DEERFIELD BEACH, Fla., March 22 /PRNewswire-FirstCall/ -- BioLok
International Inc. (OTC Bulletin Board: BLLI), the manufacturer and worldwide
distributor of leading-edge dental implant technology, today announced that it
has received 510(k) clearance from the United States Food and Drug
Administration (FDA) to market BoneGen-TR. The FDA clearance, which could
have taken up to 90 days or longer, was granted 5 weeks after BioLok made its
BoneGen-TR from BioLok, a pioneer in merging technological innovation and
cell biology, is a clinically safe, nano-composite, time release calcium
sulfate product used for bone regeneration, augmentation, and as a soft tissue
barrier in Implantology, Periodontology, Endodontics and Oral Surgery. The
broad bone augmentation market is estimated at $1 billion annually.
"We are excited to have received FDA clearance for BoneGen-TR," said Bruce
L. Hollander, President of BioLok International. "BoneGen-TR for the dental
bone market is an extraordinary complement to the Laser-Lok(R) dental implant,
our other core product which uses a micro-grooving nanotechnology process to
promote tissue and bone attachment. Each of our core products is patented and
approved by the FDA for unique and safe dental applications. Collectively,
these products position us with a differentiated value proposition for
marketing to professionals while addressing a combined $2 billion market. The
entire BioLok organization is energized by the prospects to grow our business
and better support our customers and their patients with clinically superior
and cost competitive products."
BoneGen-TR has been under development at BioLok's Orthogen Research
Division and at the New York University College of Dentistry. The patent
protected product is made in small pellet form. Calcium sulfate has been used
for bone augmentation for many decades. A pure calcium sulfate product
(BoneGen) was previously approved for marketing by BioLok and has been sold by
the Company for use in implant dentistry. According to Dr. Harold Alexander,
President of Orthogen, the limitations of traditional calcium sulfate led
BioLok to develop BoneGen-TR. He noted that existing forms of calcium sulfate
products may be resorbed too rapidly by the body, before full bone defect
filling can be accomplished. The new BoneGen-TR product has an 18 week period
over which full resorbtion occurs, compared to a 4 week resorbtion period for
previous products offered. This allows the user to fill larger voids and get
full bone regeneration. The application method is not technique sensitive, is
easy, gets excellent results and is cost effective.
Traditional calcium sulfate products, including BioLok's regular BoneGen,
are considered very technique-sensitive and are used mainly for filling small
voids and as an additive to more expensive bone augmentation products to
"stretch" the volume, reduce overall cost and enhance bone formation.
BoneGen-TR is designed as a stand-alone product, having a substantially longer
resorbtion rate, and costing significantly less than other materials in the
Recent problems in the bone augmentation market make BoneGen-TR an even
more compelling new product. In the last few months there have been recalls
of potentially contaminated human source material used for bone augmentation.
In several high profile cases this included the bone and tissue bank marketing
of freeze dried human bone that was illegally harvested from cadavers and from
bone cancer victims. Furthermore, animal, human and disease issues, such as
mad cow disease with a third case in the US reported last week, have emerged
as new found concerns. Other bone augmentation materials contain bio-active
glass or silicon which do not resorb and leave residual particles that may
cause a long term problem. Accordingly, many healthcare professionals are
seeking an alternative synthetic material. Now cleared for marketing by the
FDA, BoneGen-TR addresses the dental professionals need for a fully resorbable
product with fully demonstrated safety and efficacy.
BioLok is ready for limited distribution of BoneGen-TR in the US for
clinical evaluation and intends to have the product available for mass
distribution in June/July 2006. A large multi-center, multi-national clinical
study to enhance the product's marketability will be conducted in April in
Argentina, Australia and Spain at multiple private practices and universities.
Now that BioLok has FDA clearance for marketing BoneGen-TR, US clinical
studies will be started at multiple private practices and Universities, all
with a common protocol so that all the results can be used together.
BioLok also intends to explore opportunities to market BoneGen-TR for uses
outside of dentistry. The Company will soon implement initiatives to identify
licensing partnerships to distribute a version of this unique bone
regeneration product for orthopedic applications.
BioLok International Inc. (OTC Bulletin Board: BLLI) is merging cell
biology and technology to develop and market products for the dental implant
and tissue regeneration markets. The Company is the worldwide manufacturer and
distributor of the BioLok Precision Dental Implant System. BioLok offers a
superior line of dental implants that incorporate many patented features and
are synonymous with quality, fit of components, leading edge technology and
design, and ease of use. Additional information is available on the Company's
Web site at http://www.biolok.com.
With the exception of the historical information contained in the release,
the matters described herein contain certain "forward-looking statements" that
are made pursuant to the Safe Harbor provisions of the Private Securities
Litigation Reform Act of 1995. The statements contained in this release, which
are not historical fact may be deemed to contain forward-looking statements,
including, but not limited to, deployment of new services, growth of the
customer base, and growth of the service area, among other items. Actual
results may differ materially from those anticipated in any forward-looking
statement with regard to magnitude, timing or other factors. Deviation may
result from risk and uncertainties, including, without limitation, the
Company's dependence on third parties, market conditions for the sale of
services, technical factors affecting networks, availability of capital and
other risks and uncertainties. More detailed information about these risk
factors are set forth and may be updated from time to time in filings by
BioLok International, Inc. with the Securities and Exchange Commission,
including the Company's most recent quarterly report on Form 10-Q and other
publicly available information regarding the Company. The Company disclaims
any obligation to update information contained in any forward-looking
BioLok International Contact: Investor Relations Contact:
Bruce L. Hollander Jordan M. Darrow
President/CEO Darrow Associates, Inc.
SOURCE BioLok International Inc.