What GAMASTECH does

GAMASTECH S.R.L is an Italian medical device company founded in 2009 and headquartered in Catania, Italy, operating as a privately held, bootstrapped micro-enterprise (1-10 employees) under founder and CEO Arturo Maravigna. The company designs, manufactures, and distributes medical equipment and infusion systems, with its portfolio spanning needle-free jet injectors (Comfort-in, patented spring-powered technology, CE Class IIb), elastomeric infusion pumps (Exacta Number One, CE Class IIb), thermochromic monitoring accessories (T-Vein, T-Patch, ExacT°), surgical sutures (AMS), automatic syringe separators (ANDY), and clinical decision support software (Drug-PIN, CE Class I). Product breadth has expanded materially in recent years into adjacent verticals, with the 2025 launches of WITHaPET, an AI-powered veterinary stethoscope for cardiac and pulmonary auscultation, and RADONE, a portable radiation dosimeter, alongside newer aesthetics-facing SKUs (Derma Shot) and a human-facing AI stethoscope (SKEEPER).

The business operates a multi-channel model combining B2B distribution through partner networks across 33+ countries (including a Mika Medical Co. partnership for Comfort-in and ANVISA certification enabling Brazil entry) with direct e-commerce for consumables and accessories. Revenue is generated through hardware unit sales (Comfort-in Starter Kit at $509, WITHaPET at $506), high-margin consumables (T-Patch at $6 per 4-pack to $245 per 50-unit blister box), training services at $120 per session, and quote-based annual Drug-PIN software subscriptions integrated into hospital EHR systems via FHIR HL7 standards. R&D is augmented through a collaboration with CNR-IPCB (Italian National Research Council), and the company has obtained multiple regulatory certifications (CE-MDR Class IIa/IIb, ISO 13485, ISO 9001) and was recognized as a PMI Innovativa in 2016.

Customer concentration is diversified across hospital infusion, aesthetic medicine, veterinary, and occupational health segments, with flagship reference centers for the Drug-PIN platform including Charité Berlin, Sant'Andrea Roma, and Policlinico Umberto I Roma. The Drug-PIN software underpins the company's most defensible AI moat, leveraging a proprietary database of 19,000+ proteins and 4M+ drug-protein associations, supported by 17+ peer-reviewed publications and a granted European patent in 2026. The combined positioning — CE-certified medical hardware portfolio, AI-differentiated clinical decision support software, multi-country distribution, and a slim operating footprint — defines a niche medical-technology operator with disproportionate product-line breadth relative to its scale.

Name

GAMASTECH

Legal name

GAMASTECH S.R.L

Website

https://gamastech.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

GAMASTECH S.R.L is an Italian medical device company that designs, manufactures, and distributes CE-certified infusion systems, needle-free injectors, monitoring consumables, and AI-powered clinical software (Drug-PIN) and veterinary diagnostics (WITHaPET), serving hospitals, aesthetic, veterinary, and occupational health customers across 33+ countries.

Ownership category

akta.pro rank

Product category

Medical Devices and Infusion Systems

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

akta.pro secondary industries

Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL), Insulin Pen Needles, Syringes & Infusion Sets (Consumables) (HLAHAHAE), Practice Consumables & General Medical Supplies (Needles, Syringes, Gloves, Swabs) (HLAMAFAO), Personal Medical Devices & Home Diagnostics (Thermometers, Blood Pressure Monitors, Glucose Meters, Rapid Tests) (CRADAMAK)

Keywords

• Needle-free injection systems
• Elastomeric infusion pumps
• Thermochromic medical devices
• Clinical decision support software
• Medical device manufacturing

Headquarters

HQ city

Catania

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of proprietary and distributed medical devices including elastomeric pumps, needle-free injectors, thermochromic monitors, and surgical sutures. One-time device sales with recurring consumables (nozzles, adapters, patches).
2. Consumables and Accessories: Recurring sales of consumables including Comfort-in nozzles (sterile, single-use), adapters (vial, insulin pen, dental, luer, T-adapter), positioning caps, and replacement components.
3. Training Services: Training courses for device usage such as Training Course Comfort-in at $120.00 per session.
4. Drug-PIN Software Licenses: Annual license per active prescriber, all-inclusive (cloud, integration, updates, support, training). Software as a Medical Device with CE Class I certification.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

GAMASTECH designs, manufactures, and distributes proprietary medical devices for hospitals, clinics, aesthetic medicine practices, and veterinary clinics. Its core offerings include the Comfort-in needle-free injection system line, the Exacta Number One elastomeric infusion pump, thermochromic monitoring patches (T-Vein, T-Patch, ExacT°), AI-powered clinical solutions (Drug-PIN software, WITHaPET stethoscope), and supporting products such as AMS surgical sutures, RADONE dosimeter, and ANDY syringe separator. The company sells through direct B2B sales, e-commerce, and an international distributor network across 33+ countries.

