What Cyclomedical does

Cyclomedical International, Inc. is a Knoxville, Tennessee-based privately held firm founded in 2002 that provides end-to-end consulting, equipment, and managed-services for cyclotron-based PET (Positron Emission Tomography) radiopharmaceutical production facilities worldwide. Its service portfolio covers facility feasibility and site planning, equipment procurement (hot cells, synthesizers, QC instruments), IQ/OQ/PQ qualification, cGMP regulatory compliance, ANDA submission support, radiation safety consultation, and full contract operation of cyclotron sites, plus proprietary consumables including a patented dose calibrator and the RTLC Daily Check Source Strip. The company's core technology is the integration of cyclotron operation, radiochemistry synthesis modules, hot cells, and QC instrumentation into cGMP-compliant production workflows for imaging agents such as [18F]FDG, [18F]NaF, and [13N]Ammonia, packaged via a proprietary Fast Track methodology capable of delivering an operational site in 6-10 months.

Cyclomedical operates through a network of wholly owned affiliates and a joint venture (Cyclomedical Applications Group LLC in the US; Cyclomedical Applications FZE in the UAE; Cyclomedical Applications Group Ltd in Qatar; Cyclomedical East Africa Limited in Kenya; and Cyclomedical Middle East DMCC joint venture in Dubai). Revenue is generated through six streams: consulting services, facility operation/managed services, site planning and project management, equipment and consumables supply, regulatory guidance/ANDA filing, and training. Pricing is quote-based with no public disclosure. The company has set up over 50 PET biomarker production centers across 23 countries and currently manages 4 cyclotron sites (2 US, 2 Gulf), with a documented record of zero adverse events across several hundred thousand patient doses and 99.9% dose delivery efficiency at managed facilities.

The company's primary customers are hospitals, cancer centers, and standalone PET/CT imaging clinics that lack in-house cyclotron, radiochemistry, and cGMP regulatory expertise, along with research institutions establishing PET facilities for both clinical and research use, and government healthcare agencies and investors developing PET capabilities in emerging markets. Go-to-market is sales-led and relationship-driven, anchored by CEO James F. Lamb's role in the original FDG NDA and President Ned Odeh's 27+ years of cyclotron sales experience with Siemens/CTI, with no external institutional capital or venture backing disclosed.

Name

Cyclomedical

Legal name

Cyclomedical International, Inc.

Website

https://cyclomedical.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

51–100 employees

Short description

Cyclomedical International provides end-to-end consulting, equipment, and managed operation of cyclotron-based PET radiopharmaceutical production facilities for hospitals, cancer centers, and government health agencies across 23 countries.

Ownership category

akta.pro rank

Product category

Nuclear Medicine Consulting and Cyclotron Facility Services

NAICS

Pharmaceutical Preparation Manufacturing (325412), Medical and Diagnostic Laboratories (62151)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Nuclear Medicine Imaging Tracers & PET/SPECT Supply Chain (FDG, Ga-68, logistics/cold chain) (EUAKAIAE)

Keywords

• PET radiopharmaceutical consulting
• Cyclotron facility management
• Radiation safety services
• Regulatory guidance cGMP
• Site planning qualification

Headquarters

HQ city

Knoxville

HQ country

United States

HQ region

North America

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting Services: Technical, business, and regulatory consulting for PET radiopharmaceutical facilities worldwide, including cyclotron selection, QC laboratory design, cGMP compliance, and regulatory submissions.
2. Facility Operation & Management: Contract operation of cyclotron facilities for production of PET radiopharmaceuticals, including staffing, production, quality control, and regulatory compliance. Cyclomedical operates sites in the US and Gulf Region (UAE, Qatar, Oman) supplying PET radiopharmaceuticals to hospitals.
3. Site Planning & Project Management: Planning, design, construction supervision, equipment procurement, and qualification of PET production sites, including IQ/OQ/PQ and process validation services.
4. Equipment & Consumables Supply: Supply of cyclotron-related equipment (hot cells, synthesizers, QC instruments) and consumables including O-18 Water, synthesis kits, endotoxin test cartridges, and RTLC daily check source strips.
5. Regulatory Guidance & ANDA Submission: Regulatory consultation including cGMP compliance, documentation preparation, FDA submissions, and ANDA (Abbreviated New Drug Application) filing support for PET radiopharmaceutical facilities.
6. Training Services: Hands-on training for site staff covering quality control procedures, cyclotron and laboratory equipment maintenance, regulatory compliance, and radiation safety, both on-site and offsite.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Cyclomedical provides end-to-end consulting, site planning, equipment supply, regulatory guidance, qualification, and managed facility operations for cyclotron-based PET radiopharmaceutical production sites. The firm supplies PET radiopharmaceuticals (e.g., [18F]FDG, [18F]NaF, [13N]Ammonia) from its own operated facilities and supports hospitals, research institutions, and healthcare developers worldwide with cGMP compliance and Fast Track site delivery. Its only manufactured physical product is the proprietary RTLC Daily Check Source Strip used for radiopharmaceutical quality control.

