With two innovative medical devices approved in one quarter, how does Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. solve surgical tissue reconstruction challenges using basement membrane technology?

In recent years, the field of regenerative medicine has witnessed rapid advancements, with novel bio-regenerative materials continuously emerging, driving sustained expansion of the regenerative medicine market. According to data from China Research and Intelligence's report "2024-2029 Market Prospects Analysis and Future Investment Strategy Report on China's Regenerative Medicine Industry," the global regenerative medicine market size exceeded 20 billion U.S. dollars in 2021 and is projected to reach 131.08 billion U.S. dollars by 2030. As the world's second-largest medical market, China's regenerative medicine market reached 28.5 billion RMB in 2021 and is steadily growing at an annual rate of 18%.

As the global regenerative medicine market approaches a scale of hundreds of billions of U.S. dollars, China's surgical repair field still faces a harsh reality: on one hand, nearly 10% of Chinese women are suffering from pelvic organ prolapse, and the number of new hernia patients increases by nearly 3 million each year... The growing number of patients directly reflects the increasing clinical demand.^{[1, 2]}。

On the other hand, there are various shortcomings of traditional surgical repair materials and synthetic meshes. Traditional surgical repair materials, such as synthetic meshes (polypropylene) and conventional biological materials, both have significant limitations. Although synthetic meshes offer high mechanical strength, they often cause strong foreign body sensation, infection rates as high as 15%-20%, and are prone to引发 chronic pain. Biological materials, due to issues such as immunogenicity and insufficient mechanical properties, struggle to meet the demands of minimally invasive surgeries and post-tumor reconstructions. Particularly in the treatment of pelvic malignancies, the lack of suitable postoperative repair materials has led to alarming clinical challenges: the complication rate after total pelvic resection can reach as high as 86%, leading to postoperative patient mortality.^{[3, 4]}。

This set of alarming data made Wang Yanyan, founder of Zhuo Ruan Medical Technology (Suzhou) Co., Ltd., realize that material innovation is urgently needed. "At that moment, I realized that materials must 'align with' the body's self-repair mechanisms, enabling functional regeneration and repair, rather than simple replacement."

It was precisely this insight that directly drove Zhuo Ruan Medical Technology (Suzhou) Co., Ltd.'s in-depth exploration and innovation in the field of basement membrane biomaterials, enabling the company to have two consecutive products enter the "National Innovative Medical Device" program in the first quarter of this year. In an interview with Zhuo Ruan Medical's core team, vcbeat uncovered the company's innovation "secrets."

The basement membrane is an extracellular matrix structure present in almost all tissues and organs, supporting normal organ metabolism and被誉为 "the starting point of tissue regeneration."

The basement membrane researched by Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. is derived from porcine bladder, with a typical thickness of only 20 micrometers, composed of components such as laminin and type IV collagen. Although thin, the basement membrane possesses excellent strength and toughness due to the characteristics of its collagen structure.^[5]The bladder basement membrane derived from a sterile environment is not only a physical support structure for cells, but also regulates and guides tissue regeneration and functional repair through biological signals such as growth factors and cell signaling sites.^{[6, 7]}。

However, the industrialization of basement membranes faces two major challenges: one is low extraction efficiency and high production costs; the other is the intricate post-extraction processing, which demands extremely high precision in production control.

In response, Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. firmly adopted an automated production strategy. However, as Zhao Meibiao, head of Zhuo Ruan Medical's production team, pointed out: "Everyone knows automation is good, but how can equipment replace hundreds of laboratory steps? We can't possibly build hundreds of automated processes, each corresponding to a single step."

Solutions to challenges come from team innovation. In response to the characteristics of basement membrane tissue, Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. adopted automated reactor systems. After three years of hundreds of tests and adjustments, dozens of preparation steps were gradually integrated into the equipment. The production capacity of basement membranes increased from a maximum of 10 sheets per day to over 3,000 sheets per day, with stable quality.

After decellularization, the basement membrane exhibits low immunogenicity and high biological activity, effectively reducing inflammatory responses, inhibiting scar formation, and promoting the recruitment of functional cells and regeneration of tissue structure. Moreover, the basement membrane retains its biological activity after processing, possesses high tensile strength, and has appropriate flexibility to withstand fluctuations in abdominal pressure. In other words, the basement membrane combines high safety, high bioactivity, specific regeneration, and functional repair. Research on the safety of basement membrane-based biomaterials has even been praised by foreign scholars as "an important reference standard for the preclinical evaluation of biological scaffolds."^{[8, 9]}

After breaking through the industrialization bottleneck of basement membrane, Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. began to consider how to precisely introduce this revolutionary material into the most clinically valuable application scenarios. Through in-depth research and expert evaluation of various surgical procedures, the team ultimately focused on the field of pelvic surgery—a domain characterized by highly complex operations, high risk of complications, and significant unmet clinical needs.

According to Wang Yanyan, Chairman of Zhuo Ruan Medical Technology (Suzhou) Co., Ltd., in the field of surgery, the physiological structure of the pelvic and abdominal cavity is extremely complex. The abdominal and pelvic cavity contain multiple independent metabolic systems, and particularly within the pelvis, a confined space houses several vital organs including those of the digestive, urinary, and reproductive systems. When any one organ becomes diseased, it easily affects the others. This complex anatomical structure often leads to high surgical difficulty and challenges in postoperative recovery. Conventional synthetic materials cannot meet extensive clinical demands, making it urgent to identify an innovative material. Basement membrane is precisely a material highly compatible with surgical tissue regeneration, especially in pelvic and abdominal tissue reconstruction.

Backed by breakthroughs in basement membrane materials, Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. has had four products approved for the "National Innovative Medical Device Expressway" certification, ranking among the top in China's tissue regeneration sector. A closer look at these four products—biological hernia patch, biological pelvic floor patch, surgical biological patch, and composite biological patch—reveals that two core characteristics, "strong clinical demand" and "high material requirements," consistently run through their applications, highlighting Zhuo Ruan Medical's outstanding capabilities in meeting rigorous clinical needs and advancing innovations in surgical tissue reconstruction technologies.

Hernia repair surgery, one of the most common clinical procedures, has an annual volume exceeding 2 million cases. Compared to traditional synthetic meshes, biological hernia meshes have become a popular choice for inguinal hernia repair due to the absence of long-term foreign body retention and improved long-term quality of life after surgery. However, some traditional biological meshes on the market still face issues such as high rates of rejection reactions and serum formation.

Zhuo Ruan Medical Technology (Suzhou) Co., Ltd.'s biological hernia mesh, as the first domestically approved biological mesh for laparoscopic hernia repair, has demonstrated excellent clinical outcomes. In a four-year long-term follow-up, its recurrence rates in open and laparoscopic inguinal hernia repairs were comparable to those of traditional biological meshes and polypropylene meshes. However, regarding serumoma incidence, the basement membrane biological mesh significantly reduced occurrences compared to traditional biological meshes, offering patients a safer and more effective treatment option.

Pelvic organ prolapse (POP), as a common pelvic floor dysfunction in adult women, significantly affects patients' quality of life. Statistics show that approximately 9.6% of adult women in China suffer from this condition, among whom 3% of moderate to severe cases require surgical treatment.^[2]。

Although traditional synthetic mesh has certain efficacy in treating POP, it carries a high risk of complications. In 2014, the U.S. FDA issued a safety warning regarding transvaginal synthetic mesh products and mandated manufacturers to conduct post-market studies in response to thousands of reports of serious adverse events, such as mesh erosion, organ perforation, chronic pain, and sexual dysfunction. These complications have led to tens of thousands of patient lawsuits. As a result, major companies such as Johnson & Johnson have paid over $8 billion in compensation and have gradually withdrawn from this market.

Faced with this clinical challenge that is difficult to address using traditional materials, Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. is committed to developing safer and more effective basement membrane biomaterials to provide solutions. Through innovative design, the biological pelvic floor mesh achieves comparable treatment efficacy to traditional synthetic meshes, while significantly reducing the incidence of mesh-related complications.

Biological surgical patches are primarily used for tissue reconstruction following surgical resection of abdominal and pelvic malignant tumors, playing a crucial role in tissue reconstruction after extensive resections. Without reconstruction after surgery, 31.6% to 86% of patients are prone to develop empty pelvis syndrome.^[3], leading to severe complications such as intestinal obstruction and pelvic floor hernia, and even causing patient death.

