ReWalk Robotics raises $4m

ReWalk Robotics

ReWalk Robotics (NSDQ:RWLK) has raised approximately $4.3 million in a new round of financing, according to recently posted SEC filings.

In the offering, ReWalk Robotics sold warrants to purchase ordinary shares at a purchase price of approximately $5.20, according to the filing. Warrants offered in the round have an exercise price of $5.14 and are exercisable for 5.5 years from the date of issuance. Warrants were issued on April 5, ReWalk Robotics said.

Money in the round came from three unnamed investors, with the first date of sale noted as having occurred on April 3.

The company is looking to raise an additional approximate $2.1 million, which would bring the total raised in the round to approximately $6.3 million, according to the filing.

Proceeds from the offering will be used to support sales, marketing and reimbursement expenses related to market development activities and broadening third-party payor coverage, as well as R&D costs related to the ReStore device and other products, according to the filing.

In February, ReWalk Robotics said that it applied to FDA for 510(k) clearance of its ReStore exoskeleton suit seeking indications for gait training during stroke rehabilitation.

ReWalk Robotics files for exoskeleton suit clearance

 

ReWalk Robotics’ exo-suit designed for stroke rehabilitation.

ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation.

The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial involving 44 patients at five rehabilitation centers in the U.S.

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ReWalk Robotics shares fall on Q4, 2018 sales miss

ReWalk Robotics

Shares in ReWalk Robotics (NSDQ:RWLK) fell today after the rehabilitation exoskeleton maker posted fourth quarter and full year 2018 earnings that beat loss-per-share expectations but missed wide on sales consensus from Wall Street analysts.

The Yokneam, Israel-based company posted losses of approximately $5 million, or 10¢ per share, on sales of approximately $1.6 million for the three months ended December 31, seeing losses shrink 18.6% while sales grew 4.2% when compared with its fourth quarter during the previous year.

Losses per share were just ahead of the 14¢ consensus on Wall Street, where analysts expected too see sales of approximately $3 million, which the company missed.

For the full year, ReWalk Robotics reported losses of approximately $21.7 million, or 59¢ per share, on sales of approximately $6.5 million, seeing losses shrink 11.9% while sales shrunk a larger 15.6% when compared with the previous fiscal year.

Losses per share were ahead of the 67¢ consensus on Wall Street, where analysts expected to see sales of $8.5 million, which the company missed.

“We believe that 2019 is poised to be a significant year for ReWalk. I am excited by the momentum we are seeing in Europe for our SCI devices and the opportunity before us as we prepare to launch our second product, the ReStore for stroke patients.  We plan to enter the stroke market with a unique lightweight product that fits into the existing reimbursement landscape, offering multiple treatment benefits for patients and a meaningful value proposition for clinics. We are excited to bring this ground-breaking technology to market and believe its unique value will support rapid adoption. In November 2018, we submitted an application for CE clearance and anticipate being able to launch ReStore mid-year. In the U.S., we are working to finalize our 510(k) submission to the FDA and, if cleared, could have a product on the market before the end of the third quarter of 2019. To support our efforts, we secured additional funding and will continue to manage our cash position. Our goal is to achieve a significant reduction in operating expenses in 2019 compared to 2018 as we complete the regulatory and key development milestones related to the ReStore launch, which we believe will reduce our burn rate in order to establish a path to break even,” CEO Larry Jasinski said in a press release.

The company has not yet released guidance for the coming year.

Shares in ReWalk Robotics have fallen 8.1% so far today, at 25¢ per share as of 11:32 a.m. EST.

Last October, ReWalk Robotics saw shares drop after it posted preliminary third-quarter sales that missed the mark on Wall Street, even as the company revealed plans for a $15 million public offering.

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ReWalk Robotics expands ReStore soft exo-suit trial

ReWalk Robotics (NSDQ:RWLK) said today that it plans to expand the clinical study of its ReStore soft exo-suit device to five U.S. research centers.

The Marlborough, Mass.-based company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.

Enrollment for the company’s multi-center study is ongoing. The five centers involved in the trial include the Shirley Ryan AbilityLab, Spaulding Rehabilitation Hospital, the MossRehab Stroke and Neurological Disease Center, TIRR Memorial Hermann and the Kessler Foundation.

“We expect that the expansion of our clinical study to these renowned research organizations will bring the ReStore exo-suit closer to CE and FDA clearance,” CEO Larry Jasinski said in prepared remarks. ”The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the U.S. with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market.”

“The ReWalk ReStore is an unobtrusive wearable robotic technology that can seamlessly interact with and enhance everyday clinical care, allowing stroke patients to walk effectively and efficiently,” lead investigator Arun Jayaraman added. 

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