Haemonetics Announces FDA Clearance of New Plasmapheresis System Branded NexSys PCS™
BRAINTREE, Mass., July 28, 2017 /PRNewswire/ -- Haemonetics Corporation (NYSE:HAE) has received FDA 510(k) clearance for its NexSys PCS™ plasmapheresis system. The NexSys PCS includes bi-directional connectivity to Haemonetics' donor management system, NexLynk DMS™, and builds on Haemonetics' industry leading position with a design inspired by extensive user research.
"NexSys PCS is designed to increase productivity and improve quality and compliance in plasma collection centers," said Christopher Simon, CEO of Haemonetics. "Each of these benefits is noteworthy and when combined we believe will unlock meaningful value for our customers."
The open architecture of NexSys PCS facilitates bi-directional connectivity to donor management systems enabling automated collection procedure programming and automated end of procedure documentation. The simple guided operation, large intuitive touch screen, and on-screen troubleshooting assistance on NexSys PCS are designed to improve plasma center efficiencies resulting in reduced total time for donors in the center and improved collection capacity per plasma center.
As previously communicated, Haemonetics plans to immediately begin limited production of NexSys PCS devices and intends to pursue further regulatory clearances for additional enhancements to the overall product offering.
NexSys PCS and NexLynk DMS were previously referred to as PCS 300 and NexGen DMS.
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative hematology products and solutions for our customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit our web site at http://www.haemonetics.com.
NexSys PCS and NexLynk DMS are trademarks of Haemonetics Corporation in the USA, other countries, or both. All rights reserved.
FORWARD LOOKING STATEMENTS
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for operations of the Company, including plans for commercialization of, and regulatory clearances related to, the Company's NexSys PSC plasma collection system and NexLynk DMS donor management system.
Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties.
Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, technological advances in the medical field and standards for transfusion medicine and our ability to successfully offer products that incorporate such advances and standards, product quality, market acceptance, regulatory uncertainties, including in the receipt or timing of regulatory clearances, the effect of economic and political conditions, the impact of competitive products and pricing, blood product reimbursement policies and practices, and the effect of industry consolidation as seen in the plasma market.
Additional risk factors are identified and described in more detail in the Company's filings with the SEC.
The Company does not undertake to update these forward-looking statements.
INVESTOR CONTACT:
Gerry Gould, VP-Investor Relations
(781) 356-9402
[email protected]
SOURCE Haemonetics Corporation
Share this article