Tissue Regeneration Systems

What Tissue Regeneration Systems does

Tissue Regeneration Systems (TRS) is a private medical device company founded in 2008 as a University of Michigan spinoff, commercializing a skeletal reconstruction and bone regeneration technology platform developed at the Universities of Michigan and Wisconsin. The platform centers on two core technologies: 3D-printed bioresorbable PCL scaffolds engineered with a porous micro-architecture that bear significant load while degrading and fully replacing themselves with natural bone over 2-3 years, and the proprietary Affinity™ osteoconductive mineral coating featuring a plate-like nanostructure that promotes cell adhesion and enables controlled growth factor (e.g., BMP) release. TRS holds the first FDA 510(k) clearance (August 2013) for a coated bioresorbable skeletal reconstruction implant fabricated by 3D printing, covering its Cranial Bone Void Filler for neurosurgical burr hole repair.

The company addresses five surgical segments — craniomaxillofacial (primary), orthopedic, spine fusion, dental implant, and bone growth factor delivery — through patient-specific implants designed from CT scans. TRS operates a partnership-driven B2B/OEM business model in which the company develops and manufactures products while established medical, dental, and 3D-printing partners commercialize FDA-cleared offerings, generating revenue through manufacturing contracts and licensing/royalty arrangements rather than direct sales. The company has secured strategic alliances with Johnson & Johnson Innovation (January 2014) and Materialise (December 2015), and has raised approximately $18.3 million across multiple venture rounds from 2008 through 2015, with investors including Clarevia Ventures, Venture Investors LLC, the University of Michigan (via MINTS), the Wisconsin Alumni Research Foundation, the Michigan Economic Development Corporation, and Michigan Accelerator Fund I, plus $1.05M in NIH grants.

Name

Tissue Regeneration Systems

Legal name

Tissue Regeneration Systems Inc.

Website

https://tissuesys.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Tissue Regeneration Systems is a private medical device company developing 3D-printed bioresorbable bone regeneration implants and proprietary osteoconductive coatings for craniomaxillofacial, orthopedic, spine, and dental surgical applications, operating through a B2B partnership manufacturing and licensing model.

Ownership category

akta.pro rank

Product category

Orthopedic & Craniomaxillofacial Medical Implants

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industries

Cartilage, Bone & Musculoskeletal Regeneration (HLAAAGAH), Periodontal Regeneration (GTR/EMD/Biologics) (HLABACAI)

Keywords

• Bioresorbable implants
• Skeletal reconstruction
• Bone regeneration
• 3D-printed scaffolds
• Craniomaxillofacial devices

Headquarters

HQ city

Kirkland

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Manufacturing and Licensing: TRS manufactures products using its technology platform while partners commercialize cleared products. TRS acts as manufacturer for partner companies that commercialize the technology.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Tissue Regeneration Systems (TRS) is a medical device company that develops and manufactures a skeletal reconstruction and bone regeneration technology platform consisting of 3D-printed bioresorbable PCL scaffolds combined with its proprietary Affinity™ osteoconductive mineral coating. TRS serves as manufacturer for partner companies that commercialize FDA-cleared products addressing craniomaxillofacial, orthopedic, spine fusion, dental, and bone growth factor delivery applications.

Product overview

Tissue Regeneration Systems (TRS) offers a technology platform comprising two core products: the TRS Scaffold Technology (3D-printed bioresorbable skeletal reconstruction implants) and the Affinity™ Coating Technology (osteoconductive mineral coating for enhanced bone regeneration). The platform supports multiple product lines addressing five distinct market segments: craniomaxillofacial (CMF) surgery, orthopedic surgery, spine fusion surgery, dental implant surgery, and bone growth factor delivery. The company's first FDA-cleared product is the Cranial Bone Void Filler for neurosurgical burr hole repair. TRS operates through a partnership business model where partners commercialize FDA-cleared products while TRS serves as manufacturer.

