Med-Device Investment News

GE brings good things to bioelectronics research

BIOELECTRONICSGeneral Electric is giving the Feinstein Institute for Medical Research a   bioelectronic jolt.

The Feinstein Institute, R&D mecca of the Northwell Health system, announced a new “strategic alliance” Tuesday with GE Ventures, the multinational conglomerate’s New Jersey-based business-licensing and equity arm.

While no financial terms were disclosed, Northwell Health did note an “investment” that will help the Feinstein Institute’s evolving Center for Bioelectronic Medicine“continue its work in discovering, developing and commercializing new diagnostic and therapeutic solutions in bioelectronic medicine for a wide range of acute and chronic diseases and injuries.”

Under the guiding hand of President and CEO Kevin Tracey, the Feinstein Institute is regarded as a global leader in bioelectronics – and some insiders see the GE partnership as a virtual bouquet to the man considered the father of nerve-stimulation science.

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How BSX Plans to Accelerate its Neuromodulation Position

By Sarah Collins, MARKET REALIST  | Aug 18, 2016

Key growth areas – The neuromodulation market is an attractive growth opportunity for Boston Scientific (BSX). The neuromodulation business is part of Boston Scientific’s Medsurg segment.

The neuromodulation business registered 12% YoY (year-over-year) growth in 2Q16, compared to its growth of around 8% in 1Q16. The above graph shows the neuromodulation business’s contributions to the company’s Medsurg segment’s sales and growth.

Having grown in the mid-teens, the US SCS (spinal cord stimulators) market is a key growth area for Boston Scientific’s neuromodulation business, and the company has a leading position in this market with its product Precision Spectra System.

Also, with the recent launch of the full body MRI (magnetic resonance imaging) SCS system, customers now have access to SCS technology with MRI capabilities.

Another potential market for the neuromodulation business is the DBS (deep brain stimulation) market. DBS systems are used for performing surgical procedures for the treatment of neurological symptoms such as tremors, epilepsy, and Parkinson’s disease.

Boston Scientific has a strong DBS business in Europe and is expected to be in the United States market by 1Q18. The company expects the US DBS market to be around $400 million–$500 million. Medtronic (MDT) and St. Jude Medical (STJ) are Boston Scientific’s major competitors in the DBS market. St. Jude Medical is being acquired by Abbott Laboratories (ABT), as announced by Abbott in April 2016.

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Johnson & Johnson’s venture arm is betting on neuromodulation

Especially in the area of chronic pain, where drugs have been the preferred therapy modality, people are looking into neuromodulation given the opioid crisis in the nation. A market research report published in October 2015 projected that the devices pain management market, will grow to $3.5 billion in 2020, up from $3.1 million last year.

Johnson & Johnson doesn’t have an internal neuromodulation program, confirmed a spokeswoman, but the company’s venture arm — Johnson & Johnson Development Corp. (JJDC) — has been pretty active in the neuromodulation space for several years.

The news of the latest investment came earlier this month when JJDC took the lead investor role in a $93 million funding round in Minneapolis-based CVRx. Last November, CVRx received FDA’s Expedited Access Pathway status for its Phase III randomized, controlled clinical, pivotal trial, Baroreflex Activation Therapy for Heart Failure (BeAT-HF). That trial will test the safety and effectiveness of Barostim Neo in congestive heart failure patients. The Expedited Access Pathway program is FDA’s fast-track method of approving novel, innovative devices and is intended to encourage innovation.

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Medtronic (MDT) Announces Acquisition of Advanced Uro-Solutions

By, February 23, 2015

Medtronic (NYSE: MDT) announced that it has acquired Advanced Uro-Solutions,a privately-held developer of neurostimulation products for the treatment of bladder control issues based in Elizabethton,Tennessee. Terms of the acquisition agreement,which closed in December 2014,were not disclosed.

Advanced Uro-Solutions develops and manufactures the NURO(TM) percutaneous tibial nerve stimulation system,which consists of a small external stimulator and a single,reusable lead to provide temporary stimulation to the tibial nerve. This therapy is 510(k) cleared by the FDA to treat patients with overactive bladder (OAB) and associated symptoms of urinary urgency,urinary frequency and urge incontinence. Medtronic is preparing to launch the NURO system in the U.S. within the next 12 months.

More than 37 million adults in the United States – one in six – suffer from OAB.1,2 By 2018,it is estimated that 546 million people worldwide will be affected by OAB.3.

