Q2 2023 SeaStar Medical Holding Corporation Earnings Call
Operator: Welcome to the SeaStar Medical Business Update Conference Call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by the number one on your touch-tone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference is being recorded. I would now like to turn the conference over to Jody Cain. Please go ahead.
Welcome to the C-STAR Medical Business Update Conference Call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key, followed by the number 1 on your touch-tone phone.
If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this conference is being recorded. I would now like to turn the conference over to Jody Kane. Please go ahead. Please Steve Bro echo at again
Jody Cain: This is Jody Cain with LHA. Thank you for participating in today's call. Please note that a slide presentation to accompany management's prepared remarks is available on the webcast and on the Events and Presentations page of the Investors section of the SeaStar Medical website at seastarmedical.com. Joining me from SeaStar Medical are Eric Schlorff, Chief Executive Officer, and Kevin Chung, Chief Medical Officer. Turning to slide two, I'd like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from any anticipated results. These statements represent the company's estimates based on the information available as of today. For a list and description of risks and uncertainties, please review SeaStar Medical's filings with the Securities and Exchange Commission at sec.gov.
This is Jody Kane with LHA. Thank you for participating in today's call. Please note that a slide presentation to accompany management's prepared remarks is available on the webcast and on the events and presentations page of the investor section of the C-STAR Medical website.ese s
at cstarmedical.com. Joining me from CStar Medical are Eric Schlorf, Chief Executive Officer, and Dr. Kevin Chung, Chief Medical Officer. Turning to slide two, I'd like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from any anticipated results. These statements represent the company's estimates based on the information available as of today. For a list and description of risks and uncertainties, please review CStar Medical's filings with the Securities and Exchange Commission at sec.gov. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, August 22nd, 2023. CStar Medical undertakes no obligation to revise or update any statement.
Jody Cain: Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, 22 August 2023. SeaStar Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law. Now I'd like to turn the call over to Eric Schlorff. Eric?
Eric Schlorff: Thank you, Jody. Good afternoon, everyone, and thank you for joining us. Starting on slide three, today we'll provide updates on our activities to gain FDA approval for our Selective Cytopheretic Device, or SCD, and share the value proposition we envision with our technology, including our insights into the commercial opportunity. We are highly enthusiastic about the future of SeaStar Medical, with multiple value-creating milestones expected over the next 24 months. These include the potential to begin commercialization of the SCD product candidate for children with acute kidney injury, or AKI, complete enrollment in NEUTRALIZE-AKI, the adult AKI pivotal targeting a multi-billion-dollar kidney market, and expand into new indications through collaborations. We understand there are challenges that lie ahead, but our experienced, dedicated team will continue to take proactive actions to meet these challenges and make sound business decisions based on the information available.
for our selective cyto-phoretic device or SCD and share the value proposition we envision with our technology including our insights into the commercial opportunity.
We are highly enthusiastic about the future of C-STAR Medical with multiple value-creating milestones expected over the next 24 months. These include the potential to begin commercialization of the SCD product candidate for children with acute kidney injury, or AKI.
complete enrollment in neutralized AKI, the adult AKI pivotal targeting a multi-billion dollar kidney market, and expand in the new indications through collaborations.
We understand there are challenges that lie ahead, but our experienced, dedicated team will continue to take proactive actions to meet these challenges and make sound business decisions based on the information available. We will continue to build our investor base and remain confident that we will attract financial partners who believe in our vision.
Eric Schlorff: We will continue to build our investor base and remain confident that we will attract financial partners who believe in our vision. I want to begin by discussing the importance of our technology and why we are optimistic about our future. Described here on slide four, we are advancing an innovative platform that addresses the life-threatening consequences of a dysregulated immune response, which can result in the overproduction and activation of inflammatory cells, leading to hyper inflammation and ultimately creating what's called the cytokine storm. This condition can result in organ failure and even death. Our platform, the Selective Cytopheretic Device, or SCD, pictured here for the adult and pediatric indications, is a cell-directed extracorporeal therapy that can target and neutralize the overactive effector cells to bring them back in a reparative state, thus quelling the cytokine storm.
I want to begin by discussing the importance of our technology and why we are optimistic about our future. Described here on slide 4.
We are advancing an innovative platform that addresses the life-threatening consequences of a dysregulated immune response, which can result in the overproduction and activation of inflammatory cells, leading to hyperinflammation and ultimately creating what's called the cytokine storm.
This condition can result in organ failure and even death.
Our platform, the selective cytoforetic device or SCD, pictured here for the adult and pediatric indications is a cell-directed extracorporeal therapy that can target and neutralize the overactive effector cells to bring them back in a reparative state.
Eric Schlorff: Now I will introduce our chief medical officer, Dr. Kevin Chung, to provide some details about our innovative platform therapy and discuss results of our completed clinical trials. Kevin?
thus quelling the cytokine storm. Now I will introduce our Chief Medical Officer, Dr. Kevin Chung, to provide some details about our innovative platform therapy and discuss results of our completed clinical trials. Kevin. Thank you, Eric. If you can turn to slide five.