Differentiator

Problem solved

Functional benefit

Products and services

• Cranial Bone Void Filler FDA 510(k)-cleared cranial bone void filler made from 3D-printed bioresorbable PCL polymer with Affinity™ coating, indicated for the repair of neurosurgical burr holes. Fully bioresorbable within two to three years, replacing itself with natural bone.
• CMF Surgery Implants Custom-designed patient-specific craniomaxillofacial reconstruction implants for complex CMF cases including cranial bone trauma repair, cranioplasty, and excised mandible tumor reconstruction, eliminating the need for autologous bone graft harvest from the hip, fibula, or scapula.
• Orthopedic Surgery Implants Patient-specific bioresorbable implants for complex orthopedic skeletal defects from trauma or tumor removal, including applications for soft tissue injury repair, rotator cuff surgery, knee ligament repair, and hip and knee replacement implant enhancement.
• Cervical Interbody Fusion Cage Bioresorbable interbody fusion cages and lateral gutter implants for cervical and degenerative spine fusion procedures, with Affinity™ coating for controlled bone growth factor delivery; designed to fully bioresorb after fusion, leaving no permanent foreign material.
• Dental Bone Restoration Implant Custom-designed patient-specific implants for two-stage dental implant surgery where the first stage restores proper bone volume and geometry, eliminating autologous bone block harvest and providing bioresorbable fixation posts that do not require removal like metal mesh.
• Bone Growth Factor Delivery Technology Structural carriers and microsphere technology for controlled delivery of bone growth factors (e.g., BMP), addressing bolus-release side effects, lowering dosage requirements, containing delivery to the target area, and preventing systemic dissipation.

Quantifiable outcome

• Fully bioresorbable within 2-3 years, replaced by natural bone
• +2 more outcomes

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core and flagship.

• MaterialisecoreStrategic or Co-development Partner · 7 December 2015Partnership to manufacture life-saving 3D-Printed tracheal splints for use in clinical trials. Materialise, a leader in 3D printing technology, collaborates with TRS to produce patient-specific medical devices.
• Johnson & Johnson InnovationflagshipStrategic or Co-development Partner · 19 June 2014Johnson & Johnson Innovation alliance focused on early-stage innovation across pharmaceuticals, medical device, diagnostics, and consumer healthcare. The partnership explores technologies including 3-D printing for trauma use. TRS technology represents a new paradigm in personalized implants.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Integra LifeSciences: Public medical device company with a meaningful regenerative technology and orthopedic/neuro/CMF portfolio, including collagen-based and synthetic bone graft substitutes. Integra competes directly with TRS in CMF reconstruction and dural repair, and provides a directly comparable commercial-stage benchmark for a regenerative implant-focused company.
• NuVasive: Spine-focused medical device company with a portfolio including bioresorbable and 3D-printed interbody fusion cages and biologics (Osteocel, AttraX). NuVasive is one of the most directly comparable spine implant and orthobiologics peers for TRS's spine fusion product line.
• Globus Medical: Spine and orthopedic medical device company with a strong 3D-printed titanium implant portfolio (ExcelsiusGPS, Creo) and orthobiologics offerings. Globus competes directly with TRS in spine fusion and complex spine reconstruction and represents a comparable mid-to-large commercial-stage implant technology peer.
• CONMED: Mid-cap medical device company with orthopedic, sports medicine, and CMF product lines, including bone graft substitutes and bioresorbable implants. CONMED is comparable to TRS in targeting multiple orthopedic and CMF surgical segments with regenerative implant solutions.

Broad incumbents

• Stryker: One of the world's largest orthopedic and spine medical device companies with extensive bioresorbable implant, bone graft substitute (Vitoss, OP-1), and 3D-printed titanium (Tritanium) offerings. Stryker is a primary competitor across TRS's targeted orthopedic and spine fusion end markets, with vastly superior commercial scale and R&D resources.
• DePuy Synthes (Johnson & Johnson): J&J's orthopedic and neurosurgery division covering CMF, spine, trauma, and biologics. DePuy Synthes is the incumbent TRS most directly competes against and is also the parent of TRS's senior BD hire's prior employer and a strategic partner via J&J Innovation.
• Medtronic: Global medical device leader with a large spine, biologics, and neurosurgery portfolio including INFUSE bone graft and 3D-printed titanium spinal implants (TiONIC). Medtronic is a primary competitor in TRS's spine fusion and CMF target markets and sets the bar for commercial scale and surgeon relationships.
• Baxter International: Global medical products company with a substantial surgical solutions and regenerative medicine portfolio (Tisseel, Floseal, Coseal surgical sealants and hemostats). Baxter competes with TRS in growth factor delivery and surgical regeneration applications and provides a relevant incumbent reference point.

Emerging players

• Xtant Medical: Smaller orthobiologics and spine medical device company focused on bone graft substitutes and spinal fixation. Xtant is a comparable emerging player in bone graft substitutes with a similar size profile and product focus, serving as a benchmark for commercial-stage orthobiologics competitors.

Others

• Materialise: Global leader in 3D printing for medical applications and an existing TRS strategic partner for tracheal splints. Materialise is a direct technology and channel collaborator for TRS's 3D-printed scaffold manufacturing and a relevant peer in patient-specific 3D-printed medical devices.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/tissue-regeneration-systems-inc-

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds5 records

Investors1 record

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 Tissue Regeneration Systems