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INSPIRA (IINN) CART Gets FDA Listing, to Enhance Healthcare

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Inspira Technologies OXY B.H.N. Ltd. (IINN - Free Report) recently announced the FDA listing of its INSPIRA CART. This medical cart, designed for use with the INSPIRA ART100 system, aims to enhance healthcare delivery in operating rooms during cardiopulmonary bypass procedures.

The FDA classification as a Class I Medical Device and 510(K) Exempt highlights its compliance with rigorous safety and efficacy standards, paving the way for its introduction to the U.S. market.

Significance of the Announcement

The FDA listing of the INSPIRA CART takes it a step closer to entry into the U.S. market. By transforming the INSPIRA ART100 system into a mobile workstation, this innovation is poised to enhance operational efficiency and support medical professionals in delivering swift, effective care during cardiopulmonary bypass procedures. The company's receipt of the first order from Glo-Med Networks, Inc. further underscores the growing recognition and potential impact of this technology in the healthcare sector.

Inspira’s Advancements

Inspira is making strides to transform the respiratory and life-support sectors with its innovative technologies, targeting a market opportunity estimated at $59 billion annually. The company is focused on deploying its FDA-cleared INSPIRA ART100 system in top U.S. and Israel hospitals and is actively pursuing partnerships to expand its impact in the industry.

Inspira is also advancing its product pipeline, which includes the HYLA blood sensor, designed for continuous real-time blood monitoring, the INSPIRA Cardi-ART, a portable device aimed at supporting patients during cardiac arrest by oxygenating the brain and the INSPIRA ART (Gen 2), or ART500, which integrates adaptive blood oxygenation technology with the HYLA sensor to elevate patient oxygen levels rapidly, potentially reducing the need for mechanical ventilation.

While INSPIRA ART100 has already received FDA and AMAR certifications for cardiopulmonary procedures, the company's other products, such as the INSPIRA ART (Gen 2), Cardi-ART and HYLA blood sensor, are still in development and have not yet been tested in humans or approved by regulatory bodies.

Industry Prospects

Per a report in Future Market Insights, the medical cart marketsize is likely to be worth $1.14 billion in 2024. It is anticipated to reach $2.76 billion by 2034 at a CAGR of 9.3%.

The robust growth is likely to be mainly driven by several key factors, including the increasing adoption of digital healthcare solutions and electronic health records (EHR), which necessitate mobile, technologically advanced carts. The demand is further fueled by the growing emphasis on providing patient care at the point of need, requiring efficient point-of-care services. Continuous innovation in medical cart technology, with features IoT connectivity, touch screens and automation, enhances functionality and usability. Additionally, the expanding elderly population, rising incidences of chronic diseases, and government regulations promoting advanced medical equipment contribute to the market's expansion. Increased awareness among healthcare professionals about the benefits of medical carts also plays a crucial role in improving patient care and workflow efficiency.

Recent Developments

Earlier this month, Inspira announced that a prominent medical technology company approached it to evaluate the performance of its proprietary product in combination with the INSPIRA ART100 system. The evaluation, conducted by Inspira researchers in their advanced laboratory, demonstrated impressive results, with the integrated system exceeding 100% of the standard value for gas transfer at maximum flow. The tests, which adhered to strict regulatory guidelines, confirmed that the system performed as expected, effectively managing blood parameters in real time without any technical issues or adverse effects on the blood.

Last month, Inspira announced the receipt of Israel Ministry of Health's AMAR approval for its INSPIRA ART100 system, designed for extra-corporeal membrane oxygenation and cardiopulmonary bypass. This approval is a key step in Inspira's strategy to expand its market presence and underscores the company's ability to secure regulatory approvals, paving the way for local adoption and support of its innovative medical technologies.

Price Performance

Shares of Inspira have decreased 15.4% so far this year against a 12.6% rise in the industry. The S&P 500 has witnessed a 26.6% rise in the same time frame.

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Zacks Rank & Key Picks

Currently, Inspira carries a Zacks Rank #3 (Hold).

Some top-ranked stocks in the broader medical space are Universal Health Services (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) and ABM Industries (ABM - Free Report) . While Universal Health Services carries a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.

Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.

Universal Health Services has gained 41.1% compared with the industry's 34.8% rise so far this year.

Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.

Quest Diagnostics shares have gained 3.7% so far this year compared with the industry’s 10.2% rise.

ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.

ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% increase.

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