Mevion receives 510(k) clearance for HYPERSCAN pencil beam scanning

LITTLETON, MASS., 3 January 2018 – Mevion Medical Systems has received FDA 510(k) clearance for the MEVION S250i Proton Therapy System®including HYPERSCAN™ pencil beam scanning (PBS) technology. HYPERSCAN PBS introduces novel energy layer switching and automated collimation systems. These advantages enable the S250i™ system to deliver faster, sharper, and more robust PBS proton radiation treatments.

“The S250i system represents the next generation of intensity modulated proton therapy (IMPT) delivered in the most compact proton therapy platform,” said Joseph Jachinowski, CEO of Mevion Medical Systems. “We are proud that the MEVION S250i system now has received both FDA clearance and CE mark. This is a very important milestone in our efforts to make precision proton therapy available to more patients in the fight against cancer.”

Next Generation Intensity Modulated Proton Therapy (IMPT) 

The MEVION S250i™ system is a compact proton therapy system capable of delivering conformal radiation therapy treatments using HYPERSCAN pencil beam scanning technology. The design of HYPERSCAN PBS technology overcomes clinical challenges that were previously faced by first generation PBS systems. Pencil beam scanning systems shape the delivered radiation dose by “painting” tumors spot-by-spot and layer-by-layer with sub-atomic particles. Prior to HYPERSCAN PBS, scanning proton systems struggled with delivery speed. Long delivery times can undermine the high precision of the treatment due to the target tumor shifting under normal organ motion such as breathing.

HYPERSCAN PBS uses a compact beam delivery path reducing delivery times to less than 5 seconds for some fields. This “hyper-fast” treatment delivery reduces treatment errors due to the sensitivity to motion that current PBS technologies face when treating tumors affected by organ motion. In addition, HYPERSCAN PBS utilizes, the Adaptive Aperture™ proton multi-leaf collimator (pMLC)  This technology uses a robotically controlled collimation system, capable of trimming the edges of the beam at every layer of delivery. This capability delivers up to a three times sharper drop off in radiation at the delivery field edge. This improves sparing of healthy tissue and limits unnecessary radiation to sensitive locations.

World’s First HYPERSCAN PBS Installation 

MedStar Georgetown University Hospital in Washington, D.C. will be the first hospital in the world to offer this latest generation of HYPERSCAN PBS once final onsite testing is completed this month.

“We are excited to be not only the first and only proton therapy system in the Washington, D.C. area, but also the first in the world to offer these advanced proton therapy treatment capabilities to our patients and community. Currently, patients who seek proton therapy need to leave the metropolitan D.C. area, which can be a significant burden on families,” said Brian T. Collins, MD, clinical director of MedStar Georgetown Proton Therapy Center. “We will now be delivering advanced proton therapy, fully integrated into our broad set of comprehensive cancer care offerings. This is critical to the patients we serve.”

Built on Leading Compact Proton Therapy Technology 

The MEVION S250i system is based on Mevion’s high efficiency, low financial risk S250™ Series platform. The core technology of the S250 Series is the world’s only gantry mounted superconducting synchrocyclotron. This compact, fully integrated platform has years of successful clinical experience and proven financial viability. While proton therapy has clear dosimetric advantages, the costs of early systems has been a significant barrier to adoption. The MEVION S250i reduces this barrier through lower capital costs, reduced operating costs, and increased treatment throughput. Mevion customers have achieved the fastest per-room patient ramp-up in the history of proton therapy. Demonstrating that compact proton therapy is a viable option for any size cancer center is core to Mevion’s mission of making proton therapy accessible to as many patients as possible.

©

RaySearch receives first order for RayCare oncology infomation system

17 January 2018 – Anderson Regional Cancer Center (ARCC) in Meridian, Mississippi, USA, has placed the first order for RayCare*, a next-generation oncology information system (OIS). RayCare is an innovative system designed to support comprehensive cancer care. It integrates seamlessly with the RayStation treatment planning system, but that’s just the start – RayCare will connect all the oncology disciplines, enabling users to fluidly coordinate tasks and ensure optimal use of resources.

