Rewalk Robotics

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 13 Nov 2017 15:54

Oppenheimer Holdings Inc. began coverage on shares of ReWalk Robotics Ltd. (NASDAQ:RWLK) in a research report sent to investors on Friday. The brokerage issued an outperform rating and a $7.00 price objective on the medical device company’s stock.

Several other brokerages have also issued reports on RWLK. Jefferies Group reissued a buy rating and issued a $10.00 price target (down from $16.00) on shares of ReWalk Robotics in a research note on Friday, November 4th. Zacks Investment Research lowered ReWalk Robotics from a hold rating to a sell rating in a research note on Thursday, November 10th. One equities research analyst has rated the stock with a sell rating and four have given a buy rating to the company. ReWalk Robotics presently has a consensus rating of Buy and a consensus price target of $9.50.

Er zit beweging naar boven aan te komen...


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Re: Rewalk Robotics

Berichtdoor Munnybunny » 13 Nov 2017 16:05

Reimbursement: ongoing discussions with US providers.

http://ir.rewalk.com/static-files/f52db ... 7cb82d2992

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 13 Nov 2017 16:29

Transcript uit de laatste CC:

Let's start with commercial insurance reimbursement as we achieved a major milestone with coverage in Germany. We now have our first broad German coverage physicians with Barmer and the DGUV. Broader reimbursement coverage has been a key strategic goal for ReWalk and for the industry to allow individuals who want to walk again access to exoskeleton technologies. These coverage achievements require expansion of scientific data, favorable court release that these devices are medically necessary and detailed educational efforts with these payers over the past three years. We anticipate these positive coverage decisions will influence other major insurers in Germany and in Europe.

As we previously reported, Barmer, a national social health insurance provider, which covers nearly 10 million lives, confirm that they will provide ReWalk systems to all qualifying beneficiaries that meet the specified inclusion criteria and assessment by the German health insurance medical system. As we previously reported, this group currently has 16 pending insurance claims and has already began processing claims of users, entering retraining for in-home use of an exoskeleton.

And today, we are pleased to announce that the German social accidents insurance provider, the DGUV, has become the second group in Germany to allow reimbursement of the ReWalk personal device. The DGUV is comprised of 35 different insurers, which provide work-related accident coverage for more than 70 million individuals in Germany.

To date, 12 of the 35 insurers have initiated procurement of systems for beneficiaries. Coverage for spinal cord injury primarily occurs through the BG, a national workmen's compensation group. The DGUV recently issued a procedural letter, stating they are entitled to grant reimbursement for robotic exoskeletons. Additionally, the BG Group has indicated it is developing and issuing a training and procurement program for its member groups.

Since September 2015, we've made good progress with these groups and have provided 20 units to BG centers. Of these, 11 have been taken home, seven are still in training and two were not successful in training. The BG has 25 ongoing applications for future potential use. The letter and policy development are expected to increase the pace of system placements.

Now let's turn to the US. The goal for the industry as a whole is to gain coverage and increase access to exoskeleton systems for the spinal cord injured community. A meaningful supporting step has been a recent establishment by the North American Spine Society, NAS, of a spinal cord injury section as a distinct standalone group. This will provide the industry with a forum for expanded scientific data discussions and for occupancy for policies based on this data.

On our last call, we indicated that we have included a comprehensive policy review submission with a large national commercial payer with an expectation for a decision within 60 days. While the review is still ongoing at this time, we are encouraged by the discussions of the group and the level of additional detail they requested as they continue to evaluate the coverage policy. We are expecting to conclude this process by the end of the year.

In Q4, we're also submitting request for coverage consideration submissions to two additional US commercial groups for policy reviews. As the scientific data has expanded, we are now better positioned for formal policy reviews with regional providers and will keep you posted on developments in due course.

Additionally, we had our first session with the CMS innovation group in October to explore pathways for coverage for the underserved SCI population, including the use of an exoskeleton in an advanced payment model with risk-sharing elements seeking savings for the overall system.

And finally, with regard to the VA, we continue to expand our business with the VA in multiple areas. During the quarter, the VA purchased four additional devices for use in its ongoing clinical study. This represents total of 60 devices purchased for the study, which now has enrolled 49 patients at a total of ten sites. Additionally, we continue to work with the VA to expand their ability to train patients under the current program to provide ReWalk personal devices to veterans who qualify. We have been working with the VA to expand their choice program, which allows veterans to be treated at a local center if a VA facility is more than 50 miles from an individual's homes.

