Absorbable sutures: chronicles and applications
Healthium Medtech amongst the first in Asia and 1st Indian Medtech Company to receive CE certification under the EU MDR norms for Class III implants
National, 29th September 2022: Healthium Medtech Limited a global medical devices company focused on surgical, post-surgical and chronic care, today announced that the company has received the new CE certification under the stringent EU MDR (European Union’s Medical Device Regulation). As a part of the regulation for CE certification, the EU MDR accreditation is mandatory for sales to European countries and several other regulated markets. The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards. Healthium Medtech is India’s largest independent medical devices company in the surgical consumables market, the largest non-captive surgical needles manufacturer globally by volume and the third largest company overall in the urology collection devices market in UK. Healthium currently operates eight integrated and scaled manufacturing facilities, several of which have global accreditations and approvals including US FDA, TGA, CDSCO, EN ISO 13485:2016, ISO 9001:2015, CE under MDD and now CE under EU MDR. The EU MDR necessitates more stringent measures versus the earlier CE norms under the European Union Medical Device Directive (EU MDD), keeping patient safety in mind. This means stricter compliance, increased vigilance, robust complaint handling, regular product and customer feedback procedures, and trend reporting requirements with periodic safety update reports. In addition, the UDI ID which will now be required on all devices will enhance traceability across the supply chain. Speaking about the EU MDR accreditation, Anish Bafna, Chief Executive Officer and Managing Director, Healthium Medtech said, “We are delighted to receive the CE certification under EU MDR. At Healthium, we strive towards achieving the highest safety and quality standards for better clinical outcomes. The certification is a testimony to our continuous commitment to operational excellence and our focus in delivering the same high quality, safe, value driven products not only to the EU but also in India and other countries. This is aligned with our vision of facilitating access to precision medtech for every patient, globally.” Dr. Ashok Moharana, Chief Medical Officer, Healthium Medtech said,“The CE certification under EU MDR reinforces our growing capabilities at Healthium towards innovation, safety, quality and clinical research for providing holistic solutions for clinicians and the patient community. EU MDR signifies a milestone for the medtech fraternity and clearly supports our calibrated efforts to bring the highest safety and quality standards for improving patient outcomes across our key therapeutic areas. We will continue to rise up the value chain by adhering to the highest standards in patient safety.” About Healthium Medtech Limited: Healthium Medtech Limited is a global medtech company focused on products used in surgical, post-surgical and chronic care. One in five surgeries conducted globally uses a Healthium Medtech product. As of fiscal 2022, it is the largest independent Indian medical device company. In the non-captive surgical needles segment, Healthium Medtech is the largest manufacturer globally. Healthium Medtech is the third-largest company overall in urology collection devices market in the U.K. With a vision to provide access to precision medtech for every patient, globally, the Company has created extensive market access in India covering over 40,000 surgeons across 18,000 hospitals, reaching 90% of all districts in India, which have secondary healthcare facilities. It also is present across 80 countries. The company’s diverse portfolio includes 52,000 SKUs across Advanced surgery, Urology, Arthroscopy and wound care products. With a strong focus on R & D, the company has 8 high precision, integrated and scaled manufacturing facilities with global certifications and approvals like US FDA, C.E, CDSCO, TGA and ISO. Since fiscal 2018, the company has sold 30 new products including a patented portfolio of arthroscopy products. The Company has 64 patents in US, Europe and India including pending applications. It has acquired 3 businesses in FY21 to expand market reach and its product portfolio.
