Project funded under the Veneto Development and Cohesion Plan - FSC 2021-2027 Stralcio (CIPESS Resolution 79/2021) - Thematic Area 01 Research and Innovation - Sector 01.01 Research Development
Project title: “Upgrade high-frequency electromedical device and therapy protocols for use on lymphedema, including post-surgical oncology, and upper limb disorders particularly the hand also in the post-surgical with and without osteosynthesis means and headaches and migraines particularly muscle-tensive or other headache forms associated with these muscle-tensive events”
Focusmed concluded the project, which was approved by Decree of the Director of the ERDF Management Area No. 214 of June 28, 2023, and submitted under the Call for Proposals for the support of research and development projects in health and wellness issues under DGR 1570 of Dec. 06, 2022.
The project, carried out in collaboration with the Department of Neuroscience, Biomedicine, and Movement at the University of Verona, was primarily aimed at optimizing the functionality of an advanced device to improve the treatment of complex conditions such as post-surgical lymphedema and traumatic wrist and hand injