Periodic Reporting for period 2 - LymphoDrain (LymphoDrain: The definitive solution for chronic lymphedema)
Berichtszeitraum: 2021-05-01 bis 2023-01-31
Lymphedema (LE) is a chronic disfunction of the lymphatic system causing fluid accumulation in the limbs, which affects more than 100 million patients worldwide. Its occurrence is closely related to cancer, being a very common side effect of cancer therapies, but can also arise from genetic disorders or due to injury, trauma, venous disorders, obesity, immobility, etc. Despite recent advances, at present there is no cure for LE which becomes a chronic disorder.
The disease must be treated constantly by the patient, to avoid complications, with daily use of compression garments, physiotherapy and skin care. Thus, it creates a constant disability for the patient and, more importantly, it affects his/her ability to work and to live a normal life.
In Europe, the financial impact of LE is valued at around €832 million in health and social welfare bills, with an additional €2.3 billion used to treat infections secondary to LE, as well as an additional €4.4 billion in loss of
earnings as a result of productive incapacity of the patients. In addition, the prevalence of chronic LE is expected to grow as the life expectancy increases and the global population ages. There is an urgent need for innovative approaches to restore continuous lymph flow drainage in affected tissues, producing a definitive solution for LE.
Lymphatica´s subcutaneous implant, LymphoDrain, consists of a draining catheter and a micro-pump externally controlled by a wearable device, and replaces the function of lymphatic vessels. It is implanted via a minimally invasive procedure, and results in the resolution of the physiological impairments caused by LE reducing pain, the risk of potential complications and the need for additional treatments. Lymphatica´s goal is to convert LymphoDrain into the first definitive solution for LE patients and a clear solution for reducing the impact of LE on both the healthcare system and the economy of each country.
The overall objective of the project is to complete development and production of LymphoDrain for upper limb lymphedema, followed by design verification activities according to international directives and standards, and by initial clinical validation in a first-in-human clinical study.
The disease must be treated constantly by the patient, to avoid complications, with daily use of compression garments, physiotherapy and skin care. Thus, it creates a constant disability for the patient and, more importantly, it affects his/her ability to work and to live a normal life.
In Europe, the financial impact of LE is valued at around €832 million in health and social welfare bills, with an additional €2.3 billion used to treat infections secondary to LE, as well as an additional €4.4 billion in loss of
earnings as a result of productive incapacity of the patients. In addition, the prevalence of chronic LE is expected to grow as the life expectancy increases and the global population ages. There is an urgent need for innovative approaches to restore continuous lymph flow drainage in affected tissues, producing a definitive solution for LE.
Lymphatica´s subcutaneous implant, LymphoDrain, consists of a draining catheter and a micro-pump externally controlled by a wearable device, and replaces the function of lymphatic vessels. It is implanted via a minimally invasive procedure, and results in the resolution of the physiological impairments caused by LE reducing pain, the risk of potential complications and the need for additional treatments. Lymphatica´s goal is to convert LymphoDrain into the first definitive solution for LE patients and a clear solution for reducing the impact of LE on both the healthcare system and the economy of each country.
The overall objective of the project is to complete development and production of LymphoDrain for upper limb lymphedema, followed by design verification activities according to international directives and standards, and by initial clinical validation in a first-in-human clinical study.
During the first reporting period, we completed the production and testing of the first version of the device, to be used in a pilot clinical study to verify safety and obtain preliminary data on device performance in patients affected by arm lymphedema. We also obtained the approval from the ethical committee and the national competent authority, to start the clinical trial.
On the regulatory side, we obtained and successfully maintained our ISO 14385 certified Quality Management System, ensuring that all internal processes of the company related to product development and clinical validation, follow rigorous methods to deliver the highest quality of products for patients, and the highest quality of results from the clinical study.
During the entire duration of the project, we also worked on refining our marketing and commercialization plan, we engaged with potential customers (doctors, physiotherapists but also lymphedema patients) and we attracted the interest of venture capitalist and private investors, and of EIT Health, that allowed us to close a Series A investment round in November 2020. On top of the financial contribution, the investment round allowed us to bring on board key investors with a strong knowledge in our primary target market, and to include a specialist in commercialization and marketing of medical devices in Lymphatica's board of directors.
