REMD Medical Completes Over RMB 100 Million Series A+ Financing to Advance Irreversible Electroporation Technology

VCBeat has learned that Shanghai Raydow Medical Technology Co., Ltd. (hereinafter referred to as “Raydow Medical”) has completed an A+ round of financing exceeding RMB 100 million. The round was led by Paradise Silicon Valley, with participation from Detong Capital, Qianzhan Capital, and other institutions. Close A and Banghua Finance served as joint financial advisors.

Ruidao Medical was established in September 2016, focusing onInnovative Medical Device Company Specializing in Irreversible Electroporation Technology, and expand the product indications based on the technology’s unique “non-thermal and tissue-selective” characteristics. Currently, Ruidao Medical has conductedProstate Tumor, Benign Prostatic Hyperplasia, Cardiac Electrophysiology (Atrial Fibrillation), Liver Tumorawaiting expansion of indications,Has become one of the companies with the broadest expansion of indications in the global irreversible electroporation field。

Among them, RayKnife MedicalLaunched the world’s first approved composite pulsed electric field ablation device, for the treatment of prostate cancer. This device represents the first application of irreversible electroporation technology for prostate cancer worldwide. Subsequently, the device was rapidly installed in hospitals, andChina’s First Irreversible Electroporation Ablation for Urological Tumors Officially Billed. In July 2022, the “Pulsed Electric Field Ablation Device,” developed by Ruidao Medical based on irreversible electroporation technology, was also approved by the National Medical Products Administration and entered the Special Review Procedure for Innovative Medical Devices.

In addition to expanding indications, RayKnife Medical is also committed to providing comprehensive solutions for mature indications. It has initially developed an intelligent focal therapy solution for prostate cancer that preserves urinary continence and sexual function.

Following this round of financing, Ruidao Medical will accelerate its product layout and innovation in benign prostatic hyperplasia (BPH), pulsed field ablation (PFA) for atrial fibrillation, liver cancer, and other therapeutic areas, while driving the adoption of its approved products to benefit a broader patient population.

Unlike thermal ablation techniques such as radiofrequency ablation and microwave ablation, irreversible electroporation (IRE) induces cell death by applying high-voltage electrical pulses to the target tissue, thereby creating irreversible pores in the cell membrane.

According to reports, the electric field threshold required to induce irreversible electroporation varies among different cell types. Typically, luminal cells such as those in blood vessels, nerves, and bile ducts have higher thresholds than other cells within the lesion area. Therefore, by applying an appropriate electric field, it is possible to ablate target cells in the lesion while sparing normal structural cells such as those in blood vessels and nerves. This principle underlies the tissue-selective characteristic of irreversible electroporation technology. Additionally, since only a very short duration of electric field application is needed to induce cell death, thermal effects are not generated.

Ruidao Medical stated, “The ultimate goal of surgical intervention is to preserve normal tissue while eradicating the lesion.”Due to its characteristics of "non-thermal and tissue selectivity," irreversible electroporation ablation has become the only clinical method currently capable of safely and efficiently ablating lesions while alsoRetainEnergy Platform for Normal Tissues such as Blood Vessels, Nerves, and Lumens“。

Leveraging these advantages, irreversible electroporation technology has been exploratorily applied in fields such as solid tumors and atrial fibrillation (cardiac electrophysiology).

In the oncology market, the number of new cancer cases in China increased from 4.1 million in 2016 to 4.6 million in 2020, and is projected to reach 5.8 million by 2030. Driven by the large patient population and the severity of cancer, the market size of China’s tumor ablation industry grew from RMB 1.88 billion in 2016 to RMB 3.92 billion in 2021, and is expected to reach RMB 15.58 billion by 2026.

In the cardiac electrophysiology market, the number of electrophysiological procedures performed on patients with arrhythmia in China has increased from 118,000 in 2015 to 212,000 in 2020, and is projected to reach 489,000 by 2024, representing a compound annual growth rate (CAGR) of 23.3%. Meanwhile, the market size of China’s cardiac electrophysiology industry has grown from RMB 1.48 billion in 2015 to RMB 5.15 billion in 2020, and is expected to reach RMB 21.11 billion by 2024.

