Author: Colin Sweeney

Ossium Celebrates National Donate Life Month

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.

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 ossiumhealth.com.

See the full press release on Businesswire here.


Contact :
Margie Mathewson
VP of Business Operations
Ossium Health, Inc.
415-513-5535
[email protected]

A Letter from Our CEO

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 Team
Ossium SF Team (and a few members of the Quality Team from Indy!)

A Day in the Lab

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.

Megan Sannito, Manufacturing Supervisor


Battling Blood Cancer at Ossium

September is Blood Cancer Awareness Month, a time to raise awareness about the many ongoing efforts to fight blood cancer and to remember the hundreds of thousands of patients who have passed away due to these devastating conditions. Blood cancer encompasses disorders that affect the blood, bone marrow, and lymphatic system. Depending on the type of cells affected, these cancers are called leukemia, lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms. Someone in the U.S. dies from blood cancer every 9 minutes, and more than 1.5 million Americans are living with or in remission from blood cancer.

Blood cancer treatment usually starts with chemotherapy and can occur alone or with other drugs and treatments. Often, these treatments are designed to destroy the patient’s cancerous bone marrow. Other times, chemotherapy and radiation that kill circulating cancer cells in the blood also have an unfortunate side effect of destroying the patient’s bone marrow, where blood cells are made. The purpose of bone marrow transplants (also called hematopoietic stem cell transplants, or HSCT) is to replenish the body with new bone marrow. The new bone marrow will start producing healthy, cancer-free blood cells after a successful transplant. In some cases, the new blood cells will even attack and destroy cancer cells that survived the initial chemotherapy round, a phenomenon called the graft-versus-tumor effect. 

The best bone marrow transplant outcomes happen when a patient’s human leukocyte antigen (HLA) genes match that of their donor. For many patients, the best match is a sibling. However, only about 30% of patients have an HLA-matched sibling, which has led to the development of global bone marrow donor registries to facilitate the act of matching patients to unrelated donors with an ideal HLA. Despite the size of these registries, not all patients are able to find a suitable donor, and large variability in group representation has a particularly negative effect on minority populations. 

At Ossium, we are driven by the opportunity to impact patients in need and we believe that a healthier world is a better one. We are working hard to build a vast and diverse bank of on-demand bone marrow that will make bone marrow transplants available for more patients.

The San Francisco team wearing red in support of Blood Cancer Awareness Month

The Return to the Office in San Francisco

Since the beginning of the pandemic, our facility in Indianapolis has had business-critical employees onsite to keep our production and manufacturing operations running smoothly. As a science-based company, we have followed the latest data-backed policies and advisories of the CDC and local governments. We are proud of our team in Indianapolis for staying safe and healthy as they achieved many milestones over the past year.

Our San Francisco team switched to working remotely in March 2020 and continued working from home through the first half of 2021 as the company more than doubled in size. During that period, the team continued to push the company forward and was able to successfully close our Series B fundraising. As a company, we strongly believe in the value of an in-person work model and a community that is built on real-life human connections. We also believe that nothing is more important than the health and safety of our employees, our partners, and our communities. This meant that any potential return to the office had to be rooted in a science-based approach — we wanted to ensure all of our stakeholders felt comfortable, safe, and supported.

San Francisco Team

Thus, once the San Francisco team was 100% vaccinated and the data suggested more broadly that vaccination efforts were vastly decreasing the spread of COVID-19, we began to scout for a new space. After looking at more than a dozen offices around the city, we finally found a new place to call ‘home’. The beautiful brick building, formerly known as “The Barrel House”, is located in the heart of downtown San Francisco and at one time served as a wine warehouse, prohibition speakeasy, and most recently a concert hall where musicians and talented artists would come together over good food, drinks, and music. The 6,400 ft2, three-story building offers plenty of space for the team to grow, be creative, and collaborate as we (re)adapt to an in-person model.

In celebration of the new office and return to in-person work, we hosted an office-warming party in mid-July with all San Francisco Ossies and their significant others. It was an extra-special event since for many it was the first opportunity to meet and get to know one another outside of Zoom. It was an amazing evening with lots of laughter, tasty hors d’oeuvres, and good company.

Later in July, we were lucky to host another dinner party as our Co-Founder and CEO, Kevin Caldwell, graciously invited the whole team to his humble home. This too was a wonderful opportunity for the San Francisco Ossies and their partners to bond over good food and drinks, and we even had Erik Woods, the Co-Founder & Chief Science Officer join us from Indianapolis.

