What changed in this filing

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Item 1. Business

2026-03-25 compared with 2025-03-27 · 152 added, 174 removed, 583 unchanged (36% of the section changed)

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(the “Predecessor”) prior to the consummation of the Business Combination.

We are a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life.

We are a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life.

Our Selective Cytopheretic Device (“SCD”) is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body.

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We shipped our first commercial pediatric SCD (“QUELIMMUNE”) in July 2024.

In addition, we are currently conducting a pivotal clinical trial to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).

Our SCD therapy has been awarded Breakthrough Device Designation (“BDD”) for four therapeutic indications by the FDA, including the use of the SCD therapy for adult patients with AKI, patients with cardiorenal syndrome awaiting left ventricular assist device (“LVAD”) implantation, patients with hepatorenal syndrome, and patients with end stage renal disease (“ESRD”).

In addition, we are currently conducting a pivotal clinical trial, also referred to as "NEUTRALIZE-AKI" to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).

We are also conducting a feasibility study of the SCD therapy in adult patients with Cardiorenal Syndrome ("CRS") awaiting left ventricular assist device ("LVAD") implantation.

Our SCD therapy has been awarded six Breakthrough Device Designations (“BDD”) by the FDA.

These BDDs cover multiple therapeutic indications for the use of our SCD therapy in adult patients with AKI, CRS awaiting LVAD implantation, hepatorenal syndrome, end stage renal disease (“ESRD”), and systemic inflammatory response while undergoing cardiac surgery.

The BDD enables the potential for a speedier pathway to approval and the ability to have more frequent and flexible meetings with FDA.

The inflammatory response is essential to the healing process of critical organs;

however, the overactivation of inflammatory cells, which can be triggered by many different bodily insults such as trauma, surgery or infection, can send the body into shock and cause severe damage to a variety of critical organs such as the heart, lungs and kidney.

Central to inflammation are the cells within blood and lymph circulatory systems, called white blood cells (primarily neutrophils and monocytes).

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If the inflammatory response becomes excessive and dysregulated (referred to as proinflammatory), the inflammatory cells will continue to produce cytokines and other damaging molecules, further enhancing the dysregulated immune response, and altering feedback mechanisms that regulate the immune system.

This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death.

This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute and potentially chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death.

This hyperinflammatory response is also known as the “cytokine storm,” referring to the body’s reaction to the category of small-secreted proteins released by hyperinflammatory cells that affect communication between cells.

Currently, there are no therapeutic options that specifically neutralize the white blood cells that are primarily responsible for the destructive hyperinflammatory response.

Clinicians typically address hyperinflammation with therapies that are either immunosuppressive or that target one cytokine, both of which are generally suboptimal in the treatment of hyperinflammation.

Clinicians typically address hyperinflammation with therapies that are either immunosuppressive or that target a specific cytokine, both of which are generally suboptimal in the treatment of hyperinflammation.

We believe our technology has the potential to overcome limitations in existing anti-inflammatory treatments and address the challenge of selectively targeting activated neutrophils and monocytes.

Clinical and preclinical studies conducted over the last 15 years have demonstrated that our SCD therapy can modulate the degree of activity of proinflammatory cells to help reduce tissue damage and speed the repair and recovery of organ function.

Data from our trials demonstrated that the use of our SCD therapy to reverse the cytokine storm in more than 150

pediatric and adult patients with acute kidney injury on CRRT reduced mortality rates by 50%, and of those patients who survived 60 days, none have required dialysis.

Data from our trials demonstrated that the use of our SCD therapy to reverse the cytokine storm in more than 150 pediatric and adult patients with acute kidney injury on CRRT reduced mortality rates by 50%, and of those patients who survived 60 days, none have required dialysis.

We believe our SCD therapy has the potential to transform the treatment of acute organ failure in the intensive care unit (“ICU”) and to improve organ function in patients with chronic kidney disease, certain cardiovascular diseases, and other serious inflammatory diseases.

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We believe that the ease of use and broad applicability of the therapy across multiple disease states should enable us to capture a sizable market for our SCD therapy with increasingly favorable economics.

Our senior management team and Board have an average of over 19 years of experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas.

Our senior management team and Board have extensive experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas.

We also have assembled a team of well-respected scientific advisors who are experts in the development of our technology and products.

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QUELIMMUNE is currently the only FDA-approved product for critically ill pediatric patients with life-threatening acute kidney injury (AKI) due to sepsis or a septic condition.

We commenced our first product shipment of QUELIMMUNE in July 2024 and are now targeting top-tier pediatric medical facilities for adoption of the QUELIMMUNE therapy.

As a condition of the approval, the FDA stipulated that we would need to institute a post approval patient surveillance registry to track certain safety and performance metrics.

This typically requires an Internal Review Board (“IRB”) review and approval to use QUELIMMUNE therapy at the medical facility, which can lengthen the QUELIMMUNE adoption process.

To date, we have 5 active commercial sites that have completed the registry process and have purchased and used QUELIMMUNE therapy.

Additional site activations are planned for 2025.

We commenced our first product shipment of QUELIMMUNE in July 2024 and continue to target top-tier pediatric medical facilities for adoption of the QUELIMMUNE therapy.

As a condition of the approval, the FDA stipulated that we would need to institute a post approval patient surveillance registry to track certain safety and performance metrics (the "SAVE Surveillance Registry").

This typically requires an Institutional Review Board (“IRB”) review and approval to use QUELIMMUNE therapy at the medical facility, which can lengthen the QUELIMMUNE adoption process.

As of December 31, 2025, we had 10 active commercial hospital customers that have completed the process for the SAVE Surveillance Registry and have purchased QUELIMMUNE therapy.

Additional customer activations are planned for 2026.

A benefit of the SAVE Surveillance Registry is the opportunity to collect real-world data from the commercial use of QUELIMMUNE therapy.

Early results from the first 21 critically ill pediatric patients with life-threatening AKI and sepsis or a septic condition in the commercial setting in the SAVE Surveillance Registry showed no device related safety events with the QUELIMMUNE therapy with 76% of patients surviving through 60 days and 71% surviving through 90 days.

We believe these data are on track to validate a 50% reduction in loss of life compared to historical data.

Additionally, in December of 2025, based on the safety data from this set of patients, the FDA approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from the originally-required 300 patients to only 50 patients.

We enrolled the 50 th patient of the SAVE Surveillance Registry on March 4, 2026.

We are also evaluating additional clinical development opportunities in children based on unmet medical needs.

One such indication is for the use of our SCD therapy for the treatment of systemic inflammatory response in pediatric patients undergoing cardiac surgery, aimed at preventing post-operative complications and adverse outcomes, for which FDA awarded BDD on March 27, 2025.

