REMD Medical Files for IPO: Pioneering Irreversible Electroporation with Proprietary H-FIRE Technology

Irreversible Electroporation (IRE) Technology Is Emerging as a “Magic Bullet” in the Treatment of Solid Tumors and Cardiac Electrophysiology

Compared with traditional thermal ablation, pulsed electric field ablation based on irreversible electroporation technology features tissue selectivity and non-thermal ablation. It can efficiently ablate target tissues locally without damaging surrounding tissues and nerves, making it a unique solution in the field of clinical surgical treatment.

Taking prostate cancer as an example, with advancements in medical care, an increasing number of patients with low- to intermediate-risk prostate cancer are being diagnosed. Among these patients, 30% experience lifelong urinary incontinence and 80% suffer loss of sexual function following radical prostatectomy. In contrast, irreversible electroporation (IRE) technology enables precise tumor ablation through local ablative therapy, better preserving urinary continence and sexual function, thereby extending patients’ lives with improved quality.

Building on the tangible resolution of clinical pain points, market interest in irreversible electroporation (IRE) has surged. Industry giants such as Boston Scientific, Johnson & Johnson, and Medtronic have established their presence, while innovative enterprises continue to enter the field. The capital market also favors the development trajectory of IRE technology, with multiple financing rounds exceeding RMB 100 million occurring in this sector in recent years.

While delivering focal therapy, preserving surrounding blood vessels and nerves has always been the ultimate goal pursued in minimally invasive surgical procedures. In the past, this could only be achieved through the exceptional skills of surgical experts. Today, irreversible electroporation (IRE) technology offers a novel approach to focal treatment. Due to its advantages in efficiently and safely ablating localized tumors without damaging surrounding vascular and neural structures, IRE technology is increasingly being adopted in clinical practice.

In clinical practice, irreversible electroporation technology mainly has two major application markets——Solid TumorsandCardiac ElectrophysiologyIn the field of solid tumor therapy, advancements in the treatment of liver cancer and prostate cancer are particularly prominent. Liver cancer ranks as the fifth most common and the second deadliest cancer in China, while prostate cancer is the second most prevalent and the fifth leading cause of cancer-related death among Chinese men. Atrial fibrillation, on the other hand, is the most common clinical tachyarrhythmia. Current therapeutic solutions for these conditions remain inadequate, indicating substantial growth potential in their respective treatment markets.

Multiple companies are vying to enter the irreversible electroporation (IRE) market, seeking to expand into new areas such as solid tumor treatment and electrophysiological applications. However, IRE technology presents significant technical barriers, and the technology continues to evolve through clinical practice. First-generation IRE technology failed to fully and uniformly cover tumor cells with an effective electric field during tissue ablation, resulting in some patients requiring secondary or multiple treatments. Furthermore, pulse delivery induced muscle contractions that caused electrode displacement, thereby adversely affecting ablation outcomes.

Ruidao Medical pioneered the High-Frequency Irreversible Electroporation (H-FIRE) technology globally. By delivering high-frequency, bipolar composite pulses to solid tumor sites, this technique achieves complete ablation of target tissues, significantly enhancing local ablation efficacy while effectively minimizing intraoperative nerve stimulation and reducing muscle contractions.

As an innovative enterprise, Ruidao Medical has been deeply engaged in the field of irreversible electroporation for many years. To date, the company has filed over 100 patent applications and holds 53 granted patents, including 30 invention patents, 13 utility model patents, and 10 design patents. Internally, the company has assembled a high-performance team comprising experts and talents across various domains, such as R&D, medical affairs, production, sales, clinical operations, regulatory affairs, and quality assurance.

Meanwhile, Ruidao Medical has established close collaborations with multiple Grade A tertiary teaching hospitals, including Changhai Hospital, Renji Hospital, Changzheng Hospital, and Peking Union Medical College Hospital. The company’s product development is driven by clinical needs and implemented in clinical practice, accompanied by extensive clinical research. Notably, a key study on Ruidao’s high-frequency irreversible electroporation therapy for prostate cancer was published this July in JAMA Surgery (IF: 16.681), the premier journal in surgery, providing robust clinical evidence for the emerging irreversible electroporation market.

Building on its long-term accumulation, Raydial Medical’s comprehensive strength has also been affirmed by the market. On November 2, the “Top 50 Most Investment-Worthy Startups in Shanghai 2022” list, organized and released by the Shanghai Municipal Commission of Economy and Informatization, was officially unveiled at the “15th Shanghai International Equity Investment Forum and Bund Finance · Shanghai International Equity Investment Forum.” Raydial Medical was included on the list, once again fully demonstrating the company’s innovative capabilities and significant investment potential.

Driven by clinical needs, the first therapeutic area that Ruidao Medical entered was prostate cancer. To date, Ruidao remains the only company in the field of irreversible electroporation (IRE) to have obtained an indication for prostate cancer.

Prostate cancer ranks as the second most common malignancy among men worldwide. In the United States, its incidence even surpasses that of lung cancer, making it the leading threat to men's health. Meanwhile, the number of prostate cancer patients in China has grown rapidly in recent years. From 2015 to 2020, new cases of prostate cancer in China increased by 60%, and deaths rose by 89%, marking it as one of the fastest-growing cancers.

