The company is quoted as saying that their device, a proprietary dual spring will remove pain by stabilizing the affected spine segment, control motion and abnormal load, and reproduce the kinematics of the segment. Yet, TSB must ask, "how does a device adapt itself to the motion characteristics of each individual patient?" This is an interesting claim!
TSB must speculate that with the FDA mandating additional post-marketing data on dynamic stabilization devices, that early-growth stage companies like Eden are in need of additional capital. The question remains how much? If it is less than $5 million they are going to have some challenges in raising this from an outside investor unless they approach Angels or individual investors. There are many lessons that can be learned from what has transpired during the last year in our industry. TSB wants to know what our readers think about this company's device?
Eden Spine is the US arm of FlexisMed, a legitimate Swiss spine company that has developed some posterior dynamic technologies. Respectfully, one shouldn't jump to conclusions and assume that any new spine company is a physician-distributor sham organization(though there are admittedly plenty of those too).
ReplyDeleteI don't know too much about their technology, but I agree it will be a long uphill battle to get FDA approval on any new posterior dynamics at this point.
SpineDoc1: Thanks for your commentary. The word on the street is that this company is subsidized by surgeons that have a vested interest in the company.
ReplyDeleteNot so quick SpineDoc! FlexisMed was founded in May 05 and in September 06 this happened:
ReplyDelete"the Eden Spine Business Model coupled with FlexisMed's European R&D platform represent the perfect synergistic alliance of scientific research and market penetration. We are confident that becoming the Swiss subsidiary of a dynamic US organization such as Eden Spine, Inc. will allow us to maximize our potential and to concentrate only on what we do best: innovations!”
Uh? FM after only 17 months as an independent development house became the R&D arm of 1 month old Eden spine, which was founded in August 2006 by the former Scient'X US marketing guy who worked for Craig Corrance, and is funded by 'private equity' whose names or organizations remain unknown.
hmmmm, SpineDoc, don't discount MM just yet, he could be more right than you think. If I look at the dynamic rod I see yet another technology looking for a patient. With enough creativity one can describe a syndrome which needs exactly what this offers. When the rods break and the springs get loose revisions will be fun.
Cerevertebral- perhaps you have a point. However, when I think of a physician-distributor sham company, I think more of profits from me-too products being dividended back to investor/consultants.
ReplyDeleteIn such creepy arrangments, there is seldom any true technology investment - which is at least what Eden appears to be doing.