Kevin Chung: Thank you, Eric. If you can turn to slide five, inflammation is essential to the body's healing process. As Eric mentioned, the overactivation of inflammatory cells triggered by trauma, major surgery, or infection can send the body into a shock state and cause damage to a variety of distant organs such as the heart, lungs, or kidneys. Left untreated, this dysregulated host response may result in multi-organ failure and even death. This process is triggered early and, once initiated, continues long after the initial insult and has been shown to be responsible for the above-mentioned damage to the body. While a variety of tools are available to physicians to simply provide supportive care in the ICU, none can modify the inflammatory process once triggered and help repair the damage done by the cytokine storm. I know from firsthand experience that these current treatment options are not enough.
Inflammation is essential to the body's healing process. As Eric mentioned, the overactivation of inflammatory cells triggered by trauma, major surgery, or infection can send the body into a shock state and cause damage to a variety of distant organs such as the heart, lungs, or kidneys.
Less untreated, this dysregulated host response may result in multi-organ failure and even death.
This process is triggered early and once initiated continues long after the initial insult and has been shown to be responsible to the above mentioned damage to the body.
While a variety of tools are available to physicians to simply provide supportive care in the ICU, none can modify the inflammatory process once triggered.
and help repair the damage done by the cytokine storm.
Kevin Chung: There is a clear, urgent, clinical unmet need to address hyperinflammation at its source. As a medical officer in the US Army, I was thrown into the critical care of combat casualties, young American service members severely wounded during combat operations in Iraq and Afghanistan. There is nothing that comes close to the destruction that human beings get subjected to than what the war wounded go through. Fresh out of fellowship training in critical care, I was assigned to the US Army burn unit in San Antonio, where I became witness to the worst injuries imaginable. That is where I gained an interest in novel life-saving technologies. Being surrounded by so much morbidity and death in the burn unit, I learned to appreciate how limited we are in healthcare. I learned that we needed better tools. This is why I joined SeaStar Medical.
I know from firsthand experience that these current treatment options are not enough.
There is a clear, urgent, clinical unmet need to address hyperinflammation at its source.
As a medical officer in the US Army, I was thrown into the critical care of combat casualties.
young American service members severely wounded during combat operations in Iraq and Afghanistan.
There is nothing that comes close to the destruction that human beings get subjected to than what the war wound go through.
Fresh out of fellowship training and critical care, I was assigned to the U.S. Army burn unit in San Antonio, where I became witness to the worst injuries imaginable.
That is where I gained an interest in novel life-saving technologies.
Being surrounded by so much morbidity and death in the burn unit, I learned to appreciate how limited we are in healthcare.
Kevin Chung: Our approach targets the source of the dysregulated host response that is responsible for much of the organ failure that occurs after severe injury or severe infection. Our first-in-class SCD is designed to reprogram activated effector cells, specifically neutrophils and monocytes, which are the inflammatory cells that cause the cytokine storm. By deactivating these key effector cells, the SCD has been shown to bring about immune homeostasis. Unlike other blood purification tools or drugs, the SCD selectively targets the most highly activated pro-inflammatory neutrophils and monocytes and essentially neutralizes them without causing immune depletion or immunosuppression. The SCD has the potential to address hyperinflammation in a variety of acute and chronic large, high-volume indications. Turning to slide six. On the left-hand side of the slide is a graphic overview of the process by which the immune system can attack vital organs.
I learned that we needed better tools.
This is why I joined C-star Medical. Our approach targets the source of the dysregulated host response that is responsible for much of the organ failure that occurs after severe injury or severe infection.
Our first-in-class STD is designed to reprogram activated effector cells.
specifically neutrophils and monocytes.
which are the inflammatory cells that cause the cytokine storm.
By deactivating these key effector cells, the STD has been shown to bring about immune homeostasis.
Unlike other blood purification tools or drugs, the STD selectively targets the most highly activated pro-inflammatory neutrophils and monocytes and essentially neutralizes them.
without causing immune depletion or immunosuppression.
The STD has the potential to address hyper inflammation in a variety of acute and chronic large high-value indications.
Turning to slide six.
On the left-hand side of the slide is a graphic overview of the process by which the immune system can attack vital organs.
Kevin Chung: On the right, you see that our SCD technology intervenes early in the process. The SCD therapy mimics nature by creating a unique microenvironment, sequestering these highly activated effector cells and neutralizing them in a low-calcium environment. These cells are returned back to the body through the blood and is signaled to focus on repair. On slide seven, our device is integrated into existing hemodialysis equipment that is widely available in ICUs across the US. It takes less than 15 minutes for critical care staff to attach our device into this equipment. Turning to slide eight. The first indication we are pursuing with the SCD is acute kidney injury, or AKI, requiring continuous kidney replacement therapy known as CKRT, which is today's standard of care for support.
On the right, you see that our STD technology intervenes early in the process.
The STD therapy mimics nature by creating a unique microenvironment sequestering these highly activated effector cells and neutralizing them in a low calcium environment.
These cells are then returned back to the body through the blood and is signaled to focus on repair.
On slide 7, our device is integrated into existing hemodialysis equipment that is widely available in ICUs across the U.S.
It takes less than 15 minutes for critical care staff to attach our device into this equipment.
Now turning to slide eight.
The first indication we are pursuing with the STD is acute kidney injury, or AKI, requiring continuous kidney replacement therapy known as CKRT.
