There was a buzz of excitement in the air as members of the University of Missouri System Board of Curators toured the new MU Health Care Children’s Hospital and Birthing Center on Thursday. The pediatric unit began operations this week, with the labor and delivery unit scheduled to open mid-June.
The project represents a $232 million investment by the university, marking it as the largest single investment in an MU Health Care facility to date.
“We are extremely proud, and we feel like we’ve made fantastic use of every dollar of that,” said Keri Simon, interim chief operating officer at MU Health Care.
The old hospital was not originally built with a specific focus on pediatric and maternal health, but it expanded over time to meet growing demand. Simon described the new facilities as being built “from the ground up with focused intentions on the needs of young patients and their families,” including deliberate designs to reduce stress and enhance comfort.
The new Children’s Hospital was designed to ensure that even while receiving care, children can still experience the joy and comfort of childhood. The facility features natural light in every area, enhancing the health and mood of patients, families and staff, Simon said. Visitors will also find depictions of Missouri’s native landscapes, including caves, trees and hills to reinforce a connection to local nature and foster a calming, familiar environment.
The hospital has also implemented a stringent security system to ensure the safety of its patients. Visitors, including parents, must check in upon arrival and receive badges that grant them access to specific areas, such as the pediatric floor.
“They’re banded, and so if they get too close to a door base and they’re not supposed to, alarms go off and things lock down,” Simon said.
This badge system, coupled with door alarms and greeters at each floor, helps maintain a secure environment for both children and infants in the hospital.
The new hospital’s pediatric section has two main areas: the Pediatric Unit and the Pediatric Intensive Care Unit, said to Laura Hesemann, director of the Division of Pediatric Nephrology and chair of the Department of Pediatrics at MU Health Care.
Hesemann emphasized the facility’s dual capability to provide general pediatric care and critical care within the same facility.
“We have 14 PICU rooms and several that can flex between standard pediatric care and intensive-care needs, depending on our patient volume and the severity of their conditions,” Hesemann said.
Hesemann emphasized the “forward-thinking” design that aims to anticipate future medical technology integrations, such as extracorporeal membrane oxygenation, a respiratory life support system that Hesemann said local children currently have to travel hours away for.
“This building was built with thinking about what are the programs, what are the technologies that we’re going to bring to this hospital, and how do we build a hospital that can accommodate that so we’re not retrofitting a few years from now?” Hesemann said.
The hospital includes a number of family rooms, including the Ronald McDonald Family Room, which is equipped with amenities like shower and laundry facilities and snack bars to meet families’ needs while they stay close to their loved ones. Patient rooms are also designed to accommodate family members.
“Families are part of the caregiving team and many families come from outside of Boone County,” Simon said. “Having the ability to stay close without having the burden of paying for hotels and driving back and forth, having meals provided and a support system is very, very valuable to the care that we provide for children in Missouri.”
A therapy gym is available for patients in recovery to provide “physical therapy, occupational therapy, all the things that kids need if they’re recovering from surgery or have been here for a long illness,” Hesemann said.
The labor and delivery floor includes a variety of specialized areas to ensure comprehensive care.
“We have 20 to 23 delivery rooms designed with intentionality to give our patients a very calming experience,” said Jean Goodman, the medical director of Women’s Services.
The rooms are structured to be multifunctional, where “everything they need, most of it is behind the walls and can be pulled up as needed if any complications should arise,” Goodman said. “This is a wonderful place to have a baby.”
The labor and delivery section is also equipped to handle emergencies. It has immediate access to operating rooms for cesarean sections, which are situated to allow for quick transitions if a delivery escalates unexpectedly.
Additionally, the facility is prepared to conduct a range of surgical procedures, including cervical cerclage, tubal ligation and dilation and curettage, all within what Goodman referred to as “the stellar operating room.”
This capability is particularly pivotal for patients with predetermined cesarean sections, streamlining their experience from admission through surgery, Goodman said.
For cases requiring intensive care post-operation, the setup is different, she said.
“We will not be getting ventilators here. If we have patients that are ventilated, we move them to the traditional ICUs.”
The floor is not only designed for patients, but also for the needs of the medical staff and residents.
“We’ll be doing a lot of our educational sessions here to protect patient information,” Goodman said.
Daniela Bichianu, the medical director of the Neonatal Intensive Care Unit, said the new facility has 62 private rooms.
“It is a step up from our previous unit that has only 20,” Bichianu said. “It’s important for us to have this large room, large space. It’s important for infection control.”
Bichianu explained that families often spend extended periods of time at the facility, with an average length of stay over 20 days, which necessitates additional space.
The new building will not house an emergency department. Instead, emergency services will continue at University Hospital, which has a dedicated entrance for pediatric patients. Despite this separation, Simon said all amenities from the previous facility are available at University Hospital, ensuring continuity and comprehensive care within the connected complex.

