Sanara MedTech Inc. Announces Exclusive License and Distribution Agreement with, and Minority Investment in, Biomimetic Innovations Ltd
Sanara MedTech (NASDAQ: SMTI) has announced an exclusive license and distribution agreement with Biomimetic Innovations (BMI), alongside a minority investment of up to €8.0 million for approximately 12.5% equity stake in BMI. The company has made an initial €4.0 million investment, with the remaining €4.0 million contingent on achieving specific milestones.
The agreement grants Sanara exclusive U.S. rights to market, sell, and distribute OsStic®, a synthetic injectable structural bio-adhesive bone void filler, along with related delivery technology. OsStic received FDA Breakthrough Device Designation in December 2023 for periarticular fractures treatment. The technology addresses an estimated 100,000+ annual U.S. procedures.
The five-year agreement includes automatic renewal options. Market introduction is anticipated in Q1 2027, complementing Sanara's existing surgical portfolio.
Sanara MedTech (NASDAQ: SMTI) ha annunciato un accordo esclusivo di licenza e distribuzione con Biomimetic Innovations (BMI), insieme a un investimento minoritario fino a €8,0 milioni per una partecipazione azionaria del 12,5% in BMI. L'azienda ha effettuato un investimento iniziale di €4,0 milioni, mentre il restante €4,0 milioni è subordinato al raggiungimento di traguardi specifici.
L'accordo conferisce a Sanara i diritti esclusivi per il mercato statunitense per commercializzare, vendere e distribuire OsStic®, un bio-adesivo strutturale sintetico iniettabile per il riempimento di cavità ossee, insieme alla tecnologia di somministrazione correlata. OsStic ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA nel dicembre 2023 per il trattamento delle fratture periarticolari. La tecnologia risponde a un numero stimato di oltre 100.000 procedure annuali negli Stati Uniti.
Il contratto di cinque anni include opzioni di rinnovo automatico. L'introduzione sul mercato è prevista per il primo trimestre del 2027, complementando il portafoglio chirurgico esistente di Sanara.
Sanara MedTech (NASDAQ: SMTI) ha anunciado un acuerdo exclusivo de licencia y distribución con Biomimetic Innovations (BMI), junto con una inversión minoritaria de hasta €8.0 millones por una participación accionaria de aproximadamente el 12.5% en BMI. La compañía ha realizado una inversión inicial de €4.0 millones, con los restantes €4.0 millones sujetos al logro de hitos específicos.
El acuerdo otorga a Sanara derechos exclusivos en EE. UU. para comercializar, vender y distribuir OsStic®, un bioadhesivo estructural sintético inyectable para el llenado de vacíos óseos, junto con la tecnología de entrega relacionada. OsStic recibió la Designación de Dispositivo Innovador de la FDA en diciembre de 2023 para el tratamiento de fracturas periarticulares. La tecnología aborda un estimado de más de 100,000 procedimientos anuales en EE. UU.
El acuerdo de cinco años incluye opciones de renovación automática. La introducción al mercado se anticipa para el primer trimestre de 2027, complementando el portafolio quirúrgico existente de Sanara.
Sanara MedTech (NASDAQ: SMTI)는 Biomimetic Innovations (BMI)와 독점 라이선스 및 유통 계약을 체결했으며, BMI의 약 12.5% 지분에 대해 최대 €8.0백만의 소수 투자도 진행했습니다. 회사는 초기 €4.0백만을 투자하였으며, 나머지 €4.0백만은 특정 이정표를 달성해야 지원됩니다.
이 계약을 통해 Sanara는 미국에서 OsStic®의 마케팅, 판매 및 유통에 대한 독점 권리를 부여받습니다. OsStic은 구조용 생체 접착제를 포함한 합성 주입형 뼈 결손 채움 재료이며, 관련 배송 기술 역시 포함됩니다. OsStic은 2023년 12월에 FDA의 혁신 의료기기 지정(Breakthrough Device Designation)을 받아 관절 주위 골절 치료에 사용됩니다. 이 기술은 매년 미국에서 100,000개 이상의 절차를 해결합니다.
5년 계약에는 자동 갱신 옵션이 포함되어 있습니다. 시장 도입은 2027년 1분기로 예상되며, Sanara의 기존 외과 포트폴리오를 보완할 것입니다.
Sanara MedTech (NASDAQ: SMTI) a annoncé un accord exclusif de licence et de distribution avec Biomimetic Innovations (BMI), ainsi qu'un investissement minoritaire allant jusqu'à 8,0 millions d'euros pour une participation d'environ 12,5 % dans BMI. La société a réalisé un investissement initial de 4,0 millions d'euros, le reste de 4,0 millions d'euros étant conditionné à l'atteinte d'objectifs spécifiques.
