9/13/04
Boca Raton, Florida
US
Spinal Technologies, an emerging leader
in the development and manufacture of innovative spinal implants,
is pleased to announce it has received 510(k) clearance to market
the LTD Polyaxial Pedicle Screw System for spinal fusion. LTD is
the first product developed by the company, and will be launched
commercially in the United States in Q4 2004.
"This is an important milestone for the company" said Doris Blake,
Founder and
President of US Spine, "It signals to our investors that we can execute
according to the schedule we presented from the onset of this venture, and deliver
effective products to market in a timely fashion".
The LTD System features a multi-directional pedicle screw that allows the surgeon
to more accurately place the screws in the posterior spine due to its reduced
profile and lower volume of metal. Traditional pedicle screws tend to be larger,
and fit less easily within the patientâs anatomy, requiring the surgeon to remove
larger portions of vital bone structures. Thanks to its advanced, two-piece design,
the LTD offers fatigue strength comparable or favorable to traditional systems,
while keeping size to a minimum. The system also features instruments that are
simpler, more intuitive, and offer greater tactile feedback to be transmitted
to the surgeonâs hand, a sense that is vital for implantation so close to sensitive
nerve structures. Several of the instruments in the system are the result of
a collaborative effort between US Spine and Beere Medical, a leading instrument
supplier to the medical device industry, and make their public debut in the
LTD instrument set. The instrument sets themselves can be customized to meet
individual
surgeon requirements; a feature large companies do
not provide.
US Spine is aggressively developing a comprehensive suite of products to treat
spinal disorders. The company plans to launch a series of products over the next
several months, including allograft tissue, synthetic bone substitutes, intervertebral
devices and discectomy instrumentation. An agreement has been reached with Berkeley
Advanced Biomaterials for the development and distribution of Tri-calcium Phosphate
Hydroxyapatite synthetic bone substitute. This material facilitates the growth
of trabecular bone, which bears weight and enhances the structural integrity
of the operative site. The company will distribute the products under a private
label in the United States beginning in Q4 2004, providing a competitive entry
into the $300mm Biologics market.
Additionally, US Spine has partnered with DCI Donor Services of Nashville, Tennessee,
a non-profit organization, for the procurement, processing and supply of precision
machined allograft bone, the current preference among surgeons for inter-vertebral
fusion due to its natural compatibility with the human body. The products can
be used in many applications of spinal surgery, and will enable the company to
compete for a portion of the $285mm Allograft market. These products, as well
as the aforementioned bone substitutes are complementary to the LTD Polyaxial
Screw System, allowing the company to maximize revenue with each procedure by
providing the surgeon with multiple products that can be used
during a procedure.
The strategic launch of these products will help US Spine recruit larger sales
organizations, increasing the companyâs distribution network and creating an
initial revenue stream while additional products are under development, such
as the artificial disc and Facet Fusion Device. Both of these products involve
proprietary technology the company is developing that will significantly improve
patient outcomes and create exponential value to the shareholders.
About US Spine
US Spine is a surgeon-focused and science-driven spinal implant and device
manufacturing company located in Boca Raton, Florida. The companyâs vision is to advance the
science of spine and firmly establish spine surgeons as the driving force of
the company. US Spineâs principal objective is to combine new technology and
design concepts to provide surgeons with products resulting in improved surgical
outcomes, shorter hospital stays and quicker recovery times, thereby reducing
the procedural and rehabilitative costs of spine surgery to the patient and/or
insurer. Development efforts are focused on motion and tissue preservation
through a minimally invasive approach to treat spinal disorders.
(September 2004)
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for further information about US Spine and its products, please
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