There was a buzz of excitement in the air as members of the University of Missouri System Board of Curators toured the new MU Health Care Children’s Hospital and Birthing Center on Thursday. The pediatric unit began operations this week, with the labor and delivery unit scheduled to open mid-June.
The project represents a $232 million investment by the university, marking it as the largest single investment in an MU Health Care facility to date.
“We are extremely proud, and we feel like we’ve made fantastic use of every dollar of that,” said Keri Simon, interim chief operating officer at MU Health Care.
The old hospital was not originally built with a specific focus on pediatric and maternal health, but it expanded over time to meet growing demand. Simon described the new facilities as being built “from the ground up with focused intentions on the needs of young patients and their families,” including deliberate designs to reduce stress and enhance comfort.
The new Children’s Hospital was designed to ensure that even while receiving care, children can still experience the joy and comfort of childhood. The facility features natural light in every area, enhancing the health and mood of patients, families and staff, Simon said. Visitors will also find depictions of Missouri’s native landscapes, including caves, trees and hills to reinforce a connection to local nature and foster a calming, familiar environment.
The hospital has also implemented a stringent security system to ensure the safety of its patients. Visitors, including parents, must check in upon arrival and receive badges that grant them access to specific areas, such as the pediatric floor.
“They’re banded, and so if they get too close to a door base and they’re not supposed to, alarms go off and things lock down,” Simon said.
This badge system, coupled with door alarms and greeters at each floor, helps maintain a secure environment for both children and infants in the hospital.
The new hospital’s pediatric section has two main areas: the Pediatric Unit and the Pediatric Intensive Care Unit, said to Laura Hesemann, director of the Division of Pediatric Nephrology and chair of the Department of Pediatrics at MU Health Care.
Hesemann emphasized the facility’s dual capability to provide general pediatric care and critical care within the same facility.
“We have 14 PICU rooms and several that can flex between standard pediatric care and intensive-care needs, depending on our patient volume and the severity of their conditions,” Hesemann said.
Hesemann emphasized the “forward-thinking” design that aims to anticipate future medical technology integrations, such as extracorporeal membrane oxygenation, a respiratory life support system that Hesemann said local children currently have to travel hours away for.
“This building was built with thinking about what are the programs, what are the technologies that we’re going to bring to this hospital, and how do we build a hospital that can accommodate that so we’re not retrofitting a few years from now?” Hesemann said.
The hospital includes a number of family rooms, including the Ronald McDonald Family Room, which is equipped with amenities like shower and laundry facilities and snack bars to meet families’ needs while they stay close to their loved ones. Patient rooms are also designed to accommodate family members.
“Families are part of the caregiving team and many families come from outside of Boone County,” Simon said. “Having the ability to stay close without having the burden of paying for hotels and driving back and forth, having meals provided and a support system is very, very valuable to the care that we provide for children in Missouri.”
A therapy gym is available for patients in recovery to provide “physical therapy, occupational therapy, all the things that kids need if they’re recovering from surgery or have been here for a long illness,” Hesemann said.
The labor and delivery floor includes a variety of specialized areas to ensure comprehensive care.
“We have 20 to 23 delivery rooms designed with intentionality to give our patients a very calming experience,” said Jean Goodman, the medical director of Women’s Services.
The rooms are structured to be multifunctional, where “everything they need, most of it is behind the walls and can be pulled up as needed if any complications should arise,” Goodman said. “This is a wonderful place to have a baby.”
The labor and delivery section is also equipped to handle emergencies. It has immediate access to operating rooms for cesarean sections, which are situated to allow for quick transitions if a delivery escalates unexpectedly.
Additionally, the facility is prepared to conduct a range of surgical procedures, including cervical cerclage, tubal ligation and dilation and curettage, all within what Goodman referred to as “the stellar operating room.”
This capability is particularly pivotal for patients with predetermined cesarean sections, streamlining their experience from admission through surgery, Goodman said.
For cases requiring intensive care post-operation, the setup is different, she said.
“We will not be getting ventilators here. If we have patients that are ventilated, we move them to the traditional ICUs.”
The floor is not only designed for patients, but also for the needs of the medical staff and residents.
“We’ll be doing a lot of our educational sessions here to protect patient information,” Goodman said.
Daniela Bichianu, the medical director of the Neonatal Intensive Care Unit, said the new facility has 62 private rooms.
“It is a step up from our previous unit that has only 20,” Bichianu said. “It’s important for us to have this large room, large space. It’s important for infection control.”
Bichianu explained that families often spend extended periods of time at the facility, with an average length of stay over 20 days, which necessitates additional space.
The new building will not house an emergency department. Instead, emergency services will continue at University Hospital, which has a dedicated entrance for pediatric patients. Despite this separation, Simon said all amenities from the previous facility are available at University Hospital, ensuring continuity and comprehensive care within the connected complex.

