MEDICAL AND DENTAL TECHNOLOGIES
Bindan has licensed its medical related technologies to Bone Solutions, Inc (BSI). BSI is a Dallas, TX based , orthobiologics technology corporation that has received FDA 510 (k) clearance for its first proprietary device, OsteoCrete™ in May 2009. This represents a critical milestone for BSI to establish a platform for its patented magnesium based technology. This magnesium based compound offers the orthopedic industry a novel solution that will be powerful yet easy for surgeons to use in multiple orthopedic applications. BSI believes its future products will result in increased success rates in a multitude of orthopedic related surgical applications.
Bone Solutions, Inc. ("BSI") a privately-owned, Dallas, TX,
orthobiologics technology corporation has received FDA 510 (k)
clearance for its first proprietary device, OsteoCrete™ in May 2009.
This represents a critical milestone for BSI to establish a platform
for its patented magnesium based technology. This
magnesium based compound offers the orthopedic industry a
novel solution that will be powerful yet easy for surgeons to use in
multiple orthopedic applications. BSI believes its future products
will result in increased success rates in a multitude of orthopedic
related surgical applications.
From this technology platform, the FDA cleared BSI' first
product, OsteoCrete™ as a Bone Void Filler for long bone and
pelvis applications. OsteoCrete™ is an injectable, moldable,
osteoconductive and biocompatible product able to be fully
resorbable within the “window of healing” improved time frame for
bone healing, providing binding and compressive strength support for
possible future application to bone on bone healing, tendon in bone
repairs, and the Company’s plans for implants to bone.
OsteoCrete™ for Human Uses
Having completed its 510 (k) FDA clearance for OsteoCrete™ long
bone and pelvis applications BSI now plans for a series of
additional 510(k) filings for other medical devices through
2009-2010, in particular, as a bone cement, bone anchor, bone void
filler with cranial and maxillofacial applications, and for non-load
bearing spine applications. With OsteoCrete™ Bone Void
Filler, BSI plans to commence sales in early 2011 in the
trauma/sports medicine markets, including extremities, podiatry, and
providing stabilization of femur and tibia fractures, ACL, bone
graft, and other applications.
New future products from this technology platform, following 510
(k) FDA clearance, are expected to have the unique application of
stabilizing and augmenting the invasive metallic fixation devices
that tend to loosen in cementless hip, knee and shoulder surgeries,
even extending to extremities and facial bone augmentation.
The Company is also applying for CE Mark Certification and is
exploring relationships with entities to help facilitate its growth.
Bone Solutions believes its magnesium-based technology features are
beyond the capabilities of any known bone filler or bone cement
deployed globally today, opening up new, lower cost, surgical
options for potentially many markets, on separate FDA clearances.