Automated rapid blood diagnostic tests for OTC markets and pre-hospital segments
OVERVIEW
RapiDx is developing a next-generation self-use rapid blood diagnostic test for the growing OTC home-care market, with the unique features of extracting accurate amount of blood with less pain whilst preventing contamination. The company has completed developing its first working prototype. It has also completed clinical trial at Tel-Aviv Medical Center with 30 volunteers demonstrating faster blood extraction and less pain compared with the gold-standard technique by nurses. The results lead to register an FDA 510K patent on the novel component of the blood extraction. Next stage is developing a Design For Manufacture (DFM) book for costs reduction & mass production. For Covid-19 we are researching the serology tests available.
RapiDx develops unique and innovative solutions for blood- based rapid diagnostic tests (RDT) based on its proprietary technology. RapiDx will offer a menu of rapid blood diagnostic self and single-use tests for an array of health conditions enabling a discreet home use. Having identified one of the main obstacles associated with performing rapid blood tests as the deterring and painful lancing process and the potential risk of contamination from exposed blood, RapiDx has integrated the lancet, blood collection and RDT into one completely disposable device and at an affordable price. RapiDx is planning to launch a series of rapid blood self-tests to be used by the growing Point-Of-Care (POC) and homecare markets.
RAPIDX brings the ultimate solution for COVID19 testing/monitoring “Everyone, any time, any place...”
Airports, sports arenas, convention halls and schools are some of the facilities that require immediate access to COVID-19 testing kits in order to able to identify and prevent the spread of the disease. Current rapid blood test kits are manually operated, nonintuitive, qualitative, non-coherent and with potential exposure for blood contamination and user error.
There is an urgent need to monitor COVID-19 for everyone at any time and everywhere.
RAPIDX brings the ultimate solution for upgrading current low-cost manual, non-intuitive COVID-19 testing kits into mass testing-oriented solution for POC (point of care) and for future home care.
The next generation product will be served as the technology platform for home care/digital health solution to monitor patients at home by combining RAPIDX technology and smart app.
PROBLEM
THE UNMET NEED
Public awareness of the importance of early detection of disease symptoms drove the rapid diagnostic market to its current growth pattern; nevertheless, even the most advanced rapid blood tests and kits remain deterring for merely self-use. The vast majority of rapid blood tests still remain within the domain of main labs, mainly due to compliance issues associated with extracting a few blood drops from the fingertip. Such cumbersome extraction involves uncomfortable and deterring finger squeezing and lancet piercing pain, exposure to contamination, and uncontrollable extraction of the blood volume required for test adequate performance. These drawbacks have limited the penetration of rapid blood tests kits into the POC and home-care markets. An easy and simple rapid blood test device, uniquely designed to overcome the above challenges and to be used without any intervention or assistance from medical personnel, is perfectly positioned to capture the vast and growing self-diagnostic market as pregnancy and glucose tests currently do.
RAPIDX solution
RAPIDX technology turns the manual procedure into an automated, quantitative and accurate solution that enables massive number of tests, simultaneously with only single/few POC staff assistance
RAPIDX single use solution, applicable to any off the shelf kits that already received the FDA approval for COVID-19 test; Each of the mentioned kits can be integrated into RAPIDX automated device that turns the manual process into a fully automated, accurate, intuitive and less painful procedure
RAPIDX’S INNOVATION -All-in-one integrative device
RapiDx’s unique solutions incorporate the following novel characteristics:
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- Fully disposable, affordable and simple-to-use device
integrating a safety lancet, blood extraction and collection
mechanism, as well as lateral flow test.
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- Significantly reduces the perceived pain associated with
finger [piercing] lancing.
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- Minimizes exposure to blood borne contamination.
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- Replaces the painful squeezing protocol currently used for fingertip blood extraction by a proprietary FDA cleared elastic ring that concentrates blood at the fingertip.
- High confidence-of-use, especially for unskilled users.
Conventional Rapid Blood Tests
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Many components (Manually)
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Cumbersome use and operation
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Deterring and painful lancing
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Separate, exposed lancet
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Finger squeeze blood extraction
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Blood exposure threat
RapTest
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Integrated system (Automatic)
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Intuitive device
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Reduced pain lancing
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Hidden lancet
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Passive blood extraction
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Blood contained within device
MARKET
The last two decades have seen a significant market trend in extending medical testing from hospitals, laboratories and POC into patients’ homes (e.g. pregnancy tests and blood glucose tests). Global market for Rapid Medical Diagnostic Kits, estimated at US$19.4 billion in 2014, forecast at US$20.4 billion in 2015 and further expected to maintain a CAGR of 5.7% between 2014 and 2020 to reach a projected US$27 billion by 202011. This market has a great growth potential, fueled by the strong tendency of patients and healthcare consumers to take charge and manage their own health
Rapid Diagnostic Tests (RDT) and Point of Care Diagnostics (POCDx)
• RDT are designed for use at the point of care (POC) by physician/nurse and not for self-testing at homethe best leader be
• Global Rapid Medical Diagnostic Kits market, estimated at US$19.4B in 2014, expected to maintain a CAGR of 5.7% between 2014 and 2020 to reach a projected US$27B by 2020(1)
•The largest RDT market segment, which has unique characteristics, is the Self Blood Glucose Monitoring (SBGM) – accounted for $11.2B in 2014, and it is expected to grow with a CAGR of 5.7% during 2015-2022(2)
Although the market is huge, MOST of the market is at the POC and yet to move to home care like other medical sectors
TEAM
MANAGEMENT
David Akunis, Chairman + interim CEO
Extensive business and financing experience with multidisciplinary overview knowhow in global strategy and corporate management.
Yoram Pony, V.P R&D
Product designer with massive experience of medical devices development, He is a partner in international and multi-disciplinary design studio company
Chen Katz, Director
• CEO of Techno PlusVentures Ltd. a diversified investment company, traded on the Tel-Aviv Stock Exchange (TASE: TNPV)
• Experienced Chief Executive Officer with a demonstrated history of working in the venture capital and private equity industry. Skilled inVenture Capital, Capital Markets, Private Equity, Deal Structures, and Investment Management.
Ofer Pintel, CTO
Experienced entrepreneur in the medical device industry.
Professional graduation from the Technion M.Ac, B.Sc and MBA
ADVISORY BOARD
Dr. Aharon Lebetzky (MD)
Has extensive clinical experience in Hematology. Dr. Lubetzky is a senior member of the Institute of Thrombosis & Homeostasis, Sheba Medical Center.
Dr. Boris Tartekovsky (PhD)
A recognized expert and consultant to Orgenic Ltd., Inverness Medical, Teva and other reputable multinational biotech companies. Dr. Tartekovsky’s Research site is located at Sourasky Medical Center.
Dr. Eran Kopel (MD, MPH)
Is a active senior public health specialist at the Israeli Ministry of Health and senior epidemiology lecturer at the Medicine Faculty of the Tel-Aviv University.
Dr. Ouriel Faktor (PhD)
Has long R&D experience in leading diagnostics companies in Israel in senior position of head of Technology and CTO.