NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) -- Sharps Technology, Inc., today announced plans to manufacture its patented SHARPS PROVENSA™ smart safety syringes for use throughout the United States. Sharps Provensa safety syringes have received Food and Drug Administration (FDA) consent for marketing in the U.S.
Independent testing shows medications presently thrown away with each inefficient injection are virtually eliminated by the SHARPS PROVENSA™ technology.
The Company expects production of its products to commence in Q4 2020 with fulfillment to pharmaceutical and healthcare partners in Q2 2021. Its 40,000 square foot manufacturing plant in the EU is being refitted to be able to produce 100 million units annually. The Company is awaiting CE Mark approval for Europe.
There are approximately 14 billion injections delivered worldwide each year, and a vaccine for COVID-19 could add another 6 billion before accounting for government stockpiling. A more efficient syringe system, with only miniscule waste space, results in more doses of costly and hard-to-manufacture injectable drugs delivered more affordably and rapidly to hospitals and doctors.
“Our multiple syringe designs have the potential to protect 40 million healthcare workers by eliminating infectious needlestick injuries and at the same time, scale up the delivery of life-saving vaccines and medicines globally,” said Soren Christiansen, MD, Chairman and CEO of Sharps Technology. “With vaccine demand likely to soar, this medical innovation could not come at a more crucial time. SHARPS PROVENSA™ helps our partners in the drug manufacturing sector to more efficiently and cost-effectively deliver medicines, ultimately benefitting the people receiving the treatments.” Dr. Christiansen is a former senior executive with Merck responsible for $10 billion a year in sales.
Pharmaceutical companies must over-fill each vial and pre-filled syringe dose they provide, to overcome waste space in the typical syringe. Overfilling increases manufacturer cost and reduces the doses yielded per production batch. With an estimated 1 billion Covid-19 doses recently announced by J&J, if paired with SHARPS PROVENSA Ultra Low-Waste™, may translate to 50-100 million additional doses from the same bulk vaccine material.
Barry Berler, Sharps Chief Technology Officer and Inventor said, “We are in a race to produce the maximum number of units in the shortest period. To maximize supply, we have teamed up with Gerresheimer, major suppliers of glass and plastic medical devices and injection vials to the pharmaceutical industry.”
Tony Mulone, Sharps Executive Vice President, and former GM of Covidien’s Custom Product Solutions, a $250 million division which marketed needles and syringes said, “This ultra-low waste technology can save billions of dollars each year, by preventing wasted injectable medicine from winding up in landfills. Instead that medicine will be effectively administered to patients who need it, and countless millions waiting for vaccines to counteract dangerous diseases, including COVID-19, should a vaccine become available.”
Syringe delivery-system pairing is essential in determining availability and cost for any manufacturer’s vaccine or injectable drug supply – both to patients, government, and insurers. SHARPS PROVENSA™ is also the first and only safety syringe designed for one hand use and ultra-low waste engaging all safety features automatically as the injection is given.
This safety syringe technology is designed to eliminate 2 million accidental needlestick injuries each year, including 600,000 occurring to U.S. medical personnel. SHARPS PROVENSA™ deploys a unique, proprietary shield that covers the needle point even before the needle is withdrawn from the skin, rendering it incapable of reuse and virtually eliminating accidental needlestick injuries.
More than 20 viruses can be spread by contaminated needles, including Hepatitis and HIV. In fact, according to the WHO, 37.6% of Hepatitis B, 39% of Hepatitis C and 4.4% of HIV/AIDS cases in healthcare workers worldwide are due to infectious needlestick injuries. A study cited by the WHO of 20 countries found that healthcare workers each experienced an average of up to 9 needle stick injuries a year.
“This is a potentially life-saving technology for doctors, nurses and other healthcare workers including EMT’s and other first responders throughout world,” said Dr. Steven Hertz, Sharps Chief Medical Officer. “In many developing countries, staff shortages and lack of training protocols can put healthcare workers and patients at increased risk. SHARPS PROVENSA can eliminate the silent scourge of needlestick infections and prevent dangerous and improper syringe and needle reuse.”
The new SHARPS PROVENSA™ syringe and needle technology allows healthcare workers to simply deliver a normal one-handed injection. Karen Daley, Ph.D., Former President of the American Nurses Association, who contracted HIV from an accidental infectious needle stick while working in an emergency room, said SHARPS PROVENSA™ would prevent similar infections in the future. “I have never seen safety syringe technology this effective,” she said. “If workers are not safe, patients are not safe.”
The WHO has listed Merck, Pfizer, GSK, Sanofi, and Moderna as having the best candidates for a Covid- 19 vaccine.
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