AllEase.BPH: World's First IRE-Based Device for Benign Prostatic Hyperplasia Treatment Unveiled at CUA 2023

On October 20, 2023, Shanghai Nuosheng Medical Technology Co., Ltd. (hereinafter referred to as “Nuosheng Medical”) unveiled Airyi, the world’s first device utilizing independently developed irreversible electroporation (IRE) technology for the treatment of benign prostatic hyperplasia (BPH)..BPH, Debuted at the 30th National Urology Academic Conference (2023 CUA).

“Airui.BPH” Treatment Device Global Launch Event Guest Group Photo

Last September, "Aier Yi.BPH" successfully obtained the world's first Class III medical device certificate for irreversible electroporation technology indicated for the treatment of benign prostatic hyperplasia.

“Airui.BPH” utilizes the world’s first irreversible electroporation technology (H-FIRE), also known as composite steep pulse technology.This technology applies high-frequency, bipolar composite pulses to the lesion site, causing permanent perforation of the cell membranes in the target prostate tissue, disrupting intracellular homeostasis, and thereby inducing apoptosis.

Currently, conventional treatments for benign prostatic hyperplasia (BPH) primarily include transurethral resection of the prostate (TURP) and laser enucleation of the prostate. Compared with these traditional surgical procedures, pulsed electric field ablation using composite steep pulse technology offers the following advantages: minimal invasiveness, shorter hospital stays, reduced operative time, a shorter learning curve, and preservation of sexual function and urinary continence.

This new product launch was co-chaired by the Co-Chairs of the CUA 2023 ConferenceAcademician of the Chinese Academy of Sciences, Chinese PLA General HospitalAcademician Zhang Xu delivered the opening remarks.

Academician Zhang Xu has recognized Nuosheng Medical’s R&D and innovation in the field of irreversible electroporation technology, while also affirming the innovativeness of “Aier Yi.BPH” and its advantages in terms of minimal invasiveness and functional preservation. Meanwhile, Academician Zhang Xu expressed his hope that this innovative product, “Aier Yi.BPH,” will see broader clinical application and enter the international market as a homegrown innovation.

Academician of the Chinese Academy of Sciences, Chinese PLA General Hospital

Academician Zhang Xu

Professor Xue Wei, Standing Committee Member of the CUA, Vice President of Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Director of the Department of UrologyIn his address, he also stated that Nuosheng Medical is the first company globally to apply irreversible electroporation technology for prostate tissue ablation. The approval of “Aireyi.BPH” for the indication of benign prostatic hyperplasia (BPH) marks a milestone whereby patients in China with BPH can restore unobstructed urination through a minimally invasive procedure while preserving 100% of their original sexual function. Furthermore, the device features simple operation and short treatment duration, effectively reducing physicians’ workload and improving their surgical experience. With the extensive application of “Aireyi.BPH” in the fields of prostate cancer and benign prostatic hyperplasia, it will also further promote the academic development and clinical application of irreversible electroporation technology.

Standing Committee Member of the CUA, Vice President of Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Director of the Department of Urology

Professor Wei Xue

The press conference also invitedProfessor Huang Jian, Chairman of the CUA; Professors Qi Lin and Zheng Junhua, Vice-Chairmen of the CUA; and Standing Committee Members Professor Wang Shaogang and Professor Tianxin LinPresent.

To enable more urologists to gain a deeper understanding of the ablation advantages of irreversible electroporation technology, Nuosheng Medical also held two separate sessions targeting two major prostatic diseases: prostate cancer and benign prostatic hyperplasia.Frontier Academic Salon on Irreversible Electroporation Technology。

At the conference, distinguished guests shared insights and engaged in discussions on the latest academic advancements in irreversible electroporation technology for the treatment ofProstate Cancer andAn extensive and in-depth discussion was held on the clinical applications, advantages, and challenges of benign prostatic hyperplasia.

First, the inaugural salon on irreversible electroporation ablation for prostate cancer invitedProfessor Dong Bojun of Renji Hospital, Shanghai Jiao Tong University School of Medicine; Professor Wang Haifeng of Shanghai East Hospital; and Dr. Luo Zhongbao, CTO of Nuosheng MedicalServed as a keynote speaker. Among them, Professor Dong Bojun delivered a presentation titled “Patient and Energy Selection for Precision Focal Therapy of Prostate Cancer.”

