In the market for neuromodulation, companies are developing spinal cord stimulation (SCS), deep brain stimulation (DBS) and other stimulation devices designed to treat a vast range of indications. Current and emerging devices are addressing care gaps in the treatment of chronic pain and movement disorders as well as epilepsy, Tourette syndrome, depression, pelvic floor dysfunction, peripheral artery disease, paralysis and spinal cord injuries.

Companies competing in the market for neuromodulation include Abbott*, Boston Scientific*, Medtronic*, Nevro*, Saluda Medical*, Newronika* and Axonics, just to name a few. To keep you up to speed on what’s new in neuromodulation, SmartTRAK highlights market updates covering clinical developments, patents, new research and other top news from Spring 2022.

SmartTRAK's Anne Staylor, Executive Editor, VP &GM of Neurotherapies, is in Barcelona attending the INS 15th Congress.

The following is just a small sampling of recent neuromodulation updates from around the world compiled, reviewed and posted daily by our SmartTRAK analysts.

Clinical Developments

• Medtronic*
• • Medtronic announced the first patient implanted in its “Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop SCS System” study of its investigative, closed-loop, ECAP-responsive device to treat back and limb pain. The prospective study is enrolling 90 patients across 10 centers in Australia.
  • A University of Florida-sponsored eight patient clinical trial will evaluate DBS to treat Tourette syndrome targeting two brain regions in each hemisphere of each patient and using two leads in each hemisphere connected to two Percept PC devices. Estimated study completion is Aug 2026. clinicaltrials.gov
    
    
•  Boston Scientific*
• • Boston Scientific received FDA approval of its latest image-guided programming software, Vercise Neural Navigator with STIMVIEW XT. Developed in collaboration with Brainlab*, STIMVIEW XT provides real-time visualization of lead position and simulation modeling for Parkinson’s Disease and essential tremor treatment.

Jason Winkler, Sales VP of cybersecurity startup Device Authority, discusses the state of cybersecurity in healthcare in an interview with SmartTRAK.

To find out more, including the devices most vulnerable to cybersecurity threats and how medical device manufacturers should think about designing cybersecurity measures into their connected products, click on the following video to listen to the full interview (17:29 min). A link to download the complete transcript of the interview is also provided below.

Wallaby Medical announced it has acquired phenox GmbH, including phenox's femtos GmbH, a German-based neurovascular company, for a total of ~$545MM (EUR 500MM) including milestone payments. SmartTRAK previously reported the possibility of the acquisition deal in early March 2022. Wallaby Medical acquiring phenox GmbH is one of the largest recent cross-border transactions in the medical device industry and will enable the Company to provide a wide range of neurovascular solutions to pts in the US, China, Europe, Japan and other international markets.

For more information about phenox, click to read "phenox Takes Aim at US Market with Novel Stroke Devices", SmartTRAK's interview with James Lago, President and CEO of phenox Inc., in which he discusses the Company's novel mechanical thrombectomy device and flow diverter, and what’s next in terms of bringing these technologies to the US market.

Abbott’s Binith Cheeran, MD, PhD discusses the latest trends in DBS as well as the Company’s strategies for growth in an interview with SmartTRAK

Binith Cheeran, MD, PhD, Abbott’s senior director of medical and clinical affairs for deep brain stimulation (DBS), discusses the latest trends, research and innovation in DBS in an interview with SmartTRAK. Abbott is focused on growing the market through patient education, improving access to care through its NeuroSphere Virtual Clinic and expanding the ecosystem in DBS through the Company’s connected devices.

To find out more, including Dr. Cheeran’s thoughts on primary cell vs rechargeable devices, use of specific image guidance systems, closed-loop DBS and empowering patients through digital health solutions, click on the video below to listen to the interview recorded online via Zoom (32:45 min). A link to download the transcript of the interview is also provided below.

In this article, SmartTRAK reviews the development of AI in healthcare and profiles four companies implementing AI-driven imaging in these spaces.

The US Orthopedic Computer-Assisted Surgery (CAS) Market is one of the fastest-growing markets in orthopedics and is expected to reach revenues of $1.14B by 2025, according to SmartTRAK estimates. The Orthopedic CAS market includes a range of enabling technologies including robotic platforms, navigation systems, surgical planning tools, augmented/virtual reality technology and artificial intelligence (AI). AI is being increasingly incorporated into diagnostics and planning to assist in optimization of surgical decision making and anomaly detection.
 
The prominence of AI and machine learning technologies in medicine has snowballed over the past decade. Diagnostic Imaging and navigation is experiencing a new paradigm of technology through the emergence of AI-driven 3D reconstruction, segmentation and navigation applications. Two areas seeing quick implementation and adoption of these new systems are orthopedic planning/navigation and neurovascular diagnostics. In this article, SmartTRAK reviews the development of AI in healthcare and profiles four companies implementing AI-driven imaging in these spaces.

Abbott’s Allen Burton, MD discusses the Company’s new MRI labeling, expanded payer coverage for DRG, big data and digital initiatives in an interview with SmartTRAK at NANS 2022

Allen Burton, MD, Abbott Divisional Vice President, Medical Director Neuromodulation, discusses Abbott’s latest research and innovation in an interview with SmartTRAK at the North American Neuromodulation Society (NANS) Annual Meeting held January 13-14, 2022.

To find out more, including about the Company’s new MRI labeling, UnitedHealthCare coverage for DRG, big data and the status of Abbott’s digital initiatives, click on the video below to listen to the interview recorded live at NANS 2022. (30:18 min.) A link to download a complete transcript of the interview is also provided below.

Medtronic Neuromodulation executives Dave Anderson and Charlie Covert discuss the Company and the future of neuromodulation in an interview with SmartTRAK at NANS 2022

Dave Anderson, Medtronic’s President Neuromodulation, and Charlie Covert, Vice President and General Manager of Pain Therapies, discuss the Company, pandemic and the future of neuromodulation in a wide-ranging interview with SmartTRAK at the North American Neuromodulation Society (NANS) 25^th Annual Meeting held January 12-15, 2022 in Orlando, Florida.

To find out more about the Company’s newest innovations, expanding indications*, clinical research and strategies for driving growth in spinal cord stimulation (SCS) and deep brain stimulation (DBS), click on the following video recorded live at NANS 2022. (33:45 minutes.) Specific interview topics by time code are also outlined below. To download a complete transcript of the interview, click here.

D. Keith Grossman, chairman, CEO and president of Nevro Corporation, discusses the Company, expanding indications and driving growth through innovation and evidence in an interview with SmartTRAK

Nevro’s Keith Grossman expects randomized controlled trials and recent FDA approvals for expanded indications--painful diabetic neuropathy (PDN) and non-surgical refractory back pain (NSRBP)--to provide a competitive edge and help drive growth in the market for spinal cord stimulation (SCS). To find out more, including Grossman’s take on Medtronic’s recent FDA approval for the diabetic peripheral neuropathy (DPN) indication, click on the following video recorded live* via Google Meet (40:20 min). Specific interview topics by time code are also outlined below. If you would like to download a complete transcript of the interview, please click here.

We are pleased to announce that Shelly Caruso has joined the team at SmartTRAK as a Market Analyst/Medical writer. Shelly has 8+ years in clinical healthcare, 4+ years neurosurgical and orthopedic intraoperative nursing working with medical devices at trauma centers and outpatient facilities, including cranial, spine, sports med, total joint and extremity. Shelly has a BA in economics and BSN in nursing and is a certified editor and member of The American Copy Editors Society.

A big boost in Q2 with double-digit gains in all segments.

The US and WW SCS Market boomeranged to pre-COVID levels in Q221 driven by declining COVID-19 cases and ongoing launches of new technologies and products. With easy comps against a quarter that was one of the hardest hit by the pandemic in 2020, Q221 growth was up in the double digits vs Q220 and was up in the low-single digits compared to Q219.

Among the many topics covered in detail in our comprehensive Q221 SCS Market Recap* are: