What Kelyniam Global does

Kelyniam Global Inc. is a U.S. medical device company that designs and manufactures patient-specific custom cranial and craniofacial implants from its single facility in Canton, Connecticut, where it has operated since 2011. The company's product portfolio spans four material families: custom-machined PEEK implants, Fusion BCP-PEEK (PEEK infused with biphasic calcium phosphate, FDA-cleared in November 2025 and the first new cranial implant material approved in the U.S. in eight years), CustomizedBone hydroxyapatite implants (licensed from Finceramica Faenza), and Osteopore bioresorbable polycaprolactone implants. Its proprietary patented Integrated Fixation System (IFS) tabs, granted in 2019, are designed to reduce or eliminate the need for separate cranial plating hardware. Manufacturing combines CNC machining of final implants with 3D-printed defect models derived from CT scan DICOM imaging, and the company integrates with Nuance PowerShare for electronic image transfer.

The company's go-to-market is enterprise field sales targeting neurosurgeons, craniofacial surgeons, and hospital value analysis committees at acute care hospitals and academic medical centers, supplemented by an authorized distributor network. Pricing is quote-based, driven by implant size, complexity, materials, and rush/expedited turnaround requirements (the company advertises a 24-48 hour rush turnaround). Revenue mix includes direct implant hardware sales, licensing royalties from the Finceramica and Evonik VESTAKEEP Fusion agreements, distribution revenue from the Osteopore partnership, and occasional non-recurring consulting services revenue.

Kelyniam Global is publicly traded on OTC markets under ticker KLYG (uplisted to OTCQB in November 2025) and has a headcount of 11-50 employees. The company has completed one PIPE financing (December 2024) and reported FY2025 revenue of approximately $3.05 million, which was down 8% year-over-year but with a stated second-half recovery, followed by Q1 2026 revenue of $1,150,130 representing 84% year-over-year growth. Leadership comprises CEO Ross Bjella (also CEO of Alithias and former CEO of DDN), CFO Terrance Kurtenbach (formerly Deloitte US Global Managing Partner, Life Sciences and Healthcare Tax), and CRO/VP of Operations Kris Renton, appointed in 2026 to scale commercial operations. In 2025, the company considered and rejected an unsolicited third-party acquisition offer.

Name

Kelyniam Global

Legal name

Kelyniam Global Inc.

Website

https://kelyniam.com

Company type

Public

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Kelyniam Global is a U.S. medical device company that designs and manufactures patient-specific custom cranial and craniofacial implants, selling PEEK, BCP-PEEK, hydroxyapatite, and bioresorbable PCL products directly to hospitals and through authorized distributors.

Ownership category

akta.pro rank

Product category

Cranial Implants

NAICS

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

SIC

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

akta.pro primary industry

Neurosurgical Implants & Cranial/CMF (Cranial Plates, Dural Repair, Shunts) (HLAHAEAD)

akta.pro secondary industries

3D-Printed & Patient-Specific Implants (Custom Ortho/Spine/Cranial) (HLAHAEAJ), Medical & Dental 3D Printing Services (patient-specific devices, dental labs) (IMAAADAG), Medical & Dental Prototyping (Models, Guides, Pre-Op Planning) (IMAAAFAI)

Keywords

• Custom cranial implants
• Patient-specific cranioplasty
• PEEK medical devices
• Neurosurgical biomaterials
• Cranial reconstruction

Headquarters

HQ city

Canton Center

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Custom Cranial Implant Sales: Sale of patient-specific custom PEEK cranial and craniofacial implants to hospitals and surgical centers. Revenue from direct product sales for surgical procedures, including standard PEEK implants, Fusion BCP-PEEK implants, and associated fixation systems.
2. Licensing Royalties - Finceramica Products: Distribution and licensing revenue from CustomizedBone hydroxyapatite cranial implants licensed from Finceramica. The company serves as US distributor and commercial partner, generating recurring revenue through product sales of licensed biomaterials.
3. Licensing Royalties - Evonik VESTAKEEP Fusion: Exclusive U.S. license to market VESTAKEEP Fusion biomaterial for cranial and craniofacial implants, providing differentiation and market exclusivity for the Fusion BCP-PEEK product line.
4. Distribution Revenue - Osteopore Products: Distribution revenue from Osteopore polycaprolactone bioresorbable implants including Osteoplug, Osteoplug-C, Osteostrip, and Osteomesh products for burr hole and craniotomy repair.
5. Consulting Services: One-time consulting agreement revenue from arrangements with other medical device companies, generating significant non-recurring revenue in certain periods.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

