Is the domestic market about to experience a major explosion in the high-end equipment segment that has been monopolized for 20 years?

Amid the general trend of centralized procurement of medical devices, many domestic device manufacturers have found alternative paths and made their mark in the surgical navigation field.

Some time ago, Yiying Medical achieved the highest market share in the 3D C-arm machine market. Recently, Zhongjia Health's independently developed MOBINEURO Alita 1.5T intraoperative magnetic resonance system (intraoperative MRI, abbreviated as iMRI) was approved for registration as a Class III medical device by the NMPA. It has become the first intraoperative MRI system in China to obtain both international and domestic certifications and the first internationally recognized and NMPA-approved ground-mobile intraoperative MRI system.

From the perspective of the development process of the iMRI market, Zhongjia Health entered at just the right time.

Currently, the iMRI markets in developed countries in Europe and America are relatively mature, while the market in the Asia-Pacific region, including China, is in its early stage of development with strong growth momentum.

Research data from Fact.MR shows that the global market size of intraoperative nuclear magnetic resonance equipment is expected to reach $1.22 billion in 2025, maintaining a CAGR of 8.5%, and reach $2.77 billion in 2035. Benefiting from the price advantage of MR brought by centralized procurement, the increasing penetration rate of minimally invasive surgeries, and the rapid development of AI technology, China will continue to grow at the world's fastest CAGR of 8.6%, becoming the core driving force for the overall development of iMRI.

However, breakthroughs in equipment alone are not enough to seize this opportunity. To achieve large-scale implementation and expand the application scenarios of iMRI in China, domestic pioneers need to connect the upstream and downstream industries and establish a complete system.

Starting from neurosurgery, iMRI is expected to reshape the logic of surgical navigation

Different from traditional magnetic resonance systems, iMRI deeply integrates magnetic resonance imaging technology with the surgical operation process and is applied during surgery. It can obtain high-resolution magnetic resonance images of the patient's surgical area in real-time in a sterile surgical environment (such as an operating room equipped with dedicated magnetic resonance equipment), providing dynamic and accurate anatomical structure information for surgeons to assist in surgical operations and decision-making.

Currently, the application of iMRI in neurosurgical operations is the most mature. It is suitable for the navigation of various surgical procedures such as glioma surgery, giant pituitary tumor surgery, cerebrovascular bypass surgery, functional neurosurgery, and intracerebral stereotactic biopsy surgery. It can achieve multiple functions during surgery, including functional magnetic resonance imaging (fMRI), magnetic resonance tensor imaging (DTI), magnetic resonance perfusion imaging (PWI), magnetic resonance spectroscopy (MRS), and magnetic resonance angiography (MRA).

Compared with traditional optical navigation, iMRI can not only provide real-time imaging and dynamically track the position of interventional devices (such as puncture needles and catheters), changes in lesions, and tissue reactions in the surrounding area to ensure the accuracy of operations (for example, avoiding damage to blood vessels and nerves) and monitor complications such as bleeding and thrombosis. It can also automatically trigger scans every 10 - 15 minutes to correct "brain shift" in real-time (such as brain tissue collapse after meningioma resection), reducing the positioning error from 0.8mm - 1.2mm in optical navigation to 0.5mm.

In clinical practice, these advantages can effectively improve the total resection rate of complex tumor resections. For example, Huashan Hospital of Fudan University conducted a retrospective study on a total of 1,172 iMRI-guided surgeries. The data showed that iMRI and multimodal brain function localization technology can increase the total resection rate of gliomas from 54.39% to 83.34% (P = 0.0008), and reduce the surgical disability rate of brain tumors in the functional area from 15.3% to 5.6%, with a perioperative mortality rate of zero.

Another study from NCBI showed that after 46 glioma patients used the third-generation iMRI, the total resection rate (EOR) of enhanced gliomas increased from 84% to 99%, and that of non-enhanced gliomas increased from 63% to 80% (P < 0.001). 23 patients had their surgeries terminated after iMRI confirmed complete resection, and 21 patients achieved radical resection through iMRI-guided supplementary resection.

Beyond neurosurgical applications, many overseas companies are further exploring the potential of iMRI in other surgical scenarios.

At the end of July this year, Cook Medical officially announced the establishment of an Interventional Magnetic Resonance Division, with an initial investment of $230 million to promote the research, production, and clinical application of magnetic resonance imaging systems.

It is reported that Cook Medical will launch three MRI devices covering different clinical scenarios in the next five years, including the first high-field open MRI optimized for neurospecialties, a 1.5T whole-body MRI system using superconducting magnet technology, and a portable low-field MRI solution.

Although Cook Medical has not clearly disclosed the direction of iMRI scenario expansion, from its production line design, it can be seen that the high-field open MRI optimized for neurospecialties will upgrade the iMRI system for neurosurgery, and the 1.5T whole-body MRI system can be used in scenarios such as cardiac surgery and urology.

Siemens Healthineers' layout in the iMRI direction is more mature. In December last year, Profound Medical signed a cooperation agreement with Siemens Healthineers, planning to jointly promote MRI-guided prostate treatment at the commercial level. Profound Medical's prostate intracavitary ablation treatment system, TULSA.

Guided by iMRI, TULSA can treat diseased prostate tissue without incisions or radiation, shortening the surgical time to a few hours, and patients can complete the surgery without hospitalization.

