Guangmai Medical: Global Leader in Digital Cardiac SPECT with Over 55% Market Share and Pioneer of the World’s First Full-Ring SPECT/CT Whole-Body System

In recent years, no topic has been more widely discussed in the medical field than “precision,” encompassing concepts such as “precision diagnosis,” “precision therapy,” and “precision medication.” Various disciplines are delving deeper into this direction; for instance, molecular techniques are being employed to identify cancer-causing genes, thereby enabling more personalized targeted therapies and immunotherapies to achieve better treatment outcomes.

Medical imaging is also continuously innovating, evolving from traditional X-ray and CT scanners to the highly popular PET/CT and SPECT/CT systems in recent years. Medical imaging has advanced from two-dimensional to three-dimensional visualization, with clearer and faster image acquisition, bringing transformative changes to the diagnosis and treatment of cardiovascular diseases and tumors.

Globally, GE, Siemens, and Philips are the major players in the field of molecular imaging, virtually monopolizing the entire market. The Chinese market remains heavily reliant on imports, but the process of localization has never ceased. In the arena of domestic substitution for SPECT/CT systems, new market participants are reshaping the industry landscape—namely, Shanghai Guangmai Medical Technology Co., Ltd. (hereinafter referred to as “Guangmai Medical”).

Guangmai Medical focuses on the development and commercialization of SPECT/CT technology. It previously launched D-SPECT, a digital dedicated cardiac SPECT system, which holds over 55% of the global market share for dedicated cardiac SPECT devices. Meanwhile, the company introduced VERITON-CT, the world’s first digital general-purpose SPECT/CT system. Featuring an innovative 360° full-ring design, it automatically moves within millimeters of the patient’s body, providing clinicians with more comprehensive information to enhance diagnostic accuracy.

International nuclear medicine originated in the late 19th century and, after extensive research and development, was formally introduced into clinical practice in 1951. In 1962, David Kuhl invented emission reconstruction tomography, namely SPECT and PET.

The fundamental principle of SPECT involves the administration of a radiopharmaceutical containing a radioisotope with an appropriate half-life. The agent accumulates in the target region of interest, emitting gamma rays due to radioactive decay. External detectors record the spatial distribution of these emissions, and data acquired through detector rotation are used to reconstruct a series of tomographic images.

Conventional SPECT systems employ sodium iodide (NaI) crystal detectors to capture gamma rays and indirectly convert light signals into electrical signals via photomultiplier tubes (PMTs). Since their introduction, these systems have garnered significant attention and are widely used for functional studies and disease diagnosis of organs such as the heart, bones, and lungs.

However, traditional SPECT equipment suffers from prolonged acquisition times, suboptimal image quality, and higher radiation exposure to patients due to its indirect photoelectric conversion. In contrast,Novel SPECT systems employing CZT semiconductor solid-state detectors eliminate the need for energy-conversion components such as PMT arrays, enabling direct conversion of light signals into electrical signals., thereby avoiding energy loss, while achieving higher imaging efficiency and superior image quality, thus offering significant guidance value for disease diagnosis.

Furthermore, SPECT/CT systems represent a key R&D focus for SPECT manufacturers both in China and abroad.These hybrid imaging products combine CT’s multi-parameter anatomical imaging with SPECT’s molecular imaging, providing multiple morphological and functional insights to help physicians achieve more precise diagnoses.。

The diagnostic efficacy of SPECT/CT is significantly greater than that of SPECT or CT alone, achieving a synergistic effect where 1+1>2.

Guangmai Medical’s internal team is a multinational, multidisciplinary talent pool.

Yoel Zilberstien, CTO of Guangmai Medical, brings over 30 years of experience in the R&D and management of advanced medical imaging products and holds dozens of patents for innovative technologies. Nathaniel Roth, Director of R&D, holds dual master’s degrees in physics and optics and previously worked at EADS, a European aerospace and defense giant.

With a multinational background and innovative products as its foundation, Guangmai Medical always prioritizes R&D.The company holds over 70 invention and utility model patents., including BroadView intelligent target tracking technology, optical motion detectors, cobalt rod linear quality control, and adjustable comfort seating.

Not long ago, the company announced that its manufacturing facility in China would be established in Lingang, Shanghai. Upon completion of the Shanghai plant, the company will achieve localized production in China, further reducing costs, while also continuing to optimize its SPECT products based on the physiological characteristics of the Chinese population.

Currently, the company’s SPECT products are deployed in more than 400 hospitals worldwide, including renowned domestic and international institutions such as Mayo Clinic, Brigham and Women’s Hospital (affiliated with Harvard University), Peking Union Medical College Hospital, Beijing Fuwai Hospital, and Zhongshan Hospital in Shanghai.

Overseas, SPECT has become a common imaging diagnostic device in clinical nuclear medicine. However, few hospitals in China possess digital SPECT products, and clinical demand remains unmet. According to the "Brief Report on the 2020 National Survey of Nuclear Medicine Status" released by the Nuclear Medicine Branch of the Chinese Medical Association, as of the end of 2019, there were a total of 307 SPECT scanners, 495 SPECT/CT scanners, and 8 cardiac-dedicated SPECT scanners nationwide. Compared with the more than one million SPECT examinations performed in 2019, the installed base of equipment is far from sufficient.

As most SPECT devices in China are operating at full capacity, each unit performs approximately 3,100 examinations per year on average, significantly higher than the ~840 examinations per unit in the United States. In the U.S., only about 50% of patients wait more than one day for a SPECT scan, whereas in hospitals across China, the majority of patients face waiting times of one week or even several weeks.

