Nosheng Medical Secures Approval for World's First Composite High-Frequency Irreversible Electroporation Device for Benign Prostatic Hyperplasia

Recently,Noya Medtech's "Eryi.BPH" Device for Benign Prostatic Hyperplasia Treatment Receives NMPA Class III Medical Device Approval — The World’s First Product Using IRE (Irreversible Electroporation) Technology for BPH Treatment."Noya BPH" device can thoroughly ablate the hypertrophic region of the prostate while avoiding damage to surrounding blood vessels and nerves, effectively preserving the patient’s urinary control and sexual functions, offering a safer and minimally invasive treatment for patients with benign prostatic hyperplasia.

This is already Noya Medtech's second globally pioneering device in the IRE field to receive certification, once again demonstrating its innovative strength. As early as 2021, the company’s world-first prostate cancer composite steep pulse treatment device, "EriEasy.PCa," was approved. In recent years, China has been strongly encouraging medical device innovation. The "14th Five-Year Plan for Medical Equipment Industry Development" mentions, "Focusing on clinical needs and health protection, strengthening collaboration between medicine and engineering, and promoting technological innovation, product innovation, and service model innovation." Especially under the trend of globalization, going overseas has become an inevitable choice, and innovative companies' "technology going overseas" will also help enhance the nation's international competitiveness.

The development of Noya Medtech is a response to the national innovation-driven development strategy. The company’s multiple pioneering devices are steadily advancing in clinical trials and are actively preparing for overseas submissions. In July, Noya Medtech was successfully selected as a 2023 national-level specialized, refined, distinctive, and innovative "Little Giant" enterprise.

Benign Prostatic Hyperplasia (BPH) is a common urinary system disease affecting elderly men worldwide, generally occurring after the age of 40, with its incidence rate increasing annually as age advances. The "Guidelines for Diagnosis, Treatment, and Health Management of Benign Prostatic Hyperplasia" mentions that the incidence rate of BPH in males aged 51-60 is approximately 20%, reaching 50% for those aged 61-70, and as high as 83% in males aged 81-90.

Noya Medtech introduced that, according to China's population census data, there are approximately 140 million men aged 60 and above. With a conservative estimated average incidence rate of 85%, this translates to 91 million patients; among men aged 50-60, there are about 70 million, with approximately 14 million BPH patients, bringing the total number of BPH patients in China to around 105 million. As China’s population ages rapidly, the number of BPH patients continues to grow.

BPH is a clinically progressive disease. Patients with early-stage BPH can alleviate symptoms such as frequent urination and difficulty in urination through medication, but this does not fundamentally solve the problem. For BPH patients with moderate to severe difficulty in urination who have significantly affected their quality of life, especially in cases where drug treatment is ineffective or refused, surgical treatment can be considered, including traditional surgery, laser therapy, urethral stent implantation, etc. CurrentlyChina performs approximately 800,000 BPH treatment surgeries annually.，With the development of new technologies, trauma is becoming smaller and smaller, and the number of surgeries will continue to grow.

Transurethral Resection of the Prostate (TURP) is the most widely used treatment for BPH globally, with mature technology development, and it is also the "gold standard" for treating benign prostatic hyperplasia in China. However, the surgical process involves significant bleeding, larger trauma, a hospital stay of 3-7 days, and potential postoperative complications such as urinary incontinence and sexual dysfunction. Laser enucleation or vaporization surgeries have a long learning curve, involve substantial bleeding, and require a hospital stay of 2-5 days, making them difficult to popularize at the grassroots level. Urethral stents are expensive and require the implantation of metal stents into the body, which can impact future prostate examinations and surgeries for patients.

While "eradicating the root cause of the disease," preserving the normal functional structure of the human body is the ultimate goal of clinical treatment. In contrast,IRE technology features tissue selectivity and non-thermal ablation, which can thoroughly ablate the hyperplastic prostate tissue while avoiding damage to surrounding tissues and nerves. The procedure involves almost no bleeding, allows for rapid patient recovery, and typically requires only about a 1-day hospital stay.This technology has previously demonstrated excellent clinical outcomes in the treatment of prostate cancer.

