No ionizing emission for patient body [in comparison to X-ray method], allows for very frequent usage, especially in anti-osteoporosis pharmaceutical treaty.
Initial purchase price may be even ten times lower [in comparison to device, which used the X-ray method]
The method is characterized by the outstanding detection resolution and reproducibility due to the application of the innovative bioimpedance procedure enabling maximum elimination of the influence of the soft tissues surrounding the bones on the EIS response.
Internal self-calibration tool,
A clear user interface designed together with medical personnel measurements,
System for verifying the proper operation of the device.
Falling is the main reason of injuries among people above the age of 65. In Europe, due to injuries, elderly people visit the doctor 8,000,000 times a year. 105,000 of them are serious injuries. Each year, one elderly person out of ten is treated due to injury. In every fourth person, who has fallen, the injury permanently limits his movements and independence, and increases the risk of premature death.
The most important risk factor in fracture is the weakening of the bone structure due to osteoporosis. In the case of 1/3 of women, osteoporosis is responsible for one or more fractures during their lifetime. There can be hundreds of millions of people suffering from osteoporosis. An important impact on the frequency of osteoporosis related injuries is the patients’ unawareness, lack of stopping its progress, and counteracting its effects. Osteoporosis must be detected as early as possible, so the group that is most exposed – postmenopausal women – should be subject to regular check-ups.
With an accurate and early diagnosis, people with osteoporosis have a chance to stop the progression of the disease through a proper diet, healthy lifestyle, and appropriate medication.
There is a reliable device, considered to be the gold standard – Dual-energy X-ray Absorptiometry. However, examination with this device is troublesome. It also exposes the patient to a noticeable dose of ionizing radiation. DXA scanners are large and expensive devices, which can only be found in large medical centres (there are only about 20 DXA scanners per 1 000 000 of people). The main problem with the introduction of universal preventive testing is therefore, limited access to DXA devices. It is virtually impossible to examine the entire part of the population requiring this method of diagnosis.
The solution to this is the introduction of the two separate stages. Most people at risk of osteoporosis, undergo screening carried out by their GP. In this group people who are suspected of suffering from osteopenia or osteoporosis are identified and only they are referred for further screening. The main problem with the introduction of the dual-stage diagnosis of osteoporosis was the lack of a reliable and inexpensive method for screening. The technology developed by us may solve this problem.
The video presents MOsteoDD device in use.
Note the much darker colour of the inside of the bone in the second simulation. It shows that our innovative method, through the use of additional electrodes, allows almost total elimination of all other routes of the current flow, apart from the most interesting one – the test bone. This effect is achieved due to the introduction of additional potential causing current flow which is marked with yellow arrows.
Impedance spectra (real and imaginary parts – Z’ and Z’’ versus frequency) were measured for every patient. While for a single patient they were quite reproducible, significant differences in impedance curves (Z’’ versus Z’) between patients (red – osteoporosis, green – healthy) could be observed. In order to obtain a reliable diagnostic rule, a detailed statistical analysis of a large data set had to be applied.
The technology might be used to detect changes in bone properties resulting from other diseases, application of medicaments and chemical substances (e.g., steroids) or environmental factors. Separate clinical studies are required for such applications.
The effectiveness of the method was confirmed in two clinical studies upon 79 chosen patients – postmenopausal women without fractures and chronic diseases. The statistical analysis results for the second version of the device presented here have shown that it is possible to obtain a sensitivity and specificity above 80% against DXA.
To concisely present the results of the clinical trial, statistical report summarizing its two stages has been prepared. Here's the final fragment:
Contact us to obtain full summary
"Overall the method seems to give good results. While the set of parameters might be not final, i.e. the algorithm might need further tuning, it seems that results cannot be an effect of pure chance and the device already successfully determines state of most patients."
Bone Vitae S.A. is the sole owner of all patent rights in Polish patent number PL 218085 (granted in April 2014), Japanese patent (granted in April 2015) Chinese granted in January 2016 (CN102781315 (B) and two international patent applications. A first patent application number WO 2011/102743 A1 covers all rights for the method of treatment and detection of osteoporosis. The application entered the National Phase in Australia, Canada, China, Japan, South Korea and the United States as well as the European Regional Phase, which covered the European patent. A second patent application number WO 2013/128243 A1 called Method for Controlling Electrodes for Bio-impedance Measurements and Control Circuit for Electrodes for Bio-impedance Measurements concerning the device structure and functions was filed in February 2012. Bone Vitae SA has instructed Reddie & Grose LLP, England (UK) to act as its Patent and Trademark Attorneys.
MOsteoDD has received a certificate of conformity with EC directive 93/42/EEC for its product for osteoporosis screening and the company has PN-EN ISO 13485:2012. The CE marking allows the product to be sold in Poland and other EU countries.
Further clinical studies on wider population and expansion into EU, US and other markets are planned.
We are looking for investors to realise our plans. More information about the company and technology can be found below.
|A graduate of the Faculty of Law at the University of Wrocław and a the National School of Judiciary and Public Prosecution in Kraków. Legal adviser, member of the District Chamber of Legal Advisers in Wrocław. Gained professional experience in the judiciary as well as in renowned law firms handling business entities including commercial companies and partnerships. Specialist in commercial law and labour law. Runs her own law firm rendering services to the benefit of commercial companies and partnerships. Author of numerous legal opinions and expert reports, in particular within the scope of commercial law. Successful in handling court cases to the benefit of her clients. Participated in the development, assessment and negotiation of numerous commercial contracts. Since 2014 professionally related to Bone Vitae S.A. in which she first was a legal adviser and a proxy. Currently, holds a position of the President of the Management Board of Bone Vitae S.A.|
|Michal Tyc owns a PhD degree in physics. Together with Mr. Just, he deals with physics and bio-physics research. He is a co-author of the bio-impedance technology applied in the devices constructed in the Company. Since beginning, he is involved in the process of defining technical specifications. He is a specialist in computational algorithms, and has experience in design of hardware and software in innovative optical and electrical measurement devices. He co-authored several Polish and international patent applications in the field of bio-impedance technologies, voice analysis, and optical tomography, and co-owner of two granted patents.|
|Marcin Just is a scientist dedicated to physics and bio-physics. He has knowledge and experience in many fields of science and engineering: electronics, computer science, numerical analysis and image analysis, optics, physics, mechanics. He specializes in combining different technical and software solutions. During last 10 years he became a co-author of of four active patents and three patent applications in bio-impedance technologies, voice analysis, and optical tomography.|
|Professor of Chemistry at Industrial Chemistry Research Institute in Warsaw, with wide experience in bio-impedance and biomedical research, development and commercialization gathered both during domestic and international employments, including his work at Dundee and St Andrews Universities, Scotland, Spain, USA, Canada and France.|