FDA Clears Sanara MedTech’s Advanced Surgical Solution

Sanara MedTech Inc. has received U.S. Food and Drug Administration 510(k) clearance for its BIASURGE Advanced Surgical Solution.

BIASURGE is a patented composition to mechanically cleanse and remove debris, including microorganisms, from wounds. Based on the firm’s BIAKŌS technology, the BIASURGE ingredients work synergistically to disrupt biofilm extracellular polymeric substances and eliminate planktonic and biofilm microbes. Sanara MedTech bigwigs claim BIASURGE’s biocompatibility, efficacy, and ability to be left in a wound without a secondary rinse are a unique combination and will be a market differentiator.
 
“A key part of our surgical market growth strategy is to expand the number of efficacious products we offer that improve outcomes and reduce costs,” Sanara MedTech CEO Zach Fleming said. “Commercializing BIASURGE is the next step in the execution of this strategy, and receiving our 510(k) clearance is a significant milestone as we advance our efforts. This clearance also highlights the capabilities and dedication of Sanara’s research and development team, Rochal Technologies, which has successfully developed this proprietary technology.” 
 
The company expects BIASURGE to be commercially available later this year.
 
With a focus on improving patient outcomes through evidence-based healing solutions, Sanara MedTech Inc. markets, distributes, and develops surgical, wound, and skincare products for use by physicians and clinicians in hospitals, clinics and all post-acute care settings and offers wound care and dermatology virtual consultation services via telemedicine. Sanara’s products are primarily sold in the North American advanced wound care and surgical tissue repair markets. Sanara markets and distributes CellerateRX Surgical Activated Collagen, FORTIFY TRG Tissue Repair Graft, and FORTIFY FLOWABLE Extracellular Matrix as well as a portfolio of advanced biologic products focusing on AMPLIFY Verified Inductive Bone Matrix, ALLOCYTE Advanced Cellular Bone Matrix, BiFORM Bioactive Moldable Matrix, and TEXAGEN Amniotic Membrane Allograft to the surgical market.

In addition, the following products are sold in the wound care market: BIAKŌS Antimicrobial Skin and Wound Cleanser, BIAKŌS Antimicrobial Wound Gel, BIAKŌS Antimicrobial Skin and Wound Irrigation Solution, and HYCOL Hydrolyzed Collagen. Sanara’s pipeline also contains potentially transformative product candidates for mitigation of opportunistic pathogens and biofilm, wound re-epithelialization and closure, necrotic tissue debridement and cell compatible substrates.