|
Kuros Biosciences AG
/ Key word(s): Regulatory Admission/Market Launch
Schlieren (Zurich), Switzerland, January 31, 2024 – Kuros Biosciences (“Kuros” or “the Company”), a leader in next generation bone graft technologies, today announced clearance of a 510(k) submission from the U.S. Food and Drug Administration (FDA) related to its MagnetOs™ Granules. The Company also announced clearance to market in New Zealand for MagnetOs Granules and MagnetOs Putty. The products are now commercially available through Vortek Spine Limited (“Vortek”), a high-tech orthopedic and biologics company specializing in healthcare solutions for surgeons and patients. This further expands the MagnetOs portfolio in terms of application and accessibility. Earlier in January, Kuros announced the FDA clearance of MagnetOs Easypack Putty for interbody use and MagnetOs Putty for standalone use in the posterolateral spine, meaning it can now be used without the need for autograft (patient’s own bone). “We are very pleased that MagnetOs Granules has received marketing clearance for interbody use given the Granules technology is the foundation of the MagnetOs platform,” commented Chris Fair, Chief Executive Officer of Kuros Biosciences. “This clearance, coupled with the MagnetOs Flex Matrix and MagnetOs Easypack Putty formulations, provides our surgeons the widest variety of advanced biologic formulations available for use in the interbody space. We are also very excited to expand our international presence through a partnership with Vortek in New Zealand and to begin working with their team to introduce our clinically proven technology to this territory.” The availability of MagnetOs in New Zealand marks a significant milestone for Kuros and the local medical community since patients can now benefit from an advanced bone graft that improves the overall quality of care in orthopedic and spinal procedures. This benefit was further demonstrated with recent level 1 clinical data in which MagnetOs outperformed the gold standard autograft by 73% in posterior spinal fusion in a difficult-to-treat real life patient population, of which 20% were current smokers.1 About MagnetOs U.S. Indications Statement MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. When used in posterolateral spine, extremities and pelvis, MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. When used in intervertebral body fusion procedures, MagnetOs Granules must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler and hydrated with blood. MagnetOs Granules may also be mixed with autograft. MagnetOs Granules resorbs and is replaced with bone during the healing process. MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. MagnetOs Putty may be used standalone or mixed with autograft. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process. MagnetOs Easypack Putty is intended to filly bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process. MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in interverterbral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process. For further information, please contact:
About Kuros Biosciences Forward Looking Statements 1. Data on file. MaxA. Autograft in a Prospective, Multi-center, Randomized, Intra-patient Controlled Trial. P2016;117(7):1511–1521.
End of Media Release |
| Language: | English |
| Company: | Kuros Biosciences AG |
| Wagistrasse 25 | |
| 8952 Schlieren | |
| Switzerland | |
| Phone: | +41 44 733 4747 |
| Fax: | +41 44 733 4740 |
| E-mail: | info@kurosbio.com |
| Internet: | www.kurosbio.com |
| ISIN: | CH0325814116 |
| Valor: | 32581411 |
| Listed: | SIX Swiss Exchange |
| EQS News ID: | 1826429 |
| End of News | EQS News Service |
|
|
1826429 31.01.2024 CET/CEST
