Breath Medical's MeheDing® Fully Absorbable Nasal Septum Fixation System Enters NMPA Innovation Green Channel
BREATH MEDICAL
ENT Medical Device R&D Company
On August 2, 2024, the Center for Medical Device Evaluation of the National Medical Products Administration released the Public Notice on the Review Results of Applications for Special Examination of Innovative Medical Devices (No. 7, 2024), concerning Hefei Qihao Medical Technology Co., Ltd. (hereinafter referred to as “BREATH MEDICAL”) and its “Meihe Staple”®The "Fully Degradable Septal Cartilage Fixation System" (hereinafter referred to as the "Meihe Clip") has entered the special review procedure.
“Meiheding” is used for the fixation of the nasal septum following septoplasty. Utilizing micro-engineering processing technology with fully degradable materials, it enables rapid, multi-point fixation of the nasal mucosa and cartilage within confined spaces, offering precise and straightforward operation.Postoperative care is simple, significantly reducing surgical difficulty and shortening operative time. It avoids drawbacks associated with traditional postoperative suturing, such as the risk of secondary injury, thereby alleviating patient suffering.
“Meiheding” received unanimous recognition from industry experts at the clinical project launch meeting. Based on current clinical trial data, the time required for “Meiheding” to fixate the nasal septum, compared to traditional suturing techniques,Can reduce surgical time by 84%.In April 2024, “Meiheding” won the Third Prize in the Grand Final of the 4th Yangtze River Delta Translational Medicine (Medical Devices) Innovation and Entrepreneurship Competition.
BREATH MEDICAL, established in July 2020, is a high-caliber medical device R&D and manufacturing enterprise characterized by its advanced starting point, cutting-edge technology, and superior quality. The company specializes in the research, development, production, and sales of high-end minimally invasive implantable and interventional medical devices for otolaryngology. It has been successively recognized as a National Science and Technology-based Small and Medium-sized Enterprise, a National High-tech Enterprise, an Anhui Province “Specialized, Refined, Differential, and Innovative” (SRDI) SME, and a Deep-Tech Enterprise in Hefei High-tech Zone. To date, BREATH MEDICAL has invested RMB 150 million in the Hefei High-tech Zone to build an industrial park covering an area of 23 mu, with a total construction area of 18,000 square meters. The park is equipped with world-class experimental, production, and testing facilities, boasting robust capabilities in high-end R&D and manufacturing.
As the “leader” in China’s ENT sector, BREATH MEDICAL’s “Biodegradable Expandable Hemostatic Sponge” entered the special review process as early as September 2022 and obtained its medical device license in March 2023. This product was the first in Anhui Province to enter the special review process, breaking the nearly 20-year monopoly held by foreign companies in the field of ear and nose hemostatic materials.
Currently, BREATH MEDICAL’s core products under development also include Meishengci® Calcium Hydroxyapatite Filling and Repair Gel, biodegradable sinus drug-eluting stents, and next-generation biodegradable expandable hemostatic sponges.
Meisheng Porcelain for Vocal Cord Injection®Utilizing calcium hydroxyapatite microspheres (25–40 μm) as the primary material, supplemented with carboxymethyl cellulose and glycerin, this product is designed for the augmentation of tissue defects or atrophy. It serves as an alternative to existing autologous fat grafting procedures and represents the first domestically developed synthetic, long-acting filler for vocal fold augmentation in China. Laboratory validation indicates an effective duration of approximately 4–5 years, achieving true long-term volumetric restoration. The product exhibits excellent biocompatibility and plasticity, has a low allergenic potential, and demonstrates a high safety profile. With its straightforward surgical technique and short patient recovery period, it provides otolaryngologists with an optimal clinical solution.
Meisheng Porcelain
Adhering to the philosophy that innovation stems from clinical practice, BREATH MEDICAL has consistently emphasized the integration of medicine and engineering. In February 2024, the project “Development and Application of Wearable Nasal Airflow Meters,” jointly applied for by Professor Su Kaiming from the Department of Otolaryngology at Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Professor Yang Zhuoqing from the School of Electronic Information and Electrical Engineering at Shanghai Jiao Tong University, and Hefei Qihao Medical Technology Co., Ltd., was awarded the “Star of SJTU” Program Interdisciplinary Research Fund in Medicine and Engineering by Shanghai Jiao Tong University.
“Empowering Every Breath” is the driving force behind BREATH MEDICAL’s development. In the future, BREATH MEDICAL will continue to leverage the “Zhongke BREATH Biomedical Materials Technology Joint Laboratory,” co-established with the Lanzhou Institute of Chemical Physics, Chinese Academy of Sciences, and collaborate with ENT experts and professors from renowned domestic hospitals to drive innovation. The company strives to develop multiple novel Class III medical devices exclusively available in China for otolaryngology applications, serving healthcare professionals and benefiting patients, while maintaining its leadership in China’s ENT sector.
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