Kevin Chung: The patients we've treated with the SCD were critically ill adults and children in the ICU who suffered an average of three organ failures, and many were septic. We did not limit study enrollment by body mass index, and in fact, we treated patients with BMIs over 40. We also did not limit the type of disease or injury that caused hyperinflammation, showing that SCD treatment is disease agnostic. On slide nine, you can see the dramatic results of these clinical studies of using our SCD therapy in very sick adults and children with AKI. We also observed in these five studies that our SCD therapy reduces the mortality rate versus control patients by up to 50%. We observed a similar reduction in mortality in 22 patients in the COVID-19 study.
which is today's standard of care for support.
The patients we've treated with the STD were critically ill adults and children in the ITU who suffered an average of three organ failures and many were septic.
We did not limit study enrollment by body mass index and in fact we treated patients with BMIs over 40.
We also did not limit the type of disease or injury that caused hyper-inflammation, showing that STD treatment is disease agnostic.
We also observed in these five studies that our STD therapy reduces the mortality rate versus control patients by up to 50%. We observed a similar reduction in mortality in 22 patients in the COVID-19 study. Equally as impressive, treatment with the STD eliminated dialysis dependency at day 60 in all non-COVID AKI patients, both in adults and children. Thank you.
Kevin Chung: Equally as impressive, treatment with the SCD eliminated dialysis dependency at day 60 in all non-COVID AKI patients, both in adults and children. Again, no patient was on dialysis at 60 days post-treatment. All those patients had renal recovery. The clinical results in the pediatric patients are particularly noteworthy. Especially interim data from the PED-02 study in children weighing between 10 to 20 kilos, where five out of the six patients survived, resulting in an 83% survival rate. About a quarter of pediatric AKI patients who enter the ICU stay there twice as long as pediatric patients without AKI, and unfortunately, about half of those children die. Of those who do survive, many have long-term chronic complications. Now on slide 10.
Again, no patient was on dialysis at 60 days post-treatment. All those patients had renal recovery. The clinical results in the pediatric patients are particularly noteworthy.
especially interim data from the PEDO2 study in children weighing between 10 to 20 kilos, where five out of the six patients survive.
resulting in an 83% survival rate.
About a quarter of pediatric AKI patients who enter the ICU stay there twice as long as pediatric patients without AKI.
Of those who do survive, many have long-term chronic complications. Now on slide 10. In reviewing the safety profile across our five completed AKI studies that included 151 critically ill patients with AKI, including half who were septic and involving greater than 800 device sessions and greater than 19,000 cumulative continuous exposure hours of treatment, we saw no device-related infections or device-related serious adverse events.
Kevin Chung: In reviewing the safety profile across our five completed AKI studies that included 151 critically ill patients with AKI, including half who were septic and involving greater than 800 device sessions and greater than 19,000 cumulative continuous exposure hours of treatment, we saw no device-related infections or device-related serious adverse events. Notably, our controlled pivotal SCD-PED-01 study in children with AKI weighing at least 20 kilos, which was funded by the FDA's Office of Orphan Products Development, showed no SCD-related adverse events or infection involving 80 device sessions in over 1,900 cumulative continuous exposure hours of treatment in 16 patients. With that, I would like to turn the call back over to Eric Schlorff.
exposure hours of treatment in 16 patients. With that, I would like to turn the call back over to Eric Schlor. Thanks, Kevin. On slide 11, it's worth mentioning that most pharmaceutical companies pursue approvals for therapies in the adult population first. Once safety and efficacy are established, they are then encouraged and even incentivized to conduct pediatric studies. Had we also followed this pathway, we would be years away from getting the SCD to the market. However, given the highly promising data from our pediatric SCD study, we would be more than happy
Eric Schlorff: Thanks, Kevin. On slide 11, it's worth mentioning that most pharmaceutical companies pursue approvals for therapies in the adult population first. Once safety and efficacy are established, they are then encouraged and even incentivized to conduct pediatric studies. Had we also followed this pathway, we would be years away from getting the SCD to the market. However, given the highly promising data from our pediatric SCD study that Kevin just discussed, we strategically elected to lead with the pediatric indication under the Humanitarian Device Exemption, or HDE, regulatory pathway. We met the HDE criteria in this indication as our clinical results showed safety and probable clinical benefit to these critically ill children who have few treatment options in the US addressable population of about 4,000 patients, which is well within the 8,000-patient HDE criteria.
who have few treatment options and the US addressable population of about 4,000 patients, which is well within the 8,000 patient HDE criteria. Importantly, we chose the HDE pathway as a means to bring these important life-saving and quality of life results to critically ill children as quickly as possible, thereby also allowing us to get the SED quickly into the market and into the hands of practicing clinicians.
Eric Schlorff: Importantly, we chose the HDE pathway as a means to bring these important life-saving and quality-of-life results to critically ill children as quickly as possible, thereby also allowing us to get the SCD quickly into the market and into the hands of practicing clinicians. There are challenges associated with this pathway for our therapeutic device. To our knowledge, our submission is among a very few and could possibly the only case in which a medical device for a pediatric patient population is under review by the FDA Center for Biologics Evaluation and Research, or CBER, rather than the Center for Devices and Radiological Health, or CDRH. Additionally, our submission is being reviewed through the HDE, which is not the typical regulatory pathway.
