Accuray partners with Chinese company to sell in China

A subsidiary of California-based Accuray (NSDQ:ARAY) has entered a joint venture with a Chinese company to manufacture and sell radiology oncology systems in China, the companies said today.

Accuray Asia Ltd. will work with Tianjin-based CNNC High Energy Equipment, a subsidiary of China Isotope and Radiation  (HKSE:01763). CNNC will own 51% of the joint venture, known as CNNC Accuray (Tianjin) Medical Technology, and Accuray’s subsidiary will own the rest.

The companies’ leaders believe they will be uniquely positioned to serve the world’s largest growth market for radiation oncology systems by helping to meet critical market demand as stipulated by the Ministry of Health of the People’s Republic of China, as well as by addressing longer-term unmet needs.

Get the full story on our sister site, Medical Design & Outsourcing.

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Accuray’s fiscal Q2 earnings top expectations despite sales miss

AccurayAccuray (NSDQ:ARAY) this week posted fiscal second-quarter earnings that beat the consensus on Wall Street but missed sales expectations.

The Sunnyvale, Calif.-based company put up losses of -$4.6 million, or -5¢ per share, on sales of $102.3 million for the three months ended YYdate, paring its losses by -1.7% on sales growth of 2.0% compared with Q2 2018.

Analysts on Wall Street were looking for losses of -8¢ on sales of $104.0 million.

“Our second-quarter gross order performance was an all-time high for the company,” president & CEO Joshua Levine said in prepared remarks. “Our 29% gross order growth was driven by the China Ministry of Health’s long-awaited issuance of new license quotas for Class A and Class B radiation systems in late October 2018, a sequential rebound in CyberKnife orders, and continued strength in Radixact demand worldwide. Going forward, we believe Accuray is well positioned to win additional orders under the new quotas as the process for hospitals to secure licenses is activated. At the same time, we continued to make progress in our efforts to establish a joint venture in China that we believe will expand our ability to meet demand for Class B systems. From a financial perspective during the quarter, Accuray grew revenue, generated adjusted EBITDA, executed our plan designed to realize $15 million in annualized cost savings and moved closer to our goal of achieving GAAP net income profitability.”

Accuray reiterated its outlook for fiscal 2019, saying it still expects to report adjusted EBITDA of $23.0 million to $29.0 million on sales of $415 million to $425 million.

ARAY shares closed up 2.6% at $3.97 apiece Jan. 22, the day it released its results. The stock was off -1.5% at $4.36 per share today in early trading.

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Senseonics CFO Elsey to retire | Personnel Moves – December 4, 2018

Former Senseonics CFO R. Don Elsey

Senseonics (NYSE:SENS) said yesterday that its CFO R. Elsey is retiring for the company, and that it has begun searching for a permanent replacement.

The Germantown, Md.-based company said that Elsey will stay on until a replacement is appointed, and remain on in an advisory role through to the completion of the company’s 2018 fiscal year.

“Don has been an important part of the growth of Senseonics as our CFO, and we thank him for his service and high level of professionalism throughout his tenure at Senseonics. Over the past several years, we have successfully completed an IPO and subsequent capital raises, enabling us to execute product launches in Europe, continue our pipeline development initiatives and position the company for a successful commercial launch that is underway in the U.S.  Don has contributed much to all of these efforts, and we wish him well in his next pursuits,” prez & CEO Tim Goodnow said in a prepared statement.

“It has been a pleasure working with the dedicated and talented team at Senseonics. I am proud of what we have accomplished and am confident the company is on a solid path toward delivering life changing technology to people with diabetes,” CFO Elsey said in a press release.

 Accuray names Hamamatsu as CFO

Accuray (NSDQ:ARAY) said late last month that it appointed Shig Hamamatsu as its CFO and senior VP, effective immediately.

Prior to joining Sunnyvale, Calif.-based Accuray, Hamamatsu served as corporate controller and VP at molecular diagnostics company Cepheid  before they were bought by Danaher in 2016.

