Senior Director of Transfusion Medicine at Johns Hopkins University Brings Global Experience in Transfusion Medicine and Research
Company Recently Received CE Mark Certification for Innovative Red Blood Cell Processing and Storage System
LEXINGTON, Mass., Aug 3, 2021, PR NEWSWIRE – Hemanext Inc. (“Hemanext” or the “Company”), an innovator in blood processing and storage technology, today announced the appointment of Paul M. Ness, M.D., to its Board of Directors. Dr. Ness, the Senior Director of the Division of Transfusion Medicine at Johns Hopkins University, has also served as a clinical advisor to Hemanext.
This news follows the company’s recent receipt of the CE mark certification for its Hemanext ONE® prescription red blood cell (RBC) processing and storage system, allowing the innovative medical device to be sold in European markets.1
“We are fortunate and delighted to welcome Paul to our Board of Directors during this extraordinarily important time for Hemanext,” said company President and CEO Martin Cannon. “He is a globally recognized expert in blood banking, blood transfusion and patient blood management, and his counsel as one of our clinical advisors has been invaluable to our team as we’ve navigated the complexities of developing and commercializing our innovative technology. We look forward to continuing to draw upon Paul’s deep experience and clinical knowledge, as we move into this next exciting chapter for our business.”
Dr. Ness’ clinical expertise includes transfusion support of hematology and oncology patients, autoimmune hematologic disorders, and massive transfusion protocols. He has an extensive background in clinical transfusion medicine and research activities related to blood safety, and has taught blood safety education curricula internationally, including in China, India and Laos, and Thailand through the Hopkins Fogarty program, and in various teaching roles throughout Vietnam, India, and Africa.
“Improving the quality of red blood cells could be an essential step toward performing fewer and better transfusions for patients,” said Dr. Ness. “Hemanext’s innovative technology allows patients to be given red blood cells that have been protected from damage by oxygen and carbon dioxide, which could enhance clinical care while potentially reducing demand on our limited global blood supply. As a longtime supporter of Hemanext’s transformative work, I am proud to join the Board of Directors as the Company continues to strive to advance the quality of transfusion therapy to save lives and improve outcomes for patients.”
“Paul brings a wealth of clinical expertise and a unique perspective that will be invaluable as Hemanext continues to drive innovation in RBC processing and storage,” said Guy Cogan, Lead Independent Director. “This appointment marks an important milestone, as we work to build a world-class Board of Directors comprised of individuals with diverse and complementary skill sets who can work closely with the management team to drive the company forward to achieve its mission.”
The innovative Hemanext ONE RBC Processing and Storage System, is a prescription medical device that aims to provide a higher quality RBC by limiting oxygen and carbon dioxide, the fuel for oxidative damage.1-4 In vitro research suggests that hypoxic RBCs can reduce plugging and slow the decline of blood flow rates when compared to conventionally stored RBCs–two indicators of RBC quality.5,6 Clinicians believe improving the quality and function of RBCs could have a meaningful impact on patient outcomes.3,5,6
On April 13, 2021, Hemanext announced that it had received a CE Certificate of Conformity for the CE Mark of the Hemanext ONE Red Blood Cell (RBC) Processing and Storage System, allowing the innovative medical device to be sold in European markets.
In the U.S., the Hemanext ONE System is an investigational device that has not yet been cleared or approved by the U.S. Food and Drug Administration (FDA), and is not currently available for sale or commercial use. The company plans to submit its application for FDA authorization of the System later this year.
About Dr. Paul Ness
Prior to his current role, Dr. Ness has served as director of the Division of Transfusion Medicine and program director of the Blood Banking/Transfusion Medicine Fellowship Program in the Department of Pathology at Johns Hopkins for 38 years. He also served as editor of Transfusion, a globally recognized journal of medicine, for 15 years, and is former president of the American Association of Blood Banks.
Dr. Ness received his undergraduate degree from the Massachusetts Institute of Technology and earned his M.D. from the State University of New York at Buffalo. He completed his residency at The Johns Hopkins Hospital and performed a fellowship in Hematology-oncology at the University of California San Francisco.
Hemanext is a privately held medical technology company dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company’s research and development efforts center on the study of hypoxically stored red blood cells (RBCs).
Since its founding in 2008, Hemanext has envisioned a world with fewer and better transfusions.
In its early years, multiple grants from the U.S. National Institutes of Health (NIH) enabled the company to demonstrate the feasibility of hypoxic RBC storage, develop its first prototype system, and conduct in vivo research.
In 2017, the NIH awarded the company an additional $3 million grant to further develop the Hemanext ONE RBC Processing and Storage System; the company also completed research that became the pivotal clinical study for obtaining CE Mark certification. In 2018, in preparation of its forthcoming FDA submission, Hemanext completed another clinical study for the Hemanext ONE RBC Processing and Storage System. In 2020, Hemanext and its research colleagues published the latest in a series of papers in important journals that added to the body of scientific evidence supporting the clinical potential of hypoxic RBC storage.
Visit Hemanext.com to learn more about the Company.
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INDICATIONS FOR USE: Blood container set used to process and store Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced. HEMANEXT ONE is intended to process and store CPD/ PAGGSM Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared and processed with the HEMANEXT ONE system within 24-hours of collection. The HEMANEXT ONE system limits the O2 and CO2 levels in the storage environment. Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. HEMANEXT ONE is used for volumes no greater than 350 ml of LR RBC.
2 Yoshida, T et al. Blood Transfus. 2019: 17 (1): 27-52.
3 D’Alessandro A, Yoshida T, Nestheide S, et al. Transfusion. 2020; 9999; 1–13
4 Whitley et al. ISBT 2018 [Meeting Abstract].
5 Burns et al. Blood Transfus 2016;14:80-8.
6 Piety et al. Scientific Reports 2016; https://doi.org/10.1038/s41598-020-79710-3