L'accord accorde à Sanara les droits exclusifs de marchandiser, vendre et distribuer OsStic®, un bio-adhésif structurel synthétique injectable pour le comblement des vides osseux, ainsi que la technologie de livraison associée, aux États-Unis. OsStic a reçu la désignation de Dispositif Innovant de la FDA en décembre 2023 pour le traitement des fractures périarticulaires. La technologie répond à un besoin estimé à plus de 100 000 interventions annuelles aux États-Unis.
L'accord de cinq ans inclut des options de renouvellement automatique. L'introduction sur le marché est prévue pour le premier trimestre de 2027, complétant le portefeuille chirurgical existant de Sanara.
Sanara MedTech (NASDAQ: SMTI) hat eine exklusive Lizenz- und Vertriebsvereinbarung mit Biomimetic Innovations (BMI) bekannt gegeben, sowie eine Minderheitsinvestition von bis zu 8,0 Millionen Euro für einen Anteil von etwa 12,5% an BMI. Das Unternehmen hat eine anfängliche Investition von 4,0 Millionen Euro getätigt, während die verbleibenden 4,0 Millionen Euro von der Erreichung spezifischer Meilensteine abhängen.
Die Vereinbarung gewährt Sanara die exklusiven Rechte, OsStic®, einen synthetischen injizierbaren strukturellen Bio-Kleber für Knochenfüllungen, zusammen mit der entsprechenden Liefersystemtechnologie in den USA zu vermarkten, zu verkaufen und zu vertreiben. OsStic erhielt im Dezember 2023 die Auszeichnung FDA Breakthrough Device Designation für die Behandlung von periartikulären Frakturen. Die Technologie adressiert schätzungsweise über 100.000 jährliche Verfahren in den USA.
Die fünfjährige Vereinbarung umfasst automatische Verlängerungsoptionen. Die Markteinführung wird für das erste Quartal 2027 erwartet, um Sanaras bestehendes chirurgisches Portfolio zu ergänzen.
- Secured exclusive U.S. distribution rights for FDA Breakthrough-designated OsStic® technology
- Addresses large market opportunity of 100,000+ procedures annually in the U.S.
- Strategic investment provides 12.5% equity stake in BMI
- Agreement includes automatic renewal options beyond initial 5-year term
- Product launch not expected until Q1 2027
- Significant capital commitment of up to €8.0 million required
- FDA clearance still pending
Insights
This strategic move by Sanara MedTech (SMTI) represents a calculated entry into the high-value orthopedic biomaterials market through a two-pronged approach: a strategic investment and exclusive distribution rights. The deal structure is particularly noteworthy:
Investment Structure:
- Initial investment:
€4.0 million (including€1.0 million converting debt) - Additional
€4.0 million tied to development milestones - Total stake:
12.5% in BMI
Market Opportunity Analysis: With over 100,000 annual periarticular fracture procedures in the U.S. and assuming a conservative average selling price of $3,000-$5,000 per procedure, this represents a potential addressable market of
Technical Differentiation: OsStic's unique value proposition lies in its three-fold functionality: fracture reduction, provisional fixation and void filling capabilities. This represents a significant advancement over traditional calcium phosphate materials, which typically only provide basic void filling. The FDA's Breakthrough Device Designation validates this technological advantage and may accelerate the regulatory pathway.
Strategic Fit: The acquisition complements Sanara's surgical portfolio while leveraging existing sales infrastructure and customer relationships. This operational synergy could accelerate market penetration upon launch in Q1 2027 while minimizing additional overhead costs.
Risk Considerations: Key milestones include regulatory approval and clinical validation. The milestone-based investment structure mitigates some development risk, but investors should monitor progress toward FDA clearance and the achievement of clinical endpoints that will trigger the remaining
OsStic® 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 portfolio
FORT WORTH, TX, Jan. 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
Under 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.
OsStic 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.
“We 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.”
Mr. 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.”
Dr. 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.”
Paul 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.”
(1) National Library of Medicine, BMI and Sanara company estimates.
About Biomimetic Innovations Ltd and PBC Biomed
Biomimetic 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/.
About Sanara MedTech Inc.
Sanara 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: BIAKŌS® Antimicrobial Skin and Wound Cleanser, BIAKŌS® Antimicrobial Wound Gel, and BIAKŌS® 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.
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 “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.
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 Relations Contact:
Jack Powell or Mike Piccinino, CFA
ICR Healthcare
IR@sanaramedtech.com
FAQ
When will Sanara MedTech (SMTI) launch OsStic® in the U.S. market?
How much is Sanara MedTech (SMTI) investing in Biomimetic Innovations?
What percentage stake will SMTI own in Biomimetic Innovations?
When did OsStic® receive FDA Breakthrough Device Designation?
How long is SMTI's exclusive license agreement for OsStic®?
What is the market size for OsStic® in the United States?
