Periodic Reporting for period 1 - TPRPK (PpSC developing Topical Platelet-rich plasma Kit (TPRPK) in order to facilitate the further development, adoption and implement. of PRP for Healthcare with initial specialisation on cell rejuvenation)
Période du rapport: 2018-09-01 au 2019-02-28
Résumé du contexte et des objectifs généraux du projet
• What is the problem/issue being addressed?
This feasibility study sought to examine the commercial potential for introducing a new Platelet-Rich Plasma (PRP) product (Topical Platelet-Rich Plasma Kit or TPRPK) for clients suffering from various skin conditions, for clients who have an injection phobia, or for clients who simply choose not to have the injectable version of the treatment which is currently available. The product is not only cost efficient pain-free for clients, it also reduces the clinician’s time as the sale can be delegated to other clinical staff on a much lower hourly rate. This leads to the increase of the clinic’s turn over. Another key innovation with TPRPK, is increased lifespan of the PRP lasting from a few minutes to a week using our innovative Storage Device. This is supported by our internationally published peer reviewed study with St Thomas’ Hospital, London. The TPRPK treatment comprises a two-part system:
● PRP Storage Device – a medical device Class IIb at TRL 6. The device will be developed further in collaboration with either 3D Engineering Prototyping Ltd. or other similar company from our list of subcontractors. During this feasibility study an ethnographic design approach has been used in collaboration with the University of Surrey (testing activity).
● Collagen Serum – this serum has been developed by a ‘Cosmetic Laboratory’ (proprietary information). A few drops of the serum will be mixed with a few drops of individual’s own PRP on daily basis. The regenerative mixture is then applied to the skin to aid rejuvenation, reverse the effects of ageing and speed-up the healing process of conditions such as eczema. An individual client’s PRP is stored inside the PRP storage device at room temperature for a week.
• Why is it important for society?
Sustainability: environmental awareness and eco-friendliness are increasingly gaining importance and business enterprises are increasingly placing huge emphasis on increasing their sustainability quotient and decreasing their carbon footprint. Increasing awareness among consumers is driving demand for production of eco-friendly products made from renewable resources, are biodegradable, and have a lesser environmental impact as compared to synthetic products from petrochemical origin.
The TPRPK environmental impact was assessed and PpSC anticipates that can achieve a reduction in non-recyclable waste by 90%. PpSC also identified that further research in this area is needed to assess if waste contaminated by human blood could be recycled safely. PpSC expects its recyclable materials approach set in the Product Requirements Specification to translate to hundreds of tons of CO2 not being released to the atmosphere annually. TPRPK will also have a positive impact in reducing health & safety risks to both professional and the end-user clients. The topical method of use will significantly reduce the number of potentially contaminated needles resulting from the current PRP method, and this will limit the risk of infection and needlestick injuries.
• What are the overall objectives?
Products: PpSC will develop two distinct devices, the Storage Device and the Ampoule Device. Each has different manufacturing requirements.
Storage Device: PpSC has designed and built the first prototype of a commercially viable device. PpSC recognises that it will not be able to nor desires to set up the necessary technical support maintenance workshops required to service and support such a large number of electromedical devices. Consequently, PpSC plans to appoint an established sub-contract manufacturer that have the capability to provide the required service support. Further PpSC will seek to appoint distributors that have established support facilities in place. PpSC will select the most appropriate partners and work with them to integrate PpSC’s specialist knowledge on PRP into their sales and servicing offering.
Ampoule Device: PpSC is seeking partners to assist in the development of the Ampoule Device. PpSC recognised during the Phase 1 study just how important a novel and sound design is to the success of this venture. PpSC has identified potential sub-contract R&D partners and more options will be sought during the Phase 2. Appointing early, a partner with proven plastics design skills in the type of product required, is essential. PpSC has identified partners in Holland and the UK who will be working together, sharing their expertise and skill set, to achieve the best possible results. PpSC also wishes to ensure that all IP developed within the project remains the property of PpSC. Ensuring the design meets user needs will be central to the success of the Business Plan and therefore PpSC will work closely with clinicians, its potential distributors and end-user clients to test, modify and improve the prototype within a controlled environment.