Professor Dong Bojun stated:Irreversible Electroporation for Focal Therapy of Prostate Cancer: Advantages and Clinical ApplicationIrreversible electroporation (IRE) technology, when applied to focal therapy for prostate cancer, offers significant advantages including minimal invasiveness, rapid recovery, fewer complications, and proven efficacy. It has become an effective treatment modality for preserving prostate function in patients with localized prostate cancer. Since the official introduction of Nuosheng’s irreversible electroporation device at Shanghai Renji Hospital in September 2022, more than 100 high-frequency irreversible electroporation ablation procedures have been successfully performed. The hospital has subsequently established IRE as a standard treatment option for focal therapy of prostate cancer.

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Professor Dong Baijun

After the sharing session,Professor Dong Bojun, Professor Wang Haifeng from Shanghai East Hospital, Professor Liu Ming from Beijing Hospital, Professor Niu Shaoxi from the Chinese People's Liberation Army General Hospital, Professor Dong Biao from the First Affiliated Hospital of Zhengzhou University, and Professor Wang Miao from Beijing HospitalTogether, we will engage in an academic discussion on the use of irreversible electroporation technology for the treatment of prostate cancer.

Academic Discussion Forum

(From left to right: Professor Wang Haifeng, Professor Dong Bojun, Professor Niu Shaoxi, Professor Wang Miao, Professor Dong Biao, Dr. Luo Zhongbao)

Next, the Second Irreversible Electroporation Technology for the Treatment of Benign Prostatic Hyperplasia Salon InvitedProfessor Tong Zhen, Shanghai Renji Hospital; Professor Wang Haifeng, Shanghai East Hospital; and Professor Yang Jun, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and TechnologyServed as a keynote speaker. Among them, Professor Yang Jun delivered a presentation titled “Precision Focal Therapy for Prostate Cancer: Tongji Practice.”

Professor Yang Jun stated:Irreversible electroporation technology offers significant therapeutic advantages, aligning with the current orientation and objectives of high-quality hospital development under medical insurance schemes. It not only effectively achieves a balance between functional preservation and tumor control but also shortens hospital stays, reduces patient suffering, lowers medical insurance costs, and effectively preserves functions such as urinary continence.

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Prof. Jun Yang

Following the presentation, multiple experts engaged in an academic discussion. The experts stated that the successful approval of “Alayi.BPH” for the indication of benign prostatic hyperplasia (BPH) further confirms the clinical advantages and development potential of irreversible electroporation technology in the treatment of prostate diseases.

Specifically, the advantages of “Airuiyi.BPH” in treating benign prostatic hyperplasia (BPH) include the following three aspects: First, it has no significant impact on sexual function or urinary continence. Second, it is highly efficient and safe, with an improvement in maximum urinary flow rate of 8.41 ml/s and a reduction in IPSS score of 13.04 points; it causes less trauma and requires only a one-day hospital stay. Third, the surgical procedure is simple, taking only approximately 15 minutes.

This salon provided attendees with a clearer perspective and deeper understanding of the latest advancements and technical advantages of irreversible electroporation (IRE) in the treatment of benign prostatic hyperplasia (BPH), thereby laying the foundation for future academic research and clinical application of this innovative ablation technique.

Benign prostatic hyperplasia (BPH) is a common urological condition affecting older men worldwide, with its prevalence increasing with age. According to a study published in The Lancet Healthy Longevity at the end of 2022, the global number of BPH cases rose by 70.5% between 2000 and 2019, while the increase in China reached as high as 99%. Furthermore, as China’s population ages at an accelerated pace, the number of patients with benign prostatic hyperplasia continues to grow rapidly and steadily.

Behind the doubling number of patients with benign prostatic hyperplasia lies an urgent clinical need that demands better solutions and fulfillment.In response, Nuosheng Medical’s proprietary irreversible electroporation technology can significantly enhance the ablation efficacy within the target zone, achieving a cell apoptosis rate of nearly 100%. Meanwhile, this procedure effectively minimizes intraoperative stimulation of blood vessels and nerves, thereby avoiding severe muscle tremors and other related complications.

For clinical applications, the use of personalized electrode needles results in only a few 1-mm puncture wounds, thereby effectively minimizing bleeding and other complications. Furthermore, this procedure has a short learning curve; physicians with prior experience in puncture techniques can typically master it after performing just 2–3 cases. This facilitates an increase in the treatment rate of benign prostatic hyperplasia (BPH) at primary care levels, truly benefiting the rapidly growing population of BPH patients in China and worldwide.

According to reports, Nuosheng Medical has assembled a team that covers the entire industrialization chain, spanning “basic research – product development – animal and clinical trials – product registration – marketing and sales,” and has leveraged this team to achieve multiple “global firsts.”