Moreover, SPECT systems in China are almost exclusively traditional sodium iodide (NaI)-based devices. To enable more precise diagnoses for physicians and enhance the patient care experience, novel cadmium zinc telluride (CZT)-based SPECT systems represent a superior choice. The commissioning of Guangmai Medical’s Shanghai manufacturing facility will further accelerate the localization of next-generation SPECT equipment in China.

In 2017, Spectrum Dynamics’ D-SPECT, a cardiac-dedicated SPECT system, obtained an import registration certificate from the National Medical Products Administration (NMPA) and was subsequently introduced into top-tier tertiary hospitals such as Zhongshan Hospital, Fuwai Hospital, and Anzhen Hospital.

In recent years, clinical practice has advocated for a diagnostic and therapeutic approach that prioritizes functional assessment over morphological evaluation. Although coronary angiography remains the gold standard for diagnosing the severity of coronary stenosis, this invasive procedure may expose patients to risks such as bleeding and myocardial infarction, potentially leading to "over-testing."

In the United States, physicians use the D-SPECT system to generate cardiac functional images and recommend coronary angiography only when at least 10% of the myocardial perfusion area is demonstrated to be impaired. In China, functional testing is also more widely applied in clinical practice, and the approval of D-SPECT will help more patients avoid unnecessary examinations.

Full-ring SPECT scanning is a “highly contested frontier,” and Guangmai Medical is also vying for “a share of the pie.” The company’s VERITON-CT product adopts a 360° full-ring design, making it the world’s first digital full-ring SPECT/CT system.

To achieve full-ring scanning with SPECT equipment, the detectors need to surround the patient's entire body. If CZT crystals are chosen to be laid flat on the dual detector heads of the SPECT device, the cost would be relatively high.Guangmai Medical’s whole-body SPECT system features retractable detector columns, enabling the acquisition of high-quality medical images with fewer than 100 CZT crystal modules, thereby significantly reducing production costs.Moreover, the relatively reduced number of probes enhances product stability and significantly lowers overall maintenance costs.

Guangmai Medical’s SPECT Whole-Body System features detector columns that automatically move within a few centimeters of the patient’s body. The detectors within each column rotate to varying degrees depending on their position, thereby enabling 360-degree scanning of the human body. Similar to zooming in with a camera lens during photography, the telescopic detector columns can approach closer to the patient’s body to capture more detailed physiological parameters, thus achieving superior imaging quality.

Yoel Zilberstien, CTO of Guangmai Medical, stated: “Previously, a whole-body bone scan could take half an hour. It is impossible for a patient to remain completely motionless while lying on the scanner; patient movement and respiration would affect the final imaging results. Now we”Reduce bone scan time to approximately 12 minutes., the impact caused by patient movement is significantly reduced, thereby improving the success rate of examinations. Innovative breakthroughs in the design of digital SPECT/CT detectors have enabled comprehensive 3D acquisition throughout the SPECT department workflow.

Following image acquisition, the VERITON-CT Data Console from Guangmai Medical performs 3D data acquisition, reconstruction, and quantitative post-processing. The system is equipped with advanced image processing algorithms, including OSEM iterative reconstruction with resolution recovery, attenuation correction (AC), scatter correction (SC), partial volume correction (PVC), and high-energy correction (HEC). These features facilitate faster convergence to optimal solutions, validate image performance, and significantly enhance image quality.

Clinical medicine advocates "early detection and early treatment."

As the aging of China’s population intensifies, the incidence rates of cancer and coronary heart disease are rising year by year. Early diagnosis and treatment can not only alleviate the medical burden on patients but also reduce healthcare insurance expenditures. In early diagnosis and treatment, the role of nuclear medicine imaging is becoming increasingly prominent.

Previously, eight departments, including the China Atomic Energy Authority, the Ministry of Science and Technology, and the Ministry of Public Security, officially released the “Medium- and Long-Term Development Plan for Medical Radioisotopes (2021–2035)” (hereinafter referred to as the “Plan”), which is China’s first programmatic document specifically addressing the application of nuclear technology in the healthcare sector.

Radiopharmaceuticals are the foundation of nuclear medicine imaging; for instance, imaging agents made from “Technetium-99m” can be used to diagnose bone lesions, while Fluorodeoxyglucose (FDG) labeled with “Fluorine-18” can detect malignant tumors.The development of radiopharmaceuticals in China has been relatively slow; while the U.S. FDA has approved approximately 60 radioactive drugs, China has only 30.。

According to the Plan, by 2025, breakthroughs will be achieved in a number of key core technologies for the development of medical isotopes, and one or two dedicated production reactors for medical isotopes will be constructed as appropriate based on market demand, thereby ensuring stable and independent supply of commonly used medical isotopes.

Some people turn pale at the mention of “nuclear,” believing that nuclear medicine examinations pose significant hazards. In reality, with the advancement of nuclear medicine, the radiation exposure patients receive during a SPECT scan is now even lower than that from an X-ray examination. Driven by strong national support and the continuously enhancing original research and innovation capabilities of enterprises, China’s nuclear medicine sector is highly likely to achieve leapfrog development in the future.

Reference Article: “Eight Departments Issue Policy to Plan ‘Medical Radioisotopes,’ China’s Nuclear Medicine Sector Poised for Explosive Growth”