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.
Ossium Health, Inc. announced today that the California Institute of Regenerative Medicine (CIRM) has awarded the company a $3.46M Clinical Stage Research Program (CLIN1) grant to support the continued clinical development of OSSM-007, Ossium’s interferon-gamma primed mesenchymal stem cell product, for the treatment of steroid-refractory acute graft versus host disease (GVHD).
This funding will support and accelerate pre-clinical and manufacturing activities for OSSM-007, with plans to initiate clinical study activities by the end of 2023.lls from deceased donors from Ossium Health’s first-in-the-world bone marrow bank in conjunction with ExCellThera’s ECT-001 cell expansion and rejuvenation technology, comprised of the UM171 small molecule and an optimized culture system, to treat blood cancers, improve solid organ tolerization and repair damage from radiation.
Kevin Caldwell, Ossium’s CEO & Co-Founder, was featured on the latest episode of Translating Aging, a podcast produced by BioAge Labs featuring entrepreneurs and scientists who are advancing the science of human longevity and developing therapeutics to extend the human healthspan.
In this episode, Kevin speaks with host Chris Patil, PhD, about Ossium’s groundbreaking approach to processing and banking bone marrow from organ donors for use in a broad range of clinical applications, including transplants for blood cancer patients and emerging stem cell therapies.
We invite you to listen-in today to not only learn about how Ossium is increasing the availability of bone marrow transplant treatment options for blood cancer patients, but to also gain valuable insights into the future of healthcare itself.
You can listen to Kevin and Chris chat on your favorite podcast platform below:
Kevin Caldwell, Ossium’s Co-Founder & CEO, gave a presentation about Ossium and the Promise of Bone Marrow Banking at Meeting on the Mesa, one of the year’s biggest biotech conferences that brings together senior executives and top decision-makers in the Cell & Gene therapy industry to share their companies’ clinical and commercial progress in the field.
Meeting on the Mesa is the flagship conference of the Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. As the global voice of the sector, ARM represents the interests of 450+ members across 25 countries, including small and large companies, academic research institutions, major medical centers and patient groups. Ossium is proud to be a new member of ARM, and we look forward to many more successful Meetings on the Mesa in the years to come.
We invite you to watch the video of Kevin’s presentation here!
The San Francisco (top) and Indianapolis (bottom) Ossium teams wearing their Blue and Green for Donate Life Month
This April, Ossium Health continues to be a proud supporter of National Donate Life Month. Founded in 2003 by Donate Life America and its partnering organizations, National Donate Life Month is an opportunity to celebrate those who have received transplants, to recognize those who continue to wait, to honor donors and donor families, and to thank registered donors for giving hope. It is also an opportunity to show appreciation for the many professionals – including researchers, advocates, volunteers, and healthcare providers – who serve the donation and transplant communities and make everything possible.
At Ossium, we’d like to give a special thanks to all of our partners and donation advocates at Organ Procurement Organizations (OPOs) around the country. OPOs are not-for-profit organizations responsible for recovering organs and tissues from deceased donors for transplantation, and they serve as the vital link between donors and patients waiting for life-saving organ transplants. Ossium’s partnerships with OPOs are the foundation of our ability to develop cellular therapies for patients in need, and are a core component to our mission to improve the health, vitality, and longevity of human beings through bioengineering.
We’d also like to give a shout out to the Donor Team here at Ossium, which ensures that the most critical part of our work, acquiring donated tissue from donors, occurs smoothly. Members of the Donor Team share a common passion for organ and tissue donation, and fully understand just how precious the gift of life can be. In honor of National Donate Life Month, we’ve asked two members of our donor team to share what donation means to them; below are quotes from Karina Chavarria, our Senior Donor Manager, and Matt Ryll, our Senior Manager of Donor Field Services.
“Donation to me means our lives never end. Signing up to be a donor, or making that difficult decision as a family member at an unexpected time, is one of the most selfless acts you can ever make. There is a legacy in donation – one of hope, caring and support that enables at least one more person to continue this beautiful journey we call life. And it doesn’t just end with that one person – there is a ripple through space and time for friends and family of that recipient. There really is no end to the gift of life.”
– Karina Chavarria Senior Donor Manager
“Donation has touched my life in many ways, most importantly as a Donor Family. I know how impactful it can be to know that your loved one will continue to live on in others.It’s my hope that knowing a family’s loved one has the ability to save more lives, not just now but in the future, helps them through some of the toughest moments they will have to face.”
– Matt Ryll Senior Manager, Donor Field Services
Though Donate Life Month is certainly a time for gratitude and celebration, it is also a time to remember there is still a long road ahead. At this moment, there are more than 100,000 people across the country who are waiting for a lifesaving organ transplant. Thousands more are waiting for life-enhancing cornea and tissue transplants. This long waiting list and critical shortage of available organs and tissues leads to 17 people dying every day while awaiting transplant. However, there continues to be hope and progress, with 2021 being a record year in the donation and transplant world. Last year, more than 41,000 transplants were performed using organs from 20,300 donors, an increase of over 5% compared to 2020 and the first time ever the number of transplants exceeded 40,000.
While transplantation continues to increase substantially and meet the needs of many people with organ failure, we must join together and continue our efforts to shorten the waiting list and encourage our friends and family to become organ donors. If you or a loved one have not signed up as an organ donor, you can visit DonateLife.net or OrganDonor.gov to learn more and register to be an organ, eye, and tissue donor. Every individual who becomes a donor has the opportunity to save up to 8 lives via organ donation and heal the lives of more than 75 people through tissue and cornea donation.
