Fort Collins-based Armis Biopharma lands FDA approval for toe-bone implant

FORT COLLINS — Armis Biopharma Inc. has secured clearance from the U.S. Food and Drug Administration for its implant design to fix hammer, claw and mallet toes.

The clearance allows the Fort Collins-based company to begin selling the implant, which is targeted at patients with small toes that are not straight. Approximately 500,000 surgeries are done in the U.S. annually to fix those toes, with the majority of patients being women.

In an interview with BizWest, CEO Ted Ziemann said the design of the implant and its titanium coating allows it to hold to the bone better than Kirschner wires, which are small steel pins designed to hold the surgery in place.

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If the pins or other holding device fails, it could lead to infection or pain while walking during rehabilitation.

Ziemann believes that Armis’ design can take a sizable cut of the $600 million to $1 billion toe-implant market, whether by marketing the implants itself to orthopedic surgeons or by licensing it to a larger medical-device maker.

“Our real target is probably about 50% of that market, in terms of a key area that we think we will fit into,” he said.

The implant is an offshoot of Armis’ main research into medical disinfectants and antimicrobials. The company’s flagship product is Veriox, which is undergoing registration with the U.S. Environmental Protection Agency as a surface disinfectant and has grant funding from the U.S. Department of Defense for research as a possible neutralizer of chemical weapons in combat areas.

Armis is also developing surface cleaners for human and animal wounds in medical settings.

“Our technology is very effective in killing any kind of microorganism, so it’s really an issue of designing a specific product or a specific application,” he said.

Veriox will eventually be combined as an antimicrobial coating for the bone implant to reduce the chance of infection, but selling the two products together would require another round of approvals from the FDA.

Armis has five full-time employees and three half-time consultants.