SEOUL, South Korea, May 14, 2024 /PRNewswire/ — CGBio, a leading medical device company, announced a significant clinical results demonstrating a 100% interbody fusion success rate at 52 weeks for its innovative bone substitutes, "Novosis" and "Excelos Inject," which have been published in the ‘Journal of Clinical Medicine’. These results not only highlight the efficacy of the products but also demonstrate their potential for entry into the U.S. healthcare market.
Novosis, a ceramic bone graft that closely mimics the structure of human cancellous bone, and Excelos Inject, a mineralized bone graft designed to enhance bone formation and improve moldability, have been approved in Korea. Both products are developed as bone graft materials with high rates of bone fusion and serve as effective delivery systems for the controlled release of recombinant human bone morphogenetic proteins (rhBMP-2, produced by Daewoong Pharmaceutical Co., Ltd).
The study, led by Prof. Jae-Hwan Cho of Asan Medical Center in Seoul and Prof. Ji-Won Kwon of Severance Hospital in Gangnam, investigated the effectiveness of Novosis in transforaminal lumbar interbody fusion (TLIF) surgery. The product, which contains human recombinant bone morphogenetic protein-2 (rhBMP-2), was shown to significantly increase fusion rates, which are critical to the success of lumbar surgery.
The clinical trial, which ran from April 2021 to December 2023, included 30 patients with degenerative lumbar spine disease. The results showed a fusion rate of 83.87% at six months post-operatively and 100% at one-year follow-up, and remained stable through year two. Patients also showed significant improvements in quality of life, back and leg pain as assessed by the Oswestry Disability Index, SF-36 Health Survey, and visual analog scale. (https://doi.org/10.3390/jcm13061733)
"The results of this study demonstrate that the bone substitute product manufactured with CGBio’s unique technology has been designed to optimize properties for BMP-2 retention and release, allowing it to show excellent effects even with a small amount of bone morphogenetic protein of 0.5 to 1 mg," said Hyun Seung Yu, CEO. "We expect that this result will have a positive impact not only on patients but also on the medical environment and society, and we are one step closer to successfully entering the U.S. market, especially since it is a preliminary result of a product similar in composition to Novosis Putty, which is about to enter the U.S. market, the largest market in the world."
CGBio will present these results at the World Spine Congress in Bangkok from May 15-18, 2024. They expect to give surgeons further confidence in the product’s potential. With these promising results, CGBio is preparing for a successful U.S. market debut of Novosis Putty, which received Breakthrough Therapy Device designation from the FDA in December. The IDE for the pivotal study of our product is expected to receive FDA approval later this year, which will increase the confidence of U.S. clinicians participating in clinical trials and accelerate entry into the U.S. market.
About CGBio
CGBio began with the mission of ‘Pursuing the Improvement of Quality of Life,’ specializing in the production and sale of therapeutic materials for reconstructing musculoskeletal tissues damaged by diseases. Expanding its scope, the company now also provides materials for the beauty and plastic surgery sectors. Building on biomaterial-based technology, CGBio collaborates with clinical experts to supply essential products for clinical use and products that are convenient for use in clinical settings. More detailed information can be found at (http://www.cgbio.co.kr/en/).
Source : Novosis Putty Sets the Stage for U.S. Market Success with Promising Clinical Results
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