Xinyun Medical Secures Tens of Millions in Series B Funding to Advance China's First-in-Class Pain Management Devices into Clinical Trials

Recently,New Cloud Medical Completes Tens of Millions of Yuan in B-Round Financing, Jointly Invested by Shazhou Sci-Tech Innovation Fund and Jinxin CapitalThe funds from this round of financing will be used to advance the clinical trials and registration approval of the company's domestically pioneering products, such as the NewMild minimally invasive surgical instrument suite for lumbar spinal stenosis and the closed-loop rechargeable spinal cord stimulation system. Additionally, the funds will support the continuous expansion of the R&D team and the enhancement of the company’s pain management device product line.

New Cloud Medical was founded in 2016, marking its 7th anniversary this year.. In the development process, New Cloud Medical has always adhered to the development of products centered on the treatment needs of the pain department, promoting the localization of pain devices in China and the development of the pain discipline. The company has adopted"Innovation Transformation Model of Industry-Academia-Research-Medicine Application", promoting the construction of an integrated innovation ecosystem, such as jointly establishing a new materials research and development center with Beijing University of Chemical Technology; co-building a spinal cord stimulator engineering laboratory with the Institute of Electrical Engineering of the Chinese Academy of Sciences; and collaboratively developing a series of pain-relief products with the Pain Department of China-Japan Friendship Hospital.

With the support of its profound technical accumulation and the multi-faceted roles within the industrial innovation ecosystem, New Cloud Medical has achieved rapid development.The company's wearable intelligent analgesic device, "Smart Cloud Patch," achieved rapid market promotion after obtaining the Class II certificate; the launch of a liquid vector electrode with fully independent intellectual property rights is currently being used for product prototyping; the minimally invasive surgical instrument kit NewMild, designed for lumbar spinal stenosis (LSS), is undergoing innovative application; China’s first closed-loop active implantable and rechargeable spinal cord stimulation system has completed animal experiments.。

Chronic pain is troubling 38% of the global population.According to the "Report on the Development of Pain Medicine in China (2020)", the number of chronic pain patients in China exceeds 300 million, and is increasing at a rate of 10 to 20 million people per year.With the acceleration of modern life pace and aging process, the incidence of various pain-related diseases is also increasing rapidly. Fan Bifa, director of the Pain Department at China-Japan Friendship Hospital, once stated: "The medical consultation rate for chronic pain patients in China is less than 60%, and many habitual chronic pains have not received sufficient attention."

In the eyes of some people, pain is not a disease but a tolerable sensation. However, much of the pain caused by illnesses serves as a "dangerous signal." If not addressed promptly, it can impact the treatment of the primary condition. In 2007, China officially established pain management departments, and over the past 16 years, these departments have gradually become more standardized while the number of pain management doctors has been steadily increasing. Nevertheless, overall, compared to the massive patient population of 300 million, there remains a shortage of hospitals and doctors specializing in pain management in China, along with a lack of dedicated medical equipment.

The Department of Pain Medicine is a comprehensive discipline that integrates multiple specialties. In many hospitals, the pain department is established based on departments such as Anesthesiology/Orthopedics/Interventional Medicine/Rehabilitation Medicine. Therefore, the equipment used in the pain department is mostly introduced from other departments, primarily for the treatment of primary diseases. Based on the clinical treatment needs of the pain department, New Cloud Medical focuses on independently researching and developing pain management devices, providing pain specialists with tools that are "convenient and efficient" to use.

Founder of New Cloud Medical, Zhao YunMentioned: "Innovation is at the core of enterprise development. New Cloud Medical hopes to continuously lead in innovation. Either we achieve domestic substitution, or we realize a first in China or a global first." To this end, the company has assembled a multidisciplinary team covering clinical medicine, materials science, artificial intelligence, and mechatronics engineering, while collaborating with experts from well-known universities and hospitals both domestically and internationally to jointly promote the application of medical new materials and neuromodulation technology in the field of pain management.

Currently, New Cloud Medical has built upA pain product pipeline covering three major fields: minimally invasive surgery, neuromodulation, and percutaneous electrical stimulation., several of which have broken the technological monopoly held by foreign enterprises.

In the field of minimally invasive interventions with a high volume of pain patients and surgeries, New Cloud Medical independently developedChina's First Minimally Invasive Surgical Instrument Kit for Lumbar Spinal Stenosis (LSS): NewMildThis will provide a better surgical option for hypertrophied ligamentum flavum-type LSS. This minimally invasive surgery requires only a small incision to remove excess ligament, treating LSS at its source. It also has safety characteristics similar to epidural steroid injections, allowing patients to move freely typically within 24 hours after the surgery. This not only shortens the patient's recovery period but also reduces their financial burden.

 Minimally Invasive Decompression Surgery for Lumbar Spinal Stenosis Using NewMild

Patients with lumbar spinal stenosis are widely distributed at the grassroots level. Performing surgeries through NewMild can reduce operational difficulty, shorten the learning curve for grassroots doctors, and improve the treatment rate for grassroots patients. Zhao Yun mentioned that, under voluntary and feasible conditions for patients, this minimally invasive surgical method for lumbar spinal stenosis could potentially be performed as day surgery, alleviating the issue of hospital bed shortages, and overall surgical costs would also decrease.

In the high-barrier field of neuromodulation, New Cloud Medical launchedChina's First Closed-Loop Active Implantable Rechargeable Spinal Cord Stimulation SystemIn recent years, neuromodulation technologies represented by spinal cord stimulation (SCS) have shown excellent results in treating chronic pain, prompting international giants such as Abbott and Medtronic to increase their R&D investment in SCS.