There are challenges associated with this pathway for our therapeutic device. To our knowledge, our submission is among a very few and could possibly be the only case in which a medical device for a pediatric patient population is under review by the FDA Center for Biologics Evaluation and Research, or CBER.
rather than the Center for Devices and Radiologic Health or CDRH. Additionally, our submission is being reviewed through the HDE, which is not the typical regulatory pathway. We believe the FDA has appropriately set a very high bar in its evaluation of the SCD pediatric device given the vulnerability of these critically ill children in the ICU.
Eric Schlorff: We believe the FDA has appropriately set a very high bar in its evaluation of the SCD-PED, given the vulnerability of these critically ill children in the ICU. That said, we are confident that the SCD-PED will meet or even exceed the high standards set by the FDA, and we continue to believe that we will gain approval by the end of 2023. On this slide, I want to begin to discuss considerable differences between our adult and our pediatric AKI programs. Among them are the FDA pathways for approval, which are completely independent of each other, and the proprietary characteristics that differ between the SCD-PED and SCD-Adult devices. These two devices are completely different products. The pediatric device is called the SCD-PED. The adult is called the SCD-Adult and meant for different patient populations.
That said, we are confident that the SCD pediatric device will meet or even exceed the high standards set by the FDA, and we continue to believe that we will gain approval by the end of 2023.
Also on this slide, I want to begin to discuss considerable differences between our adult and pediatric AKI programs.
Among them are the FDA pathways for approval, which are completely independent of each other and the proprietary characteristics that differ between the STD pediatric and STD adult devices.
These two devices are completely different products. The pediatric device is called the SCD-PED or PED. The adult is called the SCD adult and meant for different patient populations. Although notably, their mechanism of action is the same. More on this in a minute.
Eric Schlorff: Notably, their mechanism of action is the same. More on this in a minute. Another difference is the size of the addressable patient population with a considerably larger opportunity in the adult AKI, which I'll detail in a couple of slides. While we address a smaller commercial opportunity in the pediatric AKI market, I want to reiterate that we are deeply committed to bringing the potential life-saving benefits of this therapy to critically ill children. Moving on to slide 12. In June 2022, we submitted an HDE application for the SCD-PED device. Following nearly a year of working collaboratively with the CBER group, responding to questions and providing support information, we were surprised in May to receive a letter from the FDA indicating that the application was not approvable in its current form. The letter outlined specific guidance as to how the application may be amended and resubmitted.
Another difference is the size of the addressable patient population with a considerably larger opportunity in the adult AKI, which I'll detail in a couple slides. While we address a smaller commercial opportunity in the pediatric AKI market, I want to reiterate that we are deeply committed to bringing the potential life-saving benefits of this therapy to critically ill children.
Moving on to slide 12. In June 2022, we submitted an HDE application for the SCD pediatric device.
following nearly a year of working collaboratively with the SEVER group. Responding to questions and providing support information, we were surprised in May to receive a letter from the FDA indicating that the application was not approvable in its current form. The letter outlined specific guidance as to how the application may be amended and resubmitted.
Eric Schlorff: Since then, we have been working diligently with the FDA towards a resolution of this review process and are engaging in ongoing discussions with the agency. In addition to providing more information, we have provided further support in the form of written testimonials we've received from clinicians who have firsthand experience using our device to improve clinical outcomes in pediatric patients, from parents of children in the ICU who attest to the role of the SCD in their child's recovery, and from a national professional society of pediatric nephrologists expressing their concern with the not approvable letter, urging FDA to ensure this device is made accessible to the pediatric nephrology and critical care community. Turning now to slide 13. This chart provides more detail about the different parameters of the SCD-PED and SCD-Adult devices, as well as the different approval pathway.
in our engaging and ongoing discussions with the agency.
In addition to providing more information, we have provided further support in the form of written testimonials we've received from clinicians who have firsthand experience using our device to improve clinical outcomes in pediatric patients from parents of children in the ICU.
who attest to the role of the SCD in their child's recovery, and from a national professional society of pediatric nephrologists expressing their concern with the not-approvable letter, urging FDA to ensure this device is made accessible to the pediatric nephrology and critical care community.
Turning now to slide 13.
This chart provides more detail about the different parameters of the FCD.
Eric Schlorff: While the pictures are not intended to show the actual devices' sizes, you can see the considerable different parameters for the membrane surface area and priming volume between the two devices. Moving on to slide 14. As I mentioned, both the SCD pediatric and SCD adult devices work with the same mechanism of action. Our studies show a similar reduction in mortality in both the pediatric and adult populations, both by up to 50% and with no dialysis dependency at day 60. Our studies produced robust safety data in both populations with no device-related serious adverse events or infections, no attributable immunosuppression, and as mentioned earlier, both devices can be readily integrated into the CKRT machines by hospital staffs in about 15 minutes. Turning to slide 15.
PED and SCD adult devices as well as the different approval pathway. While the pictures are not intended to show the actual devices.
sizes, you can see the considerable different parameters for the membrane surface area and priming volume between the two devices. Moving on to slide 14, as I mentioned, both the SCD pediatric and SCD adult devices work with the same mechanism of action. Our studies show a similar reduction in mortality in both the pediatric and the adult devices.
robust safety data in both populations with no device-related serious adverse events or infections, no attributable immunosuppression, and as mentioned earlier, both devices can be readily integrated into the CKRT machines by hospital staffs in about 15 minutes. Turning to slide 15, while we remain fully committed to our HDE submission to the SCD pediatric device to vulnerable and underserved children with AKI, the addressable adult AKI market is significantly larger, in fact, about 50 times the size of the addressable pediatric AKI market, with more than 200,000 cases per year in the U.S. On slide 16, we've outlined the financial value proposition for adopting the pediatric SCD by a single leading children's hospital, which is based on the assumptions that our therapeutic device reduces mortality by half and dialysis dependency by a third. For the year 2022, this...
