Home Sharps Technology Completes IPO to Commercialize Its Auto-Activating Needle-Safety, Ultra-Low-Waste Injection System Endorsed for Pfizer’s COVID-19 Vaccine

Sharps Technology Completes IPO to Commercialize Its Auto-Activating Needle-Safety, Ultra-Low-Waste Injection System Endorsed for Pfizer’s COVID-19 Vaccine

May 15, 2022 08:00 CST Updated 08:00
Sharps Technology

Developer of Safety Syringe Products

“If the needle extending from the syringe had been from Sharps Technology, my needlestick injury would never have happened, and my life would be entirely different.” Dr. Karen Daley, former president of the American Nurses Association, contracted HIV after an accidental needlestick injury with a used needle while working in an emergency department. During her visit to Sharps Technology, Dr. Daley praised the company for inventing the most effective safety syringe technology.

 

April 14, 2022, innovative medical device company Sharps Technology, Inc.(Nasdaq stock tickers: "STSS" and "STSSW")Announced the completion of an initial public offering of 3,750,000 shares at a public offering price of $4.25 per share.This IPO raised approximately $16,000,000 in total, which the Company plans to use primarily for expanding production capacity and investing in product sales.

 

IMG_5378.PNG

Sharps Technology, Inc.’s Nasdaq Closing Bell Ceremony on April 14, 2022

 

Sharps Technology, Inc. is headquartered in New York, United States.is a medical device company focused on the research and development of safe, low-waste syringes. The companySharps ProvensaTMThe product series has secured three product patent registrations and one Patent Cooperation Treaty (PCT) application, with three additional patent applications pending approval.

 

Since its establishment in 2017, Sharps Technology has devoted all its efforts to the research and development of Sharps ProvensaTMAlthough its product series has not yet generated any revenue from sales, these R&D achievements have enabled the company to raise over $6.8 million in the past two years. What kind of disruptive innovative technology is compelling investors to continuously back it? For five years, Sharps Technology has been dedicated to pursuing one single goal.

 

Sharps Provensa™: “Three Birds with One Stone,” Addressing Needlestick Injuries, Medication Waste, and Reuse


Sharps Technology has always pursued a new type of syringe that can simultaneously address issues such as needlestick injuries, medication waste, and reuse., and thus they dedicated themselves to the development of Sharps ProvensaTMSeries Products.

 

IMG_5379.JPG 

Five Sharps Provensa Models Fail to Meet SpecificationsTMSafety Syringe

 

1Automatically activate needle protection for healthcare workers

 

Healthcare workers are a vital national resource; while they care for others, they must also be protected from harm. Furthermore, the safety of healthcare workers is an integral component of patient safety and the overall safety and quality of the healthcare environment.

 

According to statistics from the World Health Organization, prior to the COVID-19 pandemic, there were over 16 billion injections administered worldwide each year, with more than 2 million of these resulting in accidental needlestick injuries (NSIs) to clinicians. Approximately 55.1% of healthcare workers have experienced a needlestick injury at some point in their careers. Over 3 million NSIs among healthcare personnel have been documented globally, a figure that likely represents only the tip of the iceberg.

 

More than 20 types of viruses can be transmitted through contaminated needles, including hepatitis viruses and HIV. According to data from the World Health Organization, 37.6% of hepatitis B cases, 39% of hepatitis C cases, and 4.4% of AIDS cases among healthcare workers worldwide are caused by infectious needlestick injuries. Although relevant U.S. agencies have consistently advocated for the use of safety-engineered syringes for injections, compliance remains low. A 2019 report by EPInet showed thatMore than 80% of NSIs still occur before the safety feature of the syringe is activated or partially activated.

 

Sharps ProvensaTMThe needlestick protection feature of the product series is activated upon completion of drug delivery, ensuring that the device is a sharps-free syringe by the time the needle is withdrawn from the patient.

