
Hemanext Announces Close of Series B3 Equity Financing Round
Advancing a New Standard in Red Blood Cell Therapy
The HEMANEXT ONE® RBC Processing and Storage system limits oxygen, the fuel for oxidative damage, providing a higher quality blood product. (1,2,3) It has the potential to benefit all patients requiring transfusion for chronic conditions, such as thalassemia (4), sickle cell disease (SCD)[5], and myelodysplastic syndromes (MDS),(6) as well as those in need of critical transfusions during acute bleeding in surgery, trauma and other medical procedures (7) Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration, is patented, and is CE marked which allows its commercial distribution within the market of the European Economic Area (EEA).
Hemanext has extensive patent coverage extending through 2039 and additional pending patent applications. Hemanext has also recently received our first US Health Care Common Procedure Coding System (HCPCS) reimbursement code from the Centers for Medicare and Medicaid Services (CMS) for hypoxic blood at $487 per unit for out-patient use — the first new code for a red blood cell product in 20 years. The Hemanext ONE System integrates seamlessly into existing transfusion medicine workflows and requires minimal clinician training or additional equipment to commence adoption.
Hospitals in select geographies have begun treating patients with hypoxic red blood cells (RBCs) produced using the Hemanext ONE system, while other leading institutions are actively validating the technology. Hemanext has:
· Begun producing hypoxic RBCs at Vitalant, one of the largest nonprofit blood centers in the United States, for use at a large, leading U.S. hospital.
· Initiated validation of the Hemanext ONE system at a world-renowned U.S. medical institution recognized for pioneering clinical research and patient care.
· Initiated use of Hemanext ONE system in Greece among patients with thalassemia.
· Commenced enrollment in a randomized controlled clinical trial in Norway for transfusion-dependent hematologic malignancy patients.
Use of Proceeds
Hemanext expects the proceeds from the B3 round to enable execution of critical commercial and clinical objectives through Q1 2026, including:
· Expanding early access deployments across hospitals and blood centers in the U.S.
· Generating real-world transfusion data across a range of clinical settings.
· Accelerating customer adoption using established reimbursement pathways.
· Establishing recurring sales from early adopter blood banking and hospital partners.
Andrew Dunham, Chief Executive Officer of Hemanext, commented, 'We are thankful for the continued trust of our existing investors and are pleased to welcome new investors who share our vision for transforming transfusion care. The capital raised gives us a clear path to generating the commercial and clinical evidence required to generate substantial revenue in 2026.'
Steve Eckert, Chairman of the Board, added, 'This financing underscores strong confidence in Hemanext's ability to achieve our mission of delivering innovations that improve the standard of care for patients who rely on transfusions by transforming RBCs through protecting their quality, functionality, and viability during storage. In addition to patient benefit, Hemanext is able to deliver a compelling value proposition to customers and investors alike. With a pure consumable model, no upfront capital investment required, simple integration into existing workflows, and materially improved reimbursement economics for providers, the company is uniquely positioned to reshape the transfusion landscape.'
About Hemanext
Hemanext is a privately held medical technology company based in Lexington, MA that is dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company's research and development efforts focus on the study of hypoxically stored RBCs. The company's aim is to significantly improve the quality of stored RBCs worldwide.
Visit Hemanext.com to learn more about the Company.
About Hemanext ONE
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. It is intended to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared within the standard 8-hour hold time. Processing of Red Blood Cells processed with the HEMANEXT ONE system must be initiated within 8 hours of collection and completed within 12 hours of collection. The Red Blood Cells must be processed at room temperature (20-26°C). The HEMANEXT ONE system limits 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.
In Europe, Hemanext ONE is CE marked, which allows its commercial distribution within the market of the European Economic Area (EEA).
HEMANEXT ONE creates hypoxic RBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level throughout storage up to 42 days. (3) Hypoxic RBCs have demonstrated positive impacts on multiple in vitro metrics of RBC quality in preclinical studies. (8,9) Clinical studies are underway to determine the impact of hypoxic RBCs on patient outcomes and estimate potential cost savings from expected improvements in care and reductions in transfusion volumes. (10)
References
1. Rabcuka J, Blonski S, Meli A, et al. Metabolic reprogramming under hypoxic storage preserves faster oxygen unloading from stored red blood cells. Blood Adv.2022;6(18):5415-5428. doi: 10.1182/bloodadvances.2022007774.
2. Reisz JA, Wither MJ et al. Oxidative modifications of glyceraldehyde 3-phosphate dehydrogenase regulate metabolic reprogramming of stored red blood cells. 2016;128(12): e32-42.
3. HEMANEXT ONE® (Blood container set used to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, and O2/CO2Reduced) [US Instructions for Use]. Lexington, MA: Hemanext Inc.
4. Farmakis D, Porter J, Taher A, et al. 2021 Thalassemia International Federation Guidelines for the management of transfusion-dependent thalassemia. 2022;6:8.
5. Chou S, Alsawas M, Fasano R, et al. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020;4:2.
6. Germing U, Oliva E, Hiwase D, and Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. 2019;3(6). doi: 10.1097/HS9.0000000000000314
7. American College of Surgeons. ACS TQIP massive transfusion in trauma guidelines. ACS TQIP.2014; https://www.facs.org/media/zcjdtrd1/transfusion_guildelines.pdf.
8. Yoshida T, Blair A, D'Alessandro A, et al. Enhancing uniformity and overall quality of red cell concentrate with anaerobic storage. Blood Transfus.2017;15(2):172-81.
9. Yoshida T, McMahon E, Croxon H, et al. The oxygen saturation of red blood cell concentrates: The basis for a novel index of red cell oxidative stress. Transfusion. 2022;62(1):183-193. doi: 10.1111/trf.16715.
10. Reikvam H, Hetland G, Ezligini F, et al. Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: An interim analysis. Transfus Apher Sci.2023; doi: 10.1016/j.transci.2023.103755.
Contact Information:
Hemanext
Daan Kok, Head of Business Development and Strategy
+41782061460
Contact via Email
https://hemanext.com
Read the full story here: Hemanext Announces Close of Series B3 Equity Financing Round
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