FDA Sinks Disc Dynamics
Minnesota-based Disc Dynamics is in the process of shutting down its business. The rumors of the company's demise were confirmed to OTW by Dave Stassen, founding managing director of Split Rock Partners, the venture capital firm that corralled $65 million in private equity funds since 2000 for the spine company.
Stassen told OTW on January 28 that the FDA's refusal to allow the company to proceed with its IDE (Investigational Device Exemption) and continued request for more and more information and data finally "bled the company dry."
Stassen said this was the third or fourth company in their portfolio that has had to cease operations because of their inability to get through the FDA. Investors have dropped $300 to $400 million "down the hole" because of the FDA.
"It's a travesty that American patients won't be able to get access to this technology," added Stassen. "Patients with the device are getting outstanding results in Europe."
While Stassen blames inexperienced FDA staff for the delays, he acknowledged that the company shares some of the responsibility for early efforts with the regulatory agency that could have been handled better by the company.
The company had developed the Dascor Disc Arthroplasty System, a catheter-based, minimally invasive nucleus replacement technology for the treatment of degenerated lumbar discs.
Stassen said the company will be closing down the business throughout February and pay off vendors. He did not expect any type of bankruptcy proceedings.