Advancing Kidney Care With Solidified Evidence - SphingoTec Presents PenKid
at AKI & CRRT Course in Vicenza

Issuer: SphingoTec GmbH / Key word(s): Conference/Product Launch
Advancing Kidney Care With Solidified Evidence - SphingoTec Presents PenKid
at AKI & CRRT Course in Vicenza

18.06.2024 / 10:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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  * SphingoTec and Boditech jointly introduced the kidney function biomarker
    Proenkephalin A 119-159 (penKid) at the 42nd AKI & CRRT course in
    Vicenza, highlighting its upcoming integration with the AFIAS platform.

  * PenKid is a real-time kidney function biomarker that addresses the
    standard acute kidney injury (AKI) diagnostic gaps.

  * During a scientific session on AKI biomarkers, penKid was presented as a
    biomarker for risk prediction and early identification of AKI, with
    performance data that could support clinical routine implementation for
    effective AKI management.

Hennigsdorf/Berlin, Germany, June 18, 2024 - Diagnostics company SphingoTec
GmbH ("SphingoTec") introduced together with Boditech Med Inc. (Boditech) at
the 42nd AKI & CRRT Course in Vicenza the innovative kidney function
biomarker penKid developed by SphingoTec and licensed to Boditech. They
highlighted the benefits of penKid on the AFIAS platform, emphasizing its
promise in enhancing kidney function assessment. With the AFIAS penKid®
test, the companies will focus on market development, engaging with
healthcare professionals, and ensuring a successful product rollout starting
in Europe.

The current standard of care diagnosis for AKI is to use serum creatinine
and urine output, which are both lagging indicators. Many clinical studies
point to the delay in AKI identification and its impact on mortality. PenKid
is a functional biomarker that overcomes the shortcomings in the standard
AKI diagnosis of critically ill patients by assessing kidney function in
real time without being influenced by inflammation. A new penKid-based
formula for estimating the glomerular filtration rate (eGFR) has been
developed, outperforming widely used conventional equations based on
creatinine alone (1). In previous studies, penKid has shown the potential to
support increased clinical vigilance by risk prediction and identifying
sub-clinical AKI, with changes in penKid levels pointing to worsening or
recovery of kidney function (2).

Prof. Lui Forni, (Professor and Consultant in intensive care at Royal Surrey
County Hospital NHS Foundation Trust and the School of Medicine, University
of Surrey) introduced penKid to the international audience during the
session "Update on biomarkers". In addition to the well-established
scientific evidence on penKid as a kidney function biomarker for critical
care settings, the presentation also included the results of a decentralized
analysis that consolidates evidence from 11 independent studies and nearly
4,000 patients (3). Beyond unified and compelling evidence of penKid's
clinical performance, the systematic meta-analysis explores the role of
penKid in identifying patients at high risk for AKI. Incorporating penKid
into patient care could enable more intensive surveillance and personalized
and early prevention efforts, including optimizing hemodynamic stability and
prudent use of nephrotoxic agents.

Prof. Lui Forni emphasizes the potential for penKid to serve as an
alternative to serum creatinine in critical care: "While creatinine is the
mainstay for monitoring kidney function in chronic kidney disease, its
limitations in the acute setting call for better solutions. It's time to
embrace novel diagnostics in our day-to-day practice."


###

References:

  1. Beunders et al. Assessing GFR With Proenkephalin, Kidney International
    Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006

  2.  Caironi et al., Circulating proenkephalin, acute kidney injury, and
    its improvement in patients with severe sepsis or shock. Clin Chem
    (2018) DOI:10.1373/clinchem.2018.288068

  3. Lin, LC., et al. Proenkephalin as a biomarker correlates with acute
    kidney injury: a systematic review with meta-analysis and trial
    sequential analysis. Crit Care 27, 481 (2023).
    https://doi.org/10.1186/s13054-023-04747-5

About SphingoTec
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a
commercial-stage diagnostic company focusing on innovative critical care
biomarkers for diagnosing, predicting, and monitoring acute medical
conditions. SphingoTec's innovative markers are made available on different
IVD platforms. SphingoTec's proprietary biomarker portfolio includes
Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney
function in critical diseases, and bioactive Adrenomedullin 1-52 (bio-ADM),
a biomarker for the assessment of endothelial function in conditions like
sepsis.

About penKid
Proenkephalin A 119-159 (penKid) is a blood-based biomarker for assessing
kidney function in acute and critical conditions. The biomarker offers a
blood-based alternative for the complex and time-consuming in vivo
measurement of true glomerular filtration rate (GFR). PenKid is independent
of common comorbidities (e.g., hypertension and diabetes) and the frequently
occurring inflammation in critically ill patients. Rising penKid blood
levels predict acute kidney injury earlier than today's standard of care,
and decreasing penKid blood levels indicate the improvement of kidney
function, even under dialysis.


Media contact:
Ruxandra Lenz
Head of Marketing and Communication
SphingoTec GmbH
Neuendorfstr. 15 A
16761 Hennigsdorf
Tel. +49-3302-20565-0


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