• With this investment, SII will acquire 20% stake in IntegriMedical.
  • The investment by SII in IntegriMedical is expected to accelerate the development and commercialization of the N-FIS technology, making it more widely accessible to patients in India and worldwide.

 

PUNE, India May 17, 2024 – Serum Institute of India (SII)the world’s largest vaccine manufacturer, has announced a strategic investment in IntegriMedical, acquiring a 20% stake in the company, to advance Needle-Free Injection System technology.

The partnership between SII and IntegriMedical aligns with SII’s vision of ‘Health for All’ and IntegriMedical’s mission to ‘Transform Healthcare Globally’ by providing patient comfort, ensuring increased patient compliance, reducing needle-stick injuries, and enhancing the efficacy of liquid medication via needle-free dispersion.

IntegriMedical has developed a US patented Needle-Free Injection System (N-FIS) that utilizes high-velocity jet stream using mechanical power to effectively and consistently administer biologics and drugs. The innovative drug delivery solution aims to alleviate pain during administration, providing needle-phobic patients with a pleasant and stress-free experience.

Commenting on the strategic investment, Mr. Adar Poonawalla, CEO, Serum Institute of India, shared, “At SII, we are constantly seeking opportunities to invest in technologies that align with our mission to make healthcare accessible and affordable for people worldwide. IntegriMedical’s Needle-Free Injection Systems (N-FIS) represent a significant advancement in drug delivery and we envision a needle-free solution to deliver vaccines. We believe, this could potentially revolutionize the way we administer vaccines, making the process more comfortable for patients & healthcare professionals.

“We are excited to have Serum Institute of India as our strategic partner,” said Sarvesh Mutha, MD, IntegriMedical“This investment is a testament to the potential of our Needle-Free Injections System technology and its ability to revolutionize drug delivery. SII’s expertise in vaccine manufacturing and global distribution will be invaluable as we work towards making our technology more widely accessible to patients worldwide,” he added.

IntegriMedical’s Needle-Free Injections System also known as N-FIS has received regulatory approvals from CDSCO, CE, MDSAP and is ISO 13485 certified. Additionally, the technology is patented in the United States. IntegriMedical’s MD, Ankur Naik, has been instrumental in the development and clinical trials of the N-FIS technology, demonstrating its effectiveness in reducing pain and eliminating needle-phobia in patients.

The collaboration between SII and IntegriMedical leverages the strengths of both companies. SII brings its extensive expertise in vaccine manufacturing and global distribution, while IntegriMedical contributes its innovative drug delivery technology and research capabilities. Together, the companies aim to expand access to care and improve efficiencies in the global healthcare industry.

N-FIS will be available in the Indian private market, offering patients and healthcare providers an alternative to traditional needle-based injections. The technology’s advantages include the elimination of needle-phobia, alleviation of pain during administration, convenience of use, and prevention of needle-stick injuries and cross-contamination.

ENDS

Notes to Editor:
The global Needle-Free Injections System market, valued at USD 12.49 billion in 2022, is projected to experience substantial expansion with a Compound Annual Growth Rate (CAGR) of 14.16% during the forecast period from 2023 to 2028, reaching a valuation of USD 27.65 billion by 2028. This market growth is attributed to factors such as the escalating prevalence of chronic diseases, increasing incidents of needle-stick injuries, surging demand for self-injection devices, expanding vaccination programs, and advancements in product development technology. Source: Global Needle-Free Injections Market Forecast 2023-2028.

About the Serum Institute of India Pvt Ltd (SIIPL)
Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world’s largest vaccine manufacturer. SII’s multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.

Founded in 1966, SII’s primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of ‘Pneumosil,’ the world’s most affordable PCV, and ‘Cervavac’ the first indigenous qHPV vaccine in India. Moreover, SII has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.

To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com

About IntegriMedical
IntegriMedical is a privately-owned medical technology company focused on providing innovative drug delivery solutions for patients suffering from needle phobia. The company has research centers and manufacturing facilities in the USA, India and Hong Kong. www.integrimedical.com

Empowered Patient Podcast: Scott McFarland, CEO, IntegriMedical has taken on the challenge of needle phobia and safe and secure disposal of sharp objects in clinics and in the field. Needle-free technology is allowing healthcare professionals to quickly administer vaccinations with a greener approach allowing regular biohazard disposal. Working with vaccine and biologic manufacturers this needle-free approach may be instrumental in the rapid deployment of a COVID-19 vaccine.

PSQH: Needlestick injuries are among both the most prevalent and the most preventable occupational hazards affecting U.S. healthcare workers. With mass inoculations on the horizon once a COVID-19 vaccine or vaccines are approved, this issue has moved to the forefront.

Needlestick injuries, which fit into the broader category of sharps injuries, can harm healthcare workers by exposing them to blood and other hazardous materials, including infections from hepatitis C, hepatitis B, and HIV, according to the U.S. Centers for Disease Control and Prevention (CDC). Most needlestick injuries are experienced by frontline healthcare workers and can result in emotional impact that is “severe and long-lasting,” according to the CDC.

For the workers who suffer needlestick injuries and the provider organizations that employ them, the consequences can be serious and include the loss of employee time and related costs to investigate the injury, laboratory testing, post-exposure treatment, and replacing or reassigning staff.

While estimates vary, direct and indirect costs of needlestick injuries average more than $3,000 per victim, according to a report from Safe in Common. Further, needlestick and sharps injuries can create “enormous stress” for victims and their families, as testing for bloodborne pathogens can last for months, producing prolonged feelings of anxiety and distress, according to the CDC.

