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Haemonetics (HAE) Autotransfusion System Gets 510(k) Clearance

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Haemonetics (HAE - Free Report) recently gained FDA’s 510(k) clearance for its next-generation Intelligent Control Software for Cell Saver Elite+ Autotransfusion System. The approval was followed by a full market release of the same.

According to Haemonetics, this software upgrade offers customers key enhancements to help simplify operations, while enhancing efficiency and improving user experience.

The latest development is expected to upgrade Haemonetics’ Cell Salvage platform and broaden the company’s scope in the growing autotransfusion space.

A Few Words on The Cell Saver Elite+

This autotransfusion system, with its advanced technology, helps hospitals to recover a patient's blood during surgical procedures with the potential for medium-to-high blood loss. This in turn helps to avoid unnecessary allogeneic transfusions while reducing related procedure costs.

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This Intelligent Control software has more than 50 automation enhancements for a better user experience. These include complete user control with a "Manual Mode" option, expanded wash volumes adjustable to the Association for the Advancement of Blood & Biotherapies (AABB) recommended levels, and enhanced emergency options.

Market Prospects

Going by a Mordor Intelligence report, the auto-transfusion systems market is projected to witness a CAGR of 5.2% from 2019 to 2027. Per the report, the initial phase of the COVID-19 pandemic lowered the demand for auto-transfusion systems, thereby impacting the market's overall growth. However, the resumption of surgeries after the relaxation of regulations increased demand for autotransfusion systems. The current scenario is expected to drive the growth of the market over the forecast period.

Haemonetics' Recent Updates

Haemonetics has been witnessing strong growth in the Plasma franchise for quite some time. In the global plasma market, Haemonetics holds approximately 80% share.  Haemonetics is currently witnessing plasma market growth above historic rates, driven by an industry striving to double collections by 2025 and the rising demand for plasma-based medicines. The company continued to benefit from the NexSys device and NexLynk donor management software (DMS), backed by increased customer adoptions.

Under the Hospital business, Hemostasis Management is witnessing strong growth over the past few quarters. The recently-acquired Vascular Closure business continues to excel. Vascular Closure represents the company’s largest hospital growth opportunity. The company is currently focusing on accelerating its penetration into the $2.8 billion U.S. market by pursuing regulatory approvals to drive international expansion and strengthen its product portfolio via pipeline innovation and inorganic investments.

In Blood Center, the environment for this business continues to be challenging. However, the company remains focused on providing innovative products, leveraging on the strength of its supply chain and technology to increase market share.

Share Price Performance

Over the past six months, Haemonetics has outperformed its industry. The stock has gained 4.3% compared with the industry's 3.1% rise.

Zacks Rank and Other Key Picks

Haemonetics carries a Zacks Rank #1 (Strong Buy).

A few other top-ranked stocks in the overall healthcare sector include Hologic, Inc. (HOLX - Free Report) , TerrAscend Corp. and Akerna Corp. . Hologic and TerrAscend both sport a Zacks Rank #1, while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Hologic has an estimated long-term growth rate of 15.2%. HOLX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 30.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Hologic has gained 10.9% against the industry’s 14.7% decline in the past year.

Estimates for TerrAscend in 2023 have remained constant at a loss of 10 cents per share in the past 30 days. Shares of TerrAscend have declined 70.6% in the past year.

TerrAscend’s earnings beat estimates in one of the last three quarters and missed the mark in the other two, with the average negative surprise being 136.11%. In the last reported quarter, TRSSF delivered an earnings surprise of 216.67%.

Akerna’s stock has declined 95.7% in the past year. Estimates for 2023 have remained constant at a loss of $1.91 per share over the past 30 days.

Akerna missed earnings estimates in each of the last four quarters, delivering a negative earnings surprise of 15.49% on average. In the last reported quarter, KERN delivered a negative earnings surprise of 13.33%.


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