Boern Rayl Launches China's First Domestically Developed Absorbable Hemostatic Fluid Gel – BonFlow®

According to statistics,The global market for absorbable hemostatic materials has already established an annual sales volume exceeding hundreds of millions of US dollars.. China’s market started relatively late, currently reaching a scale of tens of billions of RMB, with imported products long dominating the landscape. As the volume of surgical procedures in China increases year by year and minimally invasive surgery rapidly gains prominence, there is growing clinical demand for domestically produced, cost-effective solutions suitable for minimally invasive applicationsHigh-End Hemostatic Consumablesthe demand has become particularly urgent.

Traditional hemostasis typically employs methods such as direct pressure, suture ligation, tourniquet application, and electrocoagulation. These approaches, to varying degrees, have limitations including the risk of muscle and nerve tissue injury, introduction of foreign bodies, susceptibility to postoperative complications, and inefficient use of valuable anesthesia time. Particularly when conventional hemostatic methods are ineffective or not feasible, reliance onNovel Hemostatic MaterialsAssist in controlling bleeding.

Currently, hemostatic materials commonly used in clinical practice include hemostatic gauze, hemostatic sponges, hemostatic dressings, and hemostatic microspheres.Fluid hemostatic materials, characterized by their fluidic properties and ease of clinical handling, overcome the application limitations associated with solid hemostatic materials.. However, this material involves high technical barriers and had not previously been manufactured domestically. The introduction of hemostatic fluid materials has provided an excellent solution for intraoperative hemostasis; however, the high clinical end-user prices of imported products in China, coupled with their limited product specifications, have prevented broader patient access.

September 2023,BORAYER(hereinafter referred to as “BORAYER”)Independently Developed and Manufactured“Absorbable Hemostatic Fluid Gelatin” (trade name: BornFlow®)The registration application was approved by the National Medical Products Administration (NMPA), and a Class III medical device registration certificate was granted.This is also the first domestic registration certificate for “absorbable hemostatic fluid gelatin” products (Registration Certificate No.: Guo Xie Zhu Zhun 20233141303)。

On Monday, July 15, at 19:30, the 74th session of VCBeat Select New Product Appreciation will feature Zhou Guoyuan, Business Director of Jiangxi BORAYER Biotechnology Co., Ltd., who will present“China’s First Approved Domestic Absorbable Fluid Hemostatic Agent—Borneo Flow®”Product Introduction.

"Absorbable Hemostatic Fluid Gelatin"It is a novel hemostatic material primarily composed of gelatin, an animal-derived protein that can form a gel-like substance and is readily absorbed and degraded by the human body. This product leverages the natural coagulation cascade within the patient's body,Fluid Morphologyenabling it to rapidly distribute around the bleeding site and achieve full contact with irregular hemorrhagic wound surfaces,Its wound contact area is nearly four times that of traditional solid gelatin.. It can rapidly achieve hemostasis and promote wound healing in clinical practice. It significantly reduces unnecessary space occupation and compression, thereby substantially enhancing surgical safety.

It overcomes the application limitations of currently common solid hemostatic materials, such as gauze, sponges, and powders, and is suitable for achieving hemostasis in areas where solid materials are difficult to apply, including deep wounds, narrow spaces, and tiny cavities.It has demonstrated excellent clinical performance across various surgical scenarios in departments such as orthopedics (e.g., spinal surgery), neurosurgery, obstetrics and gynecology, general surgery, and otolaryngology.Easy to use, absorbable by the human body within 4–6 weeks, and fully equivalent to imported counterparts in terms of safety and efficacy.

- New product with technical barriers, independently developed in China, newly obtained official Class III medical device approval, and few competitors;

- Fluid material that penetrates deep into cavities, providing rapid and efficient hemostasis;

- Multi-catheter compatibility for diverse surgical scenarios;

- Easy to use and convenient to operate.

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Zhou Guoyuan

BORAYER, Business Director

Educational Background: B.S. and M.S. degrees from the Department of Materials Science and Engineering, Tsinghua University.

Work Experience: 8 years of experience in production and R&D management of high-tech materials, and 9 years of experience in marketing management. Possesses a profound understanding of the operational models of R&D-driven manufacturing enterprises and omni-channel marketing strategies integrating online and offline platforms.

BORAYER, a “potential unicorn” enterprise founded by a Tsinghua University team, specializes in the research, development, and production of high-end biomaterials for wound hemostasis, wound adhesion, and tissue regeneration. With the mission of “Enabling Tissue Regeneration,” it is committed to becoming a leader in the field of biomaterials.

The company has established multiple biomaterial technology platforms, including those for biological polysaccharides, protein extracts, acrylic compounds, biodegradable polyurethanes, and polyethylene glycol derivatives, providing a series of high-end medical consumables for rapid hemostasis, wound repair, and tissue regeneration in clinical medicine.

The company is equipped with a 10,000-square-meter facility comprising biomaterials laboratories, testing laboratories, animal laboratories, and Class 10,000 cleanrooms. Meanwhile, it has established academic collaborations with relevant laboratories at Tsinghua University and Beihang University, and forged close academic ties with renowned Grade A tertiary clinical institutions, including China-Japan Friendship Hospital, Beijing Friendship Hospital, Shanghai Renji Hospital, and Nanjing Drum Tower Hospital, thereby constructing a comprehensive R&D ecosystem.

The company has established a comprehensive industrialization system for biomaterials and operates as a platform-based innovative enterprise with integrated capabilities in product R&D, manufacturing, registration, and sales. It currently holds over 20 granted patents and five registration certificates for Class II and Class III medical devices. The company boasts a diverse product portfolio, including hemostatic materials, tissue adhesives, tissue regeneration consumables, cell culture carriers, gelatin microcarriers, and collagen fillers. Additionally, it has a pipeline of more than 10 high-value consumables with significant market potential, several of which have already initiated registration applications with China’s National Medical Products Administration (NMPA), the European CE certification, and the U.S. Food and Drug Administration (FDA).

“Artery Select New Product Launch” is a live-streaming program under the “Artery Select” brand, dedicated to supporting medical enterprises in launching innovative products. The program’s mission is to empower every milestone launch of medical innovations.

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