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Public pain prevention: Nevro sets terms for $100 million IPO
By ,  October 27, 2014

Nevro,which is awaiting approval for a spinal cord stimulation device that treats leg and back pain,announced terms for its IPO on Monday. The Menlo Park,CA-based company plans to raise $100 million by offering 6.3 million shares at a price range of $15 to $17. At the midpoint of the proposed range,Nevro would command a fully diluted market value of $401 million. 
Nevro has developed an implantable spinal cord stimulation ( SCS ) system that treats chronic pain in the back and legs. The company notes that currently-approved SCS treatments,which are reimbursable,have limited efficacy for back pain. Its Senza device has been available in European markets since 2010 and Australia since 2010. It submitted a PMA to the FDA in June 2014,and is preparing to launch its device as early as the 1H16,if approved. 

Nevro,which was founded in 2006 and booked $27 million in sales for the 12 months ended June 30,2014,plans to list on the NYSE under the symbol NVRO. J.P. Morgan and Morgan Stanley are the joint bookrunners on the deal. It is expected to price during the week of November 3,2014. 

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Global Neurostimulation Devices Market Is Expected To Be Worth $8,791.8 Million By 2020: Grand View Research,Inc
San Francisco,California (PRWEB) September 26, 2014 

The global market for neurostimulation devices is expected to reach USD 8,791.8 million by 2020,according to a new study by Grand View Research,Inc. The presence of high unmet medical needs with limited treatment options in disease segments such as epilepsy,Parkinson’s disease and migraine is one of the highest impact rendering drivers of the market. Other key drivers for this market include growing global base of geriatric population,growing use of neuromodulation as an add on therapy and the introduction of technological advancements such as the transdermal neuromodulation technology by Neurowave Medical Technologies and MRI safety enabled devices by Medtronic Inc.

Neuromodulation or the use of neurostimulation devices for therapeutic purposes is one of most promising healthcare technologies. The global neurostimulation devices market is expected to grow at a CAGR of 14.3% from 2013 to 2020 on account of future growth opportunities such as the presence of untapped markets in rapidly growing Asian and Latin American economies and the growing number of externally funded clinical programs working towards the development of new products (e.g. the National Institute for Health Research funded a research program initiated by the NIHR/Nottingham Hearing Biomedical Research Unit to develop neuromodulation devices for the treatment of tinnitus).

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Venture Capital Soars in Med-Tech Space According to PwC’s MoneyTree Report

Venture capital funding for the Life Sciences sector,which includes biotechnology and medical devices,reached $2.5 billion in 195 deals for 2Q14,according to a new report,“Biotech soars to record high,” that includes data from the MoneyTree Report from PricewaterhouseCoopers (PwC; New York) and the National Venture Capital Association (NVCA),based on data provided by Thomson Reuters (New York). While this quarter was the highest Life Sciences investment since 2Q07,it was also the strongest second quarter since 1995,which is the earliest data recorded by the MoneyTree.

Investments in medical device companies reached $649 million in 73 deals for the quarter,which represented a 23% increase in dollars invested but a 5% decrease in the number of deals. On a quarter-over-quarter basis,funding increased 69% for biotechnology and 23% for medical devices. On a year-over- year basis,biotechnology and device investments increased by 25% and 23%,respectively,in terms of dollars invested.

Medtronic Buys Brain-Stimulation Firm for $200 Million
Medical-Devices Maker Looks to Broaden Capabilities in Brain-Function Field
August 26, 2014 from THE WALL STREET JOURNAL

MedtronicMedtronic Inc. on Tuesday said it acquired privately held Sapiens Steering Brain Stimulation for about $200 million in cash,as the medical-devices maker looks to broaden its capabilities in the brain-function field. Medtronic said the deal doesn’t have an impact on its earnings guidance for fiscal year 2015.

Netherlands-based Sapiens is developing a deep-brain-stimulation system that would allow for more precise stimulation of intended targets in a patient’s brain,according to Medtronic.

Sapiens and Medtronic will continue work on the project while beginning clinical research into integrating the technologies into Medtronic’s existing portfolio.

“This acquisition broadens our neuroscience leadership position with innovative brain modulation technology that,along with our comprehensive portfolio of DBS solutions,may one day transform the way physicians are able to treat patients with neurodegenerative diseases like Parkinson’s disease and essential tremor,” Medtronic executive Lothar Krinke said in a news release.

