The following content is a reprint from iyiou.com.

The continuously growing PFA (pulsed field ablation) market has received another good news.

Alpmed's Pulsed Field Ablation (PFA) System has completed registration for clinical trials. The multi-center registered clinical trial was officially launched in April this year, with the participation of many well-known tertiary hospitals across the country. Despite setbacks caused by the recurrence of the COVID-19 pandemic and difficulties in hospital admissions, more than 100 subjects were successfully enrolled in the trial within seven months. The clinical trials were all completed under local anesthesia, and clinical follow-up data showed that all indicators of the subjects had recovered well without any complications such as pulmonary vein stenosis, phrenic nerve injury, or atrial esophageal fistula. The clinical effect was significant, and the recurrence rate was low.

As the first domestically produced PFA system approved to enter the special approval procedure for innovative medical devices by the China National Medical Products Administration, Alpmed's Pulsed Field Ablation (PFA) System can perform surgery under local anesthesia and achieve true non-temperature ablation. This greatly improves the safety and effectiveness of atrial fibrillation ablation surgery.

Alpmed  Pulse  Field  Ablation System

Professor Lu Chengzhi, Director of the Cardiology Department at the First Central Hospital of Tianjin, said, "The pulse field ablation system used in this clinical trial has truly changed the existing cardiac electrophysiological ablation methods. A complex atrial fibrillation ablation surgery can be completed in half an hour, and the surgery is very safe, with no cases of complications such as pulmonary vein stenosis, phrenic nerve injury, or atrial esophageal fistula. We believe that this technology will definitely become the mainstream technology for the treatment of atrial fibrillation, benefiting more patients in the future."

The completion of this clinical trial enrollment not only represents a further step forward for the company's pulse field ablation system in the registration and approval process, but is also expected to be launched in 2024, potentially breaking the domestic blank situation and bringing a new solution for clinical atrial fibrillation ablation treatment.

Behind the impressive clinical performance is the confidence of Yuanshan Medical's technological innovation and the research and development path based on clinical needs.

Alpmed's pulse field ablation system has a unique gradient electric field selection feature, which allows it to completely ablate myocardial cells while avoiding damage to surrounding tissues. At the same time, the pulse field ablation system adopts a lantern skeleton structure and a high-speed discharge mode, simplifying the surgical procedure and greatly improving the ablation efficiency. With precise energy control, Yuanshan Medical's pulse field ablation system achieves true irreversible electroporation, realizing non-thermal ablation in the true sense. The system does not generate heat during operation, avoiding tissue thermal damage.

Meanwhile, Alpmed's pulsed field ablation (PFA) system can perform treatment under local anesthesia. Previously, during PFA surgery, patients were prone to experiencing generalized muscle spasms, so most patients required general anesthesia. Fundamentally, this was due to poor control of pulse form and energy. However, Alpmed's PFA system can avoid muscle tremors in patients while achieving efficient ablation through precise energy control, meeting the surgical conditions of local anesthesia. This not only improves surgical safety but also helps increase patient acceptance of surgical treatment.

Based on years of technical accumulation in the field of irreversible electroporation (pulse electric field ablation), Alpmed's pulse field ablation system has complete independent intellectual property rights and has applied for patents in multiple countries and regions. It can be said that in the future, its pulse field ablation products will be aimed at global atrial fibrillation patients, with huge market space. Recently,Alpmed also plans to conduct clinical trials of its pulse field ablation system in Europe.

At the same time, in order to improve the safety of PFA surgery, Alpmed is independently developing a dedicated three-dimensional mapping system to provide a complete three-dimensional PFA solution. The existing three-dimensional mapping systems in clinical use are all developed for procedures such as radiofrequency ablation, based on temperature ablation, while the PFA system acts on myocardial cells, causing apoptosis, which is different from the necrosis mechanism of cold and heat ablation and cannot be directly applied.Alpmed's dedicated three-dimensional mapping system will further improve the safety of PFA surgery.

Currently, the 3D measurement system has entered the registration and inspection stage, and will conduct clinical trials in conjunction with the company's pulse field ablation system. The two products will also work together for clinical promotion in the future.

Alpmed is facing a blue ocean.

Due to its minimally invasive and efficient characteristics, catheter ablation has become one of the main treatment methods for atrial fibrillation patients. However, traditional cold and hot ablation methods have their drawbacks. Radiofrequency ablation may damage surrounding tissues and cause complications, while cryoablation may not completely ablate the tissue and lead to atrial fibrillation recurrence. In addition, both radiofrequency and cryoablation surgeries have long operation times and a steep learning curve for doctors. Furthermore, the domestic electrophysiology market is dominated by foreign giants, with a domestication rate of less than 10%, resulting in a low penetration rate of electrophysiology surgery.

In contrast, Pulsed Field Ablation (PFA) achieves non-thermal ablation through efficient and precise release of energy via irreversible electric perforation, resulting in better safety and effectiveness, as well as simpler operation and reduced operational barriers. At present, there are no domestically approved products in the PFA field, and only one product has obtained CE certification overseas. Domestic companies are expected to quickly seize the market with their original irreversible electric perforation technology, change the monopoly of imported electrophysiology products, and further promote the popularization of electrophysiological surgery.

Atrial fibrillation is one of the most common clinical arrhythmias, with 12 million patients in China and the number of patients continues to grow, driving the continuous expansion of the PFA market. Giants such as Boston Scientific, Medtronic, and Johnson & Johnson have entered the market, with capital chasing after them, and there have been several large-scale financing deals worth over 100 million yuan.

While the capital market is hot, clinical practice has remained cautious and calm towards new technologies. Although PFA technology has greatly improved in terms of operation difficulty and safety, visual evidence may be the most direct way to change doctors' concerns about incomplete ablation. The 3D mapping system can be used for real-time monitoring of atrial fibrillation ablation surgery, achieving visual electrophysiological surgery. Its emergence greatly improves the safety of atrial fibrillation ablation surgery, reduces the risk of doctor's operation, and is expected to quickly promote the popularization of PFA technology.

Johnson & Johnson, Medtronic, and Boston Scientific have all laid out their 3D mapping systems for cardiac electrophysiology, and the PFA products of the three giants have entered the "green channel" of the National Medical Products Administration for innovative medical devices, promoting the clinical application of their products. Domestic companies in the PFA field have also made technological breakthroughs in the field of 3D mapping.

Although there is still a gap between domestic and foreign companies in the 3D electrophysiology market, the person in charge of Alpmed also mentioned that "in the field of atrial fibrillation, compared with radiofrequency ablation, PFA technology does not require strong demand for 3D mapping. Conventional atrial fibrillation pulse ablation therapy (such as the treatment of paroxysmal atrial fibrillation) can also be safely and effectively completed under DSA guidance. However, considering that the 3D mapping system can reduce X-ray exposure, shorten the doctor's learning curve, and has obvious advantages in complex arrhythmia mapping and ablation of key areas, the 3D mapping system is still necessary."

The PFA market is heating up, with many innovative companies entering the field. However, the barriers in the field of electrophysiology are high, and only true gold can be found in the big waves. Farapulse took nearly 10 years to launch the FARAPULSE PFA system in the European market, and talent, technology, market, and commercialization capabilities are all indispensable.

The reason why Alpmed can make such rapid progress is also inseparable from the company's long-term accumulation.Alpmed has formed a high-precision and cutting-edge R&D team led by high-educated talents such as professors, associate professors, doctors, and masters, and has been deeply cultivating irreversible electroporation technology for nearly 10 years. All products of the company have independent intellectual property rights, with nearly 50 patents accumulated.

Based on the confidence brought by talents and technology,Alpmed has laid out in two major application markets of pulse ablation - electrophysiology and solid tumor therapy, and its product progress is leading.

The High Voltage Steep Pulse Minimally Invasive Therapeutic System under the company is the first pulse ablation system in China for the treatment of malignant solid liver tumors. It has previously obtained NMPA approval and CE certification. The product has completed nearly 300 surgeries in China and has been clinically applied in more than 30 domestic provincial-level tertiary hospitals, with treatment effects highly recognized by clinicians.

In clinical applications, for tumors that are insensitive to chemotherapy and radiotherapy, the High Voltage Steep Pulse Minimally Invasive Therapeutic System can also be combined with targeted drug therapy to effectively improve the survival period of patients with advanced pancreatic cancer.Currently,Alpmed is conducting a multi-center registered clinical trial for pancreatic cancer ablation therapy with several domestic hospitals.

Liver cancer and pancreatic cancer both have the characteristics of insidious onset and rapid progression, with a high degree of malignancy. Most pancreatic cancer patients are already in the middle and late stages when diagnosed, making surgery difficult. However, through local ablation or combined immunotherapy, Alpmed's Steep Pulse Minimally Invasive Therapeutic System will bring new solutions to patients with locally advanced pancreatic cancer, maximizing tumor control, prolonging patient life, and improving quality of life, effectively addressing clinical needs.

In the future, Alpmed will continue to enrich its two product lines for the treatment of malignant tumors and cardiovascular diseases. Based on irreversible electroporation technology, the company will expand its indications to include neurological diseases and the treatment of coronary heart disease. At the same time, the company will simultaneously promote research and development, clinical validation, and market promotion. Based on a global strategy and global patent layout, the original pulse ablation products will be further promoted to foreign markets.

Compared to mountains, Alpmed is more like a flowing stream gradually heading towards the peak of high-end medical equipment.