"Early Non-Invasive Microcirculation-based Detection"

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picture1 DermaFlow has developed a non-invasive proprietary technology that simply, accurately and cost effectively measures directly dermal blood flow (microcirculation in the capillaries). The company's bold mission is to evolve this product into a routine measurement tool that can be utilized to increase the quality of patient care in three important healthcare environments; in-patient, out-patient and home situations. Abundant data has shown that a preponderance of disease states or illnesses, estimated at close to 90%, directly or indirectly result in microcirculation insufficiencies. Therefore, having a simple, non-invasive, easy-to-use, and cost-effective way to monitor the microcirculation is of significant value to modern healthcare.

These peripheral blood flow (dermal) changes are amongst the very first to occur in a multitude of acute and chronic medical situations including multi-organ dysfunction, sepsis, shock, vascular (Peripheral Arterial Disease) insufficiencies and cardiovascular distress (Congestive Heart Failure, Coronary Arterial Disease), etc. and, therefore, this platform lends itself to become a premier early-alert monitoring system which will integrate well into the emerging telemedicine scene in a timely way. There are also a host of other non-acute medical applications that this technology can add value to as a monitoring tool, i.e. wound healing, diabetes, peripheral neurological disorders, neonatal, physiotherapy, etc.

Unlike other non-invasive devices in this overall niche, i.e., laser Doppler and pulse oximetry, which are optically based, DermaFlow's technology is thermally based, and, therefore, essentially a direct measurement of peripheral flow, very sensitive and very cost-effective. More specifically, DermaFlow's technology takes into account thermal conductance and convection principles with its skin contacted sensors. DermaFlow has already developed a first generation working prototype device with which multiple early proof-of-concept clinical studies on humans were conducted in the US and Israel, in the acute care, vascular and wound healing fields. The company is ready with designs and developers/manufacturers for an advanced device version (2nd generation) which will be targeted to the market. This version will have disposable sensors, micro-processing, on-line connectivity to a PC, and proprietary software having appropriate graphical displays. A 3rd generation wireless and wearable sensor with direct transmission, preferably via mobile phone, is already in the design stage.

DermaFlow anticipates a streamlined regulatory track with a 510 K predicate device strategy to affect a timely launch in the US market, earlier in Europe and Asia. This technology lends itself to multiple medical (and non-medical) applications and, therefore, affords a very attractive ROI. The opportunities are vast as DermaFlow technologies spans in-patient, out-patient and home care monitoring needs. Essentially, DermaFlow sensors will be able to be interfaced with a variety of existing or future monitors to act as embedded or remain as stand- alone devices.

DermaFlow's management and advisory team includes veterans of medical device innovation and commercialization, electronic monitoring systems, health care regulatory/reimbursement strategists, medical device marketing and entrepreneurial financing.

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