Demonstrations and testing: once the products are fully released PpSC will perform demonstrations in a number of influential and potential clinical purchasers and at local and national research centres. The company has management in place with prior experience of supporting distributors in the medical device sector. PpSC will employ experienced medical device Sales Promoters/Educators and equip them with the necessary materials to successfully implement use of the TPRPK technology.
Phase 2 project: to implement the business plan PpSC will require additional funding through a Phase 2 award. Consequently, an outline plan of the Phase 2 project has been developed and is now summarised.
PpSC will submit a Phase 2 grant request at the earliest opportunity. PpSC has commenced the process of obtaining detailed quotations for the equipment, materials and sub-contract work required. Estimates of the Work Package costings have been made but are likely high and will be refined for the Phase 2 submittal. A series of detailed work packages have been outlined, budgeted and scheduled to form the basis of Phase 2 plan which will require €1.9m of grant funding over a 20-month period to take the product to manufacture. After launch PpSC will use finances from investors for the manufacturing start-up and first year of sales cash flow requirements. PpSC expects to be self-sufficient in Year 2 of sales.
This feasibility study sought to examine the commercial potential for introducing a new Platelet-Rich Plasma (PRP) product (Topical Platelet-Rich Plasma Kit or TPRPK) for clients suffering from various skin conditions, for clients who have an injection phobia, or for clients who simply choose not to have the injectable version of the treatment which is currently available. The product is not only cost efficient pain-free for clients, it also reduces the clinician’s time as the sale can be delegated to other clinical staff on a much lower hourly rate. This leads to the increase of the clinic’s turn over. Another key innovation with TPRPK, is increased lifespan of the PRP lasting from a few minutes to a week using our innovative Storage Device. This is supported by our internationally published peer reviewed study with St Thomas’ Hospital, London. The TPRPK treatment comprises a two-part system:
● PRP Storage Device – a medical device Class IIb at TRL 6. The device will be developed further in collaboration with either 3D Engineering Prototyping Ltd. or other similar company from our list of subcontractors. During this feasibility study an ethnographic design approach has been used in collaboration with the University of Surrey (testing activity).
● Collagen Serum – this serum has been developed by a ‘Cosmetic Laboratory’ (proprietary information). A few drops of the serum will be mixed with a few drops of individual’s own PRP on daily basis. The regenerative mixture is then applied to the skin to aid rejuvenation, reverse the effects of ageing and speed-up the healing process of conditions such as eczema. An individual client’s PRP is stored inside the PRP storage device at room temperature for a week.
• Why is it important for society?
Sustainability: environmental awareness and eco-friendliness are increasingly gaining importance and business enterprises are increasingly placing huge emphasis on increasing their sustainability quotient and decreasing their carbon footprint. Increasing awareness among consumers is driving demand for production of eco-friendly products made from renewable resources, are biodegradable, and have a lesser environmental impact as compared to synthetic products from petrochemical origin.
The TPRPK environmental impact was assessed and PpSC anticipates that can achieve a reduction in non-recyclable waste by 90%. PpSC also identified that further research in this area is needed to assess if waste contaminated by human blood could be recycled safely. PpSC expects its recyclable materials approach set in the Product Requirements Specification to translate to hundreds of tons of CO2 not being released to the atmosphere annually. TPRPK will also have a positive impact in reducing health & safety risks to both professional and the end-user clients. The topical method of use will significantly reduce the number of potentially contaminated needles resulting from the current PRP method, and this will limit the risk of infection and needlestick injuries.
• What are the overall objectives?
Products: PpSC will develop two distinct devices, the Storage Device and the Ampoule Device. Each has different manufacturing requirements.
