Safe Orthopaedics Announces the Commercial Launch of SteriSpineTMVA, a Balloon for the Vertebral Augmentation

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (FR0012452746 – SAFOR) (Paris:SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, today announces its worldwide launch of its Kyphoplasty System: the SteriSpine^TM VA.

The new system adds to an already existing portfolio of sterile & single use devices and establishes Safe Orthopaedics as the only company that can offer a comprehensive portfolio of ready to use spinal fracture treatment options, which consists of a balloon and cement systems for restoring the vertebral body and a complete range of implants for stabilizing the spinal segment (Screw, rod, cross connectors…) post-fracture…

The European market for the treatment of vertebral compression fractures (VCF) via vertebral augmentation (Kyphoplasty) is estimated at €82M in 2018 and is expected to grow to over €120M in 2026¹ with a CAGR of 4.8%, in large part, because of the ageing population in Europe.

Sjors Hermans, Global sales director of Safe Orthopaedics comments: “The SteriSpine^TM VA is one of the two first systems in the market to offer a high quality, high pressure balloon of 700 PSI. Safe Orthopaedics is now the only one in the world to propose a full ready to use spinal treatment for the vertebral fracture.”

Pierre Dumouchel, CEO of Safe Orthopaedics, concludes: “Reinforcing our leadership in the fracture segment, we address a new segment representing €72M in France, Germany and the UK that will sustain our strong growth and reinforce our gross margin.”

In last July, Safe Orthopaedics announced the launch of its kyphoplasty offer in the countries where Safe Orthopaedics has a direct sales force. From September 2018, this offer is extended to all countries where the Safe Orthopaedics is present. This cement injection method, performed with a balloon, allows Safe Orthopaedics to provide a complete emergency fracture treatment package to push the penetration of its products towards the surgeons and strengthen its gross margin.

The SteriSpine^TM VA balloon is a high pressure, high quality balloon that can be inflated up to 700 PSI. The majority of the systems in the market today allow between 300 and 400 PSI. It comes in different sizes to accommodate all different kinds of patient anatomy.

¹ 2017 Millennium Research data

Next financial publication: First half 2018 results, September 28, (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 37 employees.

For more information, visit: www.SafeOrtho.com