Yet another company that’s hungry for some of Medtronic Infuse’s shrinking slice of the bone graft substitute pie is raising money to commercialize its technology in the U.S.
Cerapedics Inc., developer of a biologic bone growth material for use in patients undergoing posterior lumbar interbody fusion spine procedures, has secured $3 million in funding. Its i-Factor Putty is being evaluated in the U.S. as part of an investigational device exemption (IDE) clinical study in the cervical spine, according to a November press release.
A message left with a company representative requesting an update on the trial’s status was not returned.
The i-Factor combines proprietary anorganic bone mineral and a synthetic small peptide, P-15, to act as an attachment factor to stimulate natural bone healing. Already being used in thousands of spine, trauma and orthopedic surgeries in Europe since it received the CE Mark in 2008, the product yields safe, predictable bone formation at a lower cost than autograft and recombinant bone growth factor products, the company says.
Medtronic, a power player in this space, has seen several consecutive quarters of declining sales for its troubled Infuse product. On Tuesday, company executives reported that sales in the biologics segment of Medtronic’s spine business had dropped from $215 million in the third quarter of last year to $165 million in the same quarter this year.
That opens up space for dozens of smaller companies developing or marketing comparable products — like NuVasive, Orthovita (part of Stryker) and Bacterin International, to name a few — to gain market share. In Europe, the $350 million market for orthopedic biomaterials is seeing fierce competition with no single company holding more than 25 percent of sales, according to Millennium Research Group. Globally, the orthopedic biomaterials market’s value was estimated at $5.8 billion in 2010 with expected double-digit growth through 2016.
Investors in Cerapedics, which is headquartered in Westminster, Colorado, include OrbiMed Advisors and NGN Capital.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
[Photo from enigma]
