Ruiyan NanoMedicine Advances Novel Anti-Adhesion Catheter Technology, Positioned as a Domestic Counterpart to Sharklet Technologies

This year12In [Month], Luo Yonghao held a press conference to introduce an initiative namedSharkletof physical antibacterial technology. This technology mimics the diamond-shaped dermal denticles of shark skin to create an extremely fine micro-textile measured in micrometers, which exerts antibacterial effects through its unique physical structure.

VCBeat (WeChat ID: vcbeat) previously reported that Sharklet Technologies, the company behind this technology, has launched multiple products in the medical field, including urinary catheters, endotracheal tubes, wound dressings, and central venous catheters.

Effective prevention of bacterial infections has long been a key focus in the medical field. Luo Yonghao, a public figure who naturally draws attention, has brought physical antimicrobial technologies into the spotlight. VCBeat has learned that there is a company in China similar to Sharklet Technologies, specializing in the healthcare sector, named Ruiyan Nano Medicine.

Luo Yonghao, formerly an English teacher, pivoted to the field of anti-bacterial infection in less than a year. In contrast, the Ruiyan Nanomedicine team spent nearly 15 years tackling challenges in this area, applying advanced biomaterials to medicine, and finally translating the “novel antibacterial adhesive biomaterial coating technology with infection-prevention functions” from laboratory science into clinically viable medical products.

Ruiyan NanoMedicine was founded in early 2012, led by Professor Wen Xuejun, a Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and a senior scientist in the field of biomedical engineering. Against the backdrop of national policies encouraging innovation and entrepreneurship, and with support from prominent investment institutions in the biopharmaceutical sector (such as Puhua Capital, Jiuren Capital, and China-Singapore Suzhou Industrial Park Venture Capital), the company has completed the commercialization of multiple products and technologies after nearly eight years of research, development, and translation. These include the CleanSur® medical antimicrobial drop-deposition coating technology. The company has secured relevant invention patents and obtained product registration certificates through clinical trials. Ruiyan NanoMedicine’s “Single-Use Antimicrobial Drop-Deposition Urinary Catheter” significantly reduces the risk of urinary tract infections associated with indwelling catheters, while avoiding the issues of bacterial resistance and heavy metal ion accumulation toxicity commonly associated with previous generations of technology. The CleanSur® antimicrobial drop-deposition indwelling urinary catheter has been adopted by more than ten major Grade A tertiary hospitals in China.

From a certain perspective, the history of human evolution is essentially an epic saga of love and hate intertwined with microorganisms, primarily bacteria. After the Dutch scientist Antonie van Leeuwenhoek first observed bacteria in the 17th century, mortality rates from bacterial infections remained extremely high for more than two hundred years. It was not until 1941, with the discovery of penicillin, that humanity gained a “superweapon” in its war against bacteria, temporarily gaining the upper hand. This was undoubtedly a groundbreaking innovation in medical history, significantly increasing average human life expectancy. The golden age of widespread antibiotic use rapidly commenced; however, while wielding this handy superweapon, we failed to anticipate the profound hidden dangers it would sow. Statistics show that due to the extensive use of antibiotics, the number of deaths from infections worldwide was only around 7 million annually during the 1950s and 1960s. By the end of the 20th century, however, the rising prevalence of drug-resistant bacteria caused this figure to climb back up to 20 million. It takes only two to three years for a bacterium to develop a more drug-resistant variant, whereas developing a new antibiotic requires at least five to ten years, or even longer.

Zhao Peng, Managing Director of Ruiyan Nano Medicine, stated, “In the past, we indiscriminately eradicated bacteria. However, research over the past decade has revealed that the relationship between humans and bacteria is not a simple ‘zero-sum’ competition but rather one of symbiosis. In the course of directly combating bacteria, the hidden dangers—primarily bacterial antibiotic resistance—are becoming increasingly significant. We must therefore pursue alternative approaches that reduce pathogenic infections while avoiding the induction or acceleration of bacterial mutation.”

For physicians, selecting an appropriate sterilization method is critical. Failure to curb bacterial infections at the source may instead accelerate the emergence of superbugs, posing substantial risks. In 2014, the World Health Organization (WHO) published a global report on antimicrobial resistance, stating that we have now entered the post-antibiotic era. According to Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, humanity is once again facing a major crisis due to the rapid emergence of antibiotic-resistant bacteria and superbugs, coupled with a lack of new, effective antibiotics.

Although there are currently many sterilization methods available, the options for sterilization in medical treatment scenarios are very limited. The process of bacterial concomitant invasion into the human body begins with colonization on the surface of interventional or implantable devices, where they form aggregates and subsequently develop bacterial biofilms through secretions. Once a biofilm is established, it becomes a potent source of infection, rendering the body’s immune system and pharmaceutical interventions largely ineffective at eradicating the bacteria embedded within the biofilm. This represents one of the powerful survival strategies evolved by bacteria to counteract adverse environments.

