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Allogeneic Growth Factor Solution to Accelerate Bone Repair
用于加速骨骼修复的同种异体生长因子溶液
BELGRADE, Mont.
贝尔格莱德,蒙大拿州
,
,
May 28, 2025
2025年5月28日
/PRNewswire/ -- Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal, orthopedic and wound care disorders, today announced the commercial launch of OsteoFactor Pro™, a naturally occurring cocktail of allogeneic growth factors engineered to improve bone healing and support surgical success across orthopedic and spine procedures..
/PRNewswire/ -- 全球医疗技术公司Xtant Medical Holdings, Inc.(纽约证券交易所代码:XTNT)专注于脊柱、骨科和伤口护理疾病的手术解决方案,今天宣布推出OsteoFactor Pro™的商业上市,这是一种天然存在的同种异体生长因子混合物,旨在改善骨愈合并支持骨科和脊柱手术的成功。
OsteoFactor Pro™ is a naturally derived, growth factor-rich formulation that enhances the biologic activity and regenerative potential of any orthobiologic scaffold. Its biphasic release profile—delivering an immediate bolus followed by sustained growth factor release—is designed to drive and stimulate the body's key natural bone regeneration pathways including targeted angiogenesis, chemotaxis, and osteogenesis throughout the healing process..
OsteoFactor Pro™ 是一种天然衍生的、富含生长因子的配方,能够增强任何骨生物支架的生物活性和再生潜力。其双相释放特性——先快速释放大量生长因子,随后持续缓慢释放——旨在驱动并刺激人体关键的自然骨再生途径,包括在愈合过程中促进靶向血管生成、趋化性和骨生成。
OsteoFactor Pro™ is an off-the-shelf, ready-to-use solution that integrates seamlessly with synthetic, allograft, or autograft scaffolds. It provides surgeons with exceptional versatility and biologic performance to support a wide range of bone regeneration approaches.
OsteoFactor Pro™ 是一种开箱即用、随时可用的解决方案,能够与合成材料、同种异体移植物或自体移植物支架无缝整合。它为外科医生提供了卓越的多功能性和生物性能,以支持各种骨再生方法。
OsteoFactor Pro™ is now available to Xtant Medical's nationwide distribution network.
OsteoFactor Pro™ 现已在 Xtant Medical 的全国分销网络中提供。
'This product reflects our commitment to advancing the science of healing through biologics that offer precision, flexibility, and meaningful clinical impact,' said
“该产品体现了我们通过提供精确性、灵活性和有意义的临床影响的生物制品,推动愈合科学发展的承诺,”
Sean Browne
肖恩·布朗
, President and CEO of Xtant Medical.
,Xtant Medical的总裁兼首席执行官。
Mark Schallenberger
马克·沙伦贝格
, COO of Xtant Medical added, 'With the launch of OsteoFactor Pro™, Xtant becomes the first vertically integrated company to offer solutions across all five major orthobiologic categories—demineralized bone matrix, cellular allografts, synthetics, structural allografts, and now growth factors. This milestone reflects our long-term commitment to innovation, scalability, and meeting the full spectrum of surgeon and patient needs in regenerative medicine.'.
Xtant Medical的首席运营官补充道:“随着OsteoFactor Pro™的推出,Xtant成为首家在所有五大主要骨生物材料类别中提供解决方案的垂直整合公司——脱矿骨基质、细胞同种移植物、合成材料、结构性同种移植物,以及现在的生长因子。这一里程碑反映了我们对创新、可扩展性以及满足再生医学领域外科医生和患者全方位需求的长期承诺。”
About Xtant Medical Holdings, Inc.
关于Xtant Medical Holdings, Inc.
Xtant Medical's mission of honoring the gift of donation so that our patients can live as full and complete a life as possible, is the driving force behind our company. Xtant Medical Holdings, Inc. (
Xtant Medical的使命是尊重捐赠的礼物,以便我们的患者能够过上尽可能充实和完整的生活,这是公司背后的驱动力。Xtant Medical Holdings, Inc. (
www.xtantmedical.com
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 spine, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers..
)是一家全球医疗技术公司,专注于设计、开发和商业化全面的骨生物制品和脊柱植入系统组合,以促进复杂脊柱、畸形和退行性手术中的脊柱融合。Xtant 的员工专注且才华横溢,以最高的诚信为客户提供服务。
The symbols ™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in
符号™和®表示Xtant Medical Holdings, Inc.或其附属公司的商标和注册商标,注册情况如所示。
the United States
美国
, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.
