In the realm of medical technology, Montreal-based startup Polytone Laser has emerged as a pioneer, spearheading a revolutionary approach to the treatment of solid tumors and other complex diseases. Founded by siblings
Karin, Luis, and Jesús Santana Rodríguez, in collaboration with their accomplished parents, Dr. Luis Santana Blank and Dr. Elizabeth Rodríguez de Santana, Polytone Laser Inc. is charting an innovative course in medicine.
The inception of Polytone Laser finds its roots in a moment of inspiration during a demonstration in Italy. Dr. Luis Santana Blank, a distinguished figure in medical research, witnessed a high-power CO2 laser vaporizing a droplet of water on an apple without causing harm to the fruit. This observation ignited a groundbreaking idea – the potential of infrared lasers, operating at lower energy levels, to safely modulate cell functions.
Motivated by this revelation, the co-founders conducted pre-clinical and clinical studies in collaboration with researchers at international universities, including Central University of Venezuela, the Venezuelan Institute for Scientific Research (IVIC), the Abdus Salam International Centre for Theoretical Physics in Italy, and Institut Pasteur Paris, France. The culmination of their efforts resulted in a phase I clinical trial utilizing a proof-of-concept device in patients with advanced solid tumors. Published in Clinical Cancer Research, the trial not only demonstrated the treatment's clinical safety but also showcased improvements in patients' quality of life. In addition, there was objective evidence of selective anti-tumor effects documented via magnetic resonance imaging (MRI), biopsies, and immune monitoring.
This pivotal study and the encouraging innovation environment of the Canadian province of Québec, where the team of co-founders resettled, prompted the establishment of Polytone Laser Inc., which is focusing on the development of KROONZ™, a patent-pending laser device. This advanced technology, while pushing the boundaries of innovation, maintains safety characteristics documented in the published trial.
Glioblastoma multiforme (GBM), the most common and aggressive primary malignant brain tumor in adults, is the first target application for KROONZ™. With approximately 250,000 new cases worldwide annually, addressing this formidable foe is imperative. KROONZ™ employs a systemic, multi-hallmark monotherapy approach, addressing metabolic energy pathways blocked by cancer to induce selective anti-tumor effects.
The laser system is applied painlessly and non-invasively to the skin, capturing radiant energy and transporting it to distant target tissues. The unique characteristics of KROONZ™ allow it to selectively absorb energy in tumors, activating programmed cell death while sparing healthy tissues. This innovative approach marks a transformative stride in the treatment of challenging cancers like GBM.
Applications in various other complex diseases
Beyond GBM, KROONZ™ exhibits promising applications in various complex diseases. These include other solid tumors and neurodegenerative diseases of the eye and brain. Preliminary data in a patient with advanced dry age-related macular degeneration (AMD) showcased positive functional and structural changes in the retina. Unlike other devices being tested for dry AMD, KROONZ™ may be safely applied systemically and at a distance, avoiding direct exposure and adverse effects.
The differentiators of KROONZ™ reinforce its position as a trailblazer. It is intended to be a standalone therapy for GBM that may be combined with surgery but does not require chemo or radiotherapy. Non-invasiveness, portability, and shorter sessions also set KROONZ™ apart from competitors. Its design allows penetration of the blood-brain barrier without breaking it, reaching all brain regions. In ophthalmology, external supplementation using KROONZ™ aims to reach the retina and other ocular structures, avoiding cumulative adverse effects. In neurology, external supplementation targets cerebral structures without invasive applications.
Polytone Laser acknowledges the importance of capital and strategic partnerships. As part of CTA-Taipei HealthTech, the company actively seeks collaborations with MedTech investors, manufacturers, research centers, and Contract Research Organizations (CROs). This multifaceted approach aligns with the company's mission to advance its technology, underscoring the pivotal role of diverse partnerships in navigating the intricacies of the medical technology landscape.
According to President Jesús Santana Rodríguez, the company opened its first funding round earlier this year, which was very successful. "We raised the money needed for our pre-seed stage in January. This allowed us to submit additional patents, including in Taiwan, a crucial market. We developed our regulatory roadmap, including approaching the FDA in the US, with a pre-submission meeting scheduled for the very near future."
He also outlined the company's growth strategy: "We believe that the goal of treating 1000 GBM patients by 2028 is conservative, representing less than 7% of the North American market." According to him, the focus is to start clinical studies for GBM in 2025. First-in-human data from GBM patients may further allow Polytone Laser to expand into other verticals.
Polytone Laser's journey is a commitment to reshaping the treatment of GBM and other complex diseases through familial dedication, scientific innovation, and strategic partnerships. As the company navigates the intricate paths of medical technology, it stands on the cusp of transformative advancements in the fight against cancer.