I don’t have any questions or concerns about my meds. I just thought these were kind of cool and a little odd to see in a nephrology office.

My first post on SeaStar was putting together a look at the history of SeaStar Medical since their Fall 2022 de-spac/reverse merger with LMAO. That can be found here.
With the markets closed today, I wanted to put together a post that looks ahead for SeaStar Medical. Not only has this changed from a catalyst driven swing trade to a long term investment in my brokerage acct and roth IRA; I believe that SeaStar is developing one of the most well informed, and cohesive public retail investor bases. That is a rarity in the world of pennystocks, nanocaps, and microcaps.
Please understand, the information that I share below is not financial advice, but rather information and thought patterns that have led to my conviction in $ICU. There are thousands of other companies that I could invest in, but here is why I am invested in SeaStar Medical ($ICU).
*Disclaimer: I hold a sizable position at a .57 avg, and started buying on Jan 8. ** Shoutout u/wavychaser for the original post that led me to significant amounts of research on SeaStar.
Let's get started.

Disease Agnostic. Organ Agnostic. Population Agnostic.

This has become sort of a mantra for me when I think about the potential of SeaStar. For those of you who aren't fully sure what this means, I will break it down simply.
Disease Agnostic: As of now, the SeaStar team believes that the SCD can be utilized across any cause of hyperinflammation. That means acute kidney injury, cardiorenal syndrom, hepatorenal syndrome, ARDS, and many more.
Organ Agnostic: As of now, the SeaStar team believes that the SCD can be utilized to combat damage/failure to any organ. That means kidney, liver, heart, lungs, etc.
Population Agnostic: As of now, the SeaStar team believe that the SCD can be used to treat humans of any age, size, gender, etc.
In combination, this means that any cause of hyperinflammation, that is affecting any organ, in any person; can potentially be treated with the SCD.

SCD Approval(s) vs Other Medical Device/Pharma Companies

One of the key things that makes me extremely bullish on SeaStar long term is the fact that they are fully focused on a single device, and exploring all of it's possible use cases (population, disease/indication, organ).
When it comes to how this device moves through the FDA, as well as the medical field; we benefit from the fact that they will begin to compound.
For a pharmaceutical company, they might be developing multiple drugs that are used for different diseases, all of which do not have a meaningful correlation to one another. That means, data from one will not have any impact on the other.
For the SCD, they all are correlated. As we have seen, we received HDE (Humanitarian Device Exemption) from the FDA for SCD-PED (AKI on CKRT). In quick order, we received BDD (Breakthrough Device Designation) for SCD-ADULT AKI on CKRT, Hepatorenal Syndrome, and Cardiorenal Syndrome in Congestive Heart Failure.
As such, we can also expect meaningful correlation between FDA approvals and market acceptance/penetration. SCD-PED (AKI) makes the path easier for SCD-ADULT (AKI). SCD-ADULT (AKI) makes the path easier for SCD-PED (Cardiorenal & Hepatorenal).
The SCD prominence and success will compound, leading to increasingly rapid growth over time in terms of treatments (and sales/revenue).
Here are the stated similarities of design and function for the SCD-PED and SCD-ADULT:
• Same mechanism of action • Reduction in mortality in AKI populations AND no dialysis dependency at Day 60* • Robust safety with no device-related serious adverse events or infections • No device-related immunosuppression •Convenient integration into the CKRT machines already in the ICU • Have been used with other therapies, including corticosteroids & other immune drugs
As stated by SeaStar:
"Technology has potential applications in multiple acute & chronic high-value indications using adult SCD with minimal to no modifications".

