First Patient Treated with OssiGraft™

SAN FRANCISCO — 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, representing Ossium’s entrance into the orthopedic biologics market.

Ossium is launching into the orthopedics space through an unconventional route. The company’s core product is cryopreserved bone marrow derived from the vertebral columns of organ donors. This product is used in curative transplant procedures for blood cancer patients that don’t have a bone marrow match in the living donor registry. OssiGraft was born out of the innovative idea that the bone grindings remaining after the bone marrow elution, which previously went unused, could have a therapeutic orthopedic purpose. Ossium carefully adapted and refined the processing steps to produce OssiGraft in addition to bone marrow.

Article content

“We’ve always strived to maximize the positive impact of each organ donor’s generous gift,” said Kevin Caldwell, Ossium’s CEO, Co-Founder & President. “First, we developed a life-saving product from organ donor bone marrow, which didn’t previously have an established therapeutic application. With the development of OssiGraft, we’re expanding the impact of each donor’s gift even further and advancing our company mission.”

Ossium’s stringent screening, testing, and processing controls already in place to ensure the quality and safety of Ossium’s bone marrow product exceed regulatory requirements for tissue products. Since OssiGraft donors must meet the screening criteria for cell therapies in addition to tissue products, OssiGraft donors are far younger than similar products on the market, further reducing disease transmission risks. Lastly, Ossium ensures finished product safety by using a best-in-class decontamination process with a cocktail of antibiotics and an antimycotic.

Orthopedic surgeons that have already trialed OssiGraft have praised it for its superior handling characteristics compared to other VBM products.

“OssiGraft was clearly designed with the surgeon’s priorities in mind,” said Dr. Jason Piraino, an orthopedic surgeon who performed the first surgery with OssiGraft. “The handling characteristics are unique and superior to any graft on the market. Its versatility in a variety of cases and ability to combine with antibiotics or bone marrow aspirate make this graft exceptional. Patient safety when choosing a product is paramount, and I have an additional layer of confidence with OssiGraft because of its superior graft source, thorough decontamination, and extensive testing. In the OR, there are multiple choices of bone graft but only one OssiGraft.”

The OssiGraft product is in use across the East Coast and will soon be available throughout the United States.

Building on the success of OssiGraft, Ossium is now working on its next-generation VBM product, which will be introduced in 2024.

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).