Can injections be needle-free, painless? This Pune-based firm has the answer

Time of India

2 days ago

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Sarvesh Mutha, MD, IntegriMedical states that this N-FIS system does not involve any needle or skin piercing, resulting in no pain or bruising.
IntegriMedical's manufacturing facility in Pune. The company is also in talks with pharmaceutical manufacturers to co-package the N-FIS device along with their vaccines while also looking to collaborate with the government for the HPV vaccine.
Vaccinating children is always a challenging task, especially when it involves needles, as they can make the process more unpleasant. But when a toddler somewhere in eastern India slept throughout her vaccination, it was a proud and joyful moment for Sarvesh Mutha . The child was vaccinated through a needle-free injection system (N-FIS) developed by Mutha's company, IntegriMedical 'It was like magic,' says the child's parents. 'The little girl is usually scared of needles, but here, she just slept throughout.'And Mutha is overjoyed. 'It is a great feeling to hear such a story,' he says.Needle phobia is very common among children. 'Recently, a seven-year-old child who was waiting for his vaccine saw the posters of the N-FIS device in our clinic and was adamant about getting it. He was very happy to receive it,' says Avinash Kulkarni, a Delhi-based senior paediatrician (consultant).IntegriMedical currently offers N-FIS devices for children's vaccinations and has tie-ups with leading hospitals, including Cloudnine, KEM Hospital, Motherhood, Apollo Cradle, etc. N-FIS is now available in more than 1,000 hospitals across the country and in Europe as well.'One of the largest paediatric institutes, called Heim Pál National Pediatric Institute in Hungary, has essentially integrated our product and is looking to use it for haematology and oncology patients as well,' says Mutha. 'Apart from that, we are there in Europe, in Croatia, Slovakia, and Poland. Conversations are on with Germany and the Netherlands, etc. We also have a CDSCO (Central Drugs Standard Control Organisation) approval, which is for India,' he adds.IntegriMedical has obtained CE (Conformité Européenne) approval, which allows the firm to sell its products in 30 European countries. The company claims that more than 45,000 kids have been vaccinated with the N-FIS device to date, which indicates growing acceptance of N-FIS.Mutha, who founded IntegriMedical during the pandemic with his former colleague Ankur Naik and associates Scott McFarland, and Mark Timm, possesses a background in the engineering and medical industry. The founders, with a cumulative experience of 90 years in the healthcare space, recognised that both children and adults often felt anxious about injections, leading to extremely stressful situations in clinics and hospitals.'Often, you would see kids running away as soon as they arrive at the doctor's clinic. I have had many colleagues who have not even taken the Covid-19 shot, purely because of the fear of needles, and that kind of further motivated us to build this NFIS device,' says Mutha.After four years of research and development (R&D) and clinical trials, IntegriMedical commercially launched the N-FIS device in May 2024. The IntegriMedical kit comes with the N-FIS device, a loader, 10 disposable cartridges, 2 vial adapters, 2 pre-filled syringe adapters, and an injection testing foam. The cartridges and vial adapters are disposable, while the device and the loader are reusable. The N-FIS device is made up of stainless steel to ensure a good grip.The device is a kind of piston that uses a high-pressure jet stream injector technology, which essentially goes through the pores of micro-orifices to administer the drug inside the body. 'You need to first prepare the N-FIS device by inserting it into the loader, which develops the piston in the device (energy has been developed inside). The cartridges are then filled with the medicine from the pre-filled syringes. These cartridges are then put on the NFIS device. The device is placed at a 90-degree angle to the skin, and a safety cap behind the device is pressed using the thumb, which enables the piston to press the drug inside the skin,' explains Mutha.'There is zero prick and only pressure. With that pressure, the pores increase a little bit. There is an extremely small opening in the skin, which is possibly smaller than an individual hair, and so what happens is, with this pressure, it minutely pierces through the skin and settles into the subcutaneous or the intramuscular region. This phenomenon is effective absorption and broad dispersion. Once it goes into the layer, it will form a pool of medicine, and then it will start dispersing into our body where it is needed,' he adds.Mutha states that this system does not involve any needle or skin piercing, resulting in no pain or bruising. According to Mutha, nearly 80% of the kids and the adults (for trials) who have taken injections using their product have experienced zero to a bit of mild pain.Although needle-free technology has been in the market for a while now, Mutha says it was IntegriMedical which brought the system to India with its patented device.The US patent awarded to IntegriMedical for the N-FIS device covers its specific design and mechanism, with a focus on the configuration and operation of its spring-actuated drug delivery system. 