ReNeuVasc Secures Tens of Millions in Series A Funding for Proprietary Active Implantable Neuromodulation Devices

36Kr has learned thatChangzhou Rishena Medical Device Co., Ltd.(hereinafter referred to as "Rishena") has completed a Series A financing round amounting to tens of millions of yuan, led by the listed companyApon MedicalandRAYSJoint Investment,Fangyuan Capital | Optimas CapitalServing as the exclusive financial advisor. It is reported that this round of financing will mainlyFor clinical trials, product development, and market promotion of implantable spinal cord stimulators.

Rishena Medical originated from the collaboration between the Institute of Microelectronics at Tsinghua University and China-Japan Friendship Hospital, which began in 2009.Novel Implantable Gastric Electrical StimulationDeviceofResearch Projects, at that time, the team began the research and development of implantable neurostimulators; after more than three years of technical practice, the gastric electrical stimulator and vagus nerve stimulator products developed by the team had commercially viable prototypes, and in 2013, they settled in Changzhou, Jiangsu, and registered the company., the implantable gastric electrical stimulator and the implantable vagus nerve stimulator completed commercial development; in 2015, its implantable vagus nerve stimulator initiated clinical trials;Currently, the product has passed clinical trials and is awaiting approval from the National Medical Products Administration (NMPA). It is expected thatExpected to be officially launched this year.

On the Clinical Significance of Implantable Vagus Nerve Stimulators,36Kr has previously provided a detailed explanation. Vagus Nerve Stimulation (VNS) is primarily targeted atFor the treatment of refractory epilepsy that cannot be resolved by either medication or lesionectomy, Du Yuhui, General Manager of Rishena Medical, stated that there are approximately 3 million such patients in China.。It is reported that VNS has an efficacy rate of over 50% in patients with refractory epilepsy (defined as at least a 50% reduction in seizure frequency), with nearly 10% of patients achieving complete seizure freedom.

Vagus Nerve Stimulation (VNS)

In 1997, the FDA approved Vagus Nerve Stimulation (VNS) for the treatment of epilepsy, leading to its international adoption; in 2012, following approval by the China Food and Drug Administration (CFDA), the technology was localized in China. However, VNS requires surgical implantation of micro-stimulation electrodes in the neck and a pulse generator in the shoulder to stimulate the cervical vagus nerve. Its widespread application has been hindered by factors such as high cost (exceeding RMB 160,000, with limited coverage under national medical insurance) and the need for parameter adjustments. It is reported that since its introduction in 2000, only a few thousand VNS procedures have been performed in China.

Du Yuhui also introduced, “Compared to the United States, which can implant 7,000-8,000 VNS devices annually, China only has 700-800 patients. Given that China's population is nearly four times that of the U.S., there is tremendous room for growth.”

She believes that the primary issue to be addressed at present is pricing, and import substitution is an inevitable trend—currentlyOnly PINS Medical's VNS product has been approved for marketing in China.; with China’s lower labor costs and the intricate manufacturing process of VNS devices—which currently rely on manual craftsmanship and are difficult to automate—once technical bottlenecks are overcome, the future domestic products will inevitably offer a higher cost-performance ratio than imported alternatives upon market launch. She anticipates that the end-user price of these future products may be only half that of imported products.

Rishena Medical's Implantable Vagus Nerve Stimulation System

Notably, Rishena Medical’s VNS product has introduced several innovations building upon existing market offerings, includingFurther optimize the manufacturing process to enhance product comfort and performance, and add remote control functionality to enablePatients can receive adjustments at home, avoiding the need for follow-up visits in other locations.。

Over the past decade, the company’s R&D efforts have not only brought its VNS products close to market launch but also yielded new discoveries and industrialization directions through continuous clinical trials. According to Du Yuhui, neuromodulation can treat a variety of conditions, including gastroparesis and chronic pain, while also improving mood, sleep, and physical development, and even addressing Parkinson’s disease... There are numerous indications yet to be explored.

It is worth noting that Rishena Medical’s current industrialization efforts extend beyond VNS; it has also independently developed stereoelectroencephalography (SEEG) deep thermal coagulation electrodes and implantable rechargeable spinal cord stimulators (SCS).

