SME Hot list

March 18, 2016

CEBR is delighted to announce the 2016 SME Medical Device Hot List.

The following 10 SMEs have been nominated by clusters across Europe as the SMEs that have demonstrated the best scientific or business advances since June 2016, when the Directory was launched.  Read and admire the following SMEs as the ones to watch.

Click here for the complete list of full profiles or on each individual company name for a specific profile.

  1. Aseptika (UK):  Selected as Innovation Partner for NHS England

Aseptika has also been confirmed as one of the innovators partnering with one of the five hospital centres selected by NHS England Innovation Test Beds, in which new approaches to healthcare provision will be assessed and adopted and two centres for the adoption of the Internet of Things (IoT) in healthcare.  Aseptika will trial and integrate its Activ8rlives solution for patients in Sheffield with respiratory disease into the new pathways of care.

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Associated cluster organisation: One Nucleus

2. egoHEALTH Ltd (IT): Winner of UV Product Innovation 2016 at World Congress of the International Ultraviolet Association (IUVA)

egoHEALTH’s new product Stet Clean® won the UV Product Innovation Award at the IUVA in Canada on February 16 2016.  Stet Clean® is an innovative and multi-patented device, which uses an Ultraviolet C Light Emitting Diode (LED), to break down/eliminate the transmission of microbes caused by the stethoscope, the most used medical device and potential source of Hospital Acquired Infections. These latter, produce: health complications, hospital mortality, increase length of hospitalization, and costs for treatments.

Stet Clean® does not interfere with the clinical activity, it is lightweight, portable (dockable to the health professional coat), good looking, customizable, practical, adaptable to all standard stethoscopes, technologically innovative, efficient (high operating speed) and effective, safe for the operator and the patient, cheap (convenient), cost saving, eco-friendly (no disposable) with a rechargeable battery, it allows also data collection (traceability).

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Associated cluster organisation: Tuscany Life Sciences Cluster & Foundation

3. Labrox Oy (FIN):  Launch of lateral flow reader prototype and award of optical component patent

Labrox Oy (FIN) launched a lateral flow reader prototype based on strips an Upcon technology at Medica in November 2015.   Labrox Oy, in partnership with Kaivogen Oy, two Finnish life science companies, introduced the Upcon™ Upconverting nanoparticle system featuring a new addition into the reader-family designed especially for lateral flow applications. The revolutionary technology enables lateral flow assays with ELISA sensitivity.

January 15th 2016 also saw Labrox receive its second patent on the company’s ground breaking dynamic filter storage carousel with positive filter ID tracking. The patent approval no.125682, ”Apparatus and Method for measuring of optical component” can identify filters by actually measuring the spectral properties of a unknown filter (Finland patent. EU submitted).

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Associated cluster: Turku Science Park

4. Lemer Pax (FR): World premier for launch of new Posijet

With a world premiere at the EANM congress (European Association of Nuclear Medicine) in Hamburg in October 2015, the new Posijet® was launched by LEMER PAX.  It is the first company worldwide to have developed a mobile unit for the preparation and injection of high energy radiopharmaceuticals.   A new feature allows measuring the mother solution by sampling to verify precisely the volumetric activity contained in the multidose vial, to adjust the data for purposes of clarification and to avoid any data entry errors. The possibility of diluting the vial provides more flexibility of work, optimizing the volumetric activity in accordance with the patient doses to prepare and facilitates the organization of the appointment scheduling.

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Associated cluster organisation: Atlanpole

5. MedaPhor Group plc (UK): American Board of Obstetrics and Gynecology (ABOG) sign agreement to develop MedaPhor’s ScanTrainer simulator for potential use in future ABOG examinations

MedaPhor North America, Inc., its US based provider of advanced ultrasound skills training simulators for medical professionals, has signed a long term agreement with the American Board of Obstetrics and Gynecology (ABOG) for potential use of ScanTrainer as the ABOG’s ultrasound skills examination simulator within its obstetrics and gynecology certification exams.  The ABOG is the official body for certifying obstetricians and gynecologists in the United States and conducts nearly 2,000 certification examinations per annum. The agreement with MedaPhor will involve the development of ScanTrainer examination modules and the purchase of ScanTrainer simulator systems.

