Yuanang Bio, Portfolio Company of Hetang Ventures, Completes Patient Enrollment in Pivotal Clinical Trial for 'Gu-02' Bone Adhesive in Comminuted Fracture Treatment

Fractures are one of the most common injuries in clinical practice. If not treated promptly and effectively, they can lead to serious consequences and are one of the main causes of disability in young adults and mortality in elderly patients. With the advancement of modern medical technology, particularly the application of metal internal fixation, the healing of fractures has greatly improved.

However, for comminuted fractures accompanied by many small bone fragments in clinical practice, traditional metal fixation methods not only present challenges such as difficulty in anatomical reduction, time-consuming and labor-intensive plate and screw fixation (a single surgery often takes several hours), and the inability to achieve close-fitting reassembly, but also tend to cause loss and resorption of bone fragments, leading to bone mass deficiency. This can subsequently result in delayed bone healing or nonunion. Particularly in comminuted fractures of joint areas, failure to achieve anatomical reduction can easily lead to articular surface defects or unevenness, eventually causing traumatic arthritis and significantly affecting the patient's quality of life.

Therefore, tens of millions of comminuted fracture patients worldwide and millions in China are in need of a disruptive technological breakthrough.

In January 2025, Origo Biotechnology launched the world's first prospective, multicenter, blinded, randomized, parallel-controlled, non-inferiority clinical trial for the indication of comminuted fracture bone adhesion, and recently completed clinical enrollment of over 150 cases. Enrollment results showed: not a single case had safety issues, and the treatment efficacy met expectations.

Origo Biotechnology's BoneGlue achieves seamless adhesion of all sizes of bone fragments through advanced bonding technology, reducing.../Avoids the use of metal internal fixation, reduces the risk of foreign body reactions and infections, and greatly improves the efficiency of surgical treatment for comminuted fractures.

Figure: Traditional Treatment for Distal Radius Fracture: Metal Internal Fixation

Fig: Distal Radius Fracture"Bone 02" Treatment Method: Independent Adhesive Fixation

In fact, for nearly a century, scientists worldwide have been dedicated to the development of bone glue but have yet to overcome two major technical bottlenecks: biosafety and adhesive strength in wet environments.

Origo Biotechnology's core founding team has deep expertise in orthopedic clinical practice.For more than 40 years, there has been a strong desire for a bone adhesive material to treat comminuted fractures.Chief Scientist Lin Xianfeng, Based on this clinical challenge, and combining extensive clinical experience with a solid foundation of basic research, led the team to devote themselves to the development of this material. However, there was minimal progress in the first few years, even contemplating giving up at one point.

The turning point came from the inspiration Lin Xianfeng gained while growing up by the sea. He was reminded of the ancient Chinese people over a thousand years ago."The Wisdom of 'Oyster Solid Foundation' – Oysters Can Secrete Natural Adhesive to Bond Shells and Bridge Piers in Water."Inspired by this phenomenon, the team readjusted the R&D pathway. Through continuous experimentation and optimization of solutions, they eventually succeeded in overcoming numerous challenges, such as biotoxicity generated during product reactions, adhesive stability in blood environments, and convenience of surgical operation, leading to the successful development of...A bone adhesive product that can quickly bond in a blood-wet environment and is fully biodegradable —— Bone 02 Fragment Adhesive.

With the boneThe successful development of 02 Bone Fragment Adhesive can achieve minimally invasive and convenient changes in fracture surgery in clinical practice, and solve the "self-service" fixation of immediate war trauma fractures in defense, marking that both the treatment concept of fracture surgery and internal fixation products in China have achieved China's "Sputnik Moment."

Bone02 Bone Fragment Adhesive Product Image

In terms of product development, the core founding team of Origo Biotechnology has been deeply engaged in the transformation and application of innovative biomaterials for over a decade, with multiple research achievements published in...Nature and its CNS sub-journals, have obtained dozens of core patents authorized by major global economies such as China, the United States, the European Union, and Japan, and have led Origo Biotechnology's R&D team in conducting a comprehensive product layout around human tissue regeneration and repair.

Its representative products include:Single-use Gel Patch Former, as recognized by regulatory authorities"First in China" PRP (Platelet-Rich Plasma) Patch Preparation Kit (Zhejiang Medical Device Registration No. 20252141621)`, obtained Zhejiang Province Class II Innovative Medical Device Certification,`Effectively solved the "last mile" problem of PRP clinical application; Porcine-derived bone repair material (China Medical Device Registration No. 20243131263) successfully overcame interspecies immune rejection issues, achieving complete replacement of allogeneic bone with porcine bone for the first time both in China and internationally, filling the current market gap for bone defect repair materials.

Bone02 Bone Fragment Adhesive is another representative product from Origo Biotechnology in its continuous pursuit of breakthroughs in orthopedic technology. Origo Biotechnology has taken a small step towards obtaining the world’s first certification for comminuted fracture indications, and it is expected to make significant progress in clinical applications such as spinal fixation alternatives and immediate oral implantation for various hard tissue bonding.

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