Novosis (bongros/BMP-2) / Daewoong Pharma - LARVOL DELTA

Clinical and Radiologic Outcomes of NOVOSIS (rhBMP-2 With Hydroxyapatite Carrier) Grafting for Scaphoid Waist Nonunion: A Preliminary Clinical Study. (PubMed, Orthop Surg) - "This preliminary clinical series demonstrated that NOVOSIS provided reliable union, functional recovery, and radiographic correction in scaphoid nonunion without donor-site morbidity. It may serve as a feasible alternative to autologous bone grafting and warrants further validation in larger studies."

Journal • Infectious Disease • Orthopedics • BMP2

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease (clinicaltrials.gov) - P3 | N=316 | Recruiting | Sponsor: CGBio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Diseases

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: CGBio Inc. | Trial completion date: Jan 2031 ➔ Nov 2031 | Trial primary completion date: Jan 2028 ➔ Dec 2028

Trial completion date • Trial primary completion date • Musculoskeletal Diseases

Navigating diagnostic challenges: E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) induced endplate osteolysis and delayed spondylodiscitis: a case report. (PubMed, J Spine Surg) - "coli)-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) (NOVOSIS®, CGbio, Inc., Seoul, Republic of Korea) is increasingly used in selected spinal fusion surgeries to promote bony fusion between vertebrae...This case demonstrates the difficulty in diagnosing rhBMP-2 induced endplate osteolysis as it mimics spondylodiscitis on imaging. Clinicians should consider this complication as a differential diagnosis to avoid unnecessary antibiotic treatment and to improve postoperative monitoring protocols, even with newer rhBMP-2 formulations."

Journal • Back Pain • Musculoskeletal Pain • Pain • BMP2

Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: CGBio Inc.

New P3 trial • Musculoskeletal Diseases

Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease (clinicaltrials.gov) - P=N/A | N=48 | Active, not recruiting | Sponsor: CGBio Inc.

New trial

rhBMP-2-loaded hydroxyapatite/beta-tricalcium phosphate microsphere/hydrogel composite promotes bone regeneration in a novel rat femoral nonunion model. (PubMed, Front Bioeng Biotechnol) - "This study focuses on NOVOSIS putty (NP), a novel biomaterial designed for the sustained release of BMP-2, aiming to mitigate these limitations and enhance bone healing...The sustained release of BMP-2 from the hydrogel component reduced inflammatory responses and enhanced bone regeneration. NP can be a promising alternative to collagen-based BMP-2 delivery systems."

Journal • Preclinical • Inflammation • Musculoskeletal Diseases • Orthopedics • BMP2

Effects of rhBMP-2-loaded hydroxyapatite granules/beta-tricalcium phosphate hydrogel (HA/β-TCP/hydrogel) composite on a rat model of caudal intervertebral fusion. (PubMed, Sci Rep) - "We developed NOVOSIS putty (NP), a novel composite material of hydroxyapatite (HA), beta-tricalcium phosphate (β-TCP)/hydrogel, and BMP-2, which can sustainably release BMP-2 over 2 weeks...Furthermore, the incidences of ectopic bone formation and soft tissue swelling were significantly lower in the NP group than in the CS group. The HA/β-TCP/hydrogel carrier enabled superior bone induction with low-dose BMP-2 and decreased the incidence of side effects caused by high-dose BMP-2 vis-à-vis the collagen carrier."

Journal • Preclinical • Immunology • Inflammation

A novel BMP-2-loaded hydroxyapatite/beta-tricalcium phosphate microsphere/hydrogel composite for bone regeneration. (PubMed, Sci Rep) - "We evaluated the bone-regenerating potential of NOVOSIS putty (NP), a novel composite combining hydroxyapatite, beta-tricalcium phosphate microsphere/poloxamer 407-based hydrogel, and recombinant human (rh) BMP-2...In a rat spinal fusion model, the volume and quality of newly formed bone was higher in the NP group than in the CS group. Use of NP results in efficient bone regeneration through sustained release of rhBMP-2 and improves the quality of BMP-induced bone."

Journal