Mirai Medical Files for IPO: Pioneering Endoscopic Pulsed Field Ablation Therapy for Gastrointestinal Tumors

Pulsed Field Ablation (PFA), as a novel technology in electrophysiological therapy, is characterized by tissue selectivity, non-thermal effects, and instantaneous action, and is emerging as a new option for minimally invasive tumor treatment.

Several pulsed electric field ablation products targeting solid malignant tumors of the liver, lung, prostate, and other organs have been successively approved for market launch in China. However, it should not be overlooked that a substantial number of cancer patients still have unmet treatment needs. A case in point is colorectal cancer, which ranks as the third most common cancer worldwide and is the second leading cause of cancer-related deaths.

Colorectal cancer is generally treated with a comprehensive approach centered on surgical resection, supplemented by chemotherapy and radiotherapy. Surgical resection is irreversible, while chemotherapy and radiotherapy, while indiscriminately targeting cancer cells, may also inadvertently damage normal cells. In contrast, pulsed electric field ablation can effectively treat lesions while preserving normal tissues and organs, and offers good repeatability. Patients who undergo pulsed electric field ablation can still receive subsequent treatment with pulsed electric field ablation or other modalities.

From a global perspective of marketed products, currently approved devices primarily adopt a percutaneous approach using electrode needles for treatment. They are indicated for solid malignant tumors but are difficult to apply to hollow-organ malignancies such as esophageal cancer, gastric cancer, and colorectal cancer.

To address unmet critical clinical needs in gastrointestinal diseases, Mirai Medical, an innovative medical device company from Ireland, has creatively proposed a pulsed field ablation therapy that combines endoscopic surgery with pulsed field ablation technology—ePORE.^®, providing a natural-orifice-based local physical therapy option for digestive tract diseases such as esophageal and gastrointestinal tumors, and gastrointestinal polyps.

Recently, VCBeat interviewed Dr. Declan Soden, Founder and CEO of Mirai Medical, to discuss the company’s technological roadmap, product portfolio, and global development strategy.

Mirai Medical was founded in 2017. Its founder and CEO, Dr. Declan Soden, holds a Ph.D. in Molecular Genetics from University College Cork (UCC) and currently serves as a Principal Investigator at Mercy University Hospital (MUH) and the Cancer Research Centre at University College Cork. With over two decades of R&D experience in gene therapy, immunotherapy, and cancer research, Dr. Soden’s work primarily focuses on PFA and its innovative applications in cancer treatment.

Under the leadership of Dr. Declan Soden, Mirai Medical developed ePORE, the world’s first CE-certified high-frequency pulsed ablation product capable of effectively ablating solid tumors.^®, and has secured full independent intellectual property rights in both Europe and the United States.

ePORE^®Energy Platform

Image source: Mirai Medical official website

During high-frequency pulsed electric field therapy, the nerve fibers in the target tissue are unable to "perceive" the high-frequency energy generated by the device, thereby reducing the need for sedatives and general anesthetics. Patients can undergo ablation treatment with only local anesthesia, which also facilitates the performance of this procedure as day-case surgery, significantly lowering surgical risks and patient burden.

Besides ePORE^®In addition to its own technological advantages, ePORE^®Energy Platform and EndoVE^®The integration of ablation electrodes has also overcome the limitations of ablation therapy for solid tumors, expanding its indications to include the treatment of malignant gastrointestinal tumors such as esophageal cancer, colon cancer, rectal cancer, and gastric cancer.

Unlike typical ablation products that utilize a percutaneous puncture approach and an electrode needle for ablation,EndoVE^®The ablation electrode, in combination with a gastroscope or colonoscope, establishes a therapeutic concept of real-time endoscopic pulsed electric field tumor ablation.

EndoVE^®Ablation Electrode

Image source: Mirai Medical official website

In terms of treatment modalities, EndoVE^®The ablation electrode can be directly connected to the distal end of the endoscope and, under the operation of the clinician, reach the target tissue via natural orifices. EndoVE^®The ablation electrode also incorporates a vacuum chamber, allowing physicians to use the vacuum suction function to draw the tumor toward the electrode. Subsequently, ePORE^®The energy platform can deliver pulsed electric fields to target tissue within seconds, increasing the porosity of cancer cell membranes through electroporation and inducing apoptosis.

EndoVE^®Ablation Electrode

Image source: Mirai Medical official website

Furthermore, due to the difference in electrical conductivity between healthy tissue and tumor tissue, this means that the permeabilization of tumor cells is selective, EndoVE^®It can target tumor tissue while preserving the surrounding healthy tissue, benefiting both clinicians and patients.

In addition to its application in malignant tumors of the digestive tract,ePORE^®The therapy can also be used to treat various types of skin cancer, such as non-melanoma skin cancer, metastatic melanoma, cutaneous metastases from other cancers (e.g., breast cancer), and rare malignancies including Merkel cell carcinoma (MCC), which carries a high risk of recurrence and dissemination.