To overcome the burden on quality of life associated with existing radical prostatectomy for prostate cancer, ultra-minimally invasive precision therapy has become a development trend in prostate cancer treatment.As industry experts deepen their research and exploration of prostate cancer, the focus of diagnosis and treatment is shifting from late-stage management to early screening and diagnosis. With the widespread adoption and implementation of early detection and intervention strategies, functional preservation—alongside tumor control—has become an increasingly important therapeutic goal in the management of early- to intermediate-stage prostate cancer. Surgical treatment for this patient population is trending away from traditional radical prostatectomy toward ultra-minimally invasive procedures utilizing novel energy platforms. Furthermore, as public health awareness continues to rise, a growing number of patients are prioritizing quality of life alongside oncological outcomes when making treatment decisions.

Currently, the majority of patients with localized prostate cancer undergo radical prostatectomy in clinical practice. However, a significant proportion of these patients still experience adverse effects such as erectile dysfunction and poor urinary continence postoperatively, which severely impair their quality of life. Although laparoscopic and robot-assisted radical prostatectomies are widely trusted by urologists, concerns regarding quality of life remain prominent among patients with early-stage disease. Reported rates of post-prostatectomy erectile dysfunction range from 11% to 87%, while urinary incontinence rates vary between 0% and 87%, depending on the timing and methods of assessment. In contrast, focal therapy, as a minimally invasive technique capable of preserving organ function, has seen a marked increase in adoption among patients with early-stage prostate cancer in recent years.

Globally, Raidao Medical pioneered the use of irreversible electroporation technology for the treatment of prostate cancer. Its developed composite steep pulse therapy device, REMD-G1, enables individualized settings for the width of each polar pulse, electrodes with distal external insulation, and needle placement strategies. This approach effectively preserves patients’ sexual and urinary continence functions while thoroughly ablating prostate cancer cells.In April 2021, the product obtained the Class III medical device certification from the National Medical Products Administration (hereinafter referred to as “NMPA”) and has since been adopted by numerous hospitals across China.

 RuiDao Medical Prostate Cancer Composite Steep Pulse Therapy Device REMD-G1

The results of a multicenter clinical study published in *JAMA Surgery* confirm that the composite steep-pulse therapy device from Ruidao Medical is effective in treating prostate cancer,The incidence of clinically significant prostate cancer at 6-month follow-up after H-FIRE was lower than that in historical controls using other energy platforms (P < 0.001), and the treatment had minimal impact on postoperative urinary continence and sexual function.。

For prostate cancer treatment, Ruidao Medical provides an intelligent solution covering the entire surgical workflow, encompassing “disease diagnosis–surgical planning–energy ablation.” In addition to its hybrid irreversible electroporation (IRE) ablation system, the company has also developed a prostate biopsy navigation robot and a cloud-based data planning platform. By leveraging multimodal image fusion navigation, it enhances the detection accuracy of prostate cancer. Its AI-powered cloud-based surgical planning platform standardizes needle placement strategies and treatment parameter protocols. By importing surgical plans into the biopsy navigation system and the hybrid IRE therapy device, it ensures precise needle positioning and accurate energy delivery, thereby further improving the efficacy and standardization of ablation surgery while reducing the learning curve for physicians.

And based on basic research and cutting-edge technologies in the field of urology,Ruidao Medical also pioneered the world’s first study on the use of irreversible electroporation technology for the treatment of benign prostatic hyperplasia.. Benign prostatic hyperplasia (BPH), as a benign condition, is a common disease among elderly men. The onset age is mostly after 50 years old, and the disease progresses slowly. Patients generally begin to experience symptoms after the age of 60. However, with advancing age and disease progression, it can affect patients' quality of life and increase the difficulty of treatment. Therefore, early diagnosis and early treatment are equally important for benign prostatic hyperplasia.

For patients who show no improvement with oral medications, are intolerant to transurethral resection of the prostate (TURP), or have no willingness to undergo the procedure, RuiDao Medical’s independently developed REMD-G3 composite steep pulse therapy device offers a localized, highly effective minimally invasive treatment. This device effectively preserves sexual and urinary continence functions while reducing reliance on the operator’s experience and skill level.

As of August 2, 2022, all 160 subjects enrolled in the clinical study evaluating the RuiDao Medical composite irreversible electroporation device for ablation therapy of benign prostatic hyperplasia have completed their clinical follow-up.Clinical results demonstrated a 0% incidence of serious adverse events during the surgical procedure. At three months postoperatively, the increase in urinary flow rate exceeded 8.4 mL/s, and the International Prostate Symptom Score (IPSS) showed substantial improvement. The mean operative time was approximately 17 minutes, with minimal trauma, allowing patients to ambulate on the same day.This indication is expected to be approved in 2023.

In the urology field, Ruidao Medical has secured a first-mover advantage, with its product development leading the pack. The company will further strengthen Ruidao’s leadership in irreversible electroporation technology by horizontally enhancing its solutions and vertically expanding coverage to more diseases.

