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FLOWER MOUND, Texas March 14, 2014 – Texas-based BioTech startup ProTom International has received FDA 510(k) Clearance for its Radiance 330 Proton Therapy System. This clearance, officially making Radiance 330 commercially available, was instrumental in ProTom being awarded two new system orders — one at Massachusetts General Hospital (MGH), Boston and another at Atlantic Health System, New Jersey.

Proton therapy, originally conceptualized and developed in the 1950s and 1960s at Lawrence Berkeley Laboratory and the Harvard Cyclotron Laboratory/MGH, is a technologically advanced method of treating solid tumors. Research has shown that by using a precise and direct dose of proton radiation, side effects and morbidity are decreased in many cancer patients compared with side-effects of standard radiation therapy.

ProTom International’s Chief Executive Officer and co-founder Steve Spotts observes that, “The receipt of 510(k) clearance is the final culmination of a thorough and rigorous FDA review of the safety and effectiveness of the Radiance 330. This achievement accelerates our team’s single and relentless mission to place this highly sophisticated and targeted cancer-fighting tool within reach of many more physicians. Our team couldn’t be more proud of reaching this milestone and will continue our work to advance the delivery of proton therapy while driving down the cost of this much needed technology.”

ProTom advocates proton therapy as a powerful weapon in the battle against cancer, and particularly so when tumors are located close to vital organs or critical structures, or for tumors diagnosed in children. The technology’s ability to deliver focused, conformal, scanned proton beams that destroy tumors with exceptionally high degrees of accuracy, while sparing surrounding healthy tissue and organs, makes proton therapy both a life-saving and quality-of-life enhancing weapon for physicians and patients in their care.

Mr. Spotts observes that Proton therapy is absolutely a better therapeutic choice for many tumor sites, such as brain tumors, and that there is consensus among radiation oncologists that protons are best for solid tumors that are near critical structures, such as brain tumors, spinal cord tumors and tumors near the heart. He explains that while traditional x-ray therapy is effective at killing solid tumor cells, it damages surrounding healthy tissue, both on the entrance dose and the exit dose, because traditional x-ray therapy goes through the patient and into the shielded treatment room. The unavoidable consequence is peripheral damage to healthy tissue.

However, proton therapy is different, he explains, in that you have the effect of the “Bragg Peak,” making it possible to deposit the energy at the distal edge of the tumor, so there is no exit dose. He says the Radiance 330 Proton Therapy System is the first of its kind, using pencil beam scanning exclusively, analogous to a laser beam allowing operating clinicians to “paint the tumor” much more precisely — left to right, up and down — and in three dimensions, thus sparing healthy adjacent tissue.

Until now, proton therapy has not been available for community based providers that treat over 85% of cancer patients due to the enormous cost and complexity of financing, building, and operating proton therapy centers. The only other option is a single-room system, recently made available by a couple of manufacturers, but limited in capabilities and impractical when two or more rooms are required. However, with the compact, modular, adaptable, customizable, and less costly Radiance 330, ProTom say they have succeeded in tearing down some of these barriers.

Mr. Spotts notes that the first hospital-based proton therapy project at Loma Linda, California began in the 1980s, and that Massachusetts General Hospital, a teaching hospital for Harvard Medical School, brought the technology mainstream in the mid 1990s, but there were only those two facilities for several years. Then, MD Anderson Cancer Center in Houston built a facility, and the University of Florida followed — both centers opening in 2006. However, he says these facilities, in today’s dollars, cost between two hundred and two hundred fifty-million dollars. Consequently, an average community based provider — such as Texas Health Resources, simply could not cost-justify a proton therapy system because they were just too expensive and too large.

