27 Dec A Pilot Open-Label Randomized Study to Evaluate the Safety, Tolerability, and Acceptability of the IntegriMedical® Needle Free Injection System versus a Conventional Needle-Based System in Healthy Volunteers, Using Normal Saline as a Placebo

Almas Pathan,¹ Kavitha Shetty Narasimha,² Ankur Naik,² Arati Ranade¹

¹Jehangir Clinical Development Centre, Pune, Maharashtra, India; ²IntegriMedical Private Limited, Pune, Maharashtra, India

Correspondence: Almas Pathan, Jehangir Clinical Development Centre, Jehangir Hospital Premises 32, Sassoon Road, Pune, Maharashtra, 411 001, India, Email almas.jikare@rediffmail.com

Purpose: The study aimed to assess the safety, tolerability, and acceptability of the IntegriMedical® Needle Free Injection System (IM-NFIS) compared to conventional hypodermic needle injections (CHN) in healthy adult subjects across multiple injection sites.
Patients and Methods: Thirty healthy male subjects aged 18– 45 years were enrolled in this open-label study. Each subject received both NF and CHN injections at five different sites (forearm, abdomen, thigh, buttocks, and arm). In the study, participants in the forearm cohort received 0.1 mL of saline, whereas, for all other injection sites, 0.5 mL of saline was administered. Both needle-free and hypodermic needle injections were used at the designated sites, with a 5- to 10-minute interval between each injection. Since no active drug was used, saline served as a placebo in both methods. Safety assessments included local and systemic reactions, pain scores using the Visual Analog Scale (VAS), and acceptability questionnaires. The study adhered to ethical guidelines and was approved by the Institutional Ethics Committee.
Results: NF injections demonstrated significantly lower pain scores compared to CHN injections (mean VAS score 0.23 vs 1.07, p < 0.01). Local site reactions were minimal and similar between NF and CHN injections, with no significant differences observed at 20– 30 minutes post-injection. Systemic reactions were absent in both groups throughout the study period. The NF injection system was highly acceptable, with a majority of subjects reporting reduced anxiety and pain compared to CHN injections (p < 0.01).
Conclusion: IM-NFIS proved to be safe, well tolerated, and highly acceptable for delivering pharmaceuticals compared to conventional needle and syringe injections. This needle-free technology offers potential advantages in improving patient compliance and reducing injection-related anxieties, suggesting its promising role in future medical practices, including pediatric vaccinations and frequent medication administration.

Keywords: medical device, acceptability questionnaire, pain, VAS score, US-FDA toxicity scale, comparative study

Introduction

Injections with hypodermic needles are a common procedure in modern medicine. Ideally, a solution of a drug is forced under piston stress straight into the bloodstream or exact tissue. This necessitates skin perforation using a needle, which is associated with trauma and pain. To overcome these drawbacks, other alternative methods have been investigated like jet injections, dermabrasion, thermal ablation, laser, tape stripping, etc.¹ Reduction of the pain may lead to improved patient satisfaction and compliance, as well as reduced anxiety in populations of patients who require frequent vaccinations or ongoing injections to treat their medical conditions.²

Needle-free injection systems have emerged as an innovative solution, delivering medications without traditional needles. The concept originated with Marshall Lockhart in 1936 and was advanced in the 1940s by Higson et al, who developed high-pressure devices that use fine liquid jets to penetrate the skin.³ Needle-free jet injectors gained popularity with the introduction of multi-use nozzle jet injectors (MUNJIs), which were utilized by the US military between 1947 and 1965 due to their ability to administer vaccinations at a high rate.⁴ Multi-use nozzle jet injectors (MUNJIs) were widely used for mass immunization campaigns until the 1980s. However, in 1985, a hepatitis B outbreak was linked to MUNJIs, likely due to contamination from body fluids. To address this, single-use nozzle devices, known as disposable cartridge jet injectors (DCJIs), were developed. These use a disposable cartridge and nozzle to prevent blood from splashing back onto the device, reducing the risk of contamination.⁵ Since the early 2000s, technological advancements have enhanced needle-free injection systems (NFIS), making them more comfortable, accurate, and user-friendly.⁶ Recently, there even has been a significant shift in technology, leading to increased interest in the use of needle-free injection methods.⁷ Currently, several notable devices, including PharmaJet Stratis, Biojector 2000, and Zetajet, are commonly used for administering vaccines and managing pain. Today, even systems like microarray patches serve as alternative to conventional hypodermic needle.⁸ The working principle of needle free injection works on different technologies including spring system, gas propelled system, etc.⁹

All these systems offer numerous advantages, including the elimination of puncture-related hazards, minimized bleeding and bruising, and faster, more reproducible drug delivery with enhanced bioavailability. They also improve drug stability, reduce needle phobia particularly benefiting vaccine delivery and the development of drug proteins. However, these systems are complex and costly, requiring trained personnel and are not suitable for intravenous use.³ Nonetheless, advantages of the needle-free injection system over power its limitations.

