With an Accelerated Near-Term Path for Product Commercialization and Expanded Manufacturing Capacity, Sharps Technology, Inc. (NASDAQ: STSS) will have the ability to Support the Industry with Innovative, Market Leading Injectable Drug Delivery Solutions and Accelerate a Path Towards Revenue Growth.
- Most syringes waste a significant amount of injectable medicine which is thrown away with the used needle/syringe.
- This adds cost and reduces the availability of life-saving injectable drugs for us all. Whether we are looking at a pandemic response, hard-to-manufacture drug products, or managing long-term chronic illness, we can't afford to waste this precious supply.
- The problem is sufficiently worrisome that the Federal Government is passing new legislation (January 1, 2023) requiring pharmaceutical companies to pay financial penalties for injectable drugs which are thrown away with the syringe and not injected into the patient.
- Current law requires the use of safety syringes to protect the nurse or clinician from accidental needlestick injuries.
- Most safety syringes require multiple steps to engage the safety features. Sharps feature engages automatically.
- The World Health Organization requires that syringes are auto disabled after use.
- Auto disable syringes prevent the improper reuse of both needles and syringes and stops the sharing of needles and the spread of bloodborne diseases.
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THE TOP TEN REASONS TO HAVE STSS ON YOUR RADAR
- The Company just entered into a partnership with Nephron Pharmaceuticals, a private US company, with an anticipated entry into the lucrative prefillable syringe market and, an anticipated launch in early 2023.
- The Nephron partnership will provide growth for both companies, and the opportunity to create new technologies to support the healthcare industry. It will be transformative for Nephron and Sharps as they navigate a bright future working together.
- Their commercialization and growth strategies also include joint presentations with their pharmaceutical partners to service the pharmaceutical industry with specialty drug delivery products produced in the US.
- Both the safety syringe market and prefillable syringe market are expected to grow rapidly between 2022 and 2028. This growth is led by the increase in Covid inoculations, the overall growth in the population, new injectable medications coming through the regulatory process, and the growing instance of chronic disease.
- The safety syringe market is expected to grow at a CAGR of 9.6% from 2021-2027 to exceed US$ 14.4 billion by 2027.
- STSS acquired Safegard Medical, an FDA/CE approved syringe manufacturer in the EU, with plans to deliver 100 million units over the next 24 months.
- Each year almost 20 billion injections are administered, globally and the World Health Organization (WHO) are advocating for the use of low waste syringes, with passive safety devices which engage automatically and have auto disable features.
- STSS anticipates signing its first product orders any moment now this development will represent a huge milestone for this recently debuted NASDAQ company, and should provide them with a solid foundation for growth.
- The company has raised $16M to scale operations in the coming quarters as they begin to meet the strong and growing demand for smart safety syringes.
- STSS is confident in its operations and multiple insiders are buying shares: In the last twelve months, the biggest single purchase by an insider was when Independent Non-Executive Director Timothy Ruemler bought US$140k worth of shares at a price of US$1.25 per share. This purchase was made at a higher figure than the current share price, which may indicate some serious optimism about STSS’s future.
NEPHRON PHARMACEUTICALS PARTNERSHIP PROVIDES SIGNIFICANT COMMERCIAL OPPORTUNITY
- STSS announced a new partnership in November of 2022 that is focused on developing and sharing best practices in innovative manufacturing, product development, customer support, and quality as Nephron prepares to launch the Company's InjectEZ component of expansion.
- Nephron Pharmaceuticals is known across the country to health systems and hospitals across the country as a leader in the production of affordable generic inhalation solutions and suspension products, as well as pre-filled sterile syringes, luer-lock vials, IV bottles, and IV bags.
- InjectEZ is part of the Nephron investment of hundreds of millions of dollars over the last two years to increase manufacturing capacity in its Lexington County, S.C. facilities.
- The partnership with Nephron opens opportunities for Sharps to expand its portfolio and make an impact on the specialized pre-fillable syringe and drug delivery systems market.
Robert Hayes, CEO of Sharps Technology
- Pre-filled syringes have emerged as one of the fastest-growing choices for unit-dose medication as the pharmaceutical industry seeks new and more convenient drug delivery methods.
- With PFS/RTF syringes, pharmaceutical companies are able to minimize drug waste and increase product life span, while patients are able to self-administer injectable drugs at their home instead of the hospital.