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 17 Nov 2017 12:58

NASDAQ COMPANY DISCLOSURES 2017-11-17 03:50:00 -08:00
ReWalk Robotics Announces Pricing of Follow-on Public Offering of Ordinary Shares

YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Nov. 17, 2017 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (Nasdaq:RWLK) (“ReWalk” or the “Company”) today announced that it has priced its underwritten public offering of 6,857,000 ordinary shares at a price to the public of $1.05 per ordinary share. All of the ordinary shares in the offering are to be sold by ReWalk.

National Securities Corporation, a wholly-owned subsidiary of National Holdings Corporation (NASDAQ:NHLD), is acting as sole book-running manager of the offering. ReWalk has granted the underwriter a 45-day option to purchase up to 1,028,550 ordinary shares sold in the public offering on the same terms and conditions. The offering is expected to close on November 21, 2017, subject to customary closing conditions.

ReWalk intends to use the net proceeds from the offering for (i) sales, marketing and reimbursement expenses related to market development activities and broadening third-party payor coverage and (ii) research and development costs related to developing its lightweight “soft suit” exoskeleton technology for various lower limb disabilities, including stroke and other indications affecting the ability to walk.

The offering is being made under an effective registration statement on file with the Securities and Exchange Commission (the “SEC”). Copies of the preliminary prospectus may be obtained from National Securities Corporation, Attention: Marguerite Rogers, 200 Vesey Street, 25th Floor, New York, NY 10281, by telephone at (212) 417-8227, or by email at prospectusrequest@nationalsecurities.com. The preliminary prospectus is also available on the SEC’s website at http://www.sec.gov. The final terms of the offering will be disclosed in a final prospectus to be filed with the SEC and made available on the SEC’s website at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities discussed in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ReWalk Robotics Ltd.

ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the U.S., Israel and Germany.

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 19 Nov 2017 10:52

An interesting new publication regarding feasibility of exoskeleton-assisted ambulation with the ReWalk system in community settings was recently posted on http://www.determined2heal.org/daily-li ... skeletons/

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 21 Nov 2017 13:06

Exoskeletons hebben meer dan alleen maar een medische functie. Ze kunnen ook ingezet worden om mensen met fysiek zware arbeid te helpen...

Bionic devices turn humans into superstrong workers

Iron Man suits might not yet be commonplace, but companies from Ford (F) to Lowe's (LOW) are testing new mechanical exoskeletons to enhance -- and extend -- human strength.

Earlier this month, Ford said it was testing four models of exoskeletal arms to help ease fatigue for assembly line workers.

https://www.cbsnews.com/news/bionic-dev ... g-workers/

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 24 Nov 2017 14:55

Stroke Rehab Technology Aims To Speed Healing
Innovative new technologies are helping patients who have suffered a stroke get back to performing everyday tasks like walking and drinking from a cup.


The technology, a soft "exosuit" from Marlborough, Mass.-based ReWalk Robotics, will be entering pre-clinical trials early in 2018.

The exosuit is the product of a collaborative agreement between ReWalk and Harvard University's Wyss Institute for Biologically Inspired Engineering, and a salient example of how publicly-funded research for one idea can be re-purposed in other areas. The exosuit research began in 2012 as a Defense Advanced Research Projects Agency (DARPA) project intended for the battlefield.

"We started to call it the exosuit because there is no rigid component," Kathleen O’Donnell, the program lead for Wyss Institute's medical exosuit program, said. "It does not restrict movement like an exoskeleton might. The first suits were developed to help able-bodied soldiers carry heavy loads and walk long distances. The purpose was to reduce the metabolic burden on them. They often carry 100 or more pounds of equipment on long marches and the goal was to make them less fatigued when they got to their destination.

"About a year or so into that program, we started looking at where we could find more medical applications of this same technology. We talked to clinicians in the Boston area, and it seemed like stroke was a really good application area that could benefit from this type of technology. The reason for that is that a stroke patient who could benefit from this has some residual walking capacity – it's not somebody who requires total support in order to walk, but they need a little help in learning how to walk better."

The exosuit is powered by a motor unit worn on a waist belt, which activates sheathed Bowden cables anchored in two spots: one in a calf-worn fabric sleeve and one in the insole of the shoe the unit is activating to achieve a more natural gait.

ReWalk already markets a rigid exoskeleton for people who have suffered a spinal cord injury who are unable to walk unassisted, and O'Donnell said the exosuit collaboration is meant for a different market—"with the exosuit we're taking somebody with some underlying ability to walk and we are injecting small levels of assistance at critical times in their gait cycle to improve their walking ability and coordination rather than taking over for them."

ReWalk CEO Larry Jasinski said the upcoming trial is not expected to enroll a large number of patients – comparable trials have consisted of 40 patients or so – and also said the trial is in the middle of IRB approval at four top research institutions nationwide.

