Qihao Medical Launches HaoChang® Fully Bioresorbable Drug-Eluting Sinus Stent System: A Breakthrough in Chronic Rhinosinusitis Post-Surgical Care

ForChronic Rhinosinusitistreatment, including common pharmacological and surgical interventions, after pharmacological treatment fails,Functional Endoscopic Sinus Surgery (FESS) is the preferred surgical treatment.. However, postoperative patients still require adjunctive pharmacotherapy to aid recovery. The efficacy of commonly used postoperative intranasal corticosteroids remains uncertain. When combined with postoperative irrigation, medication adherence becomes even more difficult to manage, making it challenging to prevent the occurrence of numerous complications and leading to a high risk of recurrence.

The incidence of early complications following FESS is approximately 4%, while the rate of severe surgical complications ranges from 0.31% to 1.91%. Common surgical complications includeSurgical cavity adhesions, sinus ostium stenosis/occlusion, polyp recurrenceetc. Approximately one-fifth of patients undergo a second surgery each year.

The independently developed products of Hefei Qihao Medical Technology Co., Ltd. (hereinafter referred to as “BREATH MEDICAL”)Haochang^®Fully Bioresorbable Sinus Drug-Eluting StentCapable of, after patients undergo FESS surgery,Precisely deliver the drug to the target site, sustain its release over a defined period, reduce postoperative complications, and enhance and prolong therapeutic efficacy.The product received market approval from the National Medical Products Administration (NMPA) for medical devices on October 17, 2024 (Registration No.: Guo Xie Zhu Zhun 20243132055).

On Thursday, October 31, at 19:30, the 107th session of VCBeat New Product Review will feature Lai Yinyan, Deputy Director of the Rhinology Division and Associate Chief Physician in the Department of Otolaryngology at The First Affiliated Hospital of Sun Yat-sen University; Cai Li, Chief Physician in the Second Department of Otolaryngology at The Second Hospital of Hebei Medical University; and Chen Yuan, Senior Product Manager at BREATH MEDICAL, to present BREATH MEDICAL’s latest product.“Haochang^®"Fully Bioresorbable Sinus Drug-Eluting Stent System,"“Haoshu^®“Biodegradable Expandable Hemostatic Sponge”, “Meihe Staple”^®"Fully Degradable Septal Cartilage Fixation System"Product Introduction and Innovation Sharing.

Haochang^®Fully Bioresorbable Sinus Drug-Eluting Stent System

I.Fully Bioresorbable Sinus Drug-Eluting Stent SystemComposed of a fully bioresorbable sinus stent (poly(lactic-co-glycolic acid)), a drug coating (mometasone furoate), a delivery system, and a crimping assembly.

II. Utilizing a newly formulated platform material, whose degradation and support properties meet clinical requirements, providing>28 dayseffective support.

III. The optimal combination of carrier selection and carrier ratio jointly controls the drug release profile and release rate from the stent, ensuringSustained drug release over 28 days, maintaining sustained pharmacological effects.

IV. The platform material and carrier are perfectly integrated, enabling optimal coordination between drug release, mechanical support performance, and degradation profile. While the stent maintains effective structural support for 28 days during degradation, the drug isEffective and sufficient release, with high drug utilization rate; moreConvenient and Safe Stent Delivery Device。

V.Additional Notes:

① Drug Loading: 650 μg mometasone furoate, a potent corticosteroid that reduces inflammation, fibrin deposition, and granulation tissue formation, with a drug release duration of approximately 30 days.

② Design Breakthrough: The crimping box for drug-eluting stents has been optimized to avoid direct manual contact during compression while preventing the stent from being ejected.

③ Degradation Cycle: Clinical observations indicate that degradation begins after 4 weeks, with individual variations in the degradation timeline.