Over subsequent releases, RayCare will evolve into a machine learning OIS with unique capabilities to coordinate oncology tasks, supporting comprehensive cancer care organized around each patient’s needs. Many cancer patients receive a combination of treatment types, driving the need for combined workflows for radiation therapy, chemotherapy and surgery.

ARCC decided to map out a future for their clinical workflows that would support advanced technology and data driven decision making. They determined that the best approach would be to move to a new treatment planning system and a new oncology information system that together would support their linacs and TomoTherapy systems, in order to have a unified platform for planning, treatment and assessment.

Paul King, Chief Medical Physicist, says: “We evaluated all the leading systems and were extremely impressed by the possibilities of RayCare. It delivers on everything we were looking for. Getting all of these pieces integrated together will help us tremendously. RaySearch is an innovator with the leading technology in this area and I have great confidence in their ability to meet our needs into the future. We will keep exploring the cutting-edge of technology in order to secure the best possible care for our patients. RayCare will help us achieve this aim.”

Dr. Scott Anderson, Radiation Oncologist and Medical Director, says: “We find ourselves in the position that we are at a decision point where we can stay static in a satisfactory status quo, or we can move into what will be the standard in the future. We look forward to working with RaySearch Laboratories to shape the future of longitudinal cancer care. Survivorship and tracking patients long term will be the benchmarks of cancer care moving forward. This new system that is being developed will give us better tools to do so.”

Johan Löf, CEO of RaySearch, says: “I am delighted by this first RayCare order and very excited about helping ARCC achieve an efficient, integrated system for the future. RayCare is fundamentally different compared to other OIS systems, and we have invested a great deal of time and effort into creating something that will truly change the way that cancer is treated. Our goal is to advance cancer treatment with high-performance tools that combine treatment planning, workflow and data management, resource optimization, machine learning and follow-up in an effective way.”

©

California Proton Therapy Center re-launches California Protons

SAN DIEGO, CA, December 7, 2017 – California Proton Therapy Center, LLC today announced the official re-launch of California Protons, a cancer treatment center located at 9730 Summers Ridge Road in San Diego. California Protons features an expanded physician group and new management team and ownership, effectively positioning the Center for continued excellent patient care, as well as growth and success. 

All of the treatment rooms at California Protons are equipped with the most advanced proton beam technology, allowing doctors to treat even the most complex and aggressive cancers. The Center uses pencil-beam scanning technology to precisely target tumors while protecting healthy, normal tissue and surrounding organs. Protons can be delivered within an accuracy of less than two millimeters, making this treatment especially effective at combatting cancer in sensitive areas such as the brain, spine, lung, breast and prostate, and is widely regarded as the best option for treating pediatric patients with cancer.

Dr. Andrew L. Chang, the department Chief of Pediatric Cancers at California Protons, is president of the Proton Doctors Professional Corporation (PDPC), the oncologist group providing clinical leadership at the Center. Dr. Carl Rossi, who has treated more than 9,000 prostate cancer patients with proton therapy – more than any other physician in the world—is the Medical Director of the Center. The Center’s physicians have more than 50 years of collective proton therapy experience.

“At California Protons, we are committed to continuing the delivery of outstanding and effective patient care,” says Dr. Carl Rossi. “By expanding our existing affiliations with the University of California, Rady Children’s Hospital in San Diego and other healthcare institutions throughout the state, we will increase patient access to the Center and, among other things, enhance our ability to participate in clinical trials and research.”

“The Center has been recapitalized and the investor group has provided additional financial support to allow the Center to grow,” says James J. Loughlin, Jr., Managing Partner at Loughlin Management Partners + Co., the healthcare turnaround specialists who are working with the physicians and ownership on the transition plan. “The re-launch of the Center as California Protons is an exciting event and we look forward to a highly successful future working with the team of expert proton physicians, nurses, physicists, technologists and dosimetrists at the Center to make this state-of-the-art cancer fighting tool available to all of the residents of San Diego and California.”

