Periodic Reporting for period 1 - ONCOscanner (ONCOscanner – oncological probe for intra-operative identification of cancerous tissues during surgical treatment for breast cancer)
Reporting period: 2018-05-01 to 2018-10-31
• What is the problem/issue being addressed?
Breast cancer is the most commonly occurring cancer among women and the second most common cancer overall. According to the World Health Organization (WHO) the number of new breast cancer cases in 2018 is estimated at the level of 2,1 m. It means that every 15 seconds someone is diagnosed with breast cancer. Moreover, breast cancer is the 5th most common cause of death from cancer.
Since 2012 worldwide breast cancer incidence increased by more than 23% and mortality by 14%. Bearing that in mind, ONCOscanner deals with both societal and market issue.
The main goal of breast conserving surgery (BCS) is the complete removal of cancer with clear surgical margins while maintaining the natural shape of the breast. However, there is a conict between obtaining an adequate excision margin around the tumor and not removing too much tissue, which may result in breast deformity. Currently, about 20-30% of patients require reoperation after a BCS, what contributes to: decreased patient satisfaction, increased health care costs and poorer cosmetic results. ONCOscanner will decrease this percentage, as it enables the surgeon to better recognise which sections of tissue still need to be removed.
• Why is it important for society?
Basing on the information from WHO that the number of new cases of breast cancer is at the level of 2,1 m in 2018, and assuming that the average percentage of breast conserving surgery will constitute about 60%, we received 1,26 m of patients who potentially will undergo BCS. Taking the rate of reoperation after lumpectomy of about 25%, then 315 000 people will possibly have to repeat their operation only in one year. If ONCOscanner probe was used worldwide, even 70% of the mentioned patients could probably avoid the reoperation procedure (by multiplying number of potentially saved patients by average cost of re-operation €11 000, the total cost benefit to society would be as high as €2,426 m).
Moreover, a study presented at the 2016 San Antonio Breast Cancer Symposiumon showed that about 23% of 9 837 women who underwent breast-conserving surgery for breast cancer between 2010 and 2013, had at least 1 repeated surgery. The average cost for patients who underwent a second breast surgery was $16 072 higher than for those who had a single surgery. Investigators also found that 34,8% of patients who underwent a repeated surgery experienced at least 1 complication compared with 23,6% of those who had 1 surgery, corresponding to a 47% higher risk of complications among patients undergoing a repeated surgery.
To sum up, the main market issue for implementing our innovative oncological probe is the increasing demand for devices capable of intra-operatively identifying the type of cells of collected tissues. Continuously increasing number of breast cancer cases resulted in higher demand and the need to equip operating rooms in such type of devices. Moreover, the overall social awareness in the context of this disease is growing – more and more people are deciding to examine themselves, what causes an upward trend in the number of diagnosed cancers at the early stages of development – which in turn favors the increase in the number of breast cancer surgery operations carried out using the conservative method. Additionally, the trend is imposed by the need to reduce costs by treatment centers and the need to increase the quality of services provided.
• What are the overall objectives?
The objectives of the Project included:
• Identification of potential technical challenges that should be addressed before or during the industrial research stage,
• Identification of crucial resources needed to success of the next stage of product development,
• Developing exploitation, dissemination, innovation & IP management strategy;
• Examining the financial viability,
• Determination of the optimum strategy for maximising the territorial scope of the implementation of the technology.
Breast cancer is the most commonly occurring cancer among women and the second most common cancer overall. According to the World Health Organization (WHO) the number of new breast cancer cases in 2018 is estimated at the level of 2,1 m. It means that every 15 seconds someone is diagnosed with breast cancer. Moreover, breast cancer is the 5th most common cause of death from cancer.
Since 2012 worldwide breast cancer incidence increased by more than 23% and mortality by 14%. Bearing that in mind, ONCOscanner deals with both societal and market issue.
The main goal of breast conserving surgery (BCS) is the complete removal of cancer with clear surgical margins while maintaining the natural shape of the breast. However, there is a conict between obtaining an adequate excision margin around the tumor and not removing too much tissue, which may result in breast deformity. Currently, about 20-30% of patients require reoperation after a BCS, what contributes to: decreased patient satisfaction, increased health care costs and poorer cosmetic results. ONCOscanner will decrease this percentage, as it enables the surgeon to better recognise which sections of tissue still need to be removed.
• Why is it important for society?
Basing on the information from WHO that the number of new cases of breast cancer is at the level of 2,1 m in 2018, and assuming that the average percentage of breast conserving surgery will constitute about 60%, we received 1,26 m of patients who potentially will undergo BCS. Taking the rate of reoperation after lumpectomy of about 25%, then 315 000 people will possibly have to repeat their operation only in one year. If ONCOscanner probe was used worldwide, even 70% of the mentioned patients could probably avoid the reoperation procedure (by multiplying number of potentially saved patients by average cost of re-operation €11 000, the total cost benefit to society would be as high as €2,426 m).
Moreover, a study presented at the 2016 San Antonio Breast Cancer Symposiumon showed that about 23% of 9 837 women who underwent breast-conserving surgery for breast cancer between 2010 and 2013, had at least 1 repeated surgery. The average cost for patients who underwent a second breast surgery was $16 072 higher than for those who had a single surgery. Investigators also found that 34,8% of patients who underwent a repeated surgery experienced at least 1 complication compared with 23,6% of those who had 1 surgery, corresponding to a 47% higher risk of complications among patients undergoing a repeated surgery.
To sum up, the main market issue for implementing our innovative oncological probe is the increasing demand for devices capable of intra-operatively identifying the type of cells of collected tissues. Continuously increasing number of breast cancer cases resulted in higher demand and the need to equip operating rooms in such type of devices. Moreover, the overall social awareness in the context of this disease is growing – more and more people are deciding to examine themselves, what causes an upward trend in the number of diagnosed cancers at the early stages of development – which in turn favors the increase in the number of breast cancer surgery operations carried out using the conservative method. Additionally, the trend is imposed by the need to reduce costs by treatment centers and the need to increase the quality of services provided.
• What are the overall objectives?
The objectives of the Project included:
• Identification of potential technical challenges that should be addressed before or during the industrial research stage,
• Identification of crucial resources needed to success of the next stage of product development,
• Developing exploitation, dissemination, innovation & IP management strategy;
• Examining the financial viability,
• Determination of the optimum strategy for maximising the territorial scope of the implementation of the technology.
The aforementioned objectives of the project were achieved through the activities carried out as part of Phase I of SME. Conclusions of the action are as follows:
• The target market is absorptive and growing;
• ONCOscanner responds to the identified needs of the target groups;
• Competitive advantages of ONCOscanner has been identified;
• Work plan and budget for next steps of development as well as reaching of 9 TRL is realistic and feasible;
• Onco scanner sp. z o. o. has sufficient human and infrastructure resources needed to market implementation of oncological probes. Financial and personal gaps has been identified and included in the financial analysis;
• All analyzed economic ratios indicated the viability of the implementation;
• Optimal path of ONCOscanner commercialization has been chosen – product sales via distributors.
Taking into account the above, main conclusion is that the project shall continue
• The target market is absorptive and growing;
• ONCOscanner responds to the identified needs of the target groups;
• Competitive advantages of ONCOscanner has been identified;
• Work plan and budget for next steps of development as well as reaching of 9 TRL is realistic and feasible;
• Onco scanner sp. z o. o. has sufficient human and infrastructure resources needed to market implementation of oncological probes. Financial and personal gaps has been identified and included in the financial analysis;
• All analyzed economic ratios indicated the viability of the implementation;
• Optimal path of ONCOscanner commercialization has been chosen – product sales via distributors.
Taking into account the above, main conclusion is that the project shall continue
The expected results until the end of the Project is to develop the point probe and create its next version – a linear probe for intraoperative identification of cancerous tissues during surgical treatment for breast cancer.
Specification of the major technological issues was a crucial step for the preparation of the development plan. In order to solve the technological issues identified in Section A1 of the Feasibility Study and achieve the objectives assumed for the Project, the previously planned actions were divided into the three following stages:
Stage 1. Modification and improvement of the basic components of the probe (for both point and linear version)
Stage 2. Creation of the final versions of the point and linear probe
Stage 3. Clinical trials performing.
The implementation of the ONCOscanner on the market will have a great socio-economic impact, as it enables:
-reducing the risk of re-operation;
-improving aesthetic and psychological effects by leaving a larger portion of healthy tissue in the breast;
-shortening the period of rehabilitation and stay in hospital;
-reducing negative impact of surgery on the performance of upper limbs,
-better mental comfort in case of attending the BCS and after it (while waiting for the histopathology report)
-improving surgeons’ comfort during surgery, by increasing frequency of breast-saving treatment (instead of mastectomy),
-higher efficiency of operations – less number of re-operations
-improving the quality of services and simultaneously reducing operating costs (one reoperation can cost even €11 000)
-better reputation of the medical entities thanks to better lumpectomy quality,
-reduction of high medical costs,
-improvement of service quality in regard to breast conserving surgery.
Specification of the major technological issues was a crucial step for the preparation of the development plan. In order to solve the technological issues identified in Section A1 of the Feasibility Study and achieve the objectives assumed for the Project, the previously planned actions were divided into the three following stages:
Stage 1. Modification and improvement of the basic components of the probe (for both point and linear version)
Stage 2. Creation of the final versions of the point and linear probe
Stage 3. Clinical trials performing.
The implementation of the ONCOscanner on the market will have a great socio-economic impact, as it enables:
-reducing the risk of re-operation;
-improving aesthetic and psychological effects by leaving a larger portion of healthy tissue in the breast;
-shortening the period of rehabilitation and stay in hospital;
-reducing negative impact of surgery on the performance of upper limbs,
-better mental comfort in case of attending the BCS and after it (while waiting for the histopathology report)
-improving surgeons’ comfort during surgery, by increasing frequency of breast-saving treatment (instead of mastectomy),
-higher efficiency of operations – less number of re-operations
-improving the quality of services and simultaneously reducing operating costs (one reoperation can cost even €11 000)
-better reputation of the medical entities thanks to better lumpectomy quality,
-reduction of high medical costs,
-improvement of service quality in regard to breast conserving surgery.