Eric Schlorff: While we remain fully committed to our HDE submission to the SCD pediatric device to vulnerable and underserved children with AKI, the addressable adult AKI market is significantly larger. In fact, about 50 times the size of the addressable pediatric AKI market, with more than 200,000 cases per year in the US. On slide 16, we've outlined the financial value proposition for adopting the pediatric SCD by a single leading children's hospital, which is based on the assumptions that our therapeutic device reduces mortality by half and dialysis dependency by a third. For the year 2022, this hospital performed 1,628 procedures on 126 pediatric patients with AKI who would have been eligible for the SCD pediatric therapy. The quality-of-life improvement is dramatic, with a reduction in the average length of stay and lower readmission rates and post-acute emergency visits.
Eric Schlorff: On slide 17, we're presenting data from our health economic and outcome research, which shows evidence of the value of new interventions for reimbursement in healthcare payers. These data support the SCD's value proposition in reducing healthcare costs. As you can see, patients who develop AKI are more likely to need dialysis, with that likelihood increasing with the severity of disease. The cost for each patient per year on dialysis is about $100,000 per year. The total cost of a full course of the SCD treatment, which is 3 to 7 days of therapy, will cost $10,000 to 20,000 range. Now I turn it back over to Kevin to provide some details of the NEUTRALIZE-AKI study, as well as how the team has been deepening and broadening the science. Kevin?
These data support the SCD's value proposition in reducing health care costs. As you can see, patients who develop AKI are more likely to need dialysis, with that likelihood increasing with the severity of disease. The cost for each patient per year on dialysis is about $100,000 per year. The total cost of a full course of the SCD treatment, which is 3 to 7 days of therapy, will cost $10,000 to $20,000 range.
Now, I turn it back over to Kevin to provide some details of the neutralized AKI study, as well as how the team has been deepening and broadening the science. Kevin?
Kevin Chung: Thank you, Eric. Turning to slide 18. Let me now discuss our progress in expanding use of the SCD to adult patients with acute kidney injury. I'm proud to say that the adult SCD device received FDA breakthrough designation last year. This designation is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on the clinically significant endpoints. Breakthrough therapies receive many benefits, including a commitment by the FDA to expedite development and review. Our pivotal NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 US medical centers. This trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CKRT as standard of care, compared with the control group receiving only CKRT alone.
Thank you, Eric.
Now turning to slide 18, let me now discuss our progress in expanding use of the STD to adult patients with acute kidney injury.
I'm proud to say that the adult STD device received FDA breakthrough designation last year.
This designation is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies and the clinically significant endpoints.
Our pivotal neutralized AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers. This trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CKRT as standard of care compared with the control group receiving only CKRT alone. Primary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at day 90, and dialysis dependency at 1 year.
Kevin Chung: Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at day 90, and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD-Adult therapy in AKI patients with sepsis and acute respiratory distress syndrome. On slide 19. As a progress update, we just activated our third trial site yesterday. For updated site activation and status, please go to clinicaltrials.gov and type in NEUTRALIZE-AKI in the search. We are working diligently to qualify additional medical centers to join this trial and expect the activation of several more sites in the coming weeks. Our goal is to increase the number of sites to between 20 and 30. We also have two patients enrolled at this time. With the activation of additional sites, we anticipate enrollment at a quicker pace.
The study will also include subgroup analyses to explore the effectiveness of SCD adult therapy in AKI patients with sepsis and acute respiratory distress syndrome.
On slide 19, as a progress update, we just activated our third trial site yesterday.
For updated site activation and status, please go to clinicaltrials.gov and type in neutralize AKI in the search. For more information onocrine- elaborated Sillery congregation returns, please visit
We are working diligently to qualify additional medical centers to join this trial and expect the activation of several more sites in the coming weeks. Our goal is to increase the number of sites to between 20 and 30.
We also have two patients enrolled at this time.
Kevin Chung: Our target is to enroll one patient per site per month. We plan to provide periodic updates on site activation and patient enrollment as this important trial progresses. We are optimistic about a favorable outcome with the adult AKI trial having previously demonstrated success in the same patient population. Based on the results of the NEUTRALIZE-AKI trial, we will submit an application under a pre-market approval pathway, or PMA. We anticipate regulatory approval in H1 2025 and commercialization in H2 2025. Now moving on to slide 20. We are taking other measures to showcase our technology aimed at creating awareness and support in the medical community. This includes assembling a board of scientific advisors who offer insights and vital guidance on additional developmental programs for our technology.
With the activation of additional sites, we anticipate enrollment at a quicker pace.
Our target is to enroll one patient per site per month.
We plan to provide periodic updates on site activation and patient enrollment as this important trial progresses.
We are optimistic about a favorable outcome with the adult AKI trial having previously demonstrated success in the same patient population.
