Ossium Health Reports Positive Initial Outcomes for First Ever Leukemia Patient Treated with Organ Donor Derived Bone Marrow

AML Patient in Need of Urgent Bone Marrow Transplant Benefits from Ossium’s On-Demand Bone Marrow

Ossium Health, a clinical-stage bioengineering company that built a first-of-its-kind organ donor-derived bone marrow bank to deploy hematopoietic stem cells for blood cancer treatment, today announced positive preliminary outcomes for its first leukemia patient.

In Detroit, a 68-year-old female diagnosed with acute myeloid leukemia required an urgent bone marrow transplant following an unsuccessful four-month search for a matching donor. Doctors at Henry Ford Health collaborated with Ossium in June to obtain and use Ossium’s stem cell product to treat the patient. Specifically, the patient received an infusion of 5.27 million CD34+ cells per kilogram of body weight from a donor that was a 4/8 HLA match to the patient. The doctors reported neutrophil engraftment by day 16 post-transplant and platelet engraftment by day 21. There have been no reported product-related adverse events to date.

“We are encouraged by the positive results seen in this first patient,” said Kevin Caldwell, Ossium’s CEO, Co-Founder and President. “The patient’s response supports our previous findings that our bone marrow banking platform offers therapeutic effects at least equivalent to marrow derived from living donors. This case exemplifies the importance of this new option for patients with urgent needs. We are inspired by this life saved and what this represents for the potential impact of Ossium’s technology on human health.”

Erik Woods, the company’s Chief Scientific Officer, Co-Founder and Executive Vice President, added, “These initial results are promising and provide a strong foundation for further investigation. We will continue collecting and analyzing data over the long term to fully understand the safety and efficacy of this treatment. Our team is dedicated to rigorously monitoring the evolution of this case, and we look forward to sharing more findings in the near future.”

The physicians at Henry Ford Health, in collaboration with Ossium, will continue to closely monitor the patient’s progress and gather comprehensive safety and efficacy data over the next year. These findings will contribute to ongoing efforts to validate the effectiveness of Ossium’s bone marrow platform for broader clinical use.

Ossium sources bone marrow from the vertebral bodies of organ donors through its partnerships with 27 Organ Procurement Organizations across the United States. Ossium’s bone marrow, referred to as “HPC, Marrow,” is processed and cryopreserved at Ossium’s production facility in Indianapolis, ensuring that transplantable units are available when patients need them most.

The on-demand availability of this cryopreserved product allows physicians to order and receive it within days, significantly accelerating the timeline for unrelated donor transplants. This capability enables the performance of allogeneic transplants at unprecedented speeds, potentially improving patient outcomes.

Ossium is currently conducting a clinical study (PRESERVE I) to evaluate the safety and effectiveness of its organ donor-derived bone marrow in patients with hematopoietic malignancies. In parallel, patients globally can access this product through Ossium’s HOPE Program (HPC Offered for PRESERVE Expansion). For further details about the HOPE Program or to inquire about participation, please visit ossiumhealth.com/hope.

About Ossium Health

Ossium Health is a bioengineering company that leverages its proprietary organ donor bone marrow banking platform to develop stem cell therapies for patients with life-threatening blood and immune diseases. Founded in 2016, the company is led by Kevin Caldwell, CEO, Co-Founder & President, and Erik Woods, Chief Science Officer, Co-Founder & EVP. Ossium Health’s manufacturing facility is registered with the FDA and its laboratory is certified under the Clinical Laboratory Improvement Amendment (CLIA). For more information, please visit https://ossiumhealth.com.

Follow the company on X at https://x.com/ossiumhealth and LinkedIn at https://www.linkedin.com/company/ossiumhealth/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240916637880/en/