BioPoly

What BioPoly does

BioPoly LLC is a Fort Wayne, Indiana-based orthopedic medical device company founded in 2004 by Dr. Herb Schwartz and Sheila Schwartz, operating as a spin-off from their parent company Schwartz Biomedical. The company develops, manufactures, and markets a portfolio of orthopedic implants fabricated from a proprietary microcomposite biomaterial that combines ultrahigh molecular weight polyethylene (UHMWPE) with hyaluronic acid (HA) — a synthetic cartilage engineered to be self-lubricating, hydrophilic, and capable of articulating against native cartilage without causing wear damage. The technology was licensed from Colorado State University research led by Professor Sue James and refined through proprietary manufacturing processes protected by more than two dozen patents and trade secrets; BioPoly has held ISO 13485 certification continuously since 2009 and manufactures from its Fort Wayne facility.

The commercial product portfolio comprises three FDA 510(k)-cleared implants: the Great Toe System (cleared 2021), the Lesser Toe System (cleared 2022), and the Radial Head System for the elbow (cleared 2024) — the latter being the only nickel-free radial head and the first synthetic cartilage radial head on the market. The Partial Resurfacing Knee System, BioPoly's largest market opportunity, received FDA Breakthrough Device Designation in 2023 and entered an FDA-approved randomized controlled IDE trial enrolling its first U.S. patient in September 2025. A pipeline of additional indications includes Hill-Sachs and Bankart lesion shoulder implants (U.S. patents granted in 2025). BioPoly monetizes through one-time hardware sales per surgical procedure, distributed in the United States via Synchrocare (national), Veteran's Health Medical Supply, and the Vizient GPO network, and in the United Kingdom through an exclusive Hospital Innovations agreement.

The company is privately held, controlled by its founder-owners, and has raised approximately $16M+ in cumulative capital across multiple SEC-exempt offerings, private equity placements, and Indiana 21st Century Fund grants. End customers are orthopedic surgeons and the hospital systems that purchase BioPoly implants; ultimate clinical users are patients with localized cartilage defects and early-stage arthritis seeking motion-preserving alternatives to fusion or total joint replacement. With 1-10 employees and more than 1,500 patients implanted globally over 15 years (including a 2012-vintage Knee recipient still pain-free), BioPoly operates as an early-commercial-stage, IP-driven, biomaterials-focused orthopedic franchise preparing for its next leg of U.S. commercial scaling.

Name

BioPoly

Legal name

BioPoly LLC

Website

https://biopolyortho.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

1–10 employees

Short description

BioPoly LLC is a Fort Wayne, Indiana orthopedic medical device company that develops, manufactures, and sells FDA-cleared implants made from a proprietary synthetic cartilage material combining UHMWPE and hyaluronic acid, targeting orthopedic surgeons and hospital systems treating patients with localized cartilage defects and early-stage arthritis.

Ownership category

akta.pro rank

Product category

Orthopedic Implants

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Orthopedic Joint Reconstruction Implants (Hip/Knee/Shoulder/Elbow/Ankle) (HLAHAEAA)

akta.pro secondary industry

Orthopedic Surgery (Operative Orthopedics) (HLAKALAC)

Keywords

• Orthopedic implants
• Cartilage repair
• Biomaterial manufacturing
• Medical device development
• Joint resurfacing systems

Headquarters

HQ city

Fort Wayne

HQ country

United States

HQ region

North America

Offices2 records

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. Orthopedic Implant Sales: BioPoly generates revenue through the sale of proprietary orthopedic implants including Great Toe, Lesser Toe, and Radial Head systems. Products are sold through distribution partners and directly to hospital systems. Revenue is one-time per procedure, with recurring revenue potential from follow-on procedures and geographic expansion as new products receive regulatory approval.
2. Knee Implant (Pending FDA Approval): The BioPoly Partial Resurfacing Knee Implant is currently in FDA-approved clinical trials and not yet commercially available in the U.S. Upon FDA approval, this product will represent a significant revenue opportunity in the larger knee implant market.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

BioPoly develops, manufactures, and markets FDA-cleared orthopedic resurfacing implants made from a proprietary microcomposite biomaterial combining ultrahigh molecular weight polyethylene (UHMWPE) with hyaluronic acid (HA). The commercial product portfolio includes the Great Toe System, Lesser Toe System, and Radial Head System, sold to hospital systems and orthopedic surgeons through distribution partners (Synchrocare, Veteran's Health Medical Supply, Hospital Innovations in the UK) and the Vizient GPO contract. A Partial Resurfacing Knee System is in an FDA-approved U.S. clinical trial.

Product overview

BioPoly develops and manufactures orthopedic implants made from a proprietary synthetic cartilage material combining hyaluronic acid (HA) and ultrahigh molecular weight polyethylene (UHMWPE). The product portfolio includes FDA-cleared commercial products: the Great Toe System, Lesser Toe System, and Radial Head System for elbow joint repair. The Partial Resurfacing Knee System is currently in FDA-approved clinical trials and is investigational. The company is expanding into shoulder implants (Bankart and Hill-Sachs designs) protected by newly granted patents. All BioPoly implants are designed to articulate with natural cartilage without causing damage, offering tissue-sparing, motion-preserving alternatives to full joint replacement or fusion procedures.

