Company Introduction
BioGend Therapeutics was established in July 2016 with a noble vision to be an innovative solutions provider for holistic medical care to restore bone and joint functions. We are committed to develop regenerative orthobiologic products that fulfill unmet clinical needs. We strive to be a trusted healthcare partner helping people maintain a healthy and active life style.The project management teams at BioGend Therapeutics are led by seasoned product development managers with team members from different functional areas. Each development project is carefully planned following the phase-gate process for effective and efficient execution. For highly regulated biomedical devices, the expertise in regulatory affairs and pre-clinical and clinical development is essential in order to gain regulatory approval and to realize the potential value of innovative bio-technologies. Through the development of innovative bio-orthopaedic products and the establishment of world class GMP processes, we hope to elevate Taiwan's biomedical industry to a new level.
Brief description of main products or services
RevoCart
RevoCart uses double-minced autologous cartilage and combines it with a bioresorbable scaffold to treat the cartilage lesion in a knee. The procedure can be done in a one-step surgery. Chondrocytes are incubated inside the patient’s knee, and no costly culture expansion of cells in vitro is needed. Minimal invasive surgery can be applied to the RevoCart procedure to shorten the recovery time. RevoCart had been launched in Taiwan market. The patients had experienced a follow-up of more than 5 years with good clinical performance.OIF
Osteoinductive factorAn E.coli expresses BMP-2, used in combination with bioceramics commonly used in clinical settings. This new material will work in a wide array of applications, including spinal fusion, long bone fractures, dentistry, maxillofacial bone grafting, and other surgical procedures that require grafting. OIF can also speed up the bone healing process, while reducing the risk of delayed union or non-union. It is expected to reduce the potential risk of existing products and be a new substitute which has osteoinductive property for the treatment of bone fracture. It is undergoing phase II trial in Japan for non-union bone fracture. Pilot trial for tibial fracture and posterior interbody lumbar fusion will be initiated soon.