VB-Find Award: Top 100 Most Innovative Medical Devices of 2023 Announced Amid IPO Filing

Since the introduction of the “green channel” for innovative medical devices in 2014, domestically produced innovative medical devices have been approved and launched at an accelerated pace. According to data from Guotai Junan Securities’ report, “Opportunities in the Innovative Medical Device Industry Are Drawing Near,” as of December 2022, more than 400 products had entered the special review pathway for innovative medical devices, with the majority being domestically produced. In terms of therapeutic areas, vascular intervention, in vitro diagnostics (IVD), and imaging equipment were the top three categories included in the green channel.

Innovation is the inevitable path for China’s medical device industry to advance toward the high-end segment.On the path of development, domestic innovation remains the central theme in the upgrading of China’s medical device industry. Medical device companies with independent R&D capabilities, high value-added products, and differentiated competitive advantages are poised for rapid growth. Compared with pharmaceuticals, medical devices undergo faster innovation cycles; a single niche segment often comprises multiple individual products that together form comprehensive solutions tailored to a broader range of clinical needs.

To identify healthcare innovation products (solutions) that are technologically advanced, meet clinical medical needs, and demonstrate outstanding industry leadership, VCBeat VB100 launched an annual brand selection campaign for innovative products (solutions) in the healthcare industry in 2022—VB-Find Award，“Find“Symbolizing the journey of discovery and exploration in the field of life and health, it also refers to innovative products that have been discovered and are transforming modern healthcare.”VCBeat VB100 aims to build a platform for showcasing frontier research and applied achievements in healthcare through the VB-Find Award, empower brand growth for healthcare companies, and conduct an in-depth analysis of the current development status of China’s healthcare industry while exploring future paradigms of medical innovation.

In June 2023, the VB-Find Award launched a call for entries targeting innovative medical device products (solutions), including high-value consumables, medical equipment, and in vitro diagnostics. Over a period of nearly 40 days, through a rigorous selection process involving corporate registrations, institutional recommendations, expert reviews, and cross-verification, the AFIC-12Ps assessment model was employed to evaluate the annual performance of participating medical device products (solutions). This evaluation involved weighted scoring across four dimensions—application value, driving support, innovation and iteration, and interactive communication—comprising a total of 12 indicators. Ultimately, 100 shortlisted products (solutions) were selected from more than 300 applications.

For this year’s VB-Find Awards, the organizing committee invited a total of eight companies from the 2023 Top 100 Future Healthcare Companies · Pengcheng Awards.Annual Medical Device Investment Institutions, 2 companies on the 2023 Future Healthcare Top 100 · Pengcheng Award ·Annual Healthcare Financial Advisory FirmTen senior medical device investors from ten institutions served as judges, conducting weighted scoring and cross-evaluation of submitted projects based on the AFIC-12Ps assessment model; they also recommended outstanding innovative medical device products that had not been submitted for participation in the selection. We extend our special thanks to the ten supporting organizations for their support of this year’s VB-Find Award selection process.

VB-Find Award：2023Most Innovative Medical Device Product (Solution) of the YearTOP100Released on August 12, 2023, at the 2023 Summit on Medical Device Product Innovation and International Cooperation.

In recent years, cutting-edge technologies such as artificial intelligence, 3D printing, 5G, and polymer materials have been applied to the research and development of medical devices and clinical studies. The interdisciplinary integration of medicine and engineering has driven advancements in materials, structural design, control systems, and biosignal processing, leading to breakthroughs in the development of artificial organs such as wearable textile exoskeletons, artificial hearts, and artificial eyes. Each technological advancement gives rise to new products, delivering tangible clinical benefits to patients.

Among the selected products, the Organizing Committee attempted to analyze each product from multiple dimensions—including technological innovativeness, product uniqueness, innovation progress and achievements, application value, market potential, and policy support/capital backing—so as to gain a more comprehensive perspective on the direction of innovation in medical devices, as well as the progress of product development and commercialization.This article provides a brief overview of the selected exemplary case products. For more information, please stay tuned.“VB-Find Product InformationQ＆APoster”

Selected Products:Respacio®Radiotherapy Protection Isolation Hydrogel

Product Stage:Clinical Trials

Product Introduction:

Respacio®ReleaseRadiotherapy Protection and Isolation Hydrogel—The world’s first radiotherapy protection and isolation product for cervical cancer, implanted via minimally invasive injection between the tumor and the rectum to establish a stable separation space, thereby significantly reducing radiation dose to the rectum and other adjacent healthy tissues and effectively lowering the risk of radiation-induced rectal injury.Currently, Respacio®Registrational clinical trials are currently underway at several renowned tertiary A-grade hospitals in China, including Peking Union Medical College Hospital, Fudan University Shanghai Cancer Center, and Sun Yat-sen University Cancer Center. Enrollment of all clinical cases has been completed, and the clinical data have met favorable expectations.

Product Technological Innovation:

Although polyethylene glycol (PEG) hydrogel products have been developed abroad for a considerable period, the precise regulation of PEG hydrogel properties remains a significant technical challenge.RuiNing Biotech has pioneered an innovative PEG hydrogel technology platform. By leveraging proprietary PEG derivative technology and advanced storage processes, the company has extended the stability of PEG derivatives in aqueous solutions from one hour to over two years, significantly enhancing product shelf-life stability and ease of use.

Product Uniqueness:

Through continuous technological breakthroughs, Ruining Biology has achieved precise control over a series of properties of hydrogels, including in situ curing characteristics, mechanical performance, degradation profiles, swelling behavior, and biocompatibility. The company has established its proprietary, globally pioneering “ready-to-use” PEG hydrogel platform and provides innovative hydrogel solutions tailored to clinical needs. In response to the high incidence of cervical cancer and the prevalent use of radiotherapy in China, Ruining Biology has developed the world’s first hydrogel spacer for radiation protection in cervical cancer treatment. Furthermore, it has established a clinical treatment protocol for cervix-rectum separation based on this product, aimed at reducing or preventing radiation-induced rectal injury.

In addition to integrating currently prevalent radiotherapy modalities, Respacio®It is also expected to facilitate the upgrading of radiotherapy models, including increasing the dose per fraction, shortening the radiotherapy course, and supporting re-irradiation for recurrent tumors, which holds significant importance for improving radiotherapy outcomes and quality of life in cancer patients.

Product Innovation Progress and Achievements:

Ruining Biotechnology’s outstanding technical capabilities have endowed its core products with unique originality on a global scale. The related research achievements have been granted multiple Chinese invention patents, and numerous PCT and U.S. patent applications have been filed.

Respacio Biotech®ProductAt the Multidisciplinary Symposium of the Chinese Collaborative Group on Radiation-Induced Intestinal Injury and the 2nd China Summit Forum on Pelvic Radiation Injury, held in April 2023, Professor Zhang Fuquan’s team from the Department of Radiation Oncology at Peking Union Medical College Hospital presented, for the first time globally, the summary report of Phase I of the product’s registrational clinical trial along with outstanding clinical cases. The clinical data were favorable and met the predefined objectives.

Meanwhile, Ruining Biotech is accelerating the expansion of indications for its radiotherapy protection and isolation hydrogel to benefit a broader population of cancer patients: Respacio®The product has also completed enrollment of multiple patients for the prostate cancer indication.

VB-Find Product InformationQ＆APoster

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Selected Products:ComboKnife®Composite Cryo-Thermal Ablation System

Product Stage:Approved for Market Launch

Product Introduction:

Comboknife®The “Yi” Series Combined Cryo-thermal Ablation System is a minimally invasive tumor treatment technology that integrates deep cryotherapy with high-intensity heating. It is used for the cryoablation of solid tumors in clinical practice, excluding hollow organ tumors, such as liver cancer, lung cancer, renal cell carcinoma, breast cancer, pancreatic cancer, and prostate cancer.In addition to human-machine interaction, CNC execution, and artificial intelligence, this generation of products introduces more than ten new safety protection systems, such as an independent RFID permission-based identity authentication and authorization system, emergency stop button, alarm system, integrated delivery tube, and pressure balance system.The world’s thinnest 1.7mm phase-change ablation needle and multi-modal ablation needle matrix, easily accommodating various surgical protocols.

Product Technological Innovation:

① True Intelligent Manufacturing in China:The world’s first tumor ablation technology integrating deep cryogenic freezing and high-intensity heating was proposed and implemented.The same microprobe achieves an ultra-wide temperature range from -196°C to +80°C, innovatively integrating the advantages of deep cryoablation and high-intensity hyperthermia. This significantly enhances the therapeutic efficacy of cryoablation for tumors, while addressing a series of issues associated with previous cryoablation products, such as incomplete treatment, high recurrence rates, prone to bleeding along the needle tract, and risk of tumor seeding.

② Highly Integrated Design: Eliminates the need to maneuver bulky traditional gas cylinders; supported by a UPS system and featuring quick-connect plug technology for a single circuit, it achieves thermal insulation across all pathways outside the treatment zone, maximizing safety assurance in all scenarios.

③ World-leading technical barriers and patent moat: Pioneered the technology for uniform, stable multi-channel transport of hot and cold working fluids with independent, rapid switching; holds proprietary patented technologies including self-designed valve boxes, ultra-low temperature adjustable valves, and cryogenic control software.

Product Uniqueness:

The Kangbo Knife is indicated for the treatment of solid tumors, excluding hollow organ tumors. Its broad range of indications facilitates clinical application across various departments and healthcare institutions at all levels. The product offers numerous clinical advantages, including minimal procedural pain, good tolerability, no requirement for general anesthesia, and low interference with pacemakers, thereby rapidly gaining widespread clinical acceptance.

Innovation and Achievements of the Product:

With over 18 years of technological accumulation, the team has developed an internationally original composite cryo-thermal ablation technology, earning the William Berg Award, the highest international honor in the field of heat transfer. The team has also facilitated the publication of expert consensus statements on the use of the Combo Knife for treating liver and lung cancer, establishing a dual-technology platform integrating percutaneous interventional and transvascular interventional techniques. To date, the team has secured more than 200 product patents, possessing a comprehensive system of independent intellectual property rights.

VB-Find Product InformationQ＆APoster

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Selected Products:uMI Panorama All-Digital PET-CT

Product Stage:Approved for Market Launch

Product Introduction:

uMI Panorama is the latest generation of fully digital PET/CT systems launched by United Imaging Healthcare. Built on the uExcel technology platform, it incorporates all groundbreaking hardware and software innovations from this platform. Driven by the first “Chinese chip” in the field of high-end medical equipment, uMI Panorama achieves industry-leading performance across all core metrics. Empowered by artificial intelligence throughout the entire workflow, it comprehensively revolutionizes system design, ushering in a new era of precision diagnosis and treatment.

Product Technological Innovation:

Centered on the uExcel Unlimited Platform, the uMI Panorama features a highly integrated, modular, and unitized detector design. Within the PET imaging paradigm that values extended axial field of view (FOV), it achieves flexible axial FOV expansion and a substantial increase in system sensitivity. This facilitates precise diagnosis and treatment of minute lesions, meeting users’ evolving demands for superior PET/CT performance across diverse clinical and research scenarios, thereby granting molecular imaging greater freedom for exploration.

Selected Products:Ultra-High-Throughput Gene Sequencer DNBSEQ-T20×2

Product Stage:Approved for Market Launch

Product Overview:

DNBSEQ-T20×2 (hereinafter referred to as “T20”) is an ultra-high-throughput gene sequencer launched by MGI in February 2023. Designed to meet the most challenging sequencing demands, it aims to support large-scale genomics projects worldwide and provide tools for multi-omics research and applications in human health and disease.

The T20 is primarily composed of a reagent module, a biochemical module, two optical modules, a power module, and an optional BIT module. It breaks away from the traditional design of closed-loop biochemical fluidic systems by adopting an open system and modular architecture. Owning such a device is equivalent to having a “sequencing factory.” In terms of its biochemical technical approach, the T20 innovatively employs a submerged biochemical reaction system, which significantly enhances sequencing efficiency and scale while further reducing sequencing costs. Building on the completion of 50,000 human whole-genome sequencing cases, it has lowered the cost per individual whole-genome sequence to under $100, setting a new global record for both throughput and per-sample cost in gene sequencers.

Currently, the T20 can simultaneously support the loading and operation of six ultra-large sequencing flow cells. Each flow cell not only operates independently with different sequencing read lengths and applications but also supports mixed sequencing of different libraries. At present, the T20 platform enables a variety of applications, including whole-genome sequencing (WGS), whole-genome bisulfite sequencing (WGBS), single-cell sequencing, and spatial omics sequencing. This better meets the demands of scientific and clinical research based on ultra-high-throughput sequencing, facilitates the launch of large-scale sequencing projects in genomics, multi-omics, and spatial omics, and opens up new possibilities for the future of genetic technology.

Product Technological Innovation:

① Ultra-high throughput: This product can elevate sequencing production scale to a new order of magnitude within a short period, while supporting the simultaneous operation of six ultra-large sequencing flow cells. Each flow cell can independently run different sequencing read lengths and applications, and also supports mixed sequencing, thereby maximizing sequencing efficiency and scale. A single run of the DNBSEQ-T20×2 achieves a throughput of up to 42 Tb (PE100) or 72 Tb (PE150), which is 4.5 to 7 times that of conventional ultra-high-throughput sequencers. The DNBSEQ-T20×2 can complete up to 50,000 human whole-genome sequencing cases per year.

② Ultra-low cost: Based on MGI’s proprietary DNBSEQ technology, the DNBSEQ-T20×2 adopts an innovative immersion-based biochemical reaction technique, whereby flow cells are directly immersed in reagent troughs for biochemical reactions, ensuring uniformity and stability. Meanwhile, the sequencing reagents in the troughs support multiple immersions of the flow cells, thereby minimizing consumable costs to the utmost extent. On the basis of completing 50,000 human whole-genome sequencing cases, the cost per individual whole-genome sequencing has been reduced to under USD 100.

③ Ultra-Large Scale: MGI’s DNBSEQ-T20×2 provides an optional one-stop toolkit for ultra-large-scale genomics projects, including sample preparation systems and reagents, automated library preparation equipment, library preparation reagents, and a suite of tools and modules supporting massive data processing. These include the ZTRON Pro, which offers petabyte-level data storage and accelerated bioinformatics analysis capabilities, and ZLIMS Pro+, which enables sample management, laboratory production, and genomic data management.

In addition to developing new innovative medical devices, the continuous innovation and iteration of existing products are also significant drivers in promoting original innovation and the substitution of imported products with domestically produced alternatives. This year’s selection has garnered support from dozens of outstanding products selected in previous editions, which have actively participated in the current application process. As evident from their product summaries, these innovative medical devices remain highly competitive in their respective niche markets. This article provides a brief overview of the innovative medical devices that were selected in previous editions and have once again applied this year.

Product Name：LuX-Valve Plus Transcatheter Tricuspid Valve Replacement System

Product Stage:Clinical Trials

Product Overview:

Jian Shi Technology’s independently developed second-generation transcatheter tricuspid valve replacement system, LuX-Valve Plus, is specifically designed for patients with severe tricuspid regurgitation. LuX-Valve Plus functionally replaces the patient’s dysfunctional native tricuspid valve with a prosthetic valve stent. Utilizing a transvascular delivery system via the transjugular approach, this method is expected to effectively simplify the procedural workflow, resulting in shorter operative times, smaller incisions, and reduced trauma to cardiac tissue. Furthermore, the delivery system of LuX-Valve Plus allows for multi-angle adjustment and deflection, enabling physicians to more conveniently optimize the deployment position and angle. This enhances the overall safety profile of the product and effectively alleviates the suffering caused by severe tricuspid regurgitation.

The market for structural heart disease is currently vast yet underpenetrated. With limited efficacy from pharmaceutical and surgical interventions, Jian Shi Technology’s core product, LuX-Valve Plus, has completed early-stage human clinical trials. This advancement is poised to unlock treatment demand, positioning the device as one of the first products to achieve commercialization in this field.

Product Name:Disposable Circular Pulmonary Artery Radiofrequency Ablation Catheter

Product Stage:Approved for Market Launch

Product Introduction:

Since its establishment in 2013, Pama Medical has remained dedicated to overcoming the therapeutic challenges of pulmonary hypertension, successfully developing China’s original disposable circular radiofrequency ablation catheter for the pulmonary artery (hereinafter referred to as the “PADN Catheter”).

The PADN catheter is designed for use in Pulmonary Artery Denervation (PADN) (hereinafter referred to as “PADN procedure”). As a breakthrough innovative therapy for pulmonary hypertension, the PADN procedure ushers in a new era of device-based interventions for this condition. The PADN procedure utilizes the PADN catheter to ablate sympathetic nerve fibers adjacent to the pulmonary arteries. By inducing localized thermal injury, it disrupts signal transmission between the sympathetic nerves and the pulmonary arteries, thereby reducing pulmonary arterial pressure. Preclinical and clinical studies have demonstrated that sympathetic nerves are predominantly distributed in the distal main pulmonary artery and its left branch. Ablation at the pulmonary artery bifurcation using the PADN catheter can lower pulmonary arterial pressure, reduce pulmonary vascular resistance, improve hemodynamics, and enhance clinical efficacy, with no significant adverse effects observed.

To date, the PADN catheter has secured over 50 invention patents and methodological protections both domestically and internationally, successfully entered the National Medical Products Administration (NMPA) Special Review Procedure for Innovative Medical Devices, and maintained CE certification for six consecutive years. In 2021, the PADN catheter obtained Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) in just 16 days, setting a new record for the shortest approval timeline achieved by a Chinese domestic enterprise. With the inclusion of the PADN procedure in the ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension in July 2022, and its increasing presence on major academic platforms worldwide in recent years, continuous clinical study results have demonstrated its safety and efficacy. It is anticipated that the formal commercialization of the PADN catheter will bring significant benefits to patients.

Product Name:UGO Interactive Rehabilitation Exoskeleton

Product Stage:Approved for Market Launch

Product Introduction:

Prior to the establishment of Hangzhou Chengtian Technology Co., Ltd., the founding team was dedicated to accumulating project experience in core exoskeleton components and their applications, including special-purpose robots, underwater robots, and industrial robots. In 2017, three years after the company’s inception, the Youxing series of rehabilitation exoskeleton products were launched and underwent a second iteration, providing digital and intelligent services covering the entire rehabilitation cycle for medical institutions and individual users. In early 2021, two iterated models of the Youxing series rehabilitation exoskeletons obtained National Medical Products Administration (NMPA) medical device registration certificates with an approved scope of application for central nervous system disorders, thereby meeting industry access standards. Subsequently, Chengtian Technology comprehensively initiated the construction of an exoskeleton supply chain ecosystem, explored innovative business models, integrated industry resources, secured capital support, and implemented standardized group operations.

Among these, the core exoskeleton product, the UGO Series Rehabilitation Exoskeleton, is designed specifically for individuals with lower-limb motor dysfunction based on the principle of “neuroplasticity.” It facilitates scientific, efficient, and accurate gait rehabilitation training by driving lower-limb movements through external mechanics, thereby stimulating neural system remodeling, enhancing independent walking ability, and promoting recovery.

In the second half of 2021, Chengtian Technology comprehensively launched its market expansion for rehabilitation and elderly care robots. To date, its solutions have been deployed in over 540 medical institutions across China, covering more than 92% of provincial-level administrative regions, with cumulative usage exceeding 300,000 sessions. Following the completion of a new round of financing, Chengtian Technology expects to achieve 50% coverage among the top 100 rehabilitation hospitals in China by 2022, extending rehabilitation services to 95% of Chinese cities at the prefecture level and above. Meanwhile, industrial application products based on its core underlying technologies have also been marketed independently to 24 countries and regions both domestically and internationally.

Product Name:K-Clip®Transcatheter Tricuspid Annuloplasty System

Product Stage:Clinical Trials

Product Introduction:

This product is the world’s first transcatheter tricuspid valve repair system featuring ultrasound-guided positioning and repeatable deployment. Its mechanism of action is as follows: Under ultrasound guidance, the system is precisely navigated via the jugular vein and superior vena cava to the designated area of the tricuspid valve. The clipping component grasps the dilated tricuspid annulus tissue, reducing the circumference of the tricuspid annulus. This subsequently decreases the area of the tricuspid orifice, which previously failed to coapt properly, thereby achieving minimally invasive treatment of tricuspid regurgitation. Based on Kay’s annuloplasty principle and utilizing a transvascular approach, the procedure does not require cardiac arrest or cardiopulmonary bypass. It offers minimal trauma, rapid recovery, and excellent protection for the cardiovascular and cerebrovascular systems. Compared with traditional open-chest surgery, it significantly reduces surgical trauma, providing an innovative therapeutic solution for patients with severe tricuspid regurgitation or frail patients at high risk for surgical intervention.

The product completed preliminary feasibility studies and pilot animal trials in 2020. Experimental results demonstrated ideal performance in terms of operation, positioning, and release of the transcatheter tricuspid annuloplasty system, exhibiting excellent ease of use and operability that meet surgical requirements. No serious adverse events or deaths occurred during the study period. Product technical requirements compliant with national and industry standards have been established, and the system has passed inspection by the Tianjin Medical Device Quality Supervision and Inspection Center under the National Medical Products Administration (NMPA). The product completed the NMPA-confirmatory clinical trial in 2022, with one-year follow-up expected to be completed in 2023, at which point submission materials will be filed. The product is currently undergoing simultaneous applications for CE marking and FDA approval.

*Note: The VB-Find Award primarily evaluates the annual innovation performance of nominated products within the year prior to their launch. Given that the timelines of the last two award cycles were closely spaced (with an interval of no more than seven months), products selected in the previous cycle were excluded from the scope of review for the current cycle. We extend our gratitude to both previously selected products and current nominees for their support of this award program.

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