SCD Therapy for Adult Patients

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The trial protocol includes an interim analysis by an independent Data Safety Monitoring Board (“DSMB”) at the trial’s 90-day primary endpoint with the first 100 subjects.

As of March 25, 2025, we had enrolled 94 patients in the pivotal trial.

We anticipate reporting topline clinical trial results and the submission of a Pre-market Approval ("PMA") application in 2026.

This pivotal trial is expected to enroll a total of 339 patients and as of March 13, 2026, we had enrolled 178 patients.

We anticipate reporting topline clinical trial results and, assuming a successful trial outcome, submission of a Pre-market Approval ("PMA") application in 2027.

We are also evaluating additional clinical development of the SCD therapy in adults based on unmet clinical needs and market opportunity.

Our BDD awards by the FDA in four therapeutic areas are expected to expedite the clinical development

and regulatory review of the SCD therapy for use in the designated patient populations and are the primary focus of our future clinical development decisions.

We received our first BDD in 2022, two additional BDDs in 2023, and a fourth BDD in 2024.

Our BDD awards by the FDA in multiple therapeutic areas are expected to expedite the clinical development and regulatory review of the SCD therapy for use in the designated patient populations and are the primary focus of our future clinical development decisions.

We received our first BDD awards in 2022 with the following additional BDDs in adult patient indications thereafter:

On April 29, 2022, we received a BDD for the use of our SCD in the treatment of immunomodulatory dysregulation in adult patients (18 and older) with AKI, which is expected to accelerate the regulatory approval process for our ongoing pivotal trial.

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This is our first BDD in a chronic disease setting.

We believe that our SCD therapy is readily applicable for use in other indications, which will increase the addressable market for our SCD therapy, but will also require additional clinical studies and FDA approval.

On March 27, 2025, the FDA awarded a BDD for our SCD therapy for the treatment of systemic inflammatory response in adult patients undergoing cardiac surgery, aimed at preventing post-operative complications and adverse outcomes.

We believe that our SCD therapy is readily applicable for use in other indications as well, which will increase the addressable market for our SCD therapy, but will also require additional clinical studies and FDA approval.

We have pursued patent protection for our SCD therapy as well as other technologies.

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and certain foreign jurisdictions.

Of these patents and patent applications 20 patents and 4 patent applications are owned exclusively by us, and 14 patents and 3 patent applications are co-owned with the University of Michigan (“UOM”).

The UOM has granted to us an exclusive worldwide, royalty bearing license to the UOM’s interest in all of the co-owned patents and applications.

Of these patents and patent applications, 21 patents and 1 patent applications are owned exclusively by us, and 25 patents are co-owned with the University of Michigan (“UOM”).

The UOM has granted us an exclusive worldwide, royalty-bearing license to the UOM’s interest in all of the co-owned patents and applications.

This license permits us to commercialize our SCD therapy in all human therapeutic indications.

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Our Approach - The SCD Therapeutic Device

Our SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body.

Our SCD therapy is designed as a disease-modifying device that neutralizes overactive immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body.

In many serious acute illnesses, a hyperinflammatory response occurs as a well-defined coordinated sequential response.

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This complex highly coordinated process is critical for host defense and tissue repair but needs to be tightly regulated by the body’s inflammatory signaling and cellular apoptosis.

If it is not tightly regulated and begins to spiral out of control, further tissue destruction may occur when uncontrolled hyperinflammation leads to degradative reparative processes with worsening tissue or organ function.

If this excessive systemic inflammation is severe and prolonged, multi-organ failure, including cardiovascular, respiratory, kidney, liver and neurologic dysfunction may occur, resulting in poor clinical outcomes.

If it is not tightly regulated and begins to spiral out of control, further tissue destruction may occur when uncontrolled hyperinflammation leads to degradative processes with worsening tissue or organ function.

If this excessive systemic inflammation is severe and prolonged, multi-organ failure, including cardiovascular, respiratory, renal, hepatic and neurologic dysfunction may occur, resulting in poor clinical outcomes.

Prior therapeutic approaches to block soluble mediator targets, such as cytokines or free radicals have not proven successful.

We believe that our SCD approach, which targets activated cells, is a potentially transformative, if not disruptive, therapeutic approach to a range of acute and chronic inflammatory disorders.

We believe that our SCD approach, which targets only highly activated cells, is a potentially transformative, if not disruptive, therapeutic approach to a range of acute and chronic inflammatory disorders.

Our SCD therapy is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) when integrated into an existing CRRT circuit in conjunction with the use of regional citrate anticoagulation (“RCA”).

The SCD is simply added to the standard CRRT circuit that uses regional citrate anticoagulation and is placed immediately following the standard hemofilter cartridge.

The SCD is simply added to the standard CRRT circuit that uses RCA and is placed immediately following the standard hemofilter cartridge.

Highly inflamed blood from the patient passes through the CRRT system and hemofilter, and into the SCD.

In the low calcium environment mediated by RCA, the inflamed cells in the blood are

modulated towards a less inflammatory state.

Upon exiting our SCD under a low calcium environment, the blood is returned to the patient’s body.

In the low calcium environment mediated by RCA, the inflamed cells in the blood are modulated towards a less inflammatory state.

Upon exiting our SCD, calcium is replaced and the blood is returned to the patient’s body.

Our SCD therapy delivers its therapeutic benefit by attenuating the excessive inflammatory response of activated neutrophils and monocytes.

Uninterrupted, the excessive inflammatory response progresses to multi-organ failure, with documented increases in both morbidity and mortality in critically ill patients.

Our initial approved product, QUELIMMUNE, is focused on critically ill AKI pediatric patients on CRRT.

Our SCD therapy leverages the existing footprint of CRRT pump systems in ICUs today, as well as the growing use and adoption of regional citrate as an anticoagulant.

Our initial approved product, QUELIMMUNE, is focused on critically ill pediatric AKI patients on CRRT.

Our SCD therapy leverages the existing footprint of CRRT pump systems in ICUs today, as well as the growing use and adoption of RCA.

Citrate is used to bind the free ionized calcium within the extracorporeal circuit which is needed to impact the neutrophils and monocytes.

A recent study in the Journal of the American Medical Association in 2020 demonstrated that while the use of regional citrate anticoagulation has the same mortality profile as heparin, regional citrate anticoagulation has been shown to be more effective in preserving filter life and is used to create the low calcium environment for our SCD therapy, which impacts the white cells interaction with the SCD membrane leading to the reduction in inflammation.

