Full Press Release Details
MedTech Inc. Announces Exclusive License and Distribution Agreement with, and Minority Investment in, Biomimetic Innovations Ltd
and related technologies represent differentiated solutions that address an estimated 100,000+ procedures in the U.S. annually(1);
arrangement leverages Sanara's existing call points and commercial infrastructure, and complements Sanara's existing surgical
WORTH, TX, January 21, 2025 (GLOBE NEWSWIRE) - 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 the execution of an exclusive license and distribution agreement (the "License
and Distribution Agreement") with Biomimetic Innovations Ltd ("Biomimetic Innovations" or "BMI"), a privately-held
medical device company headquartered in Shannon, Ireland. In tandem, Sanara agreed to contribute up to 8.0 million in cash to BMI
in exchange for approximately 12.5% of BMI's outstanding equity. Sanara made an initial cash investment totaling 4.0 million,
including 1.0 million of converting debt. The remaining 4.0 million contribution is due upon the achievement of certain development,
clinical and regulatory milestones.
the terms of the License and Distribution Agreement, Sanara has acquired the exclusive U.S. marketing, sales, and distribution rights
to OsStic Synthetic Injectable Structural Bio-Adhesive Bone Void Filler ("OsStic"), as well as a hardware
agnostic adjunctive internal fixation technology featuring novel delivery to promote targeted application of OsStic, for use in fracture
management. The License and Distribution Agreement is for an initial five-year period, with the option to automatically renew for successive
two-year periods at Sanara's discretion.
was granted a Breakthrough Device Designation by the U.S. Food and Drug Administration ("FDA" or the "Agency")
on December 10, 2023, with proposed indications for use as a "structural, mechanically enhanced bioadhesive for reduction, provisional
fixation, or void filling of periarticular fractures or defects to enhance structural stability where standard fixation alone cannot
provide sufficient support for functional mobilization." Breakthrough Device Designation is granted to medical devices that provide
for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
are excited to announce this strategic agreement and investment in Biomimetic Innovations," said Ron Nixon, Sanara's Executive
Chairman and CEO. "OsStic offers a truly differentiated solution, designed to enhance the fracture repair process. We believe OsStic
represents a compelling treatment option for the more than 100,000 periarticular fractures that occur in the U.S. annually."
Nixon continued: "Leveraging the receipt of FDA Breakthrough Device Designation for OsStic, BMI is engaging with the Agency in
pursuit of U.S. regulatory clearance. We look forward to introducing this innovative surgical solution to the U.S. market, which we anticipate
in the first quarter of 2027. Importantly, we expect OsStic and related delivery technologies to complement our existing surgical product
portfolio, as we continue our focus on enhancing patient outcomes, improving healthcare providers' surgical experience, and reducing
the total cost of care."
Thomas Russell, Chief Medical Officer of PBC Biomed (an affiliate of BMI), stated, "While traditional calcium phosphate bone substitute
materials offer basic bone void filling properties, they are limited in their ability to fully integrate with the bone and ultimately
do not provide the adequate mechanical support to assist fracture repair. OsStic sets a new standard with its innovative formulation.
Unlike conventional materials, OsStic is engineered to optimize fluidic dispersion into bone defects, interdigitate with the surrounding
boney structure, and firmly adhere to bone surfaces. These properties provide exceptional structural integrity and mechanically enhanced
bioadhesion, making OsStic uniquely suited for reducing periarticular fractures, achieving provisional fixation, and filling voids. As
the first calcium phosphate-based synthetic technology to address all three critical clinical needs, OsStic offers an unparalleled solution
for preserving joint congruency and improving patient outcomes."
Burke, Managing Partner of PBC Biomed Ltd and acting CEO of Biomimetic Innovations stated, "Our goal is to enhance patient
wellness' using disruptive medical innovations. With its market expertise, sales and distribution network, and existing customer
relationships, Sanara represents an ideal partner to commercialize our innovative technologies. Together, we look forward to bringing
transformative solutions to market that enhance the surgeon's treatment approach and improve patient outcomes."
Biomimetic Innovations Ltd and PBC Biomed
Innovations Ltd is an affiliate of PBC Biomed, a medical device company involved in design, development and manufacturing. PBC Biomed
partners with medical device, biologic, pharmaceutical and combination product innovators to accelerate their technology through the
product lifecycle stages. The company offers regulatory, clinical, quality assurance and commercial support, and facilitates the design,
development and validation of medical devices, biologics, and combination products. PBC Biomed's ISO 13485 facilities and ISO 9001
certified processes enable the company to perform clean room manufacturing, packing and sterilization for a range of medical device products.
The company is headquartered in Shannon, Ireland, with offices in Memphis, Tennessee and Chamonix, France. PBC Biomed has a track record
in developing and commercializing new technologies, bringing the N-Force Fixation/iN3 Cement to market through its affiliate company,
CelgenTek Innovations (acquired by Zimmer Biomet in 2016), and more recently bringing ReFeel to market as a nerve regeneration
solution, with partner company Mochida Pharmaceuticals Ltd (Japan). For more information, please visit pbcbiomed.com and pbcbiomed.com/affiliates/biomimeticinnovations/.
MedTech Inc. is 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. The Company 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 ACTIGEN Verified Inductive Bone Matrix, ALLOCYTE Plus
Advanced Viable Bone Matrix, BiFORM Bioactive Moldable Matrix, TEXAGEN Amniotic Membrane Allograft, and
BIASURGE Advanced Surgical Solution to the surgical market. In addition, the following products are sold in the wound
care market: BIAK S Antimicrobial Skin and Wound Cleanser, BIAK S Antimicrobial Wound Gel,
and BIAK S Antimicrobial Skin and Wound Irrigation Solution. 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. For more information, please visit sanaramedtech.com.
about Forward-Looking Statements
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 "aims," "anticipates," "believes," contemplates," "continue,"
"could," "estimates," "expect," "forecast," "guidance," "intends,"
"may," "plans," "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 Company's arrangement with BMI and the integration of BMI's OsStic and related technologies
into the Company's product and service offerings, the timing of the introduction of OsStic and related technologies to the U.S.
market, the Company's business strategy and mission, the development of new products, the timing of commercialization of the Company's
products, the regulatory approval process and expansion of the Company's business in telehealth and wound care. These items involve
risks, contingencies and uncertainties such as uncertainties associated with the development and process for obtaining regulatory approval
for new products and OsStic and related technologies, the Company's ability to build out its executive team, the Company's
ability to identify and effectively utilize the net proceeds of its term loan to support the Company's growth initiatives, 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.
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
Powell or Mike Piccinino, CFA