March 26, 2025 • 13 mins
This week on BioTech Nation, Ossium Health co-founder and CEO Kevin Caldwell shares how their breakthrough approach is changing bone marrow transplants. By cryobanking marrow from organ donors, Ossium is reducing wait times, improving access, and preparing for future emergencies. With support from BARDA and promising clinical trial results, this new system could help thousands more receive lifesaving transplants—right when they need them.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Dr. Moira Gunn (00:11):
Often the next thing we hear after learning
that someone needs a bone marrowtransplant is that they have to
find a living donor that matchesthem to give it. When no family
member is a match, this can takemonths and many challenges
before the transplant iscomplete. Today we're talking
(00:32):
with Ossium Health and its newtechnology which cryobanks bone
marrow, all with the hope thateventually only a few will be
left without a ready match.Kevin Caldwell is its cofounder
and CEO. Kevin, welcome to theprogram.
Kevin Caldwell (00:51):
Thank you for having me, Moira.
Dr. Moira Gunn (00:53):
Now we've all heard of bone marrow
transplants. They're permanentlife saving treatments for
various kinds of blood cancer,be it leukemia or lymphoma or
multiple myeloma. And to beclear, the clearing of your
unhealthy bone marrow and givingyou new bone marrow, either from
(01:14):
a match in your family, whichcan just be a few more weeks or
more likely an unrelated donor,which can take months, all
includes being in a medicalsetting or a hospital. So let's
start there. How many bonemarrow transplants are there in
The US today?
Kevin Caldwell (01:35):
So there are two major types of bone marrow
transplants. There's autologousbone marrow transplants which is
where a person gives atransplant to themselves and
then there are allogeneic bonemarrow transplants which is
where one person gives bonemarrow to another person. And
what we're really working on atOssium is the second kind of
bone marrow transplant where youneed a donor and there's about
(01:57):
twenty thousand people who golooking for one of those
transplants each year in TheUnited States and we only do
about ten thousand of thosetransplants.
Dr. Moira Gunn (02:05):
Now if someone's a family member, you know,
frequently they're right therewith you, co located, so that
can happen in the same place.But many times the donor, even
in your family, but certainly anunrelated donor found somewhere
in the system somewhere thatmatches you, they may not be co
located with you. How do youmaneuver or navigate that
(02:26):
disparate geographic distance?
Kevin Caldwell (02:28):
Right. So today, bone marrow donors are found
through registries. And so manycountries, including The United
States, have national registriesof bone marrow donors. And these
are basically people who havevolunteered to be potential
donors for someone else whoneeds a transplant who happens
to be a close genetic match tothemselves. And when a person
(02:51):
requires a transplant anddoesn't have a match readily
available in the family, theseregisters are called upon.
It's true that usually the donorand the recipient are not in the
same location. The donor couldbe anywhere in the country or
even elsewhere in the world. Andso when that happens, the donor
goes to a bone marrow collectioncenter that is typically
(03:12):
geographically close to wherethe donor lives. Their bone
marrow will be removed, at thatcenter, and then it's
transported to the bone marrowtransplant center where the
patient, resides. It'stypically, shipped overnight
fresh.
Dr. Moira Gunn (03:29):
And so within twenty four to thirty six hours,
you've connected the donor withthe, recipient. Although this
may have taken months to findthe right person to get that all
set up, everybody's gotta be inthe in a medical setting to make
that happen.
Kevin Caldwell (03:44):
Exactly. There's a lot of logistics and
coordination that have to bedone in order to make a
transplant possible. It's reallya herculean effort on the part
of both the patient's team, theregistry, the team recovering
the cells from the donor.Everyone has to coordinate
perfectly in order to make thetransplant happen.
Dr. Moira Gunn (04:01):
Now, Ossium has come up with the technology to
make an impact here. What hasOssium Health done?
Kevin Caldwell (04:08):
So Ossium has developed the capability to
recover bone marrow from organdonors. And these are the same
deceased organ donors that werely upon for hearts, livers,
lungs, kidneys, etcetera. OssiaMhas developed a process for
obtaining bone marrow from thosesame individuals and then
cryopreserving or banking thatbone marrow so that it can be
(04:30):
used later. This allows someonewho is an organ donor today to
provide a transplant for andultimately save the life of
someone who needs a bone marrowtransplant in the future. One of
the things that we've reallyworked on is the ability to
maximize the lifesaving value ofevery donation that we get.
