Akern: a legacy of 300 years of science in the world of bioimpedance
Over the course of the centuries, countless discoveries have paved the way for the use of bioimpedance analysis as a method of body composition analysis, allowing this technique to gain ground in the field of clinical research.
There is indeed a long tradition of using electrical currents in medicine. Luigi Galvani – the renowned 18th century Italian physiologist and anatomist best remembered for his studies on animal tissue conductivity – advanced a theory on a link between electricity and life. The Scientist’s great intuition was that muscle contraction was caused by “intrinsic electricity” in the muscle itself. This notion was taken up with enthusiasm by many physiologists who came after him.
In the latter half of the 19th century, R. Vigouroux theorised that the body’s response to an electrical current being passed through it could be useful for diagnosing some conditions.
This century, other great electrophysiologists like J. Nyboer, A.L. Thomasset (1962) and E.C. Hoffer (1970) applied bioelectrical impedance analysis in the study of bodily fluids.
Today, in Italy, AKERN develops new technologies with the same pioneering spirit that inspired those early exponents of this sector.
40 years of innovation in the world of body composition
1980THE EARLY DAYS
AKERN is established in Florence in early 1980, at a time when a growing number of companies are founded in the healthcare sector in Italy. It quickly develops into a bona fide biotech company, combining medical and engineering expertise and opening up hitherto unexplored paths in the sector of diagnostics and prevention.
AKERN DEVELOPS THE FIRST BIO-ANALYSERS FOR THE DIRECT MEASUREMENT OF RESISTANCE, REACTANCE AND PHASE ANGLE
In 1981 AKERN produces the first Computerised Impedance Plethysmography CIP 8/32 (hereinafter CIP PLUS) for the diagnosis of venous circulation in the limbs, validated thanks to one of the first European multicentric studies carried out on bioelectrical impedance.
A collaboration with Prof. J. Nyboer (world-renowned reference on bioimpedance at Wayne State University) culminates in the development of professional analysers sensitive to the impedance phase = Bioelectrical Impedance Analyser (BIA).
AKERN SUPPORTS THE FIRST VALIDATION STUDIES ON THE BIOELECTRICAL IMPEDANCE METHOD
The first financed studies focus on the effects of dehydration on cognitive function in US Air Force pilots during the Cold War. The usefulness of this new technology soon becomes apparent and AKERN is involved in validation studies of the technique with a view to allowing use of bioimpedance analysis as a non-invasive diagnostic method.1, 2
AKERN releases the first software for analysis of bioimpedance data.
THE FIRST TO PROVIDE THE BODY CELL MASS PARAMETER (BCM)
Thanks to the use of AKERN technology, 1990 sees the introduction of the Body Cell Mass (BCM) calculation, i.e. the metabolically active component of fat-free mass. A few years later, this parameter is acknowledged to be the best predictor of a subject’s nutritional status. ³
BIOIMPEDANCE VALIDATION STUDIES VS BENCHMARK TECHNIQUES
The ’90s sees the publication of a large volume of scientific validation studies by hospitals and universities using benchmark techniques: isotope dilution, DEXA, hydrostatic weighing, air displacement plethysmography, on different populations, ages and pathologies.4, 5, 6
The first studies on the use of Phase Angle as a prognostic indicator of various pathologies are published.
In 1993 the Haemoguard® reflection photoplethysmography is produced for monitoring fluctuations in blood volume during dialysis and for DVT diagnosis.
BIA 101: THE BENCHMARK FOR BODY COMPOSITION ANALYSIS IN AREAS RANGING FROM RESEARCH AND CLINICAL SETTINGS TO WELLNESS
Total-body impedance analysis begins to be used not only in clinical settings but also in the fitness and dietary sectors, quickly becoming a routine test. The reliability and accuracy of the BIA 101 device makes it the technology of choice of many researchers, as well as the benchmark device for body composition analysis. After its launch, the BIA 101 goes on to have four new releases and is cited in over 1500 articles in international journals.
A NEW APPROACH: BIOIMPEDANCE VECTOR ANALYSIS (BIVA)
AKERN’s close links to the scientific community enables the company to have a finger on the pulse of the sector’s needs. In the mid ‘90s, a number of studies begin to underline how the use of hydration-related constants in predictive formulas makes the conventional BIA approach less accurate for generating estimates in subjects with significant fluctuations in tissue hydration. To overcome this limitation, which slows the adoption of this technology in key areas of medicine, many researchers and manufacturers opt to settle for a quantitative approach and develop equations for specific diseases or physical conditions. By contrast, AKERN begins studies on the prediction of body composition based directly on the physical quantities of resistance, reactance and phase angle. The electrical values become the main protagonists of the analysis, not mediated by mathematical constants that reduce sensitivity and predictive ability.
