Tema Sinergie

Name

Tema Sinergie

Legal name

TEMA SINERGIE S.p.A.

Website

https://temasinergie.it

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Nuclear Medicine and Pharmaceutical Isolation Equipment

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Radiopharmacy Compounding & Dispensing (Hospital/Commercial) (HLAIAGAE)

akta.pro secondary industries

Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC), Diagnostic Radiopharmaceuticals (SPECT/PET Tracers) (HLAIAGAA)

Keywords

• Nuclear medicine equipment
• Radiopharmaceutical dispensing systems
• Barrier isolation technology
• Pharmaceutical isolators
• Radiopharmacy automation

Headquarters

HQ city

Faenza

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Hardware Sales - Radiopharmacy Equipment: Sale of automated dispensing systems, hot cells, manipulation cells, and shielded equipment for nuclear medicine and radiopharmacy applications
2. Hardware Sales - Pharmaceutical Isolation Systems: Sale of barrier isolation systems for aseptic processing and containment applications in pharmaceutical and biotech industries
3. Hardware Sales - Radiation Oncology Equipment: Sale of products for radiation therapy and medical imaging including SpaceOAR and related technologies
4. Professional Services: Consulting during design phase, user training, commissioning and clinical start-up support, and technical assistance during and after warranty period

Go-to-market motion2 records

Distribution channels10 records

Marketing channels4 records

Core offering

Tema Sinergie designs, manufactures, and services specialized medical and pharmaceutical equipment across four business units: (1) Radiopharma & Nuclear Medicine — automated radiopharmaceutical dispensing systems, shielded hot cells, and synthesis modules for PET/SPECT applications; (2) Pharma & ATMP — GMP-compliant barrier isolation systems for aseptic processing and containment in pharmaceutical and biotechnology manufacturing; (3) Radiation Oncology & Medical Imaging — distribution of advanced treatment devices including Sonablate HIFU for prostate ablation and SpaceOAR hydrogel; (4) Uro-Oncology — minimally invasive solutions for cancer diagnosis and treatment.

Product overview

Tema Sinergie is a multi-disciplinary Italian company (established 1985, 280+ employees) operating in healthcare technology across four business units: Radiopharma & Medicina Nucleare, Pharma & ATMP (Barrier Isolation Technology), Radioterapia & Medical Imaging, and Uro-Oncologia. The Radiopharma division offers a complete portfolio centered on KARL100 automatic radiopharmaceutical dispenser, complemented by µ DDS-A dose fractionation units, CRP Compact dispensers, and ASTER theranostic injector, alongside various hot cells (DHC, FLEX, NMC DSI, NMC Ga-68, TEC4) for PET/SPECT applications. The Pharma & ATMP division provides isolation systems including pharmaceutical isolators, HC-IS containment series, Aseptic Filling Isolators, AP-IS transfer isolators, and accessories like AGLTS 2 glove testing and ZEROC integrity verification. The Radiotherapy division offers Sonablate HIFU for focal prostate ablation and SpaceOAR hydrogel spacer. The company serves hospitals, research institutes, universities, and pharmaceutical industries worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• KARL100: Automatic system for dispensing and infusion of PET and SPECT radiopharmaceuticals
• VI
• µ DDS-A
• CRP Compact
• ASTER
• AseptiFill
• AGLTS 2
• ZEROC

