Accuray Inc. Archives - Medical Design Sourcing

Accuray gets FDA nod for breast cancer treatment on Radixact system

The Radixact system. [Image from Accuray]Accuray (Nasdaq:ARAY) announced that the FDA granted 510(k) clearance to its VitalHold breast package on the Radixact system.

The company also says it expects the treatment option to become available in Europe.

VitalHold facilitates deep inspiration breath hold (DIBH) treatments. It uses the Radixact System’s fixed beam angle delivery mode (TomoDirect) and fully integrated, automated surface-guided radiation therapy (SGRT). This features the Catalyst+ HD system from C-RAD.

DIBH treatments help to minimize radiation doses to organs at risk, reducing associated complications later in life. During treatment, a patient takes a deep breath, moving the heart away from the chest wall and the targeted tumor. SGRT tracking continuously monitors the breathing and positions with cameras to confirm the position is appropriate for radiation delivery. This method allows care teams to effectively position the patient and conf…

Accuray stock rises on Street-beating Q2

Accuray (Nasdaq:ARAY) shares rose this morning on second-quarter results that topped the consensus forecast.

ARAY shares ticked up 12.1% at $2.75 apiece. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 14.4%.

The Sunnyvale, California–based radiation oncology company posted losses of $1.9 million. That amounts to losses of 2¢ per share on sales of $114.8 million for the three months ended Dec. 31, 2022.

Accuray reported a large bottom-line slide into the red from profits of $179,000 this time last year. Its sales dipped 1.3% year over year. The company’s earnings came in 1¢ ahead of expectations on Wall Street, while revenues topped estimates by 33.3%.

“We have delivered another strong quarter of performance in Q2 showcasing the growing customer demand for our precision radiotherapy solutions and the excellent operational execution by the Accuray team amidst chal…

Accuray partners with Limbus AI on adaptive radiotherapy

Accuray (Nasdaq:ARAY) and Limbus AI announced today that they are partnering to augment Accuray’s adaptive radiotherapy capabilities.

The partnership aims to leverage Limbus’ artificial intelligence (AI)-driven auto contouring algorithms to enable a streamlined treatment planning process.

Sunnyvale, California-based Accuray and Saskatchewan, Canada-based Limbus AI anticipate an integrated offering will be made available beginning in 2023, according to a news release.

Limbus AI’s contouring algorithms help to define the border of the tumor and organs at risk during radiation therapy, completing what the companies described as one of the most critical steps in the planning process. That step accounts for a significant proportion of both the personnel and time involved in plan adaptation, too.

The automation of the contouring portion of the planning process also allows for practical adaptive plan modification, when warranted, withou…

Accuray names Sandeep Chalke as chief commercial officer

Accuray (NSDQ:ARAY) today announced it appointed Sandeep Chalke as senior VP and chief commercial officer, effective May 16.

Chalke will report to President and forthcoming CEO Suzanne Winter and will be responsible for the global commercial, product development, R&D and engineering functions of the Sunnyvale, California-based company.

“I am thrilled to join the Accuray team and have been impressed with the organization’s passion and commitment to creating a better future for cancer patients through technology innovation and advancing radiation therapy care. I look forward to leading the company’s efforts to drive patient access, gain market share and create long-term value for all stakeholders,” Chalke said in a news release.

Chalke has more than 25 years of medical device expertise in commercialization, business development and operations for a number of medtech segments, including interventional catheterization systems, dia…

10-year data shows sustained pain relief with Accuray’s CyberKnife system

CyberKnife S7 system (Image from Accuray)

Accuray (NSDQ:ARAY) announced today that long-term follow-up data demonstrated pain relief after image-guided robotic radiosurgery treatments with its CyberKnife system.

The data from a study of men and women with trigeminal neuralgia (TN) showed that 72% continued to experience pain relief 10 years after receiving the treatments delivered with the CyberKnife system.

“Robotic Image-Guided Radiosurgery for Trigeminal Neuralgia: Results after 10 Years,” the study abstract, was recognized as “Best Clinical Abstract” at the recent 2022 Radiosurgical Society Meeting in Carlsbad, California, according to a news release.

Sunnyvale, California-based Accuray designed the CyberKnife system to treat diseases in the head and base of the skull, as well as functional disorders, with radiosurgery, but without the use of a fixed frame bolted to the patient’s head.

The company said the system features a l…

Accuray dips despite Q2 revenue beat, raised guidance

Accuray (NSDQ:ARAY) shares dipped this morning despite second-quarter results that beat the consensus sales forecast.

The Sunnyvale, California-based radiation oncology company posted profits of $179,000, breaking even at $0.00 on earnings per share, on sales of $116.3 million for the three months ended Dec. 31, 2021, for a major bottom-line slide from profits of $4.8 million this time last year despite sales growth of 19.3%.

Accuray’s earnings per share of $0.00 equaled expectations on Wall Street, where analysts were looking for sales of $103.3 million.

“Accuray’s fiscal 2022 second-quarter performance continues to reflect the strong customer demand and revenue momentum our business is generating, but also highlighted global supply chain challenges and operational headwinds created by the Covid environment,” Accuray CEO Joshua Levine said in a news release. “Driving our accelerated revenue growth is the continued adoption …

Accuray posts Street-beating Q1

Accuray (NSDQ:ARAY) shares were slightly down after hours today on first-quarter results that beat the consensus forecast.

The Sunnyvale, Calif.-based radiation oncology company posted losses of $1 million, or 1¢ per share, on sales of $107.4 million for the three months ended Sept. 30, 2021, seeing its bottom line slide into the red despite sales growth of 25.9%.

Accuray’s losses per share of 1¢ came in 5¢ ahead of Wall Street, where analysts were looking for sales of $93.9 million.

“By any measure, our Q1 performance was a very strong start to our FY22 fiscal year. Q1 revenue of $107.4 million represents the largest first fiscal quarter revenue that Accuray has ever recorded,” Accuray CEO Joshua Levine said in a news release. “Our performance reflects the visible impact of the investments in innovation we have made to our product portfolio, how those new technologies are being received by customers across the world and a laser-l…

Accuray beats The Street in Q4

Accuray (NSDQ:ARAY) shares dipped this morning despite fourth-quarter results that beat the consensus forecast.

The Sunnyvale, Calif.-based radiation oncology company posted losses of -$11.1 million, or -12¢ per share, on sales of $110.9 million for the three months ended June 30, 2021, for a massive bottom-line slide from losses of $152,000 this time last year despite sales growth of 16.8%.

Adjusted to exclude one-time items, earnings per share were -1¢, 1¢ ahead of Wall Street, where analysts were looking for sales of $102.1 million.

“Despite the challenging environment caused by the COVID-19 pandemic, we finished fiscal year 2021 on a strong note with 17% year-over-year revenue growth and 19% year-over-year gross order growth in the fourth quarter, both of which were ahead of our expectations,” Accuray CEO Josh Levine said in a news release. “I am proud of the team’s execution during the quarter and for the entire year, conside…

Accuray promotes exec Suzanne Winter to president

Accuray (NSDQ:ARAY) announced that it promoted executive Suzanne Winter to president, effective as of July 1, 2021.

Winter, who previously served as Sunnyvale, Calif.-based Accuray’s chief commercial officer and SVP of R&D & medical & scientific affairs, will continue to report to CEO Joshua Levine.

“Suzanne has had a significant impact on Accuray’s product portfolio and commercial momentum since joining the company. She is a leader who has a proven track record of building performance-oriented commercial organizations. We believe that her strategic leadership of Accuray’s commercial and R&D teams has successfully positioned the company for accelerated revenue growth,” Levine said in a news release. “In her expanded role, Suzanne will focus on the day-to-day business operations of the company, which will allow me to focus on growing Accuray’s external strategic collaborations and business development opportunities.

“I lo…

Accuray names chief medical, technology officer

Accuray (NSDQ:ARAY) today said it has appointed Jean-Philippe Pignol as its chief medical and technology officer, effective April 15.

Pignol will lead the company’s scientific and clinical research activities, develop strategic collaborations, evaluate new technologies and serve as the representative with important industry partners.

“We’re thrilled to welcome Dr. Pignol, whose rich and unique experience base within the global radiation therapy community will help the Accuray team to achieve its vision of ‘expanding the curative power of radiation therapy.’ He joins the company at an important time in its growth and is a key addition to our executive leadership team,” president and CEO Joshua Levine said in a news release.

Pignol has more than 26 years of experience in academia and clinical practice. He has served as the professor and department head of radiation oncology at Dalhousie University in Halifax, Canada.

…

Accuray beats The Street in Q2 earnings

Accuray (NSDQ:ARAY) yesterday posted second-quarter results that beat the consensus forecast on Wall Street.

The Sunnyvale, Calif.-based company reported profits of $4.8 million, or 5¢ per share, on sales of $97.5 million for the three months ended Dec. 31, 2020, for a bottom-line slide of -55.5% sales loss of -1.4% compared with Q2 2020.

Earnings per share were 5¢, 9¢ ahead of The Street, where analysts were looking for sales of $92.4 million.

“Our second-quarter performance continues to reflect the positive momentum our business is making despite the headwinds created by the COVID-19 environment,” president and CEO Josh Levine said in a news release. “Highlights from our second quarter performance include the beginning of system revenue conversion related to the Type A radiotherapy licenses in China as well as receiving 510(k) FDA clearance of our ClearRT Helical kVCT Imaging platform for the Radixact System. We are pleased with the continued res…

Accuray dips on mixed bag Q4

Accuray (NSDQ:ARAY) shares took a hit today on fourth-quarter results that were mixed compared to the consensus forecast.

The Sunnyvale, Calif.-based radiotherapy device maker posted losses of -$823,000, or -1¢ per share, on sales of $94.98 million for the three months ended June 30, 2020, for a 41.2% bottom-line gain on a sales decline of -19.1%.

Accuray’s adjusted EPS of -1¢ came in 1¢ ahead of Wall Street projections, while its revenues missed the analysts’ projections by 4%.

“Despite the circumstances and the uncertainties associated with the COVID-19 pandemic, we finished fiscal 2020 with a solid performance and grew our gross orders by 10 percent year over year,” Accuray president & CEO Josh Levine said in a news release. “I am proud of the team’s execution during the quarter, especially given the challenging operating environment created by the pandemic. … We believe that our operational focus, joint venture strategy in…