During the second reporting period we conducted a first-in-human pilot clinical investigation on patients affected by upper limb lymphedema, which allowed us to collect results on device safety and preliminary performance. There were no safety concerns during the trial and LymphoDrain proved to be able to reduce or maintain limb volume without the need of additional treatments. If these results will be confirmed in the pivotal trial, LymphoDrain will prove to be an innovative life changing treatment for lymphedema patients.
The results of the study will be made publicly available in a peer reviewed publication and on the study registry.
On the regulatory side, we obtained and successfully maintained our ISO 14385 certified Quality Management System, ensuring that all internal processes of the company related to product development and clinical validation, follow rigorous methods to deliver the highest quality of products for patients, and the highest quality of results from the clinical study.
During the entire duration of the project, we also worked on refining our marketing and commercialization plan, we engaged with potential customers (doctors, physiotherapists but also lymphedema patients) and we attracted the interest of venture capitalist and private investors, and of EIT Health, that allowed us to close a Series A investment round in November 2020. On top of the financial contribution, the investment round allowed us to bring on board key investors with a strong knowledge in our primary target market, and to include a specialist in commercialization and marketing of medical devices in Lymphatica's board of directors.
During the second reporting period we conducted a first-in-human pilot clinical investigation on patients affected by upper limb lymphedema, which allowed us to collect results on device safety and preliminary performance. There were no safety concerns during the trial and LymphoDrain proved to be able to reduce or maintain limb volume without the need of additional treatments. If these results will be confirmed in the pivotal trial, LymphoDrain will prove to be an innovative life changing treatment for lymphedema patients.
The results of the study will be made publicly available in a peer reviewed publication and on the study registry.
Nowadays, the most common treatment for LE is a combination of manual compression (manual lymphatic drainage) and garments or bandaging called Complete Decongestive Therapy (CDT). This treatment is conservative and aims to treat lymphedema symptoms, but does not address the cause of lymphedema, therefore it has to be performed periodically by the patient, for the rest of his/her life, with major drawbacks on patient's quality of life but also on the recurring costs with a heavy impact on the patient himself and on the healthcare system.
Less common solutions include lymphatic microsurgery and lymph node transplant, which consist in complicated and often expensive surgical procedures applied only in few selected cases.
With LymphoDrain, we want to provide a system that substitute the damaged lymphatic system providing continuous recirculation of accumulated fluids, in a seamless way for the patient.
Compared to the standard of care, the advantages of LymphoDrain are:
Definitive, long-term solution. The material used in the device is tolerated and does not cause rejections.
✓ Long-term use.
✓ Elimination of the need for time-consuming physiotherapy sessions and continuous self-treatment (continuous use of compression garments vs. a programmed daily drainage compatible with an active regular life).
✓ Reduction of infection risk by a regular continuous drainage (approx. 8h/day).
✓ Application extended to a large number of patients with vascular surgeons qualified to implant the device.
✓ Improvement of patient quality of life through limb volume reduction, elimination of discomfort, pain and psychological stress.
✓ Recovery of a regular lifestyle for the patient.
✓ Reduction of the individual cost for the long-lasting treatment with savings estimated at least at 20% reduction in healthcare system cost compared to standard chronic treatment.
The LymphoDrain project allowed to complete technical vaildation of the product and to test the device in a first-in-human clinical investigation on patients affected by upper limb lymphedema.
Less common solutions include lymphatic microsurgery and lymph node transplant, which consist in complicated and often expensive surgical procedures applied only in few selected cases.
With LymphoDrain, we want to provide a system that substitute the damaged lymphatic system providing continuous recirculation of accumulated fluids, in a seamless way for the patient.
Compared to the standard of care, the advantages of LymphoDrain are:
Definitive, long-term solution. The material used in the device is tolerated and does not cause rejections.
✓ Long-term use.
✓ Elimination of the need for time-consuming physiotherapy sessions and continuous self-treatment (continuous use of compression garments vs. a programmed daily drainage compatible with an active regular life).
✓ Reduction of infection risk by a regular continuous drainage (approx. 8h/day).
✓ Application extended to a large number of patients with vascular surgeons qualified to implant the device.
✓ Improvement of patient quality of life through limb volume reduction, elimination of discomfort, pain and psychological stress.
✓ Recovery of a regular lifestyle for the patient.
✓ Reduction of the individual cost for the long-lasting treatment with savings estimated at least at 20% reduction in healthcare system cost compared to standard chronic treatment.
The LymphoDrain project allowed to complete technical vaildation of the product and to test the device in a first-in-human clinical investigation on patients affected by upper limb lymphedema.