11 Dec 4 Companies Making Their Mark on the Global Nerve Stimulator Market
Nerve Stimulation is a process that involves the use of electrical stimulation technology to treat chronic pain and is categorized into Spinal Cord Stimulation and Peripheral Nerve Stimulation. These are further classified into deep brain stimulators, vagus nerve stimulators, spinal cord, sacral nerve and gastric enteric stimulators. Electrical Pulses are transmitted through a pulse generator to the affected nerve, which inhibits pain and provides relief. The technology is generally used to treat severe pain caused due to nerve damage, complex regional pains, multiple sclerosis, epilepsy and paraplegia to name a few. The treatment has also demonstrated the ability to reduce chronic back pain, ischemic leg pain and even pain after spinal surgery.
A device is surgically implanted under the skin using local anesthesia, allowing the user to control the frequency and intensity of the pulse generation through a device. There are certain non-invasive options also available. The rise in geriatric population, increasing spinal cord injuries, neurological and lifestyle related diseases and increased awareness and demand for minimally invasive options are driving the growth in the market. In addition, the increased investment in research and development by companies will have a positive impact on the industry.
However, the scope of the treatment is limited by the cause of the pain as there is a lack of research to understand its full application and limitations. Furthermore the risks and side-effects associated with the treatment include fibrosis /scar tissue, the decline in effectiveness, hardware failure, fluid leakage, headaches and bladder related issues.
According to a report by Global Market Insights, the global Neurostimulation devices market is expected to grow at a CAGR of 15.4% from 2020 to 2026. We take a look at some companies that are bringing innovation and cutting-edge technology to the industry.
electroCore Inc (NASDAQ: ECOR)
Market Cap: $78.64M; Current Share Price: 1.73 USD
Data by YCharts
The Company’s gammaCore™ (nVNS), is a first-in-class non-invasive, hand-held medical device that enables a patient to self-administer mild electrical stimulation at the neck, as an adjunct therapy for migraine and cluster headache. By targeting the afferent fibers in nerves, gammaCore is able to reduce pain, while eliminating the side-effects and risks associated with orally administered drugs or surgically implanted devices. The U.S FDA has approved the use of gammaCore for adjunctive use in the treatment of cluster headaches, episodic cluster headaches and migraines in adults. In the EU, the device is CE marked for acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.
Furthermore, the company has received an Emergency Use Authorization (EUA) from the FDA for the use of gammaCore Sapphire™ CV, at home or in healthcare settings for patients suffering from or suspected of asthma-related dyspnea and reduced airflow as a result COVID-19, in cases where approved drug therapies have been ineffective or intolerable.
The Device has also been selected for evaluation in a study being sponsored by the National Institute on Drug Abuse (NIDA) to understand its efficacy in the treatment of opioid use disorders. The Company has a robust intellectual property rights portfolio of over 200 patents and patent applications worldwide covering its proprietary signal, methods of treatment, non-invasive delivery means, and mechanisms of central action which will enable patent protection through 2033.
The Company has a diverse pipeline of candidates that are leveraging its expertise in nVNS therapy and targeting treatment of Migraine and cluster headaches, Acute stroke, subarachnoid hemorrhage, Parkinson’s disease to name a few.
LivaNova PLC (NASDAQ: LIVN)
Market Cap: $3.02B; Current Share Price: 62.16 USD
Data by YCharts
A medical device Company that is pioneering cardiovascular and neuromodulation solutions such as oxygenators, perfusion tubing sets, cannulae and heart-lung machines, LivaNova is committed to delivering innovative technologies that can transform patient lives.
The Company is deemed the number one in cardiopulmonary bypass in the world and offers advanced cardiovascular support that is used in more than 50 percent of open heart surgeries worldwide. LivaNova has entered into an agreement with Gyrus Capital (Gyrus), an investment firm for divesting its heart valve (HV) business. It will now realign its focus on its neuromodulation and cardiovascular platforms and will seek to advance its promising pipeline of candidates.
LivaNova’s pioneered the Vagus Nerve Stimulation Therapy System for the treatment of epilepsy. In addition, the therapy can also be applied for the treatment of difficult-to-treat depression, and is currently being evaluated for its efficacy in delivery of Autonomic Regulation Therapy in cases of heart failure. The Company has also used the therapy to stimulate the hypoglossal nerve as a treatment for obstructive sleep apnea.
The company has robust intellectual property rights portfolio covering its Neuromodulation systems the VNS Therapy® System, the VITARIA® System and its pulse generator products. S5® heart-lung machine, S3® heart-lung machine, Inspire®, Heartlink® and numerous other surgical tissue and mechanical heart valve replacement and repair products.
The Company is engaged in two pivotal clinical studies namely ANTHEM-HFrEF heart failure and RECOVER depression study and is enrolling patients after a COVID-19 related delay.
Pulse Biosciences, Inc. (NASDAQ: PLSE)
Market Cap: $433.09M; Current Share Price: 17.09 USD
Data by YCharts
Pulse Biosciences, Inc (formerly known as Electrobate Inc) is a bioelectric medical device company developing the CellFX system that leverages its path-breaking Nano-Pulse Stimulation (NPS™) technology. The proprietary technology is targeted at dermatological or aesthetic skin applications that require a precise removal of cellular lesions or structures. The device is non-thermal and can deliver targeted action on the desired cell, with no peripheral non-cellular tissue damage. It can produce ultrafast nano-second pulses of electrical energy, with durations from billionths up to a millionth of a second, which can enter cells and modify the function of the internal cellular organelles, including the mitochondria and endoplasmic reticulum as per the Company.
The technology has the potential to offer a highly differentiated treatment approach and upon approval will be the first commercial product to build on the Nano-Pulse stimulation technology. The Company has over 99 issued patents worldwide, and intends to extend the application of its proprietary technology to numerous medical applications that have a large unmet need.
Pulse Biosciences is building a robust pipeline of candidates that can benefit greatly from the application of the NPS technology such as Seborrheic and Actinic Keratosis, Acne, Melasma, Warts, Moles, Keloid Scare, Sebaceous hyperplasia to name a few. The Company has submitted a 510(k) Premarket Notification application to the FDA for the CellFX® System for general dermatologic applications and is expecting an approval in Q1, 2021. Furthermore it has also received an Investigational Device Exemption (IDE) approval from the FDA for a clinical study to evaluate the efficacy of sebaceous hyperplasia (SH) lesions. The Company is also gearing up for a potential Health Canada license in Q1, 2021 after submitting a Medical Device License application.
As per its Q3,2020 financial results, the Company had Cash, cash equivalents and investments of $29.6 million as of September 30, 2020, as against $37.8 million as of June 30, 2020.
SetPoint Medical (Private)
The Company received a Breakthrough Therapy Designation from the U.S Food and Drug Administration (FDA) for its innovative bioelectronic device that helps with rheumatoid arthritis (RA) in patients who are intolerant to conventional biologic drugs. SetPoint Medical is developing a portfolio of candidates that target chronic and inflammatory autoimmune diseases. The device aims to meet the needs of approximately 1.5 million Americans who suffer from RA yet cannot use conventional therapeutics either due to intolerance or lack of effectiveness or diminishing therapeutic response.
The device stimulates the endogenous inflammatory reflex, thereby reducing inflammation, and is deemed to be less risky and more cost-effective than drug therapy. The Company has received an Investigational Device Exemption (IDE) approval from the FDA for initiating a crucial trial with up to 250 patients across 40 clinical trials in the U.S. The trial will study the efficacy of this device as against biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).
The technology was discovered by its Co-founder Dr. Kevin Tracey, who found the Inflammatory Reflex that uses electronic pulses to treat chronic autoimmune diseases. His work resulted in the Company designing an implantable MicroRegulator and positioning device.
The Company is pursuing various applications of its unique technology to treat conditions such as Crohn’s Disease and Multiple Sclerosis.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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