- The hygh-tec Odor Solution™ is scheduled for release in the second quarter of 2025.
- It has already received FDA clearance and MDR certification.
- The initial hygh-tec™ catheter quickly captured over a third of the German market, tapping into a global market valued at over $600 million.
WAGHAEUSEL, Germany, March 24, 2025 — Advanced Medical Balloons GmbH (AMB), a medical technology company based near Heidelberg, Germany, today announced the hygh-tec Odor Solution™ as a new addition to its hygh-tec™ catheter line for critical care. Designed to minimize odor during fecal management, the hygh-tec Odor Solution™ is expected to be available commercially in the US and Europe in Q2 2025.
In January 2025, the hygh-tec Odor Solution™ was granted 510(k) clearance by the FDA in the United States and received certification under the European MDR, classifying it as a Class II medical device.
The core of the hygh-tec™ catheter technology lies in its innovative, flexible, and adaptable polyurethane tube, which allows for exceptional sealing. The hygh-tec Odor Solution™ improves on this design with an additional barrier to prevent odor from escaping, greatly enhancing the experience for patients and caregivers in critical care environments.
“hygh-tec has demonstrated its transformative potential in the fecal management sector. A reliable seal that prevents stool in bed changes is revolutionary. It greatly eases the burden of unnecessary cleaning for patients and hospital personnel, prevents the spread of infection, avoids severe peri-anal skin breakdown, and promotes greater patient mobility. With our new hygh-tec Odor Solution product, we are now targeting unpleasant odors by adding a true odor barrier. Patients, families, and nurses will all benefit from the elimination of odors in the ICU,” stated Frank Gehres, CEO of Advanced Medical Balloons.
The first-generation hygh-tec™ catheter rapidly secured over a third of the market share in Germany, competing with market leader Flexi-Seal™, and addresses a global market worth more than $600 million. With FDA and MDR approvals in hand, AMB is well-positioned to replicate its market success with the hygh-tec Odor Solution™. The product will be introduced in both the US and Europe.
About Advanced Medical Balloons
Advanced Medical Balloons (AMB) is a specialist medical technology firm focused on developing and marketing innovative catheter technologies based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB leverages the unique characteristics of these structures to create problem-solving platform concepts in the Fecal, Urinary, and Respiratory sectors. Currently, the company is focused on systems for containing patient contamination, developing contamination-free drainage technology for fecal management in intensive care patients to improve nursing, hygiene management, and patient therapy. The initial product utilizing this technology, hygh-tec®, has already seen great success in German-speaking countries and has been marketed in the USA since 2023. AMB was established in 2009 and has locations in Waghaeusel, near Heidelberg, Germany, and Atlanta, GA, USA. Since 2021, the company has been supported by a strong investor syndicate led by Wellington Partners, Munich, and including MIG AG and Salvia GmbH.
| Contact: | Media relations: |
| Advanced Medical Balloons GmbH Frank Gehres, CEO Phone: +49-7254-4039710 |
MC Services AG Eva Bauer Phone: +49-89-210228-0 |
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