The surgical biological patch for the basement membrane, through pelvic and abdominal cavity isolation and tissue reconstruction, has significantly reduced the perioperative mortality rate from 35% to 1.8%, and the complication rate from 86% to 4.9%.^{[3, 10, 11]}For patients with advanced or recurrent rectal cancer, it enables postoperative reconstruction of the pelvic and abdominal cavities, increasing the five-year survival rate from 30% to 80%, while also promoting rapid recovery of gastrointestinal function and comprehensively improving quality of life.

Repairing complex abdominal wall defects has always been a challenging issue in general surgical procedures. Taking abdominal wall hernia as an example, some patients develop severe abdominal wall hernias due to congenital developmental defects or poor postoperative wound healing, with higher incidence among elderly and obese populations. In severe cases, patients may even face life-threatening conditions such as infectious shock, and surgery remains the only curative treatment.

Traditional treatments often use synthetic materials, but these come with various drawbacks, such as a higher risk of complications and prolonged healing periods, significantly affecting patients' quality of life. Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. has developed an innovative composite biological patch, which for the first time in China combines basement membrane biomaterials with slow-degrading materials. Under high-tension conditions, this product fully leverages the basement membrane's tissue regeneration capability, effectively reducing recurrence rates, alleviating postoperative pain, and shortening recovery time, thus offering dual advantages of mechanical support and tissue regeneration.

Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. focuses on unmet clinical needs in the field of pelvic and abdominal surgery, strategically developing four innovative medical device product lines, and providing customized innovative tissue repair solutions for patients with malignant tumors, female reproductive health issues, and complex critical surgical conditions. Currently, Zhuo Ruan Medical has obtained Class III medical device registration certificates for three products, received the "National Innovation Medical Device Pathway" designation for four products, and is actively applying for two additional products.

When technological innovation closely aligns with clinical needs, regenerative medicine ceases to remain a theoretical concept confined to laboratories, transforming instead into a tangible response to patients' profound needs. In the philosophy of Zhuo Ruan Medical Technology (Suzhou) Co., Ltd., the ultimate pursuit of medicine is enabling every patient to regain dignity and embrace a new life. With unwavering determination, Zhuo Ruan Medical moves forward, fully aware that "behind every patch lies a life awaiting a fresh start."

[[1] Li Shaojie, et al., Randomized, controlled, multicenter clinical study on the application of composite basement membrane biological patch in Lichtenstein repair for inguinal hernia, Chinese Journal of Hernia and Abdominal Wall Surgery (Electronic Edition) 18(2) (2024) 132-138.

[2] Zhu Lan, et al., Chinese Guidelines for the Diagnosis and Management of Pelvic Organ Prolapse (2020 Edition), Chinese Journal of Obstetrics and Gynecology, Vol. 55, No. 5, pp. 300-306, MEDLINE ISTIC PKU CSCD CA (2021).

[3] Tao Yu, et al., Focus and challenges of total pelvic organ exenteration for locally advanced/recurrent rectal cancer, Journal of Naval Medical University (2023).

[4] Dis Colon Rectum. 2002 Aug;45(8):1078-84.

[5] D.O. Freytes, et al., Biaxial strength of multilaminated extracellular matrix scaffolds, Biomaterials 25(12) (2004) 2353-61.

[6] W. Zhong, et al., A Novel UBM/SIS Composite Biological Scaffold for 2‐Year Abdominal Defect Repairing and Strength Recovery in Canine Model, Advanced Biology   2400131.

[7] S.Y. Chun, et al., Identification and characterization of bioactive factors in bladder submucosa matrix, Biomaterials 28(29) (2007) 4251-4256.

[8] W. Cheng, et al., Endotoxin, not DNA, determines the host response and tissue regeneration behavior of acellular biologic scaffolds, Acta Biomaterialia 195 (2025) 157-168.

[9] E. Keshi, et al., Comment on "Endotoxin, not DNA, determines the host response and tissue regeneration behavior of acellular biologic scaffolds", Acta Biomater 198 (2025) 22-23.

[10] Chen Guoliang, et al., Clinical application of basement membrane biological patch for pelvic floor reconstruction in en bloc pelvic organ resection for locally advanced or locally recurrent rectal cancer, Chinese Journal of Gastrointestinal Surgery 26(3) (2023) 9.

[11] G.H. Hafner, et al., Morbidity and mortality after pelvic exenteration for colorectal adenocarcinoma, Ann Surg 215(1) (1992) 63-7.