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Home/Company News/Bacterin Receives Patent for Bone Matrix
Company News

Bacterin Receives Patent for Bone Matrix

September 25, 2015 1 min read Premium comments

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Bacterin Receives Patent for Bone Matrix
Patent No. 9, 114, 191 and patent symbol / U.S. Patent and Trademark Office
Secondary

Bacterin International, Inc. has received notification that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9, 114, 191 entitled “Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors.”

According to a September 22, 2015 announcement by Xtant Medical Holdings, Inc., the patent covers demineralized bone matrices derived from cortical bone, which include Bacterin’s branded product lines OsteoSTX, OsteoWrap, and OrbitalWrap HD. Bacterin has pending patent applications in the U.S. to pursue protection on other aspects of its allograft processing and demineralization technologies. Bacterin is a wholly owned subsidiary of Xtant Medical.

Gregory Juda, Ph.D., Bacterin’s chief scientific officer said the issuance of the patent confirms the company’s position as a leader in allograft processing innovation. “This patent adds to the growing body of evidence substantiating the superior processing methodologies associated with Bacterin’s allograft portfolio.”

The company claims its patented processing technologies “impart ideal handling properties to allografts while simultaneously exposing native growth factors that are inherent to natural human bone. The resulting enhanced biologic activity promotes rapid healing via tissue regeneration for patients requiring bone-grafting procedures.”

In peer-reviewed, published studies, clinical investigators have demonstrated fusion rates greater than 97%, according to the company.

The patent abstract from the patent application states:

A demineralized bone matrix is produced by a process in which a bone body is placed in a first processing solution comprising an acid to demineralize the bone body. The bone body is periodically removed from the first solution at specific time intervals to perform at least one test, such as a compression test, on a mechanical property of the bone body. When the test yields a desired result, the bone body is exposed to a second processing solution that is less acidic than the first, thus minimizing the exposure of the bone body to the harsh acidic conditions of the demineralization phase of the process.

Inventors include: Nancy Shelby; Steven Scott; Benjamin Luchsinger; Greg Juda, Kelly Kirker, Darrel Homes and Jesus Hernandez.

The patent was filed in February, 2014 and is assigned to Bacterin International.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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