PixCell Medical Announces Regulatory Approval from Australian Therapeutic Goods Administration (TGA) for HemoScreen Point-of-Care Hematology Analyzer

YOKNEAM ILIT, Israel, Oct. 5, 2020 /PRNewswire/ -- PixCell Medical^[1], innovator of rapid diagnostic solutions at the point-of-care, announced today that it has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for the HemoScreen™, PixCell's hematology analyzer that offers a 5-part differential CBC intended for point-of-care (POC) use. Under the TGA approval, PixCell's HemoScreen is cleared for use with adults and infants alike, from as early as 2 months of age.

The HemoScreen provides insights on 20 CBC parameters as well as comprehensive abnormal cell flagging, which can assist in the early detection of diseases, including several types of cancer. This approval confirms inclusion of HemoScreen™ in the Australian Register of Therapeutic Goods (ARTG), authorizing commercialization throughout Australia.

"We are delighted to receive TGA approval and are already in the process of making HemoScreen™ available to patients in Australia," said PixCell Medical CEO Dr. Avishay Bransky. "Almost 30% of Australians live in rural areas making access to many healthcare services difficult. To take a simple blood test, one may have to travel hours to the nearest city or have blood samples flown out to a lab, causing significant delays in receiving results. This technology makes the most common complete blood count (CBC) test accessible locally when results are needed quickly," Bransky explained.

The HemoScreen™ is designed to be simple for users. It requires no maintenance or calibration and does not require technical expertise to operate. The whole CBC testing process entails three steps from sample collection to results delivery, and eliminates the manual sample preparation procedure, which can generally compromise test results. A single drop of blood is collected in PixCell's "lab-on-a-cartridge," which is outfitted with all necessary reagents; the cartridge is inserted into the HemoScreen and within 6 minutes, the device provides lab-accurate results. Having blood test results on the spot allows clinicians to make decisions based on accurate data when they are in front of their patients, improving care delivery and clinical decision making.

A highlight of PixCell's technology is its patented Viscoelastic Focusing (VEF) technology causes cells to line up in a single cell plane. This phenomenon forms the basis of PixCell's AI-driven solution, which leveraging advanced computer vision technology, can rapidly analyze and differentiate cells within a sample.

The portable hematology analyzer is suitable for both human and veterinary care settings. In June, North Rocks-based Point of Care Diagnostics (POCD) announced it would make PixCell's small-sized, simple-to-operate HemoScreen™ platform available to Australian healthcare providers across the country. In addition, several government organizations in Australia have evaluated the instrument and ordered units for rapid deployment as part of their COVID-19 efforts to monitor patients.

About PixCell MedicalPixCell Medical provides the first truly portable point-of-care blood diagnostic solution. Leveraging the company's patented Viscoelastic Focusing technology, along with AI-powered machine vision, PixCell's FDA-approved and CE-cleared HemoScreen diagnostic platform shortens diagnostic results delivery from days to minutes. With just one drop of blood and within five minutes, PixCell delivers accurate readings of 20 standard blood count parameters, saving patients, clinicians and health systems significant time and costs.

For more information: www.pixcell-medical.com^[2] and follow PixCell on LinkedIn^[3].

Media Contact:Finn Partners for PixCell MedicalLior Feiginlior.feigin@finnpartners.com@LiorFeigin^[4][5]

References

1. ^{^} PixCell Medical (www.pixcell-medical.com)
2. ^{^} www.pixcell-medical.com (www.pixcell-medical.com)
3. ^{^} LinkedIn (www.linkedin.com)
4. ^{^} lior.feigin@finnpartners.com (www.prnasia.com)
5. ^{^} @LiorFeigin (twitter.com)