Advanced Medical Balloons presents results from HYDRA-PMCF study of hygh-tec®, demonstrating high performance and safety

• HYDRA-PMCF-study evaluated hygh-tec®, a new polyurethane fecal management system
• hygh-tec® showed a high level of sealing performance (no leakage in 89.3%) and was safe to use (94.2% no signs of infection; GLOBIAD score = 0+1A)
• Full results will be presented at upcoming ABA Annual Meeting and WOCNext 2025

Waghaeusel (Germany), April 1, 2025 – A significant and insufficiently resolved clinical problem in intensive care, fecal incontinence, increases the risk of complications, impacts patient well-being, and places a heavy burden on healthcare staff and resources. The stool drainage systems currently in use in hospitals are associated with leakage in up to 30% of ICU patients, low anal/rectal tolerance and safety concerns. Severe skin breakdowns and ulceration can lead to potentially life-threatening spread of infection (e.g., Clostridioides difficile), an increased risk of sepsis, and reduced patient mobility. The labor-intensive process of frequently cleaning patient beds is inefficient and places a heavy burden on nursing staff, contributing to increased burnout and staff resignations.

Advanced Medical Balloons GmbH (AMB), a specialist in medical technology, today announced data from the prospective observational HYDRA-PMCF-study which will be presented at upcoming scientific meetings in the U.S. The study has been designed to assess the sealing efficiency and product safety of hygh-tec®, a new polyurethane (PU) stool drainage system based on the use of thin PU films. The study included 39 ICU patients aged 18 and older. Sealing efficiency was evaluated based on the nursing shift documentation using a predefined contamination score (rank 1 to 4). The safety endpoints focused on the prevalence of perianal lesions and the perianal skin status, as measured by the GLOBIAD score (Ghent Global Incontinence-Associated Dermatitis Categorisation Tool).

The sealing performance was evaluated across 1,110 nursing shifts, with no drainage-associated SAEs reported. The mean duration of the drainage was 10.8 days (median: 8 days, minimum: 3 days, maximum: 31 days). Stool consistency, depth of sedation and level of mobilization were recorded once a day. No visible perianal contamination (rank 1) was found in 76.0%, visible perianal contamination (rank 2) was observed in 13.2%, while a visible contamination of patient pad (rank 3; 7.57%) and marked patient contamination (rank 4; 3.15%) occurred less frequently. Leakage was defined as a scale of 3 or 4; accordingly, 10.7% of patients experienced leakage (119 shifts), no leakage was experienced in 89.3% (991 shifts) of patients. The perianal skin status showed that in 362 of 384 days (94.2%), no signs of infection were observed (GLOBIAD score 0=78.6%; 1A=15.6%). With regards to safety, none of the clinical events reported were related to the device.

Data from the HYDRA-PMCF-study have already been discussed at the Boswick Burn & Wound Care Symposium in January and at the North American Burn Society (NABS) Meeting in February 2025. The full results will be presented at the upcoming ABA Annual Meeting on April 10^th in Phoenix, Arizona and at the WOCNext 2025 on June 1^st in Orlando, Florida.

“We are very pleased with the results of the HYDRA-PMCF study, which clearly demonstrate the effectiveness and safety of hygh-tec®,” said Prof. Andreas Pfuetzner, MD, PhD, CMO of Advanced Medical Ballons. “Eliminating one of the key hygiene challenges in the ICU—fecal contamination in the bed—not only reduces nursing workload but also helps prevent costly medical complications such as lesions, infection spread, and delayed mobilization. Given these benefits, hygh-tec® is set to become an indispensable tool for burn patients, those at risk of skin ulceration, and patients requiring early mobilization for better care and faster healing.”

AMBs flagship product hygh-tec® is designed for urgent care in hospitals, including intensive care units, burn units, and other specialized departments, where managing fecal output is critical. hygh-tec®, which is CE-marked and has received FDA approval in 2023 as well as MDR approval in 2024, is a novel fecal management system that provides a safe and effective solution for managing fecal incontinence, reducing the risk of skin breakdown and pressure injuries. The technology represents a paradigm shift in fecal management and the critical need to reduce leakage in these critical care departments. In addition, AMB has developed a strong pipeline of unique products addressing unmet clinical needs, including significantly improved endotracheal tubes for mechanical ventilation and novel urinary catheters, addressing a market potential in excess of $ 2.0 billion annually.

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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