In addition, Ruidao Medical continues to expand the indications for irreversible electroporation technology, having innovatively and successfully applied it to the treatment of benign prostatic hyperplasia (BPH). Currently, there are approximately 13 million BPH patients in China, with around 700,000 requiring surgical intervention. As the population ages and life expectancy increases, the number of individuals affected by this condition is expected to continue rising.

Overall, leveraging its advantages of "non-thermal effects and tissue selectivity," irreversible electroporation technology is highly likely to become a mainstream application across various specialized fields, with its combined market size in China reaching tens of billions of yuan.。

Since the advent of irreversible electroporation (IRE) technology in the medical field, a significant number of companies have entered this business sector, including renowned multinational medical device corporations as well as numerous innovative enterprises from both domestic and international markets.

Among them, Ruidao Medical is undoubtedly a leading enterprise in the global field of irreversible electroporation, having pioneered the High-Frequency Irreversible Electroporation (H-FIRE) technology on the international stage.

According to reports, H-FIRE delivers high-frequency, bipolar composite pulses to the lesion site, achieving complete ablation of pathological tissue. This approach significantly enhances local ablation efficacy while effectively minimizing intraoperative neural stimulation and reducing muscle contractions.

Currently, based on H-FIRE, Ruidao Medical has developed corresponding innovative products for indications such as prostate tumors, liver tumors, benign prostatic hyperplasia, and atrial fibrillation.

According to reports, the standard surgical treatment for prostate cancer is radical prostatectomy; however, this procedure inevitably leads to numerous complications. Statistics indicate that 80% of patients experience significant impairment of sexual function postoperatively, while 30% suffer from substantial urinary incontinence.

The REMD-G1 hybrid high-voltage pulsed electric field ablation system, developed by Ruidao Medical, addresses this challenge. By leveraging irreversible electroporation technology, it achieves complete ablation of cancer cells without damaging blood vessels or nerve function, thereby effectively preserving sexual and urinary continence functions.

Clinical trial data for this composite steep-pulse therapy device show a 1% local recurrence rate at 6 months, with a 97% continence rate among patients.

In JAMA Surgery, the journal with the highest impact factor in the field of irreversible electroporation (IRE), we have observed clinical data from Raydow Medical regarding prostate cancer: patients treated with Raydow devices demonstrated significantly better preservation of sexual function and urinary continence compared to those undergoing conventional surgical treatment, with no serious postoperative complications such as severe bleeding, rectal injury, or urethral injury. Compared with conventional tumor ablation therapies, the REMD-G1 composite steep pulse therapy device offersComplete tumor cell ablation, intact preservation of functional tissue, short operative time, ultra-minimally invasive procedure, and low complication ratesuch advantages, truly achieving minimal intraoperative injury and faster postoperative recovery for patients.

Supported by robust clinical data, the product was approved by the National Medical Products Administration (NMPA) in 2021, becoming the world’s first approved combined irreversible electroporation therapy device.

In response, Ruidao Medical’s independently developed REMD-G2 composite steep-pulse ablation system utilizes irreversible electroporation technology to effectively eliminate tumors adjacent to major blood vessels and bile ducts. This approach enables tumor ablation while preserving surrounding veins and critical ductal structures, thereby reducing the risk of complications.

To date, patient enrollment for the REMD-G2 trial in primary liver cancer is actively underway across multiple centers.

For patients who show no improvement with oral medications, have poor compliance, or fear the complications and sequelae of transurethral resection of the prostate (TURP), Ruidao Medical has independently developed the REMD-G3 Composite Steep Pulse Therapy Device. This device can completely ablate hyperplastic tissue without damaging blood vessels or nerves in or around the ablation zone, thereby effectively preserving urinary continence and sexual function.

Currently, the composite steep pulsed electric field device for ablative treatment of benign prostatic hyperplasia has completed clinical trials, and the clinical trial summary report along with relevant registration materials have been submitted to the National Medical Products Administration.

Clinical results showed no significant severe adverse reactions. The increase in urinary flow rate exceeded 8.4 mL/s at 3 months, with a significant improvement in IPSS scores. The average operative time was approximately 17 minutes, involving minimal trauma, and patients were generally able to ambulate on the same day. Pre- and postoperative MRI scans indicated a significant reduction in prostate volume, with no damage outside the ablation zone, while preserving sexual function and urinary continence.