And so unlike living donors,sort of volunteer donation where
(04:53):
one donor saves the life of onepatient, we were able to obtain
many more bone marrow stem cellsfrom a deceased organ donor, and
this allows us to save multiplelives from each donor. For an
adult transplant, a typicalorgan donor could provide enough
bone marrow for two or threetransplants. And if the patients
are pediatric patients andleukemia is the most common
(05:17):
cancer that children do get,then we could do four to six
transplants from a single donor.
Dr. Moira Gunn (05:23):
Now I know that the US government under its
administration for strategicpreparedness and response and
specifically its agency calledBARDA, and listeners may
remember BARDA from during theCOVID pandemic. It supported all
the development of vaccines andCOVID diagnostics and anything
to do with the pandemic. BARDAhas awarded Ossium Health a
(05:47):
hundred and $25,000,000contract. What is that contract
for and why is the US governmentinterested in this?
Kevin Caldwell (05:55):
Right. So one of the goals that HHS is charged
with, and in particular theBiomedical Advanced Research and
Development Authority, or BARDA,is preparing The United States
for catastrophic events, masscasualty events that would
significantly harm large numbersof U. S. Persons. And within
(06:20):
their mandate is nuclear andradiological countermeasures.
And in particular, one scenariothat they want us to be prepared
for is one where, God forbid,there's a a nuclear weapon that
detonates on US soil. Were thatto happen, tens of thousands of
people would be exposed toenough radiation that they would
(06:44):
be at risk of what we callhematopoietic acute radiation
syndrome. And that just meansthat the stem cells in their
bone marrow sort of mutate, andthis puts them at risk of death
within about a month, unlessthose people are treated. One of
the best treatments for someonewho is at risk of sort of
(07:05):
radiation poisoning is a bonemarrow transplant because that
allows us to permanently replacetheir blood and immune system,
in this case the disease orradiation poisoned immune
system, with a new healthyimmune system from a donor. So
we mentioned earlier, Moira,that there are only about ten
thousand bone marrow transplantsper year in The United States.
(07:28):
In this scenario, we would needto do 50 or 100,000 transplants
in just a few weeks. The systemwould be overwhelmed in this
scenario unless there was a wayto do the transplants much more
quickly, unless it were possibleto get the bone marrow
immediately on demand withoutneeding to identify thousands of
(07:49):
donors in real time. Thisrequires banked bone marrow
that's already been collected,tested, sort of characterized,
and it's ready to deploy ondemand. That, of course, is
exactly what Osteum does. Andthis is an example of what we
think of as dual use.
And so we're building the bonemarrow bank so that we can treat
patients with blood cancers whoneed a transplant under sort of
(08:11):
conventional medicalcircumstances, but the same
capability that we're buildingthat will enable many of those
patients who are currently goingunserved to receive a transplant
would also allow us to respondfar more effectively doing one
of these catastrophic events.
Dr. Moira Gunn (08:27):
Now I know that this bone marrow transplant
procedure, which Ossium hasavailable today and is in use,
does not need any more approvalsto go forward. You could just
continue from here. But I wasinterested, Ossium has decided
on its own to conduct clinicaltrials. What are you studying
(08:49):
and why are you doing this?
Kevin Caldwell (08:51):
So it's true, Mora. Bone marrow transplants
have been around for aboutseventy years. The earliest bone
marrow transplants were done inthe 1950s and 60s, and more than
one and a half million of theseprocedures have been done around
the world. We often think ofstem cell therapy as twenty
first century medicine, but bonemarrow transplants are really
the original stem cell therapy,and Ossium is building upon that
(09:14):
sort of deep clinical history.Although bone marrow transplants
themselves have a lot ofprecedent, our process where we
are obtaining bone marrow fromorgan donors, cryopreserving it,
and then using that bone marrowfor transplant, is a novel
process that we've developed.
We have a lot of confidence inthat process based on the
(09:35):
quality of the data that we'reseeing so far from the initial
transplants that we've done, andwe want to make sure that
physicians have access to thatdata. And so in order for
physicians to develop confidencethat our product can be used to
reconstitute the blood andimmune systems of their
patients, they need a data setto rely on. And so the purpose
of this study is to produce thatclinical data set. And so we are
(09:59):
measuring the rate ofengraftment, how much time
passes between when the bonemarrow is transplanted and when
the patient's blood and immunesystem is reconstituted. We're
also measuring the amount oftime the patient spends in the
hospital and a variety of othermetrics and really, really
trying to show that they haveexcellent outcomes.
And so far, that's bearing out.
