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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - LUMAX (Innovative Laser and Fiber System for Non-Toxic, Efficient and Cost-Effective Treatment of Cancer)

Teaser

Summary

Problem to be addressed: Business Idea & Medical Need
Lab-on-Fiber GmbH (LoF) aims to develop and bring into market innovative medical products in the areas of minimally invasive laser surgery and oncology. The main products of LoF are single-use laser probes in combination with a sophisticated laser system capable to measure in-situ temperature and/or pressure in the surgical zone in real time. Special emphasis is given to temperature critical tumor treatment in prostate cancer. Patented LoF technology provides first fiber probe and laser system with intrinsic and purely optical sensor, providing 100% safe surgeries with no side-effects at disposal of interventional oncologists. Our price competitive technology will advance laser surgeries to become widely accepted while it will also open new technology applications. LoF brings solution to two critical problems of laser surgery: 1) control over changing physical parameters like temperature in the tumor during surgery enabling safe apoptosis 2) tailored and personalized laser radiation for desired thermal volume for the apoptosis. With our new product we aim to solve these problems which market is eagerly waiting for. The companyâ€™s customers are surgical device manufacturers (lasers and medical devices in a B2B structure as OEM partners). Basically, all cytotoxic drugs (chemotherapy) and radiation therapy lead to apoptosis, the programmed cell death of tumor cells. These techniques on the other hand have well documented side effects due to their chemical or radioactive toxicity, like losing hair, teeth, damaged quality of life, effecting lives of more than 14M cancer patients and their families worldwide. They also increase a personâ€™s risk of developing different types of cancer later in life as well. Possible mutations in apoptotic pathways may result in resistance to drugs and radiation leaving the treatment ineffective. This leads to additional inpatient hospitalization burden to clinics, outpatient (drug) treatments and increased financial burden for the patients and insurers. If one uses modern laser and fiber optic systems, then apoptosis can be generated in a localized, non-toxic manner, at almost any location in the human body via hyperthermia. However, current laser-fiber systems lacking temperature control leading a random treatment efficacy.

Importance for society: Clinical Advantages & Medical Indications
The optimized radiation profile and the possibility of actively determining the temperature and/or pressure at the probe surface, dose of emission and the degree of charring can, above all, (1) significantly increase patient safety, (2) shorten operating times, (3) increase treatment success and avoid repetitive application and (4) open up new fields of application for laser surgery which were not possible before. LoF focuses on a first clinical indication in tumor treatment of prostate cancer with focal therapy. The technology applied and developed can be also extended to other tumor treatment like e.g. thyroid, lung, liver, etc. and further fields, e.g. glaucoma treatment, endovenous laser ablation (EVLA), aesthetic surgery (lipolysis), general surgery.

Overall objectives of LUMAX
LUMAX project serves as a proof-of-concept study in a cell model (PC3 prostate cancer cells) where, based on the use of a LUMAX laser system and laser probe, the functional dependency and interaction of laser intensity and wavelength, irradiation time and temperature increase versus cell lifetime is investigated.

Work performed

Work performed and main results achieved
At the beginning of the project, first actively sensing fiber probes were assembled. Simultaneously, a feedback loop laser system, consisting of a 50W diode laser emitting at 980 nm, an interrogator and a control unit for the communication between laser and interrogator, have been built and programmed. The overall system has been tested at the Fraunhofer Institute for Cell Therapy and Immunology IZI on human PC3 cancer cells. The prototype has been successfully verified.

Final results

Progress beyond the state of the art, expected results until the end of the project and potential impacts
To our knowledge, as of today, no actively sensing fiber probes, with the ability to sense physical parameters like temperature and/or pressure directly in the irradiation zone, do exist. Thus, we made the first demonstration of such a feedback loop system and we experimentally have demonstrated the dependency between temperature-controlled laser irradiation on PC3-cells and sudden cell death due to laser irradiation. These results were performed on thin cell layers. In a next step, animal studies will be performed in order to proof the concept on living organs. This will pave the way to a subsequent clinical study and a final release of our products.