Storage Device: PpSC has designed and built the first prototype of a commercially viable device. PpSC recognises that it will not be able to nor desires to set up the necessary technical support maintenance workshops required to service and support such a large number of electromedical devices. Consequently, PpSC plans to appoint an established sub-contract manufacturer that have the capability to provide the required service support. Further PpSC will seek to appoint distributors that have established support facilities in place. PpSC will select the most appropriate partners and work with them to integrate PpSC’s specialist knowledge on PRP into their sales and servicing offering.
Ampoule Device: PpSC is seeking partners to assist in the development of the Ampoule Device. PpSC recognised during the Phase 1 study just how important a novel and sound design is to the success of this venture. PpSC has identified potential sub-contract R&D partners and more options will be sought during the Phase 2. Appointing early, a partner with proven plastics design skills in the type of product required, is essential. PpSC has identified partners in Holland and the UK who will be working together, sharing their expertise and skill set, to achieve the best possible results. PpSC also wishes to ensure that all IP developed within the project remains the property of PpSC. Ensuring the design meets user needs will be central to the success of the Business Plan and therefore PpSC will work closely with clinicians, its potential distributors and end-user clients to test, modify and improve the prototype within a controlled environment.
Demonstrations and testing: once the products are fully released PpSC will perform demonstrations in a number of influential and potential clinical purchasers and at local and national research centres. The company has management in place with prior experience of supporting distributors in the medical device sector. PpSC will employ experienced medical device Sales Promoters/Educators and equip them with the necessary materials to successfully implement use of the TPRPK technology.
Phase 2 project: to implement the business plan PpSC will require additional funding through a Phase 2 award. Consequently, an outline plan of the Phase 2 project has been developed and is now summarised.
PpSC will submit a Phase 2 grant request at the earliest opportunity. PpSC has commenced the process of obtaining detailed quotations for the equipment, materials and sub-contract work required. Estimates of the Work Package costings have been made but are likely high and will be refined for the Phase 2 submittal. A series of detailed work packages have been outlined, budgeted and scheduled to form the basis of Phase 2 plan which will require €1.9m of grant funding over a 20-month period to take the product to manufacture. After launch PpSC will use finances from investors for the manufacturing start-up and first year of sales cash flow requirements. PpSC expects to be self-sufficient in Year 2 of sales.
Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent
1. Assess the technical requirements of designing an industrial scale beta launch
a technology review identified the range and limitations of competitive technology and the specifications for materials and equipment required from each of the key partners. The review also highlighted the importance of developing the existing prototype storage device to preserve maximum platelet function; and to develop an ampoule system that would allow the user to divide the PRP into fourteen aliquots, whilst maintaining sterility. Further opportunities for future improvements to both the PRP storage device and PRP serum were identified and have the potential to reduce cost, improve functionality and widen the range of ‘conditions’ that could benefit from the use of the technology.
2. Market analysis determining need for cost optimization and feature development
Key Competitor stakeholder identification: a detailed market analysis was undertaken showing competitors to be scattered across the entire EU. PpSC has established that there are 24,000 PRP injection-based procedures done in the UK annually. In the EU TPRPK has the commercial potential to replace the current injection-based procedures. Clinicians in the EU (France, Poland, jersey, UK, and Sweden) were approached for their views on topical application; the market potential of the TPRPK treatment; desired TPRPK features (unique selling points); and their preferred commercial arrangements. Outside the EU as a means of gauging the international sales potential, clinicians in the US, Japan, Dubai, California and China have been approached. The discussions in the UK have triggered considerable interest in TPRPK, resulting in a letter of intent from a leading, multi-award winning, UK medical device distributor.
3. investment requirements, identify available sources of future finance and investigate suitable licensing pricing and commercialization strategies
The feasibility study concluded, that access to the healthcare market, will be achieved by obtaining registration with a Notified Body within the EU through compliance to the Medical Device Regulation 2017/745 of 5 April 2017. This target is at the heart of the funding plan (and Phase 2 application). The amount required to reach the market is €1,887,229.
