DASCOR received its CE Mark in Europe and was sold on a limited basis in Europe over the past three years. Unable to obtain FDA approval to commence a pivotal study in the U.S., it seems DD has exhausted all possible funding and with its operating funds depleted, DD commenced a wind down of its business effective December 31st, 2009 and has terminated all of its employees and discontinued all financial support of clinical studies.
$65 million? Hopefully, some of those prudent investors will have learned their lesson. IST, Archus, Vertebron, Inion, Pegasus, and now Disc Dynamics.
"lookin' back over the years, we've all shed some tears
Told ourselves time and time again, this time we're gonna win
But another fight, things ain't right, we're losin' again
Takes a fool to lose twice, and start over again
Think I better let it go, looks like another spine TKO
$65 million? No wonder the CEO left when he had the opportunity. How many more crazy ideas will we see where investors will throw millions of dollars at companies that are run by people that do not posess the skills nor business acumen to bring a venture to fruition? TSB wants to know what our readers have heard and what they think the residual fallout will be for many of the companies that are underfunded?
I think we will continue to see the fall out of more small companies. One need look no further than Abbott's acquisition of Spinal Concepts. You know back in the day where everyone wanted in on the spine game and venture capital flowed. This Darwinian attrition that we are witnessing helps everyone from the Spine Cartel down to any smaller company with good management and products. The management, marketing, sales and engineering forces have been depleted over the past 10 years to feed the spine/VC machine. Hopefully the talented ones will land back on their feet and remain in the industry.
ReplyDeleteIt seems DD made several changes to the design of DASCOR over the years (e.g., lower modulus). I thought maybe they had things figured out. Why were they not able to obtain FDA approval for a pivitol study? Is this really a "crazy idea"?
ReplyDeleteThe FDA has definitely tightened the requirements for new approvals, particularly when it comes to the class III environment. Due to the extensive investment and regulatory expertise needed, small companies and startups are at a disadvantage versus larger well equipped companies. Not to mention, there is also the potential reimbursement challenge that awaits beyond approval that has become more commonplace recently.
ReplyDeleteThe FDA was afraid of the carcinogenicity of the in-situ cured polyurethane. No Surprise. But, so what, DD was going nowhere anyway. The fundamental idea was great, a custom nucleus replacement, but its implementation was terribly wrong: A risky polymer choice (which couldn't be terminally sterilized), coupled with fussy handling requirements for hospitals. Add to that, complicated and expensive equipment for preparing and injecting the polymer. Adios 65 million, you forgot about KISS (Keep it Simple, Stupid).
ReplyDeleteit's all good
ReplyDeletehello
ReplyDeleteI had two of them fitted, now they have got to come out as the operation has failed and one of them is pushing it's way into the vertebra, 3.5 yrs of hell...
ReplyDeleteHi, I know you don't know me but I too have this device and it has failed and has to come out for fear of it pushing further into the spine. Were you able to get yours removed and if so, may I ask where you are located? Because the surgeons here don't know how to take it out and they know of no one that has. Thanks
DeleteI also have a failed device. Any information either of you or anyone else may have would be greatly appreciated. Now just trying to move forward. Thank you.
DeleteThe big boys put them out of business.
ReplyDeleteI worked at this company, and the world can be glad the FDA did not approve the product and procedure. A short story could be written on the absence of ethics that was involved every stage of this start-up's evolution.
ReplyDeleteIt has been five years since I had the Dascor device put in and my doctors and I are in the dark as to how to move forward, as things seem to be getting worse. Any information you may have would be greatly appreciated. Thank you.
DeleteI also worked there and can attest to how poorly run the company and research was.
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