Based on the results of the neutralized AKI trial, we will submit an application under a premarket approval pathway.
or PMA. We anticipate regulatory approval in the first half of 2025 and commercialization in the second half of 2025.
Now, moving on to slide 20.
We are taking other measures to showcase our technology aimed at creating awareness and support in the medical community.
This includes assembling a board of scientific advisors who offer insight and vital guidance on additional developmental programs for our technology.
Kevin Chung: Our advisors are the world's leading experts in nephrology and critical care medicine and represents both adult and pediatric disciplines across multiple renowned institutions globally. They include pediatric experts such as Dr. Stu Goldstein from Cincinnati Children's, recently named the number one children's hospital in the United States, Dr. Raj Basu and Teresa Matas from Lurie in Chicago, Dr. David Askenazi from the University of Alabama at Birmingham. Our adult nephrology and critical experts include Dr. Kathleen Liu from UC San Diego, Dr. Sean Bagshaw from the University of Alberta, and Dr. Jay Koyner from the University of Chicago. We also have translational science experts such as Dr. Sarah Faubel from the University of Colorado, Dr. Andrew Pachinsky from the University of the Incarnate Word, and Dr. Mark Jeske from the Hamilton Health Sciences to help guide our research efforts.
Our advisors are the world's leading experts in nephrology and critical care medicine and represents both adults and pediatric disciplines across multiple, renowned institutions globally.
They include pediatric experts such as Dr. Stu Goldstein.
from Cincinnati Children's, recently named the number one children's hospital in the United States. Dr. Raj Basu and Teresa Mathes from Lurie's in Chicago. Dr. David Askinazi from the University of Alabama, Birmingham.
Our adult nephrology and critical experts include Dr. Kathleen Lu from UC San Diego, Dr. Sean Bagshaw from the University of Alberta, and Dr. Jay Koiner from the University of Chicago
We also have translational science experts such as Dr. Sara Fobel from the University of Colorado, Dr. Andrew Paczynski from the University of Uncarnate Word and Dr. Mark Jeske from the Hamilton Health Sciences.
Kevin Chung: We will be issuing a more detailed press release on our SAB in the near future. We are also focusing on publications and peer-review journals, presentations of data at scientific conferences, and highlighting compassionate and emergency use cases. Of note, we recently got two of our abstracts accepted to the American Society of Nephrology Kidney Week in 2023, later this year in November, and we'll provide more information on these within the coming weeks. We have also approached government agencies for potential non-dilutive funding grants and currently work with advocacy groups and associations to garner further support. With that, I'd like to turn the call back to Eric Schlorff.
to help guide our research efforts. We will be issuing a more detailed press release on our SIB, SAB in the near future.
We are also focusing on publications and peer-reviewed journals, presentations of data at scientific conferences and highlighting compassionate and emergency use cases.
Of note, we recently got two of our abstracts accepted to the Association of the American Society of Nephrology Kidney Week in 2023 later this year in November . And we'll provide more information on these within the coming weeks.
We have also approached government agencies for potential non-dilutive funding grants and currently work with advocacy groups and associations to garner further support.
Eric Schlorff: Thanks, Kevin. Turning to slide 21. While we are addressing AKI as our first target indication, we are also exploring other potential applications for our technology in conjunction with the University of Michigan. This includes a broad range of both acute and chronic indications involving dysregulated immune processes, where pro-inflammatory activated neutrophils and monocytes may contribute to disease progression or severity. As you can see, some of these represent large future market opportunities. On slide 22, I want to mention that we are prepared for commercializing the SCD pediatric device subject to FDA approval through a license and distribution agreement with Nuwellis. Our initial focus will be on the top 50 US hospitals that treat pediatric AKI patients. We selected to partner with Nuwellis based on their sales forces' established relationships with nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
With that, I'd like to turn the call back to Eric Schlorf.
Thanks, Kevin.
Turning to slide 21, while we are addressing AKI as our first target indication, we are also exploring other potential applications.
for our technology in conjunction with the University of Michigan. This includes a broad range of both acute and chronic indications involving dysregulated immune processes where pro-inflammatory, activated neutrophils, and monocytes may contribute to disease progression or severity.
As you can see, some of these represent large future market opportunities.
On slide 22, I want to mention that we are prepared for commercializing the STD pediatric device subject to FDA approval through a license and distribution agreement with New Welles. Our initial focus will be on the top 50 US hospitals that treat pediatric AKI patients.
We selected to partner with New Wellis based on their sales forces, establish relationships with nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
Eric Schlorff: Our Nuwellis partnership has the added advantage of allowing our team at SeaStar Medical to focus on additional clinical applications without the expense of hiring and training a commercial team. To summarize on Slide 23, we have a proprietary technology that has shown significant benefit against an unmet clinical need. We are diligently working toward approval of our HDE, followed by a commercial launch in pediatric AKI patients. We are enrolling patients and activating medical sites in our ongoing pivotal NEUTRALIZE-AKI trial in adults that addresses a different regulatory pathway and a significantly larger patient population. We are working toward generating clinical data in support of demonstrating the economic value of our technology. Our technology has a potential application in multiple acute and chronic high-value indications.
Our New Welles partnership has the added advantage of allowing our team at C-STAR Medical to focus on additional clinical applications without the expense of hiring and training a commercial team.
To summarize, on slide 23, we have a proprietary technology that has shown significant benefit against an unmet clinical need. We are diligently working toward approval of our HDE, followed by a commercial launch in pediatric AKI patients.
We're enrolling patients and activating medical sites in our ongoing pivotal neutralized AKI trial in adults that addresses a different regulatory pathway in a significantly larger patient population.
We are working toward generating clinical data in support of demonstrating the economic value of our technology.
Our technology has a potential application in multiple acute and chronic high value indications.
Eric Schlorff: Importantly, we have a dedicated world-class team that is focused on execution of our business strategy and achieving our goal of improving patient outcomes and saving lives. In summary, we are highly enthusiastic about the future of SeaStar Medical with multiple value-creating milestones expected over the next 24 months. These include the potential to begin commercialization of the SCD product candidate for children with AKI, complete enrollment in NEUTRALIZE-AKI, which is the AKI pivotal study targeting a multi-billion-dollar kidney market, and expand into new indications through collaborations. We understand there are challenges that lie ahead, our experienced, dedicated team will continue to take proactive actions to meet these challenges and make sound business decisions based on the information available. We will continue to build our investor base and remain confident that we will attract financial partners who believe in our vision.
And importantly, we have a dedicated world-class team that is focused on execution of our business strategy and achieving our goal of improving patient outcomes and saving lives.
In summary, we are highly enthusiastic about the future of C-STAR Medical with multiple value creating milestones expected over the next 24 months.
These include the potential to begin commercialization of the SCD product candidate for children with AKI, complete enrollment in neutralized AKI, which is the AKI pivotal study targeting a multi-billion dollar kidney market, and expand into new indications through collaborations.
We understand there are challenges that lie ahead, but our experienced, dedicated team will continue to take proactive actions to meet these challenges and make sound business decisions based on the information available. We will continue to build our investor base and remain confident that we will attract financial partners.
Eric Schlorff: With that overview and update, operator, we are now ready to take questions. Operator.
who believe in our vision. With that overview and update, Operator, we are now ready to take questions.
Operator: Thank you very much. As a reminder, if you wish to register a question in today's Q&A session, you will need to press star, then the number one on your telephone. If your question has been answered and you wish to withdraw your polling request, you may do so by pressing the star key followed by the number two. If you are using a speakerphone, please pick up your handset before entering your request. Today's first question comes from Anthony Vendetti with Maxim Group. Please go ahead.
Thank you very much. As a reminder, if you wish to register a question in today's Q&A session, you will need to press star then the number one on your telephone.
If your question has been answered and you wish to withdraw your polling request, you may do so by pressing the star key followed by the number 2. If you are using your speakerphone, please pick up your handset before entering your request.
Today's first question comes from Anthony with Maxing Group. Please go ahead. Hello.
Anthony Vendetti: Thank you. That was a good overview, Eric and Kevin. Really appreciate it. With the compelling data that you have for both adults and pediatrics, as well as the safety data, because I think you mentioned there were no serious SAEs, adverse events, on either the adults or the pediatrics, and with reducing mortality by up to 50% and not any of these patients needing dialysis after day 60. I'm curious what the, in your opinion at least, or if the FDA hasn't outlined exactly what else they're looking for. In your opinion, what else do you think the FDA needs or is requiring? Is it just more patients to confirm what you've already witnessed in both the adult and the pediatric population, or is it something else that I'm missing? Thank you.
Thank you. That was a good overview Eric and Kevin really appreciate it. You know with with the compelling data that you have for both adults.
and pediatrics as well as the safety data because I think you mentioned there were no serious
at ADs adverse events on either the adults or the pediatrics.
and with reducing mortality by up to 50 percent.
and not any of these patients needing dialysis after day 60. I'm curious what the, in your opinion at least, if the FDA hasn't outlined exactly what else they're looking for. In your opinion, what else do you think the FDA needs or is requiring to Finance Pow Swiss
Is it just more patience to confirm what you've already witnessed in both the adult and the pediatric population? Or is it something else that I'm missing?
patients to confirm what you've already witnessed in both the adult and the pediatric population or is it something else that I'm missing? Thank you.
Eric Schlorff: Thanks, Anthony, for the question. Yeah. I think you come back to what you've said, which is, it's really probable benefit case in the HDE, it's probable benefit and safety, which we've shown. There are some slight manufacturing differences between the processes, between the products, and that's kind of where a lot of the focus has been. As we look at this and we see what the community is, research, clinician community has said, as well as those parents, as well as the society, there's clearly a need, and this fulfills that need. We strongly believe that in the current form, that this should be something that we move forward with. Obviously we will work closely with the FDA to find the win-win for everybody.
Thanks Anthony for the question. Yeah you know I think you come back to what you've said which is
It is, you know, it's really probable benefit in case in the HDE, probable benefit in safety, which we've shown. There are some slight manufacturing differences between the processes, between the products, and that's kind of where a lot of the focus has been. But as we look at this and we see what the community is researching, you know,
We strongly believe that.
in the current form that this should be something that we move forward with.
But you know obviously we will work closely with the FDA to find you know the win-win for everybody.
Anthony Vendetti: Okay. Just to follow up, you did mention, Eric, that you do expect, I guess based on your current conversations with the FDA, that whatever hurdles remain, you think SeaStar Medical can overcome and you do expect before the end of the year FDA approval, correct?
Okay, and then just to follow up, you did mention, Eric, that you do expect
I guess based on your current conversations with the FDA, that whatever hurdles remain, you think
C-STAR Medical can overcome and you do expect before the end of the year FDA approval, correct? Yeah, thanks Anthony. Yes, we are reaffirming that that guidance that based on the information we have today.
Eric Schlorff: Yeah. Thanks, Anthony. Yes, we are reaffirming that guidance, that based on the information we have today, and the discussions that we've had, we still believe that we should be successful at getting the approval of that HDE by year-end.
In the discussions that we've had, we still believe that we should be successful at getting the approval of that HDE by year-end.
Anthony Vendetti: Lastly, before I jump back in queue, you did reference that the adult AKI population is much greater. Can you just remind us how much larger the adult population is? On the pediatrics side, you're working with Nuwellis. After, obviously I know you're enrolling patients and you're expanding the sites to 20 to 30, what commercialization could look like on the adult side and how you would pursue that? Or is that too early to say at this point?
And then lastly before I jump back in queue you did reference that the the adult aka aka Population is much greater Can you just remind us what you know how much larger the adult population is?
And then on the pediatric side, you're working with Newellis. After, you know, obviously I know you're enrolling patients and you're expanding the sites to 20 to 30. What commercialization could look like on the adult side and how you would pursue that? Or is that too early to say at this point?
Eric Schlorff: Yeah, I would say that's, on the second question, that's probably too early to say. Obviously, we're going to be focused on with once we have FDA approval for the HDE, obviously we're going to be focused on ramping up and launching that. We've worked very closely with Nuwellis since we've signed the deal with them back in December. We've had time to get some of the logistics and those pieces in place. It really, that just comes down to now getting the approval and then it's executing, which we're very comfortable with. What was your first question again, Anthony?
Yeah, I would say that's on the second question that's probably too early to say but obviously you know we're going to we're going to be focused on with once we have FDA approval for the HD you obviously we're going to be focused on ramping up and launching that you know we've worked very closely with
Anthony Vendetti: Just on the difference in the size of the population.
what was your first question again Anthony? Just on the difference in the size of the population. Yeah I mean look the population difference as you can see is is dramatic so you know if you can kind of start to do some market assessment.
Eric Schlorff: Oh, yeah.
Anthony Vendetti: between the-
Eric Schlorff: I mean, look, the population difference, as you can see, is dramatic. If you can kind of start to do some market assessment, we say there's about 4,000 children that meet the criteria for this. The treatment cost that we're looking at is between $10,000 and $20,000. You can do the math. It's about, what, $40 million to $80 million. You can then do the math to see what $200,000 looks like, kind of in that same range. That's obviously not in millions, but it's in billions. We believe that it's very achievable, especially when you look at some of the data that came out of the children's hospital example, where we showed about $50,000 is spent on each one of those patients. We're not even attributing the additional annuity stream, which I'd call dialysis every year.
We say there's about 4,000 children, you know, that meet the criteria for this and the treatment cost that we're looking at is between 10 and 20,000. So you can do the math. It's about what, 40 to 80 million. You can then do the math to see what.
200,000 looks like kind of in that same range and it's obviously not in millions but it's in billions and we believe that it's very achievable especially when you look at some of the data that came out of the children's hospital example where we showed about $50,000 goes spent on each one of those patients.
we're not even attributing the additional annuity stream which I'd call you know dialysis every year. So there's obviously we're looking at ways to be able to gain rapid adoption of this just purely based on some of the economics.
Eric Schlorff: There's obviously, we're looking at ways to be able to gain rapid adoption of this, just purely based on some of the economics.
Anthony Vendetti: Okay, excellent. Thank you for all of that. Kevin, thank you for your explanations as well, and I'll turn it back over to the queue. Thank you.
Okay, excellent. Thank you for all of that. Kevin, thank you for your explanations as well. And I'll turn it back over to the queue. Thank you.
Thank you for all of that. Kevin, thank you for your explanations as well. And I'll turn it back over to the queue. Thank you. Great.
Eric Schlorff: Great.
Operator: Thank you. Seeing no further questions at this time, I would like to turn the conference back over to Eric Schlorff for closing remarks.
Thank you. Seeing no further questions at this time, I would like to turn the conference back over to Eric Schlor for closing remarks.
Eric Schlorff: Thank you, operator. I want to mention that we're participating in the Dawson James Small Cap Growth Conference, to be held on 12 October in Jupiter, Florida. We invite those of you attending this conference to meet with us. Thank you once again for joining us today and for your interest in SeaStar Medical. We are excited about the many opportunities we have with our technology, and we will keep you updated on developments along the way. Thanks again, and have a great afternoon.
Thank you, operator. I want to mention that we're participating in the Dawson James Small Cap Growth Conference, which begins to be held on October 12th in Jupiter, Florida. We invite those of you attending this conference to meet with us. Thank you once again for joining us today and for your interest in C-STAR Medical.
We are excited about the many opportunities we have with our technology, and we will keep you updated on developments along the way. Thanks again, and have a great afternoon.
Operator: Thank you. The conference has now concluded. Thank you for your participation. You may now disconnect your lines.
Thank you. The conference has now concluded.
Thank you for your participation. You may now disconnect your lines.