Ready-To-Use - Pre-Filled Syringes:
- Types: Plastic and Type I B/S Glass
- Applications: Vaccines, Diabetes, Complex High Value Therapies (Gene-Therapy)
- End Users: Branded Pharma, CMOs, and Biologics
- Target Markets: North America
There is a growing demand for efficient and easy-to-use drug delivery devices and increasing efforts of healthcare professionals to reduce hospital errors are the principal factors driving the market growth.
THE VACCINES MARKET
The global vaccines market is projected to grow from $61.04 billion in 2021 to $125.49 billion in 2028 at a CAGR of 10.8% in the forecast period, 2021-2028.
Vaccines are the most powerful and cost-effective way to protect billions of people in the world, and according to the WHO, immunization awareness and government initiatives have helped prevent 2-3 million deaths a year.
The Covid-19 outbreak led to a shutdown of syringe manufacturing which in turn led to a supply shortage at a global scale.
Mergers and acquisitions of companies such as STSS are highly attractive and are providing the needed innovation to the vaccine market.
The rise in the need for vaccinations and immunizations, plus a surge in the geriatric population, an increase in the number of surgical procedures, as well as a rise in chronic diseases have contributed to a demand for syringes.
Specialty Syringes - Vial Application
- Global Smart Syringe Market @ $14 billion USD by 2026 w10.0%+ CAGR
- Types: Auto-Disable Syringes and Safety Syringes
- Applications: Vaccination and Drug Delivery
- End Users: Hospitals, HMOs and Clinics
- Target Markets: North America, Europe, and ROW
- Sharps Technology listed as a supplier
The Pre-Filled Syringe (PFS)/Ready- To- Fill (RTF) syringe product segment will be a priority for the company through its collaboration with Nephron, and is expected to be a gamechanger for the company.
MANUFACTURING FACILITY
- 40,000 sq. ft. factory on 250,000 sq. ft. site
- 20-year history of safety syringe manufacturing
- FDA registered since 1999
- ISO 13485 certified
- CE Mark approved products
- Injection molding and assembly expertise
- ETO on-site sterilization capacity
STSS announced over the summer that it had completed its acquisition of Safegard Medical’s syringe manufacturing facility in Hungary.
The manufacturing facility is located 2 hours from Budapest (160km from Budapest Airport)
“The acquisition of our first manufacturing facility is an important milestone in our transformation from an R&D-focused enterprise to revenue-generating commercial operations. With the acquisition now complete, with the addition of further assembly and manufacturing capacity, our team is confident we can deliver world-class products to meet the strong and growing demand for smart safety syringes, a market forecasted to reach $14 billion globally by 2026.”
Robert Hayes, CEO of Sharps Technology
A GROWING PROBLEM
- Depending on the inefficiency of the syringe, dose, and waste space, a pharmaceutical company may OVERFILL by 200% or twice the amount to be injected into the patient – a waste/cost born by all.
- Waste space in the syringe is the amount that fails to be injected into the patient and is thrown away with the used syringe.
- Eliminating this waste space produces more life saving doses of vaccines and drugs and it also means that hard-to-manufacture drugs can be made available more rapidly.
- Sharps Technology, Inc. (NASDAQ: STSS) has a solution that minimizes wasted product for ALL injectables.
- The Sharp Provensa: Ultra-Low Waste™ solution is a smart safety syringe that has 10 microliters of dead space and delivers up to seven doses from a five-dose vial, which allows for the most efficient use of the vaccine for the industry and people that need it.
- To put it simply…. MORE DOSES of life saving vaccines could be available because of the company’s syringes!
- In an arena with leading key players that include Becton Dickinson and Co. (NYSE: BDX) and Cardinal Health Inc. (NYSE: CAH), there is a key opportunity for STSS to grab a big piece of the market as the company has developed the world’s first smart safety syringes designed to:
- Eliminate two million potentially infectious accidental needlestick injuries.
- Save billions of dollars in the medicines wasted by today’s inefficient syringes, using the company’s low-dead space feature.
INJECTIONS SHOULD NOT CAUSE INFECTIONS
When you think about the magnitude of the number of injections being given to respond to the pandemic, this is not a place where we can afford shortcuts, shortages or anything short of full safety for patients and healthcare staff.”