A study in the Journal of the American Medical Association in 2020 demonstrated that while the use of RCA has the same mortality profile as heparin, RCA has been shown to be more effective in preserving filter life and is used to create the low calcium environment for our SCD therapy, which impacts the white blood cells interaction with the SCD membrane leading to the reduction in inflammation.

Mechanism of Action

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(i) selectively binding activated neutrophils and monocytes on our SCD biomimetic membrane (ii) deactivating the activated neutrophils by maintaining a specified ionized calcium level within our SCD, and (iii) shifting proinflammatory monocytes to a lower inflammatory profile.

Our SCD utilizes clinically validated regional citrate anticoagulation protocols to lower the ionized calcium level, which not only prevents clotting within the circuit but also immuno-modulates the activated neutrophils and monocytes, which are then returned to the patient.

Calcium is then infused into the blood returning to the patient from the SCD, thereby maintaining normal calcium levels in the patient throughout the process.

Our SCD utilizes clinically validated RCA protocols to lower the ionized calcium level, which not only prevents clotting within the circuit but also immuno-modulates the activated neutrophils and monocytes, which are then returned to the patient.

Calcium is then infused into the blood line returning to the patient from the SCD, thereby maintaining normal calcium levels in the patient throughout the process.

Our SCD and Neutrophils

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Our SCD is designed to selectively bind the most highly activated neutrophils, associated with hyperinflammation, and in a low ionized calcium (“iCa”) environment, the activated neutrophils are deactivated, which has the downstream effect of reducing hyperinflammation.

These deactivated cells are then released back into circulation, resulting in no downstream immunodepletion or immunosuppression.

These deactivated cells are then released back into circulation, resulting in no downstream immunosuppression, immunodepletion, leukopenia or neutropenia.

When neutrophils are in homeostasis, the normal half-life is six to eight hours, but in a hyperinflammatory state, neutrophil apoptosis is delayed, leading to increased numbers of activated neutrophils in circulation.

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It is important to note that our SCD does not sequester 100% of these monocytes as they are important to maintaining immune homeostasis.

Similar to neutrophils above, immunomodulated monocytes are also released back into circulation following treatment, resulting in no downstream immunodepletion or immunosuppression.

We call the SCD mechanistic process of binding these cells, deactivating them, and releasing them back into circulation as “catch-and-release” system.

Similar to neutrophils above, immunomodulated monocytes are also released back into circulation following treatment, resulting in no downstream immunosuppression, immunodepletion, leukopenia or neutropenia.

We call the SCD mechanistic process of binding these cells, deactivating them, and releasing them back into circulation, a “catch-and-release” system.

Histological evaluation of our SCD

Microscopy of our SCD after being used for patient treatment demonstrated the binding of leukocytes on the outer surface of the hollow fiber membranes of the cartridge along the blood flow path within the extracorporeal circuit.

Flow cytometry confirmed that they were the most activated neutrophils and monocytes (see Figure 1 below).

Activated leukoctyes adherence to the membranes.

Flow cytometry confirmed that they were the most activated neutrophils and monocytes (see below)

Activated leukocytes adherence to the membranes.

Light micrograph stained with Hematoxylin and Eosin (H&E).

Low-power micrograph showing adherent cells around each fiber (160x).

Panel B and C:

Panel B and Panel C:

Higher-power micrographs showing the clustering of bound leukocytes (400x).

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The unique blood path within the SCD mimics capillary flow, providing a more stable microenvironment for the neutrophils and monocytes, enabling the cells to bind to the outer surface of the hollow fibers long enough for the critically low iCa to have its impact.

This is then followed by cells being released back into the circulation.

This is then followed by cells being released back into circulation.

– “catch and release”).

Our Market Opportunity

We are a therapeutic medical device company pursuing multiple large market indications with our SCD .

We are a commercial-stage healthcare company pursuing multiple indications, both small and large market opportunities, with our SCD therapy.

Our clinical data was initially used to support an HDE submission to the FDA to request approval to market our SCD to hospitals and clinicians with pediatric patients suffering from AKI.

Our clinical data has also been used to support the initiation of a pivotal PMA study in adult AKI which has an estimated 210,000 patients annually in the United States.

Our clinical data has also been used to support the initiation of a pivotal study that would support a PMA submission in adult AKI which has an estimated incidence of approximately 200,000 patients annually in the United States.

In the long term, based on preliminary clinical evidence, we intend to expand the application of our SCD technology to additional indications with large patient populations, including acute respiratory distress syndrome, chronic dialysis, cardiorenal syndrome and hepatorenal syndrome and others.

Our Initial Market Opportunity in Acute Kidney Injury

We believe AKI has increasingly received the attention of healthcare professionals and academic publications that reveal the devastating clinical and financial impact of what is most-often a multi-organ syndrome.

A 2017 study by Samuel A.

Silver and Glenn M Chertow titled “The Economic Consequences of Acute Kidney Injury” stated hospital costs associated with AKI in the U.S.

With over 5 million ICU admissions in the U.S.

each year, and approximately 50-60% of these patients experiencing AKI, AKI has increasingly received the attention of healthcare professionals and academic publications that elucidate the devastating clinical and financial impact of what is most-often a multi-organ syndrome.

In fact, a 2017 study by Samuel A.

Silver and Glenn M.

Chertow titled “The Economic Consequences of Acute Kidney Injury” stated hospital costs associated with AKI in the U.S.

are between $5.4 billion and $20 billion per year.

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Kidneys also refrain from revealing the impact to the rest of body and organs (and vice-versa) and often are not considered systemically for co-treatment.

Globally consistent criteria for diagnosing AKI have recently emerged with Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease, an international consensus classification for AKI staging and diagnosing guidelines introduced in 2004, the Acute Kidney Injury Network staging system in 2007, and finally the Kidney Disease:

Globally consistent criteria for diagnosing AKI have recently emerged with the RIFLE classification (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease), an international consensus classification for AKI staging and diagnosing guidelines introduced in 2004, the Acute Kidney Injury Network staging system in 2007, and finally the Kidney Disease:

Improving Global Outcomes, AKI Staging and Diagnosing Guidelines published in 2012.

These sources have helped clinicians to improve recognition, staging,

diagnosing and subsequent documentation of less obvious cases of AKI secondary diagnoses.

These sources have helped clinicians to improve recognition, staging, diagnosing and subsequent documentation of less obvious cases of AKI secondary diagnoses.

While our initial market is focused on AKI patients on CRRT, future indications will likely benefit from improved characterization and diagnosis of patients.

As a result, demand for ICU renal replacement therapy is growing.

