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The first Chinese manufacturer to conduct exploratory human clinical trials of intracardiac ultrasound (ICE), the first manufacturer to have its ICE product approved for marketing by the National Medical Products Administration, the first Chinese manufacturer to complete 4D ICE human clinical research, and the first Chinese manufacturer to have its ICE diagnostic system certified and approved by the US Food and Drug Administration…
So many “firsts” all come from a new district enterprise – Jiangsu Tingsheng Technology Co., LTD. (hereinafter referred to as “Tingsheng Technology”).
This leading team in the domestic field of intracardiac ultrasound is also the third company in the world, following Philips and Johnson & Johnson, to complete the research and development of ASIC-integrated 4D intracardiac ultrasound products and enter the clinical stage.
How was it achieved to be the top in the country and the third in the world?
“Make our own ICE product
Before introducing Tingsheng Technology, let’s first learn about intracardiac ultrasound (ICE).
As we all know, the heart is the “source of power” of the human body. It has a precise structure, like a constantly beating “maze”. But during surgery, doctors often face huge challenges: How to complete the repair safely and precisely without being able to see or touch it?
At this point, intracardiac ultrasound comes in handy – it is a new type of ultrasound imaging technology. The tip of the catheter is equipped with a miniature probe, resembling a slender “hair”, which can “drift” along the blood vessels all the way into the heart, allowing doctors to “see through” the heart in real time and precisely. This not only serves as a powerful auxiliary for interventional surgery, but also brings new hope to patients with emphysema, contrast agent allergy and other conditions that are difficult to achieve with traditional ultrasound imaging.
The technology is advanced enough, but the threshold is also very high. For a long time in the past, the domestic intracardiac ultrasound market was almost dominated by multinational giants.
“Why can’t we make our own ICE product?” “
In 2019, the founding team of Tingsheng Technology began to gather: five partners including a senior scientist in the field of ultrasound, a cardiologist, and a serial entrepreneur, to embark on the path of innovation together.
From then on, the story of “First” began to be written.
Three years of research and development, breaking the monopoly
It is by no means possible to break the technological monopoly overnight. Like all “game-breakers”, the Tingsheng team has also gone through a long period of exploration.
Transducers, chip design, bonding processes, ultrasonic imaging algorithms, ultrasonic modeling and navigation algorithms… An ICE catheter integrates numerous technologies, and behind each step lies hundreds of experiments.
Take the transducer in the 2D ICE product probe as an example. This component, which is 8mm long and 2mm wide, may seem unremarkable at first glance, but it is actually equipped with over 60 micron-level array elements inside. To ensure the clarity and stability of real-time images, the array elements need to uniformly and stably transmit and receive signals, which places extremely high demands on the processing technology. Since no one in China had done it before, the team could only feel their way forward and tried over a hundred methods.
After more than three years of hard work and numerous process verifications, in 2022, Tingsheng Technology fired the first shot in the industry – the team’s independently developed two-dimensional intracavitary ultrasound product completed the first exploratory human clinical trial and successfully treated a patient with patent foramen ovale. Throughout the entire operation, not only is the imaging clear, but the doctor can also monitor the progress of the operation in real time throughout the process; Most importantly, the patient does not need general anesthesia and there is no radiation during the operation.
Since then, Tingsheng’s development has hit the “acceleration button”, quickly completing the registration clinical trials and entering the special approval channel for innovative medical devices.
In November 2023, TINGSN Sonic Eyes 10 was approved for marketing. Just as the team expected when starting the business, this is the first domestically developed and approved intracardiac ultrasound diagnostic catheter, breaking the long-term monopoly of imported products. At present, this product has been used in nearly 500 hospitals across the country, covering all 31 provincial administrative regions.
Meanwhile, the intracardiac ultrasound diagnostic system independently developed by Tingsheng Technology has also successfully passed the approval of the US Food and Drug Administration (FDA). For a long time, the FDA certification has been hailed as the “pass” to the global medical device market due to its strict standards. As the first Chinese “player” to be approved to enter the field of intracardiac ultrasound, the technical strength, safety and effectiveness of Tingsheng’s products are self-evident.
From “following” to “running side by side”
Nowadays, intracardiac ultrasound products have been officially included in the centralized procurement directory. The latest data shows that six domestic enterprises have been granted nine registration certificates, among which Tingsheng Technology holds four, accounting for nearly half of the total.
Despite having become the “number one in the country”, the team did not stop there but continued to move forward towards 4D intracardiac ultrasound products. It is reported that this is the “ceiling” in the field, with even higher technical barriers. For instance, the transducer of the 4D product is internally equipped with nearly 1,000 array elements and needs to be controlled by an ASIC chip. This chip also needs to be independently developed.
At present, there are only two enterprises worldwide that have truly completed the research and development of ASIC integrated 4D ICE and entered the clinical trial stage: Philips and Johnson & Johnson, both of which are giants in the medical field. It was not until April this year that Tingsheng Technology’s independently developed TINGSN 4D ICE successfully completed the first human clinical study in China. The innovative force from the new district once again broke the monopoly pattern.
From “following” to “keeping pace”, Tingsheng Technology’s “third place globally” is also a crucial leap in the field of cardiovascular interventional imaging.
This innovative team will continue to take root in Jiangbei and write more stories about “first”.
