WaveRx Inc.’s head slipped under the water forever, a victim of its backers’ doubts about the FDA ever giving a green light to its technology for treating diabetic neuropathy.
Mark Wan, a founding partner at Three Arch Partners, told the VentureWire blog that his VC company and its two other partners in WaveRx, 5AM Ventures and Polaris Venture Partners, shut the taps last year after waiting for an answer from the FDA’s Center for Devices & Biological Health about its proposal for a re-vamped clinical trial.
Initially founded five years ago to pursue treatments for nail and skin disorders, WaveRx pulled good and bad news out of its first clinicals, examining the technology for treating the toenail fungus onychomycosis, Wan told the blog. The company’s device, which used electro-stimulation and microwaves, proved to be a minor improvement over other treatments for onychomycosis, but some subjects in the trial who suffered from diabetic neuropathy showed "marked improvement" after receiving the WaveRx treatment, according to VentureWire.
The company ran another trial examining the treatment for diabetic neuropathy and passed the results along to the CDRH.
"This was a multi-center, sham controlled, double-blind study," Wan told the blog.
That means each arm of the trial was conducted in separate clinical settings, with the control group receiving "sham" placebo treatments and the study cohort receiving the WaveRx treatment.
But after examining the trial results, the FDA asked for more information, inaugurating "an ongoing cycle of back and forth" about the next set of trials, Wan told VentureWire.
"We as investors said ‘enough,’" he said. "We can’t keep funding this company to an unknown endpoint."
WaveRx drummed up $500,000 in an equity offering in April 2010, according to a regulatory filing, adding that to the $6.8 million kitty it had already raised.
An email to the CDRH seeking comment was not immediately returned.
