On January 20th, the National Medical Products Administration approved the registration applications for Xinuopu Medical Technology (Beijing) Co., Ltd.'s "Cryoablation Device" and Wuhan Kaidewis Biotechnology Co., Ltd.'s "Human CDO1/AJAP1/GALR1 Gene Methylation Detection Kit (Fluorescent PCR Method)", two innovative products.

Xinnopu Medical specializes in the field of electrophysiology
Xinnopu Medical, founded in 2005, has been focusing on the field of cardiac electrophysiology for nearly 20 years and continues to lead industry technological innovation. It is a leader in the Chinese atrial septal puncture market. At present, Xinnopu Medical's existing products cover dozens of categories including atrial septal puncture instruments, diagnostic instruments, and therapeutic instruments, and have established a complete business system covering research and development, manufacturing, and sales.

Xinnopu Medical is actively promoting revolutionary innovation projects such as cryoablation system (Nordica), 3D mapping system (Meridian), intracardiac ultrasound (ICE) diagnostic catheter and equipment (enVision) with the innovation research and development center in the United States as the engine, comprehensively improving surgical outcomes, continuously enhancing the safety and effectiveness of atrial fibrillation surgery, continuously improving the clinical operation experience of surgeons, and benefiting the vast number of cardiovascular disease patients.

Atrial fibrillation (AF), abbreviated as "atrial fibrillation", is the most common disease among rapid cardiac arrhythmias. At present, cryoablation for pulmonary vein isolation (PVI) has become one of the mainstream methods for treating drug-resistant atrial fibrillation. The principle is to use a cryoballoon to adhere to the pulmonary vein opening, and use low temperature to inactivate the tissue, thereby achieving the therapeutic effect of isolating electrical signals and allowing the heart to resume normal beating. With its "Single Shot" ablation method, cryoablation technology significantly shortens the surgical duration and optimizes the learning curve, and has been widely used in atrial fibrillation ablation surgery worldwide.

The cryoablation device approved for market this time consists of a host, coaxial fluid connecting tube, and connecting cable, which are used in conjunction with the balloon type cryoablation catheter produced by the company. It adopts pressure flow dual control technology, and achieves pressure stability of the balloon during inflation and ablation by real-time monitoring and control of refrigerant flow rate and balloon pressure. This technology can effectively reduce the risk of bouncing and displacement caused by pressure fluctuations during the occlusion and ablation of pulmonary veins, and is used for the treatment of drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation in adult patients.

In addition to this cryoablation device, Xinnopu Medical also has a heavyweight product that may be launched in 2025, which is also the Nordica cryoablation system mentioned earlier. Nordica has improved the design of cryoballoons and circular mapping catheters. The balloon adopts a single-layer polyurethane design, with adjustable balloon size, and maintains low pressure and constant pressure inside the balloon during the freezing process.

The latest update shows that Nordica's latest animal experiment results were released in June 2024, which showed that 50% of pulmonary veins can achieve "Single Shot" to achieve acute and persistent isolation; The width of the cryoablation lesion is greater than 10mm, and all of them are transmural injuries; No major perioperative complications or instrument failure; No related adjacent tissue or downstream organ damage.

Caldwell, innovative products provide more choices
Founded in February 2018, Kaidewisi focuses on the development and service of diagnostic reagents, innovative biological drugs, and technologies, covering the entire process of early prevention, screening, diagnosis, intraoperative auxiliary diagnosis, and treatment of five major diseases, especially gynecological tumors. We are committed to providing effective and accessible innovative solutions for the entire disease process.

According to the Medicine Intelligence Data Investment Pattern Database, on December 5, 2024, Kaidewis successfully completed its Series B financing, with a total amount of up to 200 million yuan.

Endometrial cancer, also known as uterine body cancer or uterine body cancer, is a common malignant tumor in the female reproductive tract. It can occur at any age, with an average age of around 55 years and a peak onset age of 55-60 years. 50% -70% of cases occur after menopause. In China, the incidence rate of uterine body cancer is only second to cervical cancer and ovarian cancer and ranks the third in malignant tumors of female reproductive organs.

The product kit approved for listing this time is an innovative product developed by Kaidewei Biotechnology, and its core patent is the first of its kind by our team, EcPredict ® Kaiyijian effectively fills the technical gap in non-invasive screening of clinical endometrial cancer in the industry, overturning the dilemma of traditional invasive sampling pathological examination that cannot be promoted at the grassroots level. Combined with the unique disposable endometrial shedding cell sampler "Kaishi brush", it applies highly sensitive and specific molecular diagnostic technology to detect methylation of ultra small amounts of endometrial shedding cells.

In addition, the project targeted the candidate targets of methylation in Chinese population through DNA methylation sequencing of clinical samples of endometrial cancer in Chinese population, and screened three optimal target combinations CDO1, AJAP1 and GALR1 through the expanded test of more than 1000 samples, and used them together for the first time for early auxiliary diagnosis of endometrial cancer.

According to Caldwell's introduction, this product has a sensitivity specificity of over 90% and excellent precision. It can perform well in dealing with various subtypes of endometrial cancer, demonstrating a wide range of applicability. And it effectively fills the gap of poor accuracy in endometrial cancer screening with vaginal ultrasound, becoming a powerful weapon to improve detection accuracy., It can also adapt to multiple fluorescence quantitative PCR instruments, covering both imported and common domestic models.

It is worth mentioning that, EcPredict ® Kaiyijian is the first domestically approved innovative medical device for endometrial cancer methylation since the implementation of the Special Approval Procedure for Innovative Medical Devices in 2014.

Source:
https://news.yaozh.com/archive/44854.html?u_atoken=285f8c7016b1688a3ca5bcb5034ba98b&u_asig=0a47309317375956293303038e0051