Latest curasan bone regeneration scaffold technology CERASORB® Foam now approved for use with antibiotics

Cerasorb_Foam_Antibiotika

Kleinostheim, 28 June 2021

The β-TCP collagen matrix CERASORB Foam, a resorbable, osteoconductive and cancellous bone-like bone regeneration material prepared from β-tricalcium phosphate and collagen, was recently recertified by curasan AG´s notified body with the additional claim for use with antibiotics. The intraoperative combination of CERASORB Foam with a wide range of commercially available antibiotics provides surgeons with a novel option in filling and bridging degenerative and traumatic bone defects.

“This is a major milestone in minimizing the risk of a reinfection at the defect site. We have been evaluating various antibiotics in combination with our industry leading synthetic bone regeneration materials under laboratory conditions for years and collected important insights and data on the commercially available composite materials in comparison to our products1)”, marks Dirk Dembski, CEO at curasan AG. “With the approval of the claim we have found a consensus for the patients and surgeons”, he continues.

“Our in-vitro studies have proven that CERASORB Foam can be soaked to saturation with antibiotic solutions that have been prepared according to the manufacturer’s instructions. Vancomycin, Gentamicin, Tobramycin, Refobacin, Imipenem / Cilastatin and Meropenem solutions were tested in the investigations. Our studies have shown, that antibiotically loaded CERASORB Foam shows an excellent initial burst release of the antibiotics into the environment, followed by a long-term elution of the substrates. Furthermore, our investigations underline, that in comparison to competitive products, the antibiotic elution from CERASORB Foam has shown to be above the necessary MIC (minimal inhibitor concentration), but below the cytotoxic level in order not to interfere with the cell activity during osteogenesis. In addition, CERASORB Foam has clearly shown to have a higher loading and release capacity than other commercially available products” states Florian Früh, Head of Global Product Management at curasan AG.

First successful revision surgeries of infected hip prosthesis and treatment of infected bone areas have been carried out with very promising results. Further clinical investigations are ongoing.

Thus, the major problem of implant and bone defect infections was addressed, and a consensus created, so that after detailed patient education and full debridement of the infected bone defect, surgeons, under their responsibility, may prophylactically use CERASORB Foam in combination with above mentioned antibiotics in the bone defect to minimize the risk of a renewed infection.

Besides many other regions, CERASORB Foam for the use in Orthopedic surgery is CE-marked, FDA and ANVISA approved. Further regulatory approval processes, e.g. in China, are currently ongoing and approvals are expected soon.

1) Data on file at curasan AG

Press contact at curasan AG
Andrea Weidner, Head of Corporate Communications +49 6027 40 900-51 pr@curasan.com

About curasan AG
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in Wake Forest, near Raleigh, N.C., USA. curasan´s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide.