Recently, NewCloud Group has completed tens of millions of dollars in Series B financing. The amount of this round of financing will be used to advance the clinical trials and registration approval of the company’s first domestic products such as NewMild, a minimally invasive surgical instrument kit for lumbar spinal stenosis, and the closed-loop active implantable rechargeable spinal cord electrical stimulation system, to continue to expand the research and development team, and to improve the company’s series of pain device product line.
NewCloud Group was founded in 2016 and has entered its 7th anniversary. In the process of development, NewCloud Group has always insisted on developing products centered on the treatment needs of the pain department, and promoting the localization of domestic pain devices and the development of the pain discipline. The company has adopted the innovation and transformation mode of “industry-university-research-medical” to promote the construction of an integrated innovation ecosystem.
NewCloud Group has realized rapid development with the support of its own profound technology accumulation and the role of industrial innovation ecosystem. The company’s wearable intelligent analgesic device “Intelligent Cloud Patch” has realized rapid market promotion after obtaining the Class II certificate; the company has launched liquid vector electrodes with completely independent intellectual property rights, which are being used in product prototypes; the minimally invasive surgical instrument suite NewMild for lumbar spinal stenosis (LSS) is in the process of filing an innovation declaration; and the first closed-loop active implantable cosmeceutical device in China is in the process of filing an innovation declaration. The first closed-loop active implantable rechargeable spinal cord electrical stimulation system has completed animal experiments.
Chronic pain is plaguing 38% of the global population. According to China Pain Medicine Development Report (2020), there are more than 300 million chronic pain patients in China, and the number is growing at a rate of 10-20 million per year. With the accelerated pace of modern life and the accelerated aging process, the incidence of various painful diseases is also growing rapidly. Fan Bifa, director of the pain department of China-Japan Friendship Hospital, has said, “The consultation rate of chronic pain patients in China is less than 60%, and a lot of chronic pain that is taken for granted has not been given enough attention.”
In some people’s eyes, pain is not a disease, but a tolerable feeling, but a lot of pain caused by diseases are “danger signals”, if not dealt with in a timely manner, it will affect the treatment of the primary disease. 2007, China’s pain department was formally established, so far, there have been 16 years, the construction of the department has been gradually standardized, and the number of pain doctors is also gradually growing. has been gradually standardized, and the number of pain doctors is also gradually growing. However, in general, compared with the huge patient group of 300 million, the number of hospitals and doctors opening pain departments in China is insufficient, and there is also a lack of specialized medical equipment.
Pain medicine is a multidisciplinary and comprehensive discipline, and many hospitals have established pain medicine departments on the basis of anesthesiology/orthopedics/interventional medicine/rehabilitation departments, etc. Therefore, the equipment used in pain medicine departments is not sufficient. Therefore, the instruments used in pain departments are basically imported from other departments to treat primary diseases. NewCloud Group focuses on the development of its own pain instruments to provide pain doctors with “hand-held” tools to meet the clinical needs of pain departments.
Founder of NewCloud Group, Mr. Zhao Yun, said, “Innovation is the core of enterprise development, and NewCloud Group hopes to continue to lead the way in innovation. We will either be a domestic alternative, or the first in China or the first in the world.” To this end, the company has set up a multidisciplinary team covering clinical medicine, materials science, artificial intelligence, electromechanical engineering and other disciplines, and has cooperated with domestic and foreign well-known universities, hospitals and other experts to jointly promote the application of new medical materials, neuromodulation technology and other technologies in pain departments.
At present, NewCloud Group has built up a pain product pipeline covering the three major fields of minimally invasive surgery, neuromodulation, and transcutaneous electrical stimulation, and a number of its products have broken the technological monopoly of foreign enterprises.