Mr. Spotts says he likes to use a comparison of the Apple MacBook Air he uses these days with the huge old IBM mainframe computers of the 1970s and 1980s. He observes that when sitting at his desk with the diminutive MacBook Air connected to ProTom’s corporate server, he has more computing power and speed at his fingertips than would have required a couple of floors of IBM mainframe computers from the 1970s. That, he says is a good illustrative analogy of what ProTom International has done with the Radiance 330; i.e.: advanced the technology, made it much smaller, much lighter and much less expensive.

Design Modularity and Scalability

The Radiance 330’s efficient design allows health care providers to develop or phase-in single-or multiple-room proton capability; the system can be embedded in an existing radiation oncology department or added-on to a facility, sharing staff and other resources. The Radiance 330 supports both isocentric gantries and fixed-beam rooms with one or more ports, and the system can be arranged and installed in a variety of configurations to fit the constraints and limitations of the available space. Its unique proton delivery design supports both horizontal and vertical beam lines to accommodate a multi-level layout.

ProTom designed their proprietary proton therapy technology in ways that they say can significantly lower the capital and operating costs of proton centers and accelerate the adoption of this clinically advanced cancer treatment modality. Developing proton therapy technology is the company’s sole focus. ProTom’s medical device operations are headquartered in the USA — from which all of their manufacturing, development, service and proton therapy projects are currently managed and operated.

The Radiance 330 proton beam delivery system’s modular design easily accommodates the client institution’s preferences for 3-D imaging solutions and treatment planning software through industry-standard interfaces. ProTom says the patented and proven design of the compact synchrotron allows for accelerator interior vault space of approximately 20’ x 30’ and requires up to 40% less radiation shielding than most other systems on the market today. The lighter-weight, compact technology simplifies the installation process; and the largest component of any system configuration (fixed beam, 180 degree gantry, etc.) requires no special road transport, facility hatch, or extraordinary cranes and can be moved in through typical freight or staff entrances. The Radiance 330 can be configured using its single, energy-efficient synchrotron to operate a single- or multiple-treatment room facility; treatment rooms can be equipped with isocentric gantries or as fixed-beam lines with one or more ports.

The “330” in the product’s name signifies that the system can accelerate protons up to 330 MeV for proton imaging use; the range 70 MeV – 250 MeV is considered the therapeutic range. As noted, ProTom has made the technology more compact, and the system operates more efficiently than previous generations of technology. The way the Radiance 330 changes energies with the synchrotron does not generate neutrons, and only negligible amounts of gamma rays, so (up to 40%) less radiation shielding is needed in the facility compared with the existing proton centers.  The ProTom system has (up to 55%) greater power efficiency than early, cyclotron-based systems and even the larger synchrotron-based systems, saving $4M-$5M in electricity costs over a 25-30 year expected useful life of the machine. Moreover, the system’s smaller scale makes it possible to add proton therapy as an extension to an existing cancer treatment program/center, saving on the cost of land and avoiding the expense of duplicating facilities, ancillary equipment, and personnel.

The Radiance 330 enables the physician to exploit the dose control advantages of protons for complex cases, while simultaneously reducing the complexity of treatment planning and treatment delivery logistics for dosimetrists, physicists, and radiation therapists. It is equipped with ProTom’s Fidelity Beam Scanning System, which accurately “paints” a tumor with the prescribed dose using beam energy variations to control penetration depth and magnetic steering to guide lateral dose deposition. The beam depth (or range) is changed in less than 1.2 seconds, with sub-millimeter accuracy.

These synchrotron-driven scanning techniques introduce faster treatment planning capabilities, allowing patients to start their therapy sooner and experience highly efficient daily treatment procedures. ProTom explains that since protons produce less entrance dose and stop after exhibiting the Bragg Peak phenomena, daily fractions require fewer beam directions than conventional radiation treatments; furthermore, in most cases spot scanning beams do not require custom shielding aperture devices per patient and per beam direction as do scattered beams. This time and cost saving beam delivery technique is a doorway to the future of adaptive radiation therapy, a technique of “adjusting” the planned beam as needed, depending on the change in the tumor or a patient’s anatomy from day to day.

