| From: Sultan | 2/5/2024 12:29:20 AM | | | | | | Just a little tidbit as a reminder while we were discussing Tigris Trial and the time lines.. No doubt this is a pivotal year for them as soon as they hit the 90 interim patient count..
Last time Eden Study was mentioned by Spectral was on December 14, 2023 news release..
EDEN Study:
- Completed the EDEN study, a parallel observational study, in which data is collected on patients with septic shock even if ineligible for Tigris. The EDEN study is among the largest ever to examine the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX and provide important data on potential expanded indications for PMX.
Also, let's not forget the following.. This was mentioned a year ago in one of the news releases..
- EUPHAS-2 is a Spectral-sponsored observational study in Italy using EAA-guided PMX, which is now complete. We have reviewed the topline results, which strongly support the preliminary data received from the Tigris trial. These data strengthen our confidence in our ability to achieve a successful trial outcome as well as potential FDA approval.
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| From: Sultan | 3/1/2024 7:25:35 PM | | | | | | CRRT CONFERENCE 2024
CRRT Conference Breakfast Symposium
Waking up to Endotoxemic Septic Shock. What do you need to be ready?
Wednesday March 13, 2024
San Diego, CA
Moderators: John Kellum and Debra Foster
Diagnosing ESS in the real world – Danielle Davison, George Washington University
Treating ESS in the real world – Javier Neyra, University of Alabama
Implementing PMX hemoadsorption at the bedside – Johann Chang, (Spectral), Tara Morgan-Gray, (Colorado Springs) |
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| From: Sultan | 3/5/2024 3:19:22 PM | | | | | | Raymond James Conference - Vantive and Today's 8-K
Questioner
Early last year, you talked about reconstructing the portfolio - big step late last year and then another additional step coming later this year with the spin of the kidney business. And so I guess the question I have here is. The initial question is you filed an 8-K this morning, so the intention was to separate the business - potentially spin - potentially sale. You filed an 8-K this morning that indicated you were in recent discussions with private equity around the potential sale of this business. I guess my first question on that is, what triggered the 8-K and then any other detail you can add.
Baxter
Sure. I think what number one, we've been pretty consistent around our messaging around this idea that our responsibility is to maximize shareholder value. And so whether that was in timing, whether there were structural areas that impacted the decisions we're going to make, we were really clear on the fact that that was our overarching objective. As part of that, we talked about the fact that there could be multiple paths and so what triggered the 8-K today was really the idea that we had actually received interest from private equity parties, that was up until this time was, we'd like to and we're going to maximize shareholder value if something comes along, we're going to consider it. What's different today is we've actually received incoming interest from private equity firms for the possibility of acquiring. But I think the key point that I just want to emphasize is, we're taking a very balanced approach to how we're thinking through this in that again, it's about maximizing shareholder value and we've worked very hard to head towards a spin, the work that we've done to get to the potential spin is very relevant to the work that would be necessary in the event that we did decide to go down the path of a sale. And so we're going to continue to ensure that we have are very balanced in how we think about these things. But again, in the end, I'll make the decision that will maximize shareholder value.
Questioner
And just the 8-K requirement, it's strictly based on timing, not probability of an event?
Baxter
It was the fact that we actually received interest from these outside parties, as opposed to just, hey, if something comes along, we'll consider it. We've now actually received specific interest from private equity firms.
Questioner
How does the 8K impact? Because you've kind of steered investors towards the second-half separation. Does that change at all given the 8-K?
Baxter
We did say as part of the 8-K that we expect to complete the separation regardless of structure in the second half of this year.
Questioner
So nothing’s changed there.
Baxter
Yes
Questioner
And just on that business, I realize the focus will be more on ?, but just on Vantive, expected to be down on the top line in 24, but if we kind of exclude some kind of one time ish dynamics, that business is kind of a 3 to 4% top line normalized business with up margins in the mid to high single digits and investors should view it as more of a margin expansion story? Is that the identity of that business?
Baxter
Yeah, I don't want to speak on behalf of the kidney Care team. I'm sure that Chris Toth, who has been kind of the designated CEO, has a very detailed strategy that will incorporate reinvestment in the business, in particular to, you know, drive top line growth, particularly around the home and accelerating the home and some digital capabilities to really expand that, coupled with, I would say meaningful margin expansion, they do obviously - we did provide our segment profitability last year. So you can see what the kidney care margins are. And I think Chris and his team have a very detailed plan to accelerate margins. You know both in the near term and over the longer term as well. |
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| From: Sultan | 3/5/2024 3:22:57 PM | | | | | | | On March 4, 2024, Baxter International Inc. (“Baxter”) provided an update on the planned separation of its Kidney Care business. Consistent with Baxter’s commitment to evaluate strategic options in the interest of maximizing stockholder value, Baxter disclosed that it has been in recent discussions with select private equity investors to explore a potential sale of the Kidney Care asset in lieu of the proposed spinoff of that business. No final decision on the separation structure has been made and Baxter continues to make progress on the previously announced proposed spinoff of the Kidney Care business. Regardless of the separation structure ultimately selected, Baxter has expressed its commitment to separating the Kidney Care business in the second half of 2024. |
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| From: Sultan | 3/7/2024 8:45:20 PM | | | | | | With only 57 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial. To bolster ongoing efforts, Spectral will convene an in-person Investigator Meeting on March 12th & 13th in San Diego, coinciding with the 29th International Conference on Advances in Critical Care Nephrology. Read more: lnkd.in
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