Products and services

• KARL100 Automatic mobile dispensing and infusion system for PET and SPECT radiopharmaceuticals, designed to reduce operator radiation exposure in hospital nuclear medicine departments. Over 140 installations worldwide.
• µDDS-A Compact plug-and-play automatic dose fractionation unit for PET and SPECT radiopharmaceuticals dispensed into shielded syringes. Over 225 installations worldwide, with 1.1 million syringes dispensed.
• CRP Compact / CRP Compact Plus Automatic radiopharmaceutical dispenser for open and closed vials with automated crimping. GMP EU Annex 1 compliant, suitable for various radiopharmaceuticals without concentration or volume limits.
• ASTER Theranostic Radiopharmaceutical Injector CE-certified theranostic administration system for managing the complete radiopharmaceutical infusion process from single-use vials. Minimizes operator exposure during radiometabolic therapies.
• DHC - Dispensing Hot Cell GMP Grade A shielded isolator with vertical laminar flow designed for radiopharmaceutical dispensing in a controlled and safe environment. Large internal work surface with automatic lead pot recovery system.
• FLEX Multi-Function Shielded Isolator Multi-function GMP Grade A shielded isolator with 75mm Pb shielding on all sides, configurable for various radiopharmaceutical dispensing applications and compatible with µDDS-A and CRP systems. 35 installations worldwide.
• NMC DSI Shielded Laminar Flow Isolator Shielded laminar flow isolator for manual and automatic FDG PET preparation and nuclear medicine isotope doses. GMP compliant with 100 installations worldwide.
• NMC Ga-68 Hot Cell GMP Grade A hot cell for the complete Gallium-68 cycle including elution, synthesis, and dispensing. Features 2 pre-chambers at GMP Grade B.
• Safeflow Biohazard Safety Cabinet Class II Biohazard Safety Cabinet with vertical laminar flow for manual preparation of injectable radiopharmaceutical doses. GMP Grade A with shielding configurations from 5 to 50mm Pb.
• VI - Visual Inspection and Labelling System Automatic visual inspection and vial labelling system for nuclear medicine applications. Available in inspection-only, inspection-with-labelling, and integrated printing/labelling versions, with VPHP cycle compatibility.
• Sonablate HIFU Robotic device for focal ablation of the prostate using high-intensity focused ultrasound with proprietary A³ technology (AIM, Ablate, Analyze). Distributed in Italy by Tema Sinergie for minimally invasive prostate cancer treatment.
• AseptiFill Automatic vial filling and capping system designed for aseptic conditions, specifically for Pharma & Biotech companies producing small batches of injectable products. Integrates within Tema Sinergie isolators.
• MorGaNA Gallium-68 Labelling Device Automatic device dedicated to Gallium-68 cold labelling and dispensing, compatible with all Gallium-68 generators. Features remote control operation and FDA 21 CFR Part 11 compliant data management. Launched January 2020.
• AGLTS 2 Automatic Glove Leak Testing System Automatic glove leak testing system developed for pharmaceutical isolators in response to the requirements of EU GMP Annex 1. Officially presented at Interphex in April 2023.
• ZEROC RTP Integrity Verification System

