Lourenco said on the call today that the tariffs are in place for 5 years before they come up for review.
The TomoTherapy System is the only radiation system specifically designed for image-guided intensity-modulated radiation therapy (IMRT). Leveraging a CT scanner-based platform, TomoHelicalTM mode enables continuous delivery from 360 degrees around the patient with highly conformal and homogeneous dose to the tumor. A clinician can also choose to deliver treatment from specific fixed angles via TomoDirectTM mode. These unique features, combined with daily 3D image guidance, enable physicians to efficiently deliver highly accurate, individualized dose distributions which precisely conform to the shape of the patient's tumor while minimizing dose to normal, healthy tissue for a variety of cancer types, including breast cancer. This is especially important for women diagnosed with cancer in the left breast, where the tumor may be close to critical organs such as the heart.
The study titled, "Once Daily Accelerated Partial Breast Irradiation: Preliminary Results with Helical TomoTherapy," provides results for 111 patients treated with APBI following lumpectomy. It also demonstrated that:
- Delivering the dose once a day over 10 days (others studies use 10 fractions twice-daily) could be a contributing factor to better cosmetic outcomes and lower toxicity. This is made possible because of the integrated image guidance of the TomoTherapy System and its excellent dose homogeneity;
- Patient compliance was remarkable as all patients completed the treatment without interruption;
- Treatments were very well tolerated with minimal acute or late side effects.
- "The TomoTherapy System is proving itself to be an excellent breast radiotherapy device. In fact, some sites have purchased the system to use solely for breast radiotherapy," said Fabienne Hirigoyenberry-Lanson, PhD, vice president medical affairs, at Accuray. "Studies such as the one undertaken by Dr. de Paula and his colleagues reinforce the benefits which the TomoTherapy System can provide and highlight why customers worldwide rely on the system as their mainstream radiation treatment device."
SUNNYVALE, Calif., July 21, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today preliminary results from a prospective, phase II trial evaluating once-daily accelerated partial breast irradiation (APBI) in patients treated with the TomoTherapy® System. The study, published in the June issue of the peer-reviewed AntiCancer Research, International Journal of Cancer Research and Treatment, reported no recurrence of cancer in the treated breast at median follow-up of 34 months. Additionally, more than 95 percent of patients and their physicians rated cosmesis -- preservation of the normal appearance of the breast -- as good/excellent.
"The phase II trial results are very encouraging for a carefully selected patient population, and should be considered by all radiation oncologists when evaluating APBI treatments for their low-risk patients," said Prof. Ugo De Paula, Department of Radiation Oncology, San Giovanni-Addolorata Hospital, Rome-Italy. "In our experience we found there was extremely good patient compliance with their APBI treatment regimen because of a very short, 10-day schedule and well-tolerated treatments. We believe that using daily image guidance, which is unique to the TomoTherapy System, is essential for the precise identification of the tumor
bed and reproducibility of treatment."
User Satisfaction Ratings Exceed Industry Average for 11 Consecutive Quarters
SUNNYVALE, Calif., July 14, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that its CyberKnife® and TomoTherapy® Systems continue to set the standard for overall user satisfaction. The Accuray systems received the highest composite overall user satisfaction rating among radiation treatment delivery systems in the U.S., according to the Q2 2016 MD Buyline Market Intelligence BriefingTM. The most recent ratings trend also shows Accuray has achieved the highest ratings among industry peers over the past three years.
In rating the Accuray systems, MD Buyline reports the company obtained the highest scores in a majority of categories measured including system performance, system reliability, service response time and service repair quality. CyberKnife System users also "highly recommend" the InCiseTM Multileaf Collimator (MLC) noting "it makes the treatment time much more efficient." CyberKnife and TomoTherapy System users continued to "praise the high level of reliability afforded by Accuray systems."
"The independent MD Buyline report is further evidence we are succeeding with our strategy to drive innovative cancer care with a clear focus on customer satisfaction," said Joshua H. Levine, president and CEO of Accuray. "The feedback continues to validate the TomoTherapy System's functionality as a workhorse radiation oncology device while also highlighting the expanded efficiency of our next generation CyberKnife System equipped with an MLC. Our strong overall user satisfaction ratings are a major factor behind our growth in the marketplace."
Of all the boards I look at this has been the most informative. Because of you surf, liske, ironstrong and others I have held onto and increased my shares to 60,000 and I intend to hold and till shaeres get to at least $20 / share and maybe longer if dividends return. Thanks you all for your honest and well informed posts.
randell, I have been watching this company Nanabiotix for a year or so. The symbol is FR:NANO. It has traded for the past year mostly between 16-18 with a 52 week high of 20 and a low of approx.12.5. I have not figured out how to buy the stock. I think it only trades on the French Stock Market. There is a article about it in MedicalPhysicsweb the link is: http://medicalphysicswebDOTorg/cws/article/research/65392
Replace DOT with period. The technology is interesting. I first came across it when Drug Discovery News, DDNEWS, devoted an issue to Nano Medicine. This is the onr company that caught my attention.
FDA Clearance continued ..............
“The Radixact System gives the radiation therapy team expanded capabilities across the widest range of patient cases, from the routine to the most complex, with precision, speed and efficient workflows,” said Joshua H. Levine, president and chief executive officer of Accuray.
According to Jennifer Smilowitz, PhD, clinical associate professor University of Wisconsin School of Medicine and Public Health, who was involved in the development of the new radiation therapy technology, “The Radixact System builds upon the unique strengths of the TomoTherapy platform. Expanded delivery capabilities enable treatment with image-guided, intensity-modulated radiation therapy (IG-IMRT, an extremely accurate form of radiation therapy) to an expanded range of patients. New database features make the ring gantry-based system even easier to operate and integrate within a radiation oncology department.”
Accuray will initiate commercial release of the Radixact System late in the first quarter of fiscal year 2017 (July – September 2016).
Accuray Receives 510(k) FDA Clearance for the RadixactTM Image-Guided Radiation Therapy Platform and Integrated Software
Next Generation "Smart" System Enables Clinicians to Provide Highly Precise Treatment, Efficiently, for More Patients, Every Day
SUNNYVALE, Calif., June 27, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RadixactTM Treatment Delivery Platform. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray PrecisionTM Treatment Planning System and iDMSTM Data Management System. These next generation hardware and software solutions which, together, make up the new Radixact system, enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment. The new Radixact system represents a major step forward in the evolution of the TomoTherapy® System in treatment speed and ease of use.
Radixact(TM) Treatment Delivery System
The system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery, so clinicians can apply highly conformal and homogenous dose distributions to any target volume, while precisely sparing normal healthy tissue during each treatment fraction. The new Accuray Precision Treatment Planning System with smart, automated workflows and midcourse decision-making tools, enables clinicians to adapt delivery to changes in tumor size, shape and location within the patient.
In the long term what is good for Liberty is good for Markets. Centralized control does not work. Especially if those in control, the regulators, have no skin in the game. Our founders fought a war, "against taxation without representation", for what the what the Brits only had to vote for. Good luck to them and and their new found freedom.
Continued ..... FUCAM Treats 1,000 Breast Cancer Patients with the TomoTherapy® System
"We are proud of the incredible work FUCAM is pioneering in Mexico and their dedication to improving the care of women with breast cancer. Their treatment milestone was achieved in a very short amount of time, demonstrating the immense need for effective breast cancer treatment in Mexico," said Joshua H. Levine, president and chief executive officer of Accuray. "The TomoTherapy System provides versatility and efficiency in the treatment of breast cancer, enabling clinicians such as Dra Huerta and her team to provide an optimal treatment for more patients."
FUCAM is a civil partnership with a mission to provide diagnosis and treatment for breast cancer, particularly in the most vulnerable socioeconomic groups, and to promote education about early detection of breast cancer. It´s the first non-profit institution established in Mexico and in Latin America with services, equipment, and highly specialized personnel fully-trained on the treatment of diseases of the breast.
FUCAM developed one of the most important campaigns in Mexico to educate women on the importance of a screening mammography in the early detection of breast cancer. For more information on FUCAM visit www.fucam.org.mx/
System Dedicated Solely to Breast Cancer Care Provides Excellent Clinical Outcomes
SUNNYVALE, Calif., June 21, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the Fundación de Cancer de Mama in México City (FUCAM) has treated 1,000 breast cancer patients with the TomoTherapy® System. The milestone was achieved less than 18 months after the center installed the technology, underscoring its value as a mainstream treatment option to maximize tumor control with low toxicities for the full range of breast cancer cases, from routine to complex.
"FUCAM is a large and busy center focused on providing the best possible care to women with breast cancer. We require a radiation therapy system which can keep pace with the demands of our clinic and enable us to deliver precise radiation to any tumor in the shortest amount of time possible," said Dra Judith Huerta Bahena, head of radiotherapy, Institute of Diseases of the Breast, FUCAM. "The TomoTherapy System helps us do just that with its TomoHelicalTM and TomoDirectTM treatment modes. The System provides the flexibility we need to precisely conform the radiation dose to the shape of the tumor and significantly decrease dose to nearby healthy organs and tissues."
The TomoTherapy System is the only radiation system specifically designed for image-guided intensity-modulated radiation therapy (IG-IMRT). Leveraging a CT scanner-based platform, TomoHelicalTM mode enables continuous delivery from 360 degrees around the patient with highly conformal and homogeneous dose to the tumor. A clinician can also choose to deliver treatment from specific fixed angles via TomoDirectTM mode. The system's unique architecture helps ensure the highest levels of precision, while minimizing dose to organs at risk. This is especially important for women diagnosed with cancer in the left breast, where the tumor may be close to critical organs such as the heart.
United Kingdom's NHS Supply Chain to Acquire Seven TomoTherapy® Systems
Largest Ever Accuray Deal Will Provide More Cancer Patients in the United Kingdom (UK) Access to Advanced, Precise Radiation Treatments
Because getting RXI recognized in the June 2016 issue of Drug Discovery News, a widely distributed publication, is new news.
MR guidance could also enable radiation treatment of non-oncologic diseases such as atrial fibrillation, currently treated via an invasive, expensive procedure. By using MRI to image the beating heart and define the small, moving target volumes, it's possible to noninvasively treat one of the most common conditions. And if physicians start to use radiation for this application, more radiotherapy departments will be needed.
Finally, Keall described the use of online MRI guidance to enable physiological targeting during radiotherapy, which no other technology can achieve. "Cancer physiology is heterogeneous and changes with time," he said, citing tumour hypoxia, which can change during a single treatment. "The ability to selectively image and target the most resistant parts of cancer could dramatically change cancer outcomes."
Are we already good enough?
Retaking the stage, Lohr addressed some of Keall's arguments. Yes, MR guidance is obvious, he agreed, but only if you've got the money. With MR-guided systems costing three times that of other radiotherapy devices, the question is "how much good can we achieve with more imaging". Lohr also noted that many professionals still do not concur that daily online imaging is useful.
Direct imaging of the tumour is already possible, said Lohr, if you treat in a static breath-hold situation, which can be created today. He noted that using MRI to enable radiation treatments of atrial fibrillation is indeed promising and merits evaluation.
As for functional imaging, Lohr again questioned whether currently available field strengths are sufficient and wondered which processes change within minutes and thus necessitate online imaging. Functional information could instead be gathered offline, he suggested, and integrated into treatment plans. "We shouldn't feel too bad, because we're already pretty good at what we're doing," he concluded.
Keall emphasized that patient motion is complex, with translations, rotations, deformations and changes in physical properties to account for. "Our patients are dynamic, our anatomy is dynamic and our physiology is dynamic," he said. And it's not just target motion that needs tracking. If a tumour is located next to the heart, for example, MRI can visualize the beating heart to reduce treatment toxicity. And while ultrasound imaging may be cheaper, image quality is far superior with MRI and of particular benefit in sites such as the kidney and liver.
Looking at the introduction of other advanced radiotherapy technologies, a show-of-hands revealed that almost all of the audience now perform stereotactic body radiotherapy, whereas 10 years ago only about 20% were using this approach. Likewise, almost everyone now employs some form of image guidance, while less than 10% were doing this 10 years previous. "I think that what we're doing with MRI is the same," said Keall.
He listed the many companies and institutions now building MR-guided radiotherapy devices. This includes ViewRay, with 20 confirmed sales to date and Elekta, which plans to ship 79 units by 2019 – a combined market of $1bn. Last year, the University of Alberta group founded Magnet-Tx to commercialize its Aurora RT, while both Siemens and the Australian MR-linac programme demonstrated prototypes.
MR-guided radiotherapy systems
Other reasons for implementing online MR guidance include the ability to exploit existing MRI expertise, the lack of imaging dose and the ability to image actual anatomy as opposed to surrogates.