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Ron Mayron has a rich experience in the pharmaceutical and medical equipment industry, having served for over 20 years in several key positions and senior management positions in the field of pharmaceuticals in the local and global market, his former positions as the CEO of Teva Israel and Vice President of Israel and Africa at Teva. In recent years, he has served as director and chairman of several private and public companies in the fields of life sciences.

His vast and long experience in management, marketing, mergers and acquisitions, business development and strategic development will greatly contribute to achieving Amendiss goals.

Ron Mayron: “I am happy for the opportunity to lead Amendis towards a promising and innovative product that will dramatically improve the quality of life of many head and neck cancer patients. Cancer is one of the main causes of mortality in the West and developments that allow for the better treatment and higher chances of recovery are extremely important.”

Amendis addresses a significant unmet market need – to dramatically reduce the number of unnecessary surgeries to detect metastasis in head and neck cancer patients.

Its unique kit investigates the RNA extracted from the tumor sample and evaluates a variety of relevant genes that have been carefully selected following many years of research. The development of metastasis can be predicted based on the behavior of these genes. Using the test results as a clinical aid, the oncologists will be able to make more informed decisions as to whether or not it is necessary to operate in order to determine metastasis. The test is fast, accurate and safe.

According to the company’s assessment, routine use of Amendis’s technology will improve the diagnostic process and prevent a significant portion of unnecessary neck surgeries performed on tongue cancer patients.

The company’s development will have a direct positive effect on the quality of life of many patients and will ease the burden on the health system due to saving on surgeries, some of which are performed unnecessarily today due to the lack of other solutions for detecting metastasis.

Dr. Gil Pogozelich, director of the company: “We ate excited to welcome Ron Mayron as the Chairman of Amendis. His familiarity with the world of health, the processes involved in this type of development and his experience with the international market are necessary to advance the company’s goals and bring exposure to the medical and business world.”

As part of the clinical study, which was conducted at the Hadassah University Hospital-Ein Kerem under Helsinki approval, cancerous tissues from the tongue of head and neck cancer patients were examined. 

Amendis’s proprietary AI based technology was used to predict the spread of the cancer to the neck, as opposed to the current standard procedure entailing a surgery protocol which is based on the depth of penetration of the tumor into the tongue.

 

Head and neck cancer is the sixth most common cancer, and one of its most common types is that of the tongue; patients face a long road of arduous treatments accompanied by severe side effects and have a 5-year survival rate of between 40 to 50 percent. As in most cancers, early detection can lead to more effective treatment and save lives. Treatment of a tongue malignancy involves dealing with both the initial tumor in the oral cavity and with the spread or potential spread of the cancer to the neck (metastasis). The risk of metastasis currently dictates neck surgery to detect whether the cancer has spread to the lymph nodes.

However, in most cases, no metastasis is found, and, in effect, the surgery was unnecessary.

Neck surgery may result in complications effecting the patients’ ability to speak, breath and swallow. Beyond the significance of the surgery for the patient, there is considerable significance for healthcare systems, due to the inherent high costs of hospitalization, surgery, rehabilitation, nursing, and the treatment of related complications. Overall, performing neck surgery places a heavy burden on the patient and the health system, so determining its necessity is paramount.

 

In practice, about 70% of these surgeries turn out to have been unnecessary!

 

Dr. Nir Hirshorn, Amendis’s Medical Director, meets such cases daily, by virtue of his position as a senior surgeon in the Division of Ear, Nose & Throat, Head & Neck Surgery at Hadassah Ein Kerem. He is also the chairman of the Israeli Society of Head and Neck Surgery and Oncology. Together with Dr. Yoav Smith, the company’s CTO who was previously the head of the Genomic Data Analysis Department in the Faculty of Medicine at the Hebrew University of Jerusalem, they have developed the technology that will prevent unnecessary surgery on patients by predicting whether the cancer will metastasize.

 

Amendis’s unique technology predicts the development of metastasis by analyzing the RNA of preselected genes taken from the patient’s tumor sample. The test results provide the oncologists with an invaluable clinical aid that enables them to make more informed decisions as to whether it is necessary to operate in order to determine metastasis. The test is fast, accurate and safe.

In the clinical study involving tongue cancer patients, the test’s gene recognition system predicted whether metastasis in the neck would occur, and these results were compared to the results of the surgery carried out on the patients.  The results showed a high correlation between the predictions and the actual clinical conditions of the patients. According to these results, the test successfully predicted the development of metastasis, and showed that 30% of the surgeries could have been prevented.

According to the company’s assessment, future routine use of Amendis’s technology will improve the diagnostic process and prevent a significant portion of unnecessary neck surgeries.

Amendis, whose primary objective is to minimize unnecessary surgery on neck cancer patients, has announced that it is initiating a limited validation study of its predictive diagnostic test based on actual cases.

At present, following a diagnosis of throat cancer, a surgeon is compelled to perform an elective neck dissection when the thickness of the tumor is greater than 3mm, in order to try and prevent metastasis. Such dissections are inherently complicated and often result in permanent damage to the patient that affect his/her quality of life.

However, 70% of these surgeries turn out to be unnecessary, as the tumor remains local. Unfortunately, there is no accurate way of predicting in which cases dissection is nonessential.

The innovative patented technology developed by Amendis is designed to minimize the number of unnecessary surgeries currently being performed.  Amendis provides a scientifically proven genomic diagnostic test that uses AI machine learning to predict if the disease will become metastatic. The test is based on the tissue obtained from the patient’s biopsy.

The first validation study will be held at the Hadassah Medical Center in Jerusalem, and is scheduled for July 2020.

The study signals the start of the implementation of this breakthrough solution in personalized medicine for head and neck cancer patients. The technology will significantly improve patients’ quality of life, reducing unnecessary surgeries by 40%.

Upon completion of the limited study the company will conduct extended clinical trials at three separate medical centers. This is expected to take place in early 2021.

The technology is the result of research carried out by Dr. Yoav Smith, and the solution was developed in cooperation together with Dr. Nirsh Hirshhorn. Dr. Smith serves as Amendis’s CTO, and until recently he was the Head of the Genomic Data Analysis Unit at the Hebrew University of Jerusalem; Dr. Hishhorn serves as Amendis’s Medical Director, and is a Senior Oncological Surgeon at the Ear Nose and Throat and Head and Neck Surgery Department at the Hadassah Medical Center Jerusalem.

Dr. Yoav Smith stated: “Performing the validation study on human tissue will demonstrate the system’s capabilities of accurate early diagnosis of throat cancer and will lead to prevention of unnecessary surgeries. The application of Amendis’s tests by oncologists as a decision aid prior to deciding upon surgery will make a revolutionary change in improving the personalized medicine for head and neck cancer patients.”

 

 

 

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