Inspira Technologies' (IINN) ART100 Gets FDA 510(k) Grant

Zacks Equity Research
·3-min read

Inspira Technologies OXY B.H.N. Ltd. IINN recently received the FDA 510(k) clearance for its INSPIRA ART100 — a Cardiopulmonary Bypass System. This approval is a significant milestone for the company, highlighting its innovative advancements in medical technology.

Inspira Technologies is a cutting-edge medical technology business that focuses on the life support arena.

Breakthrough Technology in Cardiology

The INSPIRA ART100 device is used in an extracorporeal perfusion circuit to pump blood during brief cardiac bypass procedures of six hours or less.

With a prominent screen, 360-degree LED flow presentation and large digit display, the patient’s information is easily viewed from a distance, making the INSPIRA ART100 ideal in both standard and challenging care situations, such as isolation or in-transit scenarios.

Potential Application of INSPIRA ART100

The INSPIRA ART100 adjusts effortlessly to various consumables. Customizing the tubing and priming set with any oxygenator and related holder simplifies purchase and inventory management.

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The next-generation INSPIRA ART100 will work with Inspira's AI-powered Clip-On HYLA blood sensor and tube. This integration enables real-time blood parameter measurements. The new features will optimize the process and save time and resources.

With this latest FDA 510(k) clearance, the company aims to revolutionize external mechanical ventilation machinery for the nearly 20 million people who need ventilation and oxygenation annually.

Industry Prospects

Per a report, the global cardiopulmonary bypass equipment market size was in $421 million 2021 and is expected to reach $810.9 million by 2028, registering a CAGR of 9.7%. The rising healthcare expenditure to curb serious illnesses, such as cardiac diseases, is estimated to drive the demand for cardiopulmonary bypass equipments.

Recent Highlights

In April 2024, Inspira announced the signing of a collaboration term sheet (the ‘Term Sheet’) with the Beilinson Hospital in Israel for the evaluation of its proprietary INSPIRA ART100 device (the ‘Device’) in organ transplant procedures.

In March 2024, Inspira reached a significant milestone with the submission of its INSPIRA ART100 for approval under the Israeli Ministry of Health's AMAR regulation. This regulatory progress is poised to open doors to new markets, particularly in Southeast Asia and South America, paving the way for remarkable growth opportunities for the company.

Price Performance

In the past year, IINN has risen 37% compared with the industry’s rise of 10.4%.

Zacks Rank and Key Picks

Inspira Technologies currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Medpace MEDP, ResMed RMD and Encompass Health Corporation EHC.

Medpace, sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2024 earnings per share (EPS) of $3.20, beating the Zacks Consensus Estimate by 30.6%. Revenues of $511 million improved 17.7% from last year’s comparable figure. You can see the complete list of today’s Zacks #1 Rank stocks here.

Medpace has an estimated 2024 earnings growth rate of 26.5% compared with the industry’s 12.3%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 12.8%.

ResMed, sporting a Zacks Rank #1, reported first-quarter 2024 EPS of $2.13, which topped the Zacks Consensus Estimate by 10.9%. Revenues of $1.20 billion surpassed the Zacks Consensus Estimate by 1.9%.

RMD has an estimated fiscal 2024 earnings growth rate of 17.9% compared to the industry’s 15.7%. In each of the trailing four quarters, the company delivered an average earnings surprise of 2.8%.

Encompass Health, carrying a Zacks Rank #2, reported first-quarter 2024 adjusted EPS of $1.12, surpassing the Zacks Consensus Estimate by 20.4%. Net operating revenues of $1.3 billion topped the Zacks Consensus Estimate by 3.6%.

EHC has an estimated long-term earnings growth rate of 15.6% compared with the industry’s 11.7% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 18.7%.

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