BLADDER CANCER

EPIDEMIOLOGY

BLADDER CANCER: A PUBLIC HEALTH ISSUE

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people are diagnosed or treated for bladder cancer worldwide

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most common cancer among men in France

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most common cancer among women in France

25% of diagnosed cancers are muscle-invasive

50% of muscle-invasive cancers recur

75% of non-muscle invasive cancers recur

17% of non-muscle invasive cancers become invasive

NUMBER OF NEW BLADDER CANCERS PER GEOGRAPHICAL AREA EACH YEAR

RISK FACTORS

Bladder cancer is associated with a wide array of risk factors, that increase the likelihood of developing the pathology.

At the moment, no non-invasive method is sufficiently efficient to detect early bladder cancers and serve as a screening tool.

SMOKING

Tobacco is the first risk factor and accounts for over 50 % of new cases.

OCCUPATIONAL EXPOSURE

Occupational exposure to two groups of carcinogenic chemical substances (aromatic amines and polycyclic aromatic hydrocarbons) is the second risk factor and accounts for 5 to 25% of bladder cancers. Hence, the chemical, rubber, metal and textile industries are areas at risk.

ENVIRONMENTAL FACTORS

Environmental factors, such as air and water pollution are also risk factors.

DIAGNOSTIC

HOW IS BLADDER CANCER DIAGNOSED?

SYMPTOMS

Hematuria, blood in the urine, is the main clinical symptom suggestive of bladder cancer. Bladder irritation symptoms can also be observed and lead to an increased frequency of urination and repeated urinary infections.

When these symptoms are observed, the urologist may prescribe a series of tests in order to make a diagnosis: ultrasound of the urinary apparatus, urinary cytology and a bladder endoscopy.

ULTRASOUND OF THE URINARY APPARATUS

The ultrasound is an imaging examination allowing the exploration of the urinary excretory tract in order to detect potential bladder abnormalities, especially large polyps (>5 mm). Is it carried out by a radiologist or directly by a urologist.

URINARY CYTOLOGY

Urinary cytology, as well as the bladder endoscopy, is the reference examination for the detection and monitoring of non-muscle invasive bladder tumors. The pathologist observes the morphological changes of the urothelial cells present in urine and thus detects tumor cells.

BLADDER ENDOSCOPY

Bladder endoscopy is carried out either as part of a diagnosis process or as part of the monitoring of bladder lesions. The observation of the bladder wall allows the urologist to validate or not the presence of polyps, by means of an endoscope equipped with a camera inserted through the urethra. During this examination, the urologist may conduct a biopsy of the suspicious lesions.

HISTOLOGICAL ANALYSIS

Following a polyp biopsy, the pathologist analyses the tissues collected under the microscope to confirm the bladder cancer diagnosis. It is the reference examination which allows the pathologist to determine the grade (level of aggressiveness) and the stage (level of infiltration: muscle-invasive tumor or not) of the cancer.

TREATMENT

OF BLADDER CANCER

The results of the histological examination allows the urologist to choose the treatment best adapted to the patient according to the risks of recurrence and progression of his cancer.

For non-muscle invasive tumors, the treatment is based on a complete resection of the lesions, supplemented by intravesical instillations of chemotherapy (Mytomicin C) or immunotherapy (BCG) to reduce recurrences.

For muscle-invasive tumors, the treatment relies on a combination of radiotherapy, chemotherapy and removal of the bladder.

New treatment perspectives are emerging with antibody-based immunotherapy (anti-PD1 and anti-PDL1) capable of targeting the mechanisms by which cancer cells escape the immune system.

MEDICAL

Immunotherapy :
- Bacille de Calmette et Guérin — BCG
- Antibodies Anti-PD1 and anti-PDL1
Chemotherapy :
- Mitomycin C, MVAC, Gemicitabine and cisplatin
Radio-chemotherapy

SURGICAL

Transurethral bladder resection (TURB)
Removal of the bladder (Cystectomy)

MEDICAL NEED

MEDICAL ISSUES

The 5-year survival and recurrence rate are correlated with the grade and the stage of the cancer.