Addressing Bacterial Infections Associated with Urinary Catheters: Initially, the common approach involved coating catheters with antibiotics; however, topical antibiotic application readily induces bacterial resistance. In addition to antibiotic coatings, another antimicrobial strategy utilizes heavy metal ions (such as silver and copper). Coating catheters with silver ions, for example, relies on the primary mechanism whereby heavy metal ions cause protein denaturation in bacteria or cells, leading to their inactivation and subsequent apoptosis. Nevertheless, once heavy metal ions enter the body, they are difficult to metabolize and tend to accumulate, posing a risk of heavy metal poisoning.

Ruiyan Nanomedicine Offers a Novel Solution for Antimicrobial Approaches.

This coating, known as “CleanSur”—derived from the English phrase “clean surface”—differs from existing technologies and methods by avoiding the “aggressive” eradication of bacteria as a means of combat. Adhering to the philosophy of minimizing disruption to the external environment and ecological balance while reducing infection risk, it denies resistant bacteria the opportunity to emerge and dominate within microbial communities. By preventing bacterial colonization and adhesion on device surfaces and inhibiting biofilm formation, it avoids infections commonly associated with the intervention or implantation of medical devices, particularly those related to long-term indwelling. Exhibiting high biosafety and friendliness toward the microenvironment, it does not induce or stimulate bacterial resistance, representing an entirely novel antibacterial/bacteriostatic strategy and mechanism.

Zhao Peng explained, “Indwelling urinary catheters, drainage tubes, and endotracheal tubes, when left in place for prolonged periods, are prone to bacterial deposition on their surfaces, leading to biofilm formation, akin to mosses and lichens in nature. Bacteria existing in the form of biofilms differ from planktonic bacteria; they exhibit strong resistance to antibiotics and other antimicrobial agents, harsh environmental conditions, and host immune defense mechanisms. Bacteria within biofilms possess unique characteristics in terms of physiology, metabolism, and environmental resilience.”

Unlike Sharklet’s biomimetic solution, Ruiyan Nanomedicine addresses bacterial adhesion and deposition through novel materials, thereby achieving infection prevention and control while avoiding the development of bacterial resistance or the accelerated evolution of superbugs.

The core team of Ruiyan Nanomedicine boasts a strong scientific research background, comprising researchers with many years of experience in biomedical engineering and biomaterials, along with substantial technological expertise. During the startup phase, Zhao Peng stated that Ruiyan Nanomedicine places great emphasis on the practicality and clinical translation of its technologies. The company is continuously refining its products through trial and error, striving to effectively translate its various technologies into clinical medical products.

Zhao Peng told VCBeat that in entrepreneurship, after overcoming the challenge of translating scientific and technical research into clinical products, one must also face the second hurdle: product commercialization.

“Our process is akin to cooking a dish; success is only achieved when people are willing to consume it and pay for it. As an emerging technology, we faced significant pressure during the initial market promotion phase. However, our solution has gradually gained recognition throughout the promotional process. For instance, our product is typically first adopted by the urology department in hospitals. Often, after witnessing its application in urology, other departments also request its introduction.”

The Ruiyan Nanomedicine team believes that, given the advantages of antimicrobial urinary catheters in reducing catheter-associated infections and lowering healthcare expenditures, these devices will capture a larger market share in the future.

From the perspective of the international market, taking the United States as an example, the initial growth of functional catheters was sluggish due to their slightly higher prices compared to conventional catheters. However, they experienced rapid growth during Barack Obama’s presidency. This was because in 2012, Barack Obama signed the Affordable Care Act, which included a provision to reduce Medicare reimbursements to hospitals with high rates of hospital-acquired infections.

Hospital-acquired infections can be classified into four categories based on the route of infection: surgical site infections, bloodstream infections, respiratory tract infections, and urinary tract infections. Among these, respiratory tract infections caused by ventilator use have the highest mortality rate, while urinary tract infections associated with catheter use are the most common.

Zhao Peng stated that foreign statistical data indicate that patients who develop urinary tract infections due to indwelling catheters experience an average hospital stay extension of 4–5 days, with additional costs amounting to approximately USD 4,000. In China, statistical data from cities such as Shanghai and Beijing show that urinary tract infections prolong the average hospital stay by approximately 3–5 days, resulting in extra medication and bed fees of around RMB 3,000.

As China intensifies its efforts to control healthcare costs and promotes the nationwide adoption of the DRG payment model, domestic hospitals are compelled to shorten patient hospital stays and reduce the incidence of infections. It is foreseeable that more hospitals and departments will adopt functional catheters incorporating novel technologies in the future.