CRRT is the newest of AKI dialysis modality in the market, first becoming available in 1997, and according to Fortune Business Insights, it is estimated that it has grown to a $986 million global market ($354 million market in the U.S.) as of 2019.

CRRT is the newest AKI dialysis modality in the market, first becoming available in 1997, and according to Fortune Business Insights, it is estimated that it has grown to a $986 million global market ($354 million market in the U.S.) as of 2019.

The two largest operators in the CRRT market by revenue are Fresenius Medical Care Holdings, Inc.

and Baxter International, which represent over 80% of the market today in the U.S.

and Vantive, Inc.

(formerly a business of Baxter International), which represent over 80% of the market today in the U.S.

Since 2010, a significant amount of data has been published to quantify the clinical and financial impact of AKI, resulting in a broadening AKI treatment “boom” beyond dialysis to areas of diagnostics, complementary therapies, and pharmacoeconomics.

As hospital administrators and government officials gain understanding of the impact and burden of AKI increases, we believe that attention will continue to grow.

As hospital administrators and government officials gain an increasing understanding of the impact and burden of AKI, we believe that attention will continue to grow.

According to Hobson in his article titled “Cost and Mortality Associated with Postoperative Acute Kidney Injury,” a 2015 study of 50,314 patients (over 11 years) found that upon greater scrutiny, AKI was found in 39% of post-surgical patients, and 19% of patients had stage 2 or 3 AKI with an average incremental cost of $29,800 per patient.

Additionally, with historical mortality rates approximately 50%, treating AKI is increasingly of interest to clinicians, hospitals, and product manufacturers alike.

Additionally, with historical mortality rates of approximately 50%, treating AKI is of increasing interest to clinicians, hospitals, and product manufacturers alike.

The AKI patient population is growing on average 6.9% per year according to the Healthcare Cost and Utilization Project commissioned by the Agency for Healthcare Research and Quality, a U.S.

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The pediatric population for AKI patients in the U.S.

on CRRT is estimated to be less than 8,000 patients per year, which is a substantially small sub-set of the 6 million AKI patient population.

The AKI market needs new and effective solutions, and hospitals continue to search for and evaluate new products.

on CRRT is estimated to be less than 8,000 patients per year, which is a substantially small subset of the combined 6 million AKI adult and pediatric patient population.

AKI patients need new and effective solutions, and hospitals continue to search for and evaluate new products.

For a product to succeed in the AKI space, it must demonstrate and achieve clear and significant clinical benefit to patients, while providing positive financial incentives for hospitals to generate revenue and profitability.

Our Growth Strategies

Key elements of our growth strategy include innovating and expand our applications through clinical trials;

Key elements of our growth strategy include innovating and expanding our applications through clinical trials;

differentiation through medical education;

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Such relationships enable us to expand and refine the design and execution of our clinical plans with a more targeted outcome and objectives.

On February 21, 2024, we received the FDA HDE Approval Order, which allows sales to qualified healthcare facilities.

On February 21, 2024, we received the FDA HDE Approval Order, which allows sales of QUELIMMUNE to qualified healthcare facilities.

In February 2023, we received FDA IDE approval for the adult AKI indication.

This indication has received the FDA BDD for our SCD therapy targeting AKI adult patients, is expected to accelerate and streamline the regulatory approval process prior to the commercial launch of our product candidates.

On September 28, 2023, we received Breakthrough Device Designation for our patented and cell-directed SCD for use with patients in the hospital ICU with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device.

On October 18, 2023, we received a BDD for our patented and cell-directed SCD for use with patients in the hospital ICU with AKI and acute on chronic liver failure.

On November 6, 2024, we received Breakthrough Device Designation for our patented and cell-directed SCD to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis.

We have been granted four Breakthrough Device Designations from the FDA for the SCD device, each of which is expected to expedite the clinical development and regulatory review of the SCD for use in the designated patient population.

Our patented and cell-directed SCD therapy has received the FDA BDD for use in adult AKI patients, which is expected to accelerate and streamline the regulatory approval process prior to the commercial launch of our product candidates.

On September 28, 2023, we received BDD for our SCD therapy for use with patients in the hospital ICU with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device.

On October 18, 2023, we received a BDD for our SCD therapy for use with patients in the hospital ICU with AKI and acute on chronic liver failure.

On November 6, 2024, we received BDD for our SCD therapy to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis.

On March 27, 2025, the FDA awarded two BDDs for our SCD therapy for the treatment of systemic inflammatory response, one in adults and one in pediatric patients, undergoing cardiac surgery, aimed at preventing post-operative complications and adverse outcomes.

We have been granted six BDDs by the FDA for the SCD device, each of which is expected to expedite the clinical development and regulatory review of the SCD therapy for use in the designated patient population.

Differentiation through medical education:

We intend to dedicate resources to educate physicians, hospital clinicians and other decision makers in the medical communities on the role of neutrophils and monocytes in both

acute and chronic indications, and therapeutic benefit of controlling and modulating excessive inflammatory response.

We intend to focus our marketing strategies not only on the therapeutic capabilities of our technology, but also the economic consequences of hyper-inflammation in the current standard of care and treatment infrastructure and highlight the differentiating factors of our SCD product candidates that can provide a cost-effective solution.

We intend to dedicate resources to educate physicians, hospital clinicians and other decision makers in the medical communities on the role of neutrophils and monocytes in both acute and chronic indications, and the therapeutic benefit of controlling and modulating excessive inflammatory response.

We intend to focus our marketing strategies not only on the therapeutic capabilities of our technology, but also the economic consequences of hyper-inflammation in the current standard of care and treatment infrastructure and highlight the differentiating factors of our SCD therapy that can provide a cost-effective solution.

Business development and out-licensing activities:

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We believe that our clinical experience and depth, combined with our understanding of the scientific mechanism of our SCD and our regulatory submissions around the world, can drive value for our partners and reduce their market risk.

We believe our partners will benefit from insight in other SCD trials around the world as well as data generation that is being conducted by our trials.

We believe our partners will benefit from insight into other SCD trials around the world as well as data generation that is being conducted by our trials.

We believe that our SCD therapy has the potential to apply to multiple indications.

By pursuing and establishing business relationships with partners who may have strong capabilities beyond AKI, such as the markets for respiratory distress syndrome, we may be able to expand our solutions to the chronic disease setting.

By pursuing and establishing business relationships with partners who may have strong capabilities beyond AKI, such as the markets for ESRD and respiratory distress syndrome, we may be able to expand our solutions to the chronic disease setting.

Scaling production with manufacturing partners:

As we progress through our planned clinical trials and the commercial launch of our SCD in pediatrics (QUELIMMUNE) as well as additional adult product candidates if FDA approval is received, we are focused on identifying and securing various suppliers and manufacturing partners to scale production in response to the expected demand for our solutions.

