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Time of India
3 days ago
- Health
- Time of India
Can injections be needle-free, painless? This Pune-based firm has the answer
Live Events 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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?
Yahoo
16-04-2025
- Business
- Yahoo
Abbott US diabetes device sales up 27% amid largely positive Q1
Abbott has posted strong revenue for its diabetes devices in Q1, despite overall sales for the company narrowly missing Wall Street expectations. The medtech giant posted an increase in year-over-year overall revenue of 4%, giving total takings of $10.36bn. After reporting a positive adjusted first-quarter profit of $1.09 per share, shares in the company rose 1% at market open today (16 April). Share prices rose further into the mid-morning. Abbott has a market cap $218.9bn. Abbott's medical device business was the strongest driver of revenue in the first quarter, driven by strong performance in the diabetes segment. A strong year for the company's diabetes devices led to a 16.5% sales increase compared to the same quarter in 2024. Abbott's US market saw a particularly high jump in growth – a 27% year-over-year change to bring diabetes sales in the US alone to $748m. This compares to $1.08bn generated internationally for the Diabetes Care unit. Sales of continuous glucose monitors (CGM), which includes the company's FreeStyle Libre range, grew 18.3% to reach $1.7bn. The company boosted manufacturing capacity for its diabetes segment with the opening of a new facility in Ireland in late 2024. The global diabetes device market is forecast to grow to over $44bn by 2033, according to analysis by GlobalData. Abbott has a 1.4% market share of the CGM market and insulin pen device market, as per further GlobalData market analysis. Segment sales for Abbott in Q1 this year are a positive sign for the company's investors given that the diabetes field saw major product launches from rivals Insulet and Medtronic in 2024. Abbott's electrophysiology business also fared well, posting $629m in global sales. The company entered the lucrative pulsed field ablation (PFA) market in Europe last month, courtesy of Conformité Européenne (CE) marking for its Volt system. Looking ahead to 2025, Abbott projects full-year 2025 organic sales growth between 7.5% and 8.5%. Abbott also announced it would invest $500m in expanding two manufacturing sites in the US amid the continuing evolution of President Donald Trump's tariffs. The doubling down in the US comes via the expansion of two of its sites in Illinois and Texas. "Abbott US diabetes device sales up 27% amid largely positive Q1" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
16-04-2025
- Business
- Yahoo
Abbott US diabetes device sales up 27% amid largely positive Q1
Abbott has posted strong revenue for its diabetes devices in Q1, despite overall sales for the company narrowly missing Wall Street expectations. The medtech giant posted an increase in year-over-year overall revenue of 4%, giving total takings of $10.36bn. After reporting a positive adjusted first-quarter profit of $1.09 per share, shares in the company rose 1% at market open today (16 April). Share prices rose further into the mid-morning. Abbott has a market cap $218.9bn. Abbott's medical device business was the strongest driver of revenue in the first quarter, driven by strong performance in the diabetes segment. A strong year for the company's diabetes devices led to a 16.5% sales increase compared to the same quarter in 2024. Abbott's US market saw a particularly high jump in growth – a 27% year-over-year change to bring diabetes sales in the US alone to $748m. This compares to $1.08bn generated internationally for the Diabetes Care unit. Sales of continuous glucose monitors (CGM), which includes the company's FreeStyle Libre range, grew 18.3% to reach $1.7bn. The company boosted manufacturing capacity for its diabetes segment with the opening of a new facility in Ireland in late 2024. The global diabetes device market is forecast to grow to over $44bn by 2033, according to analysis by GlobalData. Abbott has a 1.4% market share of the CGM market and insulin pen device market, as per further GlobalData market analysis. Segment sales for Abbott in Q1 this year are a positive sign for the company's investors given that the diabetes field saw major product launches from rivals Insulet and Medtronic in 2024. Abbott's electrophysiology business also fared well, posting $629m in global sales. The company entered the lucrative pulsed field ablation (PFA) market in Europe last month, courtesy of Conformité Européenne (CE) marking for its Volt system. Looking ahead to 2025, Abbott projects full-year 2025 organic sales growth between 7.5% and 8.5%. Abbott also announced it would invest $500m in expanding two manufacturing sites in the US amid the continuing evolution of President Donald Trump's tariffs. The doubling down in the US comes via the expansion of two of its sites in Illinois and Texas. "Abbott US diabetes device sales up 27% amid largely positive Q1" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Associated Press
19-03-2025
- Health
- Associated Press
Terumo Neuro Celebrates 15 Years of the WEB™ Device: A Game-Changing Innovation in Aneurysm Treatment