According to ProTom, the Radiance 330 with its clinical treatment energy range of 70-250 MeV and capacity of 330 MeV, is the only proton beam system with the accelerating capability required for the future of imaging the patient with the beam itself. This proton imaging capability is on the technological horizon, and is believed to hold promise for enabling future image-guidance and adaptive proton therapy techniques. Proton Radiography (PR) may be used for pre-treatment set-up, beam delivery, and range verification. Radiance 330’s unique PR capability has the potential to obviate the need for in-room X-ray imaging equipment, making real-time image-guided radiotherapy schemes possible utilizing the same beam line for both imaging and treatment. This technology will also open up new capabilities in such areas as adaptive treatment planning, precise respiratory gating compensation (including motion control and beam gating), and decision support.

User-friendly, Patient-focused

The Radiance 330’s intuitive design harnesses advanced technology with a more user-friendly interface. Experienced users of a variety of proton therapy systems were consulted during design of the control system, and ProTom used those empirical data to integrate workflow guidance into the control system, enabling radiation therapists to spend less time interacting with the equipment and more time focusing on the patient.

The unit’s ProTom-designed screens feature uncluttered, organized display panels, with integrated touch-screen technology employed inside and outside the treatment room. Outside the treatment room, the Treatment Delivery Control System screen provides the radiation therapist with a single-screen view of all required patient information including plan information, treatment fields, room coordinates, digitally reconstructed radiographs, beam status, and a “beam-on” dose monitor. Inside the treatment room the control touchscreen provides a unique workflow-driven view.

Choice of Volumetric Imaging

The Radiance 330 is equipped with orthogonal imaging and an image registration system, and leaves the choice of a volumetric imaging solution with the healthcare provider. The Radiance 330 system is designed to readily interface with any number of in-room imaging solutions such as CT or CBCT and is fully DICOM compliant. The modular design of the software control architecture lets the provider choose from among best-in-class technology solutions not only for imaging but for treatment planning and oncology information systems as well.

ProTom International, founded in 2008 at Flower Mound, a Dallas suburb, is a USA and Texas success story. Despite the economic meltdown from 2008 to 2010 when banks were closed and the investor community was in a shambles, ProTom not only survived, but persevered and still achieved FDA clearance and has subsequently signed a new contract with one of the most prestigious hospitals in the world – Massachusetts General Hospital (MGH) in Boston.

ProTom received no government bailouts. The company just developed a better treatment technology for cancer patients, and while the company name is one of the newest to proton therapy, its personnel are not, with a senior leadership team that has over 150 years of combined experience in healthcare, and more than 75 years of combined experience in proton therapy, while CEO Stephen Spotts is a self-described “serial entrepreneur.”

Currently two proton therapy centers are being built in the Dallas metro area — one with 5 treatment rooms for $225M, and another with 3 treatment rooms for $105M. As forenoted, most proton therapy centers in the world built by commercial manufacturers have ranged in cost from $150M to $220M. ProTom’s alpha project cost a total of $65M and is equipped with 3 gantry treatment rooms.

At MGH, the entire Radiance 330 system will be installed inside a radiation-shielded vault embedded within the existing radiation oncology department — a solution that enables the facility to share clinical staff, ancillary equipment, and patient support areas. The Radiance 330 synchrotron can be installed within an interior accelerator vault space of 20′ x 30′ and requires up to 40% less radiation shielding than many other systems on the market today.

With an eye toward the future for this early-stage Texas-based medical device company, Mr. Spotts says: “We are seeing explosive growth in this field in the international markets — particularly in the Pacific Rim and in Europe – and we have a lot of interest in our product. We are poised now, with FDA approval, to really go after the domestic and international markets. We have plans to get CE Mark in Europe, and have a number of potential international clients. To facilitate this, we are beginning the process of raising growth equity.”

This article was written by Charles Moore and was originally published in BIONEWS Texas.