ENDRA Life Sciences Activates TAEUS System to Initiate Clinical Study at LMU University Hospital in Germany
ENDRA Life Sciences (NASDAQ: NDRA) has initiated a post-CE mark clinical study for its TAEUS liver system at LMU University Hospital in Munich, Germany. The study aims to assess TAEUS' liver fat measurement capabilities against the gold standard MRI-PDFF test. LMU researchers plan to present findings at future medical congresses and publish in peer-reviewed journals.
This collaboration is expected to:
- Build upon ENDRA's growing portfolio of clinical data
- Support the company's FDA De Novo submission targeted for mid-2025
- Support the adoption of TAEUS technology as a reliable and accurate biomarker for liver fat
- Mark a strategic entry into Germany's healthcare market, the largest in Europe
ENDRA Life Sciences (NASDAQ: NDRA) ha avviato uno studio clinico post-CE per il suo sistema TAEUS per il fegato presso l'ospedale universitario LMU di Monaco, Germania. Lo studio mira a valutare le capacità di misurazione del grasso epatico del TAEUS rispetto al test di riferimento MRI-PDFF. I ricercatori della LMU intendono presentare i risultati in futuri congressi medici e pubblicare su riviste peer-reviewed.
Questa collaborazione si prevede che:
- Espanda il crescente portfolio di dati clinici di ENDRA
- Supporti la sottomissione De Novo per la FDA prevista per metà 2025
- Faciliti l'adozione della tecnologia TAEUS come biomarcatore affidabile e preciso per il grasso epatico
- Segmenti un ingresso strategico nel mercato sanitario tedesco, il più grande d'Europa
ENDRA Life Sciences (NASDAQ: NDRA) ha iniciado un estudio clínico post-MCE para su sistema TAEUS para el hígado en el Hospital Universitario LMU de Múnich, Alemania. El estudio tiene como objetivo evaluar las capacidades de medición de grasa hepática del TAEUS en comparación con la prueba de oro MRI-PDFF. Los investigadores de LMU planean presentar los hallazgos en futuros congresos médicos y publicar en revistas revisadas por pares.
Se espera que esta colaboración:
- Amplíe la creciente cartera de datos clínicos de ENDRA
- Apoye la presentación De Novo a la FDA programada para mediados de 2025
- Facilite la adopción de la tecnología TAEUS como un biomarcador fiable y preciso para la grasa hepática
- Marque una entrada estratégica en el mercado de la salud de Alemania, el más grande de Europa
ENDRA Life Sciences (NASDAQ: NDRA)는 독일 뮌헨의 LMU 대학 병원에서 TAEUS 간 시스템에 대한 CE 마크 후 임상 연구를 시작했습니다. 이 연구는 TAEUS의 간 지방 측정 능력을 황금 표준인 MRI-PDFF 테스트와 비교 평가하는 것을 목표로 하고 있습니다. LMU 연구자들은 향후 의료 회의에서 결과를 발표하고 동료 검토 저널에 게재할 계획입니다.
이번 협업은 다음과 같은 기대 효과가 있습니다:
- ENDRA의 증가하는 임상 데이터 포트폴리오를 확장할 것
- 2025년 중반을 목표로 FDA De Novo 제출을 지원할 것
- TAEUS 기술이 간 지방에 대한 신뢰할 수 있고 정확한 바이오마커로 채택되는 것을 지원할 것
- 유럽에서 가장 큰 독일 의료 시장에 전략적으로 진입할 것
ENDRA Life Sciences (NASDAQ: NDRA) a lancé une étude clinique post-marque CE pour son système TAEUS pour le foie à l'hôpital universitaire LMU de Munich, en Allemagne. L'étude vise à évaluer les capacités de mesure des graisses hépatiques de TAEUS par rapport au test standard de référence MRI-PDFF. Les chercheurs de la LMU prévoient de présenter les résultats lors de futurs congrès médicaux et de publier dans des revues à comité de lecture.
Cette collaboration devrait :
- Élargir le portefeuille croissant de données cliniques d'ENDRA
- Soutenir la soumission De Novo à la FDA prévue pour mi-2025
- Faciliter l'adoption de la technologie TAEUS comme biomarqueur fiable et précis pour les graisses hépatiques
- Marquer une entrée stratégique sur le marché de la santé allemand, le plus grand d'Europe
ENDRA Life Sciences (NASDAQ: NDRA) hat eine klinische Studie nach dem CE-Zeichen für sein TAEUS-Leber-System am LMU Universitätsklinikum in München, Deutschland, initiiert. Die Studie zielt darauf ab, die Fähigkeiten von TAEUS zur Messung von Lebergewebe im Vergleich zum Goldstandardtest MRI-PDFF zu bewerten. Die Forscher der LMU planen, die Ergebnisse auf zukünftigen medizinischen Kongressen zu präsentieren und in peer-reviewed Fachzeitschriften zu veröffentlichen.
Diese Zusammenarbeit wird voraussichtlich:
- Auf dem wachsenden Portfolio klinischer Daten von ENDRA aufbauen
- Die Einreichung bei der FDA De Novo, die für Mitte 2025 geplant ist, unterstützen
- Die Einführung der TAEUS-Technologie als zuverlässigen und genauen Biomarker für Lebergewebe unterstützen
- Einen strategischen Einstieg in den deutschen Gesundheitsmarkt ermöglichen, der der größte in Europa ist
- Initiation of post-CE mark clinical study at a leading European medical research center
- Potential support for FDA De Novo submission targeted for mid-2025
- Strategic entry into Germany's healthcare market, the largest in Europe
- Planned presentation of study findings at medical congresses and peer-reviewed publication
- None.
Insights
The activation of ENDRA Life Sciences' TAEUS system for a post-CE mark clinical study at LMU University Hospital in Germany is a significant development. This study aims to validate TAEUS' liver fat measurement capabilities against the gold standard MRI-PDFF test, potentially establishing it as a reliable biomarker for liver fat assessment.
Key points to consider:
- The study could provide important real-world clinical evidence to support TAEUS' utility in metabolic disease management.
- Positive results may accelerate ENDRA's FDA De Novo submission, targeted for mid-2025.
- Collaboration with a prestigious institution like LMU University Hospital adds credibility and could influence adoption in Europe's largest healthcare market.
- The non-invasive nature of TAEUS technology could offer a competitive advantage in the growing field of liver health assessment.
While promising, investors should note that clinical study outcomes are uncertain and regulatory approval is not guaranteed. The
Scans first patient in post-CE mark clinical study with Munich’s center of excellence in Europe’s largest healthcare market
LMU University Hospital is conducting a post market clinical study to collect data to assess TAEUS’ liver fat measurement capabilities against the gold standard MRI-PDFF test. This study is intended to collect real-world clinical evidence to further establish the utility of the TAEUS system for metabolic disease management. LMU researchers plan to present the findings of the study at future medical congresses followed by a peer-reviewed publication.
“LMU University Hospital is one of
About LMU University Hospital Munich
The LMU University Hospital is one of the largest university hospitals in
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology that characterizes tissue similar to an MRI, but at 1/40th the cost and at the point of patient care. TAEUS® is initially focused on the non-invasive assessment of fatty tissue in the liver. Steatotic liver disease (SLD, formerly known as NAFLD-NASH) is a chronic liver disease spectrum that affects over two billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including non-invasive visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.
Forward-Looking Statements
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as “approximate,” "anticipate," “attempt,” "believe," "could," "estimate," "expect," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: expectations with respect to FDA requirements regarding its clinical trials and de novo submission for its TAEUS liver device; estimates of the timing of future events and anticipated results of its development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches and sales; statements relating to future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; and statements regarding ENDRA’s ability to find and maintain development partners. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain FDA and other regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; ENDRA’s ability to maintain compliance with Nasdaq listing standards; ENDRA’s dependence on its senior management team; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
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Company Contact:
Richard Jacroux
Chief Financial Officer
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Source: ENDRA Life Sciences Inc.
FAQ
What is the purpose of ENDRA Life Sciences' clinical study at LMU University Hospital?
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