasted compounded annual growth rate of 14.01% over 2022-2030, the U.S. mechanical ventilation market was worth $5.9 billion in 2021 and is projected to soar to reach $19.2 billion by 2030. The success and potential have been noticed; Inspira looks to be leading the charge, signing multimillion-dollar distribution agreements worldwide* as part of their commitment to providing cost-effective lifesaving care for those suffering from respiratory failure – unlocking access on a global scale. 

INSPIRA ART aims to set the bar for safe and effective respiratory care by targeting to prevent the need for invasive mechanical ventilation and changing the landscape of acute respiratory care. The company plans to lead the industry to possibly move away from intensive care units towards general wards and rural settings. Perhaps in a similar way that Tesla has championed the accessibility and safety of electric cars, INSPIRA ART might change the landscape for acute respiratory care.

Featured photo by rosario janza on Unsplash

*The pre-conditional distribution agreements are for a period of up to 7 years and are subject to completion of development, and the required regulatory approvals or clearances.

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