Jasinski said the Wyss Institute researchers had shown the device worked, but didn't have a product that would meet commercial requirements.

"It could not have gotten past the FDA, would not have been durable enough for a rehab lab and use by 100 patients, and it wasn't really designed for home use," he said. "And that's why this relationship is so ideal. They are doing a high level of fundamental research that, generally, small companies can not afford to do. They are making it work for that individual situation. We are going to be able to take it through the FDA, through the reimbursement processes, and manufacture it at a price point with the quality control and functional level that can meet a mass audience. That is why it's a good marriage."

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 28 Nov 2017 12:03

Jerusalem’s Alyn Hospital recently discussed at its annual conference a variety of modern ways to improve the quality of life of disabled young people.

Rehabilitation of disabled children and teens no longer involves just training in the use of wheelchairs and providing prostheses to replace missing limbs. Ever-advancing technology has added robots, virtual reality, video screens and other assisting devices and ways to improve the youngsters’ quality of life and family cohesion. There are even (highly expensive) drugs that significantly ameliorate diseases that used to be considered hopeless. One powerhouse behind this revolution is Jerusalem’s ALYN Hospital, a national and comprehensive rehabilitation center for physically challenged and disabled children, adolescents and young adults.

The nonprofit facility, which treats all young patients, regardless of religious belief, nationality or ethnic background, was founded in 1932 by American orthopedist Dr. Henry Keller, who dedicated his life to such children. Working out of an old re-purposed monastery in the capital’s Katamon neighborhood, the medical staff cared for children disabled in the polio epidemic that spread through Israel and the rest of the world in the 1940s and 1950s. ALYN served as a treatment center, residence and school for 200 young patients.

In 1971, the voluntary organization was able to build the impressive Woldenberg Family Hospital complex in Jerusalem’s Kiryat Hayovel neighborhood to serve inpatients and outpatients.

Today, it is one of the world’s leading hospitals specializing in the active and intensive rehabilitation of children who have a broad range of physical disabilities caused not only by various congenital and progressive muscle, nerve and bone diseases, but also feeding disorders, severe respiratory problems, road and home accidents, terrorist attacks and severe burns. Patients who underwent orthopedic operations and neurosurgery also recover and are rehabilitated at ALYN.

The center includes a pre-school daycare center for children aged six months to three years, kindergartens, an after-school integration program and school classes. It provides services including occupational therapy, physiotherapy, hydrotherapy, speech therapy and psychological counseling in addition to support by medical specialists and social workers.

Its director-general since 2011, Dr. Maurit Beeri recently opened ALYN’s Third Annual Conference on Rehabilitation at the capital’s Crowne Plaza Hotel. An accompanying exhibition displayed a large variety of equipment available for disabled youngsters from wheelchairs to electronic devices.

Rehabilitation of disabled children and teens no longer involves just training in the use of wheelchairs and providing prostheses to replace missing limbs. Ever-advancing technology has added robots, virtual reality, video screens and other assisting devices and ways to improve the youngsters’ quality of life and family cohesion. There are even (highly expensive) drugs that significantly ameliorate diseases that used to be considered hopeless. One powerhouse behind this revolution is Jerusalem’s ALYN Hospital, a national and comprehensive rehabilitation center for physically challenged and disabled children, adolescents and young adults.

...

A successful item for rehabilitation is video on a screen so disabled children can move. There are relatively cheap virtual reality devices that can benefit them and are easy to use. A company named SenSerum offers a virtual playground that children with autism can use to jump as if they were on a real trampoline.

“There is a need to find a way for robots to copy human movements, and the technology should be inexpensive, small in size and light in weight. They should be adaptable to the intelligence and abilities of each child and be able to document changes and improvements.”

Robots are very good for disabled kids because “they repeat and are consistent. They can provide exact, continuous quantitative feedback through sensors,” Weiss said. Obviously, robots alone are not enough. They must be complemented by human therapists.

ALYN PHYSIOTHERAPIST Orit Bartov presented the benefits of “intelligent wheelchairs” with built-in sensors to prevent collisions and “eye-drivers” that enable steering with one’s eyes. Children can visit the zoo along with the family using a respirator that’s the size of a laptop. There are cheap children’s plastic and metal wheelchairs for the developing countries.”

While physiotherapy in the 1990s was aimed at strengthening one joint at a time, said Bartov, today it involves rehabilitating the whole body, creating balance, control of movement and coordination.

“Muscle tone is not an aim but a means. There is cognitive rehabilitation, not just medical but also biological, psychological and social. We have to learn about the longterm effects of operations on muscle and use new knowledge in engineering, neuroscience and rehabilitation to create new interventions.”

