Samaritan Biologics

What Samaritan Biologics does

Samaritan Biologics is a privately held developer, processor, and distributor of human allograft products founded in 2019 and headquartered in Cordova, Tennessee. The company supplies a broad catalog spanning perinatal tissue allografts (sourced from scheduled C-section births) and cadaveric allografts (sourced from AATB-accredited tissue bank partners), serving surgeons, hospitals, ambulatory surgery centers, and independent distributors across wound care, orthopedic, sports medicine, ocular, and surgical applications. Its product portfolio includes multi-layer wound care grafts (MLG-COMPLETE, COMPLETE-AA, COMPLETE-SL, MOST Perforated), ocular grafts (EyeGen Amniotic Membrane), full-thickness grafts (AmnioStratis-FT), collagen and biopolymer matrices (BioconneKt, Foundation DRS), and a comprehensive cadaveric line covering DBM putties and fibers, structural grafts, and soft tissue/sports tendons.

The company's technology foundation rests on its proprietary RETAIN processing technique, developed at the Clemson University Biomedical Engineering Innovation Campus (CUBEInC), which is engineered to preserve naturally occurring components of birth tissue throughout processing. Six CMS-assigned HCPCS codes (Q4256, Q4303, Q4270, Q4328, Q4161, A2034) underpin Medicare reimbursement for its wound care portfolio, and two products (BioconneKt, Foundation DRS) hold FDA 510(k) clearances. Manufacturing is anchored by a new 11,000-square-foot, five-clean-room facility on Clemson's CU-ICAR campus opened in November 2024 with a $5 million investment and a planned 85 new jobs; R&D is co-located at CUBEInC in Greenville, SC. A 170-patient randomized controlled trial for non-healing diabetic foot ulcers is underway with SerenaGroup at 15+ US sites (first patients enrolled June 2025).

Samaritan operates a B2B medical device go-to-market that combines a national direct field sales force (led by a President of Sales, Wound Care) with a network of independent distributors and direct hospital/ASC relationships across at least seven US states. Revenue is generated primarily through unit pricing of allograft products reimbursed under Medicare HCPCS codes, with WAC pricing established via Redbook. The company is woman and minority-owned and commits at least 10% of after-tax profits to charity, principally Breakthrough T1D (formerly JDRF).

Name

Samaritan Biologics

Legal name

Samaritan Biologics, LLC

Website

https://samaritanbiologics.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

Samaritan Biologics is a privately held Tennessee-based processor and distributor of human allograft products, including perinatal and cadaveric tissue grafts, serving surgeons, hospitals, and ASCs across wound care, orthopedic, ocular, and surgical applications in the United States.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Tissue Products

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers (42345)

SIC

Biological Products, (No Disgnostic Substances) (2836), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

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

akta.pro secondary industry

Bone Graft Substitutes & Orthobiologics (Synthetic/Allograft/DBM) (HLAHAEAG)

Keywords

• Human allograft products
• Wound care grafts
• Perinatal tissue allografts
• Cadaveric bone allografts
• Regenerative medicine devices

Headquarters

HQ city

Cordova

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Human Allograft Product Sales: Samaritan Biologics generates revenue primarily through the sale of human allograft products including perinatal tissue allografts (wound care grafts, ocular grafts) and cadaveric allografts (bone void fillers, DBM, tendons, fascia) to surgeons, hospitals, and ASC facilities via independent distributors.
2. Distributor Channel Revenue: Revenue flows through independent distributors who resell Samaritan grafts to end customers. The company maintains transparent financial relationships with distributors for compensation clarity.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

Samaritan Biologics develops, processes, and distributes human allograft products sourced from AATB-accredited tissue banks, specializing in perinatal tissue grafts (amnion and chorion from scheduled C-section births) and cadaveric allografts (bone, tendons, fascia, soft tissue). The portfolio is organized into three categories: Wound Care Grafts (MLG-COMPLETE, COMPLETE-AA, COMPLETE-SL, MOST, BioconneKt, Foundation DRS), Perinatal Allografts (EyeGen for ocular use, AmnioStratis-FT), and Cadaveric Allografts (DBM products, structural grafts, soft tissue grafts), each processed with the proprietary RETAIN technique to preserve native tissue components and sold to surgeons, hospitals, ASCs, and independent distributors.

Product overview

Samaritan Biologics is a comprehensive supplier of 361 HCT/P human allografts, offering three main product categories: Perinatal Allografts (sourced from scheduled c-section births), Cadaveric Allografts (processed bone and soft tissue), and Wound Care Grafts. The perinatal portfolio includes EyeGen Amniotic Membrane Allograft for ocular use, MLG-COMPLETE™ multi-layer grafts, COMPLETE-AA dual-layer grafts, COMPLETE-SL single-layer grafts, AmnioStratis-FT full-thickness grafts, and MOST Perforated Multi-Layered grafts—all processed with the proprietary RETAIN™ technology. The wound care portfolio also includes BioconneKt™ Wound Matrix (equine collagen-based, FDA 510(k) cleared) and Foundation DRS Dermal Regeneration Scaffold (chitosan-chondroitin sulfate complex). Cadaveric products include DBM fillers and forms (putties, cubes, strips, fibers), structural allografts (reconstructive grafts, femoral grafts, shafts, machined specialty grafts, long bones), and soft tissue allografts (sports tendons, bone block/non-bone block tendons, patient matched meniscus, fascia, pericardium, cartilage). All grafts are processed in partnership with AATB-accredited tissue banks. The company also offers an electronic graft registration portal for product tracking.

Differentiator

Problem solved

Functional benefit

Brands

• EyeGenMD: EyeGen Amniotic Membrane Allograft product for ocular use, launched via EyeGenMD.com website. Available in 8mm, 12mm, and 15mm discs for treatment of various ocular conditions.

Products and services

• EyeGen Amniotic Membrane Allograft Single-layer perinatal tissue disc graft for ocular use (8mm, 12mm, 15mm sizes), processed with proprietary technique to optimize handling and accurate single-layer placement, for surgeons treating ocular surface conditions.
• MLG-COMPLETE Multi-Layer Graft Full-thickness multi-layer perinatal tissue membrane allograft processed with RETAIN technology for use as barrier and protective coverage of acute and chronic wounds. CMS HCPCS Code Q4256; available in sizes from 15mm disc to 15x20cm.
• COMPLETE-AA Wound Care Grafts Dual-layer amnion perinatal tissue allograft processed with RETAIN technique for wound care applications; CMS HCPCS Code Q4303, reimbursable by Medicare per unit, available in sizes 2x2cm to 15x20cm.
• COMPLETE-SL Wound Care Grafts Single-layer amnion perinatal tissue allograft processed with RETAIN technique for wound care applications; CMS HCPCS Code Q4270, reimbursable by Medicare per unit, available in sizes 2x2cm to 15x20cm.
• MOST Perforated Multi-Layered Perinatal Tissue Allografts Perforated four-layer wound care graft (amnion, intermediate layer, chorion, amnion) processed with RETAIN technique for wound care; CMS HCPCS Code Q4328, reimbursable by Medicare per unit.
• BioconneKt Wound Matrix FDA 510(k)-cleared suturable wound dressing made of reconstituted equine type I collagen, sterilized to SAL 10-6 and stored at room temperature; CMS HCPCS Code Q-4161; for full/partial thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, and surgical wounds.
• Foundation DRS Dermal Regeneration Scaffold FDA 510(k)-cleared biodegradable, suturable biopolymer scaffold made from Chitosan-Chondroitin Sulfate complex, indicated for full/partial thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, burns, and surgical wounds; CMS HCPCS Code A2034.
• AmnioStratis-FT Full-thickness perinatal tissue graft that is approximately 4x thicker than single-layer amnion, easily repositions after hydration and naturally holds position in wounds, for surgeons needing thick structural graft material.
• DBM Products (Demineralized Bone Matrix) Comprehensive line of cadaveric bone allografts including Crushed Cancellous Chips (CCC), DBM Putty Products (Standard, Crush/Crunch, Premium Enhanced), Cancellous Cubes (8-14mm), Cancellous Strips, and DBM Cortical Fibers (Fusion Fibers) in multiple volumes, for orthopedic and spine surgeons.
• Structural Allografts Reconstructive cadaveric structural grafts including Cotton-Evans Wedges, Calcaneous, Patella, Tri-Cortical and Bi-Cortical grafts; Femoral Grafts (femoral heads, hemi-condyles); Shafts (Femoral, Tibial, Ulnar, Radial, Humeral); Machined Specialty Allografts; and Long Bones for challenging reconstructive procedures.
• Soft Tissue Allografts Sports tendons including MOST Sports Tendons; PASCO2 processed tendons; Bone Block Tendons (Achilles, Hemi & Whole Patellar); Non-Bone Block Tendons (Post & Anterior Tibialis, Semi-T, Gracilis, Peroneus Longus); Patient Matched Meniscus; and other soft tissues including Fascia, Pericardium, and Cartilage, for orthopedic and sports medicine surgeons.

Quantifiable outcome

• 170 patients enrolled in clinical trial for diabetic foot ulcer treatment
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

13 partnerships are on record, tiered core, support and minor.

