Akern S.r.l. - European Leader in Bioimpedance Body Composition Analysis

Company Profile (Updated April 2026)

Akern S.r.l. is an Italian medical device company dedicated to the research, development, and manufacture of bioimpedance analyzers and diagnostic software for body composition assessment. Founded in 1980 and headquartered in Pontassieve, Florence, Italy, Akern has established itself over 45 years as a recognized European leader in bioelectrical impedance analysis (BIA) technology. The company's devices and software are trusted by physicians, researchers, dietitians, and sports professionals across clinical, nutritional, and athletic fields to deliver clinically significant diagnostic insights.

Development History:

- 1980: Akern founded in Italy with a mission to develop innovative bioimpedance technology for body composition Science

- 1980s–2000s: Built a strong scientific Foundation through continuous collaboration with the interdisciplinary research community; developed early BIA devices and validated regression equations for body cell mass (BCM), extracellular water (ECW), and fat-free mass (FFM) estimation

- 2001: Introduced the Soft Tissue Analyser (STA), a novel BIA method for predicting body cell mass and extracellular water without requiring height measurement, published in peer-reviewed clinical nutrition literature

- 2010s: Expanded product portfolio to include the BIA 101 Anniversary series, EFG-3 ElectroFluidGraph, and advanced software platforms including BodyGram, BodyGramPlus, and Bodygram Dashboard v.3.0

- 2018: Yann Inghilesi appointed Chief Executive Officer to lead corporate development and value creation

- 2022: Acquired by PharmaNutra S.p.A. (June 2022) for an undisclosed amount, becoming a wholly owned subsidiary and the Group's dedicated medical device division for bioimpedance analysis

- 2024: Recorded net revenues of €5.922 million; integration into PharmaNutra's distribution network accelerated international expansion

- 2025: Achieved €6.816 million in net revenues (+15.1% vs. 2024), of which €6.073 million from Italy and €0.744 million from foreign markets; launched the redesigned BIA 101 BIVA PRO (September) and the new NUTRILAB PRO (October)

- 2026: PharmaNutra Group obtained U.S. FDA registration and AEO (Full) status (February) and ISO 13485 certification (January) for its manufacturing facility; announced plans to expand Akern's product range in the U.S. and China with 3 new SKUs in Q3 2026 and 4 additional SKUs in Q1 2027; Akern celebrated its 45th anniversary

Core Mission: To stand alongside body composition experts, anticipating the needs of the future by opening new scientific and technological frontiers for the study of body composition. Akern aims to guide professionals toward innovative approaches capAble of responding to today's needs while anticipating those of tomorrow, supporting doctors and researchers in the fight against chronic degenerative diseases with clinically relevant diagnostic results.

BIA Technology ＆ Product Portfolio

BIA 101 BIVA PRO (Flagship Portable Analyzer)

The BIA 101 BIVA PRO is Akern's latest-generation phase-sensitive single-frequency bioimpedance analyzer, operating at 50 kHz with a tetrapolar technique. Launched in September 2025 with a redesigned proprietary case, it represents the company's most advanced portable BIA system.

Key Features:

- Signal Quality Index (SQI): Proprietary real-time signal validation system measuring five parameters—stability, variability, oscillation, drift, and motion—visualized via a 6-star rating to ensure measurement reliability

- Dual Measurement Configuration: Supports both TOTAL BIA (full-body analysis using standard tetrapolar technique) and REGIONAL BIA (assessment of single anatomical regions)

- Dual Working Modalities: Configurable for outpatient clinic practice or fieldwork, with a high-capacity database recording up to 150 analyses

- Advanced Battery Management: Recharges in approximately 2 hours, providing up to 5 hours of continuous use and supporting up to 200 measurements per charge

- Display: 5-inch capacitive touch-screen with icon-based graphic interface for immediate access to operating functions

- Portability: Lightweight ergonomic design at 600 grams (dimensions 20.5 x 15 x 4 cm)

- Safety ＆ Compliance: Class IIa CE Medical Device; tested for safe measurements on children, pregnant women, and patients carrying implantable medical devices or prostheses

- Accuracy: Device accuracy of 0.1% for both resistance (R) and reactance (Xc)

NUTRILAB PRO (Hospital ＆ Research System)

Launched in October 2025, NUTRILAB PRO is Akern's next-generation body composition analyzer designed specifically for hospitals, healthcare institutions, and research facilities. It is aligned with the most up-to-date guidelines of leADINg scientific societies including ESPEN, EASO, and EWGSOP.