It takes about a decade for knowledge to be translated from development of technology into a product used in the field.

“We used to try to change the patient, but it’s more important to change the patient’s environment to suit him,” she explained.

The physiotherapist’s take-home message is that the disabled patient should always be the focus; we are not technicians but evidence-based clinicians; there is no alternative to using your hands; and don’t be afraid to try something new.”

ALYN RECENTLY set up a program called PELE (Child Solutions) to create individualized products for helping children with special needs identified by therapists or family members. Professionals and volunteers in engineering and other fields donate their time to design what they need, said Dana Hochstein Mann, the director of ALYNnovation to match the innovative products with manufacturers around the world who want, through cooperation, to bring it to the world market.

Mann noted that zippers developed by Under Armor for the disabled to close with one hand have expanded their use to the wider public. “A child asked Nike to make a shoe with a zipper in the back to make it easy to put on. Now they are being made as a fashionable item for the general public. Companies such as ReWalk and OrCam, are talking about accessibility for the disabled all the time.”

Israel became the “Startup Nation,” said Mann, for good reasons.

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 28 Nov 2017 14:15

ReWalk Robotics Announces Full Exercise of Underwriter’s Option to Purchase Additional Ordinary Shares in Follow-on Public Offering

GlobeNewswire•November 28, 2017
YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Nov. 28, 2017 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (RWLK) (“ReWalk” or the “Company”) today announced that National Securities Corporation (“National”), the underwriter of ReWalk’s underwritten public offering of ordinary shares, exercised in full its option to purchase 1,028,550 additional ordinary shares at a price to the public of $1.05 per ordinary share for total proceeds (after underwriting discounts and commissions and before expenses) of $998,979.19. After the exercise of the option, the total number of ordinary shares sold by ReWalk in the offering increased from 6,857,000 to 7,885,550.

National, a wholly-owned subsidiary of National Holdings Corporation (NHLD), acted as sole book-running manager of the offering. National exercised the option on November 22, 2017, after the offering of the 6,857,000 base shares closed on November 21, 2017, and the offering of the shares subject to the option closed on November 27, 2017.

ReWalk intends to use the net proceeds from the offering for (i) sales, marketing and reimbursement expenses related to market development activities and broadening third-party payor coverage and (ii) research and development costs related to developing its lightweight “soft suit” exoskeleton technology for various lower limb disabilities, including stroke and other indications affecting the ability to walk.

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Re: Rewalk Robotics

Berichtdoor Munnybunny » 30 Nov 2017 15:59

Nog wat bijgekocht. Ik zie deze niet lager gaan.

ICYMI: ReWalk’s Restore technology for stroke patients featured in MD&DI

MARLBOROUGH, MA / YOKNEAM ILIT, ISRAEL—November 30, 2017– ReWalk Robotics’ innovative Restore soft exoskeleton system was featured in a recent story as one of the cutting edge technologies seeking to help stroke survivors heal and retain critical motor skills. The story published in Medical Device & Diagnostic Industry (MD&DI), a leading industry trade magazine.

The article examines the latest advancements in technology for stroke-assistive medical devices, and outlines the inspiration for a soft suit exoskeleton, with interviews with ReWalk CEO Larry Jasinski and Kathleen O’Donnell, lead of the medical exosuit program at Harvard’s Wyss Institute, ReWalk’s collaborative partner on the Restore system. The story also walks the reader through the device’s components:

The exosuit is powered by a motor unit worn on a waist belt, which activates sheathed Bowden cables anchored in two spots: one in a calf-worn fabric sleeve and one in the insole of the shoe the unit is activating to achieve a more natural gait.

In his interview, Jasinski speaks to the different pieces ReWalk and the Wyss Institute bring to the table, and the effort to obtain FDA clearance and offer a commercial system:

“They [Wyss] are doing a high level of fundamental research that, generally, small companies cannot afford to do. They are making it work for that individual situation. We are going to be able to take it through the FDA, through the reimbursement processes, and manufacture it at a price point with the quality control and functional level that can meet a mass audience. That is why it’s a good marriage.”

The Restore is a soft suit exoskeleton designed for the stroke survivor patient community; exosuits are expected to offer additional use for other patient populations, including individuals with Parkinson’s Disease, Multiple Sclerosis or other mobility challenges where normal walking gait is impacted. ReWalk recently unveiled the commercial Restore unit, which is already in use in a pre-clinical study and is preparing to expand to the US Pivotal Clinical trials in Q1 2018. Priced at $19,500, the soft exosuit is anticipated to begin commercialization in late 2018 or early 2019.

http://rewalk.com/icymi-rewalks-restore ... ured-mddi/