Latest news with #EuropeanUnionMedicalDeviceRegulation
Yahoo
22-05-2025
- Business
- Yahoo
ReGelTec's system for disc augmentation gains CE Mark approval
ReGelTec has secured CE Mark approval for the Class III Hydrafil System for disc augmentation, under the European Union Medical Device Regulation (MDR). The approval is based on a clinical trial involving 75 subjects, which revealed that the system's treatment led to significant improvements in disability and pain. According to the findings, an improvement exceeding 80% was observed in Oswestry Disability Index (ODI) scores and a decrease of more than 70% in Numeric Pain Rating Scale scores post-treatment, with sustained results for two years. ReGelTec noted that the system is designed to be an outpatient procedure performed under local anaesthesia. It involves the injection of a permanent hydrogel into a degenerated disc for filling cracks and tears while also recruiting water to restore the disc's natural biomechanics and alleviate pain. Once solidified in the disc, the hydrogel implant helps in distributing the strain and load across the intervertebral segment, enhancing function and decreasing pain signals to the brain. The data that supported this approval also contributed to the US Food and Drug Administration's (FDA) decision to grant an investigational device exemption (IDE) for the company's US pivotal study, HYDRAFIL-D. This single-blinded, 225-patient, randomised, controlled study is actively enrolling subjects across eight sites and aims to support future regulatory approval in the country. The study includes an interim safety analysis scheduled after the first 60 subjects complete their six-month follow-up. ReGelTec's percutaneous hydrogel implant is intended for treating chronic low back pain caused by degenerative disc disease. ReGelTec CEO and co-founder Bill Niland said: 'Receiving CE Mark for the Hydrafil System is another major milestone for ReGelTec. We are leveraging this momentum to drive enrolment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the US and globally.' In June 2023, the company reached an exclusive distribution agreement with BCWorld Healthcare for the system in South Korea. "ReGelTec's system for disc augmentation gains CE Mark approval" 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-05-2025
- Health
- Yahoo
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
Clinical data show the percutaneous disc augmentation system generated significant improvements in pain and disability scores through 2-year follow-up BALTIMORE, May 21, 2025--(BUSINESS WIRE)--ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This approval creates a European commercial pathway for the HYDRAFIL System, an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain, improve daily function and eliminate the need for invasive surgeries. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit. "Chronic low back pain is a debilitating condition that impacts millions of people every year. Degenerative disc disease, which is the largest driver of chronic low back pain, is especially challenging to treat and manage because there are limited treatment options between conservative care and more invasive surgeries," said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. "After following 35 patients treated with HYDRAFIL over the last three years, I've witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability. HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery, and we are excited to start enrolling patients in the HYDRAFIL-D U.S. pivotal study." More than 1 in 10 U.S. adults suffer from chronic low back pain.1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease2, a condition which is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL® System injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain. Data used to secure CE Mark also led the FDA to approve an investigational device exemption (IDE) for ReGelTec's U.S. pivotal study of its HYDRAFIL System. The HYDRAFIL-D study is currently enrolling patients at eight sites in the U.S. and will be used to support U.S. regulatory approval. The study is a 225-patient, multicenter, single-blinded, randomized, controlled trial that includes an interim safety analysis when the first sixty patients complete their 6-month follow-up visit. "Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec," said Bill Niland, Co-Founder and CEO, ReGelTec. "We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally." ABOUT REGELTEC, INC: ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL® System is an outpatient disc augmentation procedure where a permanent hydrogel is injected into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit ______________________________ 1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174. 2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233, View source version on Contacts MEDIA CONTACT: Sam ChoinskiPazanga Health Communications(860) 301-5058schoinski@ Sign in to access your portfolio
Business Wire
21-05-2025
- Health
- Business Wire
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
BALTIMORE--(BUSINESS WIRE)-- ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This approval creates a European commercial pathway for the HYDRAFIL System, an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain, improve daily function and eliminate the need for invasive surgeries. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit. 'Chronic low back pain is a debilitating condition that impacts millions of people every year. Degenerative disc disease, which is the largest driver of chronic low back pain, is especially challenging to treat and manage because there are limited treatment options between conservative care and more invasive surgeries,' said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. 'After following 35 patients treated with HYDRAFIL over the last three years, I've witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability. HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery, and we are excited to start enrolling patients in the HYDRAFIL-D U.S. pivotal study.' More than 1 in 10 U.S. adults suffer from chronic low back pain. 1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease 2, a condition which is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL® System injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain. Data used to secure CE Mark also led the FDA to approve an investigational device exemption (IDE) for ReGelTec's U.S. pivotal study of its HYDRAFIL System. The HYDRAFIL-D study is currently enrolling patients at eight sites in the U.S. and will be used to support U.S. regulatory approval. The study is a 225-patient, multicenter, single-blinded, randomized, controlled trial that includes an interim safety analysis when the first sixty patients complete their 6-month follow-up visit. 'Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec,' said Bill Niland, Co-Founder and CEO, ReGelTec. 'We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally.' ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL® System is an outpatient disc augmentation procedure where a permanent hydrogel is injected into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit 1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174. 2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233,
Yahoo
13-05-2025
- Business
- Yahoo
Cervos Medical's CERVOS® KeyPRP System Achieves EU MDR Certification Advancing Regenerative Medicine with Quality, Safety, and Exclusive European Distribution through Aspire Medical
AVON, Mass., May 13, 2025 /PRNewswire/ -- Cervos Medical, a wholly owned subsidiary of Ranfac Corp, is proud to announce the CERVOS® KeyPRP System has received official certification under the European Union Medical Device Regulation (MDR) EU 2017/745. This certification affirms the system's compliance with the EU's most stringent standards for medical device safety, performance, and quality. "Getting CE (MDR) certification for our Platelet Separator isn't just about meeting regulations—it's proof of our commitment to safety, quality, and compliance," said Michaela Gates, Quality Assurance Project Manager at Ranfac. "We are incredibly proud of our team's hard work here at Ranfac. With this certification, we're excited to explore new markets in the EU and see the impact of our CE-marked Platelet Separator growth." The MDR certification represents a major milestone in Cervos Medical's ongoing mission to support healthcare providers with innovative regenerative solutions. In Europe, the CERVOS® KeyPRP System is available exclusively through Aspire Medical, Cervos's official European sales partner. "This certification validates our ongoing dedication to product excellence and patient safety," said Eric Kreuz, Vice President of Quality Assurance and Regulatory Affairs at Ranfac. "With the strength and support of our parent company, Ranfac Corp, we are well-positioned to bring innovative regenerative technologies to clinicians and patients across global markets." Cervos Medical continues to lead in the development of advanced autologous tissue processing systems, supporting clinicians in the areas of platelet-rich plasma (PRP), bone marrow aspiration, and adipose tissue processing. About Cervos MedicalCervos Medical is a regenerative medicine company focused on developing innovative, minimally invasive technologies for autologous tissue collection and processing. A wholly owned subsidiary of Ranfac Corp, Cervos combines clinical insight with advanced engineering to deliver solutions that meet the highest regulatory and performance standards. About Ranfac CorporationBased in Avon, Massachusetts, Ranfac Corp has been a trusted name in medical device manufacturing for over 100 years. View original content to download multimedia: SOURCE Cervos Medical
Associated Press
30-04-2025
- Health
- Associated Press
RetinAI and FVS Announce CE-MDR Certification for Co-developed AI-based Diabetic Retinopathy Screening Algorithm, LuxIA®
BERN, Switzerland and MADRID, April 30, 2025 (GLOBE NEWSWIRE) -- RetinAI US Inc. (RetinAI) and Fundación Ver Salud (FVS) are pleased to jointly announce that LuxIA®, their co-developed innovative AI algorithm for Diabetic Retinopathy (DR) screening, has successfully received CE-MDR certification as a Class IIb medical device under the European Union Medical Device Regulation (EU MDR 2017/745). The certification was granted through Ikerian AG, RetinAI's parent company. LuxIA is designed to screen adult diabetic patients for more-than-mild diabetic retinopathy (mtmDR). This indication for use provides critical support for ophthalmologists, general practitioners and trained healthcare professionals across the European Union to achieve an earlier diagnosis of mtmDR, a vision-threatening eye disease. This new certification demonstrates the strong collaboration between FVS and RetinAI, emphasizing both entities' commitment to deliver AI-driven tools that meet stringent regulatory standards and significantly enhance patient management and clinical outcomes. The device is indicated for processing digital 45-degree colour fundus images from NW200, NW400 or equivalent Topcon cameras, ensuring seamless placement into existing clinical workflows. Together with RetinAI's existing portfolio of AI-based OCT analysis solutions, LuxIA complements a comprehensive suite of clinically validated, CE-certified AI modules focused on ophthalmology. Dr. Carlos Ciller, CEO and co-founder of RetinAI, commented: 'Receiving CE-MDR certification for LuxIA underscores our shared commitment with FVS to advance leading-edge ophthalmic care to patients through reliable and impactful AI technology. This milestone is pivotal, enabling healthcare providers to improve patient management and outcomes for diabetic retinopathy across Europe, reinforcing our joint mission of transforming vision care through innovation.' Dr. Juan Donate, MD, President of Fundación Ver Salud stated: 'We are excited about the newly received certification and look forward to the significant impact LuxIA will have in the European ophthalmology market. AI-driven screening solutions are critical to improving patient care, and we anticipate LuxIA will play a central role in achieving this.' For further information or to request a demonstration of LuxIA and other ophthalmic solutions from FVS and RetinAI, please visit For further information please contact: At the company Carlos Ciller, PhD, CEO - Ikerian AG and RetinAI Inc US [email protected], [email protected] Media enquiries Sue Charles, Charles Consultants - [email protected] +44 (0)7968726585 About Ikerian AG and RetinAI Inc. US Established in 2017, Ikerian AG (formerly RetinAI Medical AG) and its subsidiary, RetinAI U.S. Inc. ('Ikerian', 'RetinAI' and, together, 'the company'), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision, across ophthalmology, neurodegenerative disorders, vascular conditions, and rare diseases. RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI's international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases. Follow us on LinkedInand About FVS FVS is a non-profit organization focused on training, research, and medical innovation, particularly in the field of ophthalmology. Its mission is to develop solutions that promote better clinical outcomes and enhance the quality of patient care. Follow us on LinkedIn and X