“Shig has a proven track record of more than 15 years building and leading public company global finance organizations that drive results. I look forward to working with Shig as strategic financial partners to execute Accuray’s growth agenda,” prez & CEO Joshua Levine said in a press release.

“I am excited about my role and appreciate the opportunity to serve as Accuray’s chief financial officer during this transformative time in the company’s history. I look forward to working with our entire executive team and leading the company’s finance organization as we execute our growth and earnings expansion initiatives,” Hamamatsu said in a prepared statement.

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 Hill-Rom adds to exec roster

Hill-Rom Holdings (NYSE:HRC) said late last month that it tapped Barbara Bodem as its new CFO and senior VP, succeeding Steven Strobel who announced plans to retire from the position.

Prior to joining Hill-Rom Holdings, Bodem held a senior VP of finance position with Mallinckrodt, Chicago-based Hill-Rom said.

“We are pleased to have an executive of Barbara’s caliber joining the Hill-Rom team. Barbara brings more than two decades of financial experience along with a deep knowledge of our field from her work with large global medical companies. I am confident that she is a great fit for our company, and will play a key role as we continue to build our diversified portfolio to drive sustainable earnings and deliver on our long-term objectives. On behalf of our entire management team, I want to thank Steve for his significant contributions to Hill-Rom. He has built a strong finance organization, contributed significantly to our financial performance, and positioned us to continue to achieve our financial objectives. I’m grateful that he has agreed to work with us for the next several months to ensure a smooth transition,” CEO John Groetalaars said in a prepared statement.

“I am honored to join Hill-Rom, and look forward to working with John and the rest of the leadership team to build on the company’s momentum and deliver strong financial and operational results, while helping to improve outcomes for the patients and caregivers around the world who rely on Hill-Rom’s products,” Bodem said in a press release.

In addition, Hill-Rom said that it appointed current corp dev & strategy senior VP Andreas Frank as its new Front Line Care biz president, replacing Alton Shader, and current investor relations VP Mary Kay Ladone was appointed as corp dev, strategy & investor relations senior VP.

“Andreas and Mary Kay are seasoned professionals who know our business inside and out. We’re thrilled to tap into their talent and expertise for these roles. I am confident they will help Hill-Rom capitalize on our strong momentum and growth prospects,” Groetalaars said in prepared remarks.

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 Former HHS head Price to join Ga. Gov’s transition team

Former Health and Human Services secretary Tom Price, who resigned following a controversy over their use of a private jet, is joining new Georgia Gov.-elect Brian Kemp’s (R) transition team, according to a report from The Hill.

Price is slated to aid in policy planning during the transition, according to the report.

“Obviously he’s got a lot of great experience with healthcare. No one is more experienced with legislative matters than Tom Price and certainly his time in D.C. as well, so he’s a valuable member of our team, but we’re going to continue to work with a lot of different people on healthcare,” Kemp said, according to The Hill.

Price resigned from his position as U.S. HHS Secretary under President Donald Trump in September amidst criticism over using a private jet paid for on the public dime.

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 Baxter controller Karp resigns, Stevens steps up

Baxter (NYSE:BAX) said last month that its controller & senior VP Carloline Karp has resigned from their position to pursue other interests and business activities, and that it added Brian Stevens as its new chief accounting officer, controller and SVP.

Prior to joining Baxter, Stevens served as chief accounting officer with Groupon, the company said. Stevens is slated to hold the position until a successor is elected and qualified, the company said in an SEC filing.

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Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018

Google Health CEO David Feinberg

Google (NSDQ:GOOG) has picked up former Geisinger Health CEO David Feinberg to lead its fragmented health divisions under the Google Health moniker, according to a recent CNBC report.

The tech giant had been searching for a head for several months, with artificial intelligence head Jeff Dean heavily involved in the process, according to the report. Other candidates include execs from health consulting, hospital management and insurance.

In his new position, Feinberg will work closely with CEO Sundar Pichai, according to CNBC, which references individuals familiar with the search process.

Feinberg will oversee multiple groups at Google interested in healthcare including its core search team, cloud business and Google Brain AI team, according to the report.

The formerly independent Alphabet DeepMind health and AI company will also merge back into Google under the newly formed Google health team, according to a separate CNBC report.

