Life Science News

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved new expanded magnetic resonance imaging (MRI) compatibility for its Proclaim™ XR Spinal Cord Stimulation (SCS) System with Octrode™ leads. The new labeling lifts MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan. The expanded labeling covers the majority of Proclaim XR patients, providing additional benefits to those patients and their health care providers.

Under the expanded MRI labeling , patients with a Proclaim XR SCS device can benefit from higher quality images with faster MRI scan times.

MRI scanners use powerful magnets and radiofrequency energy to create detailed images of the inside of the body. Concern over how those magnets and radiofrequency energy could impact placement of implantable devices led to conditions being placed on the use of MRIs when a patient had a particular device. Restricted MRI labeling adds a layer of complexity on both patients and radiologists. They must find an imaging facility willing to modify their workflow and work within the MRI labeling limitations of the patient's implant.

"MRIs have increasingly become an important tool helping doctors diagnose an illness or injury. They are particularly important for patients who have certain comorbidities, such as cancer or multiple sclerosis," said Allen W. Burton , M.D., medical director of Abbott's neuromodulation business. "We made it our mission to secure expanded MRI labeling for our spinal cord stimulation devices – both those that were already implanted and those still to be implanted – for the sake of the patients and their doctors."

With the new labeling, Octrode lead tips can be placed anywhere they are needed along the spine and still be considered MR Conditional, which means a patient can undergo MRI scans within the approved outlined conditions. Radiofrequency energy no longer needs to be limited with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode.

"The expanded labeling and reduced scan time address two major issues we face with these implantable devices. By improving the quality of imaging, as well as the experience for both the patient and radiologist, I can now enable more of my existing and new patients to benefit from MRI scans improving their care," said Steven Falowski , M.D., neurosurgeon at Neurosurgical Associates of Lancaster in Pennsylvania .

Under the expanded labeling, patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes, allowing them to safely receive an MRI scan in a fraction of the time. If a scan exceeds a certain amount of time without a break, radiofrequency energy used during the scans has the potential to heat up the implanted device, which can damage the surrounding tissue. In general, the FDA requires radiologists to pause MRIs for anywhere from 30 to 60 minutes between scan cycles for patients with implants.

The label update will also benefit existing patients implanted with Proclaim XR SCS Systems with Octrode leads improving their access to MRI imaging. "Now more clinicians can utilize MRIs to improve quality of care among a patient population with complex needs. It allows clinicians to get to the source of a particular issue in less time and without fear of compromising safety or creating complications, " said Timothy Deer , M.D., president and chief executive officer at The Spine and Nerve Centers of the Virginias, serving West Virginia .

The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. More than 50 million Americans suffer from chronic pain. i There is a high level of clinical evidence for the efficacy of SCS on pain intensity after one year of therapy in patients suffering from a variety of chronic pain conditions. ii

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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i Centers for Disease Control and Prevention. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults – United States, 2016. https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm . Accessed Oct. 7, 2020.

ii Burst Spinal Cord Stimulation : A Clinical Review . Kirketeig T, Schultheis C, Zuidema X, Hunter CW, Deer T. Pain Med. 2019 Jun 1;20(Suppl 1):S31-S40. doi: 10.1093/pm/pnz003.

Cision View original content: https://www.prnewswire.com/news-releases/abbotts-proclaim-xr-spinal-cord-stimulation-system-now-offers-expanded-mri-compatibility-in-us-301451750.html

SOURCE Abbott

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Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

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Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

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Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 “long haulers,” who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 "long haulers," who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

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  • Two industry leaders join forces to empower people living with diabetes by providing information and insights to improve weight loss, glucose control and overall health
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Maintaining a healthy body weight and having proper nutrition are critical to living well with diabetes. 3 Yet, for many people living with diabetes, determining what to eat and following a meal plan is the most challenging part of diabetes management. 4 Through this partnership, participants can receive glucose insights from Abbott's FreeStyle Libre sensor-based technology that show the impact of food choices, alongside the empirically validated 5 WeightWatchers' diabetes-tailored nutritional guidance to help them achieve their healthier living goals.

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Notice of Knight Therapeutics' Second Quarter 2022 Results Conference Call

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its second quarter 2022 financial results on Thursday, August 11, 2022 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

Date : Thursday, August 11, 2022

Time : 8:30 a.m. ET

Telephone : Toll Free: 1-855-669-9657 or International 1-412-317-0790

Webcast : www.gud- knight .com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay : An archived replay will be available for 30 days at www.gud-knight.com .


________________________________________
About Knight Therapeutics Inc.

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About Knight Therapeutics Inc.

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This conference call will be available to investors and other interested parties by visiting the Johnson & Johnson website at www.investor.jnj.com .

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