FDA approves pain neurostim implant, to go with Greatbatch spinout Nuvectra

Algovita Spinal Cord Stimulation System--Courtesy of Greatbatch

The final obstacle has fallen for Greatbatch ($GB) to spin out its neurostimulation platform into new company Nuvectra. The FDA has approved its Algovita Spinal Cord Stimulation (SCS) System to treat chronic intractable pain of the trunk and/or limbs. Commercializing Algovita, as well as bringing additional neurostim products to market, will be Nuvectra's focus.

When it announced it would spin out its neurostimulation unit in April, Nuvectra already had a CE mark for Algovita in hand. At that time, it already had submitted for PMA approval with the FDA but had gotten an approvable letter that required additional FDA inspection of "the manufacturing facilities, methods and controls in compliance with the applicable requirements of the Quality System regulation," the company said.

Having satisfied the U.S. regulatory agency's concerns, the Nuvectra spinout now remains on track to complete during the first quarter of 2016. Marketing Algovita will be the new company's top priority, and finding one or more partners to do that is likely the next step. Greatbatch is expected to continue in its role as the manufacturer of Algovita.

After the spinout, "that management team would then articulate its strategy for how it's going to commercialize the Algovita Spinal Cord Stimulation system and Greatbatch would be the manufacturing partner for it," said Greatbatch President and CEO Thomas Hook on an April conference call when the spinout was first announced.

"So the decisions of the mechanisms for how they would go from there, in terms of by country or by either other forms that we've talked about before, the distribution agreements or partnerships, would be determined by the spun off company," he added.

Algovita is an implantable stimulator that can be attached to one, two or three leads upon implantation. It also requires a charging system and handheld programmer. The FDA-approved indication includes unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

Scott Drees is slated to lead Nuvectra as CEO, he previously headed the neurostimulation business within Greatbatch. At the same time in July, Dr. Joseph Miller stepped down from the Greatbatch board to become chairman at Nuvectra. The new company is expected to be publicly traded.

Greatbatch was up 5% in early trading on the Algovita approval news; that pushed it close to 52-week highs. Greatbatch has a market cap of almost $2 billion and it's up by almost one-quarter thus far in 2015.

- here is the Algovita company announcement
- and here are the FDA approval documents