Soteira emerges from stealth mode

November 13, 2009 by David Spenciner

Soteira Inc. emerged from stealth mode at the 24th annual meeting of the North American Spine Society.

CEO Larry Jasinski and other representatives of the Natick, Mass.-based spine start-up showed a video describing their vertebroplasty system to conference attendees and publically parted with a few details of their technology:

• Soteira has a cement-directing kyphoplasty system that uses a flexible cutting implement to make a central cavity in the vertebral body and then a stent-like flexible barrier to partially restrict the flow of bone cement.
• They now have two-year follow-up clinical data from a small series of Mexican patients and one-year follow-up data from a larger series of German patients.
• In fact, with CE Mark in hand, they have begun selling their system in Germany.

Based on their data, Soteira's technology is equivalent to balloon kyphoplasty, but with a uni-pedicular approach. It seems to me that only requiring the doc to violate one pedicle is the key differentiating factor. I haven't seen any of their clinical data, but my guess is that such an approach would reduce OR time and perhaps other less tangible metrics like blood loss and anesthesia use.

Jasinski wouldn't comment about whether Soteira will be raising additional funds now that they have sales outside the U.S. but lack Food & Drug Administration approval. According to VentureSource data, Soteira has raised a total of $22 million in two rounds, with the most recent round closing last September.

Some of the nitty-gritty details of the clinical trial can be found in the NASS abstracts, which are slated to be published in The Spine Journal in the next few months by Dr. Robert Pflugmacher of Berlin and colleagues.

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