,并在其他国家。本发布中提到的所有其他商标和商号均为其各自所有者的财产。
Non-GAAP Financial Measures
非公认会计准则财务指标
To supplement the Company's consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures in this release, including adjusted EBITDA. Reconciliations of the non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release.
为了补充公司根据美国公认会计原则(GAAP)编制的合并财务报表,公司在本公告中使用了某些非GAAP财务指标,包括调整后的EBITDA。本公告中使用的非GAAP财务指标与相应期间最可比的GAAP指标的对账信息可以在本公告后文的表格中找到。
The Company's management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company's operations, period over period. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources.
公司管理层认为,这些指标的呈现为投资者提供了有用的信息。这些指标可以帮助投资者评估公司运营情况,进行跨期比较。管理层在内部使用这些非GAAP指标来评估业务表现,包括资源分配。
Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP..
投资者应将非GAAP财务指标仅视为根据GAAP编制的财务业绩指标的补充,而非替代或优于该等指标。
Cautionary Statement Regarding Forward-Looking Statements
关于前瞻性声明的警告声明
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,'' 'potential,' 'going forward,' 'guidance,' similar expressions or the negative thereof, and the use of future dates.
本新闻稿包含1995年《私人证券诉讼改革法》意义上的前瞻性陈述。前瞻性陈述包括具有预测性质的陈述,取决于或涉及未来事件或条件的陈述,或包含诸如“意图”、“预期”、“预计”、“计划”、“相信”、“估计”、“继续”、“未来”、“将”、“潜在”、“展望”、“指导”、类似表达或其否定形式的陈述,以及使用未来日期的情况。
Forward-looking statements in this release include the Company's full year 2025 revenue guidance and the statement that it expects to begin generating free cash flow in the second half of 2025, enabling the Company to support expected organic growth without the need for additional external capital. 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; the Company's ability to become operationally self-sustaining and less reliant on third-party manufacturers and suppliers; risks associated with its acquisitions and the integration of those businesses; anticipated shortages of stem cells which will adversely affect future revenues; the ability to implement successfully its future growth initiatives and risks associated therewith; 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 and the success of those products; the ability to engage and r.
本发布中的前瞻性声明包括公司对2025年全年收入的预测,以及预计将在2025年下半年开始产生自由现金流的声明,这将使公司能够在不需要额外外部资本的情况下支持预期的有机增长。公司提醒,其前瞻性声明因其性质而涉及风险和不确定性,实际结果可能因多种重要因素而存在重大差异,这些因素包括但不限于:公司未来的运营结果和财务表现;其增加或维持收入的能力;公司实现运营自给自足并减少对第三方制造商和供应商依赖的能力;与其收购及业务整合相关的风险;预期的干细胞短缺将对未来收入产生不利影响;成功实施未来增长计划及相关风险的能力;未来可能发生对长期资产和商誉的减值损失以及过剩库存的减记;保持竞争力的能力;创新能力、开发和推出新产品及其产品成功的可能性;与客户和合作伙伴的互动能力等。
December 31, 2024
2024年12月31日
to be filed with the Securities and Exchange Commission (SEC) on
将提交给美国证券交易委员会 (SEC)
March 6, 2025
2025年3月6日
and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarterly period ended
公司随后向美国证券交易委员会提交的文件,包括但不限于其最近一期截至季度的10-Q表季度报告
September 30, 2024
2024年9月30日
filed with the SEC on
提交给美国证券交易委员会的文件
November 12, 2024
2024年11月12日
. Investors are encouraged to read the Company's filings with the SEC, available at
投资者应阅读公司向美国证券交易委员会提交的文件,可访问
www.sec.gov
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.
,有关这些及其它风险和不确定性的讨论。公司不承担任何义务公开发布对任何前瞻性声明的修订,以反映本日期之后的事件或情况,或反映未预期事件的发生,除非法律要求。
All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement..
本公司或代表其行事的人员的所有前瞻性声明均应以此警示性声明为准,完全符合其规定。
SOURCE Xtant Medical Holdings, Inc.
来源:Xtant Medical Holdings, Inc.
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