As early as 2021, Nuosheng Medical successfully obtained the Class III medical device certification for “Aieryi.PCa,” an irreversible electroporation-based therapeutic device. This marks the world’s first regulatory approval for a device utilizing irreversible electroporation technology to treat prostate cancer, with related clinical study results published in JAMA Surgery.

It is reported that through close collaboration with clinical experts both in China and abroad, “Airui.PCa” has been adopted by more than 40 Grade-A tertiary hospitals across China. To date, nearly 500 ablation procedures have been performed, and reimbursement approval for the procedure has been successfully obtained, marking a transition from clinical application to market commercialization. While gaining widespread recognition from urology specialists, Nuosheng Medical continues to incorporate direct feedback from frontline clinical practice to advance collaborative R&D innovation between clinicians and engineers.

Furthermore, leveraging its profound technical foundation and industrialization experience in the field of irreversible electroporation technology,Nuosheng Medical has also deployed pulsed field ablation products for indications such as liver cancer and atrial fibrillation, with all related products successfully entering the clinical trial phase.

Specifically, the irreversible electroporation (IRE) treatment device for liver cancer is currently undergoing intensive patient enrollment across multiple centers, with an expected cohort of 180 subjects. The product for pulsed field ablation in atrial fibrillation electrophysiology was approved by the National Medical Products Administration (NMPA) in July 2022 and entered the Special Review Procedure for Innovative Medical Devices.

As an innovative enterprise, Nuosheng Medical has been deeply engaged in the field of irreversible electroporation technology for many years.Since its establishment in 2016, Nuosheng Medical has filed over 100 patents of various types, including 79 invention patents, with 32 invention patents granted. A total of two products have entered the National Special Review Channel for Innovative Medical Devices, and the company has participated in eight national-level and Shanghai municipal special research projects.

In addition to its abundant innovative achievements, Nuosheng Medical has also attracted frequent capital interest, successfully completing Series A and Series A+ financing rounds exceeding RMB 100 million each in 2021 and 2023, respectively. The company was listed among the “Top 50 Most Investable Startups in Shanghai 2022” and received the First Prize for Scientific and Technological Progress in the 2022 Ministry of Education Higher Education Institution Scientific Research Outstanding Achievements Awards (Science and Technology).

In July 2023, Nuosheng Medical was successfully selected as a national-level “Little Giant” enterprise specializing in refinement, specialization, novelty, and innovation, following rigorous screening by the Ministry of Industry and Information Technology. Additionally, Nuosheng Medical is recognized as a High-Tech Enterprise in Shanghai and has been designated as a Shanghai municipal-level “Specialized, Refined, Differential, and Innovative” enterprise by the Shanghai Municipal Commission of Economy and Informatization.These achievements fully demonstrate the company’s innovative strength and substantial investment potential.

With the advancement of pulsed electric field technology, global interest in pulsed electric field ablation medical devices has been steadily rising. From a market perspective, China’s tumor ablation industry is projected to reach RMB 6.15 billion in 2023, not to mention the benign prostatic hyperplasia (BPH) market, which boasts a large patient base and rapid growth.

In response, Sun Zhuo, founder and chairman of Nuosheng Medical, stated:“Domestic innovation has always been an enduring theme in the healthcare industry. Nuosheng Medical chose to launch this world-first product at the Chinese Urological Association (CUA) Annual Conference—the most important annual academic event in the field of urology—to enable more urologists to understand and experience this innovative device, thereby helping more patients with prostate diseases benefit from worry-free, minimally invasive irreversible electroporation therapy. This also demonstrates to the outside world that Chinese-made devices now possess the capability to compete on par with international giants, propelling high-end domestic medical devices to new heights. In the future, Nuosheng Medical will continue to innovate and expand its product portfolio, further consolidating its global leadership in the field of irreversible electroporation technology.”

References:

1. World’s First Combination Irreversible Electroporation Device for Benign Prostatic Hyperplasia Approved, Nuosheng Medical Scores Another Milestone, VCBeat

2. Scaling the Pinnacle of Technology Together, Envisioning the Pulsed Future: Nuosheng Medical’s 2023 CUA Event Concludes Successfully, Shanghai Nuosheng Medical

3. Pulsed Ablation Technology, a Hot Topic in Electrophysiology: Can It Revolutionize Cancer Treatment Again? VCBeat

4. We have identified five key sectors in original innovative medical devices, a top priority for investors — VCBeat