First product experience exchange meeting of 博瑞强 SIS Staple Line Reinforcement ended successfully


On August 13, 2022, Biosis Healing Excellent Surgery Training Base welcomed a number of distinguished guests. They are Professor Wu Aiwen from Beijing Cancer Hospital, Professor Ma Huachong from Beijing Chao-Yang Hospital, Capital Medical University, Dr. Liu Yang from Beijing Friendship Hospital Affiliated to Capital Medical University, Professor Yan Wei from Yuquan Hospital of Tsinghua University in Beijing, President Li Baozhong of Henan Anyang Cancer Hospital, Director Zhang Jiancheng from Henan Provincial People's Hospital, Director Hu Yangxi from Zhengzhou Central Hospital in Henan Province, Director Dai Xiaojiang from Jinshazhou Hospital of Guangzhou University of Traditional Chinese Medicine and more than ten experts and professors from many hospitals. They conducts in-depth product experience exchange of domestic exclusive and innovative medical device products-- 博瑞强TM SIS Staple Line Reinforcement, and jointly explores the better clinical application effect of SIS Staple Line Reinforcement.


At the beginning of the meeting, Zhao Bo, chairman of Biosis Healing, gave a welcome speech. In his speech, Dr. Zhao said: We are very honored that all experts can come to the experience exchange meeting of 博瑞强TM SIS Staple Line Reinforcement products during their busy schedules.

At the beginning of August, we obtained the registration certificate for this domestic exclusive and innovative medical device product, which is both an opportunity and a great challenge for us. Lack of competitors is our opportunity, but market education is our challenge. The clinical application of SIS Staple Line Reinforcement can reduce the occurrence of anastomotic leakage, bleeding and other related complications after gastrointestinal resection, and bring benefits to patients. However, because it is an exclusive product in China, hospitals, doctors and patients are still in the stage of zero awareness of our products. Before the product is officially launched on the market, we are very eager to hear the voice from the clinical front line.

All the experts and professors present here have rich clinical experience, and they have a deep understanding of clinical pain points and difficulties. We hope that through today's product exchange meeting, together with the experts, we can jointly explore the better clinical application of SIS Staple Line Reinforcement. We look forward to benefiting more patients as soon as possible.


Li Xuejun, Chief Marketing Officer of Biosis Healing, pointed out in the following speech: 博瑞强TM SIS Staple Line Reinforcement is prepared based on the SIS material platform with independent intellectual property rights of Biosis Healing. The creative design was started in 2016, the clinical trial was started in 2017, and it was officially approved to enter the special approval procedure for innovative medical devices of the China National Medical Products Administration (NMPA) in 2018. It took 6 years and the process was arduous and tortuous. As the exclusive and first Staple Line Reinforcement product in China, the SIS Staple Line Reinforcement is widely used and can be adapted to all types of stapler products on the market for reinforcement of anastomotic sites, suitable for distal gastrectomy and proximal gastrectomy surgery, sleeve gastrectomy, gastrointestinal anastomosis.

Moreover, the SIS Staple Line Reinforcement used for linear cutting staplers have many years of application experience in foreign surgical operations. The analysis of large sample data of nearly 100,000 patients shows that SIS Staple Line Reinforcement used in sleeve gastrectomy, gastrojejunostomy can significantly reduce the incidence of bleeding and anastomotic leakage, and biomaterial anastomotic reinforcement products are superior to synthetic material anastomotic reinforcement products.

In order to allow the experts to experience the product in person, we have arranged a number of animal experiments today. We hope that the experts can experience the clinical application effect of SIS Staple Line Reinforcement more intuitively through animal experiments. We are also looking forward to the feedback from the experts, so that we can improve and enhance.



Afterwards, Yu Xueqiao, Chief Medical Officer of Biosis Healing, focused on the excellent surgery special fund and project application channel initiated by Biosis Healing and Wu Jieping Medical Foundation. Qiao Wei from the Marketing Center gave a detailed product explanation of 博瑞强TM SIS Staple Line Reinforcement.