'While needle-free technology itself is not new, our patent protects our unique product construction, including the housing, trigger mechanism, and energy storage system, rather than the broad concept of needle-free injection,' says Mutha.He further mentions that there are certain global companies that have developed needle-free injections. However, their applications are limited. For instance, one of them, he says without disclosing the company name, is into dental applications only; another company is working with pharmaceutical companies but has not released any final product, unlike IntegriMedical. Canada-based NuGen Medical Devices has developed a needle-free injection system for insulin uptake for people with diabetes, but it is available in Canada only. US-based PharmaJet's needle-free injections are used for various vaccines, including influenza, polio, and Covid-19. Its products have a global presence in Europe as well as developing countries like Brazil and Vietnam.As a result of its increasing acceptance and market potential for this innovation, Serum Institute, the largest vaccine maker in the world, in April 2024 acquired a 20% stake in IntegriMedical to further advance the needle-free injection system technology. 'IntegriMedical's N-FIS represents a significant advancement in drug delivery, and we envision a needle-free solution to deliver vaccines. We believe this could potentially revolutionise the way we administer vaccines, making the process more comfortable for patients and healthcare professionals,' states Adar Poonawalla, CEO, Serum Institute of India, after the deal.Although the product seems quite promising, Mutha and his team are struggling with awareness issues. He says that doctors are surely curious and want to adopt this technology; however, they also have a lot of questions and concerns around its efficiency and operation.Pricing poses another challenge. The N-FIS device comes in the range of Rs 300-400, which is considered premium in India, while a normal syringe used for vaccination costs around Rs 50. However, both Mutha and Kulkarni state that parents are willing to pay a premium for a completely painless injection for their child. According to them, the price will come down over the years with increased usage.Also, from a regulatory perspective, it takes a lot of time for such a product to be accepted, as per experts. However, if IntegriMedical is able to navigate regulatory compliance in other countries the way it manages in India, experts say N-FIS could be used on a larger scale.Kulkarni mentions that other needle-free injectables have been used globally, such as in South Africa, when there was an endemic of meningitis. 'It wasn't the same device as IntegriMedical but some other needle-free device. So mass vaccination can be done with this needle free, without any problem,' he says.Through its Universal Immunisation Programme (UIP), the Indian government provides free vaccinations to children under 12 and pregnant women, with a targeted annual reach of around 26.7 million newborns and 29 million pregnant women. Experts say that IntegriMedical's N-FIS can be very beneficial to further expand the programme. However, there is a limitation. IntegriMedical's N-FIS device is capable of administering only 0.5 ml of drugs. While this volume accommodates most vaccines, any dosage over it will require 2-4 times the shot or must be administered with a needle.In May, IntegriMedical achieved a significant milestone by officially launching N-FIS in the gynaecology segment, expanding our footprint beyond paediatrics. 'This is just the beginning, says Mutha. Several other specialities, including IVF and diabetic, present strong potential for integration in the future. As more departments recognise the clinical and patient-centric benefits of needle-free vaccinations, we expect a sharp increase in hospital adoption over the next couple of years,' he says.The company is also in talks with pharmaceutical manufacturers to co-package the N-FIS device along with their vaccines while also looking to collaborate with the government for the HPV vaccine.According to MD Mutha, the company is looking at anywhere between 2 and 5 lakh vaccinations this year. 'Today, around 25 million kids are born every year, and even if you consider five vaccinations per kid a year, the number is just huge,' he explains.The global market for needle-free injectors, valued at approximately $1.3 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 7.8%, according to Nilaya Varma, Co-founder of management consultancy Primus Partners. He believes that the needle-less injections will dominate the market in the near future, due to a number of factors, such as the increasing incidence of needle-stick injuries and related infections, the rising prevalence of chronic conditions that necessitate frequent injections, a growing need for mass vaccination and home-based care, as well as advancements in jet-based and spring-based delivery systems.'While it is challenging to determine the precise size of the needle-less injection market in India, it is reasonable to conclude that the future looks promising for this segment in both the Indian and global markets,' Varma says.As per market researcher Grand View Research, India's vaccine market, which generated a revenue of $4.3 billion in 2023, is projected to reach $5.3 billion by 2030, growing at a CAGR of 3.3%. Furthermore, the needle-free vaccine market globally could be worth $27 billion by 2028, as per Mutha. No doubt the opportunity is big, but the question remains: will IntegriMedical be able to navigate the challenges and take a bigger share of it?