• MLM BiologicscoreTechnology or IntegrationAATB accredited tissue bank partner providing human allograft products to Samaritan's portfolio. Selected based on corporate experience with management team and products.
• LifeLink Tissue BankcoreTechnology or IntegrationAATB accredited tissue bank partner providing human tissue allografts. One of several established tissue banks in Samaritan's supplier network.
• AllosourcecoreTechnology or IntegrationAATB accredited tissue bank partner. Allosource is a major tissue bank providing structural and non-structural allografts to Samaritan's product portfolio.
• Alamo Tissue BankcoreTechnology or IntegrationAATB accredited tissue bank partner supplying human allografts to Samaritan's comprehensive product offering.
• CellRight TechnologiessupportTechnology or IntegrationMedical device company partner providing products that complement Samaritan's allograft offerings.
• Clemson University (CUBEInC)coreStrategic or Co-development PartnerR&D partnership at Clemson University Biomedical Engineering Innovation Campus. Samaritan secured wet lab space for developing and evaluating next generation allograft and biomaterials products with world-class clinicians and scientists. Dr. Mercuri is Professor of Practice in Clemson Bioengineering Department.
• Prisma Health UpstatecoreStrategic or Co-development PartnerMedical campus partner hosting CUBEInC facility. Samaritan's lab is located on Patewood Memorial medical campus directly above Steadman Hawkins Clinic and Vascular Health Alliance. Received $1.5M donation for maternal-child health endowment.
• SerenaGroupcoreStrategic or Co-development PartnerGlobal wound care clinical trials leader conducting randomized controlled trial for Samaritan's perinatal tissue allografts (Complete AA and MOST) to treat non-healing diabetic foot ulcers. Trial enrolling 170 patients at 15+ research sites nationwide.
• Breakthrough T1D (formerly JDRF)coreOthersGlobal Type 1 diabetes research nonprofit. Samaritan committed $1 million multi-year gift to support T1D research. Personal connection through CEO David Szalay and CFO Ginny Szalay whose daughter was diagnosed with T1D at age 5. Company donates 10%+ of after-tax profits to Breakthrough T1D since founding in 2019.
• Paper Cutters, Inc.minorStrategic or Co-development PartnerBusiness development partner for COVID-19 mask production. Partnered with Samaritan and Indiana University to develop origami masks made from poly-coated chipboard that were distributed to 30,000 South Carolina residents.
• Buffalo Trace DistilleryminorGTM or Marketing PartnerFrankfort, Kentucky distillery partner for JDRF fundraising. Helped secure collectible rare bottle from sixth millionth barrel to raise over $6,000 for Western Carolina Chapter of JDRF.
• Hogan LovellssupportImplementation/ SI/ Consulting PartnerWashington DC based legal firm engaged for regulatory and compliance guidance. Most respected regulatory and compliance firm in life sciences field. Developed compliant contracts for practices and independent distributors, reviewed business for PHI compliance.
• Diaxamed, Zylo Therapeutics, TGenTech, Precision GeneticsminorOthersOther biotechnology and medical device companies co-located at CUBEInC facility, enabling potential future collaboration and knowledge sharing in the life sciences ecosystem.

Scale indicators11 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• AlloSource: AlloSource is an AATB-accredited tissue bank that is both an explicit Samaritan supply partner and a direct seller of allografts in wound care, sports medicine, and orthopedics — making it simultaneously a peer and a competitor for downstream hospital contracts.
• Organogenesis: Organogenesis is a major wound care biologic company (Apligraf, Dermagraft, Affinity, PuraPly) with established Medicare reimbursement and a national sales infrastructure. It competes head-to-head with Samaritan's perinatal allografts in diabetic foot ulcer and chronic wound accounts.
• MiMedx Group: MiMedx is the largest U.S. provider of amniotic membrane allografts (EpiFix, AmnioFix) for wound care, surgical, and ocular use — the same core categories Samaritan targets. Jeff Schultz's prior tenure at MiMedx and the overlapping product positioning make it the closest direct competitor.
• MTF Biologics: MTF Biologics is one of the largest U.S. tissue banks and a direct competitor in perinatal, dental, sports medicine, and wound care allografts. It also functions as a supplier to distributors serving the same hospital accounts Samaritan targets.

Emerging players

• AxoGen: AxoGen (COO Jerry Chang held early operational roles there) is a peripheral nerve repair company built around processed human allograft technology. It represents a comparable small-mid cap specialty allograft model with similar go-to-market dynamics.
• Tides Medical: Tides Medical is a smaller amniotic membrane allograft manufacturer focused on wound and surgical applications, competing for the same community office and ASC accounts where Samaritan is building its perinatal allograft business.

Broad incumbents

• Smith & Nephew: Smith & Nephew is a global medical device incumbent with a sizable Advanced Wound Management business (PICO, ALLEVYN, collagen products). It competes indirectly with Samaritan via hospital and ASC formularies across chronic wound and surgical applications.
• ConvaTec: ConvaTec operates one of the largest advanced wound care portfolios globally (AQUACEL, Foam dressings) and is increasingly active in skin substitutes. Its hospital and homecare distribution footprint overlaps directly with Samaritan's target call points.
• Coloplast: Coloplast is a global player in wound and skin care, including foam, hydrocolloid, and collagen-based products. It competes for hospital formulary and home-health spend in the same chronic wound segments where Samaritan sells its perinatal allografts.
• Integra LifeSciences: Integra acquired BioD LLC (former employer of CEO David Szalay) and operates a broad orthobiologics, dural repair, and wound care portfolio including competing amnion grafts. It competes in the same hospital and ASC channels while serving many adjacent surgical specialties.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

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Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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 Samaritan Biologics