Quantifiable outcome

• 140+ KARL100 installations worldwide
• +4 more outcomes

Named customers14 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• Acrux Radiopharma ConsultingcoreChannel Partner/ Reseller/ Distributor · 1 May 2023Strategic partnership to provide solutions and post-sale services dedicated to the Chilean nuclear medicine market. Acrux provides specialized radiopharma consulting services.
• ATS ElektronikminorChannel Partner/ Reseller/ Distributor · 1 September 2022ATS Elektronik is the new partner of Tema Sinergie in Turkey for the Barrier Isolation Technology business unit.
• EnvopackminorChannel Partner/ Reseller/ Distributor · 1 August 2022Envopack c.a. is the exclusive partner of Barrier Isolation Technology business unit for Venezuela and Dominican Republic.
• Be.Integral International DistributioncoreChannel Partner/ Reseller/ Distributor · 1 June 2022Be.Integral International Distribution is the new technical-commercial partner in Germany for increasingly capillary presence on European territory.
• AMERICAN FARMAGRUP S.A.S.coreChannel Partner/ Reseller/ Distributor · 7 May 2022New partner for Barrier Isolation Technology for Colombia, Peru, Ecuador, Panama, and Honduras with over 35 years of activity in the pharmaceutical sector. Based in Bogota, Colombia.
• STEQ AmericacoreChannel Partner/ Reseller/ Distributor · 1 March 2022STEQ America is the new partner for Barrier Isolation Technology business unit for the North American market with nearly 20 years of market experience representing world's leading manufacturers of Pharma and Biotechnology equipment.
• STEQ Comércio e RepresentaçõescoreChannel Partner/ Reseller/ Distributor · 1 March 2022New technical-commercial partner for Barrier Isolation Technology division for the Brazilian market with nearly 20 years of experience representing leading Pharma and Biotechnology equipment manufacturers.
• LabLogiccoreChannel Partner/ Reseller/ Distributor · 19 November 2019Exclusive commercial agreement with LabLogic for distribution of PET and Nuclear Medicine products in the United Kingdom. LabLogic is one of the world's most respected manufacturers of instrumentation and software for Life Science, PET, Nuclear Medicine and Security sectors.
• CyclomedicacoreChannel Partner/ Reseller/ DistributorPartner for Australian nuclear medicine market. Collaboration on Cyclowest nuclear medicine center project in Western Australia for FDG production.
• Sonablate Corp.coreTechnology or IntegrationPowered by Sonablate Corp., Tema Sinergie distributes Sonablate HIFU - a robotic device for focal ablation of prostate using high-intensity focused ultrasound with proprietary A³ technology.
• LabLogiccoreTechnology or IntegrationPartnership with LabLogic for customer installation support and collaboration including Royal Free London case study publication.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Comecer S.p.A. Italian-headquartered manufacturer of shielded cells, hot cells, and radiopharmacy equipment. Direct competitor named alongside Tema Sinergie as a top-3 global player in the radiopharmaceutical dispensing market, with overlapping product lines in PET/SPECT shielding and isolators.
• EDAP TMS: Developer of focused ultrasound devices including Focal One for prostate tissue ablation. Direct peer in the uro-oncology HIFU segment where Tema Sinergie distributes Sonablate HIFU.
• Trasis: Belgian developer of automated radiopharmaceutical synthesis and dispensing systems (e.g., AllInOne, Synthera). Named as the third top-3 player in radiopharmaceutical dispensing alongside Tema Sinergie and Comecer, with comparable PET/SPECT and Ga-68 product lines.
• SKAN AG: Swiss manufacturer of aseptic and containment isolators for pharmaceutical and biotech manufacturing, including GMP-compliant barrier systems. Direct peer in the Pharma & ATMP / barrier isolation business unit.

Broad incumbents

• Siemens Healthineers: Major medical imaging and diagnostics player with PET/CT systems and growing nuclear medicine footprint. Competes indirectly through end-to-end imaging suite sales that bundle radiopharmacy workflow components.
• GE HealthCare: Global medical device and imaging giant offering PET tracers, cyclotrons, and increasingly adjacent radiopharmacy workflow solutions. As a broad incumbent, it competes at the system level and could expand into shielded-equipment categories.
• Cytiva (Danaher): Global bioprocessing and aseptic manufacturing equipment provider. Competes with Tema Sinergie's pharmaceutical isolation business through broader aseptic filling and containment portfolios.
• Getinge (Getinge Life Science): Global provider of sterilizers, isolators, and GMP process equipment for pharmaceutical manufacturing. Competes with Tema Sinergie's Pharma & ATMP division as a broad incumbent offering integrated aseptic processing solutions.
• Curium Pharma: World's largest nuclear medicine company, supplying SPECT/PET diagnostic tracers and therapeutic radiopharmaceuticals. Comparable as a downstream customer for shielded dispensing systems and as a potential in-house equipment competitor.

Others

• Sonablate Corp. Manufacturer of Sonablate HIFU high-intensity focused ultrasound device for prostate ablation. Technology partner of Tema Sinergie rather than a direct competitor, but represents an upstream relationship that mirrors peer dynamics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights6 records

Customer concentration

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Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

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 Tema Sinergie