HCMED INNOVATIONS, specializing in inhalation drug-device combination CDMO products, announced that its breath-activated nebulizer AdheResp has recently received U.S. FDA 510(k) clearance. AdheResp is the world’s first FDA-cleared breath-activated nebulizer with built-in connectivity, and currently the only advanced nebulizer device with mass production capacity to support pharmaceutical clients’ clinical trials.

AdheResp utilizes HCMED’s adaptive breath-driven technology platform, incorporating multiple advanced patented technologies highly anticipated by international pharmaceutical customers. It automatically adjusts nebulization timing based on each patient’s breathing, releasing medication during inhalation to enhance efficacy and reduce costly drug waste. During nebulization, AdheResp does not generate heat buildup, offering a significant advantage for delivering temperature-sensitive and expensive biologics such as mRNA or antibody drugs, thereby preserving drug activity and improving therapeutic outcomes.

HCMED stated that through its innovative and patent-protected nebulization technology platform, it provides pharmaceutical companies developing inhaled therapies with high-quality, customizable nebulizer devices. With 510(k) clearance, AdheResp’s safety and efficacy have been recognized by the U.S. FDA, boosting pharmaceutical companies’ confidence in nebulizer device use and helping shorten development timelines. These benefits create substantial market value for partner pharma companies and ultimately bring patients more effective and convenient treatment options.

Founder and Chairman Chieh-Sheng Cheng said, “Obtaining FDA approval marks a significant milestone! It demonstrates HCMED’s continued dedication to R&D and delivering innovative solutions for pharmaceutical clients, solidifying our leadership position in the global inhalation drug-device combination CDMO market. We will continue expanding development collaborations with international pharmaceutical companies to drive significant operational growth.”

Resource: 心誠鎂邁突破性里程碑，創新呼吸偵測啟動霧化器獲美國FDA核可