About

Founded in 2014, RTsafe has introduced Personalized Care to Radiation Oncology. It designs and manufactures the first FDA-cleared, patient-specific, anatomically-exact models of human head and brain tissue. These are offered to Radiotherapy clinics for simulating radiation therapy for each patient ahead of actual treatment in a totally risk-free environment, thus maximizing cancer patient safety and treatment effectiveness.
This solution is also sold to RT equipment manufacturers for machine-testing purposes. The company already generates revenues and has signed a commercial agreement with a leading radiation therapy company, Elekta A.B. As a winner of an R&D 100 Award, RTsafe’s PseudoPatient® is recognized as one of the 100 most significant high-tech products worldwide for 2019.
Vision: Helping to create a world where every radiotherapy intervention is tested on a personalized phantom before the real patient, thus enhancing safety and effectiveness of treatment.

Solution & Product

RTsafe has developed, patented, and commercialized a world-first technology that allows the production of an accurate model of the human head and brain (phantom) for each patient. The final product perfectly mimics the individual head and brain tissue in terms of external and internal anatomy and bone and soft tissue interaction with radiation. This enables the RT team to irradiate an exact replica of the patient in advance of the actual treatment, establishing radiological and geometrical accuracy of the delivery and identifying any errors in advance. This provides greater confidence in the individual treatment, but also the ability to improve the overall treatment protocols. Our technology harnesses the latest developments in CT-scanning, 3D-printing, and gel radiation dosimetry (the science of determining appropriate radiation doses). The result is the first ever patient-specific QA process in RT for truly personalized brain tumor treatments. We call our unique product PseudoPatient®. It is perfectly suited to high-dose, high-accuracy brain treatment techniques, such as Stereotactic Radiosurgery (SRS), increasingly being used to treat brain metastases.

Innovation & Scalability

The core of the solution lies in the combination of three recent technological advances: (i) medical imaging technology (CT and MRI), (ii) the emerging 3D printing technology and (iii) point, 2D and, most importantly, 3D radiation dose detection using polymer gels. The key idea is to produce a patient’s anatomical replica (PseudoPatient®), install radiation detectors, treat PseudoPatient® as if it was the real patient, verify dose delivery or highlight errors detected, allow for corrections, and then treat the actual patient. This approach constitutes a simulation of patient’s treatment, and verifies not only the dose distribution calculated by the treatment-planning system, but also serves as an end-to-end test for the entire treatment protocol implemented. Through this method, the following steps of the treatment chain are reproduced: (a) patient imaging, (b) patient immobilization (e.g., stereotactic frame or thermoplastic mask), (c) image guidance and patient positioning, and (d) radiation dose delivery.
Manufacturing hardware consists of easy-to-install 3D printers and standard laboratory equipment, the cost of which is not significant. Thus, scalability is achievable via the multiplication of production sites in sites that will support demand accordingly.

Traction & achievements

RTsafe has achieved significant commercial traction, and its products and services are already being sold across all our target customer segments (2019 revenue: €0.5M). Noteworthy examples are:
•tCommercial distribution agreement for Machine QA with Elekta A.B. – Secured revenues for 3 years to end of 2022
•tExclusivity agreements with independent distributors:
otReached in Italy, Spain, Turkey, Cyprus, SE Asia.
otPending currently in 7 EU countries, Saudi Arabia, Israel & China
otUSA: RTsafe has established its subsidiary company at San Antonio Texas since 2017.
•tStrategic partner hospitals – Some of the world’s leading cancer treatment hospitals:
otUSA: UT Health San Antonio MD Anderson; UK: The Royal Marsden / GenesisCare (and worldwide), Germany: University of Freiburg.
•tSelected end users:
otMAYO clinic, UCLA, OhioHealth, Thomas Jefferson University Hospital.
For a detailed list of our end users, please visit our website at https://rt-safe.com/clients/

Team & Why Us

Our team consists of 21 members combining profund business acumen and high technological know-how based in strong scientific background. This team is capable of executing RTsafe's robust business plan.
The global Personalized PseudoPatient® market is worth €6.0b (2018: 4M brain-lesions patients x €1.5K, cost of a PseudoPatient®). In particular, SRS treatments (which RTsafe services are essential for), will grow by 150% in next 10 years making this a great opportunity. RTsafe projects annual revenues of > €60M with gross margin of > 70% by 2025. This is an entirely new market sector with no direct competitors.
Initial growth is projected from commercial expansion in developed markets that have high SRS utilization, particularly the USA and EU5. We will leverage our existing commercial footprint and distributor network to expand further into the top Comprehensive Cancer Centers (CCCs) and Academic Medical Centers (AMCs) in the USA and the EU5, with the aim of acquiring a 10% share in both regions through recurrent paying customers by Yr3 post-financing. These early notoriously adopters are closely monitored by other countries before accepting new technologies into their healthcare systems. Once established in the USA and EU5, we will continue expanding into new territories, and aim to have made significant commercial in-roads in such regions as the UAE, Japan and China by end of Yr3 post financing.

Funding Needs

RTsafe is raising €3 million of growth capital in its second funding round, to drive commercial growth in targeted works and further expand its product portfolio. This financing is projected to propel the Company to €63 million in revenues and €24 million in EBITDA within five years, and fully fund the Company to a strategic exit. Management seeks to partner with investors who will bring value beyond capital.
The company aims to meet very specific commercial and technical milestones in the timeframe that is relevant to the investment sought to be used as metrics for the company’s progress.