As we progress through our planned clinical trials and the commercial launch of our QUELIMMUNE in pediatrics as well as potential additional adult indications for our SCD therapy if FDA approval is received, we are focused on identifying and securing various suppliers and manufacturing partners to scale production in response to the expected demand for our solutions.

We continue to negotiate with suppliers of raw materials, including cartridges, tubing and other components, to establish redundancies and alternative sources to mitigate interruptions in the supply chain in the future.

In addition, we may also explore strategic relationships with partners who can provide sources of raw materials while collaborating with us on the marketing and distribution of our product candidates.

Our Commercial Stage Product

Our Clinical Development of the SCD Product Candidates

The following disclosure summarizes the key clinical studies in which our SCD product candidates (QUELIMMUNE for pediatrics) have been evaluated.

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On February 21, 2024, we announced a final Approval Order for the HDE, which allows us to commercialize QUELIMMUNE.

As of the date of this report, we have five commercial customers and several potential customers evaluating QUELIMMUNE.

Clinical Progression

SCD 006 Pivotal Study (“SCD 006”) Design

We are actively enrolling and treating patients in a pivotal clinical trial of the SCD for the treatment of AKI in adults under a granted BDD (April 2022) by the FDA.

NEUTRALIZE-AKI Design

We are actively enrolling and treating patients in a pivotal clinical trial of the SCD for the treatment of AKI in adults, an indication awarded BDD by the FDA in April 2022.

This trial (NCT05758077) is a 339 subject, prospective, multi-center, open-label, randomized, two-arm comparative pivotal study conducted in the United States.

SCD-006 is designed to assess a composite endpoint of both mortality or dialysis dependency at Day 90 (see schematic figure below).

NEUTRALIZE-AKI is designed to assess a composite endpoint of both mortality or dialysis dependency at Day 90 (see schematic figure below).

The control arm will consist of adults with AKI who undergo CRRT in hospital ICUs who typically have estimated mortality of nearly 50%.

Among those with AKI who undergo CRRT and survive hospitalization, nearly one in four (25%) usually require long-term dialysis.

The study design was recently published in the journal Nephron (Yessayan et al., Nephron.

The study design was published in the journal Nephron (Yessayan et al., Nephron.

10.1159/000531880).

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Current Trial Status

As of March 25, 2025, we have enrolled 94 patients into our SCD-006 pivotal trial.

We submitted the SCD-006 IDE Protocol to the FDA on January 6, 2023, and attained approval in March 2023.

We began enrollment in the second quarter of 2023, and we anticipate the enrollment period to last 24 to 28 months.

On April 29, 2022, we received a BDD for the use of our SCD in the treatment of immunomodulatory dysregulation in adult patients (18 and older) with AKI, which is expected to aid our discussions related to the regulatory review and approval process for SCD-006.

We currently anticipate generating interim results from this trial in the middle of the 2025 calendar year and topline study results and submission of a PMA application in the middle of the 2026 calendar year.

We submitted the NEUTRALIZE-AKI protocol to the FDA on January 6, 2023, and attained approval to proceed in March 2023.

We began enrollment in the second quarter of 2023, and we anticipate the enrollment period to last up to 48 months.

A s of March 21, 2026, we have enrolled 181 patients into the NEUTRALIZE-AKI study.

Additional clinical studies under IDEs include cardiorenal syndrome and hepatorenal syndrome.

We are also conducting exploratory clinical research with the University of Michigan to define the patient population for potential treatment with SCD product candidates, and any future studies will be based upon initial clinical data collected in these studies.

Other Clinical Studies

We have also conducted exploratory clinical research with the University of Michigan to define the patient population for potential treatment with SCD product candidates, and any future studies will be based upon initial clinical data collected in these studies.

Other Clinical Studies in AKI

The table below lists the major studies conducted in AKI to date with our SCD.

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Kidney Medicine.

https://doi.org/10.1016/j.xkme.2024.100).

See additional details below on the SCD-PED studies.

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Kidney Medicine.

https://doi.org/10.1016/j.xkme.2024.100).

See additional details below on the SCD-PED studies.

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SCD-003 was a controlled, randomized, and multicenter clinical trial that was initiated in September 2011 and terminated in September 2013 under an FDA-approved IDE.

For this trial, the control group received standard CRRT with regional citrate

anticoagulation (“RCA”) and the SCD-treated group received up to seven days of SCD therapy.

For this trial, the control group received standard CRRT with regional citrate anticoagulation (“RCA”) and the SCD-treated group received up to seven days of SCD therapy.

The study was sponsored by the Predecessor with the support of a third-party contract research organization.

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Secondary objectives included an assessment of renal replacement therapy dependency at Day 60, mortality at Day 28, the number of ventilator free days at Day 28, and the mortality of the subset of patients with severe sepsis at Day 60.

A total of 134 patients were enrolled in 21 United States medical centers.

An overall two-sided 0.05 level of significance at 80% power was used to calculate a sample size of 344 patients, assuming a mortality rate of 50% for the control group and 35% for the treatment group.

Adaptive design and interim analysis were planned at the mid-point of enrollment (i.e., 172 patients).

Several exploratory biomarkers were also compared between the control and treatment groups, including urine output, serum levels of elastase, cytokines, and total absolute white blood cell, neutrophil and platelet counts throughout treatment.

Patients receiving care in the ICU of each participating hospital were randomized to intensive care treatment for patients undergoing CRRT or CRRT + SCD.

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Once the patient met all eligibility criteria, including being on CRRT for a minimum of four hours, but no longer than 24 hours, and had signed an informed consent, the subject was randomized in a 1:1 allocation utilizing a random permuted block design into either the control or treatment group, stratified by study center and the presence of severe sepsis.

Adaptive design and interim analysis were planned at the mid-point of enrollment (i.e., 172 patients).

During the second quarter of the enrollment period, a national calcium shortage occurred in the United States due to certain FDA-related quality manufacturing issues at major U.S.

Due to the reliance of the SCD on a narrow intra-circuit iCal range for functional efficacy and the concern that patients randomized to the SCD were not receiving effective therapy due to insufficient iCal levels, the interim analysis was performed early, after enrollment of 134 patients.

Enrollment was paused on May 24, 2013, to assess the clinical impact of the calcium shortage on study endpoints.

At the time of the shortage a total of 134 patients had been enrolled in 21 United Stated Medical centers.

Due to the reliance of the SCD on a narrow intra-circuit iCal range for functional efficacy, there was a concern that patients randomized to the SCD were not receiving effective therapy due to insufficient iCal levels.

