SpineGuard Files Its “510K” Dossier for the Clearance of Its New “DSG Connect” Platform in the United States
04 Juin 2020 - 6:00PM
Business Wire
Regulatory News:
SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an
innovative company that deploys its DSG® (Dynamic Surgical
Guidance) sensing technology to secure and streamline the placement
of bone implants, announced today the filing of its “510K”
regulatory dossier with the FDA, seeking the authorization to
commercialize its DSG Connect platform in the USA.
Already being utilized experimentally in a new strategic high
value platform to guide surgical robots, SpineGuard will now apply
this platform to its entire range of products. The
commercialization in the United States will commence as soon as the
file is validated, which usually takes 3 to 9 months. As a
reminder, DSG Connect is a tablet based software interface that
adds visual interpretation to the auditory feedback for optimal
exploitation of the signal during pedicle screw placement. It also
allows for data recording of bone impedance values as evidence of
optimal screw placement within the pedicle and for bone quality
studies.
Stéphane Bette, co-founder and Deputy CEO of SpineGuard,
said: “SpineGuard generates a large portion of its revenue in
the United States, the first market worldwide in our sector that
strongly rewards innovation. Therefore, it is our priority to
quickly clear there the innovations that we launch. We are very
proud, during the COVID period, to have assembled this regulatory
file which is substantial because for the first time in the history
of the company it entails radio frequency transmission, as well as
a software application on a visual terminal. On the heels of the
recent CE mark, as spine surgeries progressively resume in Europe,
we will soon perform the first surgery in France with DSG Connect,
and we look forward to doing the same in the USA. DSG Connect is a
major step in the development of the company and the deployment of
the DSG technology, not only because of the commercial potential
but also due to the strategic value of this new platform. DSG
Connect is also an essential component of the application for
surgical robots aiming at enhancing their safety and autonomy. We
are progressing this application rapidly for which we are in
discussions with potential strategic partners.”
About SpineGuard® Founded in 2009 in France and the USA
by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative
company deploying its proprietary radiation-free real time sensing
technology DSG® (Dynamic Surgical Guidance) to secure and
streamline the placement of implants in the skeleton. SpineGuard
designs, develops and markets medical devices that have been used
in over 75,000 surgical procedures worldwide. Fifteen studies
published in peer-reviewed scientific journals have demonstrated
the multiple benefits DSG® offers to patients, surgeons, surgical
staff and hospitals. Building on these solid fundamentals and
several strategic partnerships, SpineGuard has expanded its
technology platform in a disruptive innovation: the « smart »
pedicle screw launched late 2017 and is broadening the scope of
applications in dental implantology and surgical robotics. DSG® was
co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D.,
and Alain Vanquaethem, Biomedical Engineer.
For further information, visit www.spineguard.com
Disclaimer The SpineGuard securities may not be offered
or sold in the United States as they have not been and will not be
registered under the Securities Act or any United States state
securities laws, and SpineGuard does not intend to make a public
offer of its securities in the United States. This is an
announcement and not a prospectus, and the information contained
herein does and shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of the
securities referred to herein in the United States in which such
offer, solicitation or sale would be unlawful prior to registration
or exemption from registration.
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version on businesswire.com: https://www.businesswire.com/news/home/20200604005499/en/
SpineGuard Pierre Jérôme Président Directeur Général Tél.
: 01 45 18 45 19 p.jerome@spineguard.com
Manuel Lanfossi Directeur Financier
m.lanfossi@spineguard.com
Europe / NewCap Investor Relations &
Financial Communication Mathilde Bohin / Pierre Laurent Tél. : 01
44 71 94 94 spineguard@newcap.eu
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