4. Evaluate the environmental impacts of the innovation
During this feasibility study, PpSC found that TPRPK has potential to reduce the use of needles (contaminated with blood) by over 90% due to its topical mode of delivery of the growth factor compared to the cur-rent injection-based treatment. PpSC will also seek to minimize the risks associated with contaminated waste by way of careful design of the Ampoule Device. This will involve use of the smallest quantities of autologous blood possible; low volume tubing; and chambers in the processing unit of the system. TPRPK will have a positive impact by reducing the costly ‘sharps waste’ in the clinics.
According to our calculations based upon interviews with clinicians and people managing facilities delivering PRP treatments, as well as other cosmeceutical procedures, TPRPK has the potential to save about €819 per clinic annually on waste collection and consumables. This amount quantified by the number of 120,000 facilities across the EU delivering PRP therapies provides staggering amount of €98m saved by the industry. Additionally, this equates to about 1m tons of CO2 not being released into the atmosphere by waste collection services, manufacturing industry, power generation etc. (www.carbonfootprint.com)
5. Business Plan including Phase 2 project plan and assessment of current IPR & plan for future IP/FTO Strategy
a business model has been developed from the market analysis in Task 2. The Company, in discussion with potential distributors, has concluded that the best route to market remains through established distributors and clinics available for both geographic territories and service sectors. There are some 500 anti-ageing / cosmetic clinics in the UK, each has on average 2,000 clients. The EU market is 10 times bigger. PpSC calculates that it achieves sales revenues of £18,731,937 and a net profit of by Year 4 of £8,879,076.
a technology review identified the range and limitations of competitive technology and the specifications for materials and equipment required from each of the key partners. The review also highlighted the importance of developing the existing prototype storage device to preserve maximum platelet function; and to develop an ampoule system that would allow the user to divide the PRP into fourteen aliquots, whilst maintaining sterility. Further opportunities for future improvements to both the PRP storage device and PRP serum were identified and have the potential to reduce cost, improve functionality and widen the range of ‘conditions’ that could benefit from the use of the technology.
2. Market analysis determining need for cost optimization and feature development
Key Competitor stakeholder identification: a detailed market analysis was undertaken showing competitors to be scattered across the entire EU. PpSC has established that there are 24,000 PRP injection-based procedures done in the UK annually. In the EU TPRPK has the commercial potential to replace the current injection-based procedures. Clinicians in the EU (France, Poland, jersey, UK, and Sweden) were approached for their views on topical application; the market potential of the TPRPK treatment; desired TPRPK features (unique selling points); and their preferred commercial arrangements. Outside the EU as a means of gauging the international sales potential, clinicians in the US, Japan, Dubai, California and China have been approached. The discussions in the UK have triggered considerable interest in TPRPK, resulting in a letter of intent from a leading, multi-award winning, UK medical device distributor.
3. investment requirements, identify available sources of future finance and investigate suitable licensing pricing and commercialization strategies
The feasibility study concluded, that access to the healthcare market, will be achieved by obtaining registration with a Notified Body within the EU through compliance to the Medical Device Regulation 2017/745 of 5 April 2017. This target is at the heart of the funding plan (and Phase 2 application). The amount required to reach the market is €1,887,229.
4. Evaluate the environmental impacts of the innovation
During this feasibility study, PpSC found that TPRPK has potential to reduce the use of needles (contaminated with blood) by over 90% due to its topical mode of delivery of the growth factor compared to the cur-rent injection-based treatment. PpSC will also seek to minimize the risks associated with contaminated waste by way of careful design of the Ampoule Device. This will involve use of the smallest quantities of autologous blood possible; low volume tubing; and chambers in the processing unit of the system. TPRPK will have a positive impact by reducing the costly ‘sharps waste’ in the clinics.
According to our calculations based upon interviews with clinicians and people managing facilities delivering PRP treatments, as well as other cosmeceutical procedures, TPRPK has the potential to save about €819 per clinic annually on waste collection and consumables. This amount quantified by the number of 120,000 facilities across the EU delivering PRP therapies provides staggering amount of €98m saved by the industry. Additionally, this equates to about 1m tons of CO2 not being released into the atmosphere by waste collection services, manufacturing industry, power generation etc. (www.carbonfootprint.com)
5. Business Plan including Phase 2 project plan and assessment of current IPR & plan for future IP/FTO Strategy
a business model has been developed from the market analysis in Task 2. The Company, in discussion with potential distributors, has concluded that the best route to market remains through established distributors and clinics available for both geographic territories and service sectors. There are some 500 anti-ageing / cosmetic clinics in the UK, each has on average 2,000 clients. The EU market is 10 times bigger. PpSC calculates that it achieves sales revenues of £18,731,937 and a net profit of by Year 4 of £8,879,076.
Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)
Progress beyond the state of the art, the desired €1.9m of grant investment, to bring our product to the market, will be used over a 20-month period to; complete prototypes; to validate the device performance; to CE mark the Storage Device and Ampoule system; to complete the filing of IP for the Ampule system; and in parallel to validate the method in terms of growth factor yield and user benefits. The additional resources required by both the Company and its partners have been evaluated and included in the plan which is likely to require 1047 Man-Days to implement. Additional staff will be required by the Company to implement the plan. Commercial arrangements with partners and suppliers have been identified and PpSC has developed a Profit and Loss statement that shows profits by the second year of sale. A Freedom to Operate search for the European area has been undertaken by an experienced Patent Attorney as part of the Intellectual Property Office’s Audit Scheme. The Company's existing intellectual property (IP) was examined and no conflicting IP was found. The IP lawyer also recommended that a new patent application be filed to cover the concepts described in this study. This action would aid in protection during pre-disclosure of the technology’s details with suppliers or partners. As a result of the advice, PpSC has filed a new application (a second patent) to extend the company’s IP coverage UK patent No. 1902993.3. PpSC is now planning an International IP search to include the USA, Japan and China. Furthermore, an additional patent to protect the final design of the Ampoule system will be included in the Phase 2 project. [Third patent]
PpSC’s aim is to introduce the TPRPK to a global market, seizing massive commercial opportunity, but also to provide a much demanded, solution for individuals suffering from various skin conditions where previous other treatments have failed to improve the condition. In addition to address a huge problem of injections and needle phobia. Our ‘topical application’ approach has significant potential to improve the quality of life (physically and psychologically) of many who are currently unable to benefit from expensive and painful injectable PRP treatment.
Successful commercialisation of TPRPK will also have a positive impact on the environment, as we are committed to limiting the amount of plastic and medical waste being sent to landfills. Circular Economy approach is at the heart of TPRPK design, we have the potential to reduce approximately 1m tons of CO2 annually. Furthermore, PpSC will also create job opportunities across the entire EU and globally - within Year 3 there will be a creation of 33 jobs.
PpSC’s aim is to introduce the TPRPK to a global market, seizing massive commercial opportunity, but also to provide a much demanded, solution for individuals suffering from various skin conditions where previous other treatments have failed to improve the condition. In addition to address a huge problem of injections and needle phobia. Our ‘topical application’ approach has significant potential to improve the quality of life (physically and psychologically) of many who are currently unable to benefit from expensive and painful injectable PRP treatment.
Successful commercialisation of TPRPK will also have a positive impact on the environment, as we are committed to limiting the amount of plastic and medical waste being sent to landfills. Circular Economy approach is at the heart of TPRPK design, we have the potential to reduce approximately 1m tons of CO2 annually. Furthermore, PpSC will also create job opportunities across the entire EU and globally - within Year 3 there will be a creation of 33 jobs.