Dr. Moira Gunn (10:20):
Now Osteum Health is in a period of
building this donor bank. Whatif you need a bone marrow
transplant today, especially ifyou don't have a match right
now?
Kevin Caldwell (10:30):
So if you're looking for a bone marrow donor,
can go to ossiumhealth.com andgo to our HOPE program, which is
a program that we establishedfor people who are looking for a
bone marrow donor and don't haveone readily available, and just
provides information, a littlebit of information about the
diagnosis and contactinformation. Our team will
(10:53):
review that and then someonefrom our clinical team will ask
to be put in touch with yourdoctor. And if you are a good
candidate for for the study orfor the expanded access program,
then our team would work withyour doctor from there.
Dr. Moira Gunn (11:07):
What if you wanna donate?
Kevin Caldwell (11:09):
The way to become an Osteum donor is to
become an organ donor. So if youjust sign up for organ donation
at the DMV, then you'll be apotential Osteum donor.
Dr. Moira Gunn (11:17):
So where do you go from here, Kevin? There's a
lot of work to be done.
Kevin Caldwell (11:21):
Well, we are looking forward to the
completion of our PRESERVEclinical trial for the treatment
of blood cancers. We hope tobring the number of patients who
go looking for a donor andultimately receive a transplant
much closer to one hundredpercent than it is today so that
fewer and fewer people die fromthis treatable disease. Beyond
(11:44):
that, there's an enormous numberof applications of banked bone
marrow and stem cells, includingenabling organ transplants
without immunosuppression,people who receive solid organs
from the same donors that werely upon for bone marrow. Our
hope is that one day they canlive without needing to have
their immune systems suppressedwith drugs. There are
(12:06):
opportunities to use some of thebone from the donors to make
orthopedic products to expeditethe healing after orthopedic
surgery and really just a vastnumber of other applications.
We're looking forward todramatically expanding our blood
cancer treatment program fromthe nine centers that are
currently participating in ourclinical trial to the hundreds
(12:26):
of bone marrow transplantcenters around The US and world
that treat patients every day.
Dr. Moira Gunn (12:30):
Well Kevin, thank you so much for joining
us. I hope you come back, keepus updated.
Kevin Caldwell (12:34):
Thanks for having me, Moira.
Dr. Moira Gunn (12:35):
Kevin Caldwell is the co founder and CEO of
Ossium Health. More informationis available on the web at
ossiumhealth.com. That's O S S Iu m o c m health dot com. And
remember, you can become anorgan donor simply by
(12:56):
registering at your local DMV.
Often the next thing we hear after learning
that someone needs a bone marrowtransplant is that they have to
find a living donor that matchesthem to give it. When no family
member is a match, this can takemonths and many challenges
before the transplant iscomplete. Today we're talking
(00:32):
with Ossium Health and its newtechnology which cryobanks bone
marrow, all with the hope thateventually only a few will be
left without a ready match.Kevin Caldwell is its cofounder
and CEO. Kevin, welcome to theprogram.
Kevin Caldwell (00:51):
Thank you for having me, Moira.
Dr. Moira Gunn (00:53):
Now we've all heard of bone marrow
transplants. They're permanentlife saving treatments for
various kinds of blood cancer,be it leukemia or lymphoma or
multiple myeloma. And to beclear, the clearing of your
unhealthy bone marrow and givingyou new bone marrow, either from
(01:14):
a match in your family, whichcan just be a few more weeks or
more likely an unrelated donor,which can take months, all
includes being in a medicalsetting or a hospital. So let's
start there. How many bonemarrow transplants are there in
The US today?
Kevin Caldwell (01:35):
So there are two major types of bone marrow
transplants. There's autologousbone marrow transplants which is
where a person gives atransplant to themselves and
then there are allogeneic bonemarrow transplants which is
where one person gives bonemarrow to another person. And
what we're really working on atOssium is the second kind of
bone marrow transplant where youneed a donor and there's about
(01:57):
twenty thousand people who golooking for one of those
transplants each year in TheUnited States and we only do
about ten thousand of thosetransplants.
Dr. Moira Gunn (02:05):
Now if someone's a family member, you know,
frequently they're right therewith you, co located, so that
can happen in the same place.But many times the donor, even
in your family, but certainly anunrelated donor found somewhere
in the system somewhere thatmatches you, they may not be co
located with you. How do youmaneuver or navigate that
(02:26):
disparate geographic distance?