Differentiator

Problem solved

Functional benefit

Products and services

• BioPoly Great Toe System FDA-cleared orthopedic resurfacing implant designed to address pain and stiffness caused by cartilage damage or arthritis in the great toe joint. Available in sizes 14mm–22mm with a porous titanium stem for bone ingrowth, providing a motion-preserving alternative to fusion surgery for orthopedic surgeons and podiatric/foot and ankle specialists.
• BioPoly Lesser Toe System FDA-cleared orthopedic resurfacing implant specifically designed for cartilage damage or arthritis in smaller toe joints. Available in sizes 9mm–13mm, resurfacing affected joint surfaces while preserving surrounding bone structure and natural anatomy. Sold to orthopedic surgeons and foot and ankle specialists as an alternative to fusion.
• BioPoly Radial Head System FDA-cleared orthopedic implant for radial head fractures, arthritis, or joint degeneration in the elbow. Features a smooth titanium stem and proprietary BioPoly synthetic cartilage articulating surface, available in 20mm, 23mm, and 26mm sizes. The only nickel-free radial head implant on the market, sold to orthopedic surgeons and shoulder/elbow specialists.

Quantifiable outcome

• Significant reduction in pain and improved quality of life maintained out to 5 years in European clinical study
• +5 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered core and minor.

• SynchrocarecoreChannel Partner/ Reseller/ Distributor · 5 March 2026Strategic distribution partnership to expand access to BioPoly polymer implant technology across the United States. Synchrocare serves as national distributor providing sales, service, and clinical support for BioPoly's products including Great Toe, Lesser Toe, Radial Head, and pending Knee implants.
• VizientcoreChannel Partner/ Reseller/ Distributor · 18 July 2025Innovative Technology contract awarded to BioPoly for its FDA-cleared implant systems. Vizient is the nation's largest provider-driven healthcare performance improvement company representing more than $140 billion in annual purchasing volume. Contract enables Vizient member hospitals to access BioPoly implants outside competitive bid cycle.
• Veteran's Health Medical SupplycoreChannel Partner/ Reseller/ Distributor · 20 April 2023Distribution agreement announced April 2023 for BioPoly products, expanding domestic distribution network alongside other distribution partners.
• Hospital Innovations (UK)minorChannel Partner/ Reseller/ Distributor · 24 July 2019Exclusive distribution agreement for United Kingdom market, supporting BioPoly's European market presence established with CE Mark certification in 2011.
• Schwartz Biomedical (Parent Company)coreStrategic or Co-development PartnerBioPoly's parent company founded by Herb and Sheila Schwartz in 2004. Schwartz Biomedical operates as an orthopedic incubator developing novel technologies and transitioning them into standalone companies. First spin-off BioDuct (meniscal repair) was sold to a major orthopedic company within three years.

Scale indicators7 records

Recent moves10 records

Expansion highlights6 records

Broad incumbents

• Stryker: Stryker is one of the largest orthopedic medical device companies globally with a broad joint reconstruction portfolio including knees, shoulders, and extremities. It competes with BioPoly in cartilage and joint preservation but addresses these as part of a much larger product portfolio.
• Zimmer Biomet: Zimmer Biomet is a leading global orthopedic device manufacturer with established knee, shoulder, and extremities franchises. It overlaps with BioPoly in joint reconstruction and cartilage restoration but competes with comprehensive solutions and far larger commercial reach.
• Smith+Nephew: Smith+Nephew operates a major orthopedics and sports medicine business and acquired CartiHeal (Agili-C) to enter the cartilage repair market. It is a relevant comparable for BioPoly because it competes in joint preservation and has the channel to scale cartilage-focused implants.
• Arthrex: Arthrex is a privately held leader in sports medicine and orthopedic soft tissue repair with a large surgeon-focused sales force. It competes with BioPoly in the sports medicine and cartilage restoration segments and has the surgeon relationships and capital to push into joint-preservation implants.
• DePuy Synthes (Johnson & Johnson MedTech): DePuy Synthes, J&J's orthopedic arm, offers a full range of joint reconstruction and extremities products, including cartilage repair solutions, and employs Herb Schwartz's former research background in orthobiologics. It competes broadly with BioPoly across multiple joint indications.

Direct peers

• Vericel: Vericel markets MACI, an autologous cultured chondrocyte implant for cartilage repair of the knee, and is the most direct U.S. cartilage repair peer to BioPoly. Both companies target the same early-stage arthritis and cartilage defect patient population seeking to delay total joint replacement.
• ConforMIS: ConforMIS develops patient-specific knee replacement implants, directly competing in the knee joint preservation and replacement space. It is a strong peer for BioPoly because both focus on minimally invasive, anatomy-preserving knee solutions for early-stage arthritis.

Emerging players

• Moximed: Moximed develops the MISHA knee system, an implantable shock absorber for medial compartment knee osteoarthritis, targeting the same joint-preservation patient population as BioPoly's knee implant. Both are emerging players in the joint-preservation segment between conservative care and total knee replacement.
• Active Implants: Active Implants developed the NUsurface meniscus implant, a polymer-based joint-preservation device. It is comparable to BioPoly as a smaller, emerging company using advanced polymer materials to preserve joint function in the knee.
• Anika Therapeutics: Anika Therapeutics specializes in hyaluronic acid-based orthobiologics and joint preservation therapies, including viscosupplementation. It is relevant because it operates in the same cartilage health and joint preservation therapeutic area, although its primary modality is injectable rather than implantable.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/biopolyortho
• Facebookfacebook.com/biopoly-llc-938327452887535
• LinkedInlinkedin.com/company/biopoly-llc
• Instagraminstagram.com/biopolyortho

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds7 records

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 BioPoly