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DeHCA Light & Sound (DeHCA L&S)

DeHCA Light & Sound (DeHCA L&S) is an innovative medical device aimed to detect breast tumors’ preparatory stages before tumors are settled and visible, independently of breast density and size.

 

 

DeHCA L&S is based upon optical and ultrasound technologies, not ionizing, painless and riskless. It will:

  • change the present paradigms: from radiations to optical light and ultrasound, from looking for tumors to looking for tumor indicators first (neo-angiogenesis), from only morphological to functional + morphological information;
  • change the market structure bringing screening from few large Hospitals only to many Health Centers on the territory, making breast screening really available for crowd.

 

 

The DeHCA L&S breakthrough idea is that, in early stage tumors, it is easier to find the tumor-feeding vascular network rather than the tumor itself, because the vascular network arises early in the disease, and results in vascular changes affecting vessels beyond the tumor itself, thus being earlier identifiable. Identification is achieved evaluating the DeHCA biomarker (Deoxy Hemoglobin Concentration Alteration) which represents the variation of concentration of deoxy-hemoglobin within the breast tissues and its abnormal values can be associated to the neo-angiogenesis at the root of the formation of new tumors.

DeHCA L&S has been designed to fulfil the following fundamental requirements:

  • Intended Use: revealing early stage tumors independently of breast density and size;
  • Applications: prevention and screening, with particular attention to young women;
  • Features: simultaneous functional and morphological analysis.

DeHCA L&S’ design is:

  • Essential: simple, easy and focused to result
  • Light: small and light
  • Pleasant: smooth and embracing contours, soft colors.

With DeHCA L&S physicians perform an initial optical examination with the objective to identify and locate areas of likely lesions. If any suspect areas are identified, physicians proceed to an ultrasound examination to exactly locate and qualify the lesion and eventually support a guided biopsy.

DeHCA L&S is made of the following main subsystems:

Breast Holder: the reliability of the combined functional – morphological examination depends on the correct positioning and immobilization of breast during the two exams. The Breast Holder is based upon an innovative silicon Pressure Applicator patented by Novaura, where a simple pressure/vacuum mechanism makes the external ambient pressure to be superior to the pressure inside the breast holder. In this way the silicon membrane collapses on the breast and, perfectly adhering to it, provokes its immobilization on a properly shaped platform.

Optical Information Acquisition: 49 LED’s are placed below the platform to illuminate the breast with bottom-up 640nm red light. 640nm is the wavelength at which healthy and pathologic tissues show the maximum difference in transparency. 

At the same time, a mild pressure exercised by the applicator stops the capillary blood flow for a short while.

Since transparency is lower in case of tumor neo-angiogenesis, its evaluation allows to predict the presence of pathologic vessels.  

 
A CCD camera situated above the scan area acquires images of the breast vessels network, discriminating normal and pathologic areas according to their red light absorption. Acquired images are post-processed and displayed in form of chromatic map on the monitor.

Ultrasound Information Acquisition: an ultrasound transducer, hosted below the CCD camera, is used to exactly locate the lesion identified by the optical scan. The ultrasound examination is carried out in cranium-caudal way with wide access to axillary regions.

Presentation Software: ultrasound and functional images can be directly compared. Both the optical and ultrasound examinations are carried out with the patient sitting on an adjustable chair, thus avoiding any risk of damage from swoon, minimizing patient’s stress and preventing from moving during the examination.


 Functional and Morphological Images

Early detection leads to less invasive interventions, tumor treatment before it spreads to nearby parts of the body, therapy tuning in real time, saving lives. However, today women below 50 and all those with dense breast have a very limited access to screening because mammography proves ineffective in presence of dense breasts and uses x-rays and breast glandular tissue has a high radiosensitivity to the used ionizing radiations, particularly in premenopausal women.

DeHCA L&S overcomes these limitations.

Moreover, the combined optical and ultrasound examination ensures important improvements:

  • Cost reduction: one device versus two, one exam and one site versus two exams and two sites;
  • Safer diagnosis: comprehensive diagnosis based upon the two examination findings;
  • Smoother treatments: less biopsies, less and lighter surgical interventions, softer radiant and drug therapies, reduced costs for physical rehabilitation and psychological support;
  • Shorter duration of inability to work.

Today, it can be claimed that DeHCA L&S has no competitors on 1st level diagnosis on young women; it strongly differentiates from existing diagnostic techniques and no competitors can claim riskless and painless early detection capability, no need for sophisticated environment, and ease-of-use.