Noya Medtech is the first in the world to apply IRE technology for the treatment of benign prostatic hyperplasia. The company's "Elli.BPH" device uses the world's firstHigh-Frequency Composite Irreversible Electroporation (H-FIRE)TechnologyBy applying high-frequency, bipolar positive and negative composite pulses to the lesion area, the target prostate tissue is thoroughly eliminated, significantly enhancing local treatment effects. This method effectively reduces nerve stimulation and muscle contractions during treatment, preserving the patient's sexual and urinary control functions. The procedure requires only local anesthesia, minimizing patient injury, and is simple to perform, shortening the learning curve for doctors and helping to improve the treatment rate of benign prostatic hyperplasia at grassroots medical facilities.

As the world's first device based on IRE technology to treat benign prostatic hyperplasia (BPH), "Noya.BPH" has undergone long-term clinical validation to earn the "pass" for entering clinical practice.The multi-center clinical trial of this product in China involved 160 subjects. The results showed no significant severe adverse reactions during the surgical treatment process. The increase in urine flow rate after 3 months exceeded 8.4ml/s, with an improvement of 13.04 points in IPSS score. The average operation time was approximately 17 minutes, with minimal trauma, and patients were generally hospitalized for only one day. The 12-month follow-up results indicated that the clinical efficacy remained consistently stable.。

After the approval of this product, with Noya's strong mass production capabilities and market promotion channels, it will quickly enter clinical use. Meanwhile, the company is pushing forward with overseas multi-center clinical trials.

Solid tumors and atrial fibrillation are the two key markets for IRE technology applications. With the approval of the "Noya.BPH" composite steep pulse treatment device for benign prostatic hyperplasia,Noya has become the company with the broadest indication expansion, the most certifications obtained, and the fastest certification process in the global irreversible electroporation field., the company has a presence in fields such as prostate cancer, benign prostatic hyperplasia, liver cancer, pancreatic cancer, thyroid cancer, and atrial fibrillation.

Currently, the "Aier.Yi.PCa," a composite steep pulse treatment device for prostate cancer developed by Noya Medtech, has been introduced into nearly a hundred top-tier hospitals in China and has gained widespread recognition from clinical urology experts. Dozens of these hospitals have already entered the equipment procurement process. Meanwhile, the company’s pulsed ablation devices for indications such as liver cancer and atrial fibrillation are advancing through clinical registration. Previously, the PFA system had entered the special approval channel for innovative medical devices under the National Medical Products Administration (NMPA).

Starting from clinical needs, Noya Medtech continuously explores the application of IRE technology in different indications, launching several pioneering pulse ablation devices and constantly updating and iterating products to address unmet clinical pain points. Meanwhile, the company provides more comprehensive clinical solutions based on the needs of various clinical departments. For instance, in the treatment of prostate cancer, the company offers an intelligent solution covering "disease diagnosis – surgical planning – energy ablation," developing products such as a prostate biopsy navigation robot and a cloud data planning platform. This makes the clinical diagnosis and treatment of prostate cancer more precise and efficient while effectively alleviating the uneven distribution of medical resources in China.

Noya emphasized that the starting point for the company's development and product research is always clinical. Supported by China’s large patient population and amid the acceleration of discipline construction, domestic medical device companies are beginning to reclaim their home turf, transitioning from domestic substitution to international innovation. Noya’s leadership in the high-barrier IRE field is closely related to the company’s deep technical expertise, clinical resources, and a development model that integrates engineering with medicine.

Noya Medtech has internally formed"A full-chain industrialization team covering basic research, product development, animal and clinical trials, product registration, and market sales", Noya has a strong technical foundation and industrialization experience in the IRE field. The company also closely collaborates with clinical experts both domestically and internationally, continuously incorporating feedback from clinical practice to develop innovative products through the integration of medical and engineering expertise. In the future, Noya Medical will continue to innovate, expand its product lines, and solidify its leading position in the IRE field.

Reference: "Guidelines for Diagnosis, Treatment, and Health Management of Benign Prostatic Hyperplasia"