Corindus touts first Japanese CorPath GRX procedures

Corindus Vascular RoboticsCorindus Vascular Robotics (NYSE:CVRS) said today that the first Japanese procedures using its CorPath GRX robot-assisted device took place as part of a post-market surveillance study.

Waltham, Mass.-based Corindus, which last June won clearance from Japan’s Pharmaceutical & Medical Device Agency for CorPath GRX, inked a distribution deal for Japan in February 2017 that included a $2 million advance and provision for 12 of the devices; the system used in the initial cases there was the first placement of that deal and followed A1 technical fee reimbursement approval last month, Corindus said today.

CorPath GRX is used to assist cardiologists during percutaneous coronary interventions including stenting procedures.

“The acceptance of robotic-assisted PCI in Japan is an important next step for Corindus to bring this critical medical advancement to additional markets across the globe. Japan represents one of the largest markets for PCI globally, with over 1,200 hospitals performing nearly 250,000 PCI procedures annually,” president & CEO Mark Toland said in prepared remarks.

“After completing the first cases with CorPath GRX, I am impressed with the capabilities of the system, including the level of precision and control during complex procedures,” added Dr. Takafumi Ueno of Kurume University Hospital. “Robotics will provide Japan with cutting-edge technology in interventional medicine, and we are pleased to be one of the first facilities in the Asia-Pacific region to offer this treatment to our patients.”

“We are thrilled to have partnered with Dr. Ueno, Kurume University Hospital, and Japan Medicalnext to launch the first vascular robotic program in Japan, offering these patients the benefits of robotic-assisted PCI,” Toland said.

Corindus Vascular Robotics meets The Street with Q4 earnings

Corindus Vascular RoboticsCorindus Vascular Robotics (OTC:CVRS) shares gained today after the robot-assisted surgery company reported fourth-quarter results that met the forecast on Wall Street.

Losses grew 3.1% for Waltham, Mass.-based Corindus posted to -$8.2 million, or -4¢ per share, on sales growth of 11.5% to $4.7 million for the three months ended Dec. 31, 2018, compared with the same period in 2017. Analysts were looking for LPS of -4¢.

Full-year losses were ip 25.0% to -$42.6 million, or -22¢ per share, on sales growth of 11.7% to $10.8 million compared with 2017.

“2019 is poised to be another significant year for Corindus. The successful completion of the world’s first-in-human remote robotic PCI procedure in India in December represents an exciting milestone for the future of our technology. Doctors around the world are embracing the technology and its life-saving potential for patients with limited access to care. Physicians increasingly understand that building clinical knowledge and expertise in robotics is a prerequisite to telerobotic intervention. As a result, we expect to see continued positive momentum and have seen a shortening of the sales cycle from initial discussion to installation of our robotic platform. Through the expansion of existing programs in the U.S., increased utilization and the broadening of our global footprint, we believe we are on the right path to serve patients and build shareholder value,” president & CEO Mark Toland said in prepared remarks. “Moreover, we have advanced our neurovascular work and look forward to receiving clearance from the FDA for the neurovascular indication for the CorPath GRX. We believe our technology has the potential to address the large unmet need and transform the standard of care for stroke patients, where access is limited and time to treatment is critical. We expect the private placement we recently completed, along with the potential strategic partnership we are pursuing, to provide us with the added financial flexibility to bring this indication to market.”

CVRS shares were ip 5.5% to $1.52 apiece today in mid-afternoon trading.

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Corindus adds $5m to private placement

Corindus Vascular Robotics

Corindus Vascular Robotics (OTC:CVRS) said today that it added onto a previously closed private placement, bringing in an additional $4.8 million.

The Waltham, Mass.-based company said that in the additional closing, it floated 3.5 million shares of its stock at a price of approximately $1.38 per share.

The placement included participation from Hudson Executive Capital and Biostar Ventures, with funds slated to support general corporate purposes, according to a press release.

With the additional $4.8 million, the company said it raised a total of $19.5 million.

Last month, Corindus Vascular Robotics announced an initial closure of the round with $15 million raised.

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Corindus closes $15m private placement

Corindus Vascular Robotics

Corindus Vascular Robotics (OTC:CVRS) said today that it closed a $15 million private placement round.

The Waltham, Mass.-based medical robotics company said it sold a total of approximately 10.9 million shares of its common stock at a purchase price of approximately $1.38 per share, for aggregate proceeds of approximately $15 million.

Net proceeds from the private placement are expected to be approximately $14.8 million, which the company said it plans to use for general corporate purposes, according to a press release.

Earlier this month, Corindus said that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions.

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Corindus asks FDA for expanded neurosurgery indication for CorPath GRX

Corindus Vascular Robotics

Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions.

The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year.