From the perspective of clinical applications in gastrointestinal and skin cancers, EndoVE^®Having completed nearly 300 clinical trials, it has achieved commercialization in multiple countries worldwide. Mirai Medical also collaborates withMayo ClinicCompleted a clinical study on gastrointestinal cancers in collaboration. In May 2024, the favorable results of this study were published at Digestive Disease Week (DDW) in the United States, showcasing the company’s R&D capabilities and EndoVE at a global professional conference.^®innovative clinical value.

Complex colorectal polyps are the third major indication in Mirai Medical's portfolio.As a common disease of the digestive system, colorectal polyps can be classified into adenomatous, inflammatory, hyperplastic, and hamartomatous polyps. Among these, adenomatous polyps are the origin of the vast majority of colorectal cancers. Therefore, early removal of precancerous polyps is expected to reduce the incidence of colorectal cancer.

In response, Mirai Medical collaborated with AIG Hospitals, a leading gastroenterology hospital in India, to conduct clinical research on indications for colorectal polyps. This pilot study was fully completed in the first half of 2024. Dr. Declan Soden described the results as “Excellent outcomes; safe and no pain for patients,” demonstrating ePORE^®Safety and therapeutic efficacy in the treatment of colorectal adenomas, as well as the broad clinical potential of this innovative therapy.

In addition, Mirai Medical is conducting proof-of-concept studies for two indications: Barrett’s esophagus (BE) and gastrointestinal bleeding. Barrett’s esophagus is a known precursor to esophageal adenocarcinoma; early diagnosis and treatment can significantly improve cure and survival rates for patients with esophageal adenocarcinoma. Therefore, early screening, diagnosis, and treatment of Barrett’s esophagus are key to the prevention and management of esophageal adenocarcinoma.

The only viable path for the prevention and control of gastrointestinal cancers lies in the “Three Earlies”: early detection, early diagnosis, and early treatment. Taking gastric cancer as an example, 90% of early-stage cases are curable. From Mirai Medical’s strategic layout, it is evident that the company is expanding into earlier stages of gastrointestinal tumor treatment and broadening its range of indications, thereby addressing more unmet needs in early-stage care. This approach not only significantly improves patients’ long-term survival rates but also alleviates their financial burden.

ePORE^®It has already been approved for marketing in Europe, Australia, Singapore, India, and other countries, and is scheduled to obtain U.S. FDA 510(k) clearance in the second half of 2025, enabling its full commercial launch in the U.S. market.

It is worth mentioning that, in addition to the first-generation EndoVE introduced earlier, the products launched in the U.S. market include^®In addition, the second-generation product will also be launched simultaneously.

According to the introduction, compared with the first-generation design that was individually connected to the distal end of the endoscope,Second-Generation EndoVE^®By leveraging the existing working channel of the endoscope to treat lesions, this more integrated design conserves operational space and simplifies surgical procedures, enabling any clinician familiar with endoscopy to complete the treatment within minutes. Meanwhile, the second-generation product also offers patients with gastrointestinal diseases a safer, more efficient, and reproducible treatment option.

In early 2024, David Pierce, former Executive Vice President and President of the Endoscopy and Endoscopic Surgery Division at Boston Scientific, assumed the role of Non-Executive Director on the Board of Directors of Mirai Medical.David Pierce has worked at Boston Scientific for over three decades, holding various positions and possessing profound industry insights. David Pierce’s addition will benefit the second-generation EndoVE^®Provides strong support for the development, clinical application, and registration of ablation electrodes.

Dr. Declan Soden also stated, “The addition of David Pierce will further enhance Mirai Medical’s capabilities and influence in interventional endoscopy. We believe that just as PFA procedures have ushered in a new era in the treatment of atrial fibrillation, EndoVE^®"It also holds promise for transforming the management of precancerous gastrointestinal diseases in a similar manner."

Mirai Medical'sCo-Founder and COO, Colin FordeAlso boasting extensive experience in the healthcare industry, he engaged in R&D management for over two decades at companies such as Clearstream Technologies, and founded Embo Medical, which was subsequently successfully acquired. The companyCTO Seán KinsellaWith nearly two decades of experience in the medical device industry, possessing full-lifecycle expertise spanning from concept and R&D to manufacturing, regulatory registration, and market launch.

It is undeniable that China faces a more severe cancer disease burden compared to developed countries in Europe and America. In January 2024, the National Cancer Center of the Chinese Academy of Medical Sciences and Peking Union Medical College published an article in a Lancet subsidiary journal, stating that China accounts for 44% of global gastric cancer incidence, ranking first worldwide. Meanwhile, both the prevalence and mortality rates of gastric cancer in China are more than twice the global average.

Mirai Medical also hopes to leverage EndoVE^®its mature technologies and innovative therapies to alleviate the growing cancer burden in China and improve global public health. Meanwhile, Mirai Medical also seeks to engage in multi-level exchanges and collaborations with Chinese enterprises, research institutions, healthcare providers, and other stakeholders. By pooling professional expertise, technological strengths, and resource advantages from all parties, we aim to jointly explore broader markets and deliver more advanced, efficient, and safe medical solutions to patients worldwide.