Baystreet Staff -

Is Neuromodulation the Next Hot Sector in Healthcare


LAS VEGAS, NV / ACCESSWIRE / July 25, 2016 / As the biotech sector has cooled down from its all time highs last summer, investors looking for growth opportunities should look to medical devices, specifically neuromodulation companies.

One company that just made a huge move in neuromodulation that investors should look at closely is Endonovo Therapeutics, Inc. (ENDV), which just announced that it is acquiring Rio Grande Neurosciences, a developer of non-invasive brain stimulation technologies for treating neuroinflammation and central nervous system diseases and disorders.

Although Neuromodulation has been around for some time and has traditionally played second fiddle to pharmaceuticals and only considered after all other drug therapies have failed to alleviate symptoms, it is now picking up steam as an innovative, beyond-the-pill technology.

Conceptually neuromodulation is quite simple: it is an emerging branch of medicine, sometimes called Electroceuticals™ or Bioelectronics, which treat the nervous system directly with implantable or non-invasive devices that rebalance the neural circuitry with electrical pulses.

The field of neuromodulation has long been dominated by the large players, such as Medtronic, Boston Scientific, and St. Jude Medical. These large companies have largely used electrical stimulation of the spinal cord (Spinal Cord Stimulators) and peripheral nerves to relieve pain, but much of the future growth of this market revolves around new and less invasive applications, such as long-term of relief of Parkinson's-related symptoms using deep brain stimulation. Other new applications of neuromodulation that show great promise include potential treatments for depression and other psychiatric disorders and multiple sclerosis.

It is no surprise that the neuromodulation market is set for high growth in the coming years. It is estimated to reach a value of $6.2 billion by 2020, growing at a CAGR of 11.2% for the period 2015-2020, according to MarketsAndMarkets.

Even struggling pharmaceutical giants, such as GlaxoSmithKline (GSK), who have seen declining earnings and drug failures, are jumping into the race for new more advanced neuromodulation technologies. The reason why is simple, economics: It can take 10 years and $2 billion to bring a new drug to market. However, the promise that advanced neuromodulation technologies known as electroceuticals or bioelectronics bring is that in the future these technologies can be modified slightly to treat a variety of diseases, making 2nd and 3rd generation devices much easier and less costly to produce than the next potential blockbuster drug.

So who are the innovators on the bleeding edge of these new neuromodulation technologies?

One small company that just made a huge move in this space is Endonovo Therapeutics, Inc. (ENDV), a developer of bioelectronic devices and medicines for treating inflammatory conditions in vital organs. It recently announced that it is acquiring Rio Grande Neurosciences, Inc., (RGN) a Santa Fe, NM-based developer of non-invasive brain stimulation technologies.

ENDV is an emerging player in bioelectronic medicine/electroceuticals, which seek to harness electrical signals from nerves to change the course of several diseases and disorders. ENDV is currently developing a non-invasive bioelectronic device, called Immunotronics™, to treat and prevent vital organ failure by reducing inflammation and cell death. It is currently concentrated on treating acute inflammatory conditions in the liver, such as acute liver injury and acute liver failure.

The acquisition of Rio Grande Neurosciences will firmly establish ENDV as a pertinent player in the neuromodulation space, as RGN's pipeline includes multi-coil repetitive Transcranial Magnetic Stimulation (rTMS) technology for treating resistant major depressive disorder, which is pending 510(k) clearance and a non-invasive Electroceutical™ for treating inflammatory conditions in the brain and central nervous system. RGN's Electroceutical™ device has been FDA-cleared for treating post operative pain and edema and is now being developed for treating traumatic brain injury, acute concussions, post concussion syndrome and multiple sclerosis.

Finally, RNG's neuromodulation portfolio includes closed-loop Transcranial Electrical Stimulation (cl-TES), which is being supported by a grant from the Department of Defense (DoD) for enhanced learning.

Other notable companies working on exciting Neuromodulation devices, include Second Sight Medical Products, Inc. (NASDAQ: EYES), EnteroMedics, Inc. (NASDAQ: ETRM), Nuvectra Corporation (NASDAQ: NVTR), and Sunshine Heart, Inc. (NASDAQ: SSH).

Second Sight Medical Products, Inc. (EYES) is engaged in developing, manufacturing and marketing prosthetic devices that restore vision to blind individuals. The Argus II Retinal Prosthesis System ("Argus II") is the world's first FDA approved device intended to restore some functional vision for people living with blindness due to severe to profound retinitis pigmentosa. The Company's Argus II System employs electrical stimulation to bypass degenerated photoreceptor cells and to stimulate remaining viable retinal cells thereby inducing visual perception in blind individuals. The Argus II System works by converting video images captured by a miniature camera housed in a patient's glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes that are implanted on the surface of the retina. EYES is targeting the expansion of the treatment label of Argus II to include dry-age-related vision issues, a move that should see the company expand the revenue potential of the device. Enrollment has been completed in a trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration.

EnteroMedics, Inc. (ETRM) is a medical device company focused on the design and development of devices that use neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders. The Company's neuroblocking technology, which is referred to as VBLOC therapy, is designed to intermittently block the vagus nerve. The VBLOC is a pacemaker-like device that sends intermittent electrical pulses, blocking hunger signals between the stomach and the brain. The Company's initial product is the Maestro Rechargeable System, which uses VBLOC therapy to limit the expansion of the stomach, help control hunger sensations between meals, reduce the frequency and intensity of stomach contractions and produce a feeling of early and prolonged fullness. The Company's VBLOC therapy is designed to block the gastrointestinal effects of the vagus nerve by replicating a vagotomy using high-frequency, low-energy electrical impulses to intermittently interrupt naturally occurring neural impulses on the vagus nerve between the brain and the digestive system. EnteroMedics' Maestro Rechargeable System has received U.S. Food and Drug Administration approval, CE Mark and is listed on the Australian Register of Therapeutic Goods.

Nuvectra Corporation (NVTR) is a neurostimulation company focused on the development and commercialization of a neurostimulation technology platform, which is used for the treatment of various disorders through stimulation of tissues associated with the nervous system. The Company's Algovita spinal cord stimulation (SCS) system is an application of its neurostimulation technology platform, and is used for the treatment of chronic pain of the trunk and limbs. The Company's technology platform supports other neurological indications, such as sacral nerve stimulation (SNS) for bladder and bowel control and deep brain stimulation (DBS) for movement disorders. NVTR recently announced a licensing deal with Aleva Neurotherapeutics to develop their DBS platform for Parkinson's disease and essential tremor.

Sunshine Heart, Inc. (SSH) is a global medical technology company, committed to the commercialization of C-Pulse®, an implantable, non-blood contacting, heart assist therapy for the treatment of people with class III and ambulatory class IV heart failure. Sunshine Heart's C-Pulse® Heart Assist System has CE Mark in Europe and is in a clinical study in the United States to determine if the C-Pulse System is safe and effective for treating moderate to severe heart failure. C-Pulse therapy is designed to reduce overall heart failure symptoms, improve quality of life, and reduce re-hospitalizations. SSH recently announced a clinical update and product development strategy. After months of collecting data and researching the optimum path forward, SSH is moving forward with a therapeutic strategy focused on neuromodulation rather than counterpulsation. During its feasibility study, SSH discovered the primary mechanism of action providing the clinical benefit was a neuromodulatory effect due to the counterpulsation balloon placement on the ascending aorta and its activation of the aortic baroreceptors with each expansion. Compared to its prior clinical strategy, Sunshine Heart believes its new focus will provide the following benefits: 1) A more cost effective way to develop a fully-implantable system, 2) a faster path to commercialization, and 3) broader access to the NYHA Class III heart failure market.

Of these growth stocks, ENDV provides the best opportunity for huge profits due to its low price and high potential for its bioelectronic medicine platforms and opportunities in neuromodulation.

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