Enrollment was paused on May 24, 2013, to assess the clinical impact of the calcium shortage on study endpoints and the interim analysis was performed early using data from the 134 patients enrolled.

The shortage of calcium infusion solutions resulted in a tendency to minimize citrate infusion rates.

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No statistically significant difference was found between the SAEs of the control and treatment groups.

Furthermore, none of the SAEs were considered ‘definitely’ device related per the principal investigator.

None of the SAEs were considered “definitely” device related per the principal investigator.

The amount of time patients in both the control and treatment groups were maintained in the recommended iCal range (0.23 - 0.40 mmol/L), as specified in the study protocol, was substantially lower than expected.

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The most frequent categories of SAEs were infections and infestations as well as cardiac, respiratory, thoracic and mediastinal disorders.

Furthermore, none of the SAEs were considered “definitely” related to the SCD device per the principal investigator.

None of the SAEs were considered “definitely” related to the SCD device per the principal investigator.

Overall adverse events did not differ between the treatment and control groups in the intent to treat analysis.

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The primary objective of the study was to evaluate the safety of up to seven consecutive 24-hour treatments of our SCD.

The secondary objective was to evaluate the efficacy of up to seven consecutive 24-hour SCD treatments on all-cause mortality and dialysis

dependency at Day 28 and Day 60.

The secondary objective was to evaluate the efficacy of up to seven consecutive 24-hour SCD treatments on all-cause mortality and dialysis dependency at Day 28 and Day 60.

This study was sponsored by the Predecessor with the support of a third-party contract research organization.

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The study enrolled 6 patients (proposed maximum of up to 10 patients).

5/6 (83%) patients survived to ICU discharge and all surviving patients were dialysis-independent by Day 60.

5 of the 6 (83%) patients survived to ICU discharge and all surviving patients were dialysis-independent by Day 60.

A combined pooled analysis of both the PED-01 and PED-02 studies (N=22 total) demonstrated a survival rate of ~77% at Day 60 in pediatric patients weighing at least 10 kg.

This data was published in the journal Kidney Medicine in February 2024.

Study in Cardiorenal Syndrome Patients

Cardiorenal syndrome (“CRS”) is a clinical disorder in which therapy to relieve the congestive symptoms of chronic heart failure is limited by a decline in renal function.

Up to one-third of patients with acute decompensated chronic heart failure admitted into a hospital in the United States present with this disorder and this condition is increasing in incidence.

Once hospitalized, these patients are treated with a high dose of intravenous diuretics to relieve persistent congestion.

The use of diuretics, however, frequently results in worsening renal function, progression of heart failure and death.

Immune dysregulation plays a key role in cardiorenal syndrome.

We are actively enrolling patients in a clinical trial of our SCD therapy for the treatment of adult patients with acute or chronic systolic heart failure with worsening renal function due to CRS or severe right ventricular failure awaiting LVAD Implantation, an indication awarded BDD by the FDA in September 2023.

This trial (NCT03836482) is a 20 subject, multi-center, open-label, feasibility study conducted in the United States.

The study is designed to assess safety and a number of endpoints including mortality, the occurrence of acute myocardial infarction, or the need for continuous IV vasopressor support amongst others.

Of note, SCD therapy in this study will be delivered for 4 hours a day for up to 6 consecutive days.

This regimen is distinct from previous trials of our SCD therapy, all of which used continuous delivery for 24 hours a day.

Chronic Applications in Inflammatory Disorders and Corresponding Studies at the UOM

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None of these adverse events were definitively linked to SCD therapy.

Cardiorenal Syndrome

Cardiorenal syndrome (“CRS”) is a clinical disorder in which therapy to relieve the congestive symptoms of chronic heart failure is limited by a decline in renal function.

Up to one-third of patients with acute decompensated chronic heart failure present with this disorder;

this condition is increasing in incidence with an estimated one million hospital admissions annually in the United States.

Once hospitalized, these patients are treated with a high dose of intravenous diuretics to relieve persistent congestion.

The use of diuretics, however, frequently results in worsening renal function, progression of heart failure and death.

Immune dysregulation plays a key role in cardiorenal syndrome.

The CRS clinical trial at the UOM is a safety and efficacy dose escalation study in 10 patients that was designed to evaluate whether ultrafiltration therapy in CRS, a disease with a dismal prognosis and currently ineffective therapy, with SCD therapy will improve cardiac and renal (production of urine) functions.

Pilot Safety Trial of SCD Therapy in Cardiorenal Syndrome Patients

The CRS clinical trial (NEUTRALIZE-CRS) is a safety and efficacy dose escalation study in 20 patients that was designed to evaluate whether CRS, a disease with a dismal prognosis and currently ineffective therapy, will improve cardiac and renal (production of urine) functions after SCD therapy.

In the study, an improvement of cardiac function is measured by the rate of ejection fraction, which is the percentage of blood leaving the heart each time it contracts.

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In addition, a variety of other biomarkers will also be measured.

One patient has been successfully treated with the SCD thus far in this study.

The effect of the SCD on cardiac function was recently demonstrated in a first-in-human case report of a 71-year-old male patient with cardiorenal syndrome including severe heart failure with reduced ejection fraction and was deemed ineligible for cardiac transplantation or LVAD due to worsening renal function (WRF) and right ventricular dysfunction.

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Based on this data, our SCD recently received BDD for CRS in October 2023.

These results were recently published in

the journal PLoS One in April 2023 and an additional perspective article was published in the journal European Journal of Heart Failure in February 2024.

Hepatorenal Syndrome (HRS)

These results were recently published in the journal PLOS One in April 2023 and an additional perspective article was published in the journal European Journal of Heart Failure in February 2024.

Pilot Safety Trial of SCD Therapy Hepatorenal Syndrome (HRS) Patients

Hepatorenal syndrome is characterized by an abrupt deterioration of kidney function, driven by a hyperinflammatory process in patients with advanced liver cirrhosis, and is associated with an unacceptably high mortality.

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This led to the FDA granting the SCD a BDD for HRS in October 2023.

Myocardial Ischemia in End-Stage Renal Disease Patients on Chronic Hemodialysis

Pilot Safety Trial of SCD Therapy in Myocardial Ischemia in End-Stage Renal Disease Patients on Chronic Hemodialysis

A major cause of death in patients on chronic dialysis is due to cardiovascular disease.

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However, there are limited manufacturers/suppliers of these IV solutions nationwide, and any supply chain disruptions may have detrimental effects to the utilization of CRRT, and subsequently, use of commercial QUELIMMUNE or the adult SCD in clinical studies.

