Akern: the legacy of the 20th century

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 second half of the 19th century, R. Vigouroux theorized that the body’s response to the application of electrical current could be useful for diagnosing some diseases.

During 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 body fluids.
With that same pioneering spirit that inspired those Scientists and researchers in the early days, AKERN® develops continuously new technologies related to Body composition.


40 years of innovation in the world of body composition

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1980THE EARLY DAYS

BIOTECH PIONEERS

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 evaluation of the venous circulation in the limbs, validated through the first European multicentric studies carried out on bioelectrical impedance.
A collaboration with Prof. J. Nyboer (world-renowned reference for bioimpedance, based at the 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 becomes clear very soon and AKERN® is involved in technique validation studies with oriented towards allowing the use of bioimpedance analysis as a non-invasive support to diagnostics.1, 2

BODYCOMP DOS

AKERN® releases the first software for bioimpedance analysis.

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1990SCIENTIFIC PROGRESS

THE FIRST TO PROVIDE THE BODY CELL MASS PARAMETER (BCM)

In 1990, AKERN® technology introduces the possibility to calculate the Body Cell Mass (BCM), 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

In The ’90s number of clinical studies are published by hospitals and universities using benchmark techniques: isotope dilution, DEXA, hydrostatic weighing, air displacement plethysmography, on different populations, ages and pathologies.4, 5, 6

PHASE ANGLE

The first studies on the use of the Phase Angle as a prognostic indicator of various pathologies are published.The first studies on the use of the Phase Angle as a prognostic indicator of various pathologies are published.

PHOTOPLETHYSMOGRAPHY

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 within the fitness and nutrition environments, 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. Since its first launch, BIA 101 evolves though four new releases and is cited in over 1500 articles in international journals.

A NEW APPROACH: BIOIMPEDANCE VECTOR ANALYSIS (BIVA)

Thanks to a long history track of partnership with the scientific community, AKERN® has always been close to the professionals needs. In the mid ‘90s, a number of studies high lightened that keeping the hydration as a fixed parameter (73,2%) within predictive formulas makes the conventional BIA approach less accurate, when analyzing subjects that do not have a constant tissue hydration. This limitation slowed down the technology adoption especially in clinical use. many researchers and manufacturers opt to settle for a quantitative approach and to develop equations for specific diseases or physical conditions. By contrast, AKERN® initiates studies on the prediction of body composition based directly on the physical measurement of resistance, reactance and phase angle. The electrical values become the main protagonists of the analysis, independent from mathematical constants that reduce sensitivity and predictive ability.

CLINICAL APPLICATION OF THE BIVA APPROACH

In 1994 Professor Antonio Piccoli, Professor of Nephrology at the Department of Medical and Surgical Sciences, University of Padua.11, chooses AKERN® technology to validate the first study on bioimpedance vector analysis, also known as BIVA.

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

A landmark study published in 1998 highlights that 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 validated for identifying fluid overload in renal patients and to obtain the so-called “ideal dry weight” in dialysis, that allow to distinguish 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, many studies are published in high impact journals using the reliability and precision of Akern technology for the monitoring of critical patients.

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2000CONSTANT EVOLUTION

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 the 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.

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2010LEADERSHIP

The precision of AKERN® products allows widespread adoption of bioimpedance-related technology. Many clinical consensus reports 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.

CARDIOLOGY

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 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® optimizes the 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.

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2013INNOVATION

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® DASHBOARD THE NEW CLOUD-BASED PLATFORM

AKERN® revolutionizes 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 sensors for body composition measurement and the company’s consolidated collaboration with the most prestigious European research centres, seal its participation in the Nutriss project 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 • BIA 101 MED FOR TELEMEDICINE

This project stems from the consolidated experience in the world of bioimpedance that today allows AKERN® to offer a system customized for telemedicine. 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 customized to the subject.

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. The result of this partnership will be the Regional analysis module, launched on the market the following year as Regional App.

2020 • BIA 101 BIVA® PRO ANALYZER

BODY ASSESSMENTS
The first bioimpedance analyzer capable of performing both Total body analysis and single anatomical region analysis through the new Regional App (Regional kit is supplied separately upon request); the sensor is validated on the real anatomical path of the current, that follows the muscular fibers. BIA 10 1BIVA® PRO also provides a quality index of the bioelectrical data measured (SQM, Signal Quality Manager).

2021 • SPECIFIC FUNCTIONAL APPS IN THE BODYGRAM PLATFORM – FITNESS APP

The performance of the BODYGRAM® software is extended with the new functional applications (APPs) designed to respond to specific needs of specific professionals. After the Regional App, Fitness App is made available in the market to sports and fitness experts.

 


Bibliographical references:
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Sacks, Michael, et al. “HIV-related cases among 2,094 admissions to a psychiatric hospital.” Psychiatric Services (1995).
  8. Chertow, Glenn M., et al. “Phase angle predicts survival in hemodialysis patients.” Journal of Renal Nutrition 7.4 (1997): 204-207.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. De Palo, Tommaso, et al. "Normal values of the bioelectrical impedance vector in childhood and puberty." Nutrition 16.6 (2000): 417-424.
  14. 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.
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