RegulatorySpine

SpineGuard Receives Regulatory Clearance in Taiwan and Starts PediGuard® Commercialization

March 28, 2019

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

SpineGuard (FR0011464452 – ALSGD) (Paris:ALSGD), an innovative company that deploys its DSG® real time digital technology for surgical guidance intended to secure and streamline skeletal implant placement, announced today that it is ready to start sales of PediGuard in Taiwan by receiving regulatory clearance to market its Classic, Curved and Cannulated PediGuard range. SpineGuard appointed Dreammed Biomedical as its distributor and received a first stocking order.

‘This regulatory clearance is the result of a strong collaborative process with Dreammed Biomedical Co., Ltd.’ said Patricia Lempereur, Sales and Marketing Director International at SpineGuard. ‘It is an important milestone for SpineGuard’s expansion in the Asia-Pacific area.’

I believe there is a strong need for a simple smart device like PediGuard consistently ensuring safe and accurate placement of pedicle screws.’ added Henry Lai, CEO of Dreammed Biomedical Co., Ltd and distributor for SpineGuard’s products in Taiwan.

Spine Market in Taiwan is estimated at 8,000 surgeries per year requiring pedicle screw placements growing 2-3% annually.

About SpineGuard®

Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative company deploying its proprietary real-time digital 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 70,000 surgical procedures worldwide. Fourteen 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.

Contacts

SpineGuard
Stéphane Bette
Chief Executive Officer
Tel: +33 (0) 1 45 18 45 19
s.bette@spineguard.com

Manuel Lanfossi
Chief Financial Officer
Tel: +33 (0)1 45 18 45 19
m.lanfossi@spineguard.com

NewCap
Investor Relations & Financial Communication
Mathilde Bohin / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
spineguard@newcap.eu

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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