Periodic Reporting for period 1 - SONOPHORESIS SMARTPATCH (Sonophoresis smartpatch for pain-free, controllable, and wearable transdermal drug delivery)
Periodo di rendicontazione: 2023-08-01 al 2024-07-31
Medicsen was founded to improve quality of life with chronic diseases. We strive to deliver the latest technological advances to the medical world in order to reduce pain and uncertainty.
The project focuses on the full commercialization of Medicsen Smartpatch, the first needle-free and wearable drug delivery device based on harmless waves which increase the size of natural skin pores so that macromolecules up to 200KDa can enter the body through skin (such as heparin, insulin...). This solution is built as a wearable, comfortable device (4x2x1cm) and, above all, it is painless and safe (pores close when device stops).
For patients suffering from chronic diseases, the pain and hassle of current drug delivery methods hinder adherence and make the disease overwhelmingly present. They have to take daily/weekly self-injections (from hundreds in multiple sclerosis to thousands in diabetes every year) or spend their life connected to a device through a subcutaneous cannula. This generates pain, body marks, risk of infection, frustration, social rejection and increases
the feeling of disease. Needles, cannulas and uncomfortable devices are the main cause for the low rate of achievement of treatment goals (35%), since 38% of chronic patients end up discontinuing the treatment and 1 in
every 4 of them ends up with an affective disorder. In many countries, having a poorly controlled disease limits access to working positions as police or firefighters, which is discriminative in terms of opportunities. In most chronic conditions non-compliance is a critical risk factor for complications and early mortality.
Current adherence to chronic treatments is extremely low, with only 1 in every 3 patients achieving treatment goals, and the existing treatments (mostly based on needles) are a big contributor to this low rate. Poorly controlled patients generate 20% more costs of care for payers like insurance companies (and 10% more carbon footprint) and die an average of 10 years earlier, which causes additional indirect costs. These patients involve more hospitalizations and a greater average cost per hospital visit. Poorly controlled chronic diseases consume the vast majority of the EU´s healthcare budget (diabetes alone takes 10-20%). And physicians (besides the risk of needles), need to invest huge amounts of time in explaining the use of needles & cannulas and become so frustrated with treatment results that end up offering their personal phone numbers for consultations and telemonitoring in their free time.
On their side, pharma companies know that having the best drug on the market is worthless without an equally good delivery method. Therefore, they spend huge resources to deliver solutions that comply with patients needs and environmental sustainability policies. To this day, they still have to rely on needle or cannula-based invasive devices that reduce adherence and limit the overall efficacy of drug treatments, so patients often wonder why Pharma focuses mainly on returns instead of prioritizing more their comfort. Competition to position and gain market share is fierce and, since there is not much innovation on delivery devices, there is almost no differentiation so the use of one generic over the other is mainly dependent on commercial networks to convince prescriptors/payers. Pharma is eager to receive innovative transdermal delivery devices for their molecules, as a way to improve patient comfort, adherence to treatment and outcomes, to increase market share and reimbursement opportunities.
The project focuses on the full commercialization of Medicsen Smartpatch, the first needle-free and wearable drug delivery device based on harmless waves which increase the size of natural skin pores so that macromolecules up to 200KDa can enter the body through skin (such as heparin, insulin...). This solution is built as a wearable, comfortable device (4x2x1cm) and, above all, it is painless and safe (pores close when device stops).
For patients suffering from chronic diseases, the pain and hassle of current drug delivery methods hinder adherence and make the disease overwhelmingly present. They have to take daily/weekly self-injections (from hundreds in multiple sclerosis to thousands in diabetes every year) or spend their life connected to a device through a subcutaneous cannula. This generates pain, body marks, risk of infection, frustration, social rejection and increases
the feeling of disease. Needles, cannulas and uncomfortable devices are the main cause for the low rate of achievement of treatment goals (35%), since 38% of chronic patients end up discontinuing the treatment and 1 in
every 4 of them ends up with an affective disorder. In many countries, having a poorly controlled disease limits access to working positions as police or firefighters, which is discriminative in terms of opportunities. In most chronic conditions non-compliance is a critical risk factor for complications and early mortality.
Current adherence to chronic treatments is extremely low, with only 1 in every 3 patients achieving treatment goals, and the existing treatments (mostly based on needles) are a big contributor to this low rate. Poorly controlled patients generate 20% more costs of care for payers like insurance companies (and 10% more carbon footprint) and die an average of 10 years earlier, which causes additional indirect costs. These patients involve more hospitalizations and a greater average cost per hospital visit. Poorly controlled chronic diseases consume the vast majority of the EU´s healthcare budget (diabetes alone takes 10-20%). And physicians (besides the risk of needles), need to invest huge amounts of time in explaining the use of needles & cannulas and become so frustrated with treatment results that end up offering their personal phone numbers for consultations and telemonitoring in their free time.
On their side, pharma companies know that having the best drug on the market is worthless without an equally good delivery method. Therefore, they spend huge resources to deliver solutions that comply with patients needs and environmental sustainability policies. To this day, they still have to rely on needle or cannula-based invasive devices that reduce adherence and limit the overall efficacy of drug treatments, so patients often wonder why Pharma focuses mainly on returns instead of prioritizing more their comfort. Competition to position and gain market share is fierce and, since there is not much innovation on delivery devices, there is almost no differentiation so the use of one generic over the other is mainly dependent on commercial networks to convince prescriptors/payers. Pharma is eager to receive innovative transdermal delivery devices for their molecules, as a way to improve patient comfort, adherence to treatment and outcomes, to increase market share and reimbursement opportunities.
The project is advancing successfully in its full clinical trials towards achieving CE labelling. This includes refining the device design and finalising its miniaturization. While this is going-on, intensive networking activities happen with trialing hospitals which will participate in the trials, regulatory bodies in Europe and the USA, pharma companies, investors, clinicians and patients.
Today, if a patient needs a large drug like heparin or insulin, the only delivery options involve:
1) For 99% of patients, needles and cannulas as injection pens, pumps & patches, which get obstructed, produce infections, pain and social rejection.
2) Or efforts to modify the molecule to adapt it for other routes as inhaled, or smart drugs, which require years to regulate & impose big risks.
3) Alternative transdermal needle-free delivery as jet injectors, which cannot be miniaturized, or iontophoresis, only working with small charged molecules.
4) Microneedles, which are disconnected and implants that cannot be extracted if they fail (risky for drugs like insulin).
Sonophoresis is the only non-invasive methodology that has proven to be effective, safe, convenient & cost-effective, but current developments are focused on trans-rectal devices or wired to the plug. Merdicsen is capable of overcoming these barriers.
1) For 99% of patients, needles and cannulas as injection pens, pumps & patches, which get obstructed, produce infections, pain and social rejection.
2) Or efforts to modify the molecule to adapt it for other routes as inhaled, or smart drugs, which require years to regulate & impose big risks.
3) Alternative transdermal needle-free delivery as jet injectors, which cannot be miniaturized, or iontophoresis, only working with small charged molecules.
4) Microneedles, which are disconnected and implants that cannot be extracted if they fail (risky for drugs like insulin).
Sonophoresis is the only non-invasive methodology that has proven to be effective, safe, convenient & cost-effective, but current developments are focused on trans-rectal devices or wired to the plug. Merdicsen is capable of overcoming these barriers.