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Vascular Optical Tomographic Imaging System” We help diabetics keep their feet

Periodic Reporting for period 1 - VOTIS (Vascular Optical Tomographic Imaging System” We help diabetics keep their feet)

Reporting period: 2019-08-01 to 2020-03-31

A wound in the foot of a healthy person heals naturally, in part because blood carries oxygen to the site of the wound and helps it heal. If a diabetic were to get the same wound, lack of blood flow, and/or oxygen in the blood, may prevent or slow wound healing. This lack of blood flow, or lack of oxygen, in the lower extremities is Peripheral Artery Disease (PAD).
Diabetics get PAD far more often than do non-diabetics. Because of this increased rate of PAD in diabetics, organizations recommend that diabetics who are more than 50 years old, have had active diabetes for 10 years, or smoke should be tested for PAD every year.

There is no good way to check the feet of diabetics for PAD. Different tests offer advantages, but no other test offers the comprehensive ability to inspect the arteries and the tissue deep within the foot with pinpoint accuracy and identify the specific locations and extent of PAD. For use with non-diabetic patients, the gold standard is the ankle-brachial index (ABI). However, the ABI is inaccurate in diabetics because their arteries often become calcified, and this makes it difficult to read blood pressure in the ankle. Moreover, the ABI only provides a non-specific reading at a location above the foot, and its results are not reliably reproducible. Ultrasound can measure blood flow in legs but does not work on the feet, and it does not measure oxygenation. Angiograms, CTs and MRAs are expensive and invasive. Hyperspectral imaging and the ox-imager scan the surface of the foot and cannot measure blood flow or oxygenation deep within the foot. The SmartMat can detect nascent foot ulcers on the bottom of the foot but does not detect PAD.

VOTIS Subdermal Imaging Technologies, Ltd. (“VOTIS” or the “Company”) helps people who are suffering from chronic limb-threatening ischemia (CLTI) to keep their feet.
During the last 8 months VOTIS has carried out a feasibility study to confirm the technical, commercial, and financial viability of its innovative solution. Results have been positive, showing that VOTIS has a market opportunity for rapid growth because of the lack of specific solutions addressing diabetics at risk for PAD. This is encouraging us to continue the project and better identify how we can overcome the risks and successfully enter the market.

Participation in the Horizon2020 program has broadened the Company’s perspective, enabled us to reconceive of the nature of our flagship products in design, functionality, and price, and also to speak with key European opinion leaders. In particular, the device was redesigned to be a patch-based system similar to EKG rather than a shoe-like device. In addition, the Company reconceived the VOTIS system as a suite of devices to accompany the diabetic throughout the patient journey from screening of asymptomatic PAD through monitoring the disease progression through adding valuable data during a revascularization procedure itself, to post-procedural monitoring.
Based on the revised design and functionality of the VOTIS suite of devices, the Company was able to begin discussions with TUV SUD, a leading European notified body, about the classification of the VOTIS devices and the process to receive CE Marking, and we were gratified to learn that it is likely to be characterized as a Class IIA device.

The feasibility study allowed us to analyse the market more deeply and understand how to enter it with our innovative technology. As will be detailed throughout this document, VOTIS evolved from the unique device we had conceived of at the beginning of our participation in the Horizon2020 program to a suite of products fitting the specific needs of our targeted customers and accompanying them throughout the patient journey.

Thus, as a consequence of the Phase-1 grant, VOTIS is developing three specialized medical imaging devices based on patented technology licensed from Columbia University. All three of VOTIS’s devices assess blood (perfusion) levels in specific regions of the foot, and two of them also assess levels of oxygen saturation: 1) PedFlo™, 2) PedStage™, 3) PedCheck™.

The current alpha-stage PedFlo™ prototype has been tested on 10 human patients in the operating suite during revascularization procedures. The prototype PedCheck™ has been tested on more than 100 human subjects, most of whom were examined longitudinally over a period of several months. The prototype PedStage™ has been tested on more than 40 human subjects.
The concept