Haemonetics' Plasma Tool Enhancement Gets 510(K) Clearance

Haemonetics Corporation HAE has recently received the 510(k) clearance from the FDA for enhancement of the company's NexSys PCS embedded software. This development is expected to boost the company's growing plasma collection business.

Per Haemonetics, this latest regulatory clearance will enable the NexSys PCS embedded software to activate the YES technology, a yield enhancing solution aiding increases in plasma yield per collection. The commercial launch of NexSys PCS is expected this summer.

With the unveiling of NexSys PCS, the company will be able to deliver its entire line of offerings — the NexSys PCS device, its embedded software including YES technology, the NexLynk DMS donor management software, disposables, technical support as well as service in the United States.

In July 2017, the NexSys PCS device was originally granted the U.S. FDA 510(k) clearance. Later in September, the company completed the first plasma collections using the NexSys PCS plasmapheresis system at a customer's donor center. Haemonetics also announced a CE-mark clearance for this device in the European Union and Australia, subject to additional local requirements.

Notably, Haemonetics has been witnessing strong growth in Plasma franchise for quite some time. This upside is consistently led by solid end-market demand for plasma-derived biopharmaceuticals. The company remains confident about continual growth in the market of commercial Plasma collection business. It also has plans to implement the first customer contract for NexSys PCS beginning summer 2018 after the embedded software is approved and released.

Importantly, with diseases on the rise and an increasing number of accident and trauma cases, the market for plasma collection is growing by leaps and bounds. Per a report published in ABOUTPHARMA, the blood collection market is projected to reach a value of $10.59 billion by 2022 from $8.10 billion in 2017, witnessing a CAGR of 5.5% during the forecast period. Accordingly, we believe this latest breakthrough by Haemonetics to be well-timed and a strategic fit for the company's portfolio.

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