IntoCare Completes RMB Hundred-Million Series D Financing and Secures China's First NMPA Class III Approval for Domestic Electric Stapler

Recently, IntoCare Medical Technology (Suzhou) Co., Ltd. (“IntoCare”), a global leader in electric staplers, announced the completion of its Series D financing round, amounting to hundreds of millions of RMB.

This round of financing was led by Qiming Venture Partners, with co-investment from Oriza Holdings, Oriza FoFs Investment Management, and Yuansheng Capital. The funds raised will continue to be used for the R&D of IntoCare’s innovative products, clinical studies, and market promotion, as well as for the renovation of new office and production facilities and the procurement of equipment required for operations.

Just recently, IntoCare’s “Electric Endoscopic Linear Cutter Stapler,” developed and manufactured by the company, officially received approval from the NMPA.

With this milestone, IntoCare Medical has become the world’s first manufacturer to launch a full portfolio of electric intelligent stapler products. Its E-Stapling™ intelligent electric-driven platform, encompassing a complete range of electric staplers, is currently the only such product in China to have obtained both China’s NMPA Class III certification and EU CE marking.

Surgical staplers are medical devices used to replace traditional manual suturing in surgical procedures. They help shorten operative time, alleviate patient discomfort, and improve surgical efficiency. Their primary working principle is similar to that of a stapler: they transect, close, and reconstruct tissue by firing metal staples into the tissue.

Surgical staplers have a wide range of applications and are currently extensively used in surgeries across numerous clinical departments, including gastrointestinal surgery, hepatobiliary and pancreatic surgery, urology, and thoracic surgery. They help improve surgical efficiency and quality, shorten recovery time, alleviate patient suffering, and reduce medical costs.

To meet the diverse needs of clinical surgery, surgical staplers are broadly categorized into two types: linear and circular. Linear staplers are commonly used for linear cutting and can be employed in both laparoscopic and open surgeries to achieve cutting and reconstruction of target organs. Circular staplers are suitable for end-to-end and end-to-side anastomoses in gastrointestinal reconstruction surgeries involving the esophagus, stomach, and intestines.

Although the stapler market has long been dominated by foreign medical device giants such as Johnson & Johnson and Medtronic, surgical staplers must come into direct contact with or penetrate deep into the human body during use. This imposes extremely high requirements on product performance, including precision and safety of treatment. Consequently, traditional staplers are continuously evolving toward minimally invasive and intelligent solutions.

IntoCare Medical has broken the import monopoly in the niche market of electric staplers, achieving a breakthrough from zero to one for domestically produced products.

For three decades, the field of surgical staplers has been dominated by an import monopoly held by medical device giants such as Johnson & Johnson and Medtronic. These foreign enterprises have “always been imitated, but never surpassed.” Many domestic manufacturers involved in this sector have, throughout their development, progressed merely from low-level imitation to high-level imitation, and finally to partial innovation.

IntoCare rejected this development path, opting instead for an independent and self-reliant route of innovation. Ms. Zhang Hui, President of IntoCare, stated, “A truly excellent innovative product stems from a profound understanding of customer needs; only by building technological innovation on this foundation can we create products that the market demands most.”

Unlike Johnson & Johnson’s single-use, semi-automatic electric stapler and Medtronic’s single-use, fully automatic electric stapler, IntoCare’s E-Stapling™ intelligent electric drive platform features a full range of electric staplers that leverage a unified intelligent electric handle platform. This design not only enables fully automated operation but also ensures compatibility with IntoCare’s entire lineup of stapler products.

IntoCare Electric Stapler Handle. Image source: IntoCare official website

IntoCare’s integrated platform-based electric solution enables intelligent interaction among various types of staplers, comprehensively empowering gastrointestinal and pulmonary surgeries with “smart” automation. The E-stapling electric platform offers the following three unique advantages:

1. Standardized Operations and Outputs.IntoCare Electric Stapler: The X-in-One design is currently the only product that utilizes automated control and a programmed operating handle to drive various types of staplers. The E-stapling electric handle features a minimalist and intuitive design; all operations for IntoCare’s five types of staplers can be executed by activating programs via two buttons on the handle. Simple and easy to master, it shortens the learning curve for physicians while ensuring consistent clinical outcomes unaffected by operator or environmental variables, thereby enhancing safety and reliability.

