A large call options sweep order took place on January 9, 2020. The call sweep was valued at a whopping $1.28 million.

Medtronic plc (NYSE:MDT) today announced the CE (Conformité Européenne) Mark for Percept™ PC neurostimulator; it is the only Deep Brain Stimulation (DBS) system to be launched in the European Union (EU) with BrainSense™ technology that can sense and record brain signals while delivering therapy to patients with neurologic disorders, such as Parkinson’s disease. BrainSense technology enables physicians to track patient-specific brain signals and correlate these with patient-recorded events, such as symptoms or side-effects associated with their disease or the medications to treat it. This enables more personalized, data-driven neurostimulation treatment. The Percept PC neurostimulator is approved in the EU for the treatment of symptoms associated with Parkinson’s disease (PD), essential tremor, primary dystonia as well as epilepsy and obsessive-compulsive disorder (OCD). It is currently under review by the U.S. Food and Drug Administration.

“DBS is proven to significantly improve motor function in people with Parkinson’s disease compared to standard medication alone – but with currently-available systems, physicians need to make therapeutic decisions mostly based on clinical assessments and patient-reported information,” said Professor Andrea Kühn, head of Movement Disorders and Neuromodulation, Charité University Hospital, Berlin. “Percept PC with BrainSense technology is a game changer. Patients and their care teams will have objective patient-specific brain signal data – including data recorded outside the clinic in patients’ everyday lives. With this technology, doctors could tailor therapy more precisely to the individual needs of each patient based on data from neuronal activity.”

In addition to BrainSense technology, the Percept PC DBS system features several leading-edge innovations, including:

  • The only DBS system with MR conditional labeling that allows for 3T and 1.5T full-body MRI scans, providing patients access to cutting-edge medical imaging
  • Improved battery longevity compared to Medtronic’s Activa™ PC neurostimulator (when using similar settings and functionality) in a smaller (reduced volume), ergonomic design for patient comfort
  • Low pulse width (duration of the pulse), providing expanded stimulation options allowing for finer control over the neural activation area
  • Enhanced Patient Programmer leveraging a user-friendly, custom-configured Samsung mobile device that allows patients to manage their therapy easily
  • Designed to easily facilitate expanded capabilities in the future via software upgrades – to prepare for what’s next in DBS
  • The Percept PC neurostimulator will be available in Western Europe beginning January 15th and will launch in additional regions based on local regulations.

“With the Percept PC device with BrainSense technology, Medtronic is truly reinventing DBS therapy, propelling it into a new frontier and empowering clinicians with new options to bring the future of DBS to patients today. Doctors can directly assess patients’ brain signals to inform and provide customized treatment for each patient,” said Mike Daly, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. “Patients are empowered to take an active role in their therapy, and physicians can deliver data-driven, personalized therapy that fits the needs of today’s patients, now and in the future.”

DBS therapy is currently approved in many locations around the world, including the United States and Europe, for the treatment of recent and longer-standing Parkinson’s disease, essential tremor, primary dystonia, the disabling symptoms of epilepsy and treatment-resistant obsessive-compulsive disorder.

DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for several neurological disorders. Medtronic was the first in the United States to offer full-body MR Conditional DBS systems for patients to have safe scans anywhere on the body under certain conditions. Since 1987, more than 150,000 Medtronic DBS devices have been implanted worldwide for movement disorders and other indications.

On January 8, 2020, Medtronic plc (NYSE:MDT) announced it has acquired Stimgenics, LLC, a privately-held company based in Bloomington, Illinois, that has pioneered a novel spinal cord stimulation (SCS) waveform known as Differential Target Multiplexed (DTM™) Spinal Cord Stimulation. The therapy, which is delivered via the Medtronic Intellis™ platform, is a new and unique programming option to treat patients with chronic pain. Three month results from a randomized control trial (RCT) evaluating DTM versus conventional SCS will be presented at the upcoming North American Neuromodulation Society (NANS) 23rd Annual Meeting on January 23-26 in Las Vegas. The RCT will continue to evaluate outcomes through 12 months follow-up.

The DTM waveform may engage a novel mechanism that modulates both neurons and glial cells, expanding the understanding of SCS mechanisms of action. The DTM waveform has been studied in animal models, showing statistically significant reversal of pain behaviors compared to either low frequency or high frequency alone.1,2 In addition, preclinical studies investigating the genome of nerve-injured animals suggests that the DTM waveform has a greater impact in the neural-glial interaction than other frequencies alone. Decades of basic science research have expanded the understanding of the role of glial cells in the nervous system, which outnumber neurons 12:1 in the spinal cord.3-6 Glial cells are no longer thought to be only “glue” in the brain and spinal cord, but active contributors to neural processing and various disease states including chronic pain.7

“Stimgenics’ research is deeply rooted in clinical science that began with animal work more than a decade ago. Our preclinical data demonstrated that the modulation of both neurons and glial cells may return glial cells to their normal state and modify how they interact with neurons, which could normalize biological processes and break the pain cascade,” said Dr. Ricardo Vallejo, co-founder and director of research at Millennium Pain Center in Bloomington, Illinois, and founder and lead investigator of Stimgenics, LLC. “I’m thrilled that Medtronic has acquired a therapy that has the potential to significantly improve outcomes for chronic pain patients.”

Stimgenics’ preclinical research on the neuronal-glial mechanism of action has been recognized at various medical society meetings. Over the course of the past two years, the team has received six “best of” awards for their research, three of which were specific to research investigating the DTM mechanism of action. NANS awarded the “Best Basic Science Research Award” to Stimgenics at their annual meeting in both 2018 and 2019.

“Medtronic is committed to providing clinically-proven therapeutic options for millions of patients suffering from chronic pain around the world,” said Marshall Stanton, M.D., president of the Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “We believe that DTM therapy will advance the treatment of chronic pain, supported by clinical evidence and preclinical research on a neuronal-glial mechanism of action. It’s an exciting, new proprietary SCS waveform that will be available on the Intellis platform, and we are looking forward to seeing the results of the randomized control trial data later this month at NANS.”

This transaction is expected to be neutral to fiscal year 2020 earnings per share and meet Medtronic’s long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed.

On January 7, 2020, SunTrust analyst Kaila Krum initiated coverage of Medtronic with a Buy rating and $130 price target. While Medtronic has offered new products over the years, its latest pipeline has included several more transformational launches, Krum tells investors in a research note. The analyst expects the company’s sales growth to drive cash flows.

On January 2, 2020, Guggenheim analyst Christopher Pasquale upgraded Medtronic to Buy from Neutral with a $135 price target. He told investors that he sees 2020 as the year that the company’s “much-touted” pipeline begins to translate into financial results given expected FDA approvals for the Micra AV leadless pacemaker and 780G insulin pump. He also thinks longer-term projects like the Hugo robotic surgery platform, Intrepid TMVR, and Symplicity RDN system could begin to move the needle in FY22 and expects Medtronic’s valuation discount to peers to narrow as visibility improves.

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