IntegriMedical® Needle Free Injection System (IM-NFIS) is intended to deliver drugs and biologics through a needle-free injection device. IM-NFIS (Figure 1) works on needle-free injection technology using the principle of generation of a high-pressure jet, which pierces the skin when it comes in intimate contact with the skin and thus delivering the liquid it contains into the tissues in and under the skin. In the NFIS, potential energy is stored in the loaded spring, which when suddenly released by trigger pushes the plunger and attached piston into the cylinder and creates a pressure surge in contained liquid drug or biologic which then escapes as a high-velocity jet stream through micro-orifice of the cartridge. Typical doses can range from 0.1 mL to 0.5 mL and are delivered to various injection depths such as Intradermal (ID), Subcutaneous (SC), and Intramuscular (IM) depending on the volume of the drug or biologic loaded in the Cartridge. The ID injection depth occurs just under the epidermal layer of skin and is usually for a smaller dose of 0.1mL. The SC and IM injection depths occur under the ID layer and are usually intended for larger doses.

Figure 1 Design and Components of the IntegriMedical® Needle Free Injection System (IM-NFIS) with Safety Features. Figure has 5 components as per below sequence. 1-IM-NFIS Device (Reusable), 2-Loader (Reusable), 3-Cartridge (Single use), 4-Vial Adapter (Single use or Multiple use for maximum 10 actuations), 5-Prefilled syringe adapter (Single use).

 

The present study was the first in human assessment of IM-NFIS to compare safety, tolerability and acceptability of needle-free injection system in healthy subjects with conventional hypodermic needle-based system at 5 different sites of administration (forearm, abdomen, thigh, buttocks and arm).

Material and Methods

Participants and Ethics

Subjects were enrolled in the study only after providing signed informed consent. Eligible participants included males and females aged 18 to 45 who were in good general health, had no significant medical history and showed no notable findings during physical examinations. Participants also had no history of liver, kidney, cardiovascular, or neurological disorders in the past three months, and female participants were non lactating and tested negative for pregnancy on the day of enrollment.

Individuals who recently used immunosuppressive or cytotoxic medications, received blood products within the last 16 weeks, or had a history of bleeding disorders were excluded from the study. The study was conducted at Jehangir Clinical Development Centre in Pune, India. The study protocol (IM/NFIS/01) was approved by the Institutional Ethics Committee (ECR/352/lnst/MH/2013/RR-19) and the study was registered with the Clinical Trial Registry of India (CTRI/2021/01/030587). The study adhered to ethical guidelines outlined in the “Ethical Principles for Medical Research Involving Human Subjects”, as specified in the Helsinki Declaration.¹⁰

Study Design

This was a 5-day open label study conducted in 30 subjects divided into 5 cohorts with 6 subjects in each cohort. Subjects were randomized sequentially on the basis of their enrolment in the study into the following cohorts- The forearms (Cohort 1), abdomen (Cohort 2), thighs (Cohort 3), buttocks (Cohort 4), and arms (Cohort 5). Each subject acted as both test (Saline delivery through Needle free injection) and control (Saline delivery through Hypodermic needle). Every site was divided into designated areas for test and control treatments. The right side of each site received saline via the needle-free injection system (NFIS), while the left side was treated with a hypodermic needle (Table 1).

Table 1 Cohorts and Areas for Receiving the Product

 

The study consisted of five visits. Visit 1 (Baseline/Screening/Day 0) involved an initial evaluation of physical examination, vital signs assessment, clinical laboratory tests (including hematology and serum creatinine), and a chest X-ray to assess the eligibility of the subject. On Visit 2 (Day 1/Enrolment), participants in Cohorts 2 to 5 received 0.5 mL of saline placebo administered by the principal investigator using both a IntegriMedical® needle-free injection and a conventional hypodermic needle at the designated site. Participants in Cohort 1 received 0.1 mL of saline placebo administered in the same way, with a 5- to 10-minute interval between injections.¹¹ The principal investigator assessed the injection sites at 2 minutes and again between 20–30 minutes after administration. Subjects were evaluated for site reactions and systemic reactions using US-FDA toxicity scale guidance,¹² Pain levels were assessed using the Visual Analog Scale (VAS),¹³ with scores categorized as None (0), Mild (1–3), Moderate (4–6), and Severe (7–10) and acceptability using inhouse questionnaire separately after each injection.¹⁴ Also, participants were trained to monitor local site reactions and reported both local and systemic reactions over the phone, sending photos of injection sites to the investigators. Visits 3 (Day 2) and visit 4 (Day 3) was the telephonic visits, follow-up assessments via telephone focused on AEs/SAEs using toxicity scale provided by FDA guidance. Those participants who experienced site reactions were called in for further evaluation. A final visit 5 follow-up on Day 4 similarly assessed AEs/SAEs, marking the end of the study (EOS).

