On November 17, 2022, as one of the key supporting events of the “2022 Shanghai International Biopharmaceutical Industry Week,” the “2022 Shanghai Municipal Hospital Clinical Technology Innovation Forum” was held under the theme “Building a New System for Clinical Research and Forming a New Pattern of Medical-Enterprise Integration,” comprehensively showcasing the clinical technology innovation achievements of Shanghai’s municipal hospitals. Zhonghui Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Zhonghui Medical”), representing innovative projects, made the global debut of its independently developed Ultrasound-Guided Phased Array High-Intensity Focused Ultrasound Therapy System (USg-PHIFU) at the exhibition.

USg-PHIFU Made Its Debut at the 2022 Shanghai Municipal Hospital Clinical Science and Technology Innovation Forum

The exhibition not only attracted significant attention from industry practitioners and clients across the upstream and downstream supply chains, but also saw multiple hospitals, medical device distributors, and investment firms express clear interest in collaborating with Zhonghui Medical.

Visitors to the exhibition streamed in endlessly.

Zhonghui Medical was established in January 2015. Leveraging its R&D strengths in ultrasound diagnostics and therapeutic ultrasound products, the company focuses on developing non-invasive flexible ultrasound therapeutic devices and services. Zhonghui Medical operates R&D centers in both Shanghai and Yangzhou, with over 90% of its team members hailing from the medical device industry.

Zhonghui Medical has been honored withSecond Prize in the Smart Healthcare Track of the 2021 Digital China Innovation Competition, was rated in September 2022 as2022 Shanghai Third Batch of High-Tech Enterprises.In November 2022, it also obtainedShanghai Municipal Patent Work Pilot Enterprise.

Uterine fibroids are among the most common benign tumors of the female reproductive system. According to relevant data, there are currently 65 million patients with uterine fibroids in China. The incidence rate is 30% among women aged 30–50 years and reaches as high as 50–60% among women aged 40–50 years.^[1]. Pharmacological treatment of uterine fibroids is primarily used to alleviate symptoms or reduce fibroid volume prior to surgery; however, long-term use is not recommended due to adverse effects. Traditional surgical approaches mainly consist of hysterectomy and myomectomy, which cause significant physical trauma to women and leave permanent scars on the abdominal wall, thereby affecting cosmetic appearance.

With scientific innovation, shifts in medical paradigms, and growing health awareness among women, there are increasing demands for safer and more efficient surgical treatments for uterine fibroids. This presents both challenges and opportunities.

After seven years of dedicated development, Zhonghui Medical has launched its flagship product—the Phased Array Focused Ultrasound Therapy System—offering a non-invasive, painless, and eco-friendly treatment solution.

Zhonghui Medical's USg-PHIFU

High-Intensity Focused Ultrasound (HIFU) is a technique that focuses ultrasonic beams to a specific location, generating high acoustic intensity in the vicinity of that point. Analogous to a lens focusing sunlight, it non-invasively concentrates ultrasonic energy onto pathological regions within the human body. This causes the tissue at the focal point to rapidly heat to temperatures exceeding 60°C due to absorption of the ultrasonic energy, thereby inducing thermal necrosis of the tissue at the focus.

Phased High-Intensity Focused Ultrasound (PHIFU) is a novel high-intensity focused ultrasound technology that achieves electronic focusing at the spatial target zone through phase control of multi-element arrays, thereby enabling more precise treatment, treatment of larger target zones, and more flexible multimodal therapy. PHIFU offers therapeuticShort treatment time, high precision, precise energy control, conformal therapy, multi-modalitysuch advantages.

Schematic Diagram of the Therapeutic Principle of USg-PHIFU

For hospitals and physicians, USg-PHIFU is green and safe, with no ionizing radiation; the installation site requires no radiation shielding or other special modifications. The intelligent and user-friendly operating system allows a single physician to oversee and complete the entire treatment process, significantly enhancing diagnostic and therapeutic efficiency, helping hospitals reduce costs and increase efficiency, and freeing up more medical resources.

