Medicrea Announces 2 FDA Clearances of New Specialized Components for Pediatric Deformity on PASS® and LigaPASS® Platforms for Complex Spine in Younger Patients

The Medicrea Group (Alternext Paris: FR0004178572 - ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced that it has received two unique 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its PASS^® XS posterior fixation and LigaPASS^® XS band connector components designed to address pediatric spinal deformities in small stature patients.

The Company has worked with a team of leading pediatric spinal surgeons to develop low-profile implants specially tailored for the unique demands of pediatric deformity surgery. The extra-small ‘XS’ extension of the PASS^® and LigaPASS^® technology will enable surgeons to now effectively treat pediatric patients using around 40% less implant volume in each surgery and the lowest construct profile in-situ available on the market, while still offering the same technical innovations of the PASS LP^® and LigaPASS^® systems used on adults and UNiD™ Lab patient-specific, digital surgical planning and analytical services.

"By adapting our industry-leading PASS^® and LigaPASS^® deformity systems for the unique requirements of pediatric deformity through the ‘XS’ components, Medicrea is continuing to strengthen its position as a leader in FDA-cleared personalized analytical services and implant solutions for the treatment of complex spinal conditions,” stated Denys Sournac, President and CEO.

Medicrea is anticipated to announce the first U.S. surgery with the PASS XS and LigaPASS XS components in early November.

Upcoming Events

Medicrea will showcase the advanced corrective capabilities of the systems and attached personalized UNiD™ services at its booth (#943) during the world’s largest scientific meeting for spine specialists, held later this month, organized by the North American Spine Society (NASS) in Boston from the 26^th to the 29^th of October. During this event, the Company is also expected to announce a major development related to the UNiD™ services and personalized treatment modalities.

A Solution Showcase will be held during the meeting in the NASS Theater on Thursday, October 27, at 12:30pm. The symposium will feature Dr. Andrew King of New Orleans, LA, and Dr. Themistocles Protopsaltis of New York, NY. Dr. King will present on Medicrea’s complex spine solutions for pediatric patients and early results showing improved alignment and patient outcomes using patient-specific UNiD™ technology. Dr. Protopsaltis will present on the Company’s complex spine solutions for cervico-thoracic indications and discuss the early results showing improved alignment and patient outcomes using patient-specific UNiD™ Cervical Rod technology, of which the Company announced FDA clearance in April.

The Company has also previously announced that it is expecting the significant 1,000^th UNiD™ surgery milestone within the next month.

About Medicrea (www.medicrea.com)

Medicrea specializes in the design, manufacture, and distribution of innovative proprietary technologies devoted exclusively to spinal surgery. Operating in a $10 billion market, Medicrea operates with 150 employees, including 50 at its Medicrea USA Corp. subsidiary based in New York City.

Medicrea is the only company to offer personalized value-based healthcare solutions to the global complex spine market. The Company has driven innovation in Spine by focusing development on market-disrupting technologies focused on patient outcomes, including the growing UNiD™ Technology Platform of Patient-Specific Implants and Analytical Services, which received the first-ever FDA clearance in November 2014 for a personalized spinal treatment modality.

Medicrea has uniquely positioned itself outside of the traditional implant manufacturer’s role in order to engage with each market player as a collaborator, offering customized implants to patients, personalized services to doctors and immediate cost-savings to providers. By leveraging its proprietary software analysis tools with big data technologies, Medicrea is well-placed to improve the efficacy of spinal care efficiency for all stakeholders in this market.

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