Sample Size

A total of 30 subjects were recruited in this study based on the inclusion/exclusion criteria. According to the FDA guidance for pilot or feasibility study of medical devices, endpoints and sample size need not be statistically driven and generally can involve around 10–40 subjects. Studies on similar devices also show use of small population for establishing safety of the device.^15,16 This justifies the selection of 30 participants in this study.

Data Analysis

Statistical analysis was performed using the SPSS Version 20 software. All available data was used in the analyses. All comparative analysis was based on two-tailed tests with a significance level of α = 0.05. The study endpoints were tested for statistical significance using paired t test/chi-square test as appropriate.

Results

The demographic and patient characteristics show (Table 2) that all the subjects enrolled were male with mean age of 26.2 years (median 22.5 years; range 18 to 43 years). Highest percentage of subjects (43.3%) were in the age range of 18–20 years, with 30.0% in the range 21–30 years and 26.7% above 31 years. Mean weight was noted as 61.6 kg (SD 11.6 kg) with minimum of 44 kg and maximum of 89 kg. Mean height was recorded as 169.2 cm (SD 7.6 cm) with minimum 146 cm and maximum 181 cm. All except one subject were non-smokers and non-alcoholics. Subjects’ healthy status was ensured through the measurement of vitals, physical examination and collection of medical history. All subjects were reported to have normal clinical relevance on above parameters. Figure 2 highlights the subject disposition pattern.

Table 2 Demographic Characteristics of the 30 Subjects at Baseline

Figure 2 CONSORT Flow Diagram of Study Participants. This flowchart summarizes participant progression through the study stages, including enrollment, allocation, follow-up, and analysis.

 

Safety Assessments Through Local Site Reactions

Data on local site reactions collected at 2 min and at 20–30 min following NF injection and CHN injection is summarized in the Table 3. Post 2 min, one subject (receiving NF injection in Arm) and three subjects post CHN injection (two in Arm and one in Abdomen) reported Grade 1 pain (does not interfere with activity). Grade 1 tenderness (mild discomfort to touch) was reported by two each, NF injection (both Forearm) and CHN injection (one Forearm and one Abdomen) subjects. None reported erythema/redness or induration. At 20–30 min post injections no local site reactions was reported for both injection methods. Further, it is worth noting that when compared to conventional needle the difference obtained in site reactions has not reached a statistical significance level.

Table 3 Summary of Local Reactions Post Injections (2 min and 20–30 min)

 

Data for all 30 study subjects who received both NF and CHN injections and collected at 24, 48, and 72 hours post injection (Table 4) revealed that none of the subjects reported any kind of complaints on all the three instances.

Table 4 Summary of Local Reactions Post Injections (24, 48 and 72 hours)

 

Safety Assessments Through Systemic Reactions

Systemic examination (nausea, diarrhea, headache, fatigue, and myalgia) carried out for after NF and CHN injections administration at 2 min and 20–30 minutes (Table 5) demonstrates that none of the subjects in both injection types reported any adverse events. This conclusion was valid across both groups at 20–30-minute post injections also.

Table 5 Systemic Examination Post Injections (2 min and 20–30 min)

 

Further, systemic examinations carried out for all subjects post 24, 48, and 72 hours (Table 6) after injections also revealed that none of the subjects reported any adverse events.

Table 6 Systemic Examination Post Injections (24, 48 and 72 hours)

 

Pain Assessment Using VAS Score

Pain score when assessed within 2 min following the NF injection and CHN injection showed 76.7% of the subjects reported no pain post NF injection compared with 30.0% in the CHN injection recipients (Table 7). The percentage of those who did not experience pain post NF injection was significantly higher as compared with CHN injection group (P < 0.01; chi-square test). Mean pain score for the NF injection was 0.23 and for CHN injection it was reported as 1.07. The lower pain score post NF injection as compared with CHN injection was statistically significant (P < 0.01; paired-t test for comparison of 2 means). Hence, tolerability of NFIS was proven through this study.

