Information for qualified healthcare professionals and institutional partners 本网站信息面向符合资格的医疗专业人士与机构合作伙伴

Regulatory notice合规说明

U.S. headquarters · Global partner support美国总部 · 服务全球合作伙伴

Tissue science,
carried with care.
以组织科学为本,
以生命关怀为心。

Axiom Tissue connects qualified clinical, distribution, and research partners with thoughtfully documented human tissue solutions across global markets. Axiom Tissue 面向全球合规市场,为医疗机构、经销与科研合作伙伴提供资料清晰、审慎负责的人体组织材料方案。

Laboratory professional handling a pipette at a clean workbench
Care begins long before a product reaches a clinical team—with attentive handling, clear documentation, and respect for human tissue. 关怀始于产品抵达临床团队之前:细致处理、清晰资料,以及对人体组织的尊重。

Donor dignity尊重捐献

Human tissue is handled with the respect its origin deserves.以符合其生命来源的尊重,审慎对待每一份人体组织。

Documented quality资料化质量

Product information and supply records support informed decisions.以产品资料与供应记录,支持合作伙伴作出知情决策。

Market awareness尊重市场差异

Availability and pathways are assessed jurisdiction by jurisdiction.根据不同司法辖区,逐一评估产品可用性与准入路径。

Human tissue portfolio人体组织产品组合

Material options for
considered care.
为审慎的临床选择,
提供材料方案。

Three product families, supported with market-specific information for qualified partners. Exact configurations depend on supplier, jurisdiction, and product labeling.三类产品线,为符合资格的合作伙伴提供与市场相适应的资料支持。具体规格取决于供应方、司法辖区与产品标签。

Cross-section of human bone tissue
01

Bone Allograft骨同种异体移植物

Processed human bone tissue in configurations selected for institutional and clinical workflows.经处理的人体骨组织,可根据机构与临床工作流程提供不同规格方案。

Possible configurations可能提供的规格

Cortical, cancellous, and demineralized options may be available. Confirm the product dossier, labeling, and local authorization before use.可能包括皮质骨、松质骨及脱矿骨等方案。使用前须确认具体产品资料、标签及当地许可状态。

Scanning electron microscope image of the surface of human skin
02

Dermal Tissue皮肤组织

Human dermal tissue configurations supported by product-specific handling and documentation.人体皮肤组织方案,并配有与具体产品相对应的处理和资料支持。

Partner information合作资料

Available formats, storage conditions, intended use, and regulatory status must be reviewed for each product and destination market.应针对每一项产品与目的市场,核查其供应规格、储存条件、预期用途及监管状态。

Axiom product systemAxiom 品牌产品体系

One identity.
Three considered forms.
统一品牌语言,
三种审慎产品形态。

This initial packaging direction brings the portfolio together through warm, restrained materials. It is a design concept—not a commercial label—and must be completed with the selected processor's validated specifications, labeling, and regulatory review.首版包装以温和、克制的材料语言统一产品组合。它目前仅为设计概念,并非商业标签;正式使用前必须加入经选定处理机构验证的规格、标签与监管审查内容。

Doctor speaking attentively with an older patient in a consultation room
A

AXIOM

AXIOM DROP

A human amniotic-fluid–derived development program with proposed injectable and ophthalmic-drop dosage forms, in collaboration with Amnio Technology, LLC. No therapeutic indication or commercial authorization is represented.来源于人羊水的开发项目,拟开发注射剂和滴眼液两种剂型,并与 Amnio Technology, LLC 合作。网站不声称任何治疗适应证或商业销售授权。

Proposed forms拟开发剂型
Injectable · ophthalmic drops注射剂 · 滴眼液
Partner合作方
Amnio Technology, LLC
Storage储存
To be established by formulation, stability data, and approved protocol/label须依据配方、稳定性数据及获准方案/标签确定
U.S. status美国状态
Investigational; not offered for commercial sale研究性产品;不用于商业销售
A

AXIOM

AXIOM ALLOGRAFT

Proposed bone allograft family. The ranges below reflect common U.S. market presentations and are not final Axiom SKUs.拟议的骨同种异体移植物产品线。下列范围参考美国市场常见形态,并非 Axiom 的最终 SKU。

Common formats常见形态
Cancellous/cortical particulate; DBM putty or mix松质骨/皮质骨颗粒;DBM 骨泥或混合物
Volumes容量
1 cc · 2.5 cc · 5 cc · 10 cc
Typical storage常见储存
Ambient for specified freeze-dried/DBM products; other forms may require frozen storage部分冻干/DBM 产品可常温储存;其他形态可能需要冷冻

Final processor, preservation method, sterility status, shelf life, and instructions must match the executed product dossier.最终处理机构、保存方式、无菌状态、有效期和说明书必须与正式产品档案一致。