Napkin Math for Total Attainable Market (TAM)

The following numbers are as stated from the SeaStar investor presentation.
$10,000-$20,000 per treatment
Patients Annually in the U.S. (TAM)
• AKI on CKRT (Pediatric) - 4,000 (Humanitarian Device Exemption, Q1 FDA Decision/Commercialization)
• AKI on CKRT (Adult) - 210,000 (Breakthrough Device Designation, 2025 FDA Decision/Commercialization)
• Cardiorenal Syndrome - 400,000 (Breakthrough Device Designation, To be determined)
• Hepatorenal Syndrome - 700,000 (Breakthrough Device Designation, To be determined)
• Acute Respiratory Distress Syndrome - 200,000
That means over 1,300,000 annual patients in just the United States that can be treated within the first 4 indications. That number is increased if you include Canada (which SeaStar recently received a patent for SCD applications).
Currently, SeaStar contains patents for SCD use in both the United States and Canada. It is possible they have applications
100,000 - 1,000,000 patients annually x $10,000 = $1-10 billion annually for 4 indications in the United States alone.
On top of that, SeaStar is partnered with University of Michigan completing exploratory clinical research to determine patient populations where the SCD may be effective.
Currently, $ICU is at a $75 million marketcap, with $0 in revenue/sales/treatments.
Once that data begins to roll in after our first approval, we will see a meaningful jump in marketcap into the hundreds of millions.

SeaStar Medical Scientific Advisory Board (SAB)

SeaStar also created their own Scientific Advisory board that hosts 11 world-renowned KOLs in pediatric & adult nephrology, critical care & translational science. The SAB is chaired by David Humes, MD/Professor, Division of Nephrology, University of Michigan. Humes is also the inventor of the SCD.
Chief Medical Officer, Kevin Chung stated:
“Several of our SAB members provided key support during discussions with the U.S. Food and Drug Administration (FDA), which resulted in the Approvable Letter for the SCD’s humanitarian device exemption (HDE) in pediatric AKI,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The advisory board also advised on design elements of our ongoing, pivotal NEUTRALIZE-AKI Phase 3 study with the SCD in adult patients with AKI. We look forward to continued engagement and collaborations with these invaluable experts.”
Members of SeaStar Medical’s SAB include the following:
• Ayse Akcan-Arikan, MD is the Medical Director of Critical Care Nephrology and Acute Dialysis at Texas Children’s Hospital and Associate Professor of Pediatrics, Baylor College of Medicine
• David Askenazi, MD, MSPH is the Director of Pediatric and Infant Center for Acute Nephrology (PICAN) at Children’s of Alabama and Professor at the University of Alabama at Birmingham
• Sean Bagshaw, MD, MSc is the Chair of Critical Care Medicine and Associate Professor of Critical Care Medicine at the University of Alberta
• Rajit Basu, MD, MS is the Division Head of Critical Care Medicine at the Lurie Children’s Hospital of Chicago and Professor of Pediatrics at Northwestern University Feinberg School of Medicine
• Andriy Batchinsky, MD is the Founder and Director of the Autonomous Reanimation and Evacuation (AREVA) Program at the Geneva Foundation
• Sarah Faubel, MD is Professor of Medicine and Nephrologist at the University of Colorado Hospital and Veterans Affairs Medical Center
• Stuart Goldstein, MD is the Director of the Center for Acute Care Nephrology and Medical Director of Pheresis Service, Co-Director of the Heart Institute Research Core at Cincinnati Children’s Medical Hospital and Professor at the University of Cincinnati’s Department of Pediatrics
• Marc Jeschke, MD, PhD is the Vice President and Medical Director of Burns and Translational Researcher at Hamilton Health Sciences
• Jay Koyner, MD is the Medical Director of Acute Dialysis and Director of Nephrology Intensive Care Unit at the University of Chicago Medical Center
• Kathleen Liu, MD, PhD is a critical care intensivist, and Professor of Medicine and clinical trialist at the University of California at San Francisco School of Medicine
• Theresa Mottes, MSN, APRN-NP, CPNP-AC, CDN is an Acute Care Nurse Practitioner at the Lurie Children’s Hospital of Chicago

Fresenius Medical Care Partnership (buyout candidate?)

