Innovation through simplification

2023 was another pivotal year for Leo Cancer Care, such as: the growing global recognition of the value of its systems in clinical settings; new contracts and partnerships; investor backing; and world-leading centres acknowledging that the future is upright.

Our Marie™ upright patient positioning system combined with a CT scanner has already been orded by centers across the United States and Europe in anticipation of regulatory clearance for patient use in delivering Proton Beam Therapy.

And it is now being applied at the cutting edge of radiation therapy in the fields of FLASH radiotherapy systems, and boron neutron capture therapy (BNCT) and soon in carbon ion therapy as a vehicle to take cancer care to a new level.

In this article, we will delve into why these newly formed and existing partnerships express the need to rethink innovation. Instead of making technology bigger, more complex and therefore more expensive to perfect cancer treatments. We believe we are entering into an era where we turn our attention to simplifying in order to innovate. With the patient, economic, spatial, and capacity benefits, upright radiotherapy is now more than ever proving to be the more “human way” to deliver modern cancer care.

BNCT treatment

Leo Cancer Care has entered a strategic partnership with Aviko Radiopharmaceuticals – a Deerfield Management-founded biotechnology company developing medicines to unlock the potential of BNCT – and Neutron Therapeutics, a provider of accelerator-based neutron systems for targeted radiation therapy of solid tumours.

The goal of the partnership is to expand BNCT as a treatment for different types of cancer with Leo’s upright patient positioning system integrated into Neutron’s nuBeam® therapy platform, which is a compact, in-hospital neutron source designed to replace legacy nuclear reactors for BNCT.

Dave Greenwald, Chief Executive Officer of Aviko and Vice President of Business Development at Deerfield, said: “The incorporation of Leo’s upright patient positioning system with Neutron Therapeutics’ nuBeam® neutron accelerator has the potential to increase the versatility and impact of BNCT for patients, physicians, treatment centres and the overall healthcare system.”

BNCT involves a non-toxic boron medicine that is designed to accumulate in cancer cells and remains inert until it is irradiated by safe, low-energy neutrons at the site of the tumour, releasing alpha particles that destroy cancerous cells.

Emerging modalities

Dr Nancy Y. Lee, MD, FASTRO, Radiation Oncologist focusing on head and neck cancer and working closely with Early Drug Development Service at the Memorial Sloan Kettering (MSK) Cancer Center in New York, said:

“BNCT will have a role in treating certain cancers, the key is delivering the boron safely and efficiently.”

“The data from Japan for head and neck cancer is very exciting and I can see BNCT becoming another tool to help personalise treatment for our patients. The introduction of upright patient positioning to these emerging modalities, such as BNCT, allows us to imagine a future where patients have the choice to remain sitting or lying down.

“More complex isn’t always better, and simplicity is always best in the clinic. Complexity can help us achieve the desired outcome but we need to consider how we combine this into a simple model that is user friendly for the patient.”

“Upright positioning provides a platform to execute complex treatment delivery and an opportunity for us to make the treatments efficient, simple and user-friendly for all.”

Nimble and cost-effective

Positioning the patient in relation to the neutron beam is important for both the safety and efficacy of BNCT. Currently, there are 21 BNCT clinics worldwide, primarily in Asia and Europe.

It is this versatility within Leo Cancer Care’s system that enables it to play a pivotal role at the cutting edge of cancer care.

Nimble, agile, flexible, cost-effective, groundbreaking, cutting-edge, and innovative – these are all buzz words, often over used in the medical technology sector.

To that, add perhaps the less grand terms of compact, space-saving and economically viable. But for Leo Cancer Care and its growing global customer base, there is a real resonance to these terms. Rather than adjectives randomly sprinkled throughout text, they ring true in the new era of cancer care and radiation therapy.

Critical partnerships
These critical partnerships are core to the advancement of the upright positioning system which allows human organs to remain in a more natural state during radiotherapy.

Evidence from the Centre Léon Bérard Hospital in Lyon, France, has shown that upright positioning offers matched, and in some cases, better reproducibility of setup and accuracy during treatment in the pelvic areas, and improved patient comfort. (S.Boisbouvier et al 2022)*

The upright positioning system overcomes space limitations by removing the need for a rotating gantry and keeps the radiation beam fixed with the patient slowly rotated through it. The value of precise patient positioning cannot be underestimated.

Immobilisation devices are paramount in reducing patient motion during treatment, underlining the importance of our long-standing partnership with CQ Medical and a new collaboration with Klarity Medical, both of which are global suppliers of head supports, vacuum bags, backrests, and masks.

FLASH radiotherapy

In a further development, Leo Cancer Care and THERYQ, a medical device company specialising in the design and manufacture of FLASH radiotherapy systems, has collaborated to create an integrated solution to revolutionise the treatment of deep-seated tumours.

An advanced form of radiation therapy that delivers high doses of radiation in a fraction of a second, FLASH has shown promise in targeting cancer cells more effectively while minimising side effects.

The alliance will help address the critical challenge of precise patient positioning in the treatment of deep-seated tumours, with Leo Cancer Care technology integrated into the first unit installed at CHUV, the university hospital centre in Lausanne, Switzerland.

Transformative stride forward

Professor Jean Bourhis, Chair of Radiation Oncology at CHUV, where the first upright FLASH deep product will be housed, said:

Professor Jean Bourhis, Chair of Radiation Oncology at CHUV

“In the pursuit of improving cancer treatment, the convergence of upright positioning with FLASH Radiotherapy is a transformative stride forward.

