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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 has announced the first-in-human use of its HYLA Blood sensor during open-heart surgery at Sheba Medical Center in Israel. This non-invasive sensor utilizes machine learning to measure key blood parameters in real-time, aiming to enhance patient care during procedures like VV-ECMO and VA-ECMO. The ongoing HYLA clinical study compares the sensor's performance against traditional blood gas analyzers. The company's advanced Augmented Respiration Technology (INSPIRA ART) seeks to improve oxygen saturation levels without invasive ventilation methods. Regulatory approval is still pending for these technologies.
Inspira Technologies OXY B.H.N. Ltd. (NASDAQ: IINN, IINNW) has received Ethics Committee approval from
Inspira Technologies has received a patent from the U.S. Patent and Trademark Office for its innovative convertible dual lumen cannula device, crucial for its INSPIRA ART System. The patent encompasses 20 claims deemed novel, emphasizing its inventive step and industrial applicability. The device allows intravascular conversion of a single-lumen cannula into a dual lumen one, enhancing usability during medical procedures like ECMO. The company plans to seek international patents, integrate this device with existing products, and consider its separate commercialization as a disposable item, aiming to improve patient safety and procedural efficiency.
Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) has signed an exclusive OEM agreement with Terumo Cardiovascular, enhancing its product development in respiratory support technology. This partnership allows Terumo to manufacture a flow mechanism for Inspira's innovative INSPIRA ART system, designed to improve oxygen saturation in patients while they remain awake. The agreement aligns with Inspira's strategy to collaborate with major medical device companies to bring its technology to market, although the products have yet to be tested in humans.
Inspira Technologies (Nasdaq: IINN) will be featured in an interview on The RedChip Money Report® airing on Bloomberg TV on December 24, 2022, at 7 p.m. ET. Co-Founder Joe Hayon will discuss their innovative respiratory technology aimed at reducing the need for invasive mechanical ventilation. The company plans to initiate human studies at leading medical centers. Inspira's technology, known as Augmented Respiration Technology (INSPIRA ART), is designed to help patients maintain oxygen levels while minimizing the risks associated with traditional ventilation methods.
Inspira Technologies will be featured on The RedChip Money Report on Bloomberg TV on December 24, 2022. Co-Founder Joe Hayon discusses Inspira's innovative respiratory support technology aimed at reducing reliance on invasive mechanical ventilation. The interview highlights plans to initiate human studies and the potential of Inspira's technology to become the new standard of care for acute respiratory failure. The company's products are still in development and have not been tested on humans.
Inspira Technologies (NASDAQ: IINN) has initiated manufacturing for the ALICE CPB device, crucial for its market strategy. This device is set for FDA 510(k) submission in 2023. The ALICE device aims to enhance CPB support in healthcare settings, equipped with a large touchscreen and real-time blood monitoring capabilities via the HYLA™ Blood Sensor. Contract manufacturing is conducted by a qualified provider meeting GMP standards. The company aims to improve patient care accessibility globally and is establishing partnerships for clinical adoption.
Inspira Technologies (NASDAQ: IINN) announced a significant agreement with Sheba Medical Center for a clinical study of its HYLA blood sensor. This study will evaluate the sensor's non-invasive capabilities for continuous blood gas measurement in patients undergoing open heart surgery. Set to commence in Q1 2023, the results aim to enhance product development. The HYLA sensor is expected to improve real-time monitoring, which could lead to better patient outcomes and reduce healthcare costs.
Inspira Technologies OXY B.H.N. Ltd. (IINN) reported financial results for Q3 2022, with cash reserves of $16.2 million. The company is focused on developing the HYLA blood sensor for cardiopulmonary bypass surgery, aiming to enhance patient monitoring.
Research and development expenses surged to $6.2 million for the nine months ending September 30, 2022, while net loss reached $7.1 million. Inspira secured strategic agreements in Europe and the U.S. for the deployment of HYLA sensors, potentially valued at $26.1 million and $59 million, respectively.
Inspira Technologies (NASDAQ: IINN) announced a 5-year exclusive distribution agreement with Innovimed for the HYLA™ Blood Sensor, designed for continuous real-time blood parameter monitoring. The agreement requires Innovimed to purchase at least 1,364 sensors and 128,511 disposable units for hospitals in Poland, Czech Republic, and Slovakia. The collaboration aims to enhance market penetration in Europe while preparing for a clinical study of the HYLA™ Blood Sensor.
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