Le Lézard
Classified in: Health, Science and technology
Subject: FDA

Haemonetics Receives FDA Clearance for Enhancements to NexSys PCS® Plasma Collection System


BOSTON, June 22, 2023 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions to drive better patient outcomes, today announced it has received clearance from the?U.S. Food and Drug Administration?(FDA) for advancements to its NexSys PCS® plasma collection system. These include a new plasma collection bowl, featuring a patented design that optimizes performance, and new Express® Plus Technology engineered to reduce procedure time.

Haemonetics is the leader in the plasma collections market, with five decades of industry experience and over 50 million real-world collections to date on NexSys PCS, the industry's most advanced, completely integrated system designed to streamline plasma collections and improve yield, productivity, safety, quality, compliance and donor satisfaction. With the latest advancements, Haemonetics expects an average procedure time of 33 to 38 minutes using the standard FDA nomogram, helping customers achieve new levels of plasma center efficiency and lower costs to collect. 

The bi-directionally connected NexSys PCS with NexLynk DMS® donor management software already delivers a 16-minute reduction in donor door-to-door time, on average, with a significant portion of this improvement occurring pre- and post-procedure. Additionally, NexSys PCS with Persona® Technology safely delivers on average a +9% to 12% additional plasma yield by personalizing each collection to the individual donor characteristics. Haemonetics is planning an initial market release of NexSys PCS with the new bowl and Express Plus Technology over the coming months.

"Haemonetics sets the standard in global plasma collection solutions that meet collectors' most critical needs. With our redesigned bowl and new Express Plus Technology for faster procedure times and enhanced plasma center efficiency, we continue to advance our innovation to lead the industry in reducing cost per liter for collectors and ensuring the best experience for their donors," said Roy Galvin, President, Global Plasma and Blood Center at Haemonetics.

ABOUT HAEMONETICS

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for 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 www.haemonetics.com.

Cautionary Statement Regarding Forward-Looking Information 

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 the operation of Haemonetics, including statements regarding potential benefits associated with the redesigned plasma collection bowl and new Express Plus Technology for the NexSys PCS plasma collection system, and Haemonetics' plans or objectives related to the commercialization of these product enhancements. 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 Haemonetics' 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, product quality and performance; market acceptance; the effect of economic and political conditions; the impact of inflationary pressures in our global manufacturing and supply chain; 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. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.

Investor Contacts:                 


Olga Guyette, Sr. Director-Investor Relations & Treasury    

   David Trenk, Manager-Investor Relations

(781) 356-9763                                                           

   (203) 733-4987

[email protected]                     

    [email protected]        


Media Contact: 

Josh Gitelson, Director-Global Communications

(781) 356-9776

[email protected] 

 

SOURCE Haemonetics Corporation


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