Peer-Reviewed Results of Haemonetics' Improving Plasma Collection (IMPACT) Trial Published in the Journal TRANSFUSION

Rhea-AI Summary

Haemonetics Corporation (NYSE: HAE) announces the publication of full results from the IMPACT trial in the journal TRANSFUSION. This multicenter study analyzed plasma collection methods involving 3,443 donors and 23,137 donations. The trial compared NexSys PCS® with YES® Technology and its Persona® Technology, achieving an 8.2% increase in plasma yield without compromising safety. The NexSys PCS® system with Persona® received FDA clearance in 2020. Plasma is vital for therapies for conditions like hemophilia and primary immunodeficiency, affecting approximately 750,000 patients across North America and Europe.

Positive

• 8.2% increase in plasma yield per collection due to Persona® Technology.
• NexSys PCS® system with Persona® received FDA 510(k) clearance.
• IMPACT trial represents one of the largest randomized controlled trials in plasmapheresis.

Negative

• None.

BOSTON, April 29, 2021 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, announced that the full peer-reviewed results of the IMproving PlasmA CollecTion (IMPACT) trial have been published in TRANSFUSION, the prime journal for transfusion medicine related research. The publication expands upon the IMPACT trial data presented in October 2020 in a plenary session at the AABB conference. IMPACT, a multicenter, prospective and double-blinded study, is one of the largest randomized controlled trials of plasmapheresis. The trial involved 3,443 donors who underwent 23,137 plasma donations.

IMPACT compared plasma collection using NexSys PCS^® with YES^® Technology, which collects plasma based on a donor's weight per the current industry standard nomogram, to collection with NexSys PCS^® with Persona^® Technology which uses a novel, personalized Percent Plasma Nomogram (PPN) based on body mass index (BMI) and hematocrit, to enable a more tailored collection target. The trial found that the personalized donation method has a non-inferior safety profile, and demonstrated a yield increase of +8.2% more plasma per collection on average as compared to the control, based on the donor population in the trial. Based on the results of the IMPACT trial, Haemonetics' NexSys PCS^® system with Persona^® Technology received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2020.

"Plasma is a critical ingredient for important medicines that can have a life-changing impact on patients suffering from hundreds of conditions including primary immunodeficiency, hemophilia, trauma and more," said Jan Hartmann, Haemonetics' Vice President, Medical Affairs, Clinical Development and Medical Safety. "We are committed to innovation and using the best available science to change the paradigm for plasma collection with our proprietary technology." ^1,2

According to the Plasma Protein Therapeutics Association (PPTA), approximately 750,000 people across Europe and North America rely on plasma for life-saving therapies³ and it can take hundreds of plasma donations to treat a single patient⁴.

The full publication, "Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram," can be accessed in the TRANSFUSION Journal here.

About NexSys PCS^® with Persona^® Technology
The NexSys PCS^® plasma collection system with Persona^® Technology is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the NexSys PCS^® system include source plasma and plasma for transfusion. The Persona^® Technology builds on NexSys PCS^® with YES^® Technology, which received FDA 510(k) clearance in 2018 and has been used to perform millions of collections to date and has been in extensive clinical use ever since. The NexSys PCS^® system with Persona^® Technology includes disposables and the ability to integrate with NexLynk DMS^® donor management system. Visit www.nexsyspcs.com to learn more.

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 NexSys PCS^® system with Persona^® Technology, and Haemonetics' plans or objectives related to the development and commercialization of this product. 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; market acceptance; the effect of economic and political conditions; the impact of the COVID-19 pandemic, including the scope and duration of the pandemic, government actions and restrictive measures implemented in response; 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 the Company's periodic reports and other filings with the U.S. Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements.

¹ https://www.donatingplasma.org/plasma-protein-therapies/who-needs-plasma-therapies
² https://www.jwatch.org/na50592/2019/12/30/prehospital-plasma-saves-lives-trauma-patients-with-longer
³ https://primaryimmune.org/specific-pi-diagnoses
⁴ https://www.donatingplasma.org/plasma-protein-therapies/who-needs-plasma-therapies

Investor Contact:	Media Contact:
Olga Guyette, Director-Investor Relations	Carla Burigatto, Vice President-Communications
(781) 356-9763	(781) 348-7263
olga.guyette@haemonetics.com	carla.burigatto@haemonetics.com

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SOURCE Haemonetics Corporation

FAQ

What were the main findings of the IMPACT trial published by Haemonetics?

The IMPACT trial found that NexSys PCS® with Persona® Technology achieved an 8.2% increase in plasma yield compared to the standard method while maintaining safety.

When was the IMPACT trial published in the journal TRANSFUSION?

The full results of the IMPACT trial were published on April 29, 2021.

How many donors participated in the IMPACT trial?

The IMPACT trial involved 3,443 donors who made a total of 23,137 plasma donations.

What impact does the IMPACT trial have on patients?

The trial's findings support improved plasma collection methods, which are critical for producing life-saving therapies for patients with conditions like hemophilia.

What is the significance of the FDA clearance for NexSys PCS® with Persona® Technology?

The FDA 510(k) clearance for NexSys PCS® with Persona® Technology signifies its approval for use in plasma collection, enhancing treatment capabilities.