Key Features:

- 7-inch capacitive display: Improved graphics and optimized screen display with highly responsive touch interface for simple, Intuitive, and fast workflow

- Clinical Decision Support: The only device that, in addition to body composition data, allows on-screen display of parameters and risk indices for malnutrition (SPhA, ASMMI), sarcopenia (FFMI, SMMI, HGS), and sarcopenic obesity (SMM/W, FM/W, HGS)

- Signal Quality Index (SQI): Real-time electrical signal quality assessment displayed via an intuitive 6-star system

- Portability: Compact and lightweight design ideal for nutritional and hydration status analyses in both hospital and home care environments

- Battery Performance: Up to 4.5 hours of continuous use

- Safety ＆ Compliance: Class IIa CE Medical Device, tested for safe measurements on children, pregnant women, and patients with implantable devices or prostheses

BIA 101 Anniversary ＆ Classic Series

Earlier-generation BIA 101 analyzers, including the BIA 101 Anniversary Sport Edition, remain widely used in clinical trials and research settings globally. These devices utilize the same 50 kHz phase-sensitive technology and are compatible with Akern's full software ecosystem.

EFG-3 ElectroFluidGraph

The EFG-3 ElectroFluidGraph Vector Impedance Analyser is a specialized device for advanced bioimpedance vector analysis (BIVA), enabling interpretation of impedance data independent of regression equations and body weight. It is widely used in research on hydration status, oncology, and chronic disease monitoring.

Software ＆ Digital Solutions

BodyGram / BodyGramPlus: Dedicated software for analyzing raw bioimpedance data (R, Xc, phase angle) and calculating body composition parameters including total body water (TBW), intracellular water (ICW), extracellular water (ECW), fat-free mass (FFM), fat mass (FM), body cell mass (BCM), and phase angle (PhA)

Bodygram Dashboard v.3.0: Advanced dashboard for classic and specific BIVA corrections, supporting clinical decision-making with reference population tolerance ellipses

Nutrilab: Software platform for nutritional assessment and body composition monitoring in clinical and sports environments

Consumables ＆ Accessories

- BIATRODES / BIVATRODE: Proprietary single-use adhesive electrodes designed for optimal signal transmission and reproducibility

- Calibration Circuits: Standard control circuits with known impedance (R = 383 Ω; Xc = 45 Ω) for daily device verification

Clinical Applications ＆ Evidence Base

Core Application Areas

Clinical Nutrition ＆ Malnutrition Screening:

- Nutritional risk assessment in hospitalized patients (NRS-2002 integration)

- Sarcopenia diagnosis and monitoring (EWGSOP criteria alignment)

- Cachexia and muscle mass evaluation in chronic disease populations

Chronic Disease Management:

- Heart Failure: Hydration and fluid status monitoring via BIVA in patients with cardiac remodeling

- COVID-19: Body composition assessment in hospitalized internal medicine patients for nutritional risk stratification

- Oncology: Longitudinal hydration and body cell mass evaluation in cancer patients

- Neuromuscular Disease: Sarcopenia and respiratory dysfunction prediction in ALS patients

Sports Medicine ＆ Performance:

- Body composition monitoring in Paralympians and endurance athletes

- Exercise-induced metabolic response assessment in trail runners

- Hydration status evaluation in athletic training protocols

Metabolic ＆ Weight Management:

- Obesity assessment and body fat percentage quantification

- Ketogenic diet monitoring and lipedema management

- Bone health evaluation in peri- and post-menopaUSAl populations

Regulatory Status ＆ Quality Standards

Certifications

- CE Mark (Class IIa Medical Device): BIA 101 BIVA PRO, NUTRILAB PRO, and core product line certified under EU Medical Device Regulation for clinical use

- Manufacturing Standards: Devices calibrated using precision verification circuits; accuracy validated at 0.1% for R and Xc

- Safety Testing: Verified for safe use on pediatric patients, pregnant women, and patients with implantable cardiac devices or prostheses

- ISO 13485: Parent company PharmaNutra obtained ISO 13485 certification in January 2026, harmonizing with FDA quality management requirements effective February 2026

- U.S. FDA: PharmaNutra manufacturing facility obtained FDA registration and AEO (Full) status in February 2026; Akern product U.S. market entry planned for 2026–2027

Financial Performance (2025 Fiscal Year)

Akern Segment Results (Within PharmaNutra Group)

- Net Revenues (FY2025): €6.816 million (+15.1% vs. €5.922 million in 2024)

- Revenue Share: Approximately 5.2% of PharmaNutra Group total net revenues (€131.687 million)

- Geographic Breakdown: €6.073 million from Italy (89.1%); €0.744 million from foreign markets (10.9%)

- Q3 2025 Performance: Net revenues of €4.969 million (+22.1% year-over-year), representing 5.5% of Group revenues for the nine-month period

- EBITDA Growth: Akern segment EBITDA increased by 19.9% compared to the previous year

- Goodwill: Akern cash-generating unit goodwill of €14.810 million as of December 31, 2025; recoverable amount exceeded book value by 40% in impairment testing

- Earn-Out Payment: Contractual Akern earn-out payment of €3.0 million paid in 2025

PharmaNutra Group Consolidated Context (FY2025)

- Group Net Revenues: €131.687 million (+14.0% year-over-year)

- Group EBITDA: €34.212 million (25.5% margin; 31.5% excluding new business units)

- Group Net Result: €20.002 million (+20.4% year-over-year)

- Global Presence: Products distributed in over 80 countries across Europe, Asia, Africa, and the Americas

Company Overview

Corporate Information

Company Name: Akern S.r.l.

Founded: 1980

Operational Headquarters: Via Lisbona 32, 50065 Pontassieve (Florence), Italy

Registered Office: Via Campodavela 1, 56122 Pisa, Italy

Parent Company: PharmaNutra S.p.A. (100% ownership since June 2022)

Company Type: Private Subsidiary (Wholly Owned)

Industry: Medical Devices / Bioimpedance Analysis / Body Composition Diagnostics

Leadership Team (2025–2026)

Chairman: Andrea La Corte

- Nutritionist and founder of the PharmaNutra S.p.A. group; describes himself as a salesman-inventor; has led the group since 1998

Chief Executive Officer: Yann Inghilesi

- Appointed CEO in 2018; co-founder and Managing Director of Red Lions S.p.A.; honours degree in Mechanical Engineering from the University of Pisa; MBA from Vlerick Management School, Leuven, Belgium

Chief Scientific Officer: Jacopo Talluri

- Degree in Electronic Engineering from the University of Florence; member of numerous international scientific communities; has led R＆D at Akern for over 20 years

President / Pioneer: Tony Talluri

- Pioneer and expert of impedance-based body composition analysis

PharmaNutra Group Structure

- PharmaNutra S.p.A. (Parent Company, Pisa, Italy) — Listed on Euronext Milan (Ticker: PHN); develops nutraceuticals and medical devices

- Akern S.r.l. (Pontassieve/Florence, Italy) — Bioimpedance medical devices and software

- PharmaNutra U.S. Corp. (USA) — North American distribution and e-commerce

- PharmaNutra España S.L.U. (Spain) — Iberian market operations

- Athletica Cetilar S.r.l. (Italy) — Sports medicine, physiotherapy, and athletic training (established 2024)