After the communication meeting, the experts came to the operating room, together with assistants, simulated the whole process of the operation on the experimental pigs. The morning schedule for surgery is the reinforcement of gastrointestinal and digestive tract anastomosis, focusing on distal gastric resection, proximal gastric resection, mesenteric resection, end-to-end anastomosis, side-to-side anastomosis, and end-to-side anastomosis, and actually experience the clinical application of the product effect. The surgical arrangements in the afternoon are gastric volume reduction surgery, gastric bypass surgery and esophagogastric anastomosis to verify the effect of anastomotic reinforcement of gastric bypass and esophagogastric anastomosis.

Through practical operation, experts agreed that: SIS Staple Line Reinforcement is very simple and convenient to use, with good compliance, through 12mm trocar smoothly and pressure-free, the operation of removing the backing after inserting the SIS Staple Line Reinforcement is also very simple and quick. No resistance increased for the endoscopic when SIS Staple Line Reinforcement loaded. The titanium staples are perfectly formed with B-shaped, and the anastomotic margins and staple holes do not have any bleeding and oozing.




President Li Baozhong of Henan Anyang Cancer Hospital performed esophagogastric anastomosis and used SIS Staple Line Reinforcement as the world's first anastomotic patch for tubular staplers. President Li believes that: in real clinical practice, the incidence of anastomosis leakage caused by tubular staplers is relatively high. The SIS Staple Line Reinforcement is convenient and simple to operate, and can successfully complete the reconstruction of the digestive tract. The anastomosis stopped bleeding perfectly after firing. If it is used in clinical practice, it should be of great help in reducing anastomotic leakage.

Professor Wu Aiwen from Beijing Cancer Hospital said: Practice is the only criterion for testing the truth. In the animal experiment just now, I also experienced the clinical advantages of SIS Staple Line Reinforcement, and I am confident in the application prospects and clinical benefits of this innovative product. It is hoped that Biosis Healing will continue to innovate and bring more innovative products to the market for the benefit of patients.

Professor Ma Huachong from Beijing Chaoyang Hospital Affiliated to Capital Medical University, said: During animal experiments, I compared the anastomotic sites with the SIS Staple Line Reinforcement and without the SIS Staple Line Reinforcement. Without the SIS Staple Line Reinforcement, there was significant bleeding from the anastomosis. However, the above situation did not occur in the site where the SIS Staple Line Reinforcement was used, indicating that this product is very effective for hemostasis and anastomotic reinforcement in clinical operations. I also congratulate our domestic medical device manufacturers for making such good products.




In early August, the team of Professor Yao Qiyuan from the Obesity and Hernia Surgery Department of Huashan Hospital Affiliated to Fudan University in Shanghai conducted an animal experiment with SIS Staple Line Reinforcement, which also verified that the SIS Staple Line Reinforcement has good hemostasis and anastomotic reinforcement effect.


After the animal experiment operation, the experts warmly discussed the Wu Jieping Medical Foundation's Biosis Healing Excellence Surgery Project, hoping to start a number of clinical studies on gastric volume reduction surgery, esophagogastric anastomosis and other clinical studies of SIS Staple Line Reinforcement as soon as possible, which will accumulate large sample study of multiple surgical applications in the next year.

Li Xuejun, Chief Marketing Officer of Biosis Healing, said in his concluding speech: Thank you experts for your support. Through today's animal experiments, we are more confident to bring this product to the market. At the same time, this is also the first exchange meeting of SIS Staple Line Reinforcement. Then, we will make more and better use of Biosis Healing Excellence Surgery animal experimental training center to build the first "Biosis Healing Excellence Surgery College" among domestic manufacturers. Hold product exchange meetings, listen to more feedback from the front line, and promote advanced new technologies, new materials, and new products in clinical surgery to more grass-roots medical workers, so as to contribute to the implementation of the Healthy China strategy and the strength of Biosis Healing.


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