Karolinska Development portfolio company OssDsign announces FDA 510(k) clearance for marketing of OSSDSIGN® Cranial for sale in the USA
STOCKHOLM - January 20, 2017 Karolinska Development AB (Nasdaq Stockholm: KDEV) notes that portfolio company OssDsign AB , a Swedish designer, manufacturer and distributor of next generation implants for cranial and facial reconstruction, has today announced it has received 510(k) clearance by the US FDA for marketing of OSSDSIGN® Cranial PSI in the USA.
Details from the OssDsign announcement follow:
Anders Lundqvist, CEO of OssDsign, said: "Receiving FDA clearance for our flagship product OSSDSIGN Cranial is extremely positive news. This means we can continue working according to our existing plan of launching OSSDSIGN Cranial on the US market in Q1 2017. We are in the final stages of setting up an experienced distribution network that will enable OssDsign to rapidly bring the benefits of OSSDSIGN Cranial to surgeons, patients and healthcare systems across the US".
OSSDSIGN Cranial is a patient-specific medical implant intended for reconstruction of cranial defects, a surgical procedure known as cranioplasty. Cranioplasty is traditionally performed by neurosurgeons using the patient's own bone or by using implants made from inert plastic or metal materials, such as PEEK or titanium. These techniques are known to have a high rate of complications, especially infections, which sometimes necessitates removal of the implant and further surgery.
Every OSSDSIGN Cranial implant is made to each patient's unique requirements based on the patient's computer tomography (CT) information. OssDsign uses advanced computer-assisted (CAD) design and state-of-the-art 3D-printing technologies to produce each unique device. The implant is made from a proprietary calcium phosphate composite, which is reinforced by a strong titanium skeleton.
The OSSDSIGN technology was developed by experienced surgeons and material scientists with the patient's needs in mind.
Lars Kihlström, MD, Senior Consultant of Neurosurgery at Karolinska University Hospital, said: "I believe that OSSDSIGN Cranial is a very promising product for cranial bone reconstruction that has led to positive results with two years follow up after introduction. We have used OSSDSIGN Cranial since it was introduced in Sweden; not only does it have good handling characteristics, it also substantially contributes to good outcomes in complex patient groups."
OSSDSIGN Cranial and other OssDsign products have been introduced step-wised in Europe since 2014. These products are already available in Germany, the UK and Nordic region, as well as Singapore and Israel. Earlier this month OssDsign announced that it had entered into new commercial partnerships to distribute its medical implants in Italy, Spain, Switzerland, Austria and the Netherlands.
Viktor Drvota, Chief Investment Officer at Karolinska Development, said: "Today's announcement represents more positive news for OssDsign, as the Company prepares to launch OSSDSIGN Cranial in the US market over the coming months."
For further information, please contact:
Jim Van heusden, CEO, Karolinska Development AB
Phone: +46 72 858 32 09, e-mail: email@example.com
Christian Tange, CFO, Karolinska Development AB
Phone: +46 73 712 14 30, e-mail: firstname.lastname@example.org
David Dible/Mark Swallow/Pip Batty, Citigate Dewe Rogerson
Phone: +44 20 7638 9571; e-mail: KDev@citigatedr.co.uk
TO THE EDITORS
About OssDsign AB
OssDsign is a Swedish medtech company dedicated to creating regenerative implants for improved healing of bone defects and deficits in skull, facial and other types of surgery. OssDsign has successfully launched its first patient specific products OSSDSIGN® Cranial and OSSDSIGN® Facial in Germany, the UK and the Nordic countries, and further global market expansion is ongoing.
By combining clinical insight with proprietary material technology and patient adapted design, OssDsign supplies an expanding range of tailored solutions for cranial repair and facial bone reconstruction. OssDsign's technology is the result of collaboration between clinical researchers at the Karolinska University Hospital, Stockholm, and material science experts at the Ångström Laboratory at Uppsala University. Main investors in OssDsign are Karolinska Development, SEB Venture Capital, Fouriertransform and Almi Invest. For more information visit www.ossdsign.com
About Karolinska Development AB
Karolinska Development AB is an investment company focused on identifying medical innovation and investing in the creation and growth of companies developing these assets into differentiated products that will make a difference to patients' lives and provide an attractive return on investment.
Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.
Karolinska Development has established a portfolio of 10 companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.
The Company is led by a team including investment professionals with strong venture capital backgrounds, experienced company builders and entrepreneurs, with access to a strong global network. For more information, please visit www.karolinskadevelopment.com
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Karolinska Development AB (publ) via Globenewswire
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