Ossium Health, Inc.

Bone marrow transplants are used to replace damaged blood cells with healthy ones in patients with blood-related conditions. Credit: Terelyuk via Shutterstock. US bioengineering company Ossium Health has treated its first leukaemia patient with cryopreserved organ donor-derived bone marrow as part of its HOPE clinical programme. Ossium’s programme offers cryopreserved bone marrow sourced from deceased organ donors. Bone marrow transplants replace damaged blood cells with healthy ones in patients suffering from blood-related conditions such as leukaemia and lymphoma. Typically, transplants involve collecting healthy stem cells from the blood or bone marrow of a matching living donor, often a close relative. Speaking to Pharmaceutical Technology , Ossium’s CEO Kevin Caldwell explained that the bone marrow is cryopreserved and available for immediate shipment on-demand, eliminating the time necessary to conduct a search and secure a graft from a living donor. A faster transplant is associated with improved survival, especially for patients with high-risk malignant disease. “Every year, 18,000 patients in the US are diagnosed with life-threatening illnesses where a bone marrow transplant is their best treatment option, but nearly 9,000 of these patients are unable to receive a transplant. Ossium’s bone marrow complements current bone marrow sources, improving donor accessibility for underserved patients,” said Caldwell. The first patient was 68 years old with a diagnosis of acute myeloid leukaemia and received the infusion at Henry Ford Health in Detroit, Michigan. The doctors observed neutrophil engraftment by day 16 and platelet engraftment by day 21 post-transplant, with no product-related adverse events reported so far. See Also: AstraZeneca’s Fasenra to challenge GSK’s Nucala in rare vasculitis after FDA nod FDA approves Accord BioPharma’s HERCESSI for cancer treatment Ossium’s bank could also improve accessibility to bone marrow transplants for patients that have the lowest matching rates through the living donor registry such as racial and ethnic minority groups. “Our bone marrow bank will also serve patients globally, including those in underserved countries that lack a living donor bone marrow registry. Since the US is a nation of immigrants from all over the world, the racial and ethnic makeup of our US-based bone marrow bank is uniquely positioned to supply the rest of the world,” added Caldwell. Apart from the HOPE programme, the San Francisco-headquartered company is running the PRESERVE I (NCT05589896) study, a Phase I/II trial to evaluate the safety and effectiveness of its organ donor-derived bone marrow in patients with haematopoietic malignancies. The HOPE programme allows access to the stem cells without needing to enrol in the PRESERVE I trial. “This platform will revolutionise transplants, making them dramatically more accessible to underserved populations around the world,” concluded Caldwell. Note: This article has been updated to clarify the patient received the cryopreserved organ donor-derived bone marrow as part of the HOPE programme.

Bone marrow transplants are used to replace damaged blood cells with healthy ones in patients with blood-related conditions. Credit: Terelyuk via Shutterstock. US bioengineering company Ossium Health has treated its first leukaemia patient with cryopreserved organ donor-derived bone marrow as part of its HOPE clinical programme. Ossium’s programme offers cryopreserved bone marrow sourced from deceased organ donors. Bone marrow transplants replace damaged blood cells with healthy ones in patients suffering from blood-related conditions such as leukaemia and lymphoma. Typically, transplants involve collecting healthy stem cells from the blood or bone marrow of a matching living donor, often a close relative. Speaking to Pharmaceutical Technology , Ossium’s CEO Kevin Caldwell explained that the bone marrow is cryopreserved and available for immediate shipment on-demand, eliminating the time necessary to conduct a search and secure a graft from a living donor. A faster transplant is associated with improved survival, especially for patients with high-risk malignant disease. “Every year, 18,000 patients in the US are diagnosed with life-threatening illnesses where a bone marrow transplant is their best treatment option, but nearly 9,000 of these patients are unable to receive a transplant. Ossium’s bone marrow complements current bone marrow sources, improving donor accessibility for underserved patients,” said Caldwell. The first patient was 68 years old with a diagnosis of acute myeloid leukaemia and received the infusion at Henry Ford Health in Detroit, Michigan. The doctors observed neutrophil engraftment by day 16 and platelet engraftment by day 21 post-transplant, with no product-related adverse events reported so far. See Also: Itacitinib adipate by Incyte for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval Itacitinib adipate by Incyte for Non-Hodgkin Lymphoma: Likelihood of Approval Ossium’s bank could also improve accessibility to bone marrow transplants for patients that have the lowest matching rates through the living donor registry such as racial and ethnic minority groups. “Our bone marrow bank will also serve patients globally, including those in underserved countries that lack a living donor bone marrow registry. Since the US is a nation of immigrants from all over the world, the racial and ethnic makeup of our US-based bone marrow bank is uniquely positioned to supply the rest of the world,” added Caldwell. The PRESERVE I (NCT05589896) study is a Phase I/II trial to evaluate the safety and effectiveness of its organ donor-derived bone marrow in patients with haematopoietic malignancies. The San Francisco-headquartered company also runs the HOPE programme to allow access to the stem cells without needing to enrol in the trial. “This platform will revolutionise transplants, making them dramatically more accessible to underserved populations around the world,” concluded Caldwell.

SAN FRANCISCO & PARSIPPANY, N.J.--( BUSINESS WIRE )--Ossium Health®, a bioengineering company that established a first-of-its-kind bone marrow banking platform, has entered into a collaborative agreement with Extremity Medical, an orthopedic device company that develops innovative fixation and fusion implants and motion preservation systems for surgeons to treat challenging reconstructions of the hand, wrist, foot, and ankle. This collaborative venture combines Ossium’s expertise in cellular therapeutics with Extremity Medical's extensive expertise in the orthopedics product sector and a robust network of orthopedic surgeons, hospitals and ambulatory surgery centers. OssiGraft TM , a revolutionary viable bone matrix (VBM) allograft, is derived from the vertebral bones of organ donors and is intended for use in orthopedic surgery to support the reconstruction or repair of musculoskeletal defects or injuries. Donors for OssiGraft must meet the stringent criteria for both cell therapies and tissue products. The product is derived from a younger donor demographic than other bone allografts on the market and is characterized by a high cancellous bone ratio for optimal bone healing. Ossium Health employs rigorous screening, testing, and processing controls, exceeding regulatory requirements. Ossium's commitment to patient safety extends to the use of a best-in-class decontamination process for the finished product. "Extremity Medical shares Ossium's ambition to apply engineering principles in developing creative solutions that enhance human health. With the development of OssiGraft, we’re expanding the impact of each donor’s gift even further and advancing patient care solutions,” remarked Kevin Caldwell, CEO, Co-Founder and President of Ossium Health. "Extremity Medical has over a decade of experience in providing innovative solutions for the orthopedic surgeon and this partnership with Ossium builds on our tradition of continuously offering the most advanced products to help drive better clinical outcomes,” added Matthew Lyons, CEO of Extremity Medical. Extremity Medical also announced the successful completion of the initial cases with OssiGraft. The product is available now to surgeons around the country through Extremity Medical. To learn more about OssiGraft Viable Bone Matrix, please visit: www.extremitymedical.com About Ossium Health Ossium Health is a bioengineering company that leverages its proprietary organ donor bone marrow banking platform to develop biological therapies for hematologic diseases, solid organ transplant rejection, and orthopedic injuries. 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). About Extremity Medical Extremity Medical, LLC, was founded in 2008, and is a privately held medical device company based in Parsippany, NJ. The company is known for creating innovative implants and instruments for upper and lower-extremity orthopedic procedures, including fusion and motion preservation. Extremity Medical is focused on developing solutions for challenging cases that promote better outcomes, especially in patients with poor bone quality.