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| But I think the reassuring thing is that those tests are going well and looking forward to that data coming in, so we can submit a very strong response to the FDA |
| There weren't many surprises there, but it's good to get that passing grades on those as well |
| But when the therapy is actually being delivered in the new model, it's been incredibly stable, which gives us a lot of confidence to be able to round out this last test subject and move forward with the data set |
| Moving beyond, miroliverELAP to our fully implantable bioengineered programs, we continue to make progress and gain industry recognition for the promise of our fully implantable bioengineered programs |
| Happy to report that preclinical team here has done a phenomenal job of really redesigning that study and working with veterinaries, working with thought leaders to be able to come up with a solution |
| And as you highlighted, really excited that the biocomp will wrap up by the end of this month, happy to report that everything that we've tested so far has passed |
| As we highlighted in the call, really happy with the progress that we made on the two kind of lead long poles of the tent that we've been working on |
| As you have highlighted before, my background is strong in the technical side and came from the R&D side |
| With that said, things continue to go very well from that standpoint |
| And that program provides us with valuable insight to our fully implantable bioengineered organ programs |
| So I think from that standpoint, the community continues to be impressed and surprised with the progress that we continue to make |
| I mean it's exciting to go to those conferences and see the excitement around the technology and start to open up the opportunity to think about what the future could look like with these types of organs going forward |
| So again, that's why the focus that we talked about before, the importance of ELAP as our first product and then the read-through to the fully transplantable organ platform is really our first opportunity to start to demonstrate that with a bioengineered organ, which we believe then opens up the opportunity for our fully transplantable programs to continue forward |
| The current safety study utilized and improved the mobilization techniques and anesthesia to reduce mortality in all animals |
| In summary, we believe we are taking all the necessary steps to submit a thorough response to the FDA's clinical hold better in the second-half of this year, and we look forward to being able to treat patients with acute liver failure in a Phase 1 clinical trial as soon as the FDA authorization is obtained |
| Jack Lake was presented a lifetime achievement award by the American Transplant Congress, which really capped off a busy and rewarding second quarter |
| We continue to make significant progress on addressing the items identified within the FDA clinical hold letter, relating to our miroliverELAP IND submission |
| Those results established a foundational platform for our ongoing research and to add to our growing body of evidence on the potential of using bioengineered kidneys as an alternative to human allograft kidneys |
| And I think our bioengineered organ approach has really addressed those risks well as we move forward |
| Alex Nowak Excellent |
| But we're really trying to evaluate is what are the clinical sites where we can be activated as soon as possible because we know there's going to be a lot of excitement and demand for this therapy once our IND is cleared |
| I think as we look at ATC, I think the community was certainly, I say, surprised or impressed with the level and the quality of data that was put forth on the renal side, not only showing the revascularization sustained ability to perfuse the organ, but also some of the stuff that we're starting to show on the protein retention and the filtration effect of the recellularized kidney that we've started to release that data out |
| As a reminder, we are prioritizing miroliverELAP in the near-term, because we believe it provides us with the fastest path to treating organ failure patients with our bioengineered organs |
| We also had a manuscript published in Frontiers and Bioengineering and Biotechnology titled, sustained in vivo perfusion of a re-endothelialized tissue engineered kidney graft in a human-scale animal model that demonstrated how a bioengineered kidney graft could maintain patency with consistent blood flow |
| Our goal remains to submit a full response to the FDA in the second-half of 2023, and we envision gaining authorization to treat patients with acute liver failure shortly thereafter |
| Alex Nowak Okay, excellent |
| Good to hear |
| Lake for being acknowledged by the transplant community and a key thought leader in the industry |
| Max Forgan Good afternoon and thank you for joining us |
| So we were able to roll that out |
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| And that was really the challenge in our initial study where we saw high levels of mortality associated with it |
| So even inside the control, which is just being anesthetized, we saw a fallout in the study of that |
| The decrease in operating loss for comparable periods was primarily attributable to decreased research and development lab supply costs |
| You know, with regards to the preclinical animal study, the problem in the past was the pig mile that you had to rely upon, and I think you had to engineer a unique pig model for the new preclinical study |
| However, there was substantial mortality in all groups due to the immobilization techniques and the anesthesia required to provide therapy in a pig model, which makes longer therapies in a mobilized animal model challenging |
| We've still had some minor complications associated with things that you normally see in a preclinical study like a catheter come in boost or something like that, that is easily excluded as part of your cohorts |
| The decrease in net loss for comparable periods was primarily attributable to decreased research and development lab supply costs in addition to one-time employee retention credits totaling $527,000 that was recorded as other income in the first quarter of 2023 |
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