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Xtant Medical Announces Launch of SimpliGraft™ and SimpliMax™ for Chronic and Acute Wounds

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Xtant Medical Holdings, Inc. announced the full commercial launch of two amniotic membrane allografts, SimpliGraft™ and SimpliMax™, for chronic and acute wounds. The products are dehydrated, terminally irradiated, single and dual-layer amniotic membrane sheets intended to provide protective coverage from the surrounding environment when applied topically. Manufactured at Xtant’s biologics processing center in Belgrade, Montana, the company aims to position itself as a leader and innovator in advanced biologic therapies.

Xtant Medical Holdings, Inc. ha annunciato il lancio commerciale completo di due allograft di membrana amniotica, SimpliGraft™ e SimpliMax™, destinati al trattamento di ferite croniche e acute. I prodotti sono fogli di membrana amniotica disidratati e irradiati terminalmente, mono e bi-strato, progettati per offrire una copertura protettiva dall'ambiente esterno quando applicati topicamente. Prodotto nel centro di lavorazione biologica di Xtant a Belgrade, Montana, l'azienda mira a posizionarsi come leader e innovatore nelle terapie biologiche avanzate.
Xtant Medical Holdings, Inc. ha anunciado el lanzamiento comercial completo de dos aloinjertos de membrana amniótica, SimpliGraft™ y SimpliMax™, para heridas crónicas y agudas. Los productos son hojas de membrana amniótica deshidratadas y esterilizadas por irradiación terminal, de una y doble capa, diseñadas para proporcionar cobertura protectora del entorno circundante cuando se aplican tópicamente. Fabricados en el centro de procesamiento biológico de Xtant en Belgrade, Montana, la compañía aspira a posicionarse como líder e innovadora en terapias biológicas avanzadas.
Xtant Medical Holdings, Inc.가 만성 및 급성 상처 치료를 위한 두 가지 양막 이종 이식편, SimpliGraft™ 및 SimpliMax™의 완전 상업 출시를 발표했습니다. 이 제품들은 건조되고 최종 방사선 조사를 받은 단일 및 이중 층 양막 시트로, 국소적으로 적용될 때 주변 환경으로부터 보호 커버를 제공하기 위해 설계되었습니다. 몬태나주 벨그레이드에 위치한 Xtant의 생물학적 가공 센터에서 제조된 이 회사는 고급 생물학적 치료에서의 리더 및 혁신자로 자리매김하려는 목표를 가지고 있습니다.
Xtant Medical Holdings, Inc. a annoncé le lancement commercial complet de deux allogreffes de membrane amniotique, SimpliGraft™ et SimpliMax™, pour les plaies chroniques et aiguës. Les produits sont des feuilles de membrane amniotique déshydratées et irradiées à terme, à simple et double couche, destinées à fournir une couverture protectrice de l'environnement environnant lorsqu'elles sont appliquées topiquement. Fabriqués au centre de traitement biologique d'Xtant à Belgrade, Montana, l'entreprise vise à se positionner comme leader et innovateur dans les thérapies biologiques avancées.
Xtant Medical Holdings, Inc. gab den vollständigen kommerziellen Start von zwei Amnionmembran-Allografts, SimpliGraft™ und SimpliMax™, für chronische und akute Wunden bekannt. Die Produkte sind dehydrierte, terminal bestrahlte Amnionmembranblätter in ein- und zweilagiger Ausführung, die als Schutzabdeckung gegen die umgebende Umwelt dienen sollen, wenn sie topisch angewendet werden. Hergestellt im biologischen Verarbeitungszentrum von Xtant in Belgrade, Montana, strebt das Unternehmen danach, sich als Führer und Innovator in fortgeschrittenen biologischen Therapien zu positionieren.
Positive
  • Strong emphasis on research and development team's revitalization.

  • Introduction of new products and robust pipeline to boost Xtant's position in biologic therapies.

  • Manufacturing of products at state-of-the-art center in Montana showcases advanced capabilities.

Negative
  • None.

BELGRADE, Mont., April 30, 2024 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of two amniotic membrane allografts, SimpliGraft™ and SimpliMax™.

“The launches of SimpliGraft and SimpliMax highlights the strength of our newly revitalized Research and Development team,” said Sean Browne, President and CEO of Xtant Medical. “We expect our new product launches and robust product pipeline will position Xtant as a leader and innovator in the field of advanced biologic therapies.”

SimpliGraft and SimpliMax are dehydrated, terminally irradiated, single and dual-layer amniotic membrane sheets intended to serve as a barrier and provide protective coverage from the surrounding environment when topically applied to chronic and acute wounds. The products are manufactured at Xtant’s state-of-the-art center for biologics processing in Belgrade, Montana.

Xtant intends to market these two new products through its nationwide distribution network of independent agents as well as adjacent market segments through original equipment manufacturer relationships. This launch is a testament to Xtant’s advancements in bio-manufacturing and marks its entry into the wound care market.

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spinBe, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.

The symbols ™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “intends,” ‘‘expects,’’ ‘‘anticipates,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ “continue,” “future,” ‘‘will,’’ similar expressions or the negative thereof, and the use of future dates. Forward-looking statements in this release include the Company’s expectations regarding the commercial launch and success of its new SimpliGraft and SimpliMax products. The Company cautions that its forward-looking statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s future operating results and financial performance; its ability to increase or maintain revenue; risks associated with its recent acquisitions and the integration of those businesses; anticipated shortages of stem cells which will adversely affect future revenues; possible future impairment charges to long-lived assets and goodwill and write-downs of excess inventory; the ability to remain competitive; the ability to innovate, develop and introduce new products; the ability to engage and retain new and existing independent distributors and agents and qualified personnel and the Company’s dependence on key independent agents for a significant portion of its revenue; the effect of COVID-19, labor and hospital staffing shortages on the Company’s business, operating results and financial condition, especially when they affect key markets; the Company’s ability to implement successfully its future growth initiatives and risks associated therewith; the effect of inflation, increased interest rates and other recessionary factors and supply chain disruptions; the effect of product sales mix changes on the Company’s financial results; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals and comply with government regulations; the effect of product liability claims and other litigation to which the Company may be subject; the effect of product recalls and defects; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; risks associated with the Company’s clinical trials; international risks; the ability to service Company debt, comply with its debt covenants and access additional indebtedness; the ability to obtain additional financing on favorable terms or at all; and other factors. Additional risk factors are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) on April 1, 2024. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.

Investor Relations Contact

David Carey
Lazar FINN Partners
Ph: 212-867-1762
Email: david.carey@finnpartners.com


FAQ

<p>What products did Xtant Medical Holdings, Inc. launch?</p>

Xtant Medical Holdings, Inc. launched SimpliGraft™ and SimpliMax™, two amniotic membrane allografts for chronic and acute wounds.

<p>Where are the products manufactured?</p>

The products are manufactured at Xtant’s biologics processing center in Belgrade, Montana.

<p>How does Xtant intend to market the new products?</p>

Xtant intends to market the products through its nationwide distribution network of independent agents as well as adjacent market segments through original equipment manufacturer relationships.

Xtant Medical Holdings, Inc.

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About XTNT

xtant medical (nyse mkt: xtnt) develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. with core competencies in both biologic and non-biologic surgical technologies, xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. for further information, please visit xtantmedical.com.