MEDICREA Announces FDA Approval of First Patient-Specific UNiD™ Cervical Rod for Spine Surgery (Video)

LYON, France & NEW YORK–(BUSINESS WIRE)–MEDICREA^®,(Paris:ALMED)(Alternext
Paris: FR0004178572 – ALMED) the only medical device company offering
patient-specific implant solutions for the treatment of spinal
conditions, has announced FDA approval of the first-ever
patient-specific UNiD™Cervical rod for spine surgery, secured by
their complementary PASS OCT^® posterior cervical
stabilization system.

Immediately following the FDA clearance, MEDICREA successfully expanded
their personalized UNiD™ technology and services to the cervical spine
with the first implantation of the UNiD™ Patient-Specific
Cervical Rod in New York City on February 17, 2016. With this latest
addition, the Company announced that UNiD™ Lab personalized spinal
alignment services are now available to cover the entire cervical,
thoracic and lumbar regions.

Denys SOURNAC, President and CEO, added: “The patient-specific
cervical rod option is a natural extension of the UNiD™ portfolio. By
providing patient-specific realignment implant options for the
entire spine, we are again confirming MEDICREA^®’s
leadership position in personalized, made-to-measure treatments. This
continued expertise brings pioneering technologies and services to the
spine that are uniquely dedicated to improving clinical results for each
patient.”

The service model for the UNiD™ Cervical Rod follows the same effective
collaboration between MEDICREA^®’s UNiD™ Lab and Spinal
Surgeons worldwide, which has surpassed the creation of custom UNiD™
Thoracolumbar Rods for more than 650 implantations to date. The
UNiD™ Rod is custom-designed for Cervical, Thoracic and Lumbar spine
operations to scientifically match the rod’s shape with the patient’s
unique spinal alignment and the surgeon’s pre-operative plan.

Following surgical intervention in the occipito-cervical spine, the
shape of the rod directly impacts the fixed position of the head and
neck and dramatically changes how the patient looks and feels.
Surgeons who do not use UNiD™ are forced to manually approximate the rod
shape – a challenge greatly increased for rods with two diameters, which
are frequently used in this type of surgery with no existing tools to
accommodate the transitional point.

This challenge is doubled as two rods are systematically used in
combination – a feat requiring precision that is simply not possible
with the naked eye. The UNiD™ Cervical Rod technology removes this
existing surgical barrier by creating two strictly identical single
or dual-diameter rods manufactured specifically for the patient and
delivered directly to the Operating Room.

To complement the landmark announcement, MEDICREA has also released
a video clip with Dr. Themistocles Protopsaltis (New York,
NY, USA), the first surgeon worldwide to utilize MEDICREA^®’s
UNiD™ patient-specific services on the cervical spine. This gives more
context on the operation and its growing impact on the medical world.

Following the surgery, Dr. Protopsaltis stated “I am so happy
to have the UNiD™ Cervical Rod available. This pre-contoured
patient-specific implant has eliminated the difficulty of manually
bending transition rods, saving OR time and optimizing the execution
of my operative plan professional collaboration with MEDICREA^®’s
UNiD™ Lab translated easily into a seamless intra-operative experience
and the best possible care I can offer my patient – a personalized
treatment.”

UNiD™ Patient-Specific Cervical Rods are available in two alloys
(Titanium TA6V ELI/Cobalt Chromium) and in a single-diameter (3.5mm) or
dual-diameter options (3.5mm transitioning to either 5.5mm or 6.0mm).
The UNiD™ Patient-Specific Cervical Rods are secured using MEDICREA^®’s
most-recent extension of their versatile ‘PASS’ (PolyAxial Spine System)
posterior fixation platform, PASS OCT^® Posterior Cervical
Stabilization System, which allows 11mm of gentle reduction capability
across all anchorages and medial or lateral rod placement.

The PASS OCT^® System has been designed specifically to
complement UNiD™ patient-specific technology, minimizing forces
applied on the spine when securing the rod.

——

About MEDICREA (www.medicrea.com)

The MEDICREA Group specializes in the design, manufacture, and
distribution of innovative proprietary technologies devoted exclusively
to spinal surgery. Operating in a $10 billion market, MEDICREA is a
small to medium-sized business with 140 employees, including 40 at its
MEDICREA USA Corp. subsidiary based in New York City.

The Company enjoys an excellent and ever-improving reputation, and
develops unique scientific partnerships with some of the most visionary
and creative spine surgeons in France, the UK, and the USA. The products
developed and patented by MEDICREA provide neurosurgeons and orthopedic
surgeons specializing in the spine with new and less-invasive surgical
solutions that are faster and easier to implement than traditional
techniques.

MEDICREA has also become a pioneer and global leader in the
manufacturing of customized implants for personalized spinal surgery
with the development of a comprehensive process incorporating the
software analysis of each patient, the pre-surgical planning of the
surgical strategy, and the production of customized spinal
osteosynthesis rods (UNiD™ rod) and lumbar interbody osteosynthesis
cages (UNiD™ ALIF cage) that are made to measure by a 3D printer.

The Group’s headquarters are based near Lyon, France. It also has an
implant and surgical instrument manufacturing facility located in La
Rochelle, France, as well as four distribution subsidiaries in the USA,
the UK, France and Germany.

MEDICREA is listed on ALTERNEXT Paris
ISIN: FR 0004178572
– Ticker: ALMED