About California Protons 

One of only two proton therapy centers in California and 25 nationwide, California Protons combines cutting-edge proton treatment capabilities with a team of radiation oncologists who amass more than 50 years of collective proton therapy experience. The Center leverages revolutionary intensity-modulated pencil-beam scanning technology to release a high dose of cancer-killing radiation that conforms precisely to the unique shape and size of the tumor. This approach effectively targets and treats even the most complex and aggressive cancers, sparing surrounding healthy tissues and organs. 

For more information, please visit www.CaliforniaProtons.com

©

RaySearch releases RayStation 7 with support For RayCare and Mevion HYPERSCAN

8 December 2017 – RayStation® 7*, the latest release of RaySearch’s innovative radiation therapy treatment planning system, adds new functionality and a wide range of improvements. Significant additions include support for HYPERSCAN technology from Mevion Medical Systems, and integration with RayCare*, the next-generation oncology information system shortly to be launched by RaySearch.

The functionality additions in the new release are in line with RaySearch’s ambition to unify treatment planning for as many systems as possible, eliminating the complications and additional steps that arise from using multiple software systems. This release also contains several enhancements to existing functionality that will contribute to improved workflows and planning efficiency.

Proton therapy is an important focus for RaySearch, and RayStation 7 contains some significant new features for the area. A key inclusion is support for Mevion’s HYPERSCAN pencil beam scanning technology. In addition, RayStation now supports uniform scanning for proton therapy systems from Mitsubishi Electric. Other proton therapy improvements include snout rotation for passive proton techniques and MLC collimation for PBS and passive techniques.

Further key refinements to RayStation functionality include the addition of robust constraints in MCO, simulated organ motion for robust optimization and evaluation, multi-atlas-based segmentation and conformal arc planning for photons.

In December this year, RaySearch will launch a groundbreaking new oncology information system, RayCare, which will integrate fully with RayStation. The new RayStation 7 release includes functionality to ensure a seamless experience for users of the combined systems.

Johan Löf, CEO of RaySearch, says: “We are working to support an integrated approach to cancer care. RayCare, which is about to be launched, is a huge leap for us in terms of unifying the main oncology disciplines. By adding support for Mevion’s HYPERSCAN technology and uniform scanning for Mitsubishi machines, we have taken another step towards our goal of harmonizing treatment planning. And we will add support for more systems in the near future.”

* Subject to regulatory clearance in some markets.

©

IBA, Beaumont Hospital to develop next-generation proton therapy delivery

Louvain-la-Neuve, Belgium, 25 September 2017 - IBA (Ion Beam Applications SA), the world's leading provider of proton therapy solutions for the treatment of cancer, is pleased to announce the research agreement with Beaumont's Proton Therapy Center to develop the next generation proton therapy delivery technique called scanned proton arc therapy (SPArc). Proton arc therapy has the possibility to further improve the quality of the treatment by enhancing the dose conformity at the tumor level while reducing the total dose received by the patient. By better shaping the tumor dose it can further reduce dose to critical organs. In addition, arc therapy technique increases the robustness of the treatment plan, and may further improve the adoption of dose escalation and hypo-fractionation. This agreement is the first step in a long-standing partnership started several years ago.

Craig Stevens, M.D., Ph.D., Chairman, Radiation Oncology, Beaumont Health, commented: "Beaumont Hospital has been leading the research in radiotherapy for decades, and we are proud and eager to start working on such an innovative project with IBA. The level of expertise combined will bring proton therapy to the next level. Proton arc therapy has been contemplated for some time, and recent improvements in beam quality and delivery are enabling us to develop this clinically viable product. Proton SPArc therapy should allow us to improve dose conformity at the tumor, while further reducing dose to surrounding healthy tissue without the need for cumbersome and expensive beam shaping systems."

Nicolas Bronchart, Executive Vice President, Research & Development Proton Therapy, added: "IBA is once again pushing the limit of proton therapy and together with Beaumont's Proton Therapy Center we will bring a technology that could offer further benefits for patients. The initial development will take place on our compact IMPT* system, the Proteus®ONE, but IBA's strategy has always been to offer break-through advancements to our entire product line. IBA's proton therapy systems are built on the most versatile platform allowing for future upgrades and making IBA a future proof choice." 

* Intensity Modulated Proton Therapy

©