The current mainstream spinal cord stimulation system is an open-loop stimulation system. During the operation, effective stimulation parameters are selected based on the patient's paresthesia and pain relief level, and then the stimulation parameters are fixed. After a period of time post-operation, it is necessary to adjust the stimulation amplitude via remote control to reduce the possibility of overstimulation or understimulation, but there is a risk of diminished treatment effectiveness.

Since the distance between the stimulation electrode and the spinal cord changes when the patient experiences variations in breathing, coughing, heartbeat, and body position (upright, prone, supine, bending, etc.), the stimulation intensity also changes accordingly, causing the pain-relief effect of the stimulation to fluctuate. As a result, a given set of stimulation parameters may be effective in one set of body positions but lead to discomfort or poor pain relief in another set, significantly impacting the patient's experience.

New Cloud Medical independently developed a closed-loop active implantable and rechargeable spinal cord stimulation (SCS) system based on evoked compound action potential (ECAP) technology. For each stimulation pulse, ECAP reflects the degree of sensory fiber excitation it induces, thereby altering the pain coverage area of SCS. The implantable pulse generator (IPG) uses ECAP as the feedback signal for stimulation and can automatically adjust stimulation parameters to maintain the sensory fiber excitation level in the spinal cord target area within an appropriate range, achieving stable and effective pain relief.

Closed-loop Active Implantable Rechargeable Spinal Cord Stimulation System

This product is able to overcome the issue of lower clinical effectiveness associated with traditional SCS systems and is expected to "disrupt" the existing market. Currently,New Cloud Medical's closed-loop active implantable rechargeable spinal cord stimulation system has completed animal experiments and is advancing to human clinical trials.。

At the same time, based on the needs of pain management inside and outside the hospital, New Cloud Medical has established a digital pain management platform using artificial intelligence algorithms. Before surgery, it can automatically select the appropriate electrode according to the patient's condition and accurately locate the electrode implantation position, providing precise preoperative planning for clinical use; after surgery, it can monitor the patient's status in real time and record relevant data, helping doctors achieve remote monitoring, which facilitates out-of-hospital management.

 Preoperative Precision Planning for SCS Based on Artificial Intelligence

The huge demand for pain treatment has created a 100-billion-yuan market, which is still a blue ocean at present, waiting for pioneers to explore. In the future, New Cloud Medical will continue to develop and iterate its products based on the treatment needs of pain departments. It will also expand its product lines to meet the demands of niche markets and provide more comprehensive solutions for pain management devices. In the increasingly competitive field of medical devices, it is difficult for a single product to dominate the market, and technology is constantly evolving, testing the innovation capabilities and industry layout of enterprises.New Cloud Medical plans to launch innovative products every six months. Currently, the company has about 11 innovative devices in progress.。

Regarding this round of financing,Shazhou Sci-Tech Innovation FundRemarks: New Cloud Medical is a key industry introduced and developed by Zhangjiagang City. The field of New Cloud Medical aligns perfectly with the city's industrial development direction. As an emerging medical field, pain management has vast development potential. In the future, China’s chronic pain medical device market holds enormous growth potential, and New Cloud Medical, as a pioneer, has a first-mover advantage. At the same time, New Cloud Medical boasts a solid team configuration and a prestigious lineup of expert advisors, which can provide strong support for the company’s development. We firmly believe that the project will have excellent development prospects.

Jinxin CapitalRepresentation: Jinxin Capital focuses on the "3+N" industrial cluster development of the park and town, and is committed to integrating high-quality project resources to empower the high-quality development of the park and town's industries. New Cloud Medical's innovation capability in pain management devices stands out, with multiple technologies at a leading level domestically. It possesses the innovative elements required to build a first-class medical device industry base in China. It is believed that by investing in New Cloud Medical, the agglomeration effect can be further enhanced, promoting the quality improvement and upgrading of the park and town’s industrial system. At the same time, through investment-driven guidance, it will help New Cloud Medical accelerate the R&D process, empowering hospitals and doctors with innovative technology for the benefit of pain patients.

Zhangjiagang Shazhou Sci-Tech Innovation Fund, jointly established by the Zhangjiagang Science and Technology Bureau and Zhangjiagang Innovative Investment Group, adopts a direct investment strategy. It focuses on emerging industrial chain projects such as specialty semiconductors, biomedicine and high-end medical devices, new energy, and the digital economy. Among these, healthcare and high-end medical devices are also key areas of focus for the fund. By attracting a group of potentially high-quality projects with advanced industrialization, high market recognition, and significant technological content, the fund aims to bring "fresh impetus" to Zhangjiagang's industrial development and promote industrial transformation and upgrading.

Zhangjiagang Jinxin Capital Investment Management Co., Ltd. mainly engages in investment financing, capital operation, and industrial cultivation. It focuses on the development of the "3+N" industrial cluster in the industrial park and town, creating an information window for industrial capital in the area. It actively plays a role in capital allocation, flexibly utilizing various investment methods to guide social capital investment into the industries of the industrial park and town. By integrating internal and external resources, channeling funds, and using investment as a guide, it promotes the enhancement, supplementation, extension, and strengthening of the industrial chain in the industrial park and town. Through strategies of "bringing in" and "going global," it leads state-owned capital and enterprises in the industrial park and town toward broader opportunities.

Reference: "Over 300 Million Chronic Pain Patients in China, Pain Has Become the Third Major Health Problem" — Xinhua News Agency