CLINICAL APPLICATION OF THE BIVA APPROACH
In 1994 AKERN takes part in the first study on bioimpedance vector analysis, or BIVA. It is led by Professor Antonio Piccoli, Professor of Nephrology at the Department of Medical and Surgical Sciences, University of Padua.11
The study combines the “conventional” BIA approach with a qualitative-quantitative type approach: as in electrocardiography, vector analysis transforms the electrical properties of tissue into clinical data.
BIAVECTOR™ THE HYDRATION AND NUTRITION COMPASS
With Biavector™, AKERN is the first manufacturer to use Impedance Vector Analysis in its systems.
BODY CELL MASS INDEX: BODY CELL MASS AS A MALNUTRITION INDEX
1998 sees the publication of the first study to highlight how Body Cell Mass Index (BCMI) is more sensitive than Body Mass Index (BMI) for determining nutritional status in patients affected by pathologies and with an abnormal body composition.
NUTRITION SOLUTIONS FOR RENAL PATIENTS
AKERN begins importing the Renacare® line of foods for special medical purposes for patients with chronic renal failure.
CLINICAL APPLICATIONS OF VECTOR ANALYSIS
Vector analysis is va lidated for identifying fluid overload in renal patients and for obtaining so-called “ideal dry weight” in dialysis, for distinguishing between fluctuations in body fat (body fat analysis) and those in fluids in subjects with obesity, hepatic disease and, in general, for the non-invasive monitoring of hydration in critical patients. Subsequently, vector analysis becomes the technique of choice in clinical settings and, thanks to the use of AKERN technology, tangible results are achieved in the monitoring of critical patients, with numerous studies published in high impact journals.
From the year 2000, there is a substantial increase in the use of BIA for epidemiological purposes. In the third National Health and Nutrition Examination Survey (NHANES III), AKERN sensor technology is used by hundreds of American investigative centres.
SOFT TISSUE ANALYSER
AKERN develops the Soft Tissue Analyser device: the first sensor capable of estimating the amount of body cell mass (BCM) directly from the electrical characteristics of tissue, without the aid of the anthropometric parameters of the subject.
BIVA IN PAEDIATRICS
Bioelectric regulations for children, obtained using AKERN BIA sensors, are published and implemented in BODYGRAM™ software. 13
2008 • AKERN WINS THE FIBO AWARD
AKERN develops the first device for segmental impedance, BIA 101 Anniversary Sport Edition, based on the segmental measurement model by Leslie W. Organ.The technology is an immediate success and wins the FIBO Innovation Award (The European Award of the Fitness and Wellness Industry) in 2008.
2010LINES DEDICATED TO CLINICAL APPLICATION
The precision of AKERN products allows widespread adoption of bioimpedance-related technology. Many clinical consensuses and guidelines include BIA analysis for diagnostic purposes, citing publications produced with our technology. AKERN begins producing dedicated lines for clinical application, optimised for correct monitoring of patients suffering from chronic diseases.
After introducing the EFG Electro Fluid Graph® device, the first touch-screen BIA providing real time BIVA analysis, AKERN develops the first bioimpedance analyser dedicated to “Fluid Therapy” for patients with heart failure: Cardio EFG®.
NEPHROLOGY AND DIALYSIS
Thanks to collaboration with IRRIV, the International Renal Research Institute of Vicenza, and the support of the renal biomarkers industry, bioimpedance vector analysis becomes an optimised technique for hydration management in critical cardio-renal patients. AKERN transfers this innovation to the market, launching the product line Renal EFG®.
TECHNOLOGICAL ENHANCEMENT AND RESTYLING OF THE ENTIRE LINE OF BIO-ANALYSERS
AKERN’s BIA line is completely updated to incorporate the latest advances in electronics for medical devices. A new model for the management of segmental analysis is developed: BIA 101 Anniversary.
THE HYDRAGRAM™ AND NUTRIGRAM™ SCALES
AKERN enhances interpretation of bioimpedance and vector analysis data by developing the Hydragram™ and Nutrigram™ scales: two new diagnostic techniques for real-time classification of hydration and nutritional status.
2013 • NUTRILAB: THE POINT OF CARE HYDRATION AND NUTRITION TREATMENT
AKERN develops Nutrilab, for bedside monitoring of patient hydration and nutrition, and enables integration of bioimpedance analysis within hospital clinical practice.