Table 7 VAS Pain Score Assessment Following NF and CHN Injections

 

Acceptability Questionnaire

Acceptability questionnaire was administered to the study subjects post administration of NF injection and CHN injection. Responses given by the subjects separately for the two injections are tabulated in Table 8. The NF injection was generally acceptable with many questions responded as “not at all” by all subjects. Significantly higher percentage (90%) responded that they did not feel anxious about receiving the NF injection as compared with 43.3% with the CHN injection (P <0.01; 2 × 2 chi-square test with continuity correction). All the subjects (100%) were not bothered by pain during the NF injection as compared with 43.3% in the CHN injection (P < 0.01; 2 × 2 chi-square test with continuity correction).

Table 8 Acceptability Responses Given by Subjects’ Post NF and CHN Injections

 

Discussion

All 30 subjects in this study received both injections. At the time of screening, vital signs of the study subjects had “normal” body temperature, heart rate, respiratory rate, and blood pressure. All subjects in both the groups were “normal” with respect to general appearance, head, ENT, eyes, skin, neck, abdomen, cardiovascular, respiratory, musculoskeletal, neurological, and lymphatic systems. None of the study subjects reported any past / current medical history. These findings ensured the healthy status of the subjects during the recruitment.

Subjects were first administered saline with needle free injection (NF Injection) system followed by conventional hypodermic needle injection (CHN Injection). NF injection was given in the right side and the CHN injection on the left side. Five injection sites were used – forearm, abdomen, buttock, thigh, and arm with six subjects in each group. Post NF injection, VAS pain score was recorded within 1 min for all subjects. In the case of CHN injection, VAS pain score was recorded within 2 minutes for 28 subjects and for remaining 2 subjects the measurement was completed in 3 minutes. FDA toxicity assessments were done within 02 min for all subjects post NF injection and CHN injection. Toxicity assessments were repeated post 20–30 min of each injection. These assessments did not highlight any safety concern following the administration of injections during the entire planned follow-up period. VAS pain assessment scores demonstrated that the NF injection induced (statistically) significantly lower pain scores as compared with CHN injection. NF injection was well tolerated as that of the convention injection (CHN injection). Hence, tolerability of NFIS was proven through this study. Only one subject complained of pain post NF injection after 2 min, three following CHN injection. Tenderness was reported by two subjects for both injection types after 2 min. No other local reactions were noted. Our findings were similar to the results of a clinical study that assessed the safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection.¹⁷

Vitals remained stable post injection and systemic examination did not highlight any complaints. Questionnaire responses suggest that IM-NFIS system was well accepted. These results can be correlated with the results of a PRCISE-II clinical study¹⁸ that assessed safety and subject preference for an innovative needle-free injection system. Overall, NF injection had a significantly higher satisfaction percentage compared with the CHN injection administration. None of the subjects reported any specific adverse events. The Needle Free Injection System (NFIS) provided easier, less painful, and more acceptable delivery technology for a layperson making it more user-friendly than traditional needles.

The study’s findings suggest that this study have several important implications. The IntegriMedical® Needle Free Injection System (IM-NFIS) could enhance patient compliance and satisfaction by reducing pain and anxiety compared to conventional hypodermic needles, making it particularly beneficial for populations with needle phobia, such as children or individuals requiring frequent injections, thereby potentially improving vaccination rates and adherence to treatment regimens. Additionally, NFIs help prevent needle-stick injuries and the risk of needle reuse, minimizing infection risks in children.^19,20

Limitations

The small sample size of thirty healthy male subjects restricts the generalizability of the results to a wider population. Additionally, the use of saline as a placebo may not accurately represent responses to actual medications. These factors underscore the need for further research to gain deeper insights into the safety and effectiveness of the IntegriMedical® Needle Free Injection System.

Conclusion

In summary, IM-NFIS demonstrated safety, tolerability and acceptability compared to a conventional needle and syringe injection. The advancement of needle-free injection technology has potential positive implications especially for patients who require frequent injections of medications for a variety of conditions. The use of this technology can significantly benefit children by minimizing discomfort, reducing anxiety associated with needles, and improving overall compliance with vaccination schedules. Further studies are needed to evaluate the effectiveness of the device in successful delivery of pharmaceuticals or biologicals.

Data Sharing Statement

The data are not publicly available due to their containing information that could compromise the privacy of patients. All data supporting this study will be provided by the corresponding author upon reasonable request.

Ethics Approval and Informed Consent

The study was conducted according to the guidelines of the Declaration of Helsinki. This study protocol was approved by the Institutional Ethics Committee of Jehangir Clinical Development Centre. The informed consent was taken from the subject.

Acknowledgments

Authors are thankful to Jehangir Clinical Development Centre Pvt. Ltd., Pune for designing the clinical study, conduct of the study and statistical analysis of the data.

