Fibralign Corporation

What Fibralign Corporation does

Fibralign Corporation is a privately held, commercial-stage medical device company founded in 2005 as a Stanford University spinout, headquartered in Union City, California with a European office in Woerden, Netherlands. The company develops and commercializes surgical implants based on its proprietary Nanoweave® 3D scaffolding technology, which induces the self-assembly of molecular type I collagen into nanoscale scaffolds that mimic native tissue architecture. Its first and only commercial product, the BioBridge® Collagen Matrix, is a thread-like, single-use sterile surgical mesh designed to repair damaged lymphatic tissue and promote formation of new lymphatic vessels; it is fabricated using zero-length crosslinking and fully resorbs in 6–9 months.

BioBridge is FDA 510(k) cleared (Class II, January 2016) for soft tissue support/repair, CE-marked (Class III, September 2020) for the surgical treatment of lymphedema, KFDA-approved in South Korea (2024), and under PMDA review in Japan following completion of a Terumo-run clinical trial in 2025. The product has been used in over 750 surgical procedures across 19 countries, primarily as an adjunct to microsurgical reconstruction (lymph node transfer, lymphaticovenular anastomosis) for breast-cancer-related lymphedema, and is being evaluated in an NCI-funded multi-site LymphBridge study (n=60), a European prevention study, and a planned 300-patient pivotal study.

Fibralign operates a hybrid commercial model: direct hospital sales to US cancer centers (UChicago, Stanford, MD Anderson) for clinical adoption, exclusive distributor agreements with Terumo in Japan and Healing Solutions in South Korea, and a network of ten European specialty distributors; the company is also pursuing a pipeline indication in volumetric muscle loss under a DoD SBIR grant and is exploring neurological, cardiovascular, and ophthalmic applications of the Nanoweave platform. Pricing is institutional/quotation-based and product is sold in non-resterilizable single-use sterile five-packs.

Name

Fibralign Corporation

Legal name

Fibralign Corporation

Website

https://fibralignbio.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

1–10 employees

Short description

Fibralign Corporation is a privately held, Stanford-spinout medical device company that develops the Nanoweave® 3D collagen scaffolding platform and commercializes the BioBridge® Collagen Matrix — a thread-like surgical implant used in microsurgical treatment of secondary lymphedema, with FDA 510(k), CE Mark Class III, and KFDA approvals.

Ownership category

akta.pro rank

Product category

Surgical Medical Devices

NAICS

Research and Development in Nanotechnology (541713)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro industry

PRIMARYHLAAAGAB

Tissue-Engineered Constructs & Scaffolds (natural/synthetic biomaterials)

Healthcare & Life Sciences/Biotechnology & Biologics/Regenerative Medicine & Tissue Engineering

SECONDARYHLAHALAE

Skin Substitutes & Biologic/Regenerative Wound Therapies (Matrices, Grafts)

Healthcare & Life Sciences/Medical Devices & Diagnostics/Wound Care, Ostomy & Continence Products

SECONDARYHLAAAGAG

Wound Healing & Skin Regeneration (advanced dressings, skin substitutes)

Healthcare & Life Sciences/Biotechnology & Biologics/Regenerative Medicine & Tissue Engineering

Keywords

• Medical devices
• Lymphedema treatment
• Collagen scaffold
• Soft tissue repair
• Biomedical implants

Headquarters

HQ city

Sunnyvale

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. BioBridge Collagen Matrix Product Sales: Sale of the BioBridge Collagen Matrix as a sterile, single-use surgical device. Commercially available in the US, Europe, South Korea, and Middle East. Provided in single-use sterile 'five-packs' (package containing five devices). Revenue is generated through direct hospital sales and distributor channel sales across international markets.
2. Terumo Distribution Agreement: Exclusive distribution agreement with Terumo Corporation for marketing and distributing BioBridge in Japan. Terumo provides defined milestone payments to Fibralign and is responsible for conducting clinical studies and completing regulatory review before commercial introduction in Japan.
3. Clinical Study and Grant Funding: Fibralign receives non-dilutive funding through SBIR grants from the Department of Defense ($996,609 Phase IIS for volumetric muscle loss) and NCI ($3M SBIR Phase IIB Bridge grant for LymphBridge study). These grants support clinical development and R&D activities.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels5 records

Core offering

Fibralign Corporation develops and manufactures therapeutic biomedical devices based on its proprietary Nanoweave® 3D scaffolding technology. Its primary commercial product is the BioBridge® Collagen Matrix, a thread-like surgical mesh made of medical-grade collagen used for soft tissue repair and surgical treatment of secondary lymphedema. The company also operates an ISO 13485:2016 certified GMP manufacturing facility in Union City, California and conducts clinical studies supporting expanded indications.

Product overview

Fibralign Corporation offers a focused portfolio built around its proprietary Nanoweave 3D scaffolding technology platform. The company's primary commercial product is the BioBridge Collagen Matrix, a thread-like surgical mesh designed for soft tissue repair and lymphatic tissue treatment. BioBridge is the first product commercialized using the Nanoweave platform. The company is developing a pipeline of additional products based on this technology for addressing other medical conditions where lymphatic impairment contributes to chronic conditions, including neurological disorders, heart disease, and glaucoma.

Differentiator

Problem solved

Functional benefit

Brands

• BioBridge Collagen Matrix: Novel thread-like surgical mesh made of medical-grade collagen for treatment of secondary lymphedema
• Nanoweave Technology
• LymphBridge

Products and services

• BioBridge Collagen Matrix A novel thread-like surgical mesh made of medical-grade collagen fabricated using Fibralign's patented Nanoweave technology. FDA 510(k) cleared Class II device for soft tissue repair, CE mark approved Class III device for surgical treatment of lymphedema. Used in over 750 surgeries across 19 countries.

Quantifiable outcome

• Over 750 surgeries in 19 countries with BioBridge, demonstrating safety and clinical effectiveness in reducing limb volume and restoring lymphatic function (shown by ICG imaging)
• +5 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Cook Medical: Cook Medical is a privately held broad medical device incumbent with a portfolio that includes small intestinal submucosa (SIS) and other extracellular matrix products for soft tissue repair. It overlaps with Fibralign in surgical regenerative matrices and brings established global distribution channels.
• Organogenesis: Organogenesis (NASDAQ: ORGO) markets Apligraf, Dermagraft, and other living cell-based regenerative skin substitutes and wound care matrices. It is a broad incumbent in the regenerative biomaterial space with overlapping technology (biologic matrices for tissue repair) and significantly greater commercial scale than Fibralign.
• Integra LifeSciences: Integra LifeSciences (NASDAQ: IART) manufactures regenerative tissue technologies including collagen-based dermal matrices and dural repair products. It operates as a broad incumbent in the surgical and regenerative biomaterials space with overlapping product categories (collagen matrices for tissue repair) and global commercial reach.

Direct peers

• BioCompression Systems: BioCompression Systems manufactures sequential compression devices (SCD Express and others) for the treatment of lymphedema and venous insufficiency. As a direct lymphedema peer, it competes for clinical adoption and reimbursement within the same patient population using conservative compression therapy rather than surgical intervention.
• LymphaPress (Mego Afek): LymphaPress, manufactured by Mego Afek, produces pneumatic compression therapy devices specifically designed for lymphedema treatment. As a direct lymphedema-focused peer, it addresses the same patient population through a different therapeutic modality (compression rather than surgical scaffold).
• Tactile Medical: Tactile Medical (NASDAQ: TCMD) markets the Flexitouch system and other pneumatic compression devices for lymphedema management. It is the most established pure-play lymphedema-focused commercial-stage medical device company and a direct peer addressing the same patient population with a non-surgical, conservative therapy approach.

Emerging players

• Koya Medical: Koya Medical developed the Dayspring wearable compression system for lymphedema. As an emerging lymphedema-focused medical device company with FDA-cleared products and venture backing, it competes for the same clinical attention and reimbursement from lymphedema patients, though via conservative therapy rather than surgical intervention.
• CorMatrix Cardiovascular: CorMatrix develops and markets ECM-based biomaterial devices for cardiac tissue repair. It represents an adjacent emerging player in the tissue-engineered ECM scaffold space, with overlapping technology in collagen/ECM-based regenerative matrices, though focused on cardiovascular indications rather than lymphatic.
• MiMedx: MiMedx (NASDAQ: MDXG) markets dehydrated human amnion/chorion membrane allografts for wound care and surgical soft tissue repair. It competes in the same surgical regenerative matrix category as Fibralign's BioBridge, though using allograft rather than collagen scaffold technology.
• ACell: ACell develops and markets MatriStem and other porcine urinary bladder matrix (UBM) devices for wound management and soft tissue repair. It is a smaller emerging player with an overlapping biologic ECM-based matrix product line targeting similar soft tissue and wound healing surgical applications as BioBridge.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/fibralignbio
• LinkedInlinkedin.com/company/fibralign-corporation

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Fibralign Corporation