ABOUT

Next round 2022
for FDA and commercialization 

Mom’s melanoma leads Dr. Aharon to invent a device for early detection. He delivered the device to his mother in Dec 2021.

https://www.israel21c.org/moms-melanoma-leads-to-israeli-device-for-early-detection/

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התקנת מאורות לשמח עולם

patternox ltdis a new Israeli start-up that developed an innovative scanner, capable of detecting precancerous skin deformations much earlier than any other scanner in the market with a high rate of accuracy. This detection does not rely on the ubiquitous mole color change but rather on deformations occurring below the skin surface. The technology (patent pending, PCT) combines innovative electro-optics with artificial intelligence (in Dev) to achieve this breakthrough. BETA Prototype of the PatScope scanner has already been used by dermatologists to successfully achieve early-stage detection of skin deformations as cancer and cosmetic problems, in trials at SKINCENTER, USA.

 

accomplished to date

 Clinical trial with over 400 scans.

Regulatory strategy. GSAP training (https://www.gsap.co.il).

 PCT patent submission 2022. 

New PatScope Scanner with its Software and database.

Business plan, business model.

 New electro-optics laboratory.

Conferences presentations.

Proposal to Space agency to investigate astronaut's skin degradation under microgravity conditions.

 

business model

 Sales of the scanner (physicians and home use) as standalone or adapter for smartphones

 Software analysis and management

 Unique AI for lesion distortion as decision support (SaaS)

 Reimbursement.

 

According to our Regulatory Pathway, PATTERNOX shall expect CE approval and FDA approval. 

market

Skin cancer is the most common cancer in the United States. One in five Americans will develop skin cancer in their lifetime. More than 9,500 people in the U.S. are diagnosed with skin cancer every day. On average, more than two people die of the disease every hour.  The annual cost of treating skin cancers in the U.S. is estimated at $8.1 billion (https://www.skincancer.org/skin-cancer-information/skin-cancer-facts). According to MARKETSANDMARKETS:  “The global dermatology devices market is expected to reach $ 14.17 billion by 2021 from $ 8.22 billion in 2016.

need

The current method of clinical diagnosis is limited to the color or pigmentation of skin lesions. But color changes are a later stage of lesion’s deterioration to distorted tissue or cancer. Changes in morphology (without color) is a precursor to change in color.

PatScope is independent of color reveals subtle tissue aberrations at the lesion morphology which could indicate malignancy. PatScope unique imaging methodology facilitates earlier detection of skin cancer by unveiling tissue distortions that were NEVER revealed before.  Skin cancer early detection is important for simpler treatment, higher cure rates, and saving lives. The ratio of skin lesions removed for suspected melanoma to true melanoma actually found in the removed specimens stands today on a stunning 1:100-1:1000 (i.e. 1 melanoma to 100-1000 excisions/biopsies). PatScope technology can significantly reduce this rate while increasing the detection of actual melanoma with obvious implications on patients' health and health costs.

technology

PatScope's proprietary technology is a new paradigm of dermoscopy applying computerized analysis of polarized light reflected from epidermal & sub-epidermal parts of inspected skin lesions. POC-Clinical studies conducted in 6 centers worldwide using an earlier prototype, showed very HIGH sensitivity and specificity of almost 100% in the detection of skin cancer and benign lesion correspondingly. The PatScope scanner is a diagnostic tool, meant to become a decision support device, providing real-time information to dermatologists in clinics and operating rooms regarding lesion tissue distortions which until now has been beyond the reach of doctors.

life saving

During the clinical trials, using PatScope we discovered that an “innocent-looking mole” of a patient was actually malignant.  Suspicious patterns appeared resembling melanoma’s distortions that could only be seen by the PatScope prototype, prompting a biopsy which proved this “innocent-looking mole” to be a Malignant Melanoma!