Product overview

GAMASTECH is an Italian medical device company founded in 2009 specializing in innovative biomedical solutions for drug delivery and patient monitoring. The product portfolio centers on four core technology platforms: (1) Needle-free injection systems (Comfort-in I.M., Comfort-in Subcutaneous, Comfort-in Derma) using patented spring technology for pain-free injections; (2) Elastomeric infusion pumps (Exacta Number One) for continuous or bolus drug delivery without batteries; (3) Thermochromic monitoring solutions (T-Vein for infusion sites, T-Patch for body temperature, ExacT° for product temperature); and (4) AI-powered medical devices (WITHaPET veterinary stethoscope, Drug-PIN clinical decision support software). Supporting products include AMS surgical sutures, RADONE portable dosimeter, ANDY automatic syringe separator, and a comprehensive range of Comfort-in accessories (nozzles, adapters, positioning caps). The portfolio serves medical, aesthetic, veterinary, and protective equipment segments across 33+ countries.

Differentiator

Problem solved

Functional benefit

Products and services

• Exacta Number One Elastomeric pump for continuous or bolus drug delivery using elastomeric energy without motors or batteries. Features a medical-grade silicone balloon with micro-tube flow regulation, supports intravenous, subcutaneous, and epidural infusion modes, and includes Air test verification for each pump. CE Class IIb medical device for hospitals, clinics, and home-care providers.
• Comfort-in Intramuscular Needle-free syringe for intramuscular injection using patented spring-powered jet technology without gas or batteries. Completes infusion in under 0.3 seconds with virtually painless delivery through a 0.15mm micro-orifice nozzle. CE Class IIb medical device distributed in Europe by GAMASTECH for healthcare professionals.
• Comfort-in Subcutaneous Needle-free syringe for subcutaneous drug administration. Three clinical versions available: SOFT (diabetology, dermatology, veterinary), MEDIUM (gynecology, pediatrics, physiotherapy), and NORMAL (obstetrics, aesthetics, urology). Distributed in Europe by GAMASTECH.
• Comfort-in Derma First CE-certified multi-shot needle-free injection device for intradermal aesthetic treatments. Creates a 'fluidic needle' for rapid, painless administration of hyaluronic acid, collagen, and botox, with an integrated loading lever for multiple injections. CE Class IIb medical device targeting aesthetic medicine practitioners (dermatologists, plastic surgeons).
• T-Patch Adhesive thermochromic patch for continuous body or local temperature monitoring. CE Class I medical device providing instant temperature checks via color change (brown below 35°C, green 35-37°C, yellow above 37.5°C). Waterproof, available in pocket packaging, for healthcare and consumer use.
• T-Vein Disposable thermochromic adhesive patch for peripheral infusion site monitoring. Detects early complications (extravasation, phlebitis, infection) via color change based on temperature variations at 1-2cm from the catheter insertion point. Designed for hospitals and infusion therapy settings.
• ExacT° Thermochromic adhesive indicator for temperature-sensitive product monitoring. 100% mechanical design with no batteries, in a compact 3x1.5cm adhesive that changes color based on temperature deviations (brown below 23°C, green 23-25°C, yellow above 25°C). Auxiliary accessory for pharmaceutical cold-chain management.
• AMS Surgical Sutures Range of surgical sutures with premium needles and innovative ADVATRAY packaging. Includes absorbable sutures (ADVACRYL, ADVACRYL RAPID, ADVAMRYL, ADVAPD) and non-absorbable sutures (ADVALENE, ADVALON, ADVASYL, ADVABOND), featuring triple-layer silicon coating and electropolished needles. Targeted at hospitals, surgical centers, and healthcare professionals.
• WITHaPET AI Veterinary Stethoscope AI-powered veterinary stethoscope for pets that measures and monitors cardiac and pulmonary parameters through auscultation analysis. Detects early stages of heart disease (B1, MMVD) and generates health reports for sharing with veterinarians. Not an MDR device. Targeted at veterinary clinics and companion animal practices.
• RADONE Portable Dosimeter Portable dosimeter for real-time X-ray and gamma radiation detection. Compact (60g), battery-powered (500-hour battery life), measures every second with ±15% precision. Includes companion mobile app for data management and exposure mapping. Targeted at radiology, nuclear medicine, and radiation safety professionals.
• ANDY Automatic Syringe Separator Automatic needle-syringe separator for safe disposal that reduces needlestick injuries by automatically separating and disposing of syringes. Features barcode/QR scanner for medical device data acquisition and traceability, omnidirectional scanner, and wireless portability. Targeted at hospitals, clinics, and healthcare workers.
• Drug-PIN Clinical Decision Support Software CE Class I Software as a Medical Device that helps physicians select safer therapy by calculating risks, drug interactions, and genetic profile into a single clinical score. Models 19,000+ proteins and ~4 million drug-protein associations, supports optional pharmacogenomic profiling (CYP2D6, CYP2C19, etc.), and integrates with hospital EHRs via FHIR HL7. Licensed annually per active prescriber. European patent granted 2026. Targeted at hospitals, oncologists, geriatricians, and pharmacy committees.
• Comfort-in Training Course One-to-one training sessions for healthcare professionals on the proper use of the Comfort-in needle-free injection system. Priced at $120.00 per session. Targeted at clinicians, dentists, veterinarians, and aesthetic practitioners adopting Comfort-in devices.