IntoCare Electric Circular Stapler Image source: IntoCare official website

2. Program control to reduce physician burden.E-stapling Electric Stapler is controlled by built-in programs and operates based on the patient’s tissue characteristics and the system’s closed-loop feedback. The program controls each step, which are embedded in the chip, helping surgeons conserve energy and freeing them from complex procedures so they can focus on the surgery and the patient.

IntoCare Electric Endoscopic Linear Cutter Stapler. Image source: IntoCare official website

3. What you see is what you get, improving anastomosis quality.During traditional manual anastomosis, the force applied by surgeons inevitably causes tissue traction during firing and closure, posing potential risks to anastomotic quality and postoperative healing. In contrast, electric staplers eliminate the need for manual force. Furthermore, laboratory data demonstrate that IntoCare’s electric stapler reduces instrument vibration during closure and firing by more than 95%, ensuring superior staple formation and thereby reducing the risk of anastomotic leakage.

To cater to different patient needs, IntoCare has currently developed two types of electric stapler handles: reusable and disposable. Although the disposable electric handle is slightly more expensive, it effectively eliminates the risk of cross-infection. The reusable electric handle can be used for up to 100 surgeries, serving 100 patients, thereby reducing surgical costs.

Zhang Hui, President of IntoCare, stated, “Our ultimate goal is to make our products affordable for patients. The government has recently been encouraging the use of surgically reusable instruments that can be repeatedly sterilized, thereby reducing costs for patients and expenditures on the national medical insurance system. Six years ago, we already implemented a platform-based and diversified strategic layout, which demonstrates our foresight in anticipating market demands.”

In 2015, Johnson & Johnson and Medtronic continued to expand their presence in the powered stapler market, while few domestic companies kept pace at that time. Zhang Hui decided to take action.

Why Her?

Zhang Hui has over 20 years of experience working at multinational corporations such as GE and Johnson & Johnson, primarily engaged in research and development. In addition to accumulating extensive expertise, Zhang has witnessed the dramatic fluctuations in the medical device market: from the initial dominance of foreign companies providing high-priced, advanced devices, to the entry of domestically produced devices into the arena, intensifying market competition.

Only through personal experience can one truly take action.

In 2015, Zhang Hui founded IntoCare and assembled a team characterized by “the courage to innovate, the determination to never give up, the perseverance to stay focused, and the willingness to embrace hardship.” Driven by profound insights into market needs, IntoCare has continuously promoted product innovation. The company’s English name, IntoCare (Insight and Innovation to Caring), was derived from this philosophy.

As the company continued to develop and grow, Zhang Hui’s role quietly evolved.

When discussing the shift in his role, Zhang Hui remarked, “Initially, I was simply an engineer leading a team. Generating new design concepts and continuously putting my ideas into practice brought me great satisfaction. However, as I founded this enterprise and came to be regarded as an entrepreneur, I became aware of my social responsibility. Why has the image of Chinese brands as low-priced and low-quality proven so difficult to change?”

“If someone has to do it, why not take the initiative myself? Why can’t I make a modest contribution? I believe I possess the perseverance and sense of responsibility required, which is a source of great pride for me. Although I do not know when this goal will be achieved, I will never deviate from this direction.”

According to the “2021-2026 Research Report on Supply-Demand Analysis and Investment Opportunity Strategies in the Stapler Industry” by Beijing Puhua Youce Information Consulting Co., Ltd., the market demand for surgical staplers in China is projected to reach RMB 19.058 billion by 2024, with a compound annual growth rate (CAGR) of approximately 15% from 2019 to 2024.

In response to market changes, IntoCare has continuously pursued technological innovation and product development under the leadership of Zhang Hui.

As of May 2021, IntoCare had filed 277 patent applications, with nearly 60% being invention patents, and held 117 granted patents. Backed by robust R&D capabilities and various certifications, IntoCare’s products are sold globally, covering regions such as the European Union, the Middle East, Africa, and North America. They are widely used and highly recognized in many renowned hospitals across China and have stood out in bidding processes in multiple provinces.

Currently, the overall image of domestic medical device brands still needs improvement. Zhang Hui, President of IntoCare, stated, “For domestically produced electric staplers to achieve widespread adoption, we must first let data and facts speak. Pre-market and real-world clinical studies will continue to provide evidentiary support. Meanwhile, we need greater recognition and support from the state and government.”

Zhang Hui further stated that IntoCare will continue to prioritize brand building and technological R&D, consistently launch innovative products, solidify its market position, and set its sights on the global market, striving to become “the most innovative surgical device company.”