Executive Summary
Highlights
· Breakthrough cancer radiotherapeutic real-time precision device addressing a significant market need – the Aurora RT™
· Leading management and scientific team with deep relationships in the radiotherapy and medical physics space and hospital experience
· De-risked with a proof-of-concept prototype in 2008 and 2nd full working prototype in 2014 utilizing ~M of non-dilutive Canadian research grants
· Responding to RFPs for research units and addressing customer interest globally
· Raising first round of M to complete the commercial version, regulatory approval and first sale
· 2016 TEC VenturePrize DynaLIFE DX Health Award winner
The Need
Approximately half of all cancer patients need radiation as part of their treatment regimen. Unfortunately, current radiation treatment devices (“Linacs”) cannot visualize tumors during the treatment set-up procedure; using X-rays they only image “bony landmarks” that are located in the vicinity of the tumor. Therefore, approximations are made in localizing the tumor for each daily treatment. In order to ensure that the tumor is always in the treatment field, the field is enlarged to account for day-to-day motion of the tumor and for movements that may occur during the treatment itself. This enlargement of the field results in the irradiation of a significant amount of normal tissue which can cause serious negative side-effects and can limit the permissible dose to non-curative levels. Such limits can substantially decrease the probability of a cure.
Most tumors are “soft tissue” types and are readily visible with Magnetic Resonance (“MR”) imagers. MR imagers are, therefore, used for highly accurate treatment planning prior to treatments, but to facilitate MR imaging for treatment set-up and during the treatments a combination Linac and MR imager (a “Linac-MR”) would be required. Because of inherent technical incompatibilities, it was long thought that such devices could not be built.
Our company, however, has accomplished the task with two working prototypes at the Cross Cancer Institute and the University of Alberta. A head-sized unit was built in 2008; a body-sized unit was completed in 2013 with first images taken in 2014. These were the first Linac-MR units in the world. Over 43 peer-reviewed scientific papers have been published on them and their associated technology. Several patent families have been issued; others are pending.
The Opportunity
Worldwide approximately one person out of three will get cancer. To treat them there are over 13,000 Linacs currently in use. Typically, they are replaced after 10-12 years of use with a replacement cost of US-4 million. This amounts to about US-4 billion per year for replacement units only with the market growing approximately 5% per year for new units. MagnetTx forecasts sales of US billion in 2019.
Competition
The advantages of MagnetTx’s Aurora RT over competitive prototype products include: accuracy, cost, safety, and efficiency.
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ACCURACY
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Optimized Magnetic Field strength & orientation
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ACCURACY
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Effectively treat peripheral tumours (e.g. breast)
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ACCURACY
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No radioactive sources used
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COST/SAFETY
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No cryogen/liquid-helium required
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COST/EFFICIENCY
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Ease of installation and maintenance
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Business Model
Sources of revenue include sales of Aurora RT units, software upgrades, maintenance contracts, consulting and training contracts, and licensing of our technology for other products (e.g. proton therapy). Our design facilitates the delivery of major components to customer sites directly from our suppliers where they will be assembled with no need for an assembly plant.
Regulatory submissions are in process for US, Canada and Europe leveraging predicate device approvals. Clinical trials are not required for regulatory submission for the Aurora RT.
Milestones
Major milestones recently met include:
√ Company incorporation and spin-off, including licensing agreement for worldwide exclusive rights
√ 2 working prototypes completed (proof of principle and full scale model)
√ Response to customers and requests for proposals for research units (to be converted to clinical units upon regulatory approval)
Major milestones for the next two years:
√ Supplier agreements for both the MR and Linac (in progress, expected 2017)
√ Regulatory submissions for 510(k), CE Mark and Health Canada approval (in progress with USA, Europe and Canada respectively, expected 2017)
√ Commercial version launch (in progress, expected 2017)
√ First patient treated in Canada (expected 2017)
Current Financing Round
We are seeking M in our current round of financing. We anticipate the following in 2017:
√ Completion of the commercial version
√ Regulatory Approval
√ First commercial sale
Industry: Electromedical and Electrotherapeutic Apparatus Mfg (NAICS: 334510)
Vertical: Radiotherapy treatment device with real-time imaging
Intellectual Property: 8 patent families, several granted
Product: The Aurora-RT™
Use of Proceeds
· Completion of commercial version (2017)
· Regulatory approvals (2017)
· Product first sale (2017)