In addition, MRI has excellent soft tissue contrast and can perform multi-parameter imaging at any angle and plane. It can detect small lesions that cannot be found by ultrasound or CT, making puncture and treatment more accurate. Therefore, it is also used for biopsy or treatment of tumors in solid organs such as the liver, lungs, kidneys, pancreas, and retroperitoneum, and is particularly suitable for children and high-frequency interventional patients.

The rapidly developing brain-computer interface in recent years also has room for the application of iMRI, which can mark the "functional no-go areas" in real-time during surgery to avoid damage to key brain regions.

For example, in the BCI electrode implantation surgery near the language area, the displacement of brain tissue during surgery may cause a change in the position of Broca's area (the language center). iMRI can "overlay" the functional area markers from preoperative fMRI onto the real-time anatomical images during surgery, allowing doctors to clearly see whether the electrode implantation path avoids Broca's area and ensuring that electrode implantation does not affect the patient's language function.

The high cost hinders the development of iMRI in the domestic market

Although iMRI has many clinical advantages in neurosurgical operations and great potential in other surgical operations, the number of iMRI units in domestic hospitals has not increased significantly, and related applications have not become mainstream. Statistical data shows that in 2023, the number of iMRI installations in China was only 350, and large tertiary hospitals are the main users of such systems.

The reason is that the configuration of iMRI and the implementation of related surgical procedures require a high level of comprehensive capabilities from hospitals and a mature domestic surgical instrument industry chain, resulting in many hospitals lacking the ability to fully utilize the value of iMRI.

To meet the operating conditions of iMRI in clinical practice, hospitals need to construct a complex system including imaging equipment, operating room environment, magnetic-resistant materials, and multimodal information systems, and at the same time solve problems such as magnetic field uniformity (error < 0.1ppm) and electromagnetic compatibility (supporting the simultaneous operation of surgical robots and electrophysiological monitoring).

The cost of this system is very high. Based on the construction costs of hospitals with iMRI hybrid operating rooms in the past, building a 1.5T MRI hybrid operating room may cost approximately 30 million - 60 million yuan. If the MR is upgraded to 3.0T, the cost will be 60 million - 90 million yuan.

In addition, iMRI has special requirements for the instrument materials used during surgery, further increasing the cost of surgery. In the field of high-value consumables, the interventional instruments (puncture needles, scalpels, ablation electrodes, etc.) used in surgery must be made of MRI-compatible materials (such as non-magnetic metals and carbon fibers) to avoid being attracted by the magnetic field (preventing instrument displacement) or interfering with imaging (reducing artifacts), and at the same time, excessive heat generation in the magnetic field should be avoided (preventing tissue burns).

Taking the puncture needle as an example, although many domestic companies can manufacture related products, there is still a gap in performance compared with imported products. The anti-magnetic interference ability of imported products reaches 99.9%, while that of domestic similar products is about 95%, which may cause image artifacts.

Some considerations in hospital management also hinder the application of iMRI to a certain extent. For example, in the current payment system, hospital managers lack sufficient motivation to upgrade navigation equipment when existing technologies can meet the indicator requirements, indirectly affecting the commercialization process of iMRI.

However, the continuous price reduction of MR equipment in recent years has significantly reduced the construction cost of hybrid operating rooms, opening a gap for the large-scale application of interventional magnetic resonance. Various policies are also encouraging hospitals to systematically promote the development of minimally invasive surgical technologies, which is also expected to promote the implementation of iMRI equipment or related applications.

In addition, the development of AI has given new value to iMRI. For example, GE's Sonic DL algorithm can shorten the time for converting iMRI sequences into images and add the function of automatically identifying tumor boundaries. After further strengthening the functions of iMRI, it may find its commercialization path in more clinical scenarios.

Comparing the advantages and disadvantages of iMRI with neurosurgical applications as an example

Obtaining registration approval is just the first step

In addition to Zhongjia Health, which has obtained the Class III medical device registration certificate for the ground-mobile intraoperative magnetic resonance system, United Imaging Healthcare and Shuojin Medical in China have also participated in the layout; leading device manufacturers such as Neusoft Medical, Wandong Medical, and Anke also have the potential to quickly enter the market.

However, as mentioned above, promoting the application of iMRI not only requires enterprises to achieve breakthroughs in equipment but also to build a systematic supply chain and find better entry points in clinical practice.

Judging from the current market situation, Cook Medical is likely to implement its iMRI plan faster than domestic enterprises. This is because it has built a solid barrier in minimally invasive surgery, can more quickly and accurately understand the clinical demand for iMRI, determine which scenarios can maximize the value of iMRI, and then strengthen its technological barrier in minimally invasive surgery with the help of iMRI.

Among many enterprises, United Imaging Healthcare is more advanced in this field with its layout of "equipment + surgical instruments". After all, achieving 100% autonomy in core components such as superconducting magnets and gradient coils makes United Imaging Healthcare's MRI more price-competitive, and the surgical instruments provided by United Imaging Intelligence can build a system according to its needs, better meeting potential clinical demands.

After obtaining the equipment access permit for iMRI, Zhongjia Health also has a good first-mover advantage. However, to take the next step in application, Zhongjia Health still needs to find high-quality partners, deeply integrate equipment and consumables, and avoid detours in clinical practice.

This article is from the WeChat official account "Arterial Network" (ID: vcbeat), author: Zhao Hongwei. Republished by 36Kr with permission.