Source: Siyu MedTech; Editor: Zhang YuqingReprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.
Recently, NoyaProstate Hyperplasia Composite Steep Pulse Treatment Device "Noya.BPH"Obtained the NMPA Class III medical device certification, this isThe World's FirstProducts Using IRE (Irreversible Electroporation) Technology for the Treatment of Benign Prostatic Hyperplasia.
# Market Overview
Benign Prostatic Hyperplasia (BPH) is a common urinary system disease affecting elderly men worldwide, generally occurring after the age of 40, with its incidence increasing annually as age advances.The incidence rate of BPH in the male population aged 51-60 is about 20%, reaching 50% for those aged 61-70, and up to 83% in the male population 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 indicates around 91 million patients; among men aged 50-60, there are about 70 million, with approximately 14 million BPH patients. In total, there are about 105 million BPH patients in China.With the accelerating aging of China's population, 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 it cannot solve the problem fundamentally.For BPH patients with moderate to severe symptoms of urinary difficulty that have significantly impacted their quality of life, especially in cases where drug treatment is ineffective or refused.Below, surgical treatment can be selected.Transurethral resection of the prostate (TURP) is the most widely used method for treating BPH globally.Technological development is mature, and it is also the "gold standard" for the treatment of benign prostatic hyperplasia in China.But there are very obvious drawbacks, such as: the surgical process involves significant bleeding, larger trauma, hospital stays of 3-7 days, and postoperative complications like urinary incontinence and sexual dysfunction; laser enucleation or vaporization surgeries have a long learning curve, involve substantial bleeding, require hospital stays of 2-5 days, and are difficult to popularize at the grassroots level; urethral stents are expensive and require the implantation of metal stents into the body, which can impact subsequent prostate examinations and surgeries for patients.# Product Advantages
The advantages of IRE technology are significant.It features tissue selectivity and non-thermal ablation, capable of completely ablating the hypertrophic 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.Launched by Noya Medtech"Noya BPH" Device, Application isThe world's first high-frequency composite irreversible electroporation (H-FIRE) technology,By applying high-frequency, bipolar positive and negative composite pulses to the lesion area, thorough ablation of the target prostate tissue is achieved, significantly enhancing local treatment efficacy. This method effectively reduces nerve stimulation and muscle contractions during treatment, preserving the patient’s sexual and urinary control functions."The '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."The surgical procedure only requires local anesthesia, reducing patient trauma. It is also simple to perform, shortening the doctor's learning curve, and helps improve the treatment rate of benign prostatic hyperplasia at the grassroots level."Noya BPH" has undergone long-term clinical validation to earn its "passport" for clinical application.The multi-center clinical trial of this product conducted across China enrolled 160 subjects. The results showed no significant severe adverse reactions during the surgical treatment process. The increase in urinary flow rate after 3 months exceeded 8.4ml/s, with an improvement of 13.04 points in IPSS scores. The average surgery time was approximately 17 minutes, and the procedure caused minimal trauma, with patients typically being hospitalized for only 1 day. Follow-up results at 12 months indicated that the clinical efficacy remained consistently stable.# Company Profile
Shanghai Noya Medtech Co., Ltd. (formerly known as Shanghai Ruidao Medtech Co., Ltd.), established in 2016 and located in Shanghai, is a company primarily engaged in the promotion and application of technology services.
As early as 2021, the company's global first prostate cancer composite steep pulse treatment device "Noya.PCa" has been approved. This time, it is already Noya Medtech.Second in the IRE FieldThe world's first device to receive certification,Once again verifying its innovative strength.Solid tumors and atrial fibrillation are the two key markets for the application of IRE technology.Accompanying the approval of the "Noya.BPH" device for treating benign prostatic hyperplasia with steep pulse therapy,Noya has become the company with the widest range of indications, 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 "Aily.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 NMPA's special approval channel for innovative medical devices.
As of the date of this report, the company's financing information is as follows:
As of the date of publication, the following partial patent information of the company has been queried:
Editor-in-Chief | Zhao Qing Reviewer | Yi He Typesetting | Miya