 

IMG_5510 改1.GIF

Sharps Provensa Before and After InjectionTMDynamic Changes in the Product Series

 

This design automatically covers the needle before it is withdrawn from the patient,Block NSI at the source, enhance the safety of healthcare workers, reduce the incidence of bloodborne disease transmission, and alleviate the financial burden on healthcare security.

 

2Only 10 μL of drug waste occurs per injection

 

Systematic errors are inevitable in real-world settings, leading to a certain degree of medication waste during aspiration and injection. Independent trials conducted by Sharps Technology have shown that the typical dead space in commonly used subcutaneous syringes ranges from approximately 50 to 140 microliters. In the absence of information regarding the specific syringe type to be used, pharmaceutical companies can only ensure that patients receive an adequate amount of active pharmaceutical ingredient by overfilling vials. For drugs that are difficult to manufacture, this significantly increases production costs; when the prescribed dose is extremely small, the wasted amount may even exceed the dose required by the patient.

 

andSharps Provensa Ultra-Low Waste Smart Safety Syringe can control waste volume to approximately 10 μL. This ultra-low waste syringe canSeven Doses Meeting Dosage Requirements Obtained from Five Vials of Pfizer’s COVID-19 Vaccine. This is achieved through the overfill volume in the vaccine vial,If standard syringes are used, two full doses of vaccine will be wasted.

 

This technology is primarily enabled by an additional space equivalent to approximately 10% of the syringe’s capacity at its distal end. Unlike traditional syringes, when the plunger tip reaches the zero mark, the plunger rod can still be advanced further until the plunger head completely passes beyond the zero mark. Simultaneously, the needle-tip covering device located at the front of the barrel is activated, thereby initiating the needle-stick protection mechanism concurrently with the completion of drug delivery.

 

IMG_5394.GIF 

Sharps ProvensaTMIt can compress all the space in the syringe that is greater than 1%.

 

Sharps Provensa EnhancementTMThe product’s market share helps pharmaceutical companies save costs associated with drug overfill. Furthermore, pharmaceutical companies can directly adopt the company’s glass pre-filled syringes, Sharps Provensa RTF PS.While reducing injection waste, it also avoids waste associated with drug withdrawal.

 

3Reduce Injection Pain, Eliminate Reuse


In addition to ensuring accurate dosing and preventing needlestick injuries, as previously mentioned, Sharps Technology has given further consideration to optimizing the patient injection experience.

 

Apart from pre-filled syringes, the other four types of syringes allEquipped with an additional 18G aspiration needle. These needles have a larger bore than standard injection needles (the higher the gauge, the finer the needle) and are specifically designed for aspirating viscous or other difficult-to-draw medications. After aspiration, the needle is replaced with a high-gauge fine needle for patient injection. This ensures that the brand-new fine needle used for injection remains sharp, having not been dulled by piercing the medication vial.Reduces pain during patient injection

 

To better eliminate bloodborne diseases transmitted via syringes, Sharps Technology not only provides needle-stick protection but also addresses the issue of syringe reuse. By utilizing the additional forward travel space available in the plunger rod, Sharps Technology enables the entire plunger flange to be fully embedded into and locked within the barrel.The non-retractable plunger rod and covered needle tip simultaneously prevent the reuse of both the syringe and the needle.

 

 IMG_5513 改.GIF

Sharps ProvensaTMDemonstration of the Complete Injection Process

 

Sharps Technology claims that,To date, no syringe on the market possesses all of the aforementioned functions and advantages., these five specifications of injectables can fully meet the demands of traditional healthcare settings, including hospitals, clinics, physician offices, and pharmacies.

 

Acquiring a Factory, Partnering with Pfizer: Sharps Technology’s Journey Has Only Just Begun


Sharps Technology acknowledges that none of its products have yet been commercialized, and the company has not generated any sales revenue since its inception. However, its relentless pursuit of innovation and upgrades in syringe technology has successfully attracted continuous capital investment. In the absence of commercial sales data,The company raised $5,180,429 in 2021 and $3,425,000 in 2020 by leveraging its patented technologies and finished product demonstrations.