The Supply Agreement contains a provision granting FUSA a right of first refusal for the first three years after regulatory approval of our SCD product candidate to distribute QUELIMMUNE and adult SCD products in the United States.

The Supply Agreement contains a provision granting FUSA a right of first refusal for the first three years after regulatory approval of our SCD product candidate to distribute the adult SCD products in the United States.

If during such period, we elect to promote and sell the SCD through distributors, we will be required to provide FUSA with a right of first refusal to be our exclusive distributor of the SCD in the United States and its territories, provided that the SCD is not promoted or sold in a manner that is incompatible with any devices manufactured and/or sold by FUSA or its affiliates.

On December 27, 2022, we entered into a license and distribution agreement with Nuwellis.

We appointed Nuwellis as our exclusive distributor for the sale and distribution of SCD product throughout the United States once we receive written authorization from the FDA to market our SCD for pediatric use pursuant to our HDE application.

We appointed Nuwellis as our exclusive distributor for the sale and distribution of SCD product throughout the United States once we received written authorization from the FDA to market our SCD for pediatric use pursuant to our HDE application.

In May 2024, we provided notice to Nuwellis that Nuwellis had breached the Distribution Agreement and that the Distribution Agreement would terminate effective August 18, 2024.

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We strive to protect the proprietary technologies that we believe are important to our business.

We have and will continue to seek patent protection for our SCD product and related technologies, as well for any future products.

In addition to seeking patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider

appropriate for, patent protection.

We have and will continue to seek patent protection for our SCD product and related technologies, as well as for any future products.

In addition to seeking patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

We also rely on know-how, confidentiality agreements, license agreements and other agreements to establish and protect our proprietary rights.

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We currently have 17 issued U.S.

patents and 4 pending U.S.

patent applications.

We also have 18 issued foreign patents and 3 pending foreign patent applications.

We also have 29 issued foreign patents and 1 pending foreign patent application.

We have issued patents that have terms expiring from 2025 through 2032, although terminal disclaimers, patent term extension or patent term adjustment can shorten or lengthen the patent term.

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Patent Family 1 contains nine U.S.

patents and one pending U.S.

patent application directed to systems and methods for processing leukocytes and for treating subjects with various inflammatory conditions using a SCD cartridge, and to a SCD cartridge.

These patents will expire from 2028-2031, and the pending application, if granted, will expire in 2028, assuming that the required maintenance fees are paid.

We also co-own with the UOM counterpart patents granted in Canada, Japan and New Zealand, and pending applications in Europe and Hong Kong.

These counterpart patents, and pending applications, if granted, will expire in 2028, assuming that the required maintenance fees are paid.

patents directed to systems and methods for processing leukocytes and for treating subjects with various inflammatory conditions using a SCD cartridge, and to a SCD cartridge.

These patents will expire from 2028-2031, assuming that the required maintenance fees are paid.

We also co-own with the UOM counterpart patents granted in Canada, Europe, Japan and New Zealand, with the European patent having been validated in Austria, Belgium, Denmark, Finland, France, Germany, Italy, The Netherlands, Spain, Sweden, and The United Kingdom.

These counterpart patents will expire in 2028, assuming that the required maintenance fees are paid.

The patents and applications in Patent Family 1 are as follows:

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Systems for treating activated leukocytes

United States

Systems for treating leukocytes and platelets and methods for treating subject having inflammatory conditions by processing leukocytes or platelets

Systems and methods for processing leukocytes and platelets and systems for treating inflammatory conditions

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Systems and methods for processing leukocytes and platelets and for treating inflammatory conditions

Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom

A device that processes platelets or leukocytes

A device for treating an inflamatory condition

* Expiration date if application is granted.

† This patent family was developed with U.S.

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Pursuant to a license agreement with the UOM (as amended and restated, the “UOM License Agreement”), UOM has granted us a worldwide, royalty bearing, exclusive license to their interest in the co-owned patents and applications in Patent Family 1 in the field of medical devices for use in human therapeutics for certain technologies used in the SCD technology platform, including composition of matter and methods of use patents.

In consideration for such exclusive license, during the term of the UOM License Agreement, we agreed to pay the UOM a royalty fee equal to 1% of net sales as well as a one-time milestone payment of $0.1 million upon FDA approval of the first licensed product under the license, and to reimburse patent costs.

As of December 31, 2024, we have incurred less than $5 thousand in royalties owed from sales of the Pediatric SCD.

As of December 31, 2025, we have incurred less than $20 thousand in royalties owed from sales of the QUELIMMUNE.

Since January 2020, we have paid approximately $0.1 million to the UOM to reimburse patent costs under the license.

The UOM License Agreement also imposes certain diligence obligations on us and requires us to achieve specified milestone events by a certain date.

Under the UOM License Agreement, the UOM’s liability is limited and we agreed to indemnify and hold the UOM harmless in connection with the use of the licensed technology and activities related to the products created using such licensed patents and/or technology.

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In addition to the co-owned patents and patent applications in Family 1, we also solely own three additional patent families (Families 2-4) directed to the SCD technology.

Patent Family 2 includes two U.S.

patents, and one pending U.S.

patent application directed to a second generation of the SCD cartridge and methods for using our SCD cartridge to process leukocytes.

The patents will expire in 2032, and the application, if granted, will expire in 2031, assuming that the required maintenance fees are paid.

Patent Family 2 includes 3 U.S.

patents directed to a second generation of the SCD cartridge and methods for using our SCD cartridge to process leukocytes.

The patents will expire from 2031 to 2032, assuming that the required maintenance fees are paid.

Counterpart patents have been granted in Australia, Canada, Europe, and Japan with the European patent having been validated in France, Germany, Italy, Spain, and the United Kingdom.

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Cartridge for treating leukocytes or platelets

* Expiration date if application is granted.

† This patent family was developed with U.S.

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federal government funding and is subject to obligations under the Bayh-Dole Act.

With respect to our other technologies, we solely own patents and patent applications in four additional patent families (Patent Families 5-8) which are summarized as follows:

Patent Family 5

Subject Matter

United States

Device and methods for reducing rejection of a transplanted organ in a recipient

*Expiration date if application is granted.

Patent Family 6

Subject Matter

Devices and methods for treating cytokine release syndrome and tumor lysis syndrome

*Expiration date if application is granted.

With respect to our other technologies, we solely own patents and patent applications in two additional patent families (Patent Families 5-6) which are summarized as follows:

Patent Family 5

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Therapies that present a cost-neutral to cost-beneficial impact to the health economic system are generally viewed as more favorable from a reimbursement perspective.