A

AXIOM

AXIOM MEMBRANE

Proposed amniotic membrane family for barrier, covering, or protective applications consistent with final labeling and local authorization.拟议的羊膜产品线;仅在符合最终标签和当地许可的情况下,用于屏障、覆盖或保护性应用。

Common forms常见形态
Single- or dual-layer; dehydrated or cryopreserved单层或双层;脱水或低温保存
Sizes尺寸
1×1 cm · 2×2 cm · 2×3 cm · 4×4 cm · 4×6 cm · 4×8 cm
Presentation产品形态
Air-dried or saline-packaged concept; storage per final processor label拟采用风干或盐水包装;储存须以处理机构最终标签为准

Processing can change regulatory classification. Final claims are limited to the approved or otherwise lawful product-specific labeling.处理方式可能改变监管分类。最终宣传内容必须限定在已获批准或其他合法的具体产品标签范围内。

Development & processing partner开发与处理合作方

Axiom identifies Amnio Technology, LLC as its contracted partner for the amnion program. Amnio Technology publicly describes amnion-derived membrane and liquid-product manufacturing and an IND-stage injectable program. The final Axiom product dossier must still verify contract scope, manufacturing responsibilities, current registrations/accreditations, specifications, stability, sterility, and whether any IND or marketing application legally covers the particular Axiom product. Registration or accreditation is not FDA approval.Axiom 确认 Amnio Technology, LLC 为羊膜项目的签约合作方。该公司公开介绍其羊膜来源的膜类与液体产品制造能力,以及 IND 阶段的注射产品项目。Axiom 的最终产品档案仍须核实合同范围、制造职责、最新注册/认证、规格、稳定性、无菌状态,以及相关 IND 或上市申请是否依法覆盖具体 Axiom 产品。注册或认证不等于 FDA 批准。

A human-centered company以人为本的组织材料公司

Science is precise.
Care is personal.
科学需要精确,
关怀始终关于人。

Behind every shipment is a clinical team preparing, a person hoping to recover, and the trust that makes tissue donation possible. That human connection informs how we communicate, document, and partner.每一批产品的背后,都有正在准备的医疗团队、有期盼康复的人,也有使组织捐献成为可能的信任。这份人与人之间的连接,影响着我们的沟通、资料管理与合作方式。

“Respect for the tissue begins with respect for every person connected to it.”“尊重组织材料,始于尊重与它相关的每一个人。”

Our operating principle我们的工作原则
Doctor speaking attentively with an older patient in a consultation room

A framework for responsible supply负责任供应的工作框架

Clarity at every handoff.让每一次交接清晰可循。

Our operating model is designed around documented review and communication. Specific quality credentials and establishment registrations must be verified for each processing partner and product.我们的工作模式围绕资料审查与有效沟通而设计。每一家处理合作方及每一项产品的质量资质与机构注册状态,均须单独核实。

  1. 01

    Partner qualification合作方评估

    Review the organization, processing scope, and supporting records.审查机构背景、处理范围及支持性记录。

  2. 02

    Product review产品审查

    Align specifications, labeling, storage, and intended market.核对规格、标签、储存条件与目标市场。

  3. 03

    Controlled logistics受控物流

    Plan shipment conditions and receiving responsibilities.规划运输条件与收货责任。

  4. 04

    Ongoing support持续支持

    Maintain product communication and market-aware follow-through.持续提供产品沟通与符合市场要求的后续支持。

Headquartered in the United States总部位于美国

One home base.
A global outlook.
立足美国,
连接全球市场。

From our U.S. headquarters, we support qualified distribution, institutional, and research relationships across international markets—always mindful that product availability and regulatory pathways differ by country.我们从美国总部出发,支持全球合规市场中的经销、机构与科研合作,同时尊重各国产品供应与监管路径的差异。

North America北美 Asia Pacific亚太 Europe欧洲 Selected global markets其他合规市场

Research & collaboration科研与合作

Exploring what comes next.共同探索下一步。

We welcome conversations with academic, translational, and industry teams working in tissue science and investigational cellular technologies.我们欢迎与从事组织科学及研究性细胞技术的高校、转化研究与产业团队交流合作。

Any cell, exosome, or investigational program is presented for research or partnership discussion only and is not represented here as an approved therapy.任何细胞、外泌体或研究性项目仅用于科研或合作讨论,本网站不将其表述为已获批准的治疗方法。

Start a conversation开启合作交流

Tell us where care
is taking you.
告诉我们,
您希望把关怀带往哪里。

Share your market, organization, and product interest. Our U.S.-based team will respond with the appropriate next questions.请告诉我们您的市场、机构和产品需求。我们的美国团队会进一步联系并确认所需信息。

info@axiomtissue.com +1 (508) 988-0105 21 Strathmore Road
Natick, MA 01760, USA