Compremium Launches First-In-Human Study on Non-Invasive Thyroid Cancer Diagnostic Medical Device

Non-Invasive Device aims to reduce Unnecessary Thyroid Surgery

The medical device used in the study employs a novel, non-invasive measurement method that quantifies tissue compressibility. Since malignant nodules tend to be stiffer than benign ones, the new technology could help distinguish between the two without surgery. The first-in-human study aims to investigate whether this approach could reduce the number of patients undergoing unnecessary thyroidectomies.

The study is being led by Prof. Dr. Marco Caversaccio, PD Dr. Urs Borner and Dr. Samuel Tschopp, in cooperation with Prof. Roman Trepp (Endocrinology) and Prof. Reto Kaderli (Visceral Surgery). Up to 30 adult patients with Bethesda IV thyroid nodules—a classification carrying an intermediate risk of cancer—will be enrolled over the next 18 months. These patients are already scheduled for surgical removal of their nodules and will also undergo compressibility testing with the CPMX2 system.

Thyroid nodules are extremely common—detected in up to two-thirds of adults via routine ultrasound—but fewer than 5% are cancerous. Patients with Bethesda IV nodules face particular uncertainty, with cancer rates of only 25% to 40%. Despite this, many undergo surgery as a precaution.

“Patients with an intermediate risk of cancer are currently referred for surgery because fine needle aspiration cannot definitively confirm or exclude a diagnosis of malignancy,” said PD Dr. med. Urs Borner. “In many cases, these surgeries turn out to have been unnecessary in retrospect. This new technology might help us make more accurate and individualized clinical decisions.”

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“This study will help us explore whether measuring the compressibility of thyroid nodules could provide additional information for clinical decision-making. By assessing the characteristics of thyroid nodules in real time, we aim to minimize invasive procedures and improve patient care through risk-adapted monitoring.”

Prof. Dr. med. Marco Caversaccio, Chief Physician and Clinic Director ENT, Head and Neck Surgery, Bern University Hospital, Inselspital

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Compremium’s medical device, already FDA-cleared for other applications, enables real-time visualization of pressure and provides precise measurements of tissue stiffness. If successful, this study could lay the foundation for broader use of the technology not just in thyroid care, but in other cancer diagnostics as well.

“We’re proud to be working with Inselspital on this important project,” said Vincent Baumann, CEO of Compremium AG. “It will allow us to evaluate whether our technology can address a critical gap in Thyroid cancer diagnostics and help reduce the current 75% false-positive rate of Bethesda IV nodules. We believe this approach could fundamentally improve how doctors evaluate tissue health and guide treatment decisions.”

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This study is registered in the Human Research Switzerland register. Access it here.

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Disclaimer

This statement describes the collaboration between Compremium AG and Insel Gruppe in the context of a clinical study. It does not constitute an endorsement of any products or services by Insel Gruppe. The study is ongoing, and results are not yet available.

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About Compremium

Compremium is a Swiss medical device company based in Bern, specializing in the non-invasive diagnosis of pressure-related conditions in the human body. Its proprietary measurement technology, which combines ultrasound imaging with pressure sensing, was originally developed by Dr. Ulrich Baumann. The company was founded in 2020 by Vincent Baumann and private investors to bring this innovation to market. The technology has been validated in more than 40 clinical studies and shows promise across over 30 medical indications. Compremium received FDA 510(k) clearance in April 2023 for its lead tissue-assessment application and plans further FDA and CE submissions in 2025. A prototype of the device has been in use aboard the International Space Station for eight years through a collaboration with NASA.

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About Inselspital

Insel Gruppe is a leading hospital group for university and integrated medicine in Switzerland. It offers comprehensive healthcare to people based on groundbreaking quality and pioneering research, innovation and education at every stage of life, around the clock and in the right location. Insel Gruppe conducts over 850,000 outpatient consultations each year across its hospital network, and treats approximately 55,000 inpatients in accordance with the latest therapy methods. Insel Gruppe is a training organisation for a multitude of professions, as well as an important institution for furthering the education of young doctors. Around 11,000 employees work at Insel Gruppe.

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