FDA OK Positions RTP’s curasan Inc. for Growth
|RTP’s curasan Inc. is now cleared to sell its innovative CERASORB Ortho FOAM, which can be moulded into different shapes. -- curasan photo|
Research Triangle Park–based curasan Inc. is poised for growth in 2017, thanks to an important December 2016 milestone for its synthetic bone regeneration material CERASORB Ortho FOAM.
The American subsidiary of publicly traded German regenerative medicine company curasan AG received marketing approval from the U.S. Food and Drug Administration to sell its pliable bone patch material throughout the nation.
“The FDA approval of CERASORB Ortho FOAM is an extremely important milestone for us in the re-orientation of our U.S. business, which will open up a potential market worth more than $ 900 million,” said Michael Schlenk, CEO of curasan AG.
“Even before the approval, major customers indicated during exploratory discussions that the flexible and mouldable version of CERASORB meets the demands of the U.S. customers perfectly, much more so than any of our other products.”
curasan Inc. was established in the Triangle in 2004 and was subsequently purchased by RIEMSER Inc., a dental supply company that was the U.S. subsidiary of RIEMSER Pharma Gmbh, a German specialty pharmaceutical company. After RIEMSER went through a period of struggle, curasan repurchased the rights to its product line, and RIEMSER, Inc., disappeared from the U.S. market.
curasan's U.S. company is set to grow
The company now has eight employees, all but one based at the Research Triangle Park headquarters. They’re involved in sales, administration, customer service and marketing in the U.S., Canada and Latin America.
That, however, is about to change, says curasan Inc. President Shane Ray, a native of Tabor City in southeastern North Carolina’s Columbus County. He plans to grow his part of the company from its Triangle roots to a far-reaching enterprise.
“We have plans to expand throughout the next several years, including some staff within North Carolina,” he said. “But more growth will be coming in our number of sales representatives elsewhere throughout the U.S. and Canada.”
curasan develops, manufactures and markets biomaterials and other medical products for bone and tissue regeneration -- products used around the world by dental surgeons, implantologists and oral, maxillary and dentofacial surgeons, as well as orthopods, traumatologists and spinal surgeons.
The portfolio primarily includes synthetic bone grafting materials for dental and orthopedic applications. Besides the newly approved CERASORB Ortho FOAM, the company sells other products in the U.S. under the brand names of Cerasorb M, Osbone, Osseolive, Epi-Guide Membranes, CollaGuide Membranes, OsteoSelect DBM Putty, OsteoWrap, AlloSorb.
Big potential going from mouth to hand...etc.
Ray says curasan is committed to expanding its reach in orthopedic applications. curasan sees bigger revenue potential developing there than in the dental market. Expansion currently relies upon independent sales distributors throughout North America, though the company also has inside sales people and a small number of resellers, who sell primarily to teaching institutions.
CERASORB Ortho FOAM is an innovative product made of resorbable ceramic (a material that can be assimilated by the body over time) and porcine (swine) collagen. With the FDA approval, it can now be used to treat bone defects in the pelvis and in extremities.
The parent company’s headquarters, including its R&D and manufacturing facilities, are in Frankfurt/Main, Germany. The manufacturing site is approved by the U.S. Food and Drug Administration and by regulators of other major global entities. The company follows an occasionally used German custom of avoiding an upper-case initial capital letter for its name.
Donated human tissue key to U.S. market
About half of curasan’s U.S. tissue sales involve human cadaver donations, says Ray, whose career has included experience with tissue banking organizations that procure donations and handle processing, sterilization, packaging and labeling.
“Human tissue remains a huge market,” he explains, “involving membranes, skin, and a lot of tendon replacement and repair of torn ACLs (anterior cruciate ligaments) in sports medicine.” Donors to tissue banks, like organ donors, have many choices, he adds. “Donors can select which tissues they want to donate, they can decide if they want it to be for research, whether it can be exported or stays in the U.S. -- all kinds of issues.”
The other half of curasan’s business involves synthetic tissues like CERASORB Ortho FOAM. In Europe, however, the market is about 95 percent synthetic tissues , he notes. He’s also excited about the opportunities he sees to grow the synthetic tissue business in North America from the company’s Triangle headquarters.