“FLASH Radiotherapy has the unique benefit of hitting the tumor in milliseconds with lower toxicity on healthy tissues. Leo Cancer Care’s upright positioning with an integrated vertical CT Scanner is innovative, highly precise, and comfortable for the patient.

“It’s a perfect alliance to deliver a tailored treatment to the patients. Leo Cancer Care and THERYQ’s partnership is a blend of innovation and care, sculpting a future where cancer patients receive the most advanced radiotherapy at the fore front of innovation in the field.”

Overcoming limitations

Several centres have identified Marie™ as a cost-effective solution for Proton Beam Therapy, which is precisely targeted with less beam exposure to healthy tissue around tumours compared to photon therapy.

Carbon ion radiation therapy shares similarities to protons, enabling treatment to precisely target the tumour, while the surrounding healthy tissue receives very little dose.

Carbon ion systems, which take radiotherapy to a new level, are available at two sites in Europe and a limited number in Japan, with none at present in the United States. **

With most carbon ion therapy treatments being delivered with a fixed beam, the current supine couch restricts the number of beam angles and therefore cancers that can be treated. Upright Radiotherapy holds promise for this relatively untapped treatment option, making it a viable option for more centres and therefore more patients who need it.

Repurposing fixed beam rooms

Despite the technological advances, there has been a somewhat unwanted by-product for hospitals which have invested in proton therapy, in finding they have under-utilised fixed beam treatment rooms, often suited only to research or to treating prostate cancers. We are confident our system can overcome these limitations.

We are now partnering with healthcare providers to re-purpose this space and replace outdated and oversized equipment with nimbler, more agile, systems that occupy a smaller footprint and are more cost-effective to purchase, install and maintain.

Current Proton Beam Therapy sees gantries rotate around the patient and stop on three or four occasions to deliver the beam but with less precision, whereas with PAT (Proton Arc Therapy), the proton beams are delivered continuously as the gantry rotates in one steady sweep.

However, delivering submillimetre accuracy to a tumour using a gantry with a weight of several tonnes, presents a huge engineering feat.

The opportunity for true advancement here lies in upright imaging and positioning technologies and the transition from machine rotation to patient rotation, simply put, it is rotating the lighter object.

Disease sites

David Raubach, Chief Development Officer from the Oklahoma Proton Center, has seen the evolution of proton technology in fixed beam rooms over the past 15 years.

Yet having acquired the proton centre in Oklahoma City after forming Allied Health Management, capacity challenges remain. He sees the smaller, cost-attractive, Leo Cancer Care system as a step forward as it allows the treatment of almost all disease sites in the fixed beam room.

It would really change the way we think about our centre and the number of patients we can treat. It makes so much commercial and clinical sense to repurpose these rooms, said Raubach.

Democratising technology

These collaborations all build on our earlier established partnerships. They include Mevion Medical Systems, which will combine their smallest-in-the-world self-shielded proton accelerator, with Leo Cancer Care’s Marie™ system to deliver the first full proton therapy system that can fit into an existing LINAC (linear accelerator) vault, named the S250-FIT.

Stanford University Medical Center in Palo Alto, California, will be among the first to benefit as it seeks to address space challenges.

“Leo Cancer Care’s upright patient positioning system complements Mevion’s core technologies very well. They share our vision of democratising proton therapy”
— Tina Yu, CEO and President of Mevion Medical Systems

Cost-benefit analysis

McLaren Proton Therapy Centre in Flint, Michigan. Where a traditional single gantry room has been split into two upright rooms, awaiting the Leo Cancer Care technology in 2024.

Elsewhere, UW Health at the University of Wisconsin continues work on a new medical centre in Madison to deliver proton therapy using the upright treatment technology, while, McLaren Health Care is installing two upright Marie™ units at its existing Proton Therapy Center in Flint, with both fitting into an area previously earmarked for a single conventional rotating gantry.

Both centres have poured concrete and significantly smaller treatment room shells await the technology that will make history. Wherever such systems are installed, the value is clear.

One cost-benefit analysis of the upright technology, conducted by Unity Insights in conjunction with Kent Surrey Sussex Academic Health Science Network (KSS AHSN), suggested the Marie™ upright PBT solution could have significant financial and cost advantages for the NHS in the future.

Regulatory clearance

With the regulatory decision for Leo Cancer Care’s patient positioning system now pending***, 510(k) clearance will pave the way for upright technology to be used in patient care in centres across the United States.

The 510(k) process, which enables medical device manufacturers to obtain permission from the Food and Drug Administration (FDA) to market its product, is a highly significant milestone and an important step forward in our drive to see “cancer therapy delivered to patients in a more human way.”

The patient positioning system is the critical component of the broader solution and the element that holds the most potential, particularly from a patient treatment delivery perspective.

With increasing confidence in Leo Cancer Care and upright, an application in a diversity of delivery methods, and a growing global footprint, 2024 is set to see innovation through simplification. Shifting to a new level in the way cancer care is offered to patients.

*To read the full paper – ‘Upright patient position for pelvic radiotherapy treatment’ – published by tipsRo (Technical Innovations and Patient Support in Radiation Oncology) click here

**Please note: The Leo Cancer Care technology is not commercially available and will not treat patients until the required regulatory clearance has been achieved.

***Leo Cancer Care is in the process of acquiring regulatory status for its upright delivery system in Europe.

****Dr. Lee has financial interests related to Leo Cancer Care.