Launching the ‘Sport of Life’ Initiative with Abhinav Bindra Foundation Trust (ABFT)
March 2022 | Bengaluru, Karnataka
Healthium acquires VitalCare Group in U.K. to strengthen its global urology portfolio
Bangalore, India, July 07,2021: Healthium, a global player in medical devices, announced that it has acquired VitalCare Group, a manufacturer of urology consumable careproducts,through its subsidiary Clinisupplies Ltd. This acquisition will help Healthium expand its urology franchise in Europe and other developed markets. Healthium has a diverse portfolio of medical devices and consumables, whichincludessurgical sutures, needles, a patented arthroscopy portfolio, urology portfolio, hernia meshes, haemostats, gloves, ligation clips, surgical staplers and other wound closure devices. The Company holds 60patents in India and U.S (including those under process). VitalCareis a manufacturer of urology consumable care products,with relationships with healthcare customers worldwide. The company is headquartered in U.K.with manufacturing operations in China. With the acquisition of VitalCare,Healthium adds to its manufacturing capabilitiesin urology and boostsits in-house R&D,which will strengthenits presence in the urology segment inEurope and the U.S.Mr. Lewis Calcutt, Managing Director, VitalCare will continue with the company, building on its global presence and creating a truly differentiated product portfolio. Commenting on the acquisition Mr. Anish Bafna, MD & CEO, Healthium Medtech said, “It is our ambition to cater to needs of India and the world when it comes to quality medical devices and consumables. We continue to invest in R & D as we aim to make products that address unmet needs of patients and medical professionals. The acquisition of VitalCarewill bring together global talent, diverse cultures, differentiated expertise, strengthen ourproduct portfolio and presence in Urology care to drive continuous value for our customers. The combined leadership and synergies in offerings from both companies will further strengthen distribution, offer more choices to our customers and enable us to deliver better patient care worldwide.” Mr. Paul Cook- CEO Clinisupplies also added, “Given the rapid changes we are witnessing in the global healthcare system, the time is right for both companies to join forces and take on the larger marketopportunity. The acquisition will help us expand our footprint inEurope and U.S. Together, we will continue to focus on bringing forward best in class and innovative solutions that will continue to redefine urology care.” Mr. Lewis Calcutt, Managing Director, VitalCare said, “We are extremely excited about our association and are looking forward to expanding our urology care portfolio under the leadership of Healthium. This relationship will be a strong contributor to our growthand give us access to attractive geographies.” About HealthiumHealthium is a global player in Medical Devices focused on surgical and post-surgical markets. Healthium is focused on developing and manufacturing quality products to meet the needs of patients and healthcare professionals with a diverse portfolio that includes a patented Arthroscopy range, a full range of Absorbable, Non- Absorbable and specialty surgical sutures, urology portfolio, and wound closure products including Meshes, surgical staplers, ligation clips and Haemostats. Healthium has manufacturing facilities across India and the company holds over 60 patents in India and the U.S.(including those under process). About ClinisuppliesClinisupplies, a subsidiary of Healthium, is based in Watford, U.K. with presence in U.K., Netherlands and Ireland. Founded over 20 years ago, it has a portfolio of products in Urology, Wound Care and Wound Closure. It partners with NHS to supply quality and cost- effective urology consumable products. About VitalCareVitalCare designs and manufacturesurology consumable products and supplies to leading healthcare customers worldwide. Thecompany was founded close to 20 years ago by founder and current Managing Director Lewis Calcutt. Itisheadquarteredin U.K. and the manufacturing is based in China. For more details, please contact: Riti RayAdfactors PRriti.ray@adfactorspr.com+91 9886989898
Leading Medtech player Healthium ramps up operations to ensure critical deliveries to healthcare providers are met within 24 to 48 hours
Bengaluru, India, July 07,2021: Healthium Medtech, a global leader in medical devices, today announced that it has strengthened its operations to fast track delivery of essentialmedical devices as the country fights the ongoing battle against COVID-19. In order to address the country’s need for essential medical consumables, Healthium Medtech has scaled its production, extended its supply chain and fast-tracked the deliveries of essential medical devices and consumables to support healthcare frontline workers. To ensure adequate supply of medical devices for healthcare practitioners, the company is running its plants during lockdown with due permissions and pre-cautionary measures. The company has also expanded supply chain by 40% to fast track critical deliveries. Considering the surge in demand for gloves at hospitals across the country, the company has utilized multiple production lines, and also stepped up production of1st of its kind Anti-microbial gloves TRUSHIELD, that protects both surgeons and patients against microbes. A significant production of gloves have been earmarked for government hospitals. The company has also provisioned for up to 2 months of stock of critical products codes for emergency surgeries like cardio-vascular surgeries and OB-GYN led surgeries, which continue despite the pandemic. Commenting