Zhishan Medical's Swallowable Intragastric Balloon Spheria™ Launches Multicenter Clinical Trial in China

2021Year2Month25Recently, the first successful swallowable intragastric balloon placement procedure in China was performed under the leadership of Vice President Zhang Zhongtao of Beijing Friendship Hospital, Capital Medical University. This milestone also marks the official launch of the multicenter clinical trial on intragastric balloons in China, led by Beijing Friendship Hospital.

Intragastric balloons have been used by the international medical community since the 1980s to manage weight in obese populations. After decades of development, their efficacy and safety have gained recognition among both physicians and patients. In February 2018,The American Society for Metabolic and Bariatric Surgery Has Officially Approved Intragastric Balloons as the Fifth Standard Surgical Treatment for Obesity, Establishing Them as the Gold Standard for Non-Surgical Device-Based Weight Loss。

It should be noted that although intragastric balloons have been widely used in Europe and the United States for a long time, there are no approved products available in China. The first swallowable intragastric balloon placement procedure performed in China usedSpheria^TMThe intragastric balloon, developed and manufactured by Changzhou Zhishan Medical Technology Co., Ltd. (hereinafter referred to as "ZhiShan Healthcare"), is the first swallowable, non-invasive weight-loss medical device in China. It requires no endoscopy, anesthesia, or surgery and is currently undergoing multi-center clinical trials.

Shi Xiufeng, General Manager of ZhiShan Healthcare, introduced Spheria to VCBeat.^TMPrinciple of the Intragastric Balloon: The intragastric balloon is pre-compressed within a capsule and connected to an infusion catheter. It is delivered into the stomach via swallowing, with the other end of the catheter remaining outside the body. Once the capsule reaches the stomach, it dissolves rapidly. Subsequently, normal saline is injected into the balloon through the external end of the catheter. Upon completion of inflation, the catheter is detached from the balloon, and the self-sealing valve on the balloon automatically closes. The inflated balloon occupies space within the stomach, and the entire insertion procedure can be completed on an outpatient basis.

Throughout the treatment period, the inflated balloon increases the patient’s sense of satiety, thereby reducing food intake and achieving weight loss. At the end of the treatment, the degradable membrane on the balloon breaks down, draining the fluid from within. Subsequently, the soft, deflated balloon is expelled from the body through the gastrointestinal tract, entirely without the need for surgery, endoscopy, or anesthesia.

Shi Xiufeng, General Manager of ZhiShan Healthcare, revealed: “Spheria^TMIntragastric Balloon Expected to Gain Market Approval in 2023, helping obese patients in China lose weight with ease.”

The World Health Organization has classified obesity as a disease, using Body Mass Index (BMI) as the diagnostic criterion, with specific classifications as follows:

According to the Global Burden of Disease Report released by the World Health Organization in 2017, a total of 107.7 million children and 603.7 million adults were diagnosed with obesity worldwide in 2015, with overall prevalence rates of 5% and 12%, respectively. A recent epidemiological survey shows thatIn 2019, nearly 2.3 billion children and adults worldwide had body weights exceeding the standard, with China having the largest obese population, numbering over 90 million.

Data shows that China has 12 million patients with severe obesity. Among the population aged 20 to 69, the overweight rate is 34.26%, and the obesity rate is 10.98%. With economic development and continuous improvement in residents' living standards, China's obesity rate has shown a significant upward trend, with the rate of increase in childhood obesity surpassing that of adults.

Obesity not only has a high incidence rate but also poses significant health risks. For instance, it can easily lead to various chronic diseases such as diabetes, hypertension, and cardiovascular disease, often resulting in the simultaneous occurrence of multiple conditions.

Current mainstream approaches to the treatment of obesity include lifestyle modifications, pharmacotherapy, and bariatric surgery. Lifestyle modifications involve dietary control and increased physical activity; however, for many individuals with obesity, adherence to such interventions is challenging, as hunger and fatigue often easily undermine their commitment to weight loss. Pharmacotherapy, serving as an adjunctive treatment, is not suitable for monotherapy and is associated with numerous adverse effects, some of which can be severe. Bariatric surgery, considered the definitive intervention for obesity, also presents significant challenges: surgical procedures such as Roux-en-Y gastric bypass and sleeve gastrectomy carry inherent risks.

Intragastric balloons, as one of the standard treatments for obesity, offer unparalleled advantages. First, intragastric balloons physically reduce gastric volume, ensuring satiety in obese individuals, thereby reducing dietary intake and facilitating gradual weight loss, without rebound weight gain after the balloon is expelled from the body. Second, intragastric balloon placement is not associated with serious adverse events, and indeed, most obese patients experience no adverse reactions. Finally, intragastric balloons are safe and effective; those developed by ZhiShan HealthcareSpheria^TMThe intragastric balloon is swallowed orally, automatically degrades within 4–6 months after placement in the body, and is ultimately excreted naturally through the gastrointestinal tract. It requires no endoscopy, anesthesia, or sedation, causing no trauma to obese patients.

Regarding efficacy, Shi Xiufeng stated, “Based on clinical data for similar products abroad, obese individuals will lose a cumulative 10% of their body weight four months after intragastric balloon implantation.”

In addition, intragastric balloons hold significant importance in the treatment of obesity and its complications. For instance, weight loss in patients with obesity can reduce the incidence of chronic diseases such as diabetes and heart disease, improve metabolic parameters in patients with comorbid obesity and chronic conditions, and even restore these metabolic parameters to normal levels.

Undoubtedly, the intragastric balloon developed by ZhiShan Healthcare will become the preferred weight-loss solution for many individuals with obesity. Based on estimates of the obese population and the future penetration rate of intragastric balloons, the potential market size in China exceeds RMB 100 billion, while the global potential market size reaches RMB 330 billion.

Spheria, developed by ZhiShan Healthcare, since February 25^TMIntragastric Balloon Initiates Multicenter Clinical Trials at Beijing Friendship Hospital, Capital Medical University, and Other Grade-A Tertiary Hospitals.

Spheria used in this clinical trial^TMThe intragastric balloon features original innovation. Dr. Liu Daozhi, Founder and Chairman of ZhiShan Healthcare and Founding and Executive Partner of Shanlan Capital, stated: “Currently, intragastric balloons widely used in overseas markets require gastroscopy and anesthesia for placement and removal, making the procedure relatively cumbersome. The Spheria developed by ZhiShan Healthcare^TMThe gastric balloon features operational innovations, enabling swallow-based placement without the need for anesthesia or gastroscopy, thereby significantly enhancing user experience. Additionally, ZhiShan Healthcare innovatively employs biodegradable materials, making Spheria^TM"The intragastric balloon can automatically degrade within 4-6 months after being placed in the human body and be expelled through intestinal peristalsis, eliminating the need for a follow-up outpatient procedure to remove it, as required by foreign products."

It is worth mentioning that, due to the R&D efforts of ZhiShan Healthcare,Spheria^TMIntragastric balloon placement is a simple procedure with minimal risk. Once the product is launched, it can be used for obesity treatment by the vast majority of medical institutions in China, including aesthetic medicine clinics and primary care outpatient facilities.

Currently, ZhiShan Healthcare has established a large-scale production base in Changzhou, set up an R&D center in Shanghai Zhangjiang Science City, and opened representative offices in the United States and France, for Spheria^TMFull preparations have been made for the research and development, production, and commercialization of intragastric balloons.

As China’s first innovative enterprise dedicated to the research, development, manufacturing, and sales of non-invasive weight-loss medical devices, ZhiShan Healthcare has attracted significant capital attention since its inception, securing investments from multiple mainstream funds, including Shanlan Capital, Legend Capital, and SoftBank China Capital.

Dr. Liu Daozhi stated, “Intragastric balloons have been widely used in European and American markets, demonstrating excellent clinical outcomes. We are highly optimistic about the growth potential of this proven weight-loss device market.”

Merely having a promising sector is not enough to attract multiple investment firms, but high-quality enterprises within such sectors are highly attractive. ZhiShan Healthcare is precisely such a high-quality enterprise in the field of weight-loss devices. Dr. Liu Daozhi stated, “Spheria^TM“Intragastric balloons represent the direction of clinical technological advancement in this field, and ZhiShan Healthcare, the developer of this product, possesses globally leading innovative technologies. Leveraging its innovative technologies and leading products, ZhiShan Healthcare has the potential to grow into a global leader in the weight-loss device sector.”

In fact, ZhiShan Healthcare aims to become a leader in the fields of diabetes and weight management in China, and an industry player with significant influence in the international market.Therefore, ZhiShan Healthcare’s next step is to develop a series of innovative products for patients with diabetes and obesity, aiming to alleviate the suffering from chronic diseases and reduce the medical burden for these patients.