Global Market ＆ Competitive Landscape

Target Markets

Italy: Core domestic market accounting for approximately 89% of Akern revenues; direct sales through agents, distributors, and online channels; deep integration with hospital nutrition departments, sports medicine clinics, and research institutions

Europe: Primary foreign market representing the majority of international sales; strong presence in France, Germany, Spain, Poland, and the UK through PharmaNutra's distribution network; Europe accounted for 48.1% of PharmaNutra's foreign market total in 2025

North America: Target market for 2026–2027 expansion; PharmaNutra U.S. Corp. preparing market entry following FDA registration and AEO status obtained in February 2026

Asia-Pacific: Growth market with increasing adoption in china (cross-border e-commerce), Japan, and Southeast Asia; supported by PharmaNutra's cross-border e-commerce infrastructure

Other Regions: Sales in South Africa, Middle East, and Central America

Primary Competitors

- InBody Co. Ltd. (South Korea): Global market leader in multi-frequency BIA systems; approximately 20% global market share

- Tanita Corporation (Japan): Consumer and professional-grade BIA scales and analyzers

- Omron Healthcare (Japan): Home-use and clinical BIA devices

- Seca GmbH ＆ Co. KG (Germany): Medical-grade precision analyzers for hospitals and research

- COSMED Srl (Italy): Italian competitor in body composition and metabolic assessment

- GE Healthcare / Hologic (USA): DXA-based systems for high-precision clinical diagnostics

- RJL Systems (USA): Bioimpedance analyzers for research and clinical applications

Competitive Advantages

- 45-Year Scientific Heritage: One of the longest-established BIA manufacturers in Europe with validated regression equations and extensive peer-reviewed clinical evidence

- Signal Quality Innovation: Proprietary SQI technology ensures measurement reliability in real time, reducing operator-dependent variability

- Clinical Validation: Devices and equations validated across diverse populations including healthy controls, athletes, elderly, pregnant women, and chronic disease patients

- Dual Configuration Versatility: Unique ability to perform both total body and regional BIA assessments with a single portable device

- Group Synergies: Integration with PharmaNutra provides access to global distribution in 80+ countries, shared R＆D resources, and cross-selling opportunities with nutraceutical portfolios

- Regulatory Foundation: CE Marked Class IIa medical device status with FDA-registered manufacturing facility and planned U.S. market entry

- Guideline Alignment: NUTRILAB PRO explicitly aligned with ESPEN, EASO, and EWGSOP international standards for malnutrition and sarcopenia screening

2026 Outlook ＆ Strategic Priorities

Near-Term Objectives

- U.S. Market Launch: Leverage PharmaNutra's FDA registration and AEO (Full) status to introduce Akern products (BIA 101 BIVA PRO and NUTRILAB PRO) to the North American market

- Product Range Expansion: Launch 3 new SKUs in Q3 2026 and 4 additional SKUs in Q1 2027 per PharmaNutra Group strategy, including products tailored for the U.S. and Chinese markets

- International Revenue Growth: Increase foreign market share from 11% toward 20% of Akern revenues through distributor network expansion in Europe and Asia

- Digital Integration: Enhance cloud-based data management, mobile application connectivity, and EHR integration capabilities to align with global telemedicine trends

- Clinical Research Expansion: Strengthen partnerships with academic medical centers to generate new disease-specific BIVA reference data and expand indications

Contact Information

Corporate Headquarters

Operational Address: Via Lisbona 32, 50065 Pontassieve (Florence), Italy
   Registered Office: Via Campodavela 1, 56122 Pisa, Italy

Parent Company

PharmaNutra S.p.A.
   Address: Via Campodavela 1, 56122 Pisa, Italy
   Phone: +39 050 7846500
   Stock Exchange: Euronext Milan (Ticker: PHN)
   Website: www.pharmanutragroup.com

Akern Online

Website: www.akern.com
   Email: info@akern.com

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