Nanjing IENT Completes Clinical Enrollment for Lesorb Fully Bioresorbable Drug-Eluting Sinus Stent, Targeting a Multi-Billion-Yuan ENT Market

VCBeat has learned at the earliest opportunity that a domestic medical device company specializing in the field of otolaryngology—Nanjing IENT Medical Device Co., Ltd. (hereinafter referred to as “Nanjing IENT”) has completed full enrollment for the multicenter randomized controlled clinical trial of its independently developed Lesorb fully bioresorbable sinus drug-eluting stent, which is indicated for the treatment of chronic rhinosinusitis.

This registry study is led by the Eye, Ear, Nose and Throat Hospital of Fudan University, with Professor Yu Hongmeng serving as the Principal Investigator (PI), and involves the participation of multiple authoritative clinical trial institutions across China.The completion of clinical enrollment marks another significant step toward the commercial launch of the company’s products.

Lesorb, a fully bioresorbable sinus drug-eluting stent, features a unique large-pore design that effectively reduces crust formation and improves the cure rate for chronic rhinosinusitis, demonstrating significant clinical efficacy.

Nanjing Yient focuses on the research, development, and industrialization of medical devices in the field of otolaryngology. The company is composed of seasoned industry professionals, with its founding and management team having over fifteen years of in-depth experience in the high-end medical device sector.

Li Jianjun, Founder of the CompanyHolding a Ph.D. in Biomechanics and possessing over 15 years of experience in the development and management of Class III interventional medical devices, the individual has served as R&D Director at several renowned companies in China, successfully developing multiple minimally invasive implantable medical devices that have gained market recognition. The company’s core team encompasses functions such as R&D, quality assurance, regulatory affairs, and marketing, with each member boasting more than ten years of extensive experience in the Class III implantable medical device industry, thereby laying a solid foundation for the rapid commercialization of the company’s products.

Currently, Nanjing Eaint has established two major technical platforms.: Degradable device technology platform and catheter technology platform, leveraging which multiple domestically pioneering implantable degradable drug-eluting devices have been developed, resulting in a rich and comprehensive product pipeline. In addition to the sinus drug-eluting stent that has just completed clinical enrollment, the portfolio includes products for obstructive sleep apnea and chronic sinusitis indicated for moderate chronic sinusitis and post-operative recurrence after endoscopic sinus surgery.

Regarding the layout of product research and development, Li Jianjun, founder of Nanjing E-Nt, stated,“While the end users of medical devices are patients, the direct customers are physicians, who alone possess a true understanding of clinical needs. In fact, the company’s product philosophy is derived entirely from physicians’ requirements. During the early stages of product development, we actively engage in communication with clinical experts and invite physicians to participate in the R&D process, with the aim of genuinely addressing clinical challenges.”

“Driven by clinical needs, Nanjing Yient’s product portfolio is primarily focused on providing solutions for ear, nose, and throat (ENT) conditions such as chronic rhinosinusitis and obstructive sleep apnea. In the short term, the company will center on passive bioresorbable implants to deliver novel solutions for hundreds of millions of ENT patients. Over the medium to long term, it will continue to develop active medical devices, creating synergies between equipment and consumables to offer comprehensive ENT solutions.”Li Jianjun added.

As the number of patients continues to rise, the market size for otolaryngology-related medical devices has also seen a steady increase in its compound annual growth rate (CAGR), with relevant medical devices achieving a CAGR as high as 20%, making it one of the fastest-growing segments within the broader medical device industry. However, despite the continuous growth in demand, there are relatively few domestic manufacturers and developers of related implantable consumables, with a market penetration rate of only about 5% in China, compared to around 20% in the United States, indicating significant potential for market expansion.

In recent years, the number of patients with various otorhinolaryngological diseases in China has increased rapidly, with over 120 million people suffering from chronic rhinosinusitis. It is understood that endoscopic sinus surgery is currently the primary treatment for severe chronic rhinosinusitis. However, due to issues such as postoperative management and patient compliance, complications like postoperative adhesions and heightened inflammation are highly likely to occur, severely affecting surgical outcomes and leading to a postoperative recurrence rate of over 55%.

Nanjing Yient has recognized the urgent clinical demand for related technologies and decided to invest in the research and development of biodegradable drug-eluting stents, aiming to address pain points such as the high postoperative recurrence rate in the treatment of chronic rhinosinusitis.

The Company's Fully Bioresorbable Sinus Drug-Eluting StentIt provides effective support to the surgical cavity for 7–14 days, preventing postoperative adhesions; meanwhile, it enables continuous targeted drug delivery for 30 days, inhibiting the proliferation of inflammatory cells and promoting the recovery of normal nasal mucosa. The application of sinus drug-eluting stents effectively addresses complications associated with traditional endoscopic sinus surgery, significantly reducing postoperative recurrence rates and improving patients’ quality of life, while also mitigating the additional financial burden and physical and psychological trauma caused by disease recurrence and subsequent reoperations.