Kelyniam Global designs and manufactures patient-specific custom cranial and craniofacial implants primarily from PEEK and advanced biomaterials (BCP-PEEK, hydroxyapatite, bioresorbable PCL). The company runs a surgeon-driven workflow from CT scan DICOM imaging through implant design, CNC machining, and 3D-printed model creation, supporting neurosurgical reconstruction procedures. All operations including design and manufacturing are based in Canton, Connecticut, with an industry-leading 24-48 hour rush turnaround for expedited cases.

Product overview

Kelyniam Global is a medical device company specializing in patient-specific cranial and craniofacial implants. The product portfolio includes three core implant lines: (1) Custom PEEK Implants—patient-specific polyetheretherketone implants manufactured via CNC machining with patented IFS tabs for fixation; (2) Fusion™ BCP PEEK Implants—next-generation PEEK implants infused with biphasic calcium phosphate for enhanced bone integration, representing the first new cranial implant material approved in the U.S. in eight years; and (3) CustomizedBone™ Hydroxyapatite Implants—distributed hydroxyapatite cranial implants from Finceramica featuring biomimetic porous structure. Additional offerings include Osteopore® bioresorbable PCL implants for burr hole and craniotomy repair (distributed from Osteopore Limited), NEOS Cranial LOOP™ fixation devices, and supporting hospital resources including VAC packs, CT scan protocols, and clinical data packages. The company also offers 3D-printed medical models for surgical planning. All implants are designed and manufactured at the company's Canton, Connecticut facility with a 24–48 hour turnaround capability for rush cases.

Differentiator

Problem solved

Functional benefit

Brands

• CustomizedBone: Hydroxyapatite (HA) ceramic cranial implants distributed from Finceramica, featuring CustomBone Service for patient-specific cranioplasty with chemico-physical features resembling natural bone structure.
• Osteopore
• Fusion BCP-PEEK
• NEOS Cranial LOOP
• Integrated Fixation System (IFS)

Products and services

• Custom PEEK Implants Patient-specific custom cranial and craniofacial PEEK (polyetheretherketone) implants manufactured via CNC machining with 3D-printed defect models for precise anatomical fit. Designed for neurosurgeons and hospitals performing cranioplasty procedures following trauma, tumor resection, stroke, or decompressive craniectomy.
• Fusion BCP-PEEK Implants Custom cranial and craniofacial implants made from PEEK infused with biphasic calcium phosphate (BCP) to promote bone in-growth and enhanced osseointegration. First new cranial implant material approved in the U.S. in eight years, sold to hospitals and neurosurgical centers for regenerative cranioplasty.
• CustomizedBone Hydroxyapatite (HA) Implant Custom-made cranial implants made of hydroxyapatite (HA) with 3D porous structure resembling natural bone mineral component and structure. Distributed in the U.S. under license from Finceramica Faenza S.p.A. for hospitals and neurosurgeons performing physiological bone replacement.
• NEOS Cranial LOOP Family of cranial fixation devices engineered from PEEK-OPTIMA polymer for securing bone flaps resulting from craniotomies. Artifact-free in X-ray, CT scan, and MRI imaging, intended for neurosurgeons performing craniotomy procedures.
• Osteopore Bioresorbable Implants (Osteoplug, Osteostrip, Osteomesh) Bioresorbable cranial scaffolds made of polycaprolactone (PCL) with patented interconnected porous architecture mimicking cancellous bone microstructure, used for burr hole closure, craniotomy gap filling, and regenerative cranial reconstruction. Fully resorbs over 24 months while maintaining mechanical integrity during healing. Distributed from Osteopore Limited.

Quantifiable outcome

• 84% year-over-year revenue growth in Q1 2026
• +4 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature6 records

Partnerships

Three partnerships are on record, tiered core.

