Primanova Medical Aims for Full Coverage in Key Areas with Next-Generation Neurosurgical Device Platform

With the continuous improvement in living standards and healthcare, coupled with the rapid acceleration of population aging, the incidence of brain diseases such as intracranial tumors, traumatic brain injury, cerebral hemorrhage, and functional neurological disorders has been on the rise in recent years. Neurosurgery, the specialty associated with these conditions, is widely recognized as one of the most complex fields in medicine.

Neurosurgical surgery is the primary treatment modality for diseases of the central nervous system. However, due to the high precision requirements and technical complexity of neurosurgical procedures, which rely heavily on surgeons’ clinical experience, issues such as unequal distribution of medical resources are pronounced given the large patient population. Consequently, the importance of neurosurgical medical devices has become increasingly prominent. Currently, there is an urgent demand in both clinical practice and the market for innovative, comprehensive solutions in neurosurgical medical devices.

In recent years, the application of cutting-edge technologies such as integrated circuits, sensors, signal processing, and artificial intelligence in medical devices has become increasingly mature, achieving iterative advancements that surpass traditional devices in departments including general surgery, cardiovascular intervention, and nephrology.Compared with other departments, the development of key devices for critical applications in neurosurgery—such as monitoring of cranial physiological parameters, cerebrospinal fluid management, and intraoperative navigation—is relatively insufficient.Drawing on the successful experience of integrating cutting-edge technologies into products in other departments, it is foreseeable that such technologies have provided significant impetus for the continuous upgrading and iteration of neurosurgical instruments, thereby helping medical institutions address critical clinical pain points.

PrimaNova Lab(Shenzhen) Limited (hereinafter referred to as “PrimaNova”) is a high-tech innovative enterprise recently identified by VCBeat, specializing in the research, development, and industrialization of next-generation, high-performance neurosurgical medical devices. The company operates on a global scale, engaging in product demand discovery, strategic layout, R&D, production translation, and promotion.

It is understood that PrimaNova was co-founded by leaders in the medical device industry with extensive global R&D and industrialization experience, scholars in the life sciences field, and clinical experts. With the Guangdong-Hong Kong-Macao Greater Bay Area serving as its base for R&D and industrialization, the company has established R&D centers in the United States and Europe. Guided by clinical needs, PrimaNova fully leverages domestic and global clinical resource advantages while integrating international advanced engineering technologies with the high-end manufacturing cluster advantages of the Greater Bay Area to develop high-performance medical devices in the field of neurosurgery.

Currently, PrimaNova is comprehensively advancing its product pipeline, with development focused on neuromonitoring, cerebrospinal fluid (CSF) management, intraoperative instruments, and surgical robots, to effectively address clinical pain points across various subspecialties of neurosurgery.

Wen Ping, Co-founder and R&D Director of PrimaNova, has many years of experience as a neurosurgeon before dedicating himself to the research, development, and industrialization of medical devices.In his conversation with VCBeat, he stated:“Compared with other disciplines, neurosurgery is more difficult to popularize and understand. In communications with clinicians, engineers often struggle to comprehend the needs and indications raised by doctors, failing to effectively integrate their technologies to develop products that meet physicians’ expectations. This remains a significant challenge facing the industry.”

Professor Pan Weisheng (center) and the founder of PrimaNova in the laboratory

In its communications, VCBeat learned that PrimaNova is led by an advisory team headed by Dr. Wen Ping; Professor Mitchel Berger, Former President of the American Association of Neurological Surgeons and Chair of the Department of Neurosurgery at the University of California, San Francisco Medical Center; and Professor Pan Weisheng, Former President of the Hong Kong Society of Neurosurgery and Director of the Center for Neuroscience at The University of Hong Kong-Shenzhen Hospital."Has effectively integrated the two distinctly different disciplines of neurosurgery and engineering technology,"Develop next-generation innovative medical device products with breakthrough clinical value.

Since its inception, PrimaNova has leveraged top-tier clinical resource networks in China, the United States, Europe, and other regions to fully engage clinical experts in product design and reviews at each development stage, ensuring that its pipeline products precisely address unmet clinical needs while delivering market and social value.

In March this year, PrimaNova held a global expert meeting in collaboration with the Clinical Research Committee on Neuropsychiatric Drugs of the China Pharmaceutical Innovation Promotion Association.In-depth discussions were held on AI-assisted neurocritical care and PrimaNova’s products under development. Participating clinical experts included Professor Mitchel Berger, Professor Pan Weisheng, Professor Zhang Yazhuo (Honorary Director of the Beijing Neurosurgical Institute and Chief Physician in the Department of Neurosurgery at Beijing Tiantan Hospital, Capital Medical University), and Professor Zhang Wangming (Deputy Chairman of the Pediatric Minimally Invasive Neurology Group under the China Maternal and Child Health Association, and Director of the Department of Pediatric Neurosurgery at Zhujiang Hospital of Southern Medical University).

On-Site at the Global Expert Demonstration Meeting of PrimaNova in March 2022

Currently, PrimaNova is fully leveraging its core technological capabilities in sensors, signal processing, artificial intelligence, and automation for active medical devices to establish a neurosurgical medical device product pipeline aimed at early diagnosis, closed-loop automated therapy, and intelligent surgical procedures, thereby building a comprehensive neurosurgery platform covering key areas.The existing product pipeline includes areas such as neuromonitoring, cerebrospinal fluid (CSF) management, intraoperative instruments, and surgical robots.

Among them, the neuro-monitoring product (SENCERE) developed by PrimaNova is an internationally innovative product.This product enables data acquisition, processing, and analysis of multiple intracranial physiological parameters, facilitating real-time computation of intracranial physiological signals, retrospective analysis of disease progression, and prediction of disease development trends.

Compared with similar products globally, it can more effectively guide clinical diagnosis, treatment, and prognosis assessment. Combined with innovative product design offering clinical advantages, it makes monitoring more human-centric and intelligent. Meanwhile, the product innovatively applies AI technology to neurological intensive care, advancing the development of “multimodal” critical care monitoring and early warning systems for disease progression trends. PrimaNova expects to submit registration applications for this product to China’s NMPA and the U.S. FDA in 2023, and is poised to become the leading domestic brand in China’s multi-billion-yuan neurological monitoring market.

In addition, the next-generation intraoperative brain functional localization and navigation device in the product pipeline was developed by Professor Mitchel Berger and commercially translated by PrimaNova.This product enables real-time intraoperative in situ analysis of brain tissue during glioma resection surgery, transforming existing clinical workflows.

Meanwhile, PrimaNova has established a strategic presence in key areas of neurosurgery, including cerebrospinal fluid management and intraoperative surgical instruments, notably through the joint development of a minimally invasive neurosurgical robot with a leading UK-based surgical robotics research institute.

Regarding the development trends of neurosurgical medical devices, Wen Ping stated:“New demands have continued to emerge over the past decade. We aim to empower traditional medical devices through innovations in new technologies such as sensors and artificial intelligence, enabling predictive analytics across various technical domains. This approach allows us to address critical challenges like early diagnosis while meeting the current needs of clinicians. Additionally, we are collaborating with several global university research institutes to pursue longer-term, more innovative breakthroughs.”

The brain is like a boundless desert; whether it involves identifying precise neural signals for early predictive diagnosis or administering subsequent therapeutic interventions for related diseases, the endeavor is akin to finding an oasis in the desert—exceptionally challenging.

Taking brain signal acquisition as an example, obtaining accurate brain signals requires establishing a direct communication and control channel between the brain and external devices. By leveraging signals generated by the central nervous system, this approach converts users’ or subjects’ perceptions, cognition, intentions, and thoughts into action commands for external devices, without relying on peripheral nerves or muscles. This enables physicians to identify intricate correlations among independent, individual brain signal parameters, thereby further recognizing disease-specific characteristics. Such advancements are inseparable from cutting-edge technologies such as artificial intelligence and big data processing.

Liu Yanshen, President of PrimaNova, told VCBeat:“Since its inception, PrimaNova has leveraged expert resources from GT Venture Capital, clinical medicine professionals both in China and abroad, as well as specialists in engineering, medical devices, and artificial intelligence technologies. The company has maintained a pragmatic yet innovation-driven approach in building its product portfolio. In light of urgent unmet clinical needs, we have identified numerous opportunities beyond our existing pipeline. We are committed to continuously providing neurosurgeons with innovative and effective clinical solutions. Guided by the principle of balancing development cycles, risks, and returns, the PrimaNova platform will continue to accelerate the R&D and industrialization of innovative products to address pressing clinical needs in neurosurgery.”

Group photo of the PrimaNova team with Dr. Cai Shaowei (center) from the Hong Kong Biopharmaceutical Innovation Association and member representatives

Looking ahead, PrimaNova is confident that, leveraging its team’s strengths and advanced technology platforms, it will continue to launch innovative medical device products and drive the advancement of neurosurgery.