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Devices Neurosurgery FDA

 News Release - October 14, 2019

OssDsign Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US

STOCKHOLM, Oct. 14, 2019 -- (Healthcare Sales & Marketing Network) -- OssDsign AB (publ) ("OssDsign" or the "Company") today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US. The cleared products are a set of 3D-printed, patient specific accessory devices designed to support and expand clinical use of OssDsign's patient specific cranioplasty implant already cleared by the FDA. The accessories are designed to make cranial reconstructions safer and easier and to enable new solutions for patients in need of complex cranial reconstructions.

OssDsign is a provider of patient specific implants and surgical solutions for cranial and facial reconstruction. As part of market expansion efforts, the company has developed an innovative set of accessory products, ranging from anatomical models to surgical guides and intraoperative implant trials. The accessories are designed to make cranial reconstructions safer and easier and to enable new solutions for patients in need of complex cranial reconstructions.

The new FDA clearance will enable OssDsign to continue to drive growth in the US by gaining access to additional cohorts of patients with complex cranial defects. The new accessories, along with OssDsign's novel implant technology, will provide US neurosurgeons the possibility to remove bone tumors or otherwise diseased bony tissue and perform cranial reconstruction in a single stage procedure. One less surgical intervention can greatly reduce patient trauma while saving time and resources for hospitals.

Cranial PSI Accessories have already been available on the European market, and European neurosurgeons have successfully been able to treat patients for whom no viable surgical solution previously existed. An example from this patient category includes a unique case of near total cranial reconstruction treated with a complete surgical solution of OssDsign implants and accessories. The surgical procedure was made possible by the use of surgical guides, part of the OssDsign Accessories product range. The case is published in The Journal of Neurosurgery.

Anders Lundqvist, CEO of OssDsign says: "I think it's safe to say that we are the only company with the technology platform and clinical competence necessary to produce implant solutions suitable for some of these extremely complex cranial reconstructions. These accessory products combined with our novel implant technology fulfil an unmet medical need, enabling treatment of very complex patient groups. Involvement with these complex cases have also resulted in new innovations, IP and product development opportunities."

Certified Adviser

The Company's Certified Adviser is Erik Penser Bank AB. Contact information: Erik Penser Bank AB, Box 7405, 103 91 Stockholm, Sweden, phone: +46 (0)8-463 80 00, email:

About OssDsign

OssDsign is a Swedish medical technology company that develops and manufactures regenerative implants for improved healing of bone defects. Providing neuro and plastic surgeons with innovative implants, OssDsign improves the outcome for patients with severe cranial and facial defects worldwide. By combining clinical knowledge with proprietary technology, OssDsign manufactures and sells a growing range of patient-specific solutions for treating cranial defects and facial reconstruction. OssDsign's technology is the result of collaboration between clinical researchers at Karolinska University Hospital in Stockholm and material scientists at the Ångström Laboratory at Uppsala University.

Source: OssDsign

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