AUGMENT® BONE GRAFT

Augment Bone GraftAugment® Bone Graft is a bioengineered alternative to autograft in orthopedic surgery (non-human origin). In clinical studies, Augment® Bone Graft has been evaluated as a healing adjunct in foot and ankle fusion surgeries and distal radius fractures.

The product consists of two primary sterile components:

  • Medical grade β-TCP granules (1000-2000 µm) granules
  • rhPDGF-BB solution (0.3 mg/mL)

At the point of use, the two components are combined, mixed and subsequently applied to the surgical site. Following mixing, the final consistency is similar to ‘wet sand’. The β-TCP component of Augment Bone Graft provides a porous, osteoconductive scaffold to support cell attachment and spreading. Augment Bone Graft is designed for use in open orthopedic surgical procedures.

Augment® Bone Graft was approved for use in Canada in November of 2009 and Australia and New Zealand in October of 2011 for foot and ankle indications. Augment® Bone Graft is currently under review by the FDA, and is not yet available for sale in the U.S. For many parts of the world, including the EU, BioMimetic is developing Augment for broader indications. See package inserts for complete indications for Augment Bone Graft's use:

Augment® Bone Graft Package Insert - Canada |  English   French

Augment® Bone Graft Package Insert - Australia & New Zealand |  English

Augment Bone Graft is commercially available in Australia, New Zealand and Canada only.

AUGMENT® INJECTABLE BONE GRAFT

Augment InjectableAugment® Injectable Bone Graft is being developed as an alternative to autograft in orthopedic surgery. In clinical studies, Augment Injectable has been evaluated as a healing adjunct in hindfoot and anklefusion surgeries and distal radius fractures.


The product consists of two primary sterile components:

  • β-TCP/collagen matrix
  • rhPDGF-BB solution (0.3 mg/mL)

At the point of use, the two components are combined, mixed and subsequently applied to the surgical site. Following mixing the final consistency is a flowable paste, which can be extruded through a narrow gauge needle. Augment® Injectable Bone Graft can be used in open as well as minimally invasive surgeries, using percutaneous delivery.

Augment® Injectable Bone Graft is currently under clinical investigation in the United States and Canada and is not available for sale.

AUGMENT® CHRONIC TENDINOPATHY

Augment Bone GraftAugment® Chronic Tendiopathy is being developed for the treatment of lateral epicondylitis, commonly known as tennis elbow.

The product consists of one primary sterile component:

  • rhPDGF-BB solution (concentration and volume to be determined by clinical trial results)

A Phase II clinical study is currently evaluating the safety and therapeutic potential of escalating doses of a one-time injection of rhPDGF-BB solution into the extensor carpi radialis brevis (ECRB), the tendon in the elbow that is generally the source of pain in tennis elbow. The study compares a placebo with one of four different doses of rhPDGF-BB.

Augment® Chronic Tendinopathy is currently under investigation in the Unites States and is not available for sale.

AUGMENT® ROTATOR CUFF GRAFT

AUGMENT ROTATOR CUFF Graft

Augment® Rotator Cuff is being developed for primary surgical treatment of full thickness rotator cuff tears as a complement to standard surgical repair. Augment Rotator Cuff represents the first use of the Company's rhPDGF-BB platform technology in a sports medicine application.

The product consists of two primary sterile components:

  • rhPDGF-BB solution (0.3 mg/mL)
  • resorbable collagen matrix

Augment® Rotator Cuff is an interpositional graft applied between the tendon edge and humeral head in a single layer. Sutures are then tied ensuring the tendon is securely fixed over the collagen matrix. In this case, the collagen serves as a delivery device for the rhPDGF-BB.

Augment® Rotator Cuff is currently under investigation in Canada and is not available for sale.

FUTURE PRODUCTS

BioMimetic is committed to developing additional products to fully leverage the therapeutic benefits of rhPDGF-BB. These products, particularly in the areas of cartilage, ligament and tendon repair, are in various stages of preclinical development. Additionally, in early 2011, the Company released results of its pre-clinical study of interbody lumbar spine fusion. The results demonstrated equivalency between the Augment® Bone Graft products as compared to autograft, the current gold standard in spine fusion procedures. In humans, the Augment® Bone Graft product candidates used in spine fusion procedures would spare the patient the increased pain and morbidity associated with harvesting autograft.