For patients, this treatment methodNon-invasive and painless, with no incision, no bleeding, and no anesthesia.It avoids complications caused by wound infection. Meanwhile, phased-array focused ultrasound therapy also avoids the incisions on the uterus caused by resection surgery, or even hysterectomy.Maximize Preservation of Uterine Integrity, accelerates uterine recovery, preserves uterine fertility, and does not affect female endocrine function. No hospitalization is required after the procedure, enabling ““Immediate treatment upon arrival, departure immediately after treatment”diagnostic and treatment model, minimizing the impact of therapy on patients' lives to the greatest extent.

The phased array focused ultrasound therapy system, embodying the wisdom and dedication of Zhonghui Medical, has secured over 40 patents. It entered clinical trials at the International Peace Maternity and Child Health Hospital of the China Welfare Institute in 2019 and was expected to receive approval for market launch in early 2023.

Discussing the rationale behind developing USg-PHIFU, Zhu Weizhen, founder of Zhonghui Medical, stated that at the outset of R&D, the company’s research team was embedded in frontline clinical settings to conduct extensive needs assessments with clinicians. They found widespread feedback indicating significant room for improvement in the positioning and focusing capabilities of existing ultrasound therapeutic devices. Furthermore, physicians expressed a strong desire for more precise and safer control over energy delivery to achieve superior therapeutic outcomes. With rapid advancements in science and technology, their translation into medical applications remains insufficient, thereby offering ample opportunities for development by the new generation.

To address the aforementioned pain points, Zhonghui Medical has partnered with Shanghai Jiao Tong University to foster industry-academia-research-clinical collaboration in the field of medical devices. Leveraging the advantages of multidisciplinary cross-integration and combining real-time B-mode ultrasound guidance, the joint team has overcome key technical challenges in Ultrasound-guided Phased High-Intensity Focused Ultrasound (USg-PHIFU). By utilizing over one hundred transducer elements distributed across a spherical cap surface, the system achieves precise electronic beam steering and focal positioning in three-dimensional space. Capitalizing on the flexibility of electronic beam steering and focusing offered by the phased array system, the team has innovatively proposed an interventional ablation therapy that blocks tumor-feeding arteries. This approach ensures accurate localization of these arteries and conformal volumetric coverage of the target area. Furthermore, through meticulous control of each individual energy emission unit in phased mode—including emission timing and energy intensity—the system achieves enhanced precision and superior operability.

Academician Chen Yazhu and Her Team Visit the International Peace Maternity and Child Health Hospital of the China Welfare Institute to Provide Guidance on Clinical Work

High-intensity focused ultrasound (HIFU) was included in the "Chinese Expert Consensus on the Diagnosis and Treatment of Uterine Fibroids" in 2017. It has also been largely incorporated into medical insurance schemes across all provinces in China, with reimbursement rates ranging from 70% to 90%. Boasting absolute advantages in both clinical acceptance and market prospects, and encouraged by national policies, HIFU is gradually attracting an increasing number of enterprises to participate, thereby accelerating the development of the "ultrasound therapy" ecosystem.

Zhu Weizhen, founder of Zhonghui Medical, believes that USg-PHIFU is a key technology for the next generation of high-intensity focused ultrasound (HIFU) and will inevitably become a highly competitive focal point for all ultrasound companies. By dedicating itself to long-term scientific research and tackling complex technological challenges, Zhonghui Medical has adhered from the outset to doing “the difficult but right thing,” thereby establishing a first-mover advantage. The phased-array focused ultrasound therapeutic system showcased at this exhibition has completed all regulatory approvals and is expected to obtain the Class III Medical Device Registration Certificate in early 2023.

Finally, he stated that Zhonghui Medical will continue to increase its R&D investment, maintain its innovation advantage, and iteratively innovate around gynecology, urology, oncology, and other fields to apply to more indications. Currently, the company is in contact with multiple strategic investors to lay the foundation for the next stage of development.

References:

1. Chengdu Fifth People's Hospital "[Popular Science] Incidence Rate Among Women Aged 40-50 Reaches as High as 50-77%: How Serious Are Uterine Fibroids?"