2014 • BODYGRAM™ PLUS, THE MODULAR SOFTWARE
The new software platform BODYGRAM™ PLUS is developed. The new multi-element structure, comprised of a series of basic functions coupled with supplementary diagnostic modules, provides access to over 50 parameters and indices.
2019 • BODYGRAM™ THE NEW CLOUD-BASED PLATFORM
AKERN revolutionises its software architecture and offers its wealth of know-how and scientific progress in a single, dynamic cloud platform .
2019 • NUTRILAB IN ORBIT
The reliability of AKERN instrumentation for body composition measurement and the company’s consolidated collaboration with the most prestigious European research centres, seal its participation in the Nutriss project (https://www.akern.com/category/progetti-di-ricerca/riabilitazione/) in conjunction with ASI (Italian Space Agency), ESA (European Space Agency) and the Dept.of Internal edicine led by Professor Biolo of the University of Trieste.
2019 • TELEMEDICINE
This project stems from AKERN’s consolidated experience in the world of bioimpedance, an experience that today allows it to offer systems optimised for this market. The system comprises a new model of analyser, BIA 101 MED, developed by AKERN as an OEM product characterised by extreme ease of use and a dedicated cloud-based software platform. The system is able to determine the state of health of the subject based on body composition data, and to suggest the most appropriate supplements.
2019 • INTERNATIONAL PROJECT ON BIA REGIONAL ANALYSIS
AKERN starts a collaboration for research purposes with the University of Lisbon – Facultade de Motricidade Humana – and its group of sport science experts. The main aim is to validate a new measurement model for regional analysis of Muscle Mass, designed to track muscle injuries, recovery and dynamic changes in muscle, marking another major step forward in the evolution of body composition techniques.
- Kushner, Robert F., and Dale A. Schoeller. “Estimation of total body water by bioelectrical impedance analysis.” The American journal of clinical nutrition 44.3 (1986): 417-424.
- Lukaski, Henry C., et al. “Validation of tetrapolar bioelectrical impedance method to assess human body composition.” Journal of applied physiology 60.4 (1986): 1327-1332.
- Richardson RA, Fearon KCH, Hannan J, Cowan S, Watson W, Shenkin A, Garden OJ (1990) Estimation of body cell mass (BCM) in surgical patients by bioelectrical impedance analysis (BIA) compared with total body potassium (TBK) (abstract). Clin Nutrition.
- Kushner, R. F. D. A., Schoeller, D. A., Fjeld, C. R., & Danford, L. (1992). Is the impedance index (ht2/R) significant in predicting total body water? The American journal of clinical nutrition, 56(5), 835-839.
- Wang, Zimian, et al. “Hydration of fat-free body mass: new physiological modeling approach.” American Journal of Physiology-Endocrinology And Metabolism 276.6 (1999): E995-E1003.
- Chumlea, W. Cameron, et al. “Total body water data for white adults 18 to 64 years of age: the Fels Longitudinal Study.” Kidney international 56.1 (1999): 244-252.
- Sacks, Michael, et al. “HIV-related cases among 2,094 admissions to a psychiatric hospital.” Psychiatric Services (1995).
- Chertow, Glenn M., et al. “Phase angle predicts survival in hemodialysis patients.” Journal of Renal Nutrition 7.4 (1997): 204-207.
- Edefonti, Alberto, et al. “Changes in body composition assessed by bioimpedance analysis in the first 6 months of chronic peritoneal dialysis.” Advances in Peritoneal Dialysis 13 (1997): 267-270.
- Selberg, Oliver, et al. "Identification of high‐and low‐risk patients before liver transplantation: a prospective cohort study of nutritional and metabolic parameters in 150 patients." Hepatology 25.3 (1997): 652-657.
- Piccoli, Antonio, et al. "A new method for monitoring body fluid variation by bioimpedance analysis: the RXc graph." Kidney international 46.2 (1994): 534-539.
- Piccoli A. Identification of operational clues to dry weight prescription in hemodialysis using bioimpedance vector analysis. Italian Hemodialysis–Bioelectrical Impedance Analysis (HD-BIA) Study Group. Kidney Int 1998; 53: 1036–1043.
- De Palo, Tommaso, et al. "Normal values of the bioelectrical impedance vector in childhood and puberty." Nutrition 16.6 (2000): 417-424.
- Organ, Leslie W., et al. "Segmental bioelectrical impedance analysis: theory and application of a new technique." Journal of Applied Physiology 77.1 (1994): 98-112.