Please see my full DD below on why SeaStar's supply and manufacturing partner Fresenius Medical Care ($FMS) is a potential buyout candidate.
https://www.reddit.com/SeastarMedical/comments/1aey2ti/icu_is_seastar_medical_a_buyout_candidate_fo

NEUTRALIZE-AKI Study (SCD-ADULT AKI/210,000 TAM)

• 5 clinical trial site activated; targeting goal of 20-30 total sites
• 12 patients enrolled in the study
• Plan to provide periodic sites activation & patient enrollment updates as milestones are reached
• Target: Enroll 1 patient/site/month; progressing on track
• Interim Analysis expected (100 patients) mid 2024
*As of 12/28/23

100% Removal of Dialysis Dependency

https://preview.redd.it/2dut5u5zjkjc1.png?width=1240&format=png&auto=webp&s=4e8ab37e9ad831afefb15bf1ff26eac8cef6a235
The global dialysis market size was $94.43 billion in 2022 and is projected to grow from $95.22 billion in 2023 to $150.84 billion by 2030, at a CAGR of 6.8% during 2023-2030.
North America is the leading dialysis market globally with a share of 40.72% in 2022.
If the SCD truly leads to a 100% removal of dialysis dependency after 60 days, this device will quickly begin to disrupt a near $100 billion market as more doctors, patients, and insurance companies begin to learn about it. Any significant reduction in dialysis dependency will see huge financial ramifications for SeaStar.

Regaining NASDAQ Compliance

One of the biggest concerns for bulls, and key arguments for bears, has been the potential of NASDAQ delisting due to compliance.
Recently, $ICU received notice from NASDAQ that their marketcap had surpassed the minimum requirements for NASDAQ compliance.
The only thing left is to reach the minimum share price of $1 across the closing of 10 consecutive trading days. With the first close above $1 happening on Friday, ICU needs to close above $1 for this entire week, and the following week.
If the share price is able to do this, SeaStar's NASDAQ compliance will be fulfilled and this concern will be diminished.
Current share price is approximately $1.18/1.19, with many bulls keeping powder to purchase any movement towards $1. With only 65 million shares, and a tremendous amount of accumulation occurring, it's very likely that ICU will be able to hold $1 for the next two weeks, regain compliance, and be opened up to many additional funds and institutional investors.

Upcoming Value-Driving Milestones

https://preview.redd.it/x3pxk4agnkjc1.png?width=1244&format=png&auto=webp&s=b3261f390e00f503e379949ea21ccadd4072ad30
As we all know, FDA approval for SCD-PED in AKI is expected SOON. It may come tomorrow, it may not. But if it doesn't, NOTHING has changed about the bull thesis for this company.
They have stated numerous times that the commercial launch of SCD-PED is already being organized with $FMS (supply/manufacturing) and $NUWE (distribution). The Scientific Advisory Board has massive reach throughout the United States, as well as Canada and Switzerland.
We can expect further value-driving milestones such as treatment/sales/partnership data from SCD-PED.
On top of that, mid-2024 we can expect Phase 3 Interim Analysis for SCD-ADULT in AKI (which is a 50x larger market than SCD-PED)... with potential PMA approval in the first half of next year and commercial launch after.

Summary

SeaStar Medical is about to go from being a pre-revenue medical device company with no fda approvals, to a revenue generating, FDA approved, life saving medical device company. While we are likely to see a great share price movement upon FDA approval, the true gains will be made over the next few years as subsequent data readouts, FDA approvals, and commercial launches take place in the larger market.
I believe that the retail base of investors that have developed for $ICU is one of the most-educated, enthusiastic, and curious that I have experienced in my 4 years of experience in nanocap and microcap stocks.
As you see, I have not shares a "target price" for $ICU. I am much more concerned with the fundamental analysis, and examining current marketcap and potential marketcap. To me, SeaStar is a billion (and multi-billion dollar) company in the making; and this first FDA approval will unlock an insane amount of growth.
Hopefully this information was interesting and/or valuable to you as an investor, potential investor, bear, or other!
Have a great holiday. Let's see what the coming weeks, months, and years bring for SeaStar Medical and the SCD.

PGH Pedia is already accepting applicants for fellowship.
Deadline of submission of applications is on February 29.

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Still accepting applicants! :)