In the field of minimally invasive intervention, which covers a large number of pain patients and a large volume of surgeries, NewCloud Group has independently developed the first minimally invasive surgical instrumentation suite for lumbar spinal stenosis (LSS) in China, NewMild, which will provide a better surgical procedure for the ligamentum flavum hypertrophicum type of LSS. The minimally invasive procedure removes the excess ligament through a tiny incision, treating LSS at its source with safety features similar to epidural steroid injections, and allows patients to move around freely, usually 24 hours after the procedure, shortening their recovery period while reducing their financial burden.
Lumbar spinal stenosis patients are widely distributed at the grassroots level, and performing the surgery through NewMild can reduce the difficulty of the operation, shorten the learning curve of grassroots doctors, and increase the treatment rate of grassroots patients. Zhao Yun mentioned that when patients volunteer and conditions permit, this type of minimally invasive lumbar spinal stenosis surgery is expected to be performed as day surgery, alleviating the problem of hospital bed tension and reducing overall surgical costs.
In the high-barrier field of neuromodulation, NewCloud Group launched the first closed-loop active implantable rechargeable spinal cord electrical stimulation system in China. In recent years, neuromodulation technology represented by spinal cord electrical stimulation (SCS) has shown excellent results in the treatment of chronic pain, and international giants such as Abbott and Medtronic have increased their investment in SCS research and development.
The current mainstream spinal cord electrical stimulation system is an open-loop stimulation system. Intraoperatively, effective stimulation parameters are selected based on the patient’s sensory abnormalities, the degree of pain relief, and the stimulation parameters are fixed after determination. Some time after surgery, the stimulation amplitude needs to be changed by remote control to reduce the possibility of over- or under-stimulation, but there is a risk of diminished therapeutic effect.
Since the distance between the stimulation electrodes and the spinal cord changes when the patient breathes, coughs, beats and changes in body position (upright, prone, recumbent, bent over, etc.), the stimulation intensity changes, and the analgesic effect exerted by the stimulation also changes. As a result, a given set of stimulation parameters may be effective in one set of positions but result in discomfort or poor pain relief in another set of positions, thus greatly affecting the patient experience.
NewCloud Group has developed its own closed-loop active implantable rechargeable spinal cord electrical stimulation system based on evoked compound action potential (ECAP) technology. For each stimulation pulse, ECAP reflects the degree of sensory fiber excitation it elicits, which in turn alters the pain coverage area of the SCS. The impulse generator (IPG) adopts ECAP as the feedback signal of stimulation, and can automatically adjust the stimulation parameters to keep the excitation level of sensory fibers in the target area of the spinal cord within an appropriate range, and realize stable and effective analgesic effect.
This product can overcome the problem of low clinical effectiveness of traditional SCS systems and is expected to “disrupt” the existing market. Currently, NewCloud Group’s closed-loop active implantable rechargeable spinal electrical stimulation system has completed animal testing and is advancing into human clinical trials.
Meanwhile, based on the demand for pain management both in and out of hospitals, NewCloud Group utilizes artificial intelligence algorithms to establish a digital pain management platform, which automatically selects the appropriate electrodes according to the patient’s condition and accurately locates the electrode implantation position before the operation, providing precise pre-operative planning for the clinic; and detects the patient’s status in real time after the operation and records the relevant data, which helps doctors to realize remote monitoring, and facilitates the implementation of out-of-hospital management. Postoperative real-time detection of patient status and recording of relevant data help doctors realize remote monitoring and facilitate out-of-hospital management.
The huge demand for pain treatment has created a market of hundreds of billions of dollars, which is still a blue ocean waiting to be explored by the pioneers. In the future, NewCloud Group will continue to develop and iterate its products according to the needs of pain management, and expand its product line to meet the needs of specific areas and provide more comprehensive pain device solutions. In the increasingly competitive medical device field, it is difficult for a single product to sustain a large market, and the technology is constantly being iterated, testing the innovative strength and industrial layout of the company.NewCloud Group plans to launch innovative products in half a year, and at present the company has about 11 innovative devices in progress.