Create Possibilities

mission

For corporate business or for more information, contact us at: Bacterin International 600 Cruiser Lane Belgrade, MT 59714, U.S.A.Phone: 406-388-0480 Fax: 406-388-1354

To place an order, or to contact Customer Service:Phone: 888-886-9354 Fax: 406-388-3380 CS@bacterin.com

w w w . b a c t e r i n . c o m

5041D 01/2012 ©2012 Bacterin International Holdings, Inc. All Rights Reserved

Spine Neuro Trauma Foot & Ankle Sports Medicine Cranio–Maxillofacial Plastic & Reconstructive

Bacterin’s mission is to design, manufacture,

and distribute innovative, safe, reliable, and

cost–effective solutions for the medical needs of patients.

OsteoSponge®

OsteoSponge® is a novel form of demineralized bone matrix (DBM) made from 100% bone. Derived from trabecular bone, OsteoSponge® provides a natural scaffold for cellular ingrowth and exposes bone growth inducing proteins to the healing environment. The malleable properties of OsteoSponge® enable it to fill and conform to irregular bony defects. Due to its shape memory characteristics, OsteoSponge® will expand to completely fill a void after graft placement. The unique mechanical and biological properties make OsteoSponge® an ideal bone graft for use with anterior spinal devices, in arthrodesis, or in fracture sites.

OsteoSponge® OsteoSponge®

In Vivo Studies (Heterotopic Bone Growth Model)Bacterin has performed preclinical studies using a heterotopic bone growth model in athymic mice and rats to test the osteoinductive properties of OsteoSponge® OsteoSponge® is prepared using methods that preserve native growth factors contained within the collagen matrix. Neovascular-ization, osteoid formation, and new bone growth has been consistently observed in subcutaneous and intramuscular implants of OsteoSponge® (Figures 1 and 2).

These results suggest that in addition to providing an excellent natural scaffold for cellular ingrowth and proliferation, OsteoSponge® also con-tains growth factors. Growth factors signal infiltrating host cells to initiate the formation of new blood vessels and to differentiate into osteoclasts and osteoblasts. This combination of signaling and structure ultimately leads to the formation of new bone.

Preclinical Scientific Evaluations of OsteoSponge®

Evidence for Osteoinductive and Osteoconductive Properties

Endogenous Native Growth Factors in OsteoSponge®

Characterization of the native growth factor content of OsteoSponge® aids in understanding its osteoin-ductive activity. To evaluate the levels of endogenous growth factors in OsteoSponge® , Enzyme-Linked Immunosorbent Assays (ELISAs) were used to measure the levels of native growth factors, including human bone morphogenic proteins (hBMPs), in extracts of OsteoSponge® blocks processed from a 27 year old male donor. Shown in Table 1 are concentrations of hBMP-2, hBMP-4, and hBMP-7 and insulin-like growth factor-1 (IGF-1).

These results illustrate that OsteoSponge® provides a host of signaling molecules that are involved in the remodeling and creation of new bone. Therefore, OsteoSponge® sup-ports the natural progression of events from bone induction to bone formation.

Growth Factor Concentration Detected (pg/g of bone)

BMP-2 8,423 ± 248BMP-4 1,112 ± 19BMP-7 50,581 ± 1,876IGF-1 713 ± 173

A scanning electron microscope image of OsteoSponge® demonstrates the open

structure and large surface area.(Magnification: 30X) Mechanical and Biological Characteristics

• 100% human demineralized cancellous bone

• Osteoconductive, interconnected porosity

• Osteoinductive properties

• Elastic, compressible handling characteristics

• Radiolucent to allow for accurate follow-up

• Sterile, room-temperature storage, 5 year shelf life

Figure 1

Figure 2

OsteoSponge® Blocks8mm, 10mm, 12mm, 14mm

OsteoSponge® Cranial Discs10mm, 12mm, 14mm

OsteoSponge® Cranial Strips50x5x5mm, 50x5x7mm

OsteoSponge® Filler1.0cc, 2.5cc, 5.0cc,

10cc,15cc, 30cc

OsteoSponge® is supplied as:

Additional OsteoSponge® products and sizes are available. Please contact your Bacterin representative for more information.

OsteoSponge® Strips20x14x5mm, 20x14x7mm, 26x19x7mm, 30x10x7mm, 50x10x7mm, 50x20x7mm