Currently, approximately 500,000 endoscopic sinus surgeries are performed annually in China, with an average of two stents potentially required per patient, indicating substantial market potential. Obstructive sleep apnea (OSA) is another common otolaryngological condition, with snoring being its primary symptom. According to the 2019 report “Obstructive Sleep Apnea and the Global Economic Burden” published in The Lancet Respiratory Medicine, the global prevalence of OSA has risen from 2%–4% a decade ago to over 24%. China has the highest number of OSA patients worldwide, reaching as high as 176 million.

Relevant studies indicate that obstructive sleep apnea (OSA)It can cause intermittent hypoxia, hypercapnia, and sleep architecture disruption, leading to multi-organ and multi-system damage, including hypertension, coronary heart disease, arrhythmias, cerebrovascular disease, and cognitive impairment. Studies have shown that the prevalence of hypertension among patients with obstructive sleep apnea (OSA) in China is 49.3%, while OSA accounts for 83% of patients with resistant hypertension; treating OSA has a definite effect on lowering blood pressure in this population. Furthermore, the risk of stroke in individuals with OSA is 4.33 times that of the control group, and the mortality rate is 1.98 times higher. OSA causes damage to multiple body systems and is truly a systemic disease.

Currently, the primary solutions for obstructive sleep apnea (OSA) include continuous positive airway pressure (CPAP) therapy and uvulopalatopharyngoplasty (UPPP). The use of CPAP is significantly limited by drawbacks such as poor comfort, dryness of the mouth and nose, high equipment costs, and inconvenience in portability. Meanwhile, UPPP has an efficacy rate of only 40–50%, involves irreversible major trauma, and may potentially exacerbate OSA.

“In the past, surgical interventions were reserved primarily for life-threatening conditions such as cardiovascular and cerebrovascular diseases. However, with rising living standards, heightened health awareness, and a deeper understanding of sleep disorder treatments, there is growing emphasis on health management and quality of life. Consequently, treatment for chronic rhinosinusitis and obstructive sleep apnea (OSA) has gradually become a critical necessity. While the diagnosis and treatment rate for OSA in the United States exceeds 20%, it remains below 1% in China. Currently, there are no effective implantable devices available in the Chinese market for OSA treatment, indicating substantial market potential.”Yuan Yubing, head of marketing at Nanjing Eant, told VCBeat.

For obstructive sleep apnea, the biodegradable anti-snoring stent developed by Nanjing Innter can fundamentally resolve snoring. Patients do not require hospitalization; the treatment can be completed in an outpatient setting in approximately 10 minutes. As the device is biodegradable within the body, it eliminates the need for secondary removal procedures and associated trauma. This novel outpatient solution fills a gap in China’s healthcare landscape, reducing medical costs and benefiting patients while effectively conserving medical resources, thereby enhancing both social and economic benefits.

Li Jianjun believes that,Nanjing Yient’s biodegradable anti-snoring stent holds immense market potential. Its innovative outpatient implantation approach significantly reduces healthcare costs for patients and shortens the learning curve for physicians, thereby facilitating clinical adoption and promotion. Moreover, outpatient procedures represent a key future direction in otolaryngology surgery, making a market surge highly likely. To capitalize on this opportunity, Nanjing Yient’s other pipeline products designed for outpatient implantation will substantially expand clinicians’ therapeutic options. Meanwhile, guided by the team’s extensive industry experience and technical expertise, the company will drive continuous product iteration and implement innovations tailored to clinical needs.

In August 2021, Medtronic acquired all outstanding shares of Intersect ENT, a global medical device company specializing in ear, nose, and throat (ENT) care, at a premium price of $28.25 per share, for a total transaction value of approximately $1.1 billion. Medical device giants are naturally adept at sensing market trends; not only Medtronic, but also other international industry leaders such as Stryker and Johnson & Johnson have detected significant business opportunities lurking within the ENT medical device sector and have frequently moved to acquire companies in this space.

Currently, domestic ENT instruments are mainly concentrated in the mid-to-low-end products, with a relatively low level of specialization and no industry leader has emerged. Nanjing Yinte is based on independent research and development, targeting the development of high-end instruments in the field of ENT, providing related products and services through continuous innovation.

Currently, the company is about to launch a new round of financing, with Xuyi Capital serving as the financial advisor for this round.

Nanjing Yient Medical Device Co., Ltd. is headquartered in the Nanjing Jiangbei New Area, a national-level new area. Lechang Medical Device (Shanghai) Co., Ltd. serves as the Shanghai-based R&D center of Nanjing Yient Medical. The company specializes in the research, development, and industrialization of high-end ENT medical devices. Adhering to the philosophy of “derived from clinical practice, returned to clinical practice,” and leveraging its proprietary core technologies, the company provides comprehensive treatment solutions for hundreds of millions of patients with ENT disorders.