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Accuray Incorporated at a Key Inflection Point

14 Jan Accuray Incorporated at a Key Inflection Point

Accuray Inc (NASDAQ: ARAY), a Company developing robotic stereotactic radiosurgery and stereotactic body radiation therapy system, specifically the CyberKnife System, announced the data from a prospective study which demonstrates the efficacy and safety of its stereotactic body radiation therapy (SBRT), administered using the CyberKnife system. The study shows that SBRT offers disease control along with minimal levels of toxicity in men with locally recurrent prostate cancer after previous treatment with radiation therapy. Most importantly 69 percent of the men no longer required androgen deprivation therapy (ADT) treatment within the first five years following CyberKnife prostate SBRT as per a Company statement.

ADT or “Hormone Therapy is a common form of treatment for those suffering from prostate cancer, however it comes with numerous side-effects such as hot flashes, loss of libido, weight gain, bone fractures, loss of muscle mass to name a few. SRBT on the other hand, uses advanced techniques to deliver ultra-hypofractionated radiation therapy, involving the delivery of higher doses of radiation over a smaller number of treatment sessions. The CyberKnife system is the only radiotherapy device that can deliver the high degree of accuracy and precision required for the administration of -hypofractionated radiation therapy. SRBT is capable of maintaining sub-millimetric accuracy as it uses continual imaging and automatic beam delivery corrections, even during the delivery of the treatment, helping minimize radiation exposure to healthy tissue.

Accuray Inc (NASDAQ: ARAY)

Market Cap: $241.17M; Current Share Price: 2.74 USDChart
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Fabienne Hirigoyenberry-Lanson, Ph.D., vice president global medical and scientific affairs, at Accuray, opines

“This study is significant because it highlights a potential new option for extending symptom-free survival in men with locally recurrent prostate cancer previously treated with radiation therapy,” He further adds “The data reinforces the benefits of the CyberKnife® System’s robotic design and motion synchronization capabilities and show why CyberKnife prostate SBRT is becoming the treatment of choice by clinicians who want a high precision, versatile and non-invasive option that provides excellent disease control with minimal side effects.”

The study evaluated 50 patients with biopsy-proven recurrent prostate cancer diagnosed at least two years after initial treatment, out of which 43 patients had previously undergone conventionally fractionated radiation therapy and seven patients had received treatment with different methods. The results demonstrated that at 5 years disease-free survival (DFS) rate was 60 percent, without the need for hospitalization, anaesthesia or recovery times associated with treatments such as salvage brachytherapy and salvage radical prostatectomy. In addition prostate specific antigen (PSA) decreased to 0.16 ng/mL at five years and there were no grade two or higher gastrointestinal (GI) events reported.

Prostate Cancer is the second leading cause of death in men in the U.S, with over 1 in 41 men likely to succumb to the disease. According to an estimate by the American Cancer Society there would be 174,650 new cases of prostate cancer and 31,620 deaths from prostate cancer in 2019.

The current treatment options for the disease, which primarily affects the prostate gland, is removal of the gland surgically (Radical prostatectomy), Brachy Therapy (Implanting Radioactive Seeds into the prostate) and Conformal Radiation therapy in combination with hormonal therapy. In addition Chemotherapy and Androgen Suppression Therapy are used in cases of advanced cases of prostate cancer. The stage and grade of the disease along with the state of the patient with respect to age, existing illnesses and certain genetic factors determine the course of treatment.

A report by Datamonitor Healthcare estimates that the Total prostate cancer drug market will reach $13.5bn in 2024, growing at a CAGR of 8.6% from $6.4bn in 2015. The introduction of novel therapeutics and treatment methodologies, a rise in geriatric population and increased awareness will drive the growth in the market. However prohibitive treatment costs, adverse side-effects that include infertility may act as a deterrent for growth.

The prostate cancer market is a subject of extensive research and development that aim at treating the disease without causing adverse affects.

Artificial Intelligence is making inroads into every segment of the economy including Medicine and Surgery. Intuitive the market leader in Robotic surgery commands $3.3 billion in annual sales, and the numbers are going to increase manifold in the near future. Companies like Alphabet by GOOGLE (NASDAQ: GOOG) and Johnson & Johnson (NYSE: JNJ) making a foray into the industry by acquiring firms with emerging innovations that can reshape the robotic surgery applications and reach.

The industry is witnessing many mergers and acquisitions such as that of Auris by Johnson and Johnson and the $1.6 billion acquisition of Mazor by Medtronic (NYSE: MDT) to name a few, that prove the growth potential that this sector has to offer.

A report by ResearchAndMarkets offers some interesting insights into the market. Most importantly the report estimates that global surgical robotics market will be worth $12.60 billion by 2025, with the instruments and accessories segment clocking growth at the CAGR of 11.4% during 2017-2025.

At present Robotic Surgery is limited to procedures involving minimally invasive technology, but with rapid advancements in technology the scope and reach of these will see an exponential increase by way of adaptation for a variety of procedures. There are a lot of niche areas that still haven’t been covered yet, and the field is wide open for new entrants who can differentiate themselves from the competition.

A report published by Mazor that states that Robot-assisted surgery has shown a five-fold reduction in complications as well as a seven-fold decrease in revision surgeries can act as a strong advocate for the use of this technology.

Accuray develops novel radiotherapy systems that are personalized to suit each patient and delivered with precision resulting in minimal side effects and cost-efficiency. Its Synchrony or Motion synchronization is the only solution available for true motion tracking for moving targets such as breasts and lungs, ensuring precise dosing and minimal peripheral tissue damage. Its product offerings include CyberKnife, Radixact, TomoTherapy and Onrad.

Image Source: Company

CyberKnife Precision Robotic Treatment is a first-in-class robotic radiation therapy system that offers multiple advantages such as real-time tracking, motion synchronization, precision and reduced toxicity. It offers Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT). It comprises of a linear accelerator mounted on a robotic arm that can greatly improve the precision and delivery of radiation beams while its integrated X-Ray imager facilitates real-time tracking.

Image Source: Company

In addition it can target various indications including intracranial, lung liver and prostate and can enhance patient experience and improve cost –effectiveness. As part of its continuous R&D efforts the company has introduced CyberKnife Volvo Optimizer that can be used in conjunction with Volo and MLC to target a disease site in 15 to 30 minutes which translates to reduced treatment planning time by 50% and delivery time by a whopping 90%. The iDMS™ Data Management System acts as a link between all Accuray treatment planning and delivery systems thereby ensuring an integrated database of all relevant patient information.

Its proprietary TomoHelical™ Treatment Delivery that works with its Radixact® and TomoTherapy®Systems, is an image guided, intensity modulated radiation therapy (IG-IMRT) that uses a unique ultra-fast multi-leaf collimator (MLC) to treat breast cancers.

Image Source: Company

The clinical data for CyberKnife for Prostate treatment shows excellent cancer control with minimal side effects as well as improved survival rates when compared with conventional radiation options. RadiXact system enables high precision handling of complex cases with motion synchronization ability.

The company has manufacturing facilities in Madison, Wisconsin, Sunnyvale, California and China. Its operations are spread over seven facilities around the world which support over 850 installed systems in 50+ countries.

Risk Assessment

  • A report by ResearchAndMarkets estimates that global surgical robotics market will be worth $12.60 billion by 2025, with the instruments and accessories segment clocking growth at the CAGR of 11.4% during 2017-2025. Accuray is aiming to garner a major share of the pie, riding on the positive feedback for CyberKnife and other advanced systems.
  • The Company has over 50 China Type A licenses which not only provides it with high visibility but also has the potential to drive an 8 – 12 percent annual revenue growth as per Company estimates. In addition, the Company expects to launch its Chinese Joint Venture Linac in FY22-FY23, which will provide a sustainable 8 – 12 percent annual revenue growth. Accuray is expecting more than 115 million in incremental revenue contribution from China starting FY20.
  • Accuray claims that its CyberKnife system is can dramatically reduce treatment times in the areas of Breast, Lung and Prostate Procedures, which constitute over 60 percent of all medicare claims. The Company’s portfolio is well-poised to support the proposed Alternative Payment Model (APM), by offering a precise and targeted approach minimizing the room for error or peripheral damage and faster recovery times, thereby improving value-based care.
  • 48 percent of the Company’s installed base is over 8 years old, with a typical replacement cycle of 10 years. The old machinery therefore creates opportunity for replacement, which will come to fruition in the next 36 months, accelerating growth as per Company estimates.
  •  Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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