Disclosure

Mr Ankur Naik reports a patent US20230414876A1 issued to INTEGRIMEDICAL LLC, a patent US11752269B2 issued to INTEGRIMEDICAL LLC. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

1. Mishra DK, Pandey V, Maheshwari Piyush Ghode R, Tekade KR, Basic Fundamentals of Drug Delivery Advances in Pharmaceutical Product Development and Research. Chapter 15 – Cutaneous and Transdermal Drug Delivery. Techniques Delivery Syst. 2019;2019:595–650.

2. Barolet D, Benohanian A. Current trends in needle-free jet injection: an update. Clin Cosmet Invest Dermatol. 2018;11:231–238. doi:10.2147/CCID.S162724

3. Kale TR, Momin M. Needle free injection technology-An overview. Innovations in Pharmacy. 2014;5(1):1.

4. Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nat Rev Drug Discov. 2006;5(7):543–548. doi:10.1038/nrd2076

5. du Châtelet IP, Lang J, Schlumberger M, Vidor E, Soula G, Genet A, Imule® Investigators Group. Clinical immunogenicity and tolerance studies of liquid vaccines delivered by jet-injector and a new single-use cartridge (Imule®): comparison with standard syringe injection. Vaccine. 1997;15(4):449–458. doi:10.1016/S0264-410X(96)00173-9

6. Schoppink J, Rivas DF. Jet injectors: perspectives for small volume delivery with lasers. Adv. Drug Delivery Rev. 2022;182:114109. doi:10.1016/j.addr.2021.114109

7. Mohizin A, Kim JK. Current engineering and clinical aspects of needle-free injectors: a review. J Mech Sci Technol. 2018;32(12):5737–5747. doi:10.1007/s12206-018-1121-9

8. Berger MN, Mowbray ES, Farag MW, et al. Immunogenicity, safety, usability and acceptability of microarray patches for vaccination: a systematic review and meta-analysis. BMJ Global Health. 2023;8(10):e012247. doi:10.1136/bmjgh-2023-012247

9. Ravi AD, Sadhna D, Nagpaal D, Chawla L. Needle free injection technology: a complete insight. Int J Pharm Investig. 2015;5(4):192–199. doi:10.4103/2230-973X.167662

10. WMA. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki/#:~:text=All%20medical%20research%20involving%20human,by%20the%20condition%20under%20investigation. Accessed 30, October 2024.

11. Kojic N, Goyal P, Lou CH, Corwin MJ. An Innovative Needle-free Injection System: comparison to 1 mL Standard Subcutaneous Injection. AAPS PharmSciTech. 2017;18(8):2965–2970. doi:10.1208/s12249-017-0779-0

12. FDA Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. CBER; 2007.

13. Dias C, Abosaleem B, Crispino C, Gao B, Shaywitz A. Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: a Randomized, Crossover Study in Healthy Subjects. AAPS Pharm Sci Tech. 2015;16(6):1500. doi:10.1208/s12249-015-0324-y

14. Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees’ Perception of Injection (Vapi) questionnaire. Health Qual Life Outcomes. 2009;7(1):21. doi:10.1186/1477-7525-7-21

15. https://www.fda.gov/media/87603/download;.

16. Berteau C, Filipe-Santos O, Wang T, Rojas HE, Granger C, Schwarzenbach F. Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance. Med Dev. 2015;8:473–484. doi:10.2147/MDER.S91019

17. Gottlieb M, Thommes JA. Safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antiviral Ther. 2008;13(5):723–727. doi:10.1177/135965350801300512

18. Kelley EL, Smith RH, Corcoran G, Nygren S, Jacoski MV, Fernandes A. Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system. Drug Deliv. 2021;28(1):1915–1922. doi:10.1080/10717544.2021.1976309

19. Abd Ellatif EM. Comparison Between needle-less injection system and Conventional injection Technique to Perform anesthesia In Children: a Randomized Clinical Trial. Egypt Dent J. 2018;64(3):1981–1985. doi:10.21608/edj.2018.76697

20. Kelly K, Loskutov A, Zehrung D, et al. Preventing contamination between injections with multiple-use nozzle needle-free injectors: a safety trial. Vaccine. 2008;26(10):1344–1352. doi:10.1016/j.vaccine.2007.12.041

07 Dec BioSpectrum Asia recognises achievements at Excellence Awards 2024 in Singapore

Witnessing the convergence of brilliance as we recognise the industry’s finest at BioSpectrum Asia Excellence awards 2024 night

To recognise and celebrate the remarkable achievements and contributions of Asian companies and individuals in the life sciences sector, BioSpectrum Asia organised the Excellence Awards 2024 in Singapore on 6th December.

