- See the pre-funding press from July 13, 2020, here.
- See a report that the $74M offering was achieved. Renalytix AI was valued at $490M in this transaction. Here and here.
- See the 295 prospectus (an F-1, equivalent to an S-1) at SEC, here.
- Company website here.
In the F-1, Renalytix AI summarizes its service and business model as follows:
We are an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs. KidneyIntelX, our first-in-class diagnostic platform, employs a proprietary artificial intelligence-enabled algorithm that combines diverse data inputs, including validated blood-based biomarkers, inherited genetics and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk. CKD affects approximately 37 million individuals in the United States, significantly impacting their quality of life and resulting in Medicare spending of over $120 billion per year. In response to this substantial kidney disease burden, a U.S. Presidential Executive Order on Advancing American Kidney Health was issued in July 2019 to support change in kidney disease care. We believe we are well-positioned to help meet this urgent medical need with KidneyIntelX, a laboratory developed test, or LDT, initially indicated for adult patients with type 2 diabetes and existing CKD, which is referred to as diabetic kidney disease, or DKD.
Renalytx AI adds that is is working on Medicare coverage with the MolDx program (no timeline provided) and has obtained one private insurance coverage decision. Renalytx has a PLA code, 0105U, from 2019, which was priced by crosswalk in the 2019 CMS pricing process at $950. Renalytx also remarks that they have an (unpublished) economic modeling, commissioned from Boston Healthcare Associates, that shows they are cost-saving.
PLA Code
PLA code 0105U states:
Nephrology (chronic kidney disease), multiplex electrochemiluminescent assay (ECLIA) of TNF receptor A1, receptor superfamily 2 (TNFR1 TNFR2) and kidney injury molecular (KIM-1), combined with longitudinal clinical data, APOL1 genotype if available, plasma, algorithm as probability score for RKFD (rapid kidney function decline).
Academic Investments Baked In
Renalytix has substantial prior and ongoing investments from Mt Sinai School of Medicine (here; see also F-1 document above). They are running a current study, PRED-MAKER (Prediction of Major Adverse Kidney Events and Recovery) with Mt. Sinai.
Serial CEO
The President and Chief Commercial Officer of Renalytix AI is Tom McLain, who had previously been CEO of ExosomeDx (acquired by Bio-Techne) and Vermillion, the developer of OVA-1.
"Digital Genomics" and Renalytx AI
Renalytix AI is a good example of what I've called Digital Genomics (see my 2017 article here, here). In that paper, I described Lab 1.0 as accessioning a sample and providing a report. Lab 2.0 is closely integrated into its environment (ACO, EHR, utilization management, outcome metrics). "Lab 3.0," which I was using somewhat tongue-in-cheek, adds more than that - another layer which might be integrated virtual tumor board, unique and/or FDA approved test offerings, clinical data partnerships (like Flatiron), or in this case, AI/machine learning integrated in a holistic way directly into the laboratory service.
In addition to its integration with artificial intelligence, Renalytix' home page indicates its corporate commitment to doing its part in the national COVID-19 battle.
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Trump Renal Executive Order 2019
I wrote a detailed analysis last summer of the Trump executive order to modernize and reform kidney care in the US (highlighting the three key phases of (1) progression of disease, (2) ESRD and dialysis, and (3) transplant care) - here.
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Not directly related to Renalytix AI, but also showing the tightening integration of lab data and bioinformatics - Genomeweb runs a subscription story on Ilumina's rapid acquisition of two different informatics companies, Enancio and BlueBee (here). Regarding Enancio, which compresses data, they write that Illumina generated 150 petabytes of data in 2019; a NovaSeq 600 can generate 7 terabytes in 2 days; and Enancio's "Lena" software can compress that by 80%. Lena will be integrated into DRAGEN, acquired by Illumina a couple years ago. Regarding BlueBee, Genomeweb writes, "ge analysis; BlueBench, a set of tools based on Jupyter notebooks for research and research and translational applications; as well as BlueBrain, artificial intelligence for generating insights from large datasets."
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