Periodic Reporting for period 3 - CareMin650 (An unrivalled medical device for severe cancer treatment complications:exact & easy red-LED photobiomodulation for mucositis and dermatitis)
Reporting period: 2021-05-01 to 2022-04-30
Over 5 million people worldwide will develop mucositis or radiodermatitis in a year.
Mucositis and dermatitis are very common side-effects during cancer treatment, induced by radiation and/or chemotherapy. Those side effects are debilitating and painful, leading to poor alimentation and general weakening; ultimately, they can lead to death. The economic burden reaches billions.
Dealing with those side effects has been a challenge as nothing seems to decrease their impact. Only one therapy has been validated: photobiomodulation or the use of light with strict parameter to help the mucosa or derma cells to “fight” against the aggression of the radiation and of the chemotherapy. Unfortunately, photobiomodulation is barely used to treat those side effects as the parameters are difficult to control and few hospitals have the expertise to handle the technique in a reproductible, effective and safe fashion.
NeoMedLight’s (NML) objective is to develop a technology allowing a widespread use of photobiomodulation, implying a perfect mastery of the parameters without the user having to worry about those. Thanks to its unique technology, NML is able to emit controlled light over a surface of fabric made of woven optic fibres, insuring homogeneous delivery of the photons to the skin or mucosa. NML therefore engaged on a project to develop a class II A medical device: the CareMin650™.
Mucositis and dermatitis are very common side-effects during cancer treatment, induced by radiation and/or chemotherapy. Those side effects are debilitating and painful, leading to poor alimentation and general weakening; ultimately, they can lead to death. The economic burden reaches billions.
Dealing with those side effects has been a challenge as nothing seems to decrease their impact. Only one therapy has been validated: photobiomodulation or the use of light with strict parameter to help the mucosa or derma cells to “fight” against the aggression of the radiation and of the chemotherapy. Unfortunately, photobiomodulation is barely used to treat those side effects as the parameters are difficult to control and few hospitals have the expertise to handle the technique in a reproductible, effective and safe fashion.
NeoMedLight’s (NML) objective is to develop a technology allowing a widespread use of photobiomodulation, implying a perfect mastery of the parameters without the user having to worry about those. Thanks to its unique technology, NML is able to emit controlled light over a surface of fabric made of woven optic fibres, insuring homogeneous delivery of the photons to the skin or mucosa. NML therefore engaged on a project to develop a class II A medical device: the CareMin650™.
1) Design validation, optimisation and industrialisation of CareMin650™
At the beginning of the project, the device was close to its final version. Remaining tasks included creation of the packaging, finalisation of the software, and all testing and qualifications to qualify the device as medical one. All those tasks have been realised either by qualified companies or internally under strict regulatory guidelines. NML also had to be able to guarantee that its suppliers were qualified to build their own parts of the device to be compliant with the rules and regulation of the European Community.
This resulted in NML’s successfully obtaining its CE mark in February 2020.
NML has also been working on a device to be used in the pelvic region and endovaginally where mucositis and dermatitis are potential side effects. During year 3, further development of the endovaginal applicators were performed. The first serie of products has been produced.
2) Clinical validation of CareMin650™
NML engaged in a clinical strategy to provide both safety and efficacy data to CareMin650™. The first step has been the safety study SafePBM, a prospective non-comparative study conducted in French radiotherapy sites.
The results shown the device is safe and although the study was not designed to demonstrate the efficacy of CareMin650, preliminary findings suggested clinical benefits at least in the preventive setting.
The FDA efficacy study PrOMiSE was supposed to enroll 100 patients. It was discontinued after 15 patients had been enrolled as the recruitment was far too slow: the target patients’ population was badly impacted by the COVID crisis, delaying their diagnosis of a head and neck cancer, which in turn diminished their ability to eat and drink properly, an exclusion criterion.
3) Dissemination of therapy
NML has designed a Multi-Channel Marketing (MCM) strategy to reach major target groups: Oncologists, Radiation Therapists, and Patients.
The first step of the MCM was to create a new website for NML articulated around the CareMin650 which was set live on 2020. In 2021, the website has been updated with a new architecture that includes an educational component 'Training & Tutorial' as well as a page dedicated to the dissemination of scientific data 'Clinical Studies & Webinars'.
After subscription, people are registered in our CRM system and receive regular news and information regarding the treatment of OM & DM as well on CareMin650.
NML then initiated a sequential e-mailing campaign targeted to HCP introducing for instance webinars or clinical studies results.
Contacts have also been made with patient associations such as Corasso in France and the European association of cancer patients.
In parallel, NML communicated through the press and social networks, using LinkedIn, television (BFM), written press (Rose, les Echos, etc.).
NML also ran communication campaigns through LinkedIn to HCP.
On top of those activities, during the third year, NML has been particularly focused on communication through social networks and at scientific congresses.
Thus, NML has participated to the following congresses ESTRO 2021 - AFSOS 2021 - SFRO 2021 -B-STRO 2021 - AIRO 2021 - Arab Health 2022
In some of these congresses such as AFSOS, ESTRO and SFRO, scientific symposiums were organised sponsored by NML on PBM in head and neck cancer and breast cancer as well as on CareMin650 and its efficiency.
More recently, data on the efficacy of CareMin650 in preventing mucositis in stem cell transplantation patients was presented at the 48th European Society for Blood and Marrow Transplantation (EBMT) Congress.
4) Market Access
A phased building up of the distribution channels is in process. With no well-established or proven treatment and almost no real competitor active in the market, NML is in a therapy development market access strategy and must partner with well-established companies in the field. Selection of the commercial partners was based on their network in oncology and radiotherapy market, the existing network but also their track record, reliability, and internal organisational structure.
A Global sales & Marketing director was hired to drive and support the development of NML in the oncology market as well as a marketing associate.
At the end of the third year distributors have been recruited in Germany, UK, Spain, Estonia, Switzerland, Italy, Australia – United Arab Emirates.
In Belgium and France the commercial coverage is ensured either by sales agents or directly by the sales director.
NML has successfully submitted a brief to NHS Health Technology Wales (HTW) in order to receive an evidence-based guide for CareMin650’s use in Wales. As part of the initiatives to obtain reimbursement for the CareMin650 in France, collaboration with IPC and St Antoine hospitals will provide data to influence the health ministry.
An expert roundtable discussion was held on patient profiling for the use of PBM for prophylaxis in head and neck cancer and recommendations for logistical implementation within a hospital department.
NML also sponsors a course on PBM given at Gustave Roussy (FR) as part of a DU (university diploma in PBM).
At the beginning of the project, the device was close to its final version. Remaining tasks included creation of the packaging, finalisation of the software, and all testing and qualifications to qualify the device as medical one. All those tasks have been realised either by qualified companies or internally under strict regulatory guidelines. NML also had to be able to guarantee that its suppliers were qualified to build their own parts of the device to be compliant with the rules and regulation of the European Community.
This resulted in NML’s successfully obtaining its CE mark in February 2020.
NML has also been working on a device to be used in the pelvic region and endovaginally where mucositis and dermatitis are potential side effects. During year 3, further development of the endovaginal applicators were performed. The first serie of products has been produced.
2) Clinical validation of CareMin650™
NML engaged in a clinical strategy to provide both safety and efficacy data to CareMin650™. The first step has been the safety study SafePBM, a prospective non-comparative study conducted in French radiotherapy sites.
The results shown the device is safe and although the study was not designed to demonstrate the efficacy of CareMin650, preliminary findings suggested clinical benefits at least in the preventive setting.
The FDA efficacy study PrOMiSE was supposed to enroll 100 patients. It was discontinued after 15 patients had been enrolled as the recruitment was far too slow: the target patients’ population was badly impacted by the COVID crisis, delaying their diagnosis of a head and neck cancer, which in turn diminished their ability to eat and drink properly, an exclusion criterion.
3) Dissemination of therapy
NML has designed a Multi-Channel Marketing (MCM) strategy to reach major target groups: Oncologists, Radiation Therapists, and Patients.
The first step of the MCM was to create a new website for NML articulated around the CareMin650 which was set live on 2020. In 2021, the website has been updated with a new architecture that includes an educational component 'Training & Tutorial' as well as a page dedicated to the dissemination of scientific data 'Clinical Studies & Webinars'.
After subscription, people are registered in our CRM system and receive regular news and information regarding the treatment of OM & DM as well on CareMin650.
NML then initiated a sequential e-mailing campaign targeted to HCP introducing for instance webinars or clinical studies results.
Contacts have also been made with patient associations such as Corasso in France and the European association of cancer patients.
In parallel, NML communicated through the press and social networks, using LinkedIn, television (BFM), written press (Rose, les Echos, etc.).
NML also ran communication campaigns through LinkedIn to HCP.
On top of those activities, during the third year, NML has been particularly focused on communication through social networks and at scientific congresses.
Thus, NML has participated to the following congresses ESTRO 2021 - AFSOS 2021 - SFRO 2021 -B-STRO 2021 - AIRO 2021 - Arab Health 2022
In some of these congresses such as AFSOS, ESTRO and SFRO, scientific symposiums were organised sponsored by NML on PBM in head and neck cancer and breast cancer as well as on CareMin650 and its efficiency.
More recently, data on the efficacy of CareMin650 in preventing mucositis in stem cell transplantation patients was presented at the 48th European Society for Blood and Marrow Transplantation (EBMT) Congress.
4) Market Access
A phased building up of the distribution channels is in process. With no well-established or proven treatment and almost no real competitor active in the market, NML is in a therapy development market access strategy and must partner with well-established companies in the field. Selection of the commercial partners was based on their network in oncology and radiotherapy market, the existing network but also their track record, reliability, and internal organisational structure.
A Global sales & Marketing director was hired to drive and support the development of NML in the oncology market as well as a marketing associate.
At the end of the third year distributors have been recruited in Germany, UK, Spain, Estonia, Switzerland, Italy, Australia – United Arab Emirates.
In Belgium and France the commercial coverage is ensured either by sales agents or directly by the sales director.
NML has successfully submitted a brief to NHS Health Technology Wales (HTW) in order to receive an evidence-based guide for CareMin650’s use in Wales. As part of the initiatives to obtain reimbursement for the CareMin650 in France, collaboration with IPC and St Antoine hospitals will provide data to influence the health ministry.
An expert roundtable discussion was held on patient profiling for the use of PBM for prophylaxis in head and neck cancer and recommendations for logistical implementation within a hospital department.
NML also sponsors a course on PBM given at Gustave Roussy (FR) as part of a DU (university diploma in PBM).
NML expects through health care professional education and patient awareness, to make the usage of photobiomodulation integrated part of the cancer treatment. As such, we aim to reduce the occurrence of the disease, improving the quality of life of the patients and prevent compromising the cancer treatment.
In preventing those side effects, NML’s ambition is also to contribute to decreasing the overall cost of mucositis and dermatitis to the health care system. At this point, the device is used in hematology and head and neck centres and as such is already contributing to reducing the overall cost to the health care system.
In preventing those side effects, NML’s ambition is also to contribute to decreasing the overall cost of mucositis and dermatitis to the health care system. At this point, the device is used in hematology and head and neck centres and as such is already contributing to reducing the overall cost to the health care system.