Medicrea (EPA:ALMED) said today it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature patients.
The New York City and Lyon, France-based company said it worked with a team of pediatric spinal surgeons to develop the low profile implants specifically designed for pediatric deformity surgery.
“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,” prez & CEO Denys Sournac said in prepared remarks.
The newly cleared devices are designed to better allow surgeons to effectively treat pediatric patients with 40% less implant volume during surgery and a lower construct profile in-situ than other offerings available.
Medicrea said it expects the 1st U.S. surgery with the components to occur in early November.
In August, Medicrea said it raised a funding round worth about $22.3 million for its UniD patient-specific spinal rod technology and tapped GMEd co-founder Richard Kienzle as its new chief commercial & business development officer.
Medicrea said the €20 million round consisted of about $16.8 million (€15 million) in 4-year, 6.75% convertible bonds due August 12, 2020 bought by Athyrium Capital Management and another $5.6 million (€5 million) in equity.
Participants in the equity offering of more than 1 million ALMED shares at €4.86 ($5.43) apiece include Kienzle, president & CEO Denys Sournac, Medicrea’s board and “various U.S. and French investors,” the company said.