The deal comes as Medtronic pursues the completion of its $42.9 billion deal to buy Covidien PLC,which has come under scrutiny over a tax tactic called inversion that has drawn criticism from U.S. officials. Medtronic plans to relocate in Ireland,where the tax load for the company would be lighter than in the U.S.,after it completes the Covidien transaction. 

Greatbatch Acquires Uruguay-based CCC Medical Devices
August 13, 2014 from ZACKS EQUITY RESEARCH

Greatbatch,Inc. acquired CCC Medical Devices,a Uruguay-based developer and manufacturer of active implantable medical (AIMD) systems,in an effort to partner with more medical device companies and complement its core discrete technology offerings. The financial terms of the transaction were kept under wraps.

Located in Montevideo,CCC Medical Devices designs and produces a range of devices for medical device companies all over the world,including implantable pulse generators,programmer systems,battery chargers,patient wands and leads.

With the acquisition of CCC Medical Devices,GB aims to enhance its medical device innovation efforts. Combining the knowledge,talent and customer base of both companies,GB hopes to produce better products for the medical community and improve the lives of people worldwide. 

St. Jude Seals the Deal with NeuroTherm to Gain Ground in Neuromodulation
August 7, 2014 from FIERCE MEDICAL DEVICES

St. Jude Medical (STJ) finalized its acquisition of interventional pain management therapy manufacturer NeuroTherm,gaining ground in a highly competitive neuromodulation market and expanding its chronic pain portfolio.

The Minnesota device giant in July said it would purchase NeuroTherm for approximately $200 million in cash to get its hands on the company’s radiofrequency ablation (RFA) technology,a minimally invasive procedure that reduces chronic pain by targeting painful nerves in the neck and back. St. Jude already boasts a number of products in its arsenal,including spinal cord stimulation implants for pain treatment and its next-generation Prodigy neurostimulator,a device that uses burst stimulation in addition to standard tonic stimulation to treat patients with chronic pain. The company launched a clinical trial for the device in December and won CE mark approval for its product earlier this year.

St. Jude expects the purchase to add $10 million to $15 million to its 2014 sales,it said in a statement at the time the deal was announced. The acquisition could also provide a welcome boost in revenue,as product sales for the company’s neuromodulation unit fell 1% to $107 million in Q2 2014. During a second- quarter earnings call,CEO Daniel Starks emphasized that the company was “on track” to renew growth of its neuromodulation business through regulatory approvals and new acquisitions. 

Neuro-Modulation 2.0: New Developments in Brain Implants,Super Soldiers and the Treatment of Chronic Disease 

September 2, 2014 from FORBES

Brain implants here we come. DARPA just announced the ElectRX program,a $78.9 million attempt to develop miniscule electronic devices that interface directly with the nervous system in the hopes of curing a bunch of chronic conditions,ranging from the psychological (depression,PTSD) to the physical (Crohn’s,arthritis). Of course,the big goal here is to usher in a revolution in neuromodulation—that is,the science of modulating the nervous system to fix an underlying problem.

We have known for a while that neuromodulation is effective. Cochlear implants,for example,use electricity to modulate the auditory nerve (really the whole auditory system),while deep brain stimulation has proven itself effective at regulating erroneous neuralelectrical activity and mitigating everything from the tremors of Parkinson’s to the terrors of chronic pain. The potential is there. But so are the issues.

As the folks at Extreme Tech recently pointed out:

So far,these implants have been fairly big things — about the size of a deck of cards — which makes their implantation fairly invasive (and thus quite risky). Most state-of-the-art implants also lack precision — the stimulating electrodes are usually placed in roughly the right area,but it’s currently very hard to target a specific nerve fiber (a bundle of nerves). With ElectRx,DARPA wants to miniaturize these neuromodulation implants so that they’re the same size as a nerve fiber. This way they can be implanted with a minimally invasive procedure (through a needle) and attached to specific nerve fibers,for very precise stimulation.

What makes all of this so much more interesting is the fact that,unlike all the other systems of the body,which tend to reject implants,the nervous system is incorporative—meaning it’s almost custom-designed to handle these technologies. In other words,the nervous system is like your desktop computer— as long as you have the right cables,you can hook up just about any peripheral device you want.

And that’s exactly what DARPA is doing here: they’re giving us the right cables.