Charles Sternberg, Associate Editor01.22.24
Biomimetic Innovations Ltd.’s OsStic Synthetic Injectable Structural Bio-Adhesive Bone Void Filler has been granted Breakthrough Device designation by the FDA for reduction, provisional fixation, or void filling of peri-articular fractures or defects to enhance structural stability where standard fixation alone cannot provide sufficient support for functional mobilization.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices, by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
This Breakthrough Designation fuels Biomimetic Innovations’ passion for earlier mobilization of trauma patients. Biomimetic Innovations is an affiliate company of PBC Biomed Ltd.
According to a recent Injury publication, periarticular fractures are unique injuries which can occur either after high energy trauma in young adults or following low velocity falls in the elderly1. The incidence of these complex fractures is over 100 fractures per 100,000 persons and growing due to higher activity levels in the elderly, and the growth of total joint replacements in younger patients2-6. With advancements in biomaterials such as OsStic Technology, surgeons will have a more biologic approach to provisionally and definitively fixate the articular surfaces, which could lead to earlier weightbearing and fewer revisions.
“OsStic pioneers the evolution of structural orthobiologics, to the point where surgeons can now use this material as an aid for the reduction, provisional fixation and void filling of peri-articular fractures. This is the first calcium phosphate that meets all these clinical requirements,” said Thomas A Russell, CMO at PBC Biomed.
References:
1 Russell et al., Editorial: Modern osteosynthesis of periarticular fractures: The role of provisional fixation revisited. Injury Volume 53, Issue 12, 111153. (December 2023), DOI: https://doi.org/10.1016/j.injury.2023.111154.
2 Tibial Plateau Fractures. [Updated April 23, 2023]. In StatPearls Publishing [internet]. Treasure Island, FL. Bookshelf ID: BK470593, PMID: 29261932.
3 Femoral Neck Fractures. [Updated February 05, 2021]. Medscape: https://emedicine.medscape.com/article/86659-overview#a6?form=fpf.
4 Elsoe et Al. Population-based epidemiology and incidence of distal femur fractures. Int Orthop. 2018 Jan; 42(1): 191-196. PMID: 29116356 DOI: https://link.springer.com/article/10.1007/s00264-017-3665-1.
5 Scheer et Al. Ankle Fracture Epidemiology in the United States: Patient-Related Trends and Mechanisms of Injury. K foot Ankle Surgery. 2020 May-Jun; 59(3): 479-483. PMID: 32354504, DOI: https://doi.org/10.1053/j.jfas.2019.09.016.
6 Karl, John W. MD, MPH*; Olson, Patrick R. MD, MS, MPH†; Rosenwasser, Melvin P. MD*. The Epidemiology of Upper Extremity Fractures in the United States, 2009. Journal of Orthopaedic Trauma 29(8):p e242-e244, August 2015. | DOI: 10.1097/BOT.0000000000000312.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices, by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
This Breakthrough Designation fuels Biomimetic Innovations’ passion for earlier mobilization of trauma patients. Biomimetic Innovations is an affiliate company of PBC Biomed Ltd.
According to a recent Injury publication, periarticular fractures are unique injuries which can occur either after high energy trauma in young adults or following low velocity falls in the elderly1. The incidence of these complex fractures is over 100 fractures per 100,000 persons and growing due to higher activity levels in the elderly, and the growth of total joint replacements in younger patients2-6. With advancements in biomaterials such as OsStic Technology, surgeons will have a more biologic approach to provisionally and definitively fixate the articular surfaces, which could lead to earlier weightbearing and fewer revisions.
“OsStic pioneers the evolution of structural orthobiologics, to the point where surgeons can now use this material as an aid for the reduction, provisional fixation and void filling of peri-articular fractures. This is the first calcium phosphate that meets all these clinical requirements,” said Thomas A Russell, CMO at PBC Biomed.
References:
1 Russell et al., Editorial: Modern osteosynthesis of periarticular fractures: The role of provisional fixation revisited. Injury Volume 53, Issue 12, 111153. (December 2023), DOI: https://doi.org/10.1016/j.injury.2023.111154.
2 Tibial Plateau Fractures. [Updated April 23, 2023]. In StatPearls Publishing [internet]. Treasure Island, FL. Bookshelf ID: BK470593, PMID: 29261932.
3 Femoral Neck Fractures. [Updated February 05, 2021]. Medscape: https://emedicine.medscape.com/article/86659-overview#a6?form=fpf.
4 Elsoe et Al. Population-based epidemiology and incidence of distal femur fractures. Int Orthop. 2018 Jan; 42(1): 191-196. PMID: 29116356 DOI: https://link.springer.com/article/10.1007/s00264-017-3665-1.
5 Scheer et Al. Ankle Fracture Epidemiology in the United States: Patient-Related Trends and Mechanisms of Injury. K foot Ankle Surgery. 2020 May-Jun; 59(3): 479-483. PMID: 32354504, DOI: https://doi.org/10.1053/j.jfas.2019.09.016.
6 Karl, John W. MD, MPH*; Olson, Patrick R. MD, MS, MPH†; Rosenwasser, Melvin P. MD*. The Epidemiology of Upper Extremity Fractures in the United States, 2009. Journal of Orthopaedic Trauma 29(8):p e242-e244, August 2015. | DOI: 10.1097/BOT.0000000000000312.