Armis Biopharma Announces FDA 510(k) Clearance for VeriFixx™ Small Bone Implant

FORT COLLINS, Colo., Nov. 19, 2020 /PRNewswire/ -- Armis Biopharma, Inc. announced today the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for the VeriFixx™ Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. VeriFixx™ is designed to make surgical corrections of this kind more accessible to patients through shorter time to ambulation, shorter overall recovery time and reduced pain.

"For patients requiring a small bone implant, the length of recovery and pain are common concerns," said Ted Ziemann, Chairman and CEO of Armis Biopharma. "With our unique proprietary design, we are excited to bring a new technology to the medical device market that specifically addresses these concerns while maintaining the benefits of current standard of care."

VeriFixx™ incorporates a unique alignment fin design and a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide ideal fixation alignment and a bone-friendly titanium surface, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for postoperative imaging.

In the U.S., there are approximately 500,000 small bone implant procedures each year. Overwhelmingly, the majority of patients are middle-aged women.

About Armis Biopharma

Armis Biopharma, Inc is a privately held biopharmaceutical company headquartered in Fort Collins, CO that is devoted to developing and commercializing products that are effective in reducing the risk of infectious disease, decontaminating chemical warfare agents, and providing differentiated medical devices. Product development is focused on surface disinfection, human and animal wound care, oral care, food safety, and decontaminating chemical and biological warfare agents.

Armis introduced its first antimicrobial product called ArmiClenz™ (www.armiclenz.com) in June 2020. More pipeline products will follow VeriFixx™ starting late 2020 through 2021.

For more information about Armis, please visit www.armisbiopharma.com.

General questions should be addressed to [email protected].

Media contact: 
Laura de Zutter
[email protected] 
(908) 234-9900

SOURCE Armis Biopharma