Kevin Caldwell (02:28):
Right. So today, bone marrow donors are found
through registries. And so manycountries, including The United
States, have national registriesof bone marrow donors. And these
are basically people who havevolunteered to be potential
donors for someone else whoneeds a transplant who happens
to be a close genetic match tothemselves. And when a person
(02:51):
requires a transplant anddoesn't have a match readily
available in the family, theseregisters are called upon.
It's true that usually the donorand the recipient are not in the
same location. The donor couldbe anywhere in the country or
even elsewhere in the world. Andso when that happens, the donor
goes to a bone marrow collectioncenter that is typically
(03:12):
geographically close to wherethe donor lives. Their bone
marrow will be removed, at thatcenter, and then it's
transported to the bone marrowtransplant center where the
patient, resides. It'stypically, shipped overnight
fresh.
Dr. Moira Gunn (03:29):
And so within twenty four to thirty six hours,
you've connected the donor withthe, recipient. Although this
may have taken months to findthe right person to get that all
set up, everybody's gotta be inthe in a medical setting to make
that happen.
Kevin Caldwell (03:44):
Exactly. There's a lot of logistics and
coordination that have to bedone in order to make a
transplant possible. It's reallya herculean effort on the part
of both the patient's team, theregistry, the team recovering
the cells from the donor.Everyone has to coordinate
perfectly in order to make thetransplant happen.
Dr. Moira Gunn (04:01):
Now, Ossium has come up with the technology to
make an impact here. What hasOssium Health done?
Kevin Caldwell (04:08):
So Ossium has developed the capability to
recover bone marrow from organdonors. And these are the same
deceased organ donors that werely upon for hearts, livers,
lungs, kidneys, etcetera. OssiaMhas developed a process for
obtaining bone marrow from thosesame individuals and then
cryopreserving or banking thatbone marrow so that it can be
(04:30):
used later. This allows someonewho is an organ donor today to
provide a transplant for andultimately save the life of
someone who needs a bone marrowtransplant in the future. One of
the things that we've reallyworked on is the ability to
maximize the lifesaving value ofevery donation that we get.
And so unlike living donors,sort of volunteer donation where
(04:53):
one donor saves the life of onepatient, we were able to obtain
many more bone marrow stem cellsfrom a deceased organ donor, and
this allows us to save multiplelives from each donor. For an
adult transplant, a typicalorgan donor could provide enough
bone marrow for two or threetransplants. And if the patients
are pediatric patients andleukemia is the most common
(05:17):
cancer that children do get,then we could do four to six
transplants from a single donor.
Dr. Moira Gunn (05:23):
Now I know that the US government under its
administration for strategicpreparedness and response and
specifically its agency calledBARDA, and listeners may
remember BARDA from during theCOVID pandemic. It supported all
the development of vaccines andCOVID diagnostics and anything
to do with the pandemic. BARDAhas awarded Ossium Health a
(05:47):
hundred and $25,000,000contract. What is that contract
for and why is the US governmentinterested in this?
Kevin Caldwell (05:55):
Right. So one of the goals that HHS is charged
with, and in particular theBiomedical Advanced Research and
Development Authority, or BARDA,is preparing The United States
for catastrophic events, masscasualty events that would
significantly harm large numbersof U. S. Persons. And within
(06:20):
their mandate is nuclear andradiological countermeasures.
And in particular, one scenariothat they want us to be prepared
for is one where, God forbid,there's a a nuclear weapon that
detonates on US soil. Were thatto happen, tens of thousands of
people would be exposed toenough radiation that they would
(06:44):
be at risk of what we callhematopoietic acute radiation
syndrome. And that just meansthat the stem cells in their
bone marrow sort of mutate, andthis puts them at risk of death
within about a month, unlessthose people are treated. One of
the best treatments for someonewho is at risk of sort of
(07:05):
radiation poisoning is a bonemarrow transplant because that
allows us to permanently replacetheir blood and immune system,
in this case the disease orradiation poisoned immune
system, with a new healthyimmune system from a donor. So
we mentioned earlier, Moira,that there are only about ten
thousand bone marrow transplantsper year in The United States.
(07:28):
In this scenario, we would needto do 50 or 100,000 transplants
in just a few weeks. The systemwould be overwhelmed in this
scenario unless there was a wayto do the transplants much more
quickly, unless it were possibleto get the bone marrow
immediately on demand withoutneeding to identify thousands of
(07:49):
donors in real time. Thisrequires banked bone marrow
that's already been collected,tested, sort of characterized,
and it's ready to deploy ondemand. That, of course, is
exactly what Osteum does. Andthis is an example of what we
think of as dual use.