More than 25,000 Devices Implanted Worldwide from 2010-20251 ALISO VIEJO, Calif., March 19, 2025 /PRNewswire/ -- Terumo Neuro, a global leader in neurovascular innovation and a wholly owned subsidiary of Terumo Corporation, proudly marks the 15th anniversary of the groundbreaking WEB™ Aneurysm Embolization System. Since its introduction, the WEB device has transformed the treatment of wide-neck bifurcation aneurysms, offering physicians and patients a clinically proven, single-device solution – One and Done – with proven simplicity, proven safety and durability, proven for ruptured aneurysms* and proven innovation2-9. The WEB device was commercially launched in October 2010 after receiving its CE (Conformité Européenne) Mark in Europe. The first implant was performed by Prof. Joachim Klisch in Germany, paving the way for a new era in aneurysm treatment. The WEB device has proven clinical data, supported by seven global Good Clinical Practice (GCP) studies2-8 and over 200 peer-reviewed publications. Over the past 15 years, this revolutionary technology has changed the paradigm for aneurysm treatment, providing a safe, effective alternative to traditional methods. Carsten Schroeder, President and CEO of Terumo Neuro, commented on this significant milestone: 'The WEB device has set a new standard in aneurysm treatment and has been instrumental in our mission to drive game-changing impact in neurovascular care. With 15 years of proven clinical success, WEB continues to advance patient outcomes, reducing the need for multiple devices and lengthy procedures. As we celebrate this achievement, we remain committed to innovating alongside leading physicians worldwide to shape the future of neurovascular care.' Transforming Aneurysm Treatment with the WEB Device The WEB device is the world's first intrasaccular flow disruptor, designed to treat brain aneurysms from inside the aneurysm sac. Unlike traditional treatments for wide-neck bifurcation aneurysms that require stents and coils, this device minimizes the need for dual antiplatelet therapy, simplifying procedures and enhancing patient safety, with a single device. Key milestones and clinical highlights of Terumo Neuro's WEB embolization system include: Unparalleled Clinical Data: The WEB device has been studied in over 600 patients across seven GCP trials, accumulating more than 1,464 patient-years with zero recorded rebleeds in a WEB device-treated aneurysm.2-8 Proven Long-Term Safety & Durability: The five-year follow-up data from the WEB-IT, WEBCAST and WEBCAST 2 trials reaffirmed the WEB system's sustained efficacy and safety, including 0% device-related morbidity and mortality.7,8 Expanding Treatment Options: The introduction of the WEB 17 system, a lower profile system to treat smaller aneurysms, has further refined aneurysm treatment providing physicians with greater flexibility and precision for a wider range of cases. The WEB device's continued evolution underscores Terumo Neuro's dedication to advancing neurovascular technology. With more than 25,000 patients treated with the WEB device worldwide, this intrasaccular device remains the trusted choice for physicians seeking a reliable, single-device solution for wide-neck bifurcation aneurysms. About Terumo Neuro (Formerly MicroVention, Inc.) We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neuroendovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in California, Terumo Neuro products are sold in more than seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California, and San José, Costa Rica. For more information on Terumo Neuro, please visit About Terumo Corporation Terumo (TSE:4543) is a global leader in medical technology and has been committed to 'Contributing to Society through Healthcare' for one hundred years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large. For full indications for use, visit: WEB™ Embolization System | Terumo Neuro *Information provided may not represent the approved indication for use for each country/market. Please refer to the Instruction for Use (IFU) in the specific market/country that you are looking into. References: Data on file, Terumo Neuro. Pierot L, Moret J, Barreau X, et al. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J Neurointerv Surg. 2018;10(6):553-559. Arthur AS, Molyneux A, Coon AL, et al. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. J Neurointerv Surg. 2019;11(9):924-930. Pierot L, Moret J, Turjman F, Herbreteau D, et al. WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory. AJNR. 2016. Spelle, L., et al. (2022) 'Clinical Assessment of WEB device in Ruptured Aneurysms (CLARYS): 12-month angiographic results of a multicenter study.' J NeuroIntervent Surg. Spelle, L., et al. (2024) 'Clinical Evaluation of WEB 17 device in intracranial aneurysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.' J NeuroIntervent Surg. Pierot L, Szikora I, Barreau X, et al. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023;15(6):552-557. Fiorella D, Molyneux A, Coon A, et al. Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular. Therapy study (WEB-IT). J Neurointerv Surg. 2023;15(12):1175-1180. Rai AT, Turner RC, Brotman RG, Boo S. Comparison of operating room variables, radiation exposure and implant costs for WEB versus stent assisted coiling for treatment of wide neck bifurcation aneurysms. Interv Neuroradiol. 2021;27(4):465-472. WEB™ is a trademark of MicroVention, Inc., registered in the United States and other jurisdictions. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties. ©2024 MicroVention, Inc. MM2034(i) WW 03/25 Media Contact: + 1 714 206 9800