• Specifically, SEEG is primarily used to acquire stereoelectroencephalography data in epilepsy patients, thereby identifying surgical targets. However, unlike existing SEEG electrode products on the market, this device incorporates built-in temperature sensors, enabling radiofrequency thermocoagulation under closed-loop temperature control—a world-first innovation. Currently, the product is undergoing application for Class III medical device certification.

• SCS is used to treat refractory chronic pain, with the advantage of a price significantly lower than that of imported products (RMB 280,000). Patients with chronic pain account for 1% of the total population. In foreign markets, the spinal cord stimulator market equals the sum of all other neurostimulator markets combined; extrapolating this to China, its future market prospects are also considerable. The product is currently undergoing clinical trials, which are expected to be completed in 2020.

Rishena's Deep Brain Thermocoagulation Electrodes

Rishena's Implantable Spinal Cord Stimulator

Currently,Neuromodulation has become an effective clinical treatment for conditions such as Parkinson’s disease, epilepsy, depression, pain, inflammation, and metabolic disorders. New products continue to gain regulatory approval; for example, the FDA has approved the Brio Neurostimulation System (St. Jude Medical) to reduce symptoms of Parkinson’s disease and essential tremor, approved Stimwave’s miniature wireless neurostimulator system, the Freedom System™, for the relief of chronic pain, and cleared Medtronic’s Specify SureScan MRI Surgical Leads for market release, to be used in conjunction with Medtronic’s Spinal Cord Stimulation (SCS) therapy for the treatment of chronic pain.

According to Arterial Network, neuromodulation is becoming one of the fastest-growing sectors in the medical device industry; an international expert panel also pointed out at the 2019 Annual Meeting of the International Neuromodulation Society that within the next five years, the neuromodulation market will double from its current value of $4.7 billion; and within the next ten years, the neuromodulation market will grow to $11 billion. From a fundamental perspective, Rishena Medical’s industrial layout in the field of neuromodulation is well-timed.

Du Yuhui stated, “These products are generally expensive and not yet covered by medical insurance on a large scale. While they may appear to cater to a niche market, they address a highly significant social pain point that current market solutions fail to adequately resolve. It is important to recognize that having a family member with epilepsy imposes a substantial burden on both the family and society. Therefore, conducting research in this area holds profound significance for both patients and society.”

However, constrained by high technical barriers and lengthy R&D cycles, market competition remains insufficient. Currently, in China, apart from Rishena Medical, there are onlyPINS Medical、Suzhou Jingyuwith a presence in only a few companies.

As for channel promotion, Du Yuhui and her team also have a clear plan. She pointed out thatIn recent years, China’s epilepsy sector has developed rapidly, with a continuous increase in the number of clinicians engaged in epilepsy diagnosis and treatment. Medical institutions across the country have established epilepsy centers at various levels, marking a favorable stage of development. Rishena Medical will leverage this momentum to implement its precise strategic layout.

Regarding the team, the core members of Rishena Medical all come from prestigious universities in China. For instance, General Manager Du Yuhui graduated from Tsinghua University, and the R&D team members all graduated from renowned institutions such as Zhejiang University. The company currently has over 50 employees.

Investment Perspective

Cao Qi of the Strategic Development Center at Apon Medical believes:

The implantable spinal cord stimulator (SCS), developed under the leadership of Rishena Medical as part of the 2016 National Key R&D Program, is currently recognized worldwide as one of the key therapeutic approaches for intractable pain. It is also a flagship product in the pain management portfolio of industry giants such as Medtronic and Boston Scientific. Jiangsu Apon Medical Technology Co., Ltd. has long been dedicated to the research, development, and manufacturing of medical products for pain treatment and management. Rishena Medical’s research, development, and expansion of neuromodulation-based pain therapies are fully aligned with Apon Medical’s strategic focus and development direction.

Dr. Xin Xiaoxiong, Investment Director at RAYS, believes that:

Neuromodulation therapy has consistently remained a focal point for research and investment both domestically and internationally. The global market is experiencing rapid growth, while China is on the verge of an explosive expansion. Rishena Medical specializes in active implantable neuromodulation products, leveraging resources from universities and medical institutions. By targeting drug-resistant epilepsy as its entry point, the company is expanding and strategically positioning itself into broader therapeutic areas, demonstrating significant development potential.