Shanghai Nuosheng Medical Files for IPO Following Global First IRE-Based BPH Therapy Breakthrough
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October 20, 2023The world's first irreversible electroporation (IRE) technology device for the treatment of benign prostatic hyperplasia (BPH) —— fromNoya MedtechMoxaNoya.BPHDebuted at the 30th Annual Meeting of the Chinese Urological Association (2023CUA).
Irreversible Electroporation (IRE) Technology is an emerging ablation technology,Achieve the purpose of ablating tissue without relying on thermal conduction effects.Compared with traditional "cold and heat" ablation modes, it can achieve excellent efficacy while protecting the surrounding tissues.
With its unique advantages, this technology has sparked a whirlwind of technological upgrading in the field of cardiac electrophysiology in recent years. In the application for prostate diseases, Noya BPH is at the forefront globally.Noya, the developer of this product, has successively obtained two global first certifications.：
On September 20, 2023, Aileyi.BPH was approved by the National Medical Products Administration for the treatment of benign prostatic hyperplasia.It is the world's first product to apply IRE technology in this field.
In April 2021, the composite steep pulse treatment device REMD-G1 was approved by the National Medical Products Administration for the treatment of prostate cancer.The world's first composite steep pulse device with an indication for prostate cancer.
So, what changes can this breakthrough product bring to patients? Please see our detailed introduction.
Benign Prostatic Hyperplasia (BPH) is a common chronic condition in middle-aged and elderly men, primarily characterized by urinary dysfunction, and is one of the most frequently encountered diseases in urology and andrology clinical practice. It not only causes symptoms such as frequent urination, urgency, nocturia, difficulty in urination, and urinary retention, but can also lead to secondary complications like bladder stones, recurrent urinary tract infections, and even upper urinary tract dilation and renal function impairment, significantly affecting the patient’s quality of life and potentially threatening their life. However, current common surgical methods in clinical practice pose numerous postoperative risks.
For the treatment of benign prostatic hyperplasia, the standard surgical procedure is transurethral resection of the prostate, or TURP.Bleeding has always been the most common and major complication of TURP, and postoperative complications such as urinary incontinence and sexual dysfunction are also likely to occur.Other treatment methods such as transurethral holmium laser, plasma enucleation, and urethral stent implantation also exist.Retrograde Ejaculation, Transient Urinary IncontinenceEqual risk.
With the progress of concepts, patients are paying more attention to the quality of life after surgery while pursuing treatment efficacy. Whether advanced treatment concepts such as precision, minimally invasive, and high efficiency can be implemented has become a new standard for evaluating the advancement of medical technology.
In response to the aforementioned clinical pain points,Aile.BPH adopts Noya's globally pioneering High-Frequency Irreversible Electroporation (H-FIRE) technology., namely, the Composite Steep Pulse Technology. This technology applies high-frequency, bipolar positive and negative composite pulses to the lesion area, causing permanent perforation of the cell membranes in the target prostate tissue, disrupting the homeostasis of the intracellular environment, and achieving the purpose of cell apoptosis.
H-FIRE TechnologyIt can significantly enhance the ablation effect within the ablation area. Meanwhile, this surgical method also effectively reduces the stimulation of blood vessels and nerves during the operation, avoiding problems such as severe muscle tremors. Specifically,This technology has the following four major advantages:
Complete Ablation
The boundary of the ablation zone is clear, with a cell apoptosis rate within the area approaching 10.0%, maximum urine flow rate improved by 8.41ml/s, IPSS score improved by 13.04 points
Preservation of Urinary Control Function
Unique tissue selectivity effectively avoids urethral and urinary control nerve injury, protecting urinary control function.
Retention of Sexual Function
No obvious damage to surrounding functional neural structures, more precise preservation of sexual function.
Easy-to-operate Super-minimally Invasive Treatment
Personalized Electrode Needle Settings,The damage to normal tissue is only a few 1mm-aperture injuries., with a hospital stay of only one day; simple operation, short surgery time, minimal bleeding and complicationsFew complications. Doctors with puncture experience can generally master the procedure after performing 2-3 surgeries, which is beneficial for improving the treatment rate of benign prostatic hyperplasia at the grassroots level.
The aforementioned advantages of Aile.BPH have also been fully validated. As of February 28, 2022, Noya's "Clinical Study on the Use of Composite Steep Pulse Treatment Device for Ablation Therapy in Benign Prostatic Hyperplasia" completed the enrollment of all 160 subjects.
Clinical results show:Incidence of Severe Adverse Reactions During Surgical Treatment: 1.33%, The increase in uroflow rate at 3 months was 8.4ml/s, with an average operation time of about 17 minutes. The trauma is minimal, and patients can generally get out of bed on the same day. Preoperative and postoperative MRI indicated significant ablation effects, with no damage outside the ablation area.Retained sexual function and urinary control function.
Noya, which developed the Ery.BPH, was originally named Ruidao Medical and completed its name change this February. The company was founded in September 2016.Is a medical technology company focused on "irreversible electroporation technology."The goal is to advance irreversible electroporation technology into indications that demand high levels of vascular and neural function preservation, while forming comprehensive solutions for well-established indications.
The company is currently focusing on the urology field, and in addition to prostate cancer and BPH, it is also conducting clinical research on new indications such as bladder cancer, while expanding into areas like liver cancer and atrial fibrillation.Irreversible electroporation technology treatment devices for liver cancer are currently being closely enrolled in multiple centers; products for atrial fibrillation electrophysiological pulse ablation received approval from the National Medical Products Administration in July 2022 and have entered the special review process for innovative medical devices.
The IRE technology developed by the company, which integrates advantages such as functional protection, safety, and therapeutic efficacy, represents an innovative treatment approach of the new generation of surgical techniques, with broad application prospects in China and even globally.
On the one hand, IRE technology is more in line with the common needs of doctors and patients today.For elderly patients in poor health with multiple comorbidities, the rapid, precise, and minimally invasive IRE technology is more tolerable and results in better postoperative recovery.For doctors, IRE is easier to operate, reducing reliance on the doctor's experience and skill level, which will help alleviate the strained medical resources in China and improve the standardization of medical services.
Meanwhile, the number of patients with benign prostatic hyperplasia is rapidly increasing. According to a study published in The Lancet Healthy Longevity at the end of 2022,From 2000 to 2019, the number of people with benign prostatic hyperplasia (BPH) globally increased by 70.5%, while the increase in China was as high as 99%.This trend will further intensify as China's population aging accelerates.
Facing the increasing demand for treatment,IRE technology is expected to usher in a golden age of development. AndNoya Medtech asThe leading company in IRE applications will not only drive industry transformation but also benefit more patients with top-tier domestically produced technology. Then, the futureIREWhat other breakthroughs will there be in the technology field? Instrument Family will continue to follow up.
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