This prestigious event honoured the outstanding performers of the calendar year 2023 & 2024, underscoring Asia’s emergence as a global hub for innovation and growth in the life sciences industry.

The BioSpectrum Asia Excellence Awards 2024 comprised of two segments- Jury Special and Industry Special Awards.

Winners for our Industry Special segment included-

Top Company for Bioprocessing – Eppendorf

Top Company in Manufacturing Technology & Equipment – Cytiva

Top Company in Packaging & Drug Delivery Services – West Pharma

Top Company in Supply Chain Logistics & Distribution – Catalent Pharma Solutions

Top Company in Clinical Research-Based Development – Medidata

Top Innovation & Collaborations in ADC Drug Development – GenScript Biotech

Innovative Biotech Solutions – Ardor Biomed India

Emerging Al Powered Drug Discovery Platform – Molecule AI

Top Company in Medical Packaging – Oliver Healthcare Packaging

Outstanding Leadership in MedTech Advocacy in Asia-Pacific Award- Special Recognition – APACMed

Excellence in medtech innovation- Medtronic

Winners of the Jury Special category included-

Entrepreneur of the year- Dr Jogin Desai from Eyestem Research & Dr Lynne Lim for NousQ

Emerging startup of the year- ImmunoAct, and Aevice Health

Businessperson of the year– Dr Christian Behrenbruch, Managing Director and Group CEO of Telix Pharmaceuticals

Product of the year– Needle free injection system technology by IntegriMedical

In conjunction with the prestigious BioSpectrum Asia Excellence Awards 2024, a panel discussion was organised on the critical topic: “Biomanufacturing: Advancing Towards a Sustainable Bioeconomy in Asia.” powered by Cytiva.

The discussion was moderated by Dr Satya Dash– President Strategy Bigtec, Founding Head Strategy, BIRAC, Government of India; while the speakers included Damian Cher, Director of Manufacturing Capacity Solution in Asia Pacific, Cytiva; Franco So, Head of Bioprocess, Sales, Asia Pacific China, Eppendorf; Lew Fei-Chuin, Biopharma Market Manager, Agilent Technologies; Dr. Saket Jhajharia, Chief Operating Officer, ID Capital; and Dr Dario Heymann, Chief Research Officer, Galen Growth Singapore & AI Office, SingHealth.

BioSpectrum Asia is proud to play a critical role of picking tomorrow’s winners, nudging today’s entrepreneurs to achieve greater glory and honouring yesterday’s key players who laid the foundation for success.

14 Nov 5 ways to nurture your child’s emotional wellbeing this Children’s Day

“I don’t want to go to school tomorrow.” Ten-year-old Aisha’s words stopped her mother mid-scroll through the parents’ WhatsApp group filled with exam preparation tips. As a pediatrician and parent in urban India, I’ve seen how academic pressure, screen time, and packed schedules are reshaping our children’s emotional spectrum. This Children’s Day, let’s look beyond report cards to understand what our children really need.

1. Listen to the unspoken

Last month, Aisha’s mother noticed her usually chirpy daughter becoming quiet and withdrawn. Instead of immediately scheduling extra tuitions – the default solution in many Indian households – she chose to dig deeper. Behind the “I don’t want to go to school” lay more complex feelings about friendship dynamics and performance anxiety. Sometimes, the first step in supporting emotional wellbeing is simply creating space for these conversations.

2. Reimagine wellness for today’s children

Physical and emotional health are deeply interconnected, yet we often treat them separately.separately. Take the case of Vihaan, whose parents were concerned about his Increasing Irritability. Their focus was on academic performance, but our discussion revealed an erratic sleep schedule due to late-night gaming and skipped meals between tuitions. By restructuring his routine to include proper rest, nutrition, and physical activity, we saw improvements not just in his mood but also his concentration.

3. Make healthcare a positive experience

Here’s where modern Innovation meets emotional wellbeing. When Zara’s mother mentioned her daughter’s anxiety about upcoming vaccinations, I introduced them to Needle-Free Injection System (N-FIS). This technology has transformed how children experience healthcare no more tears or trauma. Research shows that nearly 68% of children fear needles, often carrying this anxiety into adulthood. With N-FIS, we’re not just making medical procedures comfortable; we’re preventing a lifetime of medical anxiety.

4. Create new-age emotional outlets

“My son only wants to play Minecraft,” a concerned parent recently shared. But when we looked closer, we found that Rehan was actually using the game to build and express his creativity much like how we used building blocks or art. Today’s children need emotional outlets that speak their language. Whether it’s coding clubs, digital art, or yes, even monitored gaming time, finding age-appropriate creative expressions helps children process their emotions in ways they understand.

