AxioMed Spine Corp. has raised $14.5 million in Series D funding to help the Garfield Heights, Ohio company finish enrolling patients for a pivotal U.S. clinical study of its lumbar disc replacement, as well as earn CE Mark approval for its cervical disc and start sales in Europe.
The developer of next-generation spinal disc replacements said it raised the money in two tranches from new and existing investors. “This Series D included all of our existing investors and significant new investors, although we are not disclosing those details,” said Jerry Baty, AxioMed’s chief financial officer, in an emailed response to a reporter’s questions.
The fundraise is notable because it’s a tough time to raise money.
“We are fortunate to have supportive, high-caliber investors and the opportunity to add new investors to form a consortium with the ability to fund our product development programs,” Patrick McBrayer, the company’s president and CEO, said in a release.
“We are very pleased to be able to put together such a significant fundraising,” said Peter McNerney, partner at Thomas, McNerney & Partners and an AxioMed board member. “It is a testament to AxioMed’s performance and promise that we were able to add new investors and gain further backing from existing investors to support the company’s development programs to such a level.”
AxioMed will use its latest raise to finish enrolling patients in a pivotal study of its lumbar disc. “The Freedom Lumbar Disc pivotal IDE study currently has almost 200 of the approximately 350 patients enrolled,” Baty said. “It is our intention to complete enrollment by the second quarter of 2011.”
The company will follow patients and their implants for two years before applying to the Food and Drug Administration for market clearance in the United States.
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.
Last May, AxioMed received a CE Marking for its lumbar discs, which are “being distributed in Germany, Switzerland and the U.K.,” Baty said. The company will use some of its latest money to expand lumbar disc sales in Europe and get a CE Marking for its cervical disc so it can start selling those discs in Europe.
In December, AxioMed Spine raised $6.4 million from “leading venture capital firms,” which also were not named. At the time, McBrayer said his company was shooting for an $18.5 million Series C round.
McBrayer also said he expected the fundraising to enable his company to expand and add to the 15 workers at its Garfield Heights headquarters, manufacturing and testing facility. AxioMed is still pondering an expansion. “Our plans for additional hires will be as needed and based on our growth,” Baty said.
Prior to the C round, AxioMed had won $34 million in venture capital from investment firms like CID Equity Partners, EarlyStage Partners, Investor Growth Capital Limited, Primus Capital, Memphis Biomed Ventures, Reservoir Venture Partners and Thomas, McNerney & Partners.
Including the C and D rounds, AxioMed Spine has raised about $55 million to develop, test and launch its lumbar and cervical disc replacements.
AxioMed, which uses dozens of Ohio suppliers to make its disc replacements, received a $750,000 Innovation Ohio Loan from the Ohio Third Frontier Project in late 2007 to help expand (pdf) its testing and manufacturing floor.