Feinberg will be looking to organize the healthcare efforts at the tech giant, including building a health team within Google’s Nest automated home division, which was also merged back into the Google Home team this year, that could help monitor seniors living independently, according to the report.

No information has emerged as to whether Feinberg will work hand-in-hand with other Alphabet healthcare plays, including Verily.

Google has not yet officially commented on the hiring.

 Owens & Minor names Sledd as interim prez & CEO, begins search for perm replacement

Owens & Minor (NYSE:OMI) said last week that it named board member Robert Sledd as its new board chair and interim prez & CEO, succeeding P. Phipps.

The Richmond, Va.-based company said that it has formed a search committee, which will be assisted by an executive search firm, as it looks for a permanent replacement for the departed Phipps.

Sledd has served as a board member since 2007 and previously spent more than 20 years as chairman and CEO of food distro company Performance Food Group, which he co-founded in 1987. He also recently served as managing partner at Pinnacle Ventures and Sledd Properties, and prior to that served as a Senior Economic Advisor to the former Governor of Virginia.

“The board believes the business will benefit from a change in leadership. We thank Cody for his contributions to Owens & Minor and appreciate Bob Sledd’s willingness to step in on an interim basis as we conduct a search for our next CEO. Bob has a long and successful track record operating a large distribution company. We will benefit from his wealth of management experience as well as his knowledge of our business from his board tenure. Under Bob’s leadership, we will continue to execute on our strategic plan to strengthen and diversify our business as we also focus on operational excellence,” lead director Anne Whittemore said in a prepared statement.

“Owens & Minor is a highly respected company that is well positioned to address the critical supply chain needs of providers and manufacturers across the continuum of care. I look forward to working with our dedicated teammates to provide our customers with services and products that improve healthcare delivery,” Sledd said.

In addition to Sledd taking over as interim CEO, the company said that its current interim CFO Robert Snead will continue in his position.

“Robert is an outstanding teammate and I look forward to working closely with him,” Sledd said.

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 EOS Imaging taps NA prez Lobinsky as CEO

EOS Imaging (EPA:EOSI) said last week that it has picked NA prez Mike Lobinsky as its new CEO, taking over for Marie Meynadier who will step away from the position at the beginning of the new year, but will retain a board seat.

The move comes as the Paris, France-based company looks to strengthen its presence in the US and to expand its shareholder base, EOS Imaging said.

Lobinsky’s election was unanimously decided by the company’s board of directors, EOS Imaging said. He has held leadership positions with Smith & Nephew (NYSE:SNN), Brainlab, Blue Belt Technologies  and Stryker (NYSE:SYK), the company added.

EOS Imaging said that it also added Valérie Worrall as its new CFO. Worrall has previously served as CFO of medical device company Balt.

“I have enjoyed working with Mike for over a year. His leadership and knowledge of the industry, combined with his fine understanding of corporate culture, are excellent assets for EOS imaging and I have complete confidence in his ability to continue and accelerate the development of the company. Our North American market is considerable, and Mike will be able to develop it without denying our European roots, relying on the talented management team present in Paris, particularly Eric Maulavé, chief operating officer, to continue to drive global growth. It was an honor and a great pleasure to serve the company and to develop it since its foundation. I am most grateful to the men and women within our staff, to our directors, shareholders and clinical partners, who contributed to this development over these last years. Our teams can be proud of the work accomplished, and I have full confidence that they will continue to build our success under Mike’s leadership,” Meynadier said in a press release.

“Marie’s vision, her energy and her remarkable managerial talent have brought EOS imaging to a stage of excellence and a unique international reputation. Marie has given the company access today to an acceleration opportunity in the United States, which is a new step. She has managed to attract a management team capable of taking up this new challenge and ensure a successful succession. It is rare to be able to apprehend the future in such optimism,” board chair Gérard Hascoet said in a prepared statement.

“I am very grateful to Marie and the board members for their trust and pleased to accept the CEO position. Few companies have accomplished what EOS has and these achievements have established a strong foundation for further development. The potential of our entire solution is outstanding, and I am confident in our ability to translate this into growth and value in the short, medium, and long terms,” Lobinsky said in a prepared release.