5. Build family connections that fit modern life

Gone are the days of joint family wisdom flowing freely over evening tea. But today’s families are finding their own rhythms. The Mehtas, for instance, turned their weekend grocery shopping into valuable one-on-one time with each child. Another family I know uses their car rides to school for meaningful conversations – no phones, just ten minutes of undivided attention that their daughter now counts on.

Supporting modern children in an ancient land

Our children are growing up in a unique time where Alexa coexists with ancient wisdom, where screen time battles with story time, and where achievement often. overshadows emotional growth. Yet, some things remain constant: children need to feel heard, understood, and supported.

This includes transforming traditionally stressful experiences into positive ones. Modern healthcare solutions like N-FIS represent more than medical innovation they show our children that their emotional comfort matters. When seven-year-old Dev recently said, “Doctor, I’m not scared anymore, it wasn’t just about needie- less injections; it was about feeling seen and cared for.

As we celebrate Children’s Day, let’s remember that nurturing emotional wellbeing in today’s children requires a fresh approach. It means embracing helpful Innovations while keeping the essence of care and connection alive. Start small – perhaps with one uninterrupted conversation, one stress-free medical visit, or one hour of play without performance pressure.

After all, in a world racing toward tomorrow, our children need us to be present today.

14 Oct Startup Mantra: Needle-free injection tech boost

IntegriMedical has launched India’s first Needle-Free Injection System to ease the pain of injections for children and adults, enhancing healthcare experiences.

Check into any pediatrician’s clinic and chances are you will hear little kids bawling. They’d be fine even during the doctor’s examination but the moment the injection is in the doctor’s hand the crying begins. And while this tears a young mother’s heart to see her baby cry, she understands that this is one ‘pain’ her child must endure and learn to accept. And if truth be told there are many adults too who fear the needle. So, what could be done?

Says Sarvesh Mutha, co-founder and managing director of IntegriMedical, “We looked at the problem deep and hard and felt that things should change. Injections should not be painful, not even for a nanosecond. That is when IntegriMedical developed the Needle Free Injection System (NFIS) in April 2024.”

Earlier device

The solution lay across the Atlantic when Jean Sales-Guirron developed a device way back in 1866 where water or medicine could penetrate the skin without a needle but under pressure. This however was further developed and patented in 1936 by Marshall Lockhart. The history of this jet injection is marked by a few lows as initial versions had issues that caused some injuries. But it was the need for rapid immunisations on account of various epidemics (plague, smallpox, measles etc) and the need to reduce the wastage of vaccines that probably egged inventors to look for this alternative.

How it started

In 2020, Sarvesh and his co-founder and managing director Ankur Naik decided that something must be done. Says Sarvesh, “We developed the solution after understanding that children and even adults faced problems when taking an injection, whether it was on account of needle phobia, discomfort or needle stick injuries. While the needle-free injection technology was readily available in the US and other European countries, our country had yet to experience the benefit of going needle-free.”

They hired a team of researchers and leveraging the existing technology they worked on it to make it India’s first needle free injection device. But how can one deliver any medication to the body without piercing the skin? Says Sarvesh, “Our skin has pores and these pores are opening in the skin. So we use the pores to deliver medication. Our N-FIS is a high-pressure, spring-driven mechanism that delivers the drug quickly and with less pain via the pores, causing no tissue damage.” Initially, they used their own funds as well as that of early investors making an investment of $ 4 million.

Approvals

No medical device can get to the market without trials and government approvals. Says Sarvesh, “When we started we knew we had to get feedback from the users and conduct trials. A major part of the investment went into trials and approvals.”

“In 2023 we had a soft launch of our device where we offered it to a few doctors to get a clearer understanding of the issues they may face. With several iterations of our product and getting approvals from CDSCO and CE (Euro) as well as clinical trials on the Indian population (they did it on 500 people) IntegriMedical was ready to launch its Needle-Free Injection System (N-FIS) in the market in April 2024.

To the market

Anything new is often seen with some trepidation. Says Sarvesh, “Our plan was not to just sell the product to doctors but to also train them on how to use it. All our doctors do their MBBS and are trained to use injections. We knew that the success of our product would depend on correct usage and that included training the doctors and medical staff who agree to use it.”

After the trial run, IntegriMedical approached the medical fraternity armed not with just the N-FIS but also trainers. “There are some companies making this device but they chose another path to the market. They sell to the pharma companies. A doctor receives training while at a medical college on how to use a needle, but this is new. Without training it can result in failure. Which is why we chose this route – of selling directly to the end user but only after he has been trained.”

IntegriMedical launched its N-FIS in April this year. They have hired 60 salespeople who meet paediatricians largely and not just sell their product but also train them to use it. The result of this deep dive into the market? Says Sarvesh, “Initially we are focusing on Tier 1 and Tier 2 cities. The response has been very good.”

