Sanara MedTech Inc. Announces 510(k) Clearance for BIASURGE™ Advanced Surgical Solution
04 Aprile 2023 - 3:15PM
Sanara MedTech Inc. Based in Fort
Worth, Texas, Sanara MedTech Inc. (“Sanara,” the “Company,” “we,”
“our” or “us”) (NASDAQ: SMTI), a medical technology company focused
on developing and commercializing transformative technologies to
improve clinical outcomes and reduce healthcare expenditures in the
surgical, chronic wound and skincare markets, announced today that
it has received 510(k) clearance for BIASURGE™ Advanced Surgical
Solution (“BIASURGE™").
Zach Fleming, Sanara's CEO, stated, “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. Commercializing BIASURGE™ is the next step in our 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.”
About
BIASURGE™ Advanced
Surgical Solution
BIASURGE™ is a patented
composition intended for mechanical cleansing and removal of
debris, including microorganisms, from wounds. Based on our BIAKŌS™
technology, the BIASURGE™ ingredients work synergistically to
disrupt biofilm extracellular polymeric substances and eliminate
planktonic and biofilm microbes. We believe 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.
The Company expects BIASURGE™ to be commercially
available in late 2023.
About Sanara
MedTech Inc.
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. The Company believes it has the
ability to drive its pipeline from concept to preclinical and
clinical development while meeting quality and regulatory
requirements. Sanara is constantly seeking long-term strategic
partnerships with a focus on products that improve outcomes at a
lower overall cost. In addition, Sanara is actively seeking to
expand within its six focus areas of wound and skin care for the
acute, post-acute, and surgical markets. The focus areas are
debridement, biofilm removal, hydrolyzed collagen, advanced
biologics, negative pressure wound therapy products and the oxygen
delivery system segment of the wound and skincare markets.
Information about Forward-Looking
Statements
The statements in this press release that do not
constitute historical facts are “forward-looking statements,”
within the meaning of and subject to the safe harbor created by the
Private Securities Litigation Reform Act of 1995. These statements
may be identified by terms such as “anticipates,” “believes,”
contemplates,” “continue,” “could,” “estimates,” “expect,”
“forecast,” “guidance,” “intend,” “may,” “plan,” “possible,”
“potential,” “predicts,” “preliminary,” “projects,” “seeks,”
“should,” “targets,” “will” or “would,” or the negatives of these
terms, variations of these terms or other similar expressions.
These forward-looking statements include, among others, statements
regarding the expected timing of commercialization of BIASURGE™ and
the expansion of the Company’s business. These items involve risks,
contingencies and uncertainties such as the extent of product
demand, market and customer acceptance, the effect of economic
conditions, competition, pricing, uncertainties associated with the
development and process for obtaining regulatory approval for new
products, the ability to consummate and integrate acquisitions, and
other risks, contingencies and uncertainties detailed in the
Company’s SEC filings, which could cause the Company’s actual
operating results, performance or business plans or prospects to
differ materially from those expressed in, or implied by these
statements.
All forward-looking statements speak only as of
the date on which they are made, and the Company undertakes no
obligation to revise any of these statements to reflect the future
circumstances or the occurrence of unanticipated events, except as
required by applicable securities laws.
Investor Contact:
Callon Nichols, Director of Investor
Relations713-826-0524CNichols@sanaramedtech.com
SOURCE: Sanara MedTech
Inc.
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