Product overview

Cyclomedical is a consulting and facility management company specializing in PET (Positron Emission Tomography) radiopharmaceutical production. The company offers a portfolio of professional services including consulting, facility management, site planning, regulatory guidance, equipment solutions, and qualification services. The main proprietary product is the RTLC Daily Check Source Strip for quality control testing. Services are delivered through multiple affiliated companies worldwide (US, UAE, Qatar, Oman, Kenya) and support commercial PET production sites, research-oriented facilities, and clinical cyclotron sites. The company manages cyclotron facilities from concept through operation, with a 'Fast Track' process capable of delivering a site in 6-10 months.

Differentiator

Problem solved

Functional benefit

Products and services

• Consulting Services Technical expertise and hands-on experience for radiopharmaceutical facilities including cyclotron selection, QC laboratory design, cGMP compliance, innovation support, and problem-solving for design, construction, site operation, and regulatory compliance worldwide.
• Facility Management Services Full operational management of cyclotron production facilities including GMP compliance, experienced staffing, document management, proactive maintenance, CAPA systems, radiation monitoring, and aseptic processing.
• Site Planning Services Comprehensive site planning including cyclotron selection consultation, synthesizer and hot cell planning, quality control laboratory design, and packaging and distribution setup for radiopharmaceutical production facilities.
• Regulatory Guidance Services Full regulatory services including consultation with regulatory bodies, QC Laboratory qualification to cGMP standards, complete documentation for radiopharmaceutical production, compliance documentation, and ANDA submission to USFDA.
• Comprehensive Solutions (Fast Track) Complete project management from concept to operation including financing consultation, marketing support, cyclotron energy decisions, lab instruments procurement, construction consultation, qualification, process validation, and site operations. Capable of delivering a site in as little as six months.
• Equipment Solutions Consulting and provision of equipment including hot cells, dispensing hot cells, QC laboratory instruments, laboratory accessories, chemicals and supplies, radiation monitoring systems, radiation safety equipment, distribution packaging, nuclear pharmacy equipment, clinical hot labs, and scanning room accessories.
• Qualification Services IQ/OQ/PQ (Installation, Operational, Performance Qualification) and PV (Process Verification) for PET cyclotron laboratories, including annual re-qualification of QC laboratory instruments to pharmacopeia standards.
• Annual Requalification Package for PET Cyclotron QC Labs Annual requalification package including Performance Qualification consistent with Pharmacopeia and facility SOPs, process validation with supervised media fill, three lot qualification and stability tests, facility operation with key performance indicators and equipment maintenance.
• PET Cyclotron Laboratory Annual GMP Audit Comprehensive GMP audit service including review of Site Master File, SOPs, batch records, quality control documentation, personnel training records, QA trend analysis, OOS incidents, and CAPA documentation, with on-site observation of manufacturing and QC processes.
• PET Biomarker Production Site New Product Introduction Assistance in introduction and business development of innovative nuclear medicine biomarkers including equipment evaluation, SOP development, manufacturing procedures, raw materials control, on-site startup, IQ/OQ/PQ for new equipment, production validation, stability testing, and personnel training.
• Radiation Safety & Control Services Radiation safety consultation including site design, shielding planning, training, laboratory techniques, radiation surveying, and documentation to minimize employee exposure, with standard of ALARA (As Low As Reasonably Achievable).
• Standard Operating Procedures (SOPs) Customized SOPs for radiopharmaceutical production covering administration, equipment, quality assurance, radiation safety, aseptic processing, staff training, and drug acceptance/distribution developed from original consortium FDG NDA submission experience.
• Training Services Hands-on training on client site or offsite for quality control procedures, cyclotron and laboratory equipment maintenance, regulatory compliance topics, and radiation safety procedures and practice.
• Project Management Services Project management for cyclotron installation including site design coordination, construction supervision, laboratory instrument selection, on-site project management during critical phases, SOPs, regulatory compliance, staff training, and bringing site into clinical production within 3 to 5 weeks.
• RTLC Daily Check Source Strip A proprietary laminated paper strip with 137Cs source drops used for daily suitability verification testing of Radio-Thin Layer Chromatography (RTLC) instruments in PET radiopharmaceutical quality control. The strips are spatially accurate (within 0.5mm) and provide activity accuracy (1-5% relative standard deviation).

Quantifiable outcome

• 99.9% dose delivery efficiency at commercially operated PET production sites
• +4 more outcomes

Named customers7 records

Segments3 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

Eight partnerships are on record, tiered core and minor.

• Cyclomedical Middle East DMCCcoreStrategic or Co-development PartnerA joint venture subsidiary of Cyclomedical International based in Dubai, UAE, managed by Nidal (Ned) Odeh. The company represents Cyclomedical Applications FZE (UAE), Cyclomedical Applications Group Ltd (Qatar), and the Oman entity managing the Royal Hospital's National Molecular Imaging Centre in Muscat. It develops and manages PET radiopharmaceutical opportunities throughout the Middle East region.
• Wisconsin Medical Cyclotron (WMC)coreStrategic or Co-development PartnerA joint venture of major hospitals and imaging centers in the Milwaukee area. Cyclomedical Applications Group, LLC provided technical management of the site for 14 years. Cyclomedical International, Inc. has acquired an equity position in the site. WMC operates a GE PETtrace cyclotron and has provided tens of thousands of patient doses of FDG to scanner operators throughout Wisconsin and the Chicago area.
• Muscat Pharmacy & StoresminorChannel Partner/ Reseller/ DistributorCyclomedical partnered with Muscat Pharmacy & Stores as contractor for laboratory equipment and project support for the National Molecular Imaging Centre at the Royal Hospital in Muscat, Oman. Cyclomedical acknowledged their efforts and support in making the Fast Track site development a success.
• Al Ibsar Group (Iraq)minorChannel Partner/ Reseller/ DistributorCyclomedical International and Cyclomedical Middle East DMCC contracted to provide services for the Al Ibsar Group's PET radiopharmaceutical production site in Al Najaf, Iraq. Cyclomedical also provided equipment to Al Itkan Company, contractors for laboratory equipment at the same site.
• Al Itkan Company (Iraq)minorChannel Partner/ Reseller/ DistributorAl Itkan Company served as contractors for laboratory equipment at the Al Najaf PET radiopharmaceutical production site in Iraq. Cyclomedical provided equipment to Al Itkan Company for this project.
• Dr. Stefan Guhlke (Research Chemist)minorStrategic or Co-development PartnerThrough Cyclomedical's international associations, Dr. Stefan Guhlke was recruited as an experienced research chemist to manage both routine production and research interests at Hamad Hospital in Doha, Qatar. Dr. Guhlke brought world-class science into the new setting as part of Cyclomedical's contribution to the project.
• Jerry Rasmussen (Site Manager)minorStrategic or Co-development PartnerSite Manager Jerry Rasmussen has been in place at Wisconsin Medical Cyclotron from the beginning and has worked as a consultant for Cyclomedical in site installations all over the world. He is well prepared to begin adding novel radiopharmaceuticals and other services to WMC activities.
• Ali bin Ali Medical (Qatar)minorChannel Partner/ Reseller/ DistributorAli bin Ali Medical was the site contractor for Hamad Hospital's new research facility and cyclotron suite in Doha, Qatar. Cyclomedical was selected by Ali bin Ali Medical as project lead for planning, design, equipment evaluation, and contract management for radiopharmaceutical production.

Scale indicators13 records

Recent moves9 records

Expansion highlights5 records

Broad incumbents

• Curium Pharma: Global nuclear medicine company producing SPECT and PET radiopharmaceuticals across Europe, North America, and emerging markets. Comparable as a vertically integrated manufacturer of diagnostic and therapeutic radiopharmaceuticals that performs facility-level production under cGMP.
• Lantheus Holdings: U.S.-listed radiopharmaceutical company with established diagnostic imaging agents and growing radiotheranostics pipeline. Comparable as a focused nuclear-medicine manufacturer expanding into PET/SPECT and therapeutic isotope production.
• IBA (Ion Beam Applications): Leading global cyclotron manufacturer and radiopharmacy operator; Cyclomedical has installed IBA cyclotrons. Comparable as both a vendor to Cyclomedical's clients and a competing provider of turnkey radiopharmacy solutions.
• GE Healthcare Pharmaceutical Diagnostics: Sells PET tracers (Vizamyl, DaTSCAN-adjacent) and supports GE PETtrace cyclotron installations. Cyclomedical has installed and operated GE PETtrace cyclotron sites, making GE both a vendor and potential integrator of competing services.
• Cardinal Health Nuclear & Precision Health Solutions: Operates one of the largest U.S. networks of radiopharmacies and distributes radiopharmaceuticals, contrast media, and SPECT agents. Comparable as a scaled operator managing production, distribution, and regulatory compliance for nuclear medicine products.

Emerging players

• NorthStar Medical Radioisotopes: Emerging U.S. radioisotope producer focused on Mo-99 and other medical isotopes without highly enriched uranium. Overlaps with Cyclomedical's cyclotron-based production and novel-tracer introduction services for hospitals building nuclear medicine programs.

Direct peers

• PharmaLogic Holdings: Operates a network of PET and SPECT radiopharmacies across the U.S. following roll-ups of regional nuclear pharmacies. Directly comparable to Cyclomedical's managed cyclotron operations and contract-pharmacy services model.
• PETNET Pharmaceutical Services (Siemens Healthineers): Subsidiary of Siemens Healthineers that builds, equips, and operates a national network of PET radiopharmacies producing FDG and other imaging tracers. Closest comparable to Cyclomedical's contract operation of cyclotron facilities and cGMP radiopharmaceutical production.
• SpectronRx: U.S. CDMO and radiopharmacy operator offering radiopharmaceutical development, fill-finish, and distribution services. Comparable to Cyclomedical's full-spectrum radiopharmacy operations and regulatory support offerings.

Others

• Advanced Cyclotron Systems Inc. (ACSI): Manufacturer of TR-series cyclotrons for PET isotope production; Cyclomedical has installed and operated ACSI cyclotrons at client sites. Adjacent as a primary equipment supplier rather than a direct service competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cyclomedical-international-inc.

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Subsidiaries5 records

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 Cyclomedical