• Evonik Industries AGcoreOEM/ Whitelabel/ Licensing Partner · 13 November 2025Kelyniam secured exclusive U.S. license from Evonik Industries AG to market VESTAKEEP Fusion, a BCP-infused PEEK material, for cranial and craniofacial implants. The licensing agreement grants two years of exclusivity and supports Kelyniam's growth in regenerative neurosurgical solutions. VESTAKEEP Fusion combines PEEK with biphasic calcium phosphate for enhanced bone integration and is the first new cranial implant material approved in the U.S. in eight years.
• Finceramica Faenza S.p.A.coreOEM/ Whitelabel/ Licensing Partner · 7 November 2025Renewed licensing agreement with Finceramica, an Italian biomaterials company, extending partnership for three years. Agreement grants Kelyniam expanded access to Finceramica's product portfolio including CustomizedBone hydroxyapatite cranial implants and SINTlife, a fully resorbable synthetic graft expected to receive FDA clearance within two years. Finceramica specializes in bio-ceramic materials development and maintains information exchange with leading neurosurgeons.
• Osteopore LimitedcoreChannel Partner/ Reseller/ Distributor · 1 May 2025Partnership formed in May 2025 with Osteopore Limited, a Singapore-based company, to enhance production, distribution, and regulatory compliance of Osteopore's biodegradable implant products in the US market. Kelyniam serves as US distribution partner for Osteopore's bioresorbable polycaprolactone (PCL) implant products including Osteoplug, Osteoplug-C, Osteostrip, and Osteomesh for burr hole and craniotomy repair.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Stryker (Craniomaxillofacial / CMF division): Stryker's CMF and Neurotechnology division offers a broad portfolio of cranial fixation, plating, and implant solutions to neurosurgeons. It competes with Kelyniam in the same hospital channel but at significantly greater scale and with a much wider product range.
• DePuy Synthes (Johnson & Johnson): DePuy Synthes' Neuro and CMF franchises include cranial plates, screws, and reconstruction systems used in cranioplasty. It is the dominant incumbent in cranial fixation and overlaps with Kelyniam's IFS and NEOS Cranial LOOP offerings.
• Zimmer Biomet: Zimmer Biomet's CMF and Surgical division provides cranial and facial reconstruction solutions to hospitals and surgeons. It competes in the same neurosurgical buyer workflow as Kelyniam with broader musculoskeletal scale.
• B. Braun (Aesculap division): B. Braun's Aesculap division provides neurosurgical and CMF implants, including cranial fixation systems. It serves the same hospital neurosurgery buyers and is a broad incumbent competitor.

Direct peers

• Integra LifeSciences: Integra's Codman Specialty Surgical / CMF business sells a range of dural repair, cranial implants, and neuro critical care products to neurosurgeons. It is one of the closest direct competitors to Kelyniam in custom cranial reconstruction.
• KLS Martin Group: KLS Martin specializes in cranio-maxillofacial surgery products including patient-specific implants, plates, and screws. It is a direct mid-sized competitor in the custom CMF implant space.
• Xilloc Medical: Dutch company specializing in patient-specific 3D-printed implants, including CMF and cranial applications. It competes with Kelyniam in the custom PEEK and titanium cranial implant category in Europe and selected international markets.

Others

• Finceramica Faenza S.p.A. Italian biomaterials company that developed the CustomizedBone hydroxyapatite implant Kelyniam distributes in the U.S. It is simultaneously a partner and a global competitor in the same cranial implant technology, and it is developing SINTlife, a fully resorbable graft.

Emerging players

• Osteopore Limited: Singapore-based developer of bioresorbable PCL cranial implants (Osteoplug, Osteomesh, Osteostrip). It is both a Kelyniam distribution partner and a competing technology in regenerative cranioplasty in markets outside the U.S.
• Renishaw (Healthcare / Neurological Solutions): Renishaw's healthcare business offers 3D-printed patient-specific cranial implants, competing with Kelyniam in custom PEEK and titanium cranioplasty using additive manufacturing technology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/kelyniam-global

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds1 record

Investors

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

M&A2 records

Investments

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

Frequently asked questions about Kelyniam Global