Guided by clinical needs and underpinned by cutting-edge technology, Raydial Medical’s scope extends beyond urology. The company has developed pulsed field ablation products for hepatocellular carcinoma and atrial fibrillation electrophysiology, with these initiatives advancing ahead of schedule and all having entered clinical trial phases. Currently, Raydial Medical is the global leader in expanding indications for irreversible electroporation.

AsIn the increasingly competitive field of PFA (pulsed field ablation), no domestic product has yet received approval, while Ruidao Medical’s PFA system has entered the National Medical Products Administration’s “green channel” for innovative medical devices.

 Ruidao Medical Atrial Fibrillation Pulsed Field Ablation System REMD-G4

Atrial fibrillation can trigger serious cardiovascular and cerebrovascular diseases, such as heart failure, myocardial infarction, and stroke, making timely treatment essential. Catheter ablation is a key therapeutic approach for atrial fibrillation; however, conventional thermal ablation techniques (both cryoablation and radiofrequency ablation) may cause collateral tissue damage and incomplete lesion formation. In contrast, Pulsed Field Ablation (PFA) technology selectively ablates cardiomyocytes while blocking abnormal electrical conduction pathways, thereby reducing the incidence of complications such as pulmonary vein stenosis and esophageal injury. PFA also significantly shortens procedural time compared with radiofrequency ablation and lowers post-procedural atrial fibrillation recurrence rates. Furthermore, PFA is technically less demanding, facilitating its adoption in prefecture-level hospitals and enabling localized, tiered diagnosis and treatment of atrial fibrillation.

Ruidao Medical’s PFA system adopts next-generation high-frequency combined irreversible electroporation technology, achieving further improvements in treatment efficacy. Currently,Ruidao Medical’s PFA system has initiated a multicenter registrational clinical trial, with all procedures performed under either “local anesthesia plus deep sedation” or “local anesthesia alone.”Most PFA procedures on the market can only be performed under general anesthesia. Ruidao Medical’s PFA procedure, performed under local anesthesia, not only effectively shortens operative time but also enhances procedural safety and patient acceptance. Furthermore, during procedures using the Ruidao Medical PFA system, patients exhibit minimal muscle tremors, and intracardiac echocardiography (ICE) reveals virtually no microbubble formation, further confirming the safety of the Ruidao Medical PFA system.

Compared with radiofrequency ablation, PFA technology has achieved significant improvements in both operability and safety. Conventional atrial fibrillation ablation procedures can be smoothly performed under DSA guidance. Moreover, the Raydow Medical PFA system delivers “band-by-band” composite ablation rather than “segment-by-segment” single-point ablation, thereby reducing reliance on three-dimensional mapping systems.

Amidst the surge in research and development of 3D mapping systems, Ruidao Medical adheres to a model of “open collaboration and strategic alliances between industry leaders.” While continuously refining its energy-based devices and ablation catheters to maintain its position as the domestic leader and an international frontrunner, the company is engaging in customized partnerships with open-platform 3D mapping system vendors that have already secured a foothold in the global market. By combining “high-quality energy platforms and consumables” with “user-friendly open platforms with established market presence,” Ruidao Medical aims to enable physicians in China to rapidly adopt Pulsed Field Ablation (PFA) technology.

Supported by proprietary technologies and a highly efficient execution team, Rayda Medical has achieved rapid growth. The company has now established a complete industry chain encompassing “R&D—clinical trials—regulatory registration—commercialization.”RuiDao Medical’s composite steep-pulse ablation system, REMD-G1, has been deployed in numerous hospitals across China, with nearly 500 ablation procedures completed. More importantly, RuiDao Medical has taken a critical step from clinical practice to commercialization by securing approval for procedural reimbursement. The REMD-G1 is now eligible for surgical billing in Shanghai and other regions, marking the full-scale launch of irreversible electroporation technology in clinical applications.

In the future, Ruidao Medical will continue to advance steadily, further expanding the indications for irreversible electroporation to include pancreatic cancer, chronic obstructive pulmonary disease (COPD), renal cell carcinoma, thyroid cancer, and gliomas. Animal trials for these indications have now been largely completed.

Meanwhile, Ruidao is continuing to refine its existing solutions. In the field of liver cancer, it is developing a needle biopsy navigation system to gradually establish a comprehensive solution for focal therapy of liver cancer. In the area of atrial fibrillation, the company is collaborating with domestic or international 3D mapping systems to expand applications to indications such as supraventricular tachycardia. Furthermore, the company will further explore the advantages of combining irreversible electroporation with immunotherapy, investigating the potential of combination regimens for treating patients with advanced-stage cancer.

As a rising star in the fields of solid tumor and electrophysiological therapy, irreversible electroporation (IRE) technology has unlocked substantial market potential and presents an opportunity for domestic innovative enterprises to achieve leapfrog development. In the IRE sector, Chinese and international companies are essentially starting from the same baseline, with Chinese firms taking the lead in pioneering multiple new areas in solid tumor treatment. Facing this blue ocean, Raydial Medical, leveraging its cutting-edge technology as its sail and clinical orientation as its rudder, is well-positioned to be the first to reach the “New World.”