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Favorable Clinical Results for HYLA Sensor Might Boost Inspira Stock

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Inspira Technologies OXY B.H.N. Ltd. (IINN - Free Report) recently announced plans to report clinical results for its new HYLA blood sensor in open-heart surgery patients. Since the medical industry is highly interested in the HYLA blood sensor, these clinical results should be on par with Inspira's long-term growth plans.

About Inspira’s HYLA Blood Sensor

HYLA blood sensor is an advanced tubing clip-on sensor designed to monitor a patient’s state in real-time by continuously measuring vital blood parameters. The clip-on HYLA sensor is aimed at alerting physicians of immediate signs of change in a patient's clinical condition without the need for intermittent actual blood samples. This proactive approach fosters informed decision-making, potentially preventing complications and enhancing patient outcomes. This sensor is applicable in intensive care units and operating rooms.

Inspira’s Future Plan for HYLA Blood Sensor

The clinical study results for the first HYLA configuration are expected to be released in the fourth quarter of 2024. The company is also aiming for a 510(k) submission to the Food and Drug Administration ("FDA") in early 2025. The first HYLA configuration is intended to integrate with the already FDA-cleared INSPIRA ART100.

To develop the HYLA Blood Sensor line, Inspira utilizes in-house lab testing as well as hospital collaborations for the purpose of clinical research and development. While it is primarily designed for INSPIRA ART devices, plans are underway to offer a variant of the blood sensor as a standalone device.

Inspira’s Business Advancements

Inspira strives to transform the respiratory and life-support sectors through innovative oxygenation and blood monitoring technologies, targeting a market opportunity estimated at $59 billion annually.

The company is expanding and leading the development of the INSPIRA ART pipeline, which consists of the HYLA blood sensor, INSPIRA Cardi-ART and INSPIRA ART (Gen 2), commonly referred to as the INSPIRA ART500. These items have not yet been tested on humans or received approval from any regulatory agency.

Inspira is focused on deploying the INSPIRA ART100 system in top hospitals in the United States and Israel. In line with this, the INSPIRA ART100 system has already obtained FDA 510(k) clearance for use in Cardiopulmonary Bypass procedures, along with the Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

Industry Prospects Favoring Inspira

Per a report from Verified Market Reports, the arterial blood gas (ABG) analyzers market was valued at $3.5 million in 2023 and is projected to reach $88.5 million by 2030, at a compound annual growth rate (CAGR) of 7.1% during the period. The key factor driving robust market growth is the increasing use of minimally invasive diagnostic techniques in medical facilities around the globe. Additionally, the expanding aging population and the rising prevalence of chronic respiratory illnesses contribute to the increase in market demand. 

 

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Per a Future Market Insights report, the point-of-care diagnostics market was valued at $36.6 billion at the end of 2022 and is anticipated to reach $74.8 billion by 2033. The increasing adoption of the latest technologies, and new product launches and approvals are likely to boost market growth.

Therefore, Inspira’s plan to report the clinical results for HYLA turns out to be in favour of the point-of-care diagnostics and ABG analyzers market potential.

Other Recent Developments by Inspira

Earlier in August, the company received an FDA listing for its INSPIRA CART. This medical cart, designed for use with the INSPIRA ART100 system, is aimed at enhancing 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.

In the past 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 issue or adverse effect on the blood.

Price Performance of Inspira

Shares of Inspira have increased 1.9% so far this year compared with the industry’s 10% growth. 

IINN’s Zacks Rank and Key Picks

IINN currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Intuitive Surgical (ISRG - Free Report) , TransMedics Group (TMDX - Free Report) and Boston Scientific (BSX - Free Report) . While Intuitive Surgical and TransMedics currently sport a Zacks Rank #1 (Strong Buy) each, Boston Scientific carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Intuitive Surgical’s shares have surged 58.8% in the past year. Estimates for the company’s earnings have remained constant at $6.67 per share for 2024 in the past 30 days.

ISRG’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 8.97%. In the last reported quarter, it posted an earnings surprise of 16.34%.

Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 48.1% to $1.20 in the past 30 days. Shares of the company have risen 143.2% in the past year compared with the industry’s 11% growth.

TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.

Estimates for Boston Scientific’s 2024 EPS have increased 1.7% to $2.40 in the past 30 days. In the past year, shares of BSX have risen 52.5% compared with the industry’s 15% growth.

In the last reported quarter, BSX delivered an earnings surprise of 6.90%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.18%.

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