 

收入支出表.png 

The Company’s Revenue and Expenditure in 2021 and 2020 (Data Extracted from Corporate Financial Reports)

 

The Company primarily utilized these funds for the acquisition of fixed assets and day-to-day operations. According to the financial reports, the Company’s operating expenses were incurred solely for research and development and general and administrative purposes.Expenditures on technological research and product development each accounted for more than one-third of daily operating expenses, at 36.3% ($1,690,865) and 35.5% ($827,005), respectively., which demonstrates its emphasis on product technology.

 

固定资产.png 

Fixed Assets of the Company in 2021 and 2020 (Data Extracted from Corporate Financial Reports)

 

Meanwhile, the company has also invested heavily in fixed assets.In 2020, Sharps Technology spent $16,600 to complete the development of its official website, laying the foundation for future corporate promotion and external collaborations.

 

On the other hand, driven by the need to protect intellectual property rights and to fully realize its own product designs, Sharps Technology has formulated plans to construct an independent manufacturing facility.On June 10, 2020, they signed a factory purchase agreement with Safegard Medical (Hungary) Kft, a traditional manufacturer of disposable syringes in Hungary., with a deposit of USD 295,600 paid, and the remaining balance of USD 2,221,830 settled in full in 2021.At this point, the company's fixed assets accounted for 64.3% of its total assets.

 

Located in Hungary, the factory occupies a site area of 250,000 square feet, with production workshops covering 40,000 square feet. It is a syringe manufacturing base with a 20-year history of production, atISO CertificationandFDA Approvalbelow, affixed withCE MarkSharps ProvensaTM has already achieved mass production. In addition to the complete production and assembly processes, the factory is also equipped withOn-Site Ethylene Oxide (ETO) Sterilization Technology, ensuring product quality from all aspects. Currently, the factory has met the company's requirements for production volume and product quality, making it well-prepared for commercial sales following the IPO.

 

IMG_5382.PNG 

Sharps Technology’s Independent Facility in Hungary

      

According to Sharps Technology’s estimates, after deducting underwriting discounts, commissions, and offering expenses payable, the company will receive approximately$14.2 million in net profit. This funding amounts to approximately60% will continue to be allocated to the comprehensive enhancement of production capacity, while an additional 26% will be dedicated to product operations.. It is evident that the company is compelled to bring its products to market, while simultaneously ensuring its own production capacity.

 

微信图片_20220506222231.png 

Sharps Technology’s Plan for IPO Proceeds

 

In addition to building high-quality factories, their confidence in product commercialization alsoRecognition from Pfizer Inc. and Johnson & Johnson. Given the excellent performance of the Sharps Provensa Ultra-Low Waste Syringe in testing,Pfizer has approved the use of this smart safety syringe for its COVID-19 vaccine.Meanwhile, Johnson & Johnson has also taken notice of this low-waste syringe. With its planned production of 1 billion doses of COVID-19 vaccine, the use of this low-waste syringe could yield an additional 50 to 100 million doses from the same volume of vaccine material.

 

At this critical juncture, it is essential to enable broader access to safe and hygienic COVID-19 vaccinations. According to WHO estimates, the outbreak of the COVID-19 pandemic may lead to an additional 6 billion vaccine doses administered globally.Sharps ProvensaTMProducts that reduce medication waste while ensuring personal hygiene and safety are poised to become an effective solution during this special period, addressing issues such as insufficient vaccine production capacity, vaccine shortages in impoverished regions, and hygiene concerns related to vaccine administration.

 

Sharps Technology has already begun discussions with pharmaceutical companies and distributors regarding product planning. The company plans to establish partnerships with the U.S. government and governments of other countries, while also considering sales to hospitals and private clinics worldwide.. Whether during the critical period of the COVID-19 pandemic or along the future path of development in human medical and public health, Sharps Technology is poised to have ample opportunities to make significant contributions.