Atrial fibrillation is primarily managed through pharmacological therapy and surgical interventions (catheter ablation and surgical maze procedure). Pharmacological therapy cannot cure atrial fibrillation nor improve prognosis, while surgical interventions are associated with an approximate 30% postoperative recurrence rate. Furthermore, ablation modalities such as radiofrequency and cryoballoon can cause injury to adjacent structures, including the esophagus and phrenic nerve, and carry risks of pulmonary vein stenosis and thromboembolism.

Compared with traditional ablation methods, pulsed field ablation offers advantages such as lower recurrence rates, fewer and milder complications, shorter procedure times, a shorter learning curve for physicians, and greater ease of adoption and application in primary care hospitals.

In 2021, the REMD-G5 Pulsed Field Ablation System, independently developed by Raidao Medical, passed type testing and initiated registration-focused multicenter clinical trials, with patient enrollment proceeding intensively. Current 6-month follow-up data indicate no recurrences among patients.

In January 2023, preliminary clinical results published in the Chinese Circulation Journal showed that the novel domestically developed pulsed field ablation system by Ruidao Medical achieved a high immediate success rate with no perioperative complications when used for ablation of paroxysmal atrial fibrillation.

In addition to its irreversible electroporation products for the aforementioned indications, Ruidao Medical has also developed an intelligent focal therapy solution for prostate cancer. Within this solution, Ruidao Medical has deployed not only ablation energy technology but also a prostate biopsy navigation system and a cloud-based data planning platform.

According to the introduction, the surgical workflow of this comprehensive solution includes targeted puncture biopsy, preoperative surgical planning, and composite pulsed focal ablation. For patients with low-to-intermediate risk prostate cancer, compared to robot-assisted radical prostatectomy, this surgical approach preserves the neurovascular bundles. Furthermore, aided by artificial intelligence and robotic technologies, it ensures tumor control efficacy, standardizes the surgical procedure, reduces inter-physician variability in treatment, and shortens the learning curve.

Leveraging its leading innovation capabilities, technological prowess, and highly competitive high-quality products, Ruidao Medical was named one of the “Top 50 Most Investable Startups in Shanghai 2022” in 2022, and received multiple honors, including “Shanghai High-Tech Achievement Transformation Project,” “2022 Pudong New Area Enterprise R&D Institution,” “2022 Pudong New Area High-Quality Development Project,” and “2022 Shanghai Innovative Product.”

Furthermore, as a company with innovation embedded in its DNA, Ruidao Medical will not halt its forward momentum. The company stated that over the next three years, it will further expand its range of indications to include pancreatic cancer, COPD, renal cell carcinoma, thyroid cancer, and glioma.

In terms of solutions, Ruidao Medical will next develop puncture navigation systems for various fields and gradually form a complete solution for focal therapy.

In the field of electrophysiology for atrial fibrillation, Ruidao Medical will adhere to its strategic positioning as a leader in irreversible electroporation technology. By forging strong partnerships with leading domestic or international open-platform 3D mapping systems, the company aims to further enhance the usability of its atrial fibrillation pulsed field ablation system and expand its indications to include supraventricular tachycardia and other conditions.

In the field of hepatobiliary medicine, Ruidao Medical will next develop a needle biopsy navigation system for liver cancer and gradually establish a comprehensive solution for focal therapy of liver cancer.

In terms of platform capabilities, Ruidao Medical will iterate its pulsed ablation devices based on clinical needs to optimize surgical treatment time; explore the enhancing effect of irreversible electroporation technology on the immune process, and combine it with immunotherapeutic agents to investigate the potential of using irreversible electroporation in combination with immunotherapy for the treatment of advanced cancer.

Prior to this funding round, Ruidao Medical had already secured investments from prominent firms such as Longsheng Capital and Detong Capital, which significantly benefited its R&D progress. This latest vote of confidence from the investment community will accelerate Ruidao Medical’s product expansion and innovation into other fields.

Mr. Sun Zhuo, founder of Ruidao Medical, statedRuidao Medical is deeply honored to have received recognition and support from a group of investors dedicated to the field of innovation, and we extend our sincere gratitude to our team for their hard work and dedication. Since its founding seven years ago, Ruidao Medical has remained committed to independent innovation. We pioneered the global launch of High-Frequency Irreversible Electroporation (H-FIRE) technology and successfully obtained the world’s first regulatory approval for an IRE-based device for the ablation treatment of prostate cancer. Furthermore, our REMD-G1 system has been adopted by numerous hospitals across China, with nearly 500 ablation procedures completed, marking a critical transition from clinical application to commercialization—specifically, the approval for procedural reimbursement.

