Demineralized Bone Matrix

RTI Biologics Announces Launch of BioAdapt™ DBM Foam

Alachua, Fla. - (BUSINESS WIRE) - RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic implants and other biological, announces the launch of BioAdapt Foam ™ DBM, a demineralized bone matrix flexible (DBM ) solution with unique processing capabilities. The first implantation occurred June 24, 2011 in proceedings of foot and ankle.

BioAdapt is the newest addition to the RTI product portfolio osteobiologic wide.Designed to maximize ease of use, BioAdapt is a sterile, room temperature implant available in five pre-form of options to meet the needs of the graft bone trauma, reconstruction, spine and extremity surgeons. With foam-like properties, BioAdapt expands with moisture to adjust to the contours of the operative site. This versatile implant offers flexible, yet cohesive handling characteristics, making it easy to shape or mold the adjustment of various defects.

BioAdapt will be available exclusively on RTI Biologics. For more information please visit BioAdapt www.rtix.com or contact RTI Department Customer Service at 1-800-624-7238.

About RTI Biologics Inc.

RTI Biologics Inc. is a leading provider of sterile biological implants surgery in the world with a commitment to advancing science, safety and innovation. RTI prepares human donated tissue and bovine tissue for transplantation through extensive testing and screening and the use of proprietary processes. These allograft and xenograft implants are used in orthopedic surgery specialties, dental and other.

RTI Innovations continue to raise the bar of science and safety for biologics - from being the first company to offer precision machined bone implants and assembled technology to maximize each gift of donation, to inventing validated sterilization processes that include viral inactivation steps.Three such processes - the BioCleanse ® tissue sterilization process, the Cancelle SP ™ DBM sterilization process and the Tutoplast ® tissue sterilization process - have a combined record of more than two million implants distributed with zero incidence of allograft-associated infections. These processes have been validated by the type of tissue to inactivate or eliminate viruses, bacteria, fungi and spores from tissue, while maintaining the biocompatibility and functionality.

New Analysis Reveals Fertility Issue With BMP-2 (CME/CE) | Sciatic ...

Has been controversial because the investigators who conducted those trials disagreed that such a conclusion was warranted. In their scientific publications, retrograde ejaculation was not mentioned as an adverse event, and the investigators — who have had financial ties to Medtronic, the drug’s manufacturer — had denied that the problem is related to rhBMP-2.

The has been linked to an increasing number of side effects besides retrograde ejaculation, including cancers, heterotopic bone formation, soft tissue swelling, and others.

In fact, some of these effects may be responsible for the increased rates of retrograde ejaculation, in which sperm flows up the urethra into the bladder instead of out the penis. Tomislav Smoljanovic, MD, PhD, of the of Zagreb in Croatia, and colleagues have previously suggested that it may result from ectopic bone formation or inflammation related to rhBMP-2.

Carragee and colleagues examined outcomes in patients undergoing one- and two-level ALIF procedures in their clinic from 2002 to 2004, which they selected because it spanned the launch of rhBMP-2 but was short enough that other aspects of the procedure remained relatively unchanged.

Carragee himself did all the surgical approaches. The Spine Journal report indicated that his experience with anterior approaches dated back to 1990.

Of the 243 procedures performed during the period, 155 involved single-level L5-S1 fusions, including 45 with rhBMP-2. The remaining 88 procedures also included L4/L5 vertebrae, with 24 using rhBMP-2.

Retrograde ejaculation was reported after three of the 45 single-level ALIF surgeries using rhBMP-2 versus none of the 110 performed conventionally (P=0.0233), the researchers reported.

The condition also was seen after three of the two-level procedures, two of which involved rhBMP-2 (P=0.179).

Retrograde ejaculation resolved in three of the six cases within one year. In two cases, both older patients (age 48 and 53), the condition did not improve.

Use of rhBMP-2 was not random in the researchers’ practice, but mean age, smoking status, weight, and diagnoses were very similar between those receiving the product and those undergoing the conventional procedures.

The researchers did not indicate the basis for choosing rhBMP-2 during the factors for nonunion.

In addition , they wrote, “it is important that men be counseled about [the retrograde ejaculation] risk and advised that avoiding rhBMP-2 in favor of alternative grafting methods may minimize the risk.

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