Vision

Our mission is driving tissue-identifying bio-impedance needles to
1) Start the transformation of lumbar puncture towards impedance augmented
2) Introduce tissue-identifying biopsy tools for tumors including cancer

How It Works

Injeq has developed bioimpedance based tissue identifying products for medical use.

Injeq IQ-Needle - tip detail
Injeq IQ-Needle - tip detail

Tissue identifying Injeq IQ-Needle feels like a high quality spinal needle. Injeq IQ-Needle includes a unique electrode that allows bioimpedance measurement of the tissue in contact with the tip of the needle.

A proprietary low energy measurement signal allows Injeq BZ-301 to analyze the changes in signal caused by the tissue contact, and calculate the impedance in multiple frequency points. The calculation is compared against a statistical tissue model in real-time and a simple text for tissue type is shown to user or an audio alert is made. The measurement is continuous and repeated hundreds of times every second.

In practice the user will enjoy real-time tissue identification in his/her application.

Key attributes of Injeq technology portfolio:

  • Medical grade real-time impedance measurement conforming to IEC 60601 and  IEC 62304
  • Proven real-time tissue identification (in vivo clinical studies)
  • Bi-polar electrode design for space constrained needle tips
  • Statistical tissue models based on proprietary tissue database
  • Parametric configuration of analyzer which allows developing new applications in rapid manner

 

Real-Time Bio-Impedance Spectroscopy

3D Impedance Plot
Impedance spectrum plot from a real spinal puncture using Injeq IQ-Needle

This image illustrates impedance frequency dependency over time in a continuous measurement session during a spinal puncture. Blue tissue in the end of the time series has been identified as fat and magenta as cerebrospinal fluid. Data source is clinical study.

Injeq has patents issued and pending. The products have been used in two clinical studies and third study is currently in planning phase.

Clinical Research

Clinical research has been on-going since 2014. A Study on spine structures and use of bio-impedance tissue sensing in adult population is currently ongoing. This investigation is performance study by nature and first results have already been published.

Following the research success in adult population a study about Injeq IQ-Needle use among pediatric patients prescribed for a diagnostic spinal fluid sample was started in August 2016.

A clinical study is about identification of liver tumors using bio-impedance core biopsy needle is another parallel research activity. The study was started in June 2016.

According to best practices of the industry also Injeq registers all studies in clinicaltrials.gov.

 

Publications

Halonen S, Kari J, Tammela O, Kronström K, Eskola V (2017) Accurate detection of cerebrospinal fluid from the tip of the IQ-Needle™ in pediatric lumbar puncture – preliminary results of clinical study. Abstract and a poster in the 2nd Congress of joint European Neonatal Societies, Venice, Italy 2017.

Halonen S et al (2017) Biopsy needle with local bioimpedance measurement and real-time tissue classification. Conference poster on July 14th, 2017 - EMBEC2017.

Halonen S et al (2016) Detection of spine structures with Bioimpedance Probe (BIP) Needle in clinical lumbar punctures. Journal of Clinical Monitoring and Computing. First online: August 4th, 2016. doi: 10.1007/s10877-016-9915-8

Halonen S et al (2016) Bioimpedance Probe (BIP) needle in spinal anesthesia - a conference abstract ICEBI 16, Stockholm.

Halonen S et al (2016) Synovial fluid detection in intra-articular injections using Bioimpedance Probe (BIP) Needle – a clinical study. Clinical Rheumatology. First online: February 12th, 2016. doi: 10.1007/s10067-016-3210-4

Halonen S et al (2015) Biopsy needle including bioimpedance probe with optimized sensitivity distribution. International Journal of Bioelectromagnetism, Vol. 17, No.1, pp. 26-30, 2015.

Parmanne P et al (2015) Novel injection needle with real-time detection of synovial fluid – Exploratory clinical study. EULAR 2015 Congress late breaking abstract and oral presentation, Rome. doi: 10.1136/annrheumdis-2015-eular.6559

Kari J et al (2015) A thin needle with bio-impedance measuring probe: tissue recognition performance assessed in in vivo animal study. Injeq White paper

Kari J et al (2014) In-Vivo tissue identification using bioimpedance spectroscopy with conventional anaesthesia needles. Euroanesthesia 2014 Congress poster presentation ESALBA-5, Stockholm

 

Quality system

Injeq operates under a comprehensive quality management system (QMS) designed to meet the requirements defined by ISO 13485:2012 and European Medical Device Directive 93/42/EEC.

The plan for certification of QMS has been aligned with CE-marking of first commercially available products.

 

Collaboration

Injeq has active clinical research ongoing with Helsinki University Hospital (HUS/HYKS) and Tampere University Hospital (TAYS) and new collaborative research is constantly being planned.

Injeq also collaborates in reasearch with Eliko OÜ through participating in Competence Centre Project (EU48693) in which Injeq is involved in development of new technologies in the focus area of sensing and signal processing in the IoT.

Please see Competence Center Program pages.

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