Category: Press Release

Ossium Health, a commercial-stage bioengineering company with the first-of-its-kind bone marrow bank for processing and deploying stem cell-based therapies, today announced the signing of a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to advance the company’s ready-to-use bone marrow for national emergency preparedness. The contract, initially funded at $21 million for its base period, has the potential to reach a total value of $125 million with additional options spanning five years.

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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, 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.

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Our next-generation viable bone matrix, OssiGraft Prime™, has been released and used in surgery for the first time.

OssiGraft Prime builds upon the success of Ossium’s established OssiGraft™ and incorporates innovative processing advancements. The result is a more cohesive product with a gum-like consistency precisely engineered to meet the demands of orthopedic and spine surgeons. The product’s optimized handling properties enable surgeons to precisely sculpt and apply the graft in the intended location with unprecedented precision and efficiency.

“OssiGraft Prime is by far the best product on the market. I actually said ‘wow!’ out loud in the OR when I handled it in surgery for the first time,” said Dr. Jason Piraino, a leader and educator in foot & ankle surgery. “This product exceeded my expectations. It’s moldable and stays exactly where you want it, which makes it ideal for minimally invasive surgery.”

The first surgery with OssiGraft Prime, an arthroscopic ankle fusion, required the graft to be precisely shaped and placed through a narrow incision, demonstrating the product’s unique value. Surgeons working with OssiGraft Prime benefit from its ability to consistently fill odd-shaped gaps and tight spaces, allowing them to push the boundaries of possibility in orthopedic procedures.

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Ossium recently introduced a new program that further expands access to Ossium’s bone marrow to patients around the globe. Through the HOPE (HPC Offered for PRESERVE Expansion) Program, patients that need an allogeneic bone marrow transplant but cannot participate in Ossium’s active clinical study (PRESERVE I) have a new opportunity to receive bone marrow from Ossium’s bank.

The goal of Ossium’s PRESERVE trials is to establish organ donor bone marrow as a new source of stem cells for hematologic reconstitution and unlock access to stem cell transplants for the thousands of patients who search unsuccessfully for a donor each year. Ossium launched the HOPE Program after recognizing the sheer volume of patients that need a bone marrow transplant but are unable to participate in the PRESERVE I study due to its eligibility criteria or the patient’s geography.

“Thousands of patients in the US and tens of thousands abroad desperately need a bone marrow transplant but can’t find a donor,” said Kevin Caldwell, Ossium’s CEO, Co-Founder & President. “The HOPE Program is intended to fill that gap.”

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Ossium Health announced today that the first patient has been treated with its newly released OssiGraft™ viable bone matrix (VBM) allograft in an ankle surgery. OssiGraft is Ossium’s viable bone matrix allograft, which is intended for use in orthopedic surgery to repair, replace, or reconstruct bone defects. This surgery represents Ossium’s transition from a clinical-stage company to a commercial company as well as its introduction to the orthopedic biologics market.

Read the press release here.