“The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a wealth of clinical knowledge and expertise, are key to preparing for a future of remote stroke treatment,” chief medical officer Dr. Aquilla Turk said in a prepared release.

Corindus touted that if it receives the clearance, the CorPath GRX system would be the world’s first and only robotic platform indicated for all three indications.

“An expansion of CorPath GRX to treat neurovascular conditions would represent a major stepping stone towards our goal of revolutionizing stroke treatment. We believe that our current robotic platform will bring benefits to neurovascular procedures today and we will leverage our recent achievements in telerobotics and strong focus on technology development to build a remote stroke solution to tackle the challenge of access to care. This would extend the reach of highly-skilled specialists across the globe by granting remote access to patients suffering from life-altering diseases where access to care is limited and time to treatment is paramount,” prez & CEO Mark Toland said in a prepared statement.

Last December, Corindus touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.

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Corindus touts first-in-human coronary telerobotics study with CorPath system

Corindus Vascular Robotics

Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.

The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab.

In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said.

The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Patel from inside the Swaminarayan Akshardham temple in Gandhinagar, while his partner, Dr. Sanjay Shah, attended to the patient in person at the Apex Heart Institute.

“The first in human cases of remote robotic PCI represent a landmark event for interventional medicine. The application of telerobotics in India has the potential to impact a significant number of lives by providing access to care that may not otherwise have been possible. For the first time in cardiology’s history, India will shine for this ground-breaking innovation, and I am honored to be a part of this historic occasion,” Dr. Patel said in a prepared statement.

Corindus said that following the study, it plans to begin commercial product development to allow the CorPath system to be used in remote interventions.

“Cardiovascular disease, including stroke, is the world’s most significant and undertreated clinical problem due to limited access to specialized, timely medical care. As a result of existing barriers to care, including increased global poverty and a declining number of trained specialists, only a fraction of patients worldwide receives life-saving treatment, resulting in substantial death or disability. We anticipate that our technology will revolutionize cardiovascular disease treatment by providing specialized and timely medical care to anyone, anywhere,” prez & CEO Mark Toland said in a press release.

Last month, Corindus saw shares rise over 10% after the robotic surgical platform maker beat loss-per-share expectations on Wall Street with its third quarter earnings.

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Corindus Shares rise on Q3 EPS beat

Corindus Vascular Robotics

Shares in Corindus Vascular Robotics (OTC:CVRS) have risen over 10% today after the robotic surgical platform maker beat loss-per-share expectations on Wall Street with its third quarter earnings.

The Waltham, Mass.-based company posted losses of approximately $7.6 million, or 4¢ per share, on sales of approximately $3 million for the three months ended September 30, seeing losses shrink 3.3% while sales grew 22% compared with the same period during the previous year.

Losses per share were just ahead of the 5¢ consensus on Wall Street, where analysts expected to see sales of $3.2 million, which the company narrowly missed.

“During the quarter, we continued to make progress on developing a vascular robotic system that can perform therapeutic procedures at any remote location. Demonstrating this technology at TCT gives us great confidence as we plan for the first-ever remote robotic in human PCI procedure later this year. Telerobotics combined with AI has generated significant interest from the clinical community as well as potential strategic partners. We look forward to updating the market as we advance our remote vascular robotic technology, which we believe has the potential to revolutionize treatment times for patients suffering from stroke and heart attacks,” prez & CEO Mark Toland said in a press release.

Shares in Corindus have risen 14.2% so far today, at $1.29 as of 10:33 a.m. EST.

In September, Corindus revealed plans for an offering worth up to $30 million.

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Corindus shares fall on Q2 earnings release

Shares in Corindus Vascular Robotics (OTC:CVRS) fell today after the robotic surgical platform maker missed loss per share expectations on Wall Street but met sales consensus with its second quarter results.

The Waltham, Mass.-based company posted losses of $9.9 million, or 6¢ per share, on sales of $1.7 million for the three months ended June 30, seeing losses grow compared with the same period last year.

Losses per share were just behind the 5¢ per share consensus on The Street, where analysts were looking for sales of $1.7 million which the company met.

“We have made meaningful progress advancing the development of remote-telestenting which has, in turn, led to the acceleration of our efforts to address the neurovascular market. We are focusing our clinical and development work in this area to leverage the GRX platform and expand upon what we are building in the interventional suite with PCI and peripheral applications. Despite purchase timing uncertainties and capital budget cycles at the hospital administration level which have impacted our results in the first half of the year, we remain confident in our long-term ability to drive widespread robotics implementation,” prez & CEO Mark Toland said in a press release.

Shares in Corindus have fallen 14.4% so far today, at 89¢ per share as of 11:11 a.m. EDT.

In June, Corindus said today that it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device.

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Corindus touts 1st Corpath GRX system installation outside the US

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