These achievements in technological innovation and market commercialization are inseparable from China’s commitment to independent innovation, the support of professional investment institutions, and the diligent efforts of our team. Following the completion of this financing round, Raydion Medical will further accelerate the deployment and innovation of its product portfolio in liver cancer, benign prostatic hyperplasia (BPH), pulsed field ablation (PFA), and other areas, while also speeding up patient access to its already approved products. Looking ahead, the company will continue to advance steadily, expanding irreversible electroporation technology to other cancer types and disease areas, refining its existing solutions, and establishing itself as a technological leader among innovative enterprises in China.

Bao Xueqing, Managing Partner at Paradise Silicon Valley, stated:It is a great honor to participate as the lead investor in Raydow Medical’s Series A+ financing round. Against the backdrop of the adverse impacts of the pandemic in 2022, the healthcare investment team at Paradise Silicon Valley adhered to its value investment philosophy, which is oriented toward hard-tech innovation and aimed at addressing clinical pain points. Overcoming numerous challenges, we conducted in-depth research into the market demand and technical feasibility of irreversible electroporation (IRE), an innovative technology. We believe that Raydow Medical holds a leading position in this niche sector, boasts a high level of technological maturity, and has a rich pipeline of products, with significant potential to expand into additional application scenarios in the future.

The completion of this funding round will significantly bolster RayKnife Medical’s marketing efforts for its certified products, bringing timely benefits to patients in the field of prostate cancer treatment. It will also accelerate the R&D progress of the company’s pipeline products, enabling their impactful application across a broader range of scenarios and demonstrating RayKnife Medical’s capacity for continuous technological advancement. With a highly executable and complementary entrepreneurial team, RayKnife Medical is poised to deliver further surprises in the future.

Yu Jiani, Partner at Detong Capital, stated: Detong Capital has long maintained an innovation-driven approach in the healthcare sector, focusing on technologically advanced enterprises in pharmaceuticals, diagnostics, medical devices, and healthcare services that are poised to fill gaps in niche markets. As early as 2021, Detong Capital recognized the technological and clinical application leadership of Raydow Medical in the field of irreversible electroporation technology in China, and led the company’s Series A financing round.

In just over a year since its initial investment, Ruidao Medical has achieved accelerated growth. As the first company in China to receive approval for a Class III medical device featuring combined steep pulse therapy technology, and the only company with an IRE product indicated for the treatment of prostate cancer, it is gradually expanding its indications to cover benign prostatic hyperplasia, liver cancer, electrophysiology, and other fields. Congratulations to the company on securing a new round of financing, with continued support from Detong Capital. We look forward to the company’s success in broader indication areas and larger market spaces, ultimately benefiting more patients.

A partner at Qian Zhan Capital stated: Tumor ablation technology holds significant advantages among various cancer therapies, serving as an efficient, safe, cost-effective, minimally invasive diagnostic and treatment modality with few complications; however, traditional ablation surgeries still have considerable limitations. Raydow Medical’s proprietary IRE (Irreversible Electroporation) technology can address tumor issues in a more minimally invasive, precise, and thorough manner, and is expected to be applicable to multiple indications, thereby expanding its commercial prospects. The niche market segment in which Raydow Medical operates boasts substantial market space, remains in a blue-ocean competitive state, and offers considerable room for future growth.

The company currently holds independent intellectual property rights and boasts a professional team with years of deep expertise in the industry. Leveraging this extensive R&D foundation, it has already obtained the Class III medical device registration certificate for prostate cancer treatment. Clinical trials for benign prostatic hyperplasia (BPH), liver cancer, and atrial fibrillation have been completed or are currently underway, with regulatory approvals expected to be secured sequentially over the next two years. The company’s product portfolio holds a leading position in China within the field of Irreversible Electroporation (IRE), and its prostate cancer treatment solutions are globally leading, demonstrating strong first-mover advantages and innovation capabilities. We believe that Raydow Medical, equipped with core technological competencies, is well-positioned to stand out and achieve greater success against the backdrop of rapid industry growth.