on the contribution, Mr. Anish Bafna, MD & CEO, Healthium Group said, “The Healthcare industry has been at the forefront in the fight against COVID. While we continue to supportthem withmedical devices and essential consumables by keeping our manufacturing facilities running during Lockdown with due safety precautions, we are also constantly evaluating how we can optimise on our operations and have reduced the time to market. We are acutely aware of the burden on the system that is not only catering to COVID emergencies but other emergency surgeries that need to be prioritised amidst the ongoing stretch and have provisioned essential products to support these.We are committed to work in solidarity with the industrythrough this situation.” On its efforts towards safeguarding employee health and well-being the company has been organising vaccination drives, mental counselling sessions and several safety measures at the manufacturing facilities including availability of oxygen concentrators in case of need. For the financial security of employees and their families, the Company has announced INR20lakh pay out to the family of the bereaved, in case of loss of life due to COVID and full gratuity payout irrespective of eligibility criteria.The company alreadyhas in place health insurance, GPA, EDLI and term benefits for employees. Healthium was amongst the first to announceQuarantine leave during the last phase of the pandemic. Additionally reimbursement of vaccine costs, RT PCR, other blood tests and scans have been provided for.As a testimony of its gratitude to employees,the company has paid out increments, incentives and bonuses. Ms. Kankana Barua, Group CHRO, Healthium further added, “The last 15 months have been a truly testing time for each one of us. Despite the personal commitments and even losses, our employees have been working hard understanding that we are an essential services provider who needs to step up our game in times like these. While our employees work tirelessly towards a mission, we have taken several measures to safeguard them physically, financially and mentally in addition to ensuring that they are adequately rewarded for their efforts.” The company’s contribution towards community welfare surpasses donation of funds and consumables. Till date, Healthium has distributed 10000 face masks, 154 PPE kits for HCPs, donated surgical consumables to Government hospitals and also associated with 154 hospitals mainly in Tier 3, 4 and 5 towns to extend safe OPD and safe surgery education during the last wave.In addition to donating towards the PM Cares fund, the company continues to educate communities around its plant and campus on COVID appropriate behaviour. About Healthium MedtechThe Healthium Group consists of Healthium Medtech Pvt. Ltd., one of the largest players in the Indian Medical Devices Market, QNPL, the largest independent manufacturer of surgical suture needles worldwide by volume, and Clinisupplies a leading player in Urology Consumables in the United Kingdom. The Healthium Group has a lineage of 36 years in creating precision based medical devices across the world. With a vision to create access to Precision MedTech for every patient globally, Healthium MedTech is present in over 80 countries, covers 18000+ hospitals across India and has a workforce of over 1500 employees of which 60% are women. Its portfolio includes minimally invasive solutions like Arthroscopy and Endoscopy implants and Ancillary devices, a full range of Absorbable, Non- Absorbable and specialty surgical sutures, wound closure products that include Meshes, Skin staplers, Cardiac Pacing wires and Haemostats. Healthium has manufacturing facilities across India and the company holds over 55 patents in India and the U.S, including those applied for. Backed by stringent R & D norms, the company’s products adhere to the highest global quality standards, having accreditations and approvals from 510k (USFDA), CE & ISO.
Healthium bags top Leadership awards at World Leadership Congress and CFO100 Awards
Bangalore, April, 2021: Healthium Group, a global leaderin medical devices, today announced that it has secured top accolades at the World Leadership Congress and CFO100 roll of honour. The Healthium Group was awarded the ‘Manufacturing Icon of the year’ and Anish Bafna, CEO& MD of Healthium Group was conferred with the ‘Business Leader Of The Year’ by the World Leadership Congress while Vishal Maheshwari, CFO of Healthium Group, was selected for the CFO100 Roll of honour in the ’Winning Edge in Collaboration’ category by the CFO Collective. The Healthium Group was presented the ‘Manufacturing Icon’ award as a testament to their sustained efforts in creating access to high precision, high quality medical devices for patients globallyand serving the Healthcare fraternity through uninterrupted supplies of essential medical devices during the pandemic. Today Healthium is present in more than 80 countries, accessing 18000+ hospitals across 500+ districts in India with medical facilities and 1 in 6 surgeries globally, uses a Healthium product. The ‘Business Leader of the Year’ award was presented to Anish for his transformational leadership in building Healthium as one of the most trusted medtech companies globally. The growth strategy which Healthium embarked upon under Anish’s leadership has resulted in a range of innovative offerings for surgeons and healthcare practitioners, 55 patents in India and the U.S, quality certifications and approvals from C.E ,ISO and 510k(US FDA) and making significant contributions to the Atmanirbhar Bharat initiative. The company today has made extensive investments in manufacturing and R&D. An important aspect of