To this end, we conducted health economic outcomes research (HEOR) to estimate the economic impact of the SCD-PED (QUELIMMUNE) within the pediatric AKI-CKRT patient population.

To this end, we conducted health economic outcomes research (HEOR) to estimate the economic impact of the QUELIMMUNE within the pediatric AKI-CKRT patient population.

Our analysis revealed that pediatric AKI hospitalizations involving CKRT were estimated to cost over $450,000 per event, reflecting an enormous burden to healthcare institutions.

The median length of stay (“LOS”) was 31 days per hospitalization.

QUELIMMUNE therapy was projected to be cost-beneficial by lowering mortality as well as reducing hospital LOS by 3 days in pediatric AKI patients requiring CKRT, with estimated savings of ~$70,000 per hospitalization.

These data were presented at the American Society of Nephrology Kidney Week 2024 and at the AKI-CRRT Annual meeting in March 2025, and have been submitted to a leading kidney disease journal for publication.

The manuscript is currently in peer review.

These data were presented at the American Society of Nephrology Kidney Week 2024 and at the AKI-CRRT Annual meeting in March 2025, and were published in the Journal of Medical Economics, titled "Projected hospitalization cost impact of selective cytpheretic device in pediatric acute kidney injury" on December 28, 2025 (1):

1467-1475 (doi:

10.1080/1369998.2025.2550860).

However, lack of third-party coverage and reimbursement for our devices could delay or limit their adoption, and as such harm our competitive advantage in the market.

Sales and Marketing

We use a direct model for marketing and selling QUELIMMUNE.

Since obtaining FDA HDE approval for pediatrics with AKI in February 2024, we terminated a distribution agreement with a third party, built a customer-facing infrastructure to support our direct sales model and will efficiently expand our footprint as new sites are added and QUELIMMUNE utilization increases.

On December 27, 2022, we entered into a U.S.

License and Distribution Agreement with Nuwellis (the “Distribution Agreement”), for the pediatric SCD.

On December 29, 2023, we amended the Distribution Agreement with Nuwellis.

In May 2024, we provided notice to Nuwellis that Nuwellis had breached the Distribution Agreement and that the Distribution Agreement would terminate effective August 18, 2024.

Nuwellis disputed the validity of the termination, and on October 20, 2024, we entered into the Settlement Agreement with Nuwellis, pursuant to which we agreed to pay Nuwellis an aggregate of $900,000 payable in three installments through December 31, 2024.

As of December 31, 2024, we have fulfilled all obligations under the settlement agreement.

In conjunction with terminating the Distribution Agreement, we have hired internal sales and marketing employees focused on the initial launch into the U.S.

We use a direct model for marketing and sales of QUELIMMUNE.

Since obtaining FDA HDE approval for pediatric patients with AKI in February 2024, we terminated a distribution agreement with a third party, built a customer-facing infrastructure to support our direct sales model and will efficiently expand our footprint as new customers are added and QUELIMMUNE utilization increases.

We have hired internal sales and marketing employees focused on the initial launch of QUELIMMUNE into the U.S.

Pediatric Market.

Our traction with QUELIMMUNE in pediatric hospitals continues to increase as we add new commercial accounts and work through the IRB process in target accounts.

We are also preparing for the launch of the SCD in the U.S.

adult AKI population.

We are conducting comprehensive analyses in the development of a U.S.

launch strategy of our SCD technology into the adult AKI population.

We are also conducting analyses and preparing for the launch of the SCD therapy in the U.S.

in the adult AKI population.

Our plans are focused on developing an optimal infrastructure for an effective U.S.

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These agencies require manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling, marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting of medical devices.

The SCD cartridge interacts with and deactivates the patient’s hyperinflammatory cells prior to their return to the patient.

The SCD therapy interacts with and deactivates the patient’s hyperinflammatory cells prior to their return to the patient.

As the primary therapeutic mode of action of our SCD is attributable to the device’s impact on these autologous cells and their timely return to patients, FDA’s Center for Biological Evaluation and Research has primary jurisdiction over the premarket development, review and approval of the SCD as a medical device.

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Premarket Approval Pathway

A premarket approval application must be submitted to the FDA for Class III devices for which the FDA has required a PMA.

The premarket approval application process is more extensive than the 510(k) premarket notification and de novo request processes.

A PMA application must be supported by extensive data, including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device.

After a premarket approval application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file the application for review.

The FDA has 180 days of FDA review time to review a filed premarket approval application, although the review of an application generally occurs over a significantly longer period of time due to hold periods during which the submitting sponsor (the Company) gathers information to address FDA requests for additional information.

A PMA application must be submitted to the FDA for Class III devices for which the FDA has required a PMA.

The PMA application process is more extensive than the 510(k) premarket notification and de novo request processes.

A PMA application must be supported by extensive data, including but not limited to technical, preclinical, clinical, manufacturing and labeling to demonstrate to the FDA’s satisfaction reasonable evidence of safety and effectiveness of the device.

After a PMA application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review and thus whether the FDA will file the application for review.

The FDA has 180 days of FDA review time to review a filed PMA application, although the review of an application generally occurs over a significantly longer period of time due to hold periods during which the submitting sponsor (the Company) gathers information to address FDA requests for additional information.

The total review process is highly variable and can take up to several years.

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If the number of devices distributed in a year exceeds the ADN, the sponsor can continue to sell the device but cannot earn a profit for the remainder of the year.

The SCD-PED (brand name QUELIMMUNE) is eligible to sell for profit as per the Final Approval Order issued to us on February 21, 2024.

We received the Final Approval Order on February 21, 2024, to sell QUELIMMUNE, the SCD therapy, for profit, to treat critically ill pediatric patients with life-threatening AKI.

Clinical Trials

Clinical trials are almost always required to support premarket approval and are sometimes required for 510(k) clearance.

Clinical trials are almost always required to support PMA and are sometimes required for 510(k) clearance.

In the U.S., for significant risk devices, these trials require submission of an application for an IDE to the FDA.

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An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety and welfare of human research subjects.

The FDA and/or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for

various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements.

The FDA and/or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements.

Even if a trial is completed, the results of clinical testing may not demonstrate the safety and effectiveness of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.

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Even if products utilizing our technology receive FDA and other regulatory clearance or approval, they may not be granted coverage and reimbursement by any payor, including by CMS.

Many private payors use coverage decisions and payment amounts determined

by CMS as guidelines in setting their coverage and reimbursement policies and amounts.

Many private payors use coverage decisions and payment amounts determined by CMS as guidelines in setting their coverage and reimbursement policies and amounts.

However, no uniform policy for coverage and reimbursement for medical devices exists among third-party payors in the United States.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business