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Etteplan supports Medtech companies with design and development. ISO 13485 certified our 70 consultant engineers and designers help large and small companies develop products in all MDD Classes I-III from idea to production. Offices are located in Stockholm, Uppsala, Halmstad, Lund, Copenhagen and Helsinki offering the following engineering skills: Usability, Innovation Workshops, Industrial Design, Mechanical Engineering, Hardware/Software Development, Project Management, Regulatory Affairs and Documentation

SpinChip; The ultimate point of care in vitro diagnostic platform of the future.

TECHNOLOGY. The SpinChip platform is based on unique patent pending lab-on-a-chip technology invented at SINTEF and to be industrialized and commercialized by SpinChip Diagnostic AS. The bioanalytical platform concept includes small polymer chips with integrated reagents being processed by a small (1.6L) low cost instrument. The concept allows for a variety of advanced analyses to be performed with very high accuracy from a fraction of a droplet within a few minutes. Potential application areas are within human and veterinary point of care in vitro diagnosis (PoC IVD) as well as within food, water and environmental analysis.       

The main advantages of SpinChip are extremely fast and flexible microfluidic sample processing and assaying, allowing for a variety of analyses to be performed fully automated at point of use settings at a low cost. The Spinning Chips instrument is based on a micro-centrifugal principle not including any pumps and valves. The availability of high centrifugal forces and the independence of design restricting interfaces make the platform particularly flexible in sample and reagents processing as well as being robust and inexpensive in production. Very fast and robust immunometric chemistries are being used in the pilot application. Further two complementary optical detection systems covering a very wide dynamic sensitivity range are included. These combined features make Spinning Chips superior to any existing bioanalytical platform. Samples that today have to be sent to advanced centralized laboratories will in SpinChip be analysed fast and reliable at a variety of point of use settings:  “Do more with less, better, faster and cheaper”.

MARKET. The main focus is on the PoC IVD market which is expected to grow from approximately 10B$ in 2011 to more than 30B$ in 2014. (Yole Development; POC 2010, March 2010). PoC IVD platforms on the market have essential limitations in; numbers of applicable parameters, sensitivity range, speed, reliability, robustness, sample handling and/or cost. The SpinChip platform has inherently the essential features of fulfilling requested requirements and becoming the leading PoC IVD platform of the future.

DEVELOPMENT PLAN: SpinChip Diagnostics AS intend to develop and install the first operating platform version at Oslo University Hospital, before partnering with a major diagnostic company for production and distribution. The milestone plan includes development of a true operating “work like” and “look like “ instrument prototype and injection molded chips for the analysis of the pilot panel of parameters within end of 2013.

CLINICAL FOCUS: SpinChip Diagnostics AS has identified several clinical fields where the platform will give substantial added value in use. These include cardiovascular disease, endocrinology, anemia, diabetics, drug of abuse, cancer, companion diagnostics, infections and non-communicable inflammations.

The pilot application of the platform is for very early detection, differentiation and monitoring of serious inflammatory reactions including severe sepsis. In the US there are more than 750 000 cases annually (210 000 proving fatal). Annual cost of treating sepsis within EU is approximately 7.6 billion Euros. In close collaboration with Oslo University Hospital we have selected a combination of parameters that will allow discrimination between various types of inflammations, in particular between viral and bacterial infections, but also those caused by non-communicable diseases. Time is usually very critical in these cases. None of the existing technologies allow for relevant diagnosis to be performed fast and efficient in relevant point of care settings. Using the SpinChip platform the measurement of several inflammatory parameters will be completed next to the patient within a few minutes using 10µL finger prick blood. Combining measurement of fast responding parameter released from the leucocytes (Calprotectin) with well established parameters (CRP and WBC) within one chip will represent a breakthrough in early identification, monitoring and discriminating between various inflammatory conditions.

The SpinChip platform with the first “sepsis application” will be launched 2016. As the SpinChip technology is extremely flexible both with respect to sample processing, assay principles and measuring range, a variety of advance analyses will be applied to the platform shortly after.

KEY STAFF: The inventor, Stig Morten Borch (CEO) was R&D director at Nycomed and at Axis Shield PoC having overall responsibility of the development of the NycoCard (www.axis-shield.com/NycoCard) and the Afinion (www.afinion.net) platforms respectively.

FUNDING:

SpinChip Diagnostics AS was founded in February 2012 as a spinoff from SINTEF. The Norwegian Research Council has confirmed supporting the development of the platform with 14,7 mill NOKs starting 2012. In collaboration with Oslo University Hospial and SINTEF a proposal for further funding by “Innovasjon Norge” is being prepared.

Several players have signaled their interest in participation in an investor consortium and two have signaled their interest in taking the lead. We are hereby inviting competent investors and strategic partners to participate.

Invest in Skåne is the official inward investment agency for Skåne. Our mission is to promote international investment and trade in Southern Sweden. We help with partnerships and assist businesses in getting access to new markets. We pursue our mission by facilitating contacts with international corporations, and by promoting the Life Science expertise already present in the region.

With several years of experience in business development and life science, our team will assist your company in a simple 4-step process:

1. We define your business and partnership goals and determine what technology, products and competencies you are looking for.
2. We identify local companies, academic institutions and CMOs/CROs in your field highlighting potential business opportunities.
3. We arrange a visiting programme where you can initiate explorative discussions with prospective business partners.
4. We will support your efforts to successfully complete your partnership or investment project.

Chundsell Medicals AB was founded in 2007 based on the need for a more specific system, the Prostatype test system, to diagnose prostate cancer and to predict the survival prognosis for patients. The test also distinguishes between the aggressive and non-aggressive tumors.

The business idea is to market and sell to the global market a complete diagnostic system consisting of reagents, an instrument platform and evaluation software. We strive to develop and produce frontline product solutions designed for optimal user compliance as well as fulfillment of the highest quality demands. Our product system will meet an urgent medical need and will have a positive impact on the overall health economy as well as preserve the quality of life for thousands of men each year.

The patent pending Prostatype test is based on real- time-quantitative-PCR (qPCR) where we analyze the expression of a set of genes in cancer stem cells. The expression of these genes can with high statistical significance identify patients with aggressive tumors (20%) from the ones with non-aggressive tumors (80%). The results are based on a clinical endpoint study where patients have been followed-up on for more than 20 years. The results have shown that the gene signatures can classify different tumor types, indicate overall and cancer specific survival and serve as a guide to the urologist to choose therapy like prostate surgery, radiation, hormone treatment or watchful waiting.