Healthium’s growth strategy has been a strong and diverse leadership team. Vishal Maheshwari, CFO – Healthium Group, was brought on board as a part of this endeavour. His role as an efficient collaborator in ensuring Healthium Group’s success has been recognised through the ‘Winning Edge in Collaboration’ conferred upon him by the CFO Collective. The award was presented to Vishal was a tribute to his exceptional contribution to the finance function. About Healthium Medtech:The Healthium Group consists of Healthium Medtech Pvt. Ltd., one of the largest players in the Indian Medical Devices Market, QNPL, the largest independent manufacturer of surgical suture needles worldwide by volume, and Clinisupplies a leading player in Urology Consumables in the United Kingdom. The Healthium Group has a lineage of 36 years in creating precision based medical devices across the world. With a vision to create access to Precision MedTech for every patient globally, Healthium MedTech is present in over 80 countries, covers 18000+ hospitals across India and has a workforce of over 1400 employees of which 60% are women. Its portfolio includes minimally invasive solutions like Arthroscopy and Endoscopy implants and Ancillary devices, a full range of Absorbable, Non- Absorbable and specialty surgical sutures, wound closure products that include Meshes, Skin staplers, Cardiac Pacing wires and Haemostats. Healthium has manufacturing facilities across India and the Company holds over 55 patents in India and the U.S, including those applied for. Backed by stringent R & D norms, the Company’s products adhere to the highest global quality standards, having accreditations and approvals from 510k (USFDA), CE & ISO. For further details, please reach out to the belowJyothsna Pai | jyothsna.pai@healthium-stagging.nestershub.comDikshant Dangwal | dikshant.dangwal@mslgroup.com | +91 7042358483
Raman spectroscopic study of the effect of the use of laser/LED phototherapy on the repair of complete tibial fracture treated with internal rigid fixation
Healthium Medtech clocks its 3rd Innovation in 6 months with TRUSHIELD AMG- first of its kind Anti-Microbial gloves in India
India, May,2020: Healthium Medtech, one of the largest medical device companies in India, today announced the launch ofthe first of its kind Anti-Microbial Gloves, TruShield. Manufactured atKunigal, Karnataka, these Anti-Microbial Gloves (AMGs)aremade from a patented technology using a Quaternary Ammonium Compound that kills microbes and provides 99.99% protection forHealthcare professionals(HCPs)andpatients upto 8 hours. The Anti-Microbial gloves are the 3rdInnovative launch for Healthium in the last 6 months. The company had launched Truglyde SN2355, a suture needles combination specially created for COMOC MG, an Innovative surgical technique to manage Postpartum Hemorrhage (PPH), which is one of the largest causes for maternal mortality. Healthium also launched the largest shoulder range of Arthroscopic devices in India benefitting Arthroscopy surgeons through simplified and functional patented designs. The Company holds 52 patents in India and the U.S. Speaking on the occasion,Anish Bafna, Group Chief Executive Officer & Managing Director, Healthium said, “We constantly endeavor to simplify for the medical fraternity through innovative precision based medical devices manufactured indigenously across our 5 facilities in India. 85%of medical devices in India areimported . As an Indian player delivering to global standards with US FDA(510k), CE and ISO approvals and 52 patents in India and U.S, we are working relentlessly to reduce the dependence on imported technology and support a self-reliant(Atmanirbhar) India. With the launch ofTrushieldAMG, we would like to further protect the hands that save lives” The surgical gloves available today, do not provide complete protection as they merely act as a passive barrier1.Doctors are at particular risk2 because their work demands close contact with patients who may be harboring pathogenic microbes. Breaching of gloves during surgery when unnoticed by the operating surgeons brings an occult risk3 to the surgeon as well as the patients.Even the efficacy of scrubbing before surgery begins to fade in 3 hours and post 54 hours into surgery, contamination reaches pre-scrub levels. This makes both surgeons and patients vulnerable. Speaking at the Launch, Dr Ashok Moharana, Chief Medical Officer at Healthium Medtech said, “Studies have shown that Surgical Site Infections account for 15% of all Healthcare Associated Infection (HAI) and 37%5 of HAI in surgical patients, putting patients at risk. On the other hand, over 45% Surgeons’ gloves get breached mostly on non-dominant hands and only 25%3notice the puncture during surgery, bringing an occult risk for HCPs. Enhancing protection from contact transmissionfor an extended duration is an unmet need today and to address this, we have launched TRUSHIELD Anti-microbial gloves. With a novel mechanism of action, this is an effective solution that protects both HCPs and patients against a range of microbes. TRISHIELD AMG is non-leaching and offers 99.99% microbicidal protectionlasting upto 8 hrs.” Ehsan Huq, SVP – Commercial, Healthium Medtech said, “Collaboration is a core value at Healthium; launching TRUSHIELD AMG during the lockdown validates our commitment to partner with surgeons and their patients in successful outcomes. Improving access is our vision; TRUSHIELD AMG is supported by the Healthium team and available through our extensive distribution footprint, covering in excess of 500 towns and cities in India.” Sources Patient safety and quality: An evidence based hand book for nurses, Vol-2, Pg. 2-557Sepkowitz KA, Eisenberg L: Occupational deaths among healthcare workers. Emerg Infect Dis 2005, 11(7):1003–1008. Prasad HP et al. Surgical Glove Perforation: An Indiscernible Hazard. Indian Journal of Contemporary Surgery, 5(2):144-177Hosseini, P., Mundis, G.M., Eastlack, R. et al. Do Longer Surgical Procedures Result in Greater Contamination of Surgeons’ Hands?.ClinOrthopRelat Res 474, 1707–1713 (2016).Prevention of Hospital Acquired Infections: A practical Guide 2nd edition. Editors G Ducel, J Gabry and L Nicolle. Published by World Health Organisation 2002.About Healthium Medtech:The Healthium Group is a conglomerate consisting of Healthium MedtechPvt. Ltd., one of the largest players in the Indian Medical Devices Market, QNPL, the largest independent manufacturer of Surgical suture needles worldwide by volume, and Clinisupplies a leading player in Urology Consumables in the United Kingdom. The Healthium Group has a lineage of 36 years in creating precision based medical devices across the world. Its products are used in 1 in 6 surgeries globally. With a Vision to create access to Precision Medtech for every patient globally, Healthium Medtech is present in over 70 countries, covers 18000+ hospitals across India and has a workforce of 1500 employees of which 60% are women. Its portfolio includes Minimally Invasive Arthroscopy implants and Endoscopy staplers and cutters, a full range of Absorbable, Non-Absorbable and Specialty Surgical Sutures, Wound Closure products including Hernia Meshes, Skin Staplers, Cardiac Pacing Wires and Haemostats. Healthium has 6 Manufacturing facilities across India and the UAE and the Company holds over 52 patents in India and the U.S, including those applied for. Backed by stringent R & D norms, the Company’s products adhere to the highest globalquality standards, having accreditations and approvals from 510k (USFDA), CE & ISO.
Healthium Medtech geared for un-interrupted production of essential medical devices amidst the Lockdown
Bangalore, April 2020: Healthium Medtech, one of the largest Medical device companies in India is geared up to ensure un-interrupted production of essential medical devices amidst the nationwide lockdown due to the COVID-19 pandemic. Continued production is essential given that the devices produced by the Company including gloves, surgical suture needles, haemostats, meshes and other surgical products are commonly used in Operation Theatres(OTs) during emergency surgeries as well as child birth, both of which continue despite the current pandemic. Healthium has stepped up safety measures to protect its employees and workers at the facilities across the country by ensuring stringent hygiene, social distancing and working within a sterile environment. Healthium Medtech has also procured the necessary permissions and is acting in close adherence to Government norms to ensure the manufacturing plants continue steady production to supply medical consumables and equipment including gloves to the healthcare industry. It has also opened its warehouses in order to transport stocks to the dealers and hospitals to keep the supply chain moving. Healthium Medtech in its continuous efforts to support communities, has distributed masks, sanitizers, gloves and also introduced awareness & education programmes to communities around their manufacturing facilities – Kunigal&Peenya to fight against COVID-19. The Healthium Group has also contributed INR 82lakhs to the Prime Minister’s National relief Fund and surgical products worth INR 20Lakhs have been accepted by Chhattisgarh Institute of Medical Science (CIMS), Bilaspur for the needypatients. These will be delivered soon. “We are committed to support our community and stand with our people in the battle against the pandemic. Safety& security of our people is the top priority during the current situation and we are ensuring adequate measures are being taken to ensure the same. The medical community has risen to support the fight against the pandemic and it is our endeavour to supply essential medical devices so that patient care remains unhindered. Our employees and the worker teams have come together to support thislarger cause and I am immensely thankful for their support.” said Anish Bafna, Chief Executive Officer, Healthium Group. Healthium Medtech commitscontinuous support to the government and its communities to fight the f COVID-19 pandemic. About Healthium Medtech:The Healthium Group is a conglomerate consisting of Healthium MedtechPvt. Ltd., one of the largest players in the Indian Medical Devices Market, QNPL, the largest independent manufacturer of Surgical suture needles worldwide by volume, and Clinisupplies a leading player in Urology Consumables in the United Kingdom. The Healthium Group has a lineage of 36 years in creating precision based medical devices across the world. Its products are used in 1 in 6 surgeries globally. With a Vision to create access to Precision Medtech for every patient globally, Healthium Medtech is present in over 70 countries, covers 18000+ hospitals across India and has a workforce of 1500 employees of which 60% are women. Its portfolio includes Minimally Invasive Arthroscopy implants and Endoscopy staplers and cutters,.a full range of Absorbable, Non-Absorbable and Specialty Surgical Sutures, Wound Closure products including Hernia Meshes, Skin Staplers, Cardiac Pacing Wiresand Haemostats. Healthium has 6 Manufacturing facilities across India and the UAE and the Company holds over 49 patents in India and the U.S, including those applied for. Backed by stringent R & D norms, the Company’s products adhere to the highest global quality standards, having accreditations and approvals from 510k (USFDA), CE & ISO.