Friday, April 11, 2025

Spine Wave Announces the Commercial Launch of Tempest® DCF Demineralized Cortical Fibers

SHELTON, Conn., April 09, 2025 (GLOBE NEWSWIRE) -- Spine Wave is pleased to announce the successful completion of its limited market release of Tempest® DCF Demineralized Cortical Fibers and its entry into the cortical fiber segment of the

spinal allograft market. This appealing new allograft broadens Spine Wave’s position in the large and growing spinal biologics market and well complements its established biologics and graft delivery portfolio. Tempest® DCF Demineralized Cortical Fibers is now fully launched and available from Spine Wave, effective immediately.

Tempest® DCF Demineralized Cortical Fibers is composed entirely of human allograft cortical bone with osteoconductive and osteoinductive potential. Because no carrier materials are included, surgeons are confident that they are getting the absolute most from each graft. The proprietary processing technology used to formulate Tempest® DCF Demineralized Cortical Fibers maintains tissue integrity and maximizes allograft surface area for cellular proliferation and fiber adhesion. Tempest® DCF Demineralized Cortical Fibers has ideal handling characteristics for fluid retention and expansion and is moldable and pliable to fit into any space. Tempest® DCF Demineralized Cortical Fibers rehydrate quickly with bone marrow aspirate, platelet rich plasma, antibiotics, whole blood, or saline and it resists irrigation after implantation.

Spine Wave’s GraftMag® Graft Delivery System, which is designed to safely and rapidly deliver large amounts of bone graft, can be used together with Tempest® DCF Demineralized Cortical Fibers.   The GraftMag® Graft Delivery System can transform the tedious and sometimes frustrating graft delivery process into a more efficient part of spine fusion surgery. And using GraftMag® Graft Delivery System may reduce injury risk because it reduces instrument passes by sensitive patient anatomy.  

The patented GraftMag® Graft Delivery System is comprised of two single use graft magazines that are loaded with bone graft on the back table. The magazines couple with the system’s specially designed funnels to rapidly deliver large amounts of graft into the graft site. This appealing grafting approach can reduce frustrating funnel jams and requires only one instrument pass into the graft site to complete the grafting procedure. The GraftMag® Graft Delivery System can be used in virtually any thoracolumbar spine fusion procedure and with any interbody device. However, it integrates particularly well with Spine Wave’s exciting line of titanium expandable interbody fusion products; the recently launched Exceed® Biplanar Expandable Interbody Device and the well-established Leva® Interbody Device, each of which uniquely accommodates large amounts of bone graft.

“Tempest® DCF Demineralized Cortical Fibers are my allograft choice for spine fusion surgery,” said Stuart D. Kinsella, MD, MSTR. “My procedures often require large amounts of allograft. I appreciate that Tempest® DCF Demineralized Cortical Fibers maximizes the amount of actual bone in each implanted graft because it is one hundred percent human cortical bone tissue. Also, Tempest® DCF Demineralized Cortical Fibers is versatile because it has great handling and is compatible with GraftMag® Graft Delivery System, which allows delivery of a lot of bone graft safely, quickly and easily.”  Dr. Kinsella is a practicing orthopaedic surgeon at the Steadman Clinic and the Steadman Philippon Research Institute in Aspen, Colorado, USA. 

“We are very excited to launch Tempest® DCF Demineralized Cortical Fibers as our newest biologic product.  This new allograft performed well in its limited market release and is a great addition to our established line of biologics and graft delivery products,” said Laine Mashburn, Spine Wave’s Executive Vice President for Global Marketing and Business Development.  He continued, “Spine Wave partnered with the respected LifeLink® Tissue Bank to bring Tempest® DCF Demineralized Cortical Fibers to market and our sales team has hit the ground running.  We are making the most of this new opportunity, right now.”

About Spine Wave
Spine Wave is a leader in minimally invasive spine surgery and expandable interbody devices. The company is committed to offering differentiated product and procedure solutions for spine surgeons and their patients. Spine Wave offers a broad portfolio of advanced spine implant and biologic products. The company is always looking to expand and continues to recruit sales managers and independent distributors to fuel growth. For more information on Spine Wave and its products please visit www.spinewave.com.

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