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Associated cluster organisation: Mediwales

6. Mensia Technologies (FR): €3.6 million SME Instrument Award

Mensia Technologies, founded in 2012 by French pioneers in the field of Brain-Computer Interfaces (BCI), has been awarded a €3.6 million SME Instrument grant in order to undertake a pan-European multicenter clinical study to demonstrate its efficacy and to accelerate the development of a novel, non-invasive therapeutic medical device for children with ADHD*.

The device is made up of an EEG headset coupled with a tablet and is based on a “serious game” which provides visual or auditory feedback of the brain activity in real time (TRL 7). The core of the technological innovation is the software suite NeuroRTtm designed for the development of applications for real-time monitoring and analysis of EEG signals.

*Attention Deficit Disorder with or without Hyperactivity

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Associated cluster organisation: ID2Santé

7. Nodea Medical (FR): CE marking aproval of its minimally-invasive Probea® device designed to aid the real-time diagnosis of breast cancer.

Nodea has obtained CE marking for its Probea® medical device to aid in the diagnosis of breast cancer using a sterile needle. The CE marking was awarded as the company is enrolling final patients in a multi-centric national clinical study to confirm the performance of Probea® in the diagnosis of suspicious breast tumours.

In addition to obtaining CE marking for the Probea® device and the Probea® sterile optical fibered-needles, Nodea Medical has achieved NF EN ISO 13485:2012 and ISO 13485:2003 certifications. These medical device certifications attest to the quality management system set up by Nodea Medical and the company’s ability to design, manufacture and distribute medical devices to aid cancer diagnosis, in compliance with current European regulatory requirements.

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Associated cluster organisation: Medicen

8. Senzime (Sweden):  OnZurf probe nominated for Sweden’s Athena Award

Senzime’s (publ) OnZurf probe has been nominated for Sweden’s largest prize for outstanding achievements in clinical research. The Athena Award recognizes research done in collaboration between healthcare, academia and industry, and the research shall be of benefit to patients and healthcare.

The current treatment today is mainly surgery with risk of multiple operations and increased mortality rate. OnZurf Probe’s technology can make it possible to post-surgically follow the healing process and provide early signs of complications. The study is expected to start by the end of the year.

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Associated cluster organisation: UppsalaBio

9. VolitionRx (BE):  75% Accuracy in Detecting Highest-Risk Pre-Cancerous Colorectal Adenomas with NuQ® Blood Test

Company’s NuQ® blood test accurately detected 75% of colorectal adenomas, or pre-cancerous polyps, that were most likely to become cancerous. A panel of five of NuQ® biomarker assays also detected 86% of early (stage I) colorectal cancers. The completed clinical trial of 430 patients was conducted with the Hvidovre Hospital and with the University of Copenhagen in Denmark.

The study was specifically designed to assess the effectiveness of VolitionRx’s NuQ® blood-based biomarker assays in detecting adenomas before they become cancerous, as well as early stage colorectal cancer. If adenomas are caught early enough and removed, the risk of subsequent cancer is significantly reduced.

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Associated cluster organisation: Biowin

10. Zilico Ltd (UK): 1,000-patient case study published for ZedScan

Zilico has published a 1,000-patient case study for its cervical cancer diagnostic system, ZedScan.  The patient review into the routine use of ZedScan as an adjunct to colposcopy has revealed that the technology significantly increases the rate of detection of high-grade cervical intraepithelial neoplasia (HG CIN).  Clinicians at Sheffield Teaching Hospitals NHS Foundation Trust’s colposcopy clinic are routinely using ZedScan alongside colposcopy. They assessed the impact of ZedScan on the patient pathway over a period of 18 months for women referred with abnormal cytology.

The data revealed that from a total of 1,052 women examined, an increase of 12.4% in the detection of high-grade cervical intraepithelial neoplasia (HG CIN) was demonstrated following the introduction of ZedScan into routine use.

There was also a marked increase (57.4%) in the number of cases of high grade disease detected in women referred with mild or borderline abnormalities.

Benefits in patient management were also evident with the rate of treatment at first visit (See and Treat), increasing from 36-39% in previous years to 61% of all high-grade referrals; high-grade disease was confirmed in 97.7% of the cases.

The report concludes that adoption of ZedScan has created opportunities for more-efficient use of resources by offering ‘See and Treat’ as well as providing the reassurance to release women without disease to routine surveillance and reducing the need for further follow-up.

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Associated cluster organisation: TRUSTECH

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