Creating a Paradigm Shift in Respiratory Care: Early Respiratory Support Reducing the Need for Invasive Mechanical Ventilation

Inspira Technologies, a MedTech company developing a new extracorporeal blood oxygenation device, aims to become a new standard of care for acute respiratory failure patients. The company mission is to reduce the need for invasive mechanical ventilation

Galiya Hipsh, in collaboration with Inspira Technologies
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Galiya Hipsh, in collaboration with Inspira Technologies
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We all remember the heart-breaking sights of awake COVID 19 patients struggling to breath while receiving non-invasive ventilation in the intensive care units. Many continued to deteriorate despite non-invasive ventilation efforts, and could not avoid invasive mechanical ventilation, which requires endo-tracheal intubation and medically induced comas, sometimes for prolonged durations.

Invasive mechanical ventilation is used to enable adequate blood oxygenation and carbon dioxide removal and is considered as the current standard of care for a variety of respiratory patients who continue to deteriorate following non-invasive ventilation. The drawbacks of this invasive and somewhat aggressive approach have been documented in thousands of peer-reviewed studies exposing a variety of associated risks and complications that damage the lungs and influence patient short and long-term outcomes, including its undesirable effect on patients’ survival rates.

Inspira Technologies, established in 2018 by Dagi Ben-Noon and Joe Hayon, set out to find a solution to enable respiratory-failure patients to maintain adequate gas exchange (oxygen and carbon-dioxide), while reducing the need for invasive mechanical ventilation. The company, based in Ra’anana, has 40 employees, and is developing several important products in the acute respiratory care sector.

Dagi Ben-NoonCredit: Chen Leopold

Why is new technology in this sector so badly needed?
The chairmen of the board, Prof. Benad Goldwasser, urologist by training and a serial entrepreneur who led more than 10 companies to M&As and commercial success, stated: “the options available today to treat patients with acute respiratory failure are very limited. If a patient’s blood oxygenation level continues to deteriorate despite non-invasive efforts, such as an oxygen mask, then invasive mechanical ventilation becomes the only option of treatment. Invasive mechanical ventilation is a highly unpleasant treatment associated with a long list of medical risks and complications resulting directly from the mechanical ventilation machine itself. Modern medicine has yet to offer an appropriate solution positioned to address the massive treatment gap between non-invasive and invasive ventilation. The device Inspira is developing, called the INSPIRA ART (Augmented Respiratory Technology) is the first to bridge this treatment gap, being designed to rebalance the patient’s oxygen level while they are awake and breathing spontaneously, reducing the need for placing the patient in an induced medical coma and intubating them to place them on an invasive mechanical ventilation machine.”

Prof. Benad GoldwasserCredit: PR

How does this technology work?
The INSPIRA ART system withdraws blood from the patient’s body via a dual-lumen cannula inserted into the jugular vein. The blood is then passed through an oxygenator, where it is enriched with oxygen and carbon dioxide is removed. The oxygenated blood is then returned to the patient via the same dual lumen cannula located in the jugular vein. The system will potentially allow the patient to remain awake and spontaneously breathing throughout the process. The ability to treat an awake patient would enable the patient to continue to communicate with his/her medical team and family, contributing to improving both their medical care and emotional wellbeing.

INSPIRA ART’s Main Benefits
“It’s a completely new class of treatment” explained by Prof. Goldwasser. “The treatment potentially prevents complications associated with invasive mechanical ventilation such as infections, lung injury, and complications resulting from the medically induced coma. In addition, the new device can potentially reduce the length of stay in the intensive care unit (ICU) resulting in significant cost savings to hospitals and payors. In the future, once established as a new standard of care, such a system will potentially migrate acute respiratory care outside the ICU as well, broadening its use to treat respiratory patients in additional clinical settings . With the number of respiratory failure patients worldwide being staggeringly high and predicted to continue to grow at a rapid pace, I think the INSPIRA ART will introduce an important solution that bridges the treatment gap for the medical community and most importantly the patient population.

