COLLEYVILLE, Texas--(BUSINESS WIRE)--Bone Solutions Inc., an orthobiologics technology company located in Colleyville, Texas, announced today 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA) for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.

德克萨斯州科利维尔市——（商业新闻短讯）——位于德克萨斯州科利维尔市的orthobiologics技术公司Bone Solutions Inc.今天宣布，510（k）从美国食品和药物管理局（FDA）获得Mg OSTEOCRETE的许可，用于椎间盘间隙，包括颈椎，胸椎和腰椎融合手术。

This marks the first and only magnesium-based bone substitute to be cleared by the FDA for this application..

这标志着第一个也是唯一一个被FDA批准用于此应用的镁基骨替代品。。

This expanded indication allows surgeons and patients to further benefit from the advantages of the Bone Solutions proprietary magnesium-based technology. Mg OSTEOCRETE is a fast-setting bone substitute that remodels into bone over time through creeping substitution. This remodeling profile means that the material provides needed support to the defect or void during the healing process then transforms into bone at an optimal rate.

这种扩大的适应症使外科医生和患者能够进一步受益于Bone Solutions专有镁基技术的优势。Mg-OSTEOCRETE是一种快速凝固的骨替代物，随着时间的推移通过爬行替代物重塑成骨。这种重塑轮廓意味着材料在愈合过程中为缺陷或空隙提供所需的支撑，然后以最佳速率转化为骨骼。

The product is already cleared for use in posterolateral spine procedures..

该产品已获准用于后外侧脊柱手术。。

“We are enthusiastic for the opportunity to positively impact more spine procedures with this expanded indication,” said Drew Diaz, CEO of Bone Solutions Inc. “Bone Solutions remains dedicated to improving patient outcomes through our superior magnesium-based orthopedic technologies.'

Bone Solutions Inc.首席执行官德鲁·迪亚兹（DrewDiaz）说：“我们非常希望有机会通过这种扩大的适应症对更多脊柱手术产生积极影响。Bone Solutions仍然致力于通过我们优越的镁基骨科技术改善患者的预后。”

The magnesium component of Mg OSTEOCRETE is the significant differentiator from other bone substitutes on the market. The crystallization reaction from magnesium oxide and the blend of phosphate-based materials allows for ideal osteoconductivity of the product. As a result, post-placement Mg OSTEOCRETE sets and cures in situ without migration.

镁骨水泥的镁成分是市场上其他骨替代品的重要区别。氧化镁和磷酸盐基材料的混合物的结晶反应使产品具有理想的骨传导性。因此，放置后的Mg骨混凝土在原位凝固并治愈而不迁移。

The material stimulates cell adhesion, proliferation, and formation of the bone extracellular matrix (ECM) by the osteoblasts, promoting bone growth..

该材料通过成骨细胞刺激细胞粘附，增殖和骨细胞外基质（ECM）的形成，促进骨骼生长。。

In addition to the superior clinical performance of the material, the handling characteristics and formulation are ideal for clinical use. Ready for use after only 30 seconds of mixing, the material is moldable or injectable and is cohesive and adhesive to the area it is filling. Once implanted, the material sets quickly, is drillable after only two minutes, and is also radiopaque..

除了该材料优越的临床性能外，处理特性和配方也是临床使用的理想选择。仅混合30秒即可使用，该材料可模塑或可注射，并且与填充区域具有粘性和粘合性。植入后，材料迅速凝固，仅两分钟后即可钻孔，并且不透射线。。

Mg OSTEOCRETE is currently being distributed to facilities and surgical centers nationwide for immediate clinical use.

Mg OSTEOCRETE目前正在全国范围内分发给设施和手术中心，以便立即临床使用。

About Bone Solutions Inc.

关于Bone Solutions Inc。

Bone Solutions Inc. is a specialized medical device company dedicated to improving clinical outcomes through biologically safe, fully resorbable magnesium-based orthopedic implant solutions, with a focus on addressing complex procedures and cost reduction. The company is developing various new orthopedic technologies within its FDA-cleared magnesium-based platform..

Bone Solutions Inc.是一家专业医疗器械公司，致力于通过生物安全，完全可再吸收的镁基骨科植入物解决方案改善临床效果，重点解决复杂的手术和降低成本问题。该公司正在其FDA批准的镁基平台上开发各种新的骨科技术。。