And so we're building the bonemarrow bank so that we can treat
patients with blood cancers whoneed a transplant under sort of
(08:11):
conventional medicalcircumstances, but the same
capability that we're buildingthat will enable many of those
patients who are currently goingunserved to receive a transplant
would also allow us to respondfar more effectively doing one
of these catastrophic events.
Dr. Moira Gunn (08:27):
Now I know that this bone marrow transplant
procedure, which Ossium hasavailable today and is in use,
does not need any more approvalsto go forward. You could just
continue from here. But I wasinterested, Ossium has decided
on its own to conduct clinicaltrials. What are you studying
(08:49):
and why are you doing this?
Kevin Caldwell (08:51):
So it's true, Mora. Bone marrow transplants
have been around for aboutseventy years. The earliest bone
marrow transplants were done inthe 1950s and 60s, and more than
one and a half million of theseprocedures have been done around
the world. We often think ofstem cell therapy as twenty
first century medicine, but bonemarrow transplants are really
the original stem cell therapy,and Ossium is building upon that
(09:14):
sort of deep clinical history.Although bone marrow transplants
themselves have a lot ofprecedent, our process where we
are obtaining bone marrow fromorgan donors, cryopreserving it,
and then using that bone marrowfor transplant, is a novel
process that we've developed.
We have a lot of confidence inthat process based on the
(09:35):
quality of the data that we'reseeing so far from the initial
transplants that we've done, andwe want to make sure that
physicians have access to thatdata. And so in order for
physicians to develop confidencethat our product can be used to
reconstitute the blood andimmune systems of their
patients, they need a data setto rely on. And so the purpose
of this study is to produce thatclinical data set. And so we are
(09:59):
measuring the rate ofengraftment, how much time
passes between when the bonemarrow is transplanted and when
the patient's blood and immunesystem is reconstituted. We're
also measuring the amount oftime the patient spends in the
hospital and a variety of othermetrics and really, really
trying to show that they haveexcellent outcomes.
And so far, that's bearing out.
Dr. Moira Gunn (10:20):
Now Osteum Health is in a period of
building this donor bank. Whatif you need a bone marrow
transplant today, especially ifyou don't have a match right
now?
Kevin Caldwell (10:30):
So if you're looking for a bone marrow donor,
can go to ossiumhealth.com andgo to our HOPE program, which is
a program that we establishedfor people who are looking for a
bone marrow donor and don't haveone readily available, and just
provides information, a littlebit of information about the
diagnosis and contactinformation. Our team will
(10:53):
review that and then someonefrom our clinical team will ask
to be put in touch with yourdoctor. And if you are a good
candidate for for the study orfor the expanded access program,
then our team would work withyour doctor from there.
Dr. Moira Gunn (11:07):
What if you wanna donate?
Kevin Caldwell (11:09):
The way to become an Osteum donor is to
become an organ donor. So if youjust sign up for organ donation
at the DMV, then you'll be apotential Osteum donor.
Dr. Moira Gunn (11:17):
So where do you go from here, Kevin? There's a
lot of work to be done.
Kevin Caldwell (11:21):
Well, we are looking forward to the
completion of our PRESERVEclinical trial for the treatment
of blood cancers. We hope tobring the number of patients who
go looking for a donor andultimately receive a transplant
much closer to one hundredpercent than it is today so that
fewer and fewer people die fromthis treatable disease. Beyond
(11:44):
that, there's an enormous numberof applications of banked bone
marrow and stem cells, includingenabling organ transplants
without immunosuppression,people who receive solid organs
from the same donors that werely upon for bone marrow. Our
hope is that one day they canlive without needing to have
their immune systems suppressedwith drugs. There are
(12:06):
opportunities to use some of thebone from the donors to make
orthopedic products to expeditethe healing after orthopedic
surgery and really just a vastnumber of other applications.
We're looking forward todramatically expanding our blood
cancer treatment program fromthe nine centers that are
currently participating in ourclinical trial to the hundreds
(12:26):
of bone marrow transplantcenters around The US and world
that treat patients every day.
Dr. Moira Gunn (12:30):
Well Kevin, thank you so much for joining
us. I hope you come back, keepus updated.
Kevin Caldwell (12:34):
Thanks for having me, Moira.
Dr. Moira Gunn (12:35):
Kevin Caldwell is the co founder and CEO of
Ossium Health. More informationis available on the web at
ossiumhealth.com. That's O S S Iu m o c m health dot com. And
remember, you can become anorgan donor simply by
(12:56):
registering at your local DMV.
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