Advanced Medical Balloons Expands its Catheter Product Lineup

Advanced Medical Balloons GmbH (AMB) has premiered its hygh-tec Odor Solution, an addition to its hygh-tec catheter products for critical care. Designed to reduce odor in fecal management, hygh-tec Odor Solution is expected to become commercially available this quarter in the United States and Europe.

hygh-tec Odor Solution received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European Medical Device Regulation (MDR) certification, classifying it as Class II medical device, in January.

At the core of hygh-tec catheter technology is an elastic, deformable polyurethane tube, which allows an improved sealing performance. hygh-tec Odor Solution 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,” Advanced Medical Balloons CEO Frank Gehres stated.

The first generation hygh-tec catheter quickly gained more than a third of market share against Flexi-Seal in Germany, addressing a $600-plus million market opportunity globally. The new product will be launched in the United States and Europe.

Advanced Medical Balloons (AMB) is a specialized medical technology company that develops and markets catheter technology based on microscopically thin, complex shaped balloon films made of polyurethane (PUR). AMB taps the properties of these structures for problem-solving platform concepts in the fecal, urinary and respiratory segments. The current focus is on systems for containing 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 United States. AMB was founded in 2009 and is based in Waghäusel, near Heidelberg, Germany, and in Atlanta, Ga. 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.