Competition

Since there is no one manufacturing N-FIS the competition comes mainly from the traditional injection. Says Sarvesh, “Our primary competitors are traditional needle-based injections and some needle-free devices. What sets us apart is our unique focus on precision, reliability, and a completely patient-centric approach. In addition to the product itself, we are the only company that has boots on the ground collaborating with paediatricians, training and hand holding them to ensure complete satisfaction for healthcare providers and patients as well. We offer a truly needle-free experience that alleviates pain and discomfort during drug delivery, ensuring high patient compliance.

“Moreover, our product is compact, lightweight, and easy to use, making it ideal for various healthcare settings. Also, it’s the first needle-free injection that has an ergonomically designed stainless steel body, ensuring smoother handling and reduced noise. Our in-house research and operations give us more flexibility and a competitive edge, setting the standard for quality and innovation, ensuring that no other solution can match the quality we offer.”

Future plans

“Our mission is to transform healthcare globally by enhancing patient comfort, reduce needle stick injuries, and increase the efficacy of liquid medication I think our N-FIS can help relieve some of that stress and make her experience at such clinics pain-free,” says Sarvesh.

They want to extend beyond the pediatricians’ clinics and reach out to other sectors of the industry such as infertility clinics. Says Sarvesh, “When a couple sees an infertility specialist there is anyway stress of not being able to conceive. Add to this is the number of injections the wife has to take. Our device could help the woman by reducing the pain of taking several injections.”

In addition to this, they are also planning on co-packaging collaborations with pharmaceutical companies to drive adoption across various medical sectors.

“Our aim is to improve clinical experiences by partnering with healthcare professionals and paediatricians. Additionally, we are expanding our regulatory approval portfolio to reach international markets and collaborating with government bodies and global foundations to integrate needle-free systems into national immunisation programmes.”

IntegriMedical has received funding from the world’s largest vaccine manufacturer Serum Institute (he cannot disclose the amount) for a 20% share in profits. With the country’s first needle-free injection device, salesmen cum trainers and the largest vaccine manufacturer backing it, looks like taking shots may truly be a painless experience.

01 Oct Serum-backed IntegriMedical’s needle-free injection picks up pace

IntegriMedical has launched India’s first Needle-Free Injection System (N-FIS), gaining popularity among healthcare professionals for its pain-reducing benefits. With CDSCO approval and partnerships, the company aims to expand its market presence in India and Europe, addressing needle-related fears.

Are you scared of needles and dread going for a vaccine or shot? Whether it’s for your children or yourself, the fear is common!

The Needle-Free Injection System is gaining traction in the country.

According to IntegriMedical, a healthcare solutions company that claims to have developed India’s first Needle-Free Injection System (N-FIS), the increase in sales since its launch indicates that healthcare professionals are recommending or switching to needle-free systems to accommodate children and needle-phobic patients.

IntegriMedical received CDSCO approval for N-FIS in December 2022 and formally launched it in the retail market in April 2024, following initial piloting in 2023.

Sarvesh Mutha, MD of IntegriMedical, told CNBC-TV18 that since the launch, “sales have been substantially growing, with over 500 doctors administering more than 35,000 injections in India, along with initiating sales activities in Europe.”

He noted that “mostly, doctors in the private sector in metro, Tier 1, and Tier 2 cities across India have adopted this technology, with North and West leading the way. Typically, paediatricians are using N-FIS to vaccinate children over six months for intramuscular and subcutaneous injections, while some use it for children over three months.”

The company believes that as awareness increases, more Indians will opt for this system to make the injection experience less traumatic and painful.

To address the widespread fear of needles, particularly among children and those who are needle-phobic, IntegriMedical aims to eliminate the need for needles in medical treatments. The company claims that the solution has been clinically proven to reduce pain during administration.

“N-FIS has regulatory approvals in Europe and India through its CE mark and CDSCO approvals and is manufactured in an MDSAP and ISO 13485 compliant facility,” the company states.

Patented in the United States, the N-FIS device utilises a high-velocity jet stream powered by mechanical force to effectively and consistently administer biologics and drugs under the skin quickly without causing tissue damage.

IntegriMedical has also formed a strategic partnership with the world’s largest vaccine manufacturer, Serum Institute of India, which has acquired a 20% stake in the company to advance needle-free injection technology.

Looking to the future, Mutha says, “With increasing demand for patient-friendly, efficient, and safe drug delivery methods, the company is well-positioned to expand its market presence, particularly in India and Europe. Additionally, we are focused on expanding our regulatory approval portfolio to facilitate broader adoption in international markets.”