Category: Press Release

Ossium Launches HOPE Program

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.”

For more details, read the press release.

Lauren Barnes Joins Ossium Health’s Board of Directors

We’re thrilled to announce that we’ve elected Lauren Barnes to our Board of Directors. Barnes is a leading expert in healthcare product commercialization, pricing, reimbursement, market access, and managed markets for products spanning various market segments. This addition significantly bolsters our capacity to drive growth and deliver life-changing solutions for patients suffering from hematologic diseases, organ transplant rejection, and musculoskeletal defects.

“We’re delighted to welcome Lauren as the newest addition to the Ossium Board,” said Kevin Caldwell, Ossium’s CEO, Co-Founder & President. “Lauren brings a fresh perspective to our shared passion for advancing the health, vitality, and longevity of human beings. I’m confident that her valuable insights and expertise will meaningfully help Ossium as the company continues to grow and positively impact more patients.”

Barnes’ appointment underscores our dedication to assembling a world-class Board of Directors equipped with diverse perspectives and proven expertise. Her expertise in commercialization and market access strategy at biopharmaceutical companies in various stages of development complements the expertise of the incumbent board members and will further propel us toward our goals.

Read the press release here.

Lauren Barnes is Ossium’s newest board member

First Patient Treated with OssiGraft™

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.

Ossium Health® and Be The Match® Unveil Partnership to Increase Bone Marrow Transplant Accessibility and Treatment Efficiency

Ossium Health, an innovative bioengineering company, is accelerating its mission to revolutionize the field of bone marrow transplantation through a new partnership with the National Marrow Donor Program (NMDP)/Be The Match, which manages the most diverse registry of blood stem cell donors and cord blood units in the world. This collaboration will enable blood cancer patients to access transplantable units of bone marrow from deceased donors through clinical trials, providing a much-needed complement to today’s living donor model.

Read the full story here.

Ossium Health Secures $52M Series C to Expand Bone Marrow Bank, Advance Clinical Trials

Ossium Health, Inc. a bioengineering company developing the world’s first bank of on-demand bone marrow, today announced a $52 million Series C funding round. The round was led by CPMG, with participation from Vivo Capital, First Round Capital, Manta Ray Ventures, Alumni Ventures, and Asahi Kasei. The company is improving the health, vitality, and longevity of human beings through bioengineering and will deploy this funding to dramatically grow its proprietary bone marrow bank, build on existing clinical trials, and accelerate new product development.

This round of funding will also support the launch of OssiGraft™, an orthopedic product for the repair, replacement, and reconstruction of musculoskeletal defects. This product is derived from the same vertebral bodies as Ossium’s other products, and provides another opportunity to honor the precious gift of donated tissue.

Read the full story here.

Kevin Caldwell, CEO & Co-Founder of Ossium Health

Ossium Health Announces FDA Clearance of its Investigational New Drug Application for Treatment of Perianal Fistulizing Crohn’s Disease

SAN FRANCISCO (March 16, 2022) – Ossium Health, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OSSM-001, a mesenchymal stem cell (MSC) product, for the treatment of refractory perianal fistulas in patients with Crohn’s disease. Ossium plans to initiate patient screening and enrollment in a multi-center Phase 1 clinical trial evaluating OSSM-001 by the end of 2022.

The FDA’s clearance of our OSSM-001 product to enter clinical trials is a major milestone in our development of advanced therapies that leverage Ossium’s proprietary manufacturing platform to treat patients with diseases of inflammation.

Kevin Caldwell, CEO and Co-Founder

“The FDA’s clearance of our OSSM-001 product to enter clinical trials is a major milestone in our development of advanced therapies that leverage Ossium’s proprietary manufacturing platform to treat patients with diseases of inflammation,” said Ossium’s Chief Executive Officer and Co-Founder, Kevin Caldwell. “OSSM-001 is the second Ossium cell therapy product to enter the clinic and the first of our MSC products to be used in patients. The initiation of this trial is a crucial step toward the development of a new treatment paradigm for patients with refractory perianal fistulas, which represent one of the most challenging manifestations of Crohn’s disease.”

This study is a double-blind, randomized, placebo-controlled Phase 1 trial to evaluate the safety and feasibility of a single dose of allogeneic bone marrow-derived MSCs at prespecified doses of 100 million or 300 million cells in adults with medically refractory perianal fistulizing Crohn’s disease. The primary endpoint of this study is product safety with secondary endpoints for fistula healing.

About Perianal Fistulizing Crohn’s Disease (CD)

CD is a chronic inflammatory disease of the digestive system. People living with CD may develop perianal fistulas, which affect an estimated 54,000 people per year in the U.S. and can cause intense pain, swelling, infection, and discharge.

About Ossium Health, Inc.

Ossium Health is a therapeutics company that leverages its unique deceased donor bone marrow banking platform to develop stem cell therapies for patients with life-threatening blood, immune, and inflammatory diseases. Founded in 2016, the company is led by its co-founders: President & CEO Kevin Caldwell and EVP & Chief Science Officer Erik Woods. The company’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. Learn more about Ossium at

See the full press release on Businesswire here.

Contact :
Margie Mathewson
VP of Business Operations
Ossium Health, Inc.
[email protected]