From all of us at Ossium Health, we wish you a Happy National Donate Life Month, and we look forward to the day where every patient in need has access to life-saving organ and tissue transplants.
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 ossiumhealth.com.
Here at Ossium, we publish monthly internal newsletters highlighting company updates and accomplishments. Each newsletter also includes a brief note from our CEO, Kevin Caldwell. In February’s edition, Kevin reflected on all of the progress we made in 2021, despite facing a host of challenges as a company and society. Check out Kevin’s letter below.
When I was younger, my parents used to tell me that every challenge was an opportunity in disguise. Back then, I thought of those words as an empty platitude, something people said to make themselves feel better about hardship. But, over the years, and especially throughout the pandemic, I have come to understand that my parents were telling the truth: that we only discover our true potential when pushed out of our comfort zones and asked to do seemingly impossible things. They taught me that greatness is forged through hard work and adversity.
The pandemic has also taught us that we must follow our core company value of ‘Truth’ through science. To roughly quote Andy Weir’s The Martian, “in the face of overwhelming odds, [we’re] left with only one option: [we’re] going to have to science the shit out of this.” Over the last two years, researchers and members of the pharma & biotech industries took this phrase to heart, and the progress we’ve made on vaccines and other therapeutics is remarkable. The world has never made and distributed a vaccine for a disease faster than it did for COVID-19. The fact that we had one—let alone multiple—vaccines during the first year of the pandemic is extraordinary.
Here at Ossium, we too have looked towards science and truth to drive progress. In the face of adversity, the team prevailed, and though I will look back at 2021 as being dominated by a global pandemic, I will also look at this year as the time we treated our first patient, got 4 INDs that used Ossium products cleared by the FDA, and grew our team by more than 100%.
2021, much like 2020, has been a year characterized by adversity, challenge, and loss. It was a hard year for many people, including myself, but amidst the chaos and stress of the ongoing pandemic, we have made incredible strides forward both globally and here at Ossium. Though 2022 will bring its own challenges, I am hopeful and optimistic that the world can get better. If the pandemic has taught us anything, it is that health is the bedrock of civilization. People will prioritize staying alive and well to the necessary detriment of everything else. Simply put, the pandemic has reinforced a phrase that here at Ossium we are quite familiar with: The Greatest Wealth is Health.
The hard work and dedication shown by each and every member of the Ossium team has given me great confidence about our ability to play a crucial role in building a world where everyone has the chance to live a healthy, happy, and productive life, free from the burden of disease.
Cheers to 2022,
Kevin Caldwell Co-Founder & CEO
Ossium Indianapolis TeamOssium SF Team (and a few members of the Quality Team from Indy!)
As a biotech company, we are in the business of helping people. We go to work with the mission to improve the health, vitality, and longevity of human beings through bioengineering. The individuals who work in our lab embody these values in their daily work making innovative cell therapy products for patients in need. With that in mind, we’d like to dedicate this post to all of the awesome Ossies on our production, manufacturing, quality, and research teams who work day-in and day-out to make the highest quality products.
Our Indianapolis facility is nearly 30,000 square feet and includes 5 cleanrooms, a bulk supply warehouse, a dedicated lab for the research and development team, and open office space for 55 employees and counting. This facility is large enough to house our growing team for the next few years.
A view into one of our cleanrooms in Indy
The production and manufacturing teams spend a majority of their time in the cleanrooms, which are highly controlled environments where pollutants like dust, microbes, and other airborne particles are filtered out to provide a near-sterile environment. Additionally, the temperature, humidity, and pressure are all highly controlled, and team members must be fully gowned head-to-toe in sterile garments while working in the cleanroom. These teams are responsible for developing our products from the bone marrow of donated tissue. Bone marrow is comprised of a variety of cell types including hematopoietic and mesenchymal stem cells, which serve as the basis for our cell therapies.
Production Team Working in the Cleanroom
The Quality Team is tasked with making sure that our cell therapy products meet all of the quality attributes — safety, efficacy, potency, and purity — required by customers and regulatory agencies. This involves testing the products at multiple time points and keeping very detailed electronic records of each production and manufacturing run. Once the product has been approved and certified, it will be placed in a cryo-storage container, which acts to cool the cell therapies below the threshold for biological activity. Once cryopreserved, products can be stored indefinitely until requested by a healthcare provider to treat a patient in need.
Manufacturing Team Examining Cells Under a Microscope
The Research and Development (R&D) team is responsible for conducting experiments, designing preclinical in-vitro and in-vivo studies, and testing new methods or equipment that could improve the manufacturing and production processes. The R&D team has its own dedicated laboratory space outside of the cleanroom.
R&D Team Performing Calculations
Check out some quotes from the team, and if you think that you’d enjoy working in the lab, head to our careers page!
“In just over a year at Ossium, I have gotten the opportunity to learn new processes that are not available anywhere else. I’ve been able to continue developing as a lab technician in not only my laboratory skills but also in my critical thinking and problem-solving. My coworkers and supervisors are not only interested in my ability to perform in the lab, but also in my capacity to understand the concepts behind our life-saving work.”
– Ellen Hicks, Senior QC Associate
“Being a part of Ossium’s production team allows me the chance to have a direct hands-on approach to helping patients every day. We constantly get to see something new, learn advanced skills and lab techniques, and produce various therapeutics that will be life-saving treatments for so many individuals. It’s exhilarating to be a teammate amongst Ossium’s finest.”
– Kenneth McGraw, Production Associate II
“Every day at Ossium I enjoy the opportunity to grow and advance my technical lab skills. I love the support I get from my manager, and knowing the work I do is critical to help change the lives of patients in need.”
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