- Lisa Hedman Senior Advisor, World Health Organization
- The World Health Organization (WHO) has named needlestick injuries “one of the greatest risks faced by the frontline healthcare worker.”
- The Covid-19 pandemic created the biggest vaccination campaign in history and put light on the importance of vaccination supply. The use of ultra-low waste space syringes could have generated approximately 75 million additional doses of Covid vaccine in the earliest stages of the pandemic, reducing the number of Covid cases and its death toll.
- Did you know that unsafe injection practices are recognized as a main source of infection in transmitting blood-borne diseases like Hepatitis B, D and C, and HIV?
With healthcare workers delivering more than 16 billion injections a year worldwide, the risk of accidental needlestick injuries and exposure to dangerous bloodborne pathogens is real and urgent.
Needlesticks disrupt the lives of at least half a million healthcare personnel each year, often with devastating results, including infections, psychological trauma, destroyed careers, and financial ruin.
THE SOLUTION
Sharps Technology’s smart safety syringes are the first of their kind designed to eliminate two million potentially infectious accidental needlestick injuries, as well as billions of dollars in medicine wasted with today’s inefficient syringes.
The company’s syringes are addressing the important needs of the global healthcare market:
- Provides automatic protection from accidental needlestick injection for clinicians and all who come in contact with contaminated needles.
- Prevents improper reuse of both needle and syringe by automatically locking the plunger and shielded needle following injection.
- Ultra Low-Waste™ dramatically reduces the amount of costly medications discarded with inefficient injections.
- STSS’s needle tips go through the skin sharp, delivering the medicine or vaccine, and come out of the body shielded, protecting the healthcare worker and the public.
- For the first time ever, needlesticks can be completely avoided, easing the financial burden on the healthcare system and giving clinical staff and the general public total protection and true peace of mind!
A MASSIVE MARKET
The global vaccines market is projected to grow from $61.04 billion in 2021 to $125.49 billion in 2028 at a CAGR of 10.8% in the forecast period, 2021-2028.
According to the WHO, vaccines are the most powerful and cost-effective way to protect billions of people in the world. Immunization awareness and government initiatives have helped prevent 2-3 million deaths a year. Great investments along with merging and partnerships of companies are boosting the production and sales of products globally.
The Covid-19 outbreak had led to a shutdown of manufacturing syringes which in turn led to a supply shortage at a global scale.
The rise in the need for vaccinations and immunizations, a surge in the geriatric population, an increase in the number of surgical procedures, in addition to the rise in chronic diseases, have contributed to a demand for syringes with a need for smart, safe technology.
According to the Occupational Safety and Health Administration (OSHA), approximately 4.6 million healthcare professionals were susceptible to blood-borne diseases in 2014, owing to a rise in the prevalence of needlestick and other sharp object injuries. Every year about 384,000 healthcare personnel still suffer from needlestick injuries in the U.S.
Needlestick injuries can be avoided by eliminating the unnecessary use of needles, using devices with safety features, and promoting education and safe work practices for handling needles and related systems.
Safety syringes, like STSS’s Sharps Provensa™, are the best protection against accidental needlestick injuries.
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IN SUMMARY
- The Company recently announced a significant partnership with Nephron Pharmaceuticals with an anticipated launch into the market in early 2023.
- STSS anticipates shipping first orders of vial draw product by the beginning of 2023 and ready to fill product in mid-2023 to create initial revenue in 2023 and profits in early 2024.
- With the global shortage of syringes that comply with the World Health Organization (WHO) requirements, there is a strategic opportunity for STSS to take market share and support the healthcare industry with a better drug delivery platform.
- The combination of features and benefits for the Sharps products will save lives and eliminate the waste of critically needed medical treatments and therapies for the industry!
- There's a key opportunity for STSS to grab a big piece of the market with its proprietary smart safety syringe technology designed to eliminate two million potentially infectious accidental needlestick injuries, as well as billions of dollars in medicine wasted with today’s inefficient syringes with their low-dead space feature.
To reiterate, the company anticipates signing its first distributor agreement during the fourth quarter of 2022, which could be at any moment!
STSS is a med-device/healthcare company to not overlook - keep a close eye on new developments at https://sharpstechnology.com/ and start your research.
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