BioTissue

Name

BioTissue

Legal name

BioTissue Holdings, Inc.

Website

https://biotissue.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Regenerative Medicine Biologics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Ophthalmic Goods Manufacturing (339115), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Biological Products, (No Disgnostic Substances) (2836), Ophthalmic Goods (3851), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Biologic API/Drug Substance Manufacturing Services (HLAAAKAA)

akta.pro secondary industries

Drug Product Fill-Finish & Aseptic Manufacturing Services (HLAAAKAB), Ophthalmology Specialty Pharmaceuticals (HLAIACAK), Aseptic Processing, Fill-Finish & Sterile Manufacturing Tech (isolators, lyophilization interfaces) (HLAAAJAG)

Keywords

• Amniotic membrane allografts
• Ocular surface healing
• Regenerative biologics
• Tissue cryopreservation
• Wound care products

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Ocular Products Sales: BioTissue generates revenue through the sale of cryopreserved amniotic membrane products for ocular surface conditions. Products include Prokera, CAM360 AmnioGraft, AmnioGraft, and AmnioGuard. Revenue is derived from healthcare providers including ophthalmologists, optometrists, and hospitals.
2. Manufacturing Services: Following the divestiture of the surgical and wound care business to BioStem Technologies, BioTissue continues to manufacture the Neox and Clarix product lines for BioStem, generating manufacturing revenue.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

BioTissue manufactures and sells cryopreserved human amniotic membrane and umbilical cord tissue allograft products processed using its proprietary CryoTek technology, primarily for the treatment of acute and chronic ocular surface conditions. The ocular portfolio includes the Prokera family of FDA-cleared therapeutic devices, CAM360 AmnioGraft, AmnioGraft, and AmnioGuard, sold to ophthalmologists, optometrists, hospitals, and ambulatory surgery centers. Following the January 2026 divestiture of its surgical and wound care business to BioStem Technologies, BioTissue also generates contract manufacturing revenue by producing Neox and Clarix product lines for BioStem.

Product overview

BioTissue offers a portfolio of cryopreserved human birth tissue products for regenerative healing, with a primary focus on acute and chronic ocular surface conditions. The ocular portfolio centers on Prokera (the only FDA-cleared cryopreserved amniotic membrane therapeutic device, available in Classic, Slim, Plus, and Clear variants), alongside amniotic membrane allografts including CAM360 AmnioGraft, AmnioGraft, and AmnioGuard. All products are processed using the proprietary CryoTek cryopreservation technology, which preserves the tissue's structural and biological integrity including the HC-HA/PTX3 complex that orchestrates regenerative healing. In January 2026, BioTissue divested its Surgical and Wound Care business (Neox and Clarix product lines) to concentrate exclusively on ocular innovation.

Differentiator

Problem solved

Functional benefit

Brands

• Sharing Miracles: Birth tissue donation program facilitating voluntary donations from mothers within the United States
• CryoTek
• SteriTek

Products and services

• Prokera Prokera is a cryopreserved amniotic membrane therapeutic device that is FDA-cleared for anti-inflammation, anti-scarring, and promoting healing of damaged eye surfaces. It contains the only FDA-cleared cryopreserved amniotic membrane supporting the corneal-healing process. Available in Classic, Slim, Plus, and Clear variants to suit different clinical needs, Prokera is used by ophthalmologists and optometrists to treat ocular surface inflammation, scarring, and non-healing corneal defects.
• CAM360 AmnioGraft CAM360 AmnioGraft is a cryopreserved human amniotic membrane allograft with anti-inflammatory and anti-scarring properties used to help restore eye health. Shown to reduce signs and symptoms associated with Dry Eye Disease and optimize comfort for patients with early-stage dry eye and reduced corneal sensitivity. Processed with proprietary CryoTek cryopreservation technology.
• AmnioGraft AmnioGraft is a cryopreserved amniotic membrane tissue recognized by the FDA for unique anti-inflammatory, anti-scarring, and anti-angiogenic properties. Used by eye surgeons worldwide to protect, repair, and promote regenerative healing of damaged eye surfaces. Known as the 'Gold Standard' for ocular surface reconstruction.
• AmnioGuard AmnioGuard is an ultra-thick cryopreserved amniotic membrane with anti-inflammatory, anti-scarring, and anti-angiogenic properties. Used by eye surgeons to cover glaucoma shunt tubes and to protect, repair, and promote regenerative healing of damaged eye surfaces.