Company Establishment
Inspira Technologies was established in 2018, with the vision to bring to market a new safe and accessible blood oxygenation device, that can be used at an early stage, and therefore reducing the need for invasive mechanical ventilation. Upon the company’s inception, it received grants from the Israeli Chief Scientist and raised capital from private angel investors and family offices and boutique funds. In July 2021, the company completed an IPO on the NASDAQ stock exchange (NASDAQ: IINN).

INSPIRA ART SystemCredit: PR

The company was established by Dagi Ben-Noon (CEO) and Joe Hayon (President). Prior to Inspira, Dagi co-founded Nano Dimension (NASDAQ: NNDM), a company developing novel 3D printing solutions for the electronic industry. At Nano Dimension, Dagi Met Prof. Goldwasser, one of Nano Dimension’s early investors.

Current Development Status
Dagi Ben-Noon: "We are currently preparing for clinical studies and development. Inspira plans pre-submission of the INSPIRA ART system with the FDA for regulatory approval at the end of 2023, which will likely require clinical trials. In addition, in the second half of 2023, the company plans to file the ALICE CPB device under a 510k for FDA regulatory clearance. The ALICE CPB device is being developed as an extracorporeal life support system aimed for the treatment of patients admitted to ICUs. Being a 510k this submission will likely not require clinical trials and as such could be deployed to penetrate the market upon regulatory clearance. In parallel the company is engaged in the development of a new non-invasive blood gas sensor named the HYLA. The HYLA is designed as a non-invasive blood sensor, intended to provide continuous blood parameter measurements at real-time, potentially alerting physicians of sudden changes in a patient’s specific key indicators and allowing them to intervene and treat patients at an earlier stage. Early medical intervention may improve patient outcomes, reduce complications, and reduce associated costs. The HYLA blood sensor is based on machine learning algorithms and is designed to provide continuous data relating to several very important parameters indicating the clinical condition of the patient in real-time as well as the extracorporeal device function. During this quarter, Inspira plans to commence a clinical study at the Sheba Medical Center to further evaluate the HYLA blood sensor’s capabilities to measure blood gases in a non-invasive and continuous manner. The study results are expected to have a significant contribution to the product’s development.

Inspira’s In-house Capabilities
Inspira has developed multiple in-house capabilities including advanced research laboratories, highly qualified multidisciplinary human-capital, including researchers, clinicians, regulatory specialists, engineers, algorithm specialists etc. Inspira’s CTO, Dr. Daniella Yeheskely-Hayon, is renowned for her broad experience in extracorporeal blood oxygenation systems.

The Company’s Scientific Advisory Board is Composed of Leading KOLs
Inspira Scientific Advisory Board is comprised of internationally renowned leading intensivists and medical researchers specializing in the treatment of acute respiratory patients. Israeli based specialists include Dr. Dekel Stavi, intensivist at Ichilov Medical Center in Tel Aviv, Dr. Stephan Ledot, ICU and ECMO specialist at Hadassah Medical Center and Dr. Yigal Kassif, senior surgeon and Director of ECMO services at Sheba Medical Center. North American based renowned KOLs include Dr. Eddy Fan, Director of the extracorporeal life support program at the Toronto General Hospital in Toronto, Canada and Dr. Daniel Brodie, Section Chief for Critical Care at Columbia University/New York-Presbyterian Hospital and is currently serving as the president of the Extracorporeal life support organization (ELSO).

Commercial Relationship Established by Inspira
The company is continuously in contact with commercial entities as well as leading medical institutions. Inspira has successfully secured several distribution agreements (the agreement have a term of up to 7 years, subject to the completion of product development and the receipt of regulatory approvals) for their products with leading distributers in the US (Texas, New Jersey, New York, Florida, North Carlina and South Carolina), Europe (Spain and Portugal, Poland, Czech Republic and Slovakia) and Israel.

in collaboration with Inspira Technologies