The survival rate is of 95% for early cancers (low grades) and of 65% for advanced cancers (high grades).

The recurrence rate varies from 55% for low-grade bladder tumors to 70% for high-grade tumors requiring patient monitoring based on:

Urinary cytology
(poor performance for early cancers, with a sensitivity ranging from 10 to 40%)
Bladder endoscopy
(more effective but invasive and which can induce side effects)

It is therefore essential to detect bladder cancers early in order to optimize patient care as part of an initial diagnosis or monitoring, while reducing the costs associated with care.

5-year survival rate (%) according to the stage upon detection

EXPRESSED MEDICAL NEED

To meet the demands of the practitioners, VitaDX is developing a new diagnostic aid tool that is:

NON-INVASIVE
MORE EFFICIENT THAN URINARY CYTOLOGY FOR THE DETECTION OF LOW GRADES
REPRODUCIBLE AND RELIABLE
SIMPLE TO IMPLEMENT

EARLY DIAGNOSIS BY FLUORESCENCE

The analysis is based on a specific and proprietary method of preparation, staining and observation of urothelial cells coupled with an image processing algorithm of urinary cytology slides, scanned in white light and in fluorescence.

The method consists in observing the localization of the fluorescence of the cells. The presence of peri-membrane localized fluorescence on urothelial cells is correlated with their malignancy, while the presence of a homogenous fluorescence indicates a healthy cell.

The observation in fluorescence allows the detection of cancer cells usually considered as atypical by the pathologist, which he cannot classify as tumorous or healthy.

The future solution will be compatible with the conventional staining techniques used in pathology laboratories, allowing a morphological analysis of the cells in white light and metabolism analysis in fluorescence, in order to detect tumor cells even at an early stage.

MACHINE LEARNING FOR PHYSICIANS

The software analysis of VisioCyt is based on machine learning algorithms and more specifically Deep Learning.

It is a set of mathematical techniques allowing algorithms to solve problems from data without being explicitly programmed.

It allows the prediction of a phenomenon from past observations.

Machine learning is a field in full extension and with great potential, exploited for medical applications since very recently.

Jacques Le Bozec

Chairman of the board

After over 15 years spent in US companies of the medical device industry, Jacques Le Bozec founded and directed Vitalitec.

The company was specialized in the design, development, manufacturing and commercialization of medical devices in cardiac and vascular fields.

Jacques Le Bozec organized the sale of Vitalitec to Peters Surgical in 2014. He has developed an expertise in financial structuring, corporate strategies and investor relations’ management.

Allan Rodriguez

CEO

Allan holds a MBA in International Corporate Management from the University of Laval (Canada) and graduated from ESIEE, an engineering school, with a specialization in biotechnologies.

He has skills in entrepreneurship and was an advisor for innovative startups in the medical field. He co-founded VitaDX and has led the project since 2013.

As the acting CEO, he guides and implements strategic decisions of the company.

Thibaut Troude

CTO

Thibaut is an engineer specialized in Signal and image processing from the Institut d’Optique Graduate School.

At the CNRS, he initiated the first technical developments, with the scientists at the origin of VitaDX. Passionate about data analysis and artificial intelligence, he is in charge of the development of the image processing algorithms of the device.

As CTO, his mission is to allow the transition from a laboratory method to an industrial solution that fits the customer’s needs and manage the scientific partnership.

Sébastien Nivet

Clinical Director

Sebastien graduated from the ESC Rennes. He has more than 15 years’ experience in the commercialization of healthcare products, first on the home care market and then on the medical device market for hospitals and clinics.

Most recently, he was Marketing Director of the vascular division of Terumo. Sebastien is currently in charge of the marketing and clinical departments and is also involved in the development strategy of the company.