Here at Ossium, we understand the importance of celebration and human connection. We look forward to many more opportunities to relish our achievements both big and small, and can’t wait to see how we continue to evolve as a company in the years to come.

Our resident competitors, Jay and Jane, battling it out on the air hockey table in the new office

LifeGift and Ossium Health Offer Hope with Bone Marrow Clinical Application

(Houston – July 26, 2021) – LifeGift, the organ procurement organization (OPO) facilitating organ and tissue donation in Southeast, West, and North Texas, and Ossium Health, a therapeutics company harnessing the power of stem cell science to improve treatment for patients with blood and immune diseases, are proud to announce a collaborative partnership. In 2017, LifeGift was the first OPO to work with Ossium and this ongoing partnership resulted in the successful banking of cells from their first clinically transplantable donor at the beginning of 2020. Cell banking systems are set up to assure a uniform population of cells is preserved, their integrity maintained, and a sufficient supply of material is accessible for the life of the product.

Bone marrow recovered by LifeGift and Ossium Health’s other OPO partners is processed for future use in transplant tolerance for individuals receiving organ and tissue transplants, bone marrow transplant for blood cancer patients, and regenerative medicine cell therapies for patients with a variety of inflammatory, autoimmune, and degenerative conditions.

Roughly 20,000 new U.S. patients seek a bone marrow transplant each year, but only 30 percent have a relative who provides a match. Of the remaining 14,000 patients, fewer than 5,000 receive transplants from unrelated donors. The living donor bone marrow registry, autologous bone marrow transplants, and umbilical cord blood banks have provided lifesaving solutions for thousands of patients with hematologic diseases. However, these methods still experience significant limitations driven by the scarcity of matched bone marrow.

LifeGift’s partnership with Ossium Health enables transformative clinical work such as Ossium’s recently approved clinical trial for intestinal transplants. Intestinal transplantation is rare because of historically high rejection rates. However, by infusing bone marrow cells from the same donor as the transplanted intestines, the immune system could see the donor organ as “self” so that long-term graft acceptance can be achieved without life-long immunosuppression.

“We are thrilled to have been the first collaborating partner with Ossium Health among all organ procurement organizations more than four years ago,” says Kevin Myer, president and CEO of LifeGift. “This partnership aligns perfectly with LifeGift’s focus on research and innovation to support our efforts to increase transplantation. We are relentless in our goal to save more lives through donation, and Ossium Health’s initiatives will drive clinical advancements allowing us to help more patients and advance important clinical research.”

“Ossium’s first of its kind bone marrow bank combined with bone marrow recovered by LifeGift establishes a powerful new platform for bringing cell therapies to patients across the globe,” says Ossium co-founder, president and CEO, Kevin Caldwell. “The future looks bright as the partnership moves forward to improve the health, vitality, and longevity of human beings through bioengineering.”

 

About LifeGift

LifeGift is a nonprofit, 501(c) 3 organization offering hope to individuals needing transplants in 109 Texas counties in Southeast, North and West Texas. LifeGift is a founding member of Donate Life Texas, the organization that manages the organ, eye and tissue donor registry. Please visit www.LifeGift.org.

About Ossium Health

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 and immune diseases. Founded in 2016, the company is run by its Co-Founder, President & CEO Kevin Caldwell, and its Co-Founder, EVP & Chief Science Officer Erik Woods. The company’s mission is “to deploy cellular therapeutics and bioengineering to produce lasting gains in the health, vitality, and longevity of human beings.” Ossium is a Public Benefit Corporation. Learn more about Ossium at www.ossiumhealth.com.

Scaling a World-Class Team in 2021

Here at Ossium, we know that hiring the right people is the most important part of building a great team, so we are very happy to announce that we have welcomed more than 35 new all-star employees over the past 6 months. We have more than doubled in size and now have almost 70 employees across our San Francisco and Indianapolis offices.

Specifically, we have rapidly scaled up the Production, Quality, Cell Manufacturing, Supply Chain, and Regulatory departments. Additionally, we are building entirely new teams focused on Clinical Affairs, Business Development, and Legal. This period of growth will help us to massively increase our production efforts and get ready to kick off multiple clinical trials evaluating Ossium products over the next 6-12 months. This is an exciting time at Ossium where we will soon be able to measure the success of the company by the number of lives we save.

Ask an Ossium team member about what life here is like and they will tell you that we empower our employees to maintain the highest standards of excellence and are a force for good. If you are interested in joining our mission-driven team and want to improve the health, vitality, and longevity of human beings, check out our job postings – we are continuing to hire for roles in both San Francisco and Indianapolis!