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Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN) is at the forefront of developing innovative respiratory support technology as an alternative to invasive mechanical ventilation. The company's flagship product, INSPIRA ART100, is a breakthrough in Augmented Respiration Technology designed to maintain optimal oxygen levels in patients without the need for intubation and sedation. This technology is particularly significant in the treatment of respiratory failure and offers a less invasive option compared to traditional mechanical ventilation.
Inspira Technologies operates in various regions, including North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa. The company is involved in the research, development, manufacture, and marketing of proprietary respiratory care devices, aiming to transform the landscape of acute and neonatal care.
Recently, Inspira Technologies has announced several key developments:
- April 3, 2024: Commencement of a program to explore the use of the INSPIRA ART100 Device for an artificial womb for neonates requiring vital respiratory support.
- April 10, 2024: Collaborative development with Ennocure MedTech Ltd. on bio-electronic treatment to prevent bloodstream infections in ICU patients, showcasing a 100% reduction in bacterial growth within 24 hours in an in vitro study.
- April 16, 2024: Signing of a collaboration term sheet with Beilinson Hospital for the evaluation of the INSPIRA ART100 device in organ transplant procedures.
- April 25, 2024: Receiving CSA Certification of Compliance to U.S. standards for the INSPIRA ART100 device.
- May 2, 2024: Initiation of the production of the INSPIRA ART100 medical device by a leading technology company.
- May 28, 2024: Notification of 510(k) class II clearance from the U.S. FDA for the INSPIRA ART100.
Inspira's products are designed not only to enhance patient outcomes but also to reduce the costs and complications associated with traditional respiratory support methods. The INSPIRA ART100 system has received FDA clearance, marking a pivotal moment in the company's history. Other products in the pipeline, including the INSPIRA ART (Gen 2) and HYLA™ blood sensor, are poised to further revolutionize respiratory care once approved.
Inspira Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) has announced that a key component of its ART and ECLS systems is now listed on the FDA Class I 510(k) exempt list. This component aims to mitigate complications from jugular vein cannula movement during patient transport and is expected to enhance safety for awake ECMO patients during mobilization. Although the ART system is designed for cost-effective respiratory support, it has not yet been tested on humans nor received approval from the FDA.
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) has announced the appointment of Professor Daniel Brodie to its Scientific Advisory Board. Prof. Brodie, known for his expertise in critical care and extracorporeal life support, leads the Adult ECMO Program at Columbia University/New York-Presbyterian Hospital. His appointment follows other notable additions to the advisory board, enhancing the company's leadership in respiratory support technology. Inspira is developing the ART device, an innovative system aimed at improving oxygenation in respiratory patients, although it has not yet received FDA approval.
Inspira Technologies (Nasdaq: IINN) has signed an exclusive distribution agreement with Innovimed for the ART device in Poland, Czech Republic, and Slovakia. The agreement, with an initial term of 7 years, includes a commitment to purchase a minimum of 1,552 ART devices and 59,040 disposable units. This follows a prior agreement with WAAS Group for potential revenues of $66 million in Spain and Portugal. The ART device aims to reduce the need for invasive mechanical ventilation for respiratory failure patients, pending regulatory approvals.
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) has filed a Patent Cooperation Treaty application for its ART device, an early-stage extracorporeal respiratory support system. Designed to assist patients while awake, the ART aims to reduce the need for invasive mechanical ventilation. This innovative system enriches blood oxygen levels rapidly, utilizing a low-flow approach that minimizes complications associated with traditional methods. The ART is poised for deployment both in and outside ICU settings, contributing to cost-effective respiratory care.
Inspira Technologies (Nasdaq: IINN) announced the addition of Professor Eddy Fan to its Scientific Advisory Board. Prof. Fan, a critical care specialist from the University of Toronto, aims to enhance the development of Inspira's innovative ART device, designed for respiratory support in patients with acute conditions. This collaboration is expected to improve the clinical applications of the ART device, although it remains untested in humans and lacks regulatory approvals. CEO Dagi Ben-Noon emphasized the significance of Prof. Fan's expertise in advancing hybrid respiratory support solutions.
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) reported its Q3 2021 financial results, showcasing significant progress following an exclusive agreement with WAAS Group for over 1,000 ART systems deployment in Spain and Portugal. The Company raised capital after most IPO warrants were exercised at $5.50 per share. R&D expenses decreased to $1.7 million while net loss increased to $6 million. Notably, Q3 net profit surged to $2.2 million. Cash reserves rose to $17 million, significantly up from $496,000 at year-end 2020, reflecting positive IPO proceeds.
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) has announced the appointment of Dr. Stephane Ledot to its Scientific Advisory Board. Dr. Ledot, an expert in critical care and anesthesia, brings extensive experience to the role, having previously served as director of the ECMO service at Royal Brompton Hospital. His expertise is expected to enhance the company’s efforts in developing the ART device, an innovative extracorporeal respiratory support system. The device aims to support patients with acute respiratory failure without the need for mechanical ventilation.
Inspira Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) announced that Co-Founder and CFO Joe Hayon will present at the H.C. Wainwright 7th Annual Israel Virtual Conference on November 15 at 2:30 PM EST. One-on-one meetings are available for attendees. A replay of the presentation will be accessible on Inspira's investor relations page post-event. Inspira Technologies is developing the ART device, an innovative respiratory support system designed to act as an 'Artificial Lung' for patients, though it has yet to be tested in humans and is not FDA-approved.
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) has filed a Patent Cooperation Treaty application for its innovative dual lumen cannula designed to enhance respiratory care. This novel device aims to improve patient outcomes by preventing complications like air embolisms, bleeding, and infection. The dual lumen cannula allows for bedside insertion into large blood vessels, quickly rebalance oxygen saturation while reducing human error. CEO Dagi Ben-Noon highlighted the goal to offer cost-effective support for patients with acute respiratory failure, though the product is still in development and not FDA approved.
Inspira Technologies (Nasdaq: IINN) has signed an exclusive distribution agreement with Anita Técnica S.L. (WAAS Group) to deploy ART devices in Spain and Portugal over a period of seven years. The agreement entails WAAS Group purchasing a minimum of 1,040 ART devices and 35,360 disposable units, pending regulatory approval. The ART device aims to support patients with respiratory failure while awake, potentially reducing mechanical ventilation reliance. This collaboration leverages WAAS Group's market penetration capabilities in the region, positioning Inspira for rapid adoption.
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