Quantifiable outcome

• 87% of employees report BioTissue as a great place to work (compared to 57% at typical US-based company)
• +3 more outcomes

Named customers5 records

Segments2 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

Partnerships

Four partnerships are on record, tiered major and minor.

• BioStem TechnologiesmajorStrategic or Co-development Partner · 21 January 2026BioStem Technologies acquired BioTissue's non-ocular Surgical and Wound Care business in January 2026 for up to $40 million, including $15 million upfront cash payment. BioTissue will continue manufacturing Neox and Clarix products for BioStem, while BioStem acquires exclusive rights to these product lines and BioTissue's surgical sales team. This divestiture allows BioTissue to concentrate on ocular innovation while enabling BioStem to expand in surgical and wound care.
• VizientmajorChannel Partner/ Reseller/ Distributor · 1 August 2025Vizient is the nation's largest provider-driven healthcare performance improvement company working with more than 65% of hospitals across the US. BioTissue received its first-ever contract in the regenerative biologics category, providing Vizient hospital clients enhanced access to BioTissue's full portfolio including Clarix 1K.
• Donate Life AmericaminorStrategic or Co-development PartnerBioTissue is a Donate Life Partner, working to raise public awareness about the importance of tissue donation and increase tissue donor registration through joint initiatives including Donate Life National Blue and Green Day celebrations.
• Mount Sinai Medical CenterminorStrategic or Co-development PartnerBioTissue's Sharing Miracles program created a direct acquisition program with Mount Sinai Medical Center to expand birth tissue donation, enabling more patients to benefit from regenerative therapies.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• MiMedx Group: MiMedx is the leading publicly-traded competitor in amniotic membrane-based regenerative medicine, using dehydrated placental tissue (versus BioTissue's cryopreserved CryoTek process). Both companies sell similar allograft products to wound care, surgical, and ophthalmology markets, making MiMedx the most direct comparable peer.
• Organogenesis Holdings: Organogenesis is a regenerative medicine company offering bioengineered skin substitutes and wound care products that overlap with BioTissue's surgical and wound care applications prior to the BioStem divestiture. Both companies target similar hospital and surgical channels with biologic regenerative products.
• TissueTech: TissueTech is a privately-held competitor that markets dehydrated and cryopreserved amniotic membrane allograft products (e.g., AmnioFix) across ophthalmology, wound care, and musculoskeletal indications, directly competing with BioTissue's Neox, Clarix, and ocular product lines.

Emerging players

• BioStem Technologies: BioStem Technologies acquired BioTissue's non-ocular Surgical and Wound Care business (Neox and Clarix product lines) in January 2026 for up to $40M and now competes in adjacent wound care and surgical regenerative markets, with BioTissue continuing as a contract manufacturer.
• Corza Medical: Corza Medical is a surgical ophthalmology and specialty medical device company providing products for cataract, glaucoma, and vitreoretinal surgery. It is comparable to BioTissue through its ophthalmic surgical channel presence and overlapping customer base of ophthalmologists and ASCs.

Broad incumbents

• Integra LifeSciences: Integra LifeSciences is a diversified medical device company with a regenerative tissue technologies segment that includes dermal matrices, wound care, and surgical products. It competes broadly with BioTissue across hospital channels and shares Vizient/GPO contracting relationships.
• Smith+Nephew: Smith+Nephew is a large global medical device company with a substantial advanced wound management portfolio. While not specializing in amniotic membrane, it competes for hospital wound care budget and provides scale benchmarks for regenerative biologics distribution.
• MTF Biologics: MTF Biologics is one of the largest US tissue banks, providing a broad portfolio of allografts for sports medicine, wound care, and ophthalmology. It competes with BioTissue in sourcing donor tissue and serves overlapping surgical and ophthalmic customer segments through different processing approaches.
• AlloSource: AlloSource is a major nonprofit tissue bank producing allografts for orthopedic, spine, sports medicine, and wound care applications. As both a potential tissue supplier and competitor in regenerative biologics, AlloSource represents a comparable player in the donor tissue value chain.
• Bausch + Lomb: Bausch + Lomb is a major global ophthalmology company with a broad surgical, pharmaceutical, and consumer eye health portfolio. As a potential strategic acquirer and adjacent player serving the same ophthalmologist customer base, it represents the natural incumbent that could pursue BioTissue for inorganic growth in ocular surface biologics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/biotissueinc
• YouTubeyoutube.com/user/biotissueinc
• Facebooklinktr.ee/biotissueholdings
• LinkedInlinktr.ee/biotissueholdings
• Instagramlinktr.ee/biotissueholdings

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries2 records

Funding overview

Funding rounds5 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 BioTissue