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 Bovie Medical CFO Ewers to retire

Bovie Medical (NYSE:BVX) said this week that its chief financial officer, treasurer and secretary Jay Ewers intends to retire.

The Clearwater, Fla.-based company said that it has launched a search for a replacement and that Ewers will stay with the company until a successor is found, after which he will aid in the transition process.

“I would like to thank Jay, on behalf of the board and the entire team at Bovie Medical, for his significant contributions since joining the company in 2014. We appreciate his continued commitment to the company and its shareholders as we identify a successor and wish him the very best in his future endeavors,” prez & CEO Charlie Goodwin said in a prepared statement.

“It has been a great pleasure to serve on the executive leadership team at Bovie Medical and I’m proud of our many accomplishments during my tenure. With the proceeds from the recent strategic transaction, Bovie Medical is in a strong financial position to pursue its future growth objectives, and I believe this was the right time to begin my transition to retirement,” Ewers said in a press release.

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 Procept BioRobotics appoints Waters as CFO

Procept BioRobotics said last week it appointed former Accuray (NSDQ:ARAY)  chief financial officer Kevin Waters as its new CFO.

Prior to joining Accuray, Waters held financial leadership positions with a number of medical device companies including Conceptus, Laserscope and Visx. He has also held positions at PricewaterhouseCoopers, the Redwood Shores, Calif.-based company said.

“Kevin’s deep industry knowledge and leadership experience in commercial stage organizations make him a valuable addition to the Procept team, as we drive towards making Aquablation therapy with the Aquabeam robotic system the standard of care for treating BPH. His appointment rounds out the executive team at Procept, well-positioning the company for strong growth ahead,” founder & CEO Nikolai Aljuri said in a press release.

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Accuray posts mixed bag FY2019 Q1 earnings


Accuray (NSDQ:ARAY) today released fiscal year first quarter earnings that beat Wall Street expectations for sales, but missed on loss-per-share consensus.

The Sunnyvale, Calif.-based company posted losses of $9.2 million, or 11¢ per share, on sales of $95.8 million for the three months ended September 30, seeing losses shrink 1.9% while sales grew 5.4% when compared with the same period during the previous fiscal year.

Adjusted to exclude one-time items, losses per share were 11¢, just behind the 9¢ loss-per-share consensus on The Street, where analysts were looking for sales of $94.3 million, which it topped.

“Our fiscal year is off to a good start with double digit gross order growth and revenue generation meeting our targets. We are also encouraged by the potential benefits to Accuray from the China Ministry of Health’s announcement yesterday of Type A and B quota and licenses. In addition, we’ve implemented a cost savings initiative designed to reduce our annual operating costs by approximately $15 million and provide us with a clear path to GAAP profitability, while preserving our ability to continue our product innovation objectives and drive improved sales growth going forward. These cost savings have enabled us to raise our adjusted EBITDA outlook for the current fiscal year,” prez & CEO Joshua Levine said in a press release.

The company reaffirmed its earlier guidance provided in August, expecting to see revenue of between $415 million and $425 million, representing 3% to 5% growth year over year. Accuracy said it also expects to post adjusted EBITDA of between $23 million and $29 million.

Shares in Accuracy closed up approximately 1.8% today, at $3.44. In after hours trading, shares have risen an additional approximate 2%, at $3.51 as of 4:12 p.m. EDT.

In September, Accuray released data from two studies of its CyberKnife stereotactic body radiotherapy device exploring its use in treating patients with low and intermediate-risk prostate cancer, touting high survival rates and minimal toxicity.

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Accuray pulls the trigger on Series A convertible senior note buyback

Accuray (NSDQ:ARAY) said yesterday it made an irrevocable net share settlement election for its 3.5% Series A convertible senior notes due February 1, 2018, looking to pay cash up to $1,000 for each $1,000 principal amount of Series A notes converted alongside delivery of shares for the conversion value in excess of $1,000.

The Sunnyvale, Calif.-based company said that any such notes converted today or afterwards will be determined based on a volume-weighted average price of its common stock over a 15 business day period beginning January 8, estimating an approximate $26.6 million aggregate principal amount as of Dec. 31, according to an SEC filing.

Currently, the conversion rate for such notes is currently roughly 187.7 shares per $1,000 principal amount of such notes, with a conversion price of approximately $5.33 per share.

The company said it is funding the buyback with a $40 million term loan with MidCap Financial Trust, according to an SEC filing.

Accuray originally announced plans for the buyback last month.

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7 medtech stories we missed this week: May 5, 2017

medtech stories missed

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From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. Biomerics opening new corporate HQ

Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The new facility will be 230,000 sq. ft and will be located in the International Center. It will have corporate offices, engineering offices, research and development labs and cleanroom manufacturing. Biomerics is expected to invest $38.5 million in the expansion and add more than 380 jobs over the next 8 years. It is expected to be completed during the second quarter of 2018 and plans to be FDA and ISO-13485 registered for medical device manufacturing.

2. Refocus completes 1-year follow-up for clinical trial

Refocus Group announced in a May 4 press release that it has successfully completed a 12-month follow-up on the 360 patients in its VisAbility Micro-Insert System for presbyopia clinical trial. The next step for Refocus will be preparing for Pre-Market Approval submission to the FDA. The VisAbility Micro-Insert System is the first presbyopic procedure performed outside the line-of-sight of the eyes that is designed to restore vision without the potential of compromising distance vision or depth perception.

3. Glytec touts study

Glytec’s eGlycemic Management System study results show that the system has a 19% reduction in average daily blood glucose between admission and discharge, according to a May 4 press release. The eGlycemic Management System allows hospitals to achieve the basal bolus standard of care for subcutaneous insulin therapy. The study also showed that there was 0% severe hypoglycemia while receiving the target blood glucose of 140-180 mg/dL at every meal and bedtime. Glycemic data from 1,687 non-critically ill patients treated with subcutaneous insulin therapy between July 2016 and January 2017 were used in this study. It was presented at the American Association of Clinical Endocrinologists 26th Annual Scientific Clinical Congress.

4. Mevion, medPhoton ink deal to integrate ImageRing, S250i

Mevion Medical Systems and medPhoton announced in a May 2 press release that they have entered a strategic agreement to integrate ImagingRing with the Mevion S250i. The ImagingRing is a cone beam computed tomography system for image guidance and the S250i is a pencil-beam scanning proton therapy system. Mevion and medPhoton hope to provide simplicity of workflow and more precise and efficient treatment delivery by adding integrated cone beam imaging to in-room image guidance capabilities.

5. Accuray touts breast cancer treatment study

Accuray announced that results from its phase I clinical trial for early stage breast cancer patients being treated with CyberKnife System have been released, according to a May 2 press release. The study showed that there was no recurrences or distant metastases at a follow-up of 26 months. More than 95% of patents and 100% of physicians rated prognosis as excellent or good after two years. The purpose of the trial was to study the maximum tolerated dose of 5 fraction stereotactic body radiation therapy for partial breast irradiation for treating early stage breast cancer after receiving a lumpectomy. Patients treated with CyberKnife System received non-isocentric and non-coplanar radiation beams had a follow-up every 3 months for a year and then a follow-up every 6 months for the next 4 years.

6. RAPS expands European footprint

The Regulatory Affairs Professionals Society is expanding its European presence, according to an April 20 press release. The European member base for RAPS has grown by almost 19% to more than 1,500 members across 29 countries. RAPS also plans to invest more than 2 million Euros over a 3 year period to implement strategic growth in Europe to launch new events and resources for regulatory professionals in the region.

7. Neural Analytics opens European office

Neural Analytics is opening a new European office based in Hamburg, Germany, according to an April 24 press release. Since the company recently received CE Mark for its Lucid System, Neural Analytics wants to enhance its presence in Europe. Neural Analytics is a medical device company that develops and commercializes technology to measure, diagnose and track brain health.

Here’s what we missed last week.