Advanced Medical Balloons announces its new hygh-tec Odor Solution^TM product, broadening its catheter portfolio

• hygh-tec Odor Solution^TM will be launched in Q2 2025
• FDA clearance and MDR certification already secured
• First generation hygh-tec^TM catheter rapidly achieved more than a third of the market share in Germany, and addressing a US$ 600+ million market opportunity globally

Waghaeusel (Germany), March 24, 2025 – Advanced Medical Balloons GmbH (AMB), a specialist in medical technology from Waghaeusel near Heidelberg, today announced hygh-tec Odor Solution^TM as an innovative addition to its hygh-tec^TM catheter products for critical care. Designed to reduce odor in fecal management, hygh-tec Odor Solution^TM is expected to become commercially available in Q2 2025 in US and Europe.

In January 2025, hygh-tec Odor Solution^TM received 510(k) clearance from the United States Food and Drug Administration (FDA) and certification under the European Medical Device Regulation (MDR), classifying it as Class II medical device.

At the core of the hygh-tec^TM catheter technology is an innovative, elastic and deformable polyurethane tube, which allows an unmatched sealing performance. hygh-tec Odor Solution^TM further enhances this design with an additional barrier layer that prevents odor from escaping, substantially improving the patient and caregiver experience in critical care settings.

“hygh-tec has proven to be transformative in the fecal management market. A seal stable enough to eliminate stool in the bed changes everything. It significantly reduces the burden of unnecessary cleaning episodes for patients and hospital staff, it prevents infection spread, prevents severe peri-anal skin breakdown and increases patient mobility. Now we are tackling unpleasant odor with our new hygh-tec Odor Solution product that includes a true odor barrier. Patients, relatives and nurses will benefit from the elimination of odor from the ICU room,” said Frank Gehres, CEO of Advanced Medical Ballons.

The first generation hygh-tec^TM catheter quickly gained over a third of market share against market leader Flexi-Seal^TM in Germany, addressing a $600+ million market opportunity globally. With the FDA- and MDR-clearances secured, AMB is primed to replicate the market success with its hygh-tec Odor Solution^TM. The new product will be launched in US and Europe.

About Advanced Medical Balloons

Advanced Medical Balloons (AMB) is a specialized medical technology company. The company develops and markets novel catheter technology based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB taps the properties of these extraordinary structures for problem-solving platform concepts in the Fecal, Urinary and Respiratory segments. The current focus is on systems for the containment of patient contamination. In this context, AMB is developing contamination-free drainage technology for fecal management in intensive care patients, which provides significant benefits in nursing, hygiene management and patient therapy. The first product utilizing this technology, hygh-tec^®, is already used in German-speaking countries with great success and since 2023 also marketed in the USA. AMB was founded in 2009 and is based in Waghäusel, near Heidelberg, Germany, and in Atlanta, GA, USA. Since 2021, the company has been financed by a strong investor syndicate led by Wellington Partners, Munich, and comprising MIG AG as well as Salvia GmbH.

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Advanced Medical Balloons GmbH    
Frank Gehres, CEO      
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