Quantifiable outcome

• Drug-PIN showed median PFS of 15 months for high-risk patients vs 23 months for low-risk patients in metastatic breast cancer study (p=0.005)
• +2 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration11 records

AI capability6 records

Feature8 records

Partnerships

Seven partnerships are on record, tiered core and flagship.

• CNR-IPCB (National Research Council - Institute for Chemical and Physical Processes)coreStrategic or Co-development PartnerResearch and development partnership with the Italian National Research Council's Institute for Chemical and Physical Processes in Catania. Collaborative R&D for advanced biomedical technologies.
• Mika Medical Co. (Korea)coreTechnology or IntegrationKorean manufacturer of Comfort-in needle-free injection devices. Gamastech serves as European distributor. Products include patented spring-powered jet injectors with CE Class IIa certification.
• CMC Medical Devices & Drugs S.L. (Spain)coreImplementation/ SI/ Consulting PartnerEU Authorized Representative for Comfort-in medical devices. Notified Body No. 2265. Handles regulatory compliance and representation for European market access.
• Drug-PIN Srl (Italy)coreTechnology or IntegrationManufacturer of Drug-PIN clinical decision support software. Based in Milan, Italy (Via Sassoferrato 1, 20135 Milan). European patent holder for drug interaction analysis algorithm.
• Charité Universitätsmedizin BerlinflagshipStrategic or Co-development PartnerReference center for Drug-PIN validation. Leading European university hospital using clinical decision support software for polypharmacotherapy management.
• Sant'Andrea RomaflagshipStrategic or Co-development PartnerItalian reference center for Drug-PIN clinical validation. University hospital conducting pharmacogenomic-guided prescribing research.
• Policlinico Umberto I RomaflagshipStrategic or Co-development PartnerItalian reference center for Drug-PIN. Major teaching hospital using drug interaction software for patient safety and clinical decision support.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• PharmaJet: US-based needle-free jet injection technology company whose Tropis and Stratis devices compete directly with GAMASTECH's Comfort-in platform across vaccine and drug delivery use cases. Most comparable in product, regulatory class (510(k) cleared), and clinical positioning.
• Mika Medical Co. Korean manufacturer of the Comfort-in needle-free jet injection devices that GAMASTECH distributes in Europe. Operates the same core jet-injection technology and CE Class IIa/IIb regulatory pathway; functions both as supplier and a competitor in other geographies.
• ICU Medical: US-based IV infusion and medical connector specialist with elastomeric and electronic infusion pumps plus needle-free access devices. Highly comparable to GAMASTECH's Exacta Number One elastomeric pump and Comfort-in product lines in clinical use cases and customer base (hospitals).
• Tandem Diabetes Care: US-based insulin delivery technology company (t:slim X2, Tandem Mobi pumps) serving the same diabetology segment that GAMASTECH's Comfort-in Subcutaneous SOFT version targets. Comparable in therapeutic focus (insulin/diabetes drug delivery) and recurring consumables business model.
• Eko Health: US-based digital health company producing AI-powered electronic stethoscopes (CORE, DUO) for cardiac and pulmonary auscultation analysis. Most direct comparable to GAMASTECH's WITHaPET veterinary stethoscope and SKEEPER (human version), sharing the AI-auscultation category and clinical-grade positioning.

Broad incumbents

• B. Braun: German-headquartered global medical device incumbent with deep portfolios in infusion therapy (including elastomeric pumps like Easypump), injection devices, and clinical software. Comparable customer base (hospitals/clinics) and overlapping elastomeric pump and IV consumable product lines, though at vastly greater scale and breadth.
• Becton Dickinson (BD): Global medical technology leader in injection and infusion systems (BD Medical), including conventional syringes, prefilled systems, sharps safety devices, and infusion consumables. Competes with both Comfort-in (needle-free) and ANDY (sharps safety) and Exacta (infusion) product lines, with much larger commercial reach.
• Baxter International: Global medical products company with significant infusion systems (Sigma Spectrum, Novum infusion pumps) and elastomeric/mobile infusion pump portfolios. Competes in the same hospital infusion use cases as GAMASTECH's Exacta Number One, with far broader global distribution.
• Insulet Corporation: US-based tubeless insulin pump manufacturer (Omnipod) with global presence in diabetes drug delivery. Comparable to GAMASTECH's Comfort-in SOFT/diabetology offering and Exacta infusion set, though operating at much larger scale with a different delivery mechanism.

Emerging players

• AliveCor: US-based AI cardiology company (KardiaMobile, KardiaBand) focused on cardiac arrhythmia and heart-monitoring AI. Comparable AI-driven cardiac monitoring capability to GAMASTECH's WITHaPET veterinary stethoscope and the in-development SKEEPER for humans, though in human health and ECG rather than auscultation.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/gamastech

Compliance15 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 GAMASTECH