However, needle-free injection technology offers strong potential to alleviate these problems. This technology is designed around a high-pressure, spring-driven, stainless-steel piston and works by using a specially designed syringe to inject liquid medication subcutaneously, intramuscularly, or intradermally via a specialized device. Citing U.S. government statistics, a report in BioMedicine International estimated that 29% of hospital needlestick injuries could be prevented through the adoption of safety-engineered needles or needle-free devices.

Needlestick and sharps injuries: The basics
Sharps injuries are defined as penetrating stab wounds from a needle, scalpel, or other sharp object that may result in exposure to blood or other body fluids. They generally occur as a result of healthcare personnel using sharp equipment in a fast-paced, stressful, and/or understaffed environment. Additionally, sharps injuries sometimes are the result of unsafe practices, including passing sharps hand-to-hand between team members, placing sharps in an overfilled disposal container, failing to use a safer device, or failing to identify a safer alternative, according to the CDC.

Although health experts acknowledge the widespread occurrence of needlestick and sharps injuries, no one really knows how prevalent they are. Figures cited in 2000 by the CDC estimate annual needlestick and other percutaneous injuries to healthcare workers range between 600,000 and 800,000. More recently, BioMedicine International estimated the annual number of needlestick injuries in the United States to be around 384,000.

The reason for the ambiguity is simple: A large amount of needlestick injuries (up to half, according to some estimates) continue to go unreported, meaning that the numbers we have access to are “only the tip of the proverbial iceberg,” the CDC reports. Reasons driving this significant under-reporting may include the time-consuming reporting process, the belief that sharps injuries are minor incidents, and fear of a positive test result for a serious infection. In other cases, workers lack proficiency in needlestick procedures and desire to avoid drawing attention to their errors.

Regardless, the healthcare industry should not be focused on getting an exact count of these incidents. “The occupational health risks associated with contaminated sharps injuries become less about national estimates of overall numbers, but more so about identifying how the injuries that are occurring can be prevented in the future,” the CDC states.

Disposable syringes are the medical devices associated with the highest percentage of sharps injuries, followed by suture needles, scalpel blades, and IV stylets. Injuries from disposable syringes affect nurses more than any other single professional group, according to the CDC.

How needle-free technology can help
Clearly, one of the best ways to reduce the prevalence of needlestick injuries is to reduce healthcare workers’ exposure to needles to the greatest extent possible. Needle-free technology is an obvious solution.

In addition to providing a safer alternative for the administration of vaccines, needle-free injection technology is easy to use and provides a consistent dose of medication compared with the variables of a needle injection, in which proper technique is required such as ideal needle angle and depth of skin penetration.

Further, needle-free injection devices offer a greener, more environmentally friendly option than traditional needles and syringes, as needle-free devices do not require disposal in sharps containers. About 16 billion injections are administered each year across the globe, but in many cases the needles and syringes used for these injections are not disposed of properly, according to the World Health Organization. That leads to risks for healthcare workers and waste handlers, who may be exposed to these sharp objects and any biohazardous materials on them.

While the true scale will likely never be fully appreciated, needlestick and sharps injuries undoubtedly affect hundreds of thousands of U.S. healthcare workers each year, leading to avoidable stress, trauma, and costs. We owe it to them to explore all reasonable alternatives to alleviate these often-preventable incidents. Needle-free injection technology is a great place to start.

Scott E. McFarland, JD, is CEO of IntegriMedical LLC.

Injection-related pain and fear are common adverse reactions in children undergoing vaccination and influence vaccine acceptance. Despite the large body of literature on sources of vaccine non-compliance, there is no estimate of the prevalence of pain and fear as contributing factors. The objective was to estimate the prevalence of injection pain or fear of needles as barriers to childhood (i.e., 0-18 years) vaccination.

Methods: Four databases were searched from inception for relevant English and French articles until August 2021. In addition, the references of recent systematic reviews and all articles included in the review were hand searched. Article screening and data extractions were performed in duplicate. Studies were included if they reported on injection-related pain or fear of needles in children (0-18 years) using a checklist/closed-ended question(s). Results were stratified by respondent (parents or children), type of pediatric population (general or under-vaccinated), and relative importance of barrier (pain or needle fear as primary reason or any reason for under-vaccination). Prevalence rates of pain or needle fear were combined using a random effects model. Quality of included studies was assessed using the Joanna Briggs Institute critical appraisal checklist for prevalence data. Quality across studies was assessed using GRADE.

Results: There were 26 studies with 45 prevalence estimates published between 1995 and 2021. For parent reports (of children) and children self-reported reasons for non-compliance, prevalence rates of pain or needle fear ranged from 5 to 13% in a general population and 8 to 28% in an under-vaccinated population, with a substantial variation in the prevalence estimates. There was no difference between category of respondent or relative importance on pain or needle fear prevalence rate. A regression model demonstrated an overall prevalence rate of pain or needle fear as an obstacle to vaccination of 8% in the general population and 18.3% in the under-vaccinated population. All evidence was very low in quality.

Conclusion: This is the first review to systematically quantify the prevalence and therefore, importance, of pain and needle fear as obstacles to vaccination in children around the world. Pain from injection or fear of needles were demonstrated to be sufficiently prevalent as barriers to vaccination in children to warrant attention. Addressing pain and fear has the potential to significantly improve vaccination acceptance.