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Lai Yinyan

Deputy Director of the Rhinology Division, Department of Otolaryngology, The First Affiliated Hospital of Sun Yat-sen University & Associate Chief Physician

M.D., Deputy Director of the Department of Rhinology, Associate Chief Physician, Master's Supervisor

Vice Chairman and Secretary-General, Allergic Diseases Branch, Guangdong Provincial Association for Precision Medicine Application

Committee Member, Allergy Branch of the Guangdong Medical Doctor Association

Member, Guangdong Medical Doctor Association

Committee Member, Guangdong Medical Association

Standing Committee Member, Professional Committee of Otorhinolaryngology-Head and Neck Surgery, Guangdong Health Management Association

Standing Committee Member, The 3rd Medication Special Committee of Otorhinolaryngology-Head and Neck Surgery, Guangdong Province

Corresponding Editorial Board Member, 2nd Editorial Board of World Journal of Otorhinolaryngology-Head and Neck Surgery (English Edition), Chinese Medical Association

Cai Li

Chief Physician, Department of Otorhinolaryngology II, The Second Hospital of Hebei Medical University

Director of Departmental Education, Master of Medicine from Hebei Medical University, Master’s Supervisor

Long-term focus on surgeries in the fields of rhinology, naso-ocular disorders, and skull base pathology within otolaryngology. Possesses extensive experience in the diagnosis and treatment of ENT diseases, with specialized training in endoscopic sinus surgery from Beijing Tongren Hospital and Fudan University Eye & ENT Hospital in Shanghai.

Specializes in functional endoscopic sinus surgery (FESS) for pansinusitis, septoplasty, transnasal resection of benign and malignant tumors of the nasal cavity and paranasal sinuses, resection of maxillary sinus lesions via the canine fossa and prelacrimal recess approaches, highly selective posterior nasal neurectomy, and surgeries involving the anterior skull base and naso-ocular region. Proficient in the diagnosis and treatment of chronic rhinosinusitis, allergic rhinitis, fungal rhinosinusitis, and other common and frequently occurring otorhinolaryngological conditions. Has undertaken multiple research projects funded by the Hebei Provincial Health Department, received two Second-Class Awards for Medical Science and Technology from the Hebei Provincial Health Department, authored two books, and published more than ten papers in core journals.

Member of the Chinese Medical Association; Member of the Expert Group for Disability Assessment of Veterans in Shijiazhuang City; Committee Member of the Rhinosinusitis Expert Committee under the Professional Committee of Otorhinolaryngology, China Association of Integrative Medicine; Committee Member of the Voice Expert Committee under the Professional Committee of Otorhinolaryngology, China Association of Integrative Medicine; Standing Committee Member of the Otorhinolaryngology and Head and Neck Surgery Professional Committee of the Hebei Health Education and Rehabilitation Society; Committee Member of the Hebei Professional Committee of Integrative Medicine in Otorhinolaryngology; Member of the Hebei Provincial Emergency Medical Response Expert Pool for Public Emergencies; Selected in 2023 as a Candidate for the Senior Title Evaluation Panel of the Hebei Health Series.

Chen Yuan

Senior Product Manager at BREATH MEDICAL

Master of Clinical Medicine, specializing in Otorhinolaryngology-Head and Neck Surgery

Headquartered at the BREATH MEDICAL Industrial Park in the Hefei High-Tech Zone, BREATH MEDICAL is a high-tech innovative enterprise integrating research and development (R&D), production, and sales. The company has jointly established the CAS-BREATH Biomedical Materials Technology Joint Laboratory with the Lanzhou Institute of Chemical Physics, Chinese Academy of Sciences, possessing advanced R&D and manufacturing capabilities.

BREATH MEDICAL specializes in the field of high-end minimally invasive implants for otorhinolaryngology-head and neck surgery (ENT). Upholding the philosophy of "innovation, efficiency, professionalism, and integrity," the company regards diversified innovation as the primary driving force for its development, providing clinicians with a comprehensive portfolio of products and surgical solutions.

Currently holding multiple patents for independently developed domestic technologies, the innovative product “Biodegradable Expandable Hemostatic Sponge” has broken through import technology barriers and filled the gap in domestic technological capabilities; the “Fully Biodegradable Sinus Drug-Eluting Stent” has been launched on the market, achieving clinical benefits of convenient drug delivery, precise dosing, and in-situ degradation; and the Meihe Staple, which disrupts traditional suturing methods.^®Approved as a National Innovative Medical Device, marking a historic step forward in novel fixation methods following septoplasty; the “Punctal Plug” product has been included in Anhui Province’s Key Technological Innovation Breakthrough Plan, exploring the nasolacrimal domain and directly addressing the needs of the vast population suffering from dry eye disease.

BREATH MEDICAL will continue to roll out more innovative products in the future, committed to breaking through longstanding technical challenges in China’s healthcare industry and providing optimized new approaches to treatment.

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