AxioMed develops a lateral viscoelastic disc replacement and is pursuing a multi-level cervical IDE. The company closed an oversubscribed first round of funding from surgeons and high-net-worth individuals and is launching a $10 million second round with pledges ahead of an October planned launch. AxioMed expects its first lateral disc to be used overseas and included in CE approval in Q1 2018 and aims to pursue aggressive overseas sales in 2018. The company is preparing to begin a multi-level cervical IDE in the U.S., anticipating an expedited cervical IDE approval and near-term U.S. availability. Leadership positions the product as the first truly viscoelastic disc in the U.S. upon FDA clearance and the most advanced viscoelastic disc OUS, citing competitor divestment from first-generation designs. Management also reports strong interest from global partners for distribution and inbound investor interest prior to the second round opening. AxioMed Spine is a Cleveland, Ohio-based spinal orthopedics company that develops products focused on spinal function for patients with degenerative spine disease. Its flagship Freedom® Lumbar and Cervical Discs were developed and designed by a team of clinicians and experts in biomechanics, pathology, spinal surgery and polymer science. Both devices have received CE Mark approval for distribution in the European Union. AxioMed is pursuing US regulatory approval for its Freedom technology. The company raised $3.6M in funding from existing and new investors. The company is led by President and Chief Executive Officer Patrick McBrayer and Chief Operating Officer James Kuras. AxioMed Spine Corporation develops spinal orthopedics products intended to restore spinal function for patients with degenerative spine disease, advancing the standard of care beyond fusion and first‑generation disc replacements. Its core products include the Freedom® Lumbar Disc (FLD) and the Freedom® Cervical Disc, both developed by a team of clinicians and experts in biomechanics, pathology, spinal surgery and polymer science. The FLD is on the market in the EU and is advancing toward completion of an IDE pivotal study in the US. The Freedom Cervical Disc recently received a CE Mark for introduction in the EU, and the company intends to follow a similar regulatory and marketing pathway for it as for the FLD. AxioMed completed the final closing of its Series D financing, raising $5 million in two tranches from current and new investors, augmenting a previously announced $15 million Series D. The company states its mission is to restore the natural function of the spine and to continue research, innovation, development and service worldwide. AxioMed Spine develops and manufactures artificial spinal disc replacements, including a CE‑marked lumbar disc and a second cervical disc product the company is preparing to launch. The company will use a $500,000 state loan to purchase machinery and equipment to manufacture the cervical discs at its Garfield Heights, Ohio plant, which is also its corporate headquarters. The loan was recommended by a group associated with the Ohio Department of Development and is pending approval from the State Controlling Board. AxioMed hopes to obtain CE Mark clearance to commercialize the cervical disc later this year; its lumbar replacement received CE Mark in 2009. The lumbar device is roughly two years away from U.S. regulatory review: AxioMed has enrolled about 300 of 350 patients in a pivotal study and expects to complete enrollment next quarter before a two‑year follow‑up to support a PMA application to the FDA. Since its 2001 inception the company has raised $56 million in financing and lists backers including CID Equity Partners, Early Stage Partners, Investor Growth Capital Limited, Primus Capital, Memphis Biomed Ventures, Reservoir Venture Partners and Thomas, McNerney & Partners. AxioMed Spine is developing next-generation Freedom lumbar and cervical spinal disc replacements made from a rubberized polymer and designed to restore natural spine function. The company won CE Marking in May, enabling sales across the European Union, and has introduced Freedom in Germany, Switzerland and the United Kingdom. AxioMed plans to use recent funding to continue product development and to expand operations, adding to a headquarters workforce of 15 people once its fundraising round is complete. AxioMed completed the first part of its third financing round, raising $6.4 million from unnamed leading venture capital firms and is working toward a Series C target of $18.5 million. Previously the company had raised $34 million from investors including CID Equity Partners, EarlyStage Partners, Investor Growth Capital Limited, Primus Capital, Memphis Biomed Ventures, Reservoir Venture Partners and Thomas, McNerney & Partners, and its most recent prior round was a $10 million fundraise in July 2008. The company's president and CEO is Patrick McBrayer and its headquarters are in Garfield Heights, Ohio.

Total raised

$16M

Funding rounds

5

Latest round

Equity

Latest activity

Jan 2013