Ocumetics Technology Corp. (TSXV:OTC, OTCQB:OTCFF, FRA:2QBO) focuses on a groundbreaking vision enhancement product - the Ocumetics Accommodating Lens. Leading the forefront of research and product development, Ocumetic's intraocular lens (IOL) is engineered to seamlessly shift the eye's focus from close to far distances without any noticeable lag. This process is called accommodation.
The eye's natural lens loses its flexibility to bend light rays accurately due to aging and injuries. This leads to the deterioration of eyesight and potential conditions like cataracts with or without astigmatism. Ocumetics has designed a very unique IOL that is surgically implanted to restore a patient’s vision. This lens is designed to harmoniously align with the eye's natural mechanisms, enhancing vision by appropriately bending light rays. Notably, it's designed to last a lifetime, presenting a significant potential advancement over other cataract technologies.
Ocumetics aims to solve the problem of eyesight degradation. The proposed solution is a surgically implanted lens that takes over the function of properly bending rays of light by working with the eye’s natural mechanisms, resulting in enhanced vision. Following a series of product enhancements, development of surgical procedure protocols, and animal testing for biocompatibility, the Ocumetics Accommodating Lens will soon begin human trials as the company works toward bringing the product to market.
This Ocumetics Technology profile is part of a paid investor education campaign.*
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Calgary, Alberta May 24, 2024 - TheNewswire . Â Ocumetics Technology Corp. (" Ocumetics " or the " Corporation ") ( TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO) announces that it has completed the first tranche of the private placement of debentures previously announced by the Corporation on May 15, 2024.
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Calgary, Alberta TheNewswire - February 29, 2024 - Ocumetics Technology Corp. ("Ocumetics") (TSXV:OTC) (OTC:OTCFF) (FRA:2QBO), is pleased to invite investors and other interested parties to attend an upcoming interview with Market Radius Research.
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Calgary, Alberta TheNewswire - December 21, 2023 - Â Ocumetics Technology Corp. (" Ocumetics " or the " Corporation ") (TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) is pleased to announce that the TSX Venture Exchange has granted a 15-day extension to close the Corporation's non-brokered private placement announced on November 15, 2023. Â The new closing deadline for the private placement is January 15, 2024.
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Ocumetics Technology Corp. (" Ocumetics ") ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) a pioneer in the field of ophthalmic innovation, announces a webinar to discuss the successful completion of its biocompatibility animal study and its upcoming first-in-human study, anticipated to commence in Q1 2024 in the Dominican Republic
Dean Burns, CEO of Ocumetics and 27-year Alcon veteran, will lead the presentation.
Click Image To View Full Size
Join the webinar to:
Learn more about the significance of the biocompatibility animal study;
Learn more about the upcoming first-in-human study; and
Ask questions regarding the Ocumetics Accommodating Lens and the company's plans.
Details are as follows:
Date: Â Â Â Â December 20, 2023
Time: Â Â Â Â 18:00 EST
RSVP: https://ocumetics.com/webinar-december-20-2023/
About Ocumetics
Ocumetics Technology Corp. ( TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO), headquartered in Calgary, Alberta, Canada, is an innovator in the field of ophthalmic technology, dedicated to developing and commercializing advanced vision correction solutions that enhance the quality of life for individuals worldwide.
Ocumetics is in the preclinical study stage of a game-changing technology for the ophthalmic industry. Â In its pursuit of a next generation interocular lens solution, Ocumetics has developed the Ocumetics Accommodating Lens, an expandable intraocular lens that fits within the natural lens compartment of the eye potentially to eliminate the need for corrective lenses. Â It is designed to allow the eye's natural muscle activity to seamlessly shift focus from distance to intermediate to near.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dean Burns
President and CEO
(817) 874-7564
Dayton Marks
Director
(778) 347-2500
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Copyright (c) 2023 TheNewswire - All rights reserved.
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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic's request to support Medicare beneficiary access to the Symplicity™ Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.
"Hypertension is a global health epidemic that impacts a wide variety of patients," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS' efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy."
CMS' action follows Medtronic's work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025 . Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
About the Symplicity Spyral renal denervation procedure
The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023 , is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design. The SPYRAL-HTN clinical program has demonstrated 18 mmHg office blood pressure reductions out to three years in a real-world setting, 1 has the longest and largest real-world registry 2 and the largest dataset showing long-term reductions without the need for additional medication. 2-3
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN in over 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials. 5-8 The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
About Hypertension Â
Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death. 4 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control 1 and half of hypertension patients become non-adherent to medication within one year. 4-5
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
2 Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug ;80(8):1759-177.
3 Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024
4 WHO. Hypertension fact sheet. September 13, 2019 . Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension . Accessed February 15, 2022 .
5 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: https://doi.org/10.1016/S0140-6736 (22)01787-1.
6 Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023; DOI: 10.1161/HYPERTENSIONAHA.123.21283.
7 Mahfoud, F. et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 2022. https://doi.org/10.1016/S0140-6736(22)00455-X(opens new window)
8 Mahfoud, F. et al. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. Journal of the American College of Cardiology. November 2022. https://doi.org/10.1016/j.jacc.2022.08.802
Contacts: | |
Krystin Hayward Leong | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-508-261-6512 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system-302349766.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic's request to support Medicare beneficiary access to the Symplicity™ Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.
"Hypertension is a global health epidemic that impacts a wide variety of patients," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS' efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy."
CMS' action follows Medtronic's work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025 . Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
About the Symplicity Spyral renal denervation procedure
The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in November 2023 , is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design. The SPYRAL-HTN clinical program has demonstrated 18 mmHg office blood pressure reductions out to three years in a real-world setting, 1 has the longest and largest real-world registry 2 and the largest dataset showing long-term reductions without the need for additional medication. 2-3
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN in over 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials. 5-8 The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
About Hypertension Â
Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death. 4 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control 1 and half of hypertension patients become non-adherent to medication within one year. 4-5
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
2 Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug ;80(8):1759-177.
3 Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024
4 WHO. Hypertension fact sheet. September 13, 2019 . Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension . Accessed February 15, 2022 .
5 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI: https://doi.org/10.1016/S0140-6736 (22)01787-1.
6 Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023; DOI: 10.1161/HYPERTENSIONAHA.123.21283.
7 Mahfoud, F. et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 2022. https://doi.org/10.1016/S0140-6736(22)00455-X(opens new window)
8 Mahfoud, F. et al. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. Journal of the American College of Cardiology. November 2022. https://doi.org/10.1016/j.jacc.2022.08.802
Contacts: | |
Krystin Hayward Leong | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-508-261-6512 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system-302349766.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
European approval introduces the world's only closed-loop DBS system with real-time, self-adjusting brain stimulation for people with Parkinson's disease
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR). In addition, the first programming was completed today, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. This landmark approval and first-in- Europe patient programming demonstrate significant advancements in personalized DBS therapy for people with Parkinson's in Europe including the UK.
For 30 years, people with Parkinson's disease have benefitted from deep brain stimulation (DBS), a technology that transmits electric signals to the brain to disrupt certain unwanted movement. With BrainSense™ aDBS, people with Parkinson's disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each person's unique brain activity, both in clinical settings and daily life 1 . BrainSense™ Electrode Identifier can improve DBS programming by ensuring optimal initial contact selection in less time 2 .
Caregivers and healthcare providers alike intimately understand how disruptive Parkinson's can be on one's daily life. Affecting over 1.2 million patients in Europe alone and more than 10 million people worldwide, Parkinson's is known to impact an individual's mobility, speech, focus, sleep, independence, and overall ability to participate fully in work, family, and social life. From sipping a cup of coffee to holding hands with a loved one, the disease can be debilitating and demoralizing, stripping away what many of us take for granted. For spouses and caregivers, this can be immensely demanding and distressing 3,4 .
"BrainSense™ technology †is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform," said Paolo Di Vincenzo , president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson's, and we're just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy."
The Medtronic Percept™ DBS system with BrainSense™ technology is designed to record and analyze brain signals, enabling therapies tailored to each patient's unique neurological patterns 1 . Medtronic has been at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy with the specific purpose of making advances in prevention, detection, diagnosis, rehabilitation, and restoration for patients with complex neurological conditions. As the world leader in DBS therapy, the Medtronic Percept™ neurostimulators with BrainSense™ technology serves as a benchmark for DBS sensing innovation.
"Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson's," said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. "By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual's unique needs."
Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing certain Parkinson's disease symptoms. BrainSenseâ„¢ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient's own brain signals 1 .
"Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson's to spend less time thinking about their disease,"Â said Amaza Reitmeier , vice president and general manager, Neuromodulation marketing and strategy at Medtronic. "Patients and clinicians have been eagerly awaiting these BrainSenseâ„¢ technology enhancements, which represent another transformative step forward in our ability to personalize therapy for people living with Parkinson's."
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson's patients receiving DBS therapy. Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings 1 . The study methodology and sensing data from the Medtronic study were published in npj Parkinson's Disease , a journal within the prestigious Nature Portfolio.
"The CE Mark approval of BrainSense TM Adaptive DBS is a critical advancement in how we treat Parkinson's disease," said Alan Whone , PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."
BrainSenseâ„¢ Electrode Identifier (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each Parkinson's patient's unique brain signals and guiding clinicians to the exact location of the strongest signal in a fraction of the time needed for standard monopolar reviews 2 . This exclusive technology pinpoints the optimal contact location by leveraging local field potentials (LFP) and alpha-beta activity to guide optimized and effective programming compared to the standard of care, the monopolar review 2 .
"BrainSense™ Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field," said Domenico De Paolis , vice president of Neuromodulation International at Medtronic. "Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world."
Since 1987, Medtronic has served more than 185,000 people with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy 5 .
BrainSenseâ„¢ aDBS and BrainSenseâ„¢ Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States .
To learn more about Medtronic DBS with BrainSenseâ„¢ technology, visit our website .
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
†The sensing feature of the Percept™ PC and Percept™ RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status.
References
Contacts: | |
Naomi Rodiles | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-612-427-5521 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-achieves-ce-mark-approval-for-brainsense-adaptive-deep-brain-stimulation-and-electrode-identifier-a-groundbreaking-advance-in-personalized-sensing-enabled-care-for-people-with-parkinsons-through-innovative-brain-comp-302348702.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
European approval introduces the world's only closed-loop DBS system with real-time, self-adjusting brain stimulation for people with Parkinson's disease
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR). In addition, the first programming was completed today, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. This landmark approval and first-in- Europe patient programming demonstrate significant advancements in personalized DBS therapy for people with Parkinson's in Europe including the UK.
For 30 years, people with Parkinson's disease have benefitted from deep brain stimulation (DBS), a technology that transmits electric signals to the brain to disrupt certain unwanted movement. With BrainSense™ aDBS, people with Parkinson's disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each person's unique brain activity, both in clinical settings and daily life 1 . BrainSense™ Electrode Identifier can improve DBS programming by ensuring optimal initial contact selection in less time 2 .
Caregivers and healthcare providers alike intimately understand how disruptive Parkinson's can be on one's daily life. Affecting over 1.2 million patients in Europe alone and more than 10 million people worldwide, Parkinson's is known to impact an individual's mobility, speech, focus, sleep, independence, and overall ability to participate fully in work, family, and social life. From sipping a cup of coffee to holding hands with a loved one, the disease can be debilitating and demoralizing, stripping away what many of us take for granted. For spouses and caregivers, this can be immensely demanding and distressing 3,4 .
"BrainSense™ technology †is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform," said Paolo Di Vincenzo , president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson's, and we're just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy."
The Medtronic Percept™ DBS system with BrainSense™ technology is designed to record and analyze brain signals, enabling therapies tailored to each patient's unique neurological patterns 1 . Medtronic has been at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy with the specific purpose of making advances in prevention, detection, diagnosis, rehabilitation, and restoration for patients with complex neurological conditions. As the world leader in DBS therapy, the Medtronic Percept™ neurostimulators with BrainSense™ technology serves as a benchmark for DBS sensing innovation.
"Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson's," said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. "By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual's unique needs."
Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing certain Parkinson's disease symptoms. BrainSenseâ„¢ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient's own brain signals 1 .
"Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson's to spend less time thinking about their disease,"Â said Amaza Reitmeier , vice president and general manager, Neuromodulation marketing and strategy at Medtronic. "Patients and clinicians have been eagerly awaiting these BrainSenseâ„¢ technology enhancements, which represent another transformative step forward in our ability to personalize therapy for people living with Parkinson's."
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson's patients receiving DBS therapy. Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings 1 . The study methodology and sensing data from the Medtronic study were published in npj Parkinson's Disease , a journal within the prestigious Nature Portfolio.
"The CE Mark approval of BrainSense TM Adaptive DBS is a critical advancement in how we treat Parkinson's disease," said Alan Whone , PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."
BrainSenseâ„¢ Electrode Identifier (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each Parkinson's patient's unique brain signals and guiding clinicians to the exact location of the strongest signal in a fraction of the time needed for standard monopolar reviews 2 . This exclusive technology pinpoints the optimal contact location by leveraging local field potentials (LFP) and alpha-beta activity to guide optimized and effective programming compared to the standard of care, the monopolar review 2 .
"BrainSense™ Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field," said Domenico De Paolis , vice president of Neuromodulation International at Medtronic. "Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world."
Since 1987, Medtronic has served more than 185,000 people with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy 5 .
BrainSenseâ„¢ aDBS and BrainSenseâ„¢ Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States .
To learn more about Medtronic DBS with BrainSenseâ„¢ technology, visit our website .
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
†The sensing feature of the Percept™ PC and Percept™ RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status.
References
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SOURCE Medtronic plc
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UK Biobank Pharma Proteomics Project aims to create a comprehensive map of disease-associated protein levels in the human body to advance biomarker discovery
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced the UK Biobank Pharma Proteomics Project (UKB-PPP) has selected its Olink ® Explore Platform to support the world's largest human proteomics study of its kind. UKB-PPP aims to analyze more than 5,400 proteins from 600,000 samples to fuel the discovery of new protein biomarkers that can be used to predict, diagnose and treat diseases.
"Studies on the human proteome are having a profound impact on our customers' fundamental understanding of disease and the advancement of life sciences research," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher. "The unprecedented scale of this project, with support from our next-generation proteomics solution, underscores the potential to deepen their knowledge and develop new applications to improve human health."
Advancement of the Olink Explore Platform, which is designed to enable deep analysis of the thousands of proteins in the human body, provides researchers with the ability to study the role they play in many types of diseases. Published studies in this emerging field, known as population proteomics, have demonstrated the potential protein signatures have to help advance the future of precision medicine.
"Proteomics provides an incredibly detailed snapshot of health. This new frontier of science can unveil how genetics and external factors – like diet, exercise and climate – interact, and will help to pinpoint the key causes of diseases and identify drug targets," said Professor Naomi Allen, chief scientist of UK Biobank. "It has already led to important scientific discoveries, such as identifying proteins that can help to diagnose disease – including multiple sclerosis - and helping to identify those at higher risk of developing dementia and cancer many years before clinical diagnosis. Over 19,000 researchers around the world are using UK Biobank data; adding proteomic data to everything else we hold will enable scientists to make rapid discoveries to help diagnose and treat life-altering diseases."
UKB-PPP is a collaboration between UK Biobank and 14 leading biopharmaceutical companies, with the goal to make available important information on the human proteome to UK Biobank-approved researchers across the world. In turn, the data can be used to validate and identify new drug targets, advance diagnostics, and help accelerate targeted drug discovery to support the development of more effective and safer medications.
"UKB-PPP brings together scientists from the world's leading pharmaceutical companies with the most advanced research technologies," said Chris Whelan, Ph.D., chair and principal investigator of UKB-PPP. "Success for projects of this size depends on having partners with the ability to scale reliably and effectively. We are excited to once again have Thermo Fisher's Olink platform as the supporting proteomics technology to drive this study."
UKB-PPP builds on the findings released in 2023 from the pilot project, which also leveraged the Olink Explore platform to analyze more than 54,000 samples from UK Biobank . The research was first published in Nature in October 2023 and has already been cited more than 400 times, laying the foundation for scientists to better understand how and why diseases develop and to advance targeted treatments. One study, published in Nature Communications , leveraged data from the pilot study to identify protein risk factors for certain cancers up to seven years in advance of diagnosis.
UKB-PPP is scheduled to begin in Q1 2025, with plans to make the proteomic data available to UK Biobank-approved researchers in staggered releases starting in 2026, followed by the full dataset in 2027. UKB-PPP will initially analyze more than 5,400 proteins from 300,000 samples and seek supplemental funding to analyze an additional 300,000 samples, bringing the total for the project to 600,000 samples.
Acquired by Thermo Fisher in July 2024, the Olink proteomics platform is a next generation proteomics solution that empowers researchers to measure more than 5,400 proteins with high specificity, speed, and the flexibility to study complex biological processes.
To learn more about the Olink Platform, please visit www.thermofisher.com/olink
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20250109316914/en/
Media Contact Information:
Sandy Pound
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Website: www.thermofisher.com
Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
News Provided by Business Wire via QuoteMedia
UK Biobank Pharma Proteomics Project aims to create a comprehensive map of disease-associated protein levels in the human body to advance biomarker discovery
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced the UK Biobank Pharma Proteomics Project (UKB-PPP) has selected its Olink ® Explore Platform to support the world's largest human proteomics study of its kind. UKB-PPP aims to analyze more than 5,400 proteins from 600,000 samples to fuel the discovery of new protein biomarkers that can be used to predict, diagnose and treat diseases.
"Studies on the human proteome are having a profound impact on our customers' fundamental understanding of disease and the advancement of life sciences research," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher. "The unprecedented scale of this project, with support from our next-generation proteomics solution, underscores the potential to deepen their knowledge and develop new applications to improve human health."
Advancement of the Olink Explore Platform, which is designed to enable deep analysis of the thousands of proteins in the human body, provides researchers with the ability to study the role they play in many types of diseases. Published studies in this emerging field, known as population proteomics, have demonstrated the potential protein signatures have to help advance the future of precision medicine.
"Proteomics provides an incredibly detailed snapshot of health. This new frontier of science can unveil how genetics and external factors – like diet, exercise and climate – interact, and will help to pinpoint the key causes of diseases and identify drug targets," said Professor Naomi Allen, chief scientist of UK Biobank. "It has already led to important scientific discoveries, such as identifying proteins that can help to diagnose disease – including multiple sclerosis - and helping to identify those at higher risk of developing dementia and cancer many years before clinical diagnosis. Over 19,000 researchers around the world are using UK Biobank data; adding proteomic data to everything else we hold will enable scientists to make rapid discoveries to help diagnose and treat life-altering diseases."
UKB-PPP is a collaboration between UK Biobank and 14 leading biopharmaceutical companies, with the goal to make available important information on the human proteome to UK Biobank-approved researchers across the world. In turn, the data can be used to validate and identify new drug targets, advance diagnostics, and help accelerate targeted drug discovery to support the development of more effective and safer medications.
"UKB-PPP brings together scientists from the world's leading pharmaceutical companies with the most advanced research technologies," said Chris Whelan, Ph.D., chair and principal investigator of UKB-PPP. "Success for projects of this size depends on having partners with the ability to scale reliably and effectively. We are excited to once again have Thermo Fisher's Olink platform as the supporting proteomics technology to drive this study."
UKB-PPP builds on the findings released in 2023 from the pilot project, which also leveraged the Olink Explore platform to analyze more than 54,000 samples from UK Biobank . The research was first published in Nature in October 2023 and has already been cited more than 400 times, laying the foundation for scientists to better understand how and why diseases develop and to advance targeted treatments. One study, published in Nature Communications , leveraged data from the pilot study to identify protein risk factors for certain cancers up to seven years in advance of diagnosis.
UKB-PPP is scheduled to begin in Q1 2025, with plans to make the proteomic data available to UK Biobank-approved researchers in staggered releases starting in 2026, followed by the full dataset in 2027. UKB-PPP will initially analyze more than 5,400 proteins from 300,000 samples and seek supplemental funding to analyze an additional 300,000 samples, bringing the total for the project to 600,000 samples.
Acquired by Thermo Fisher in July 2024, the Olink proteomics platform is a next generation proteomics solution that empowers researchers to measure more than 5,400 proteins with high specificity, speed, and the flexibility to study complex biological processes.
To learn more about the Olink Platform, please visit www.thermofisher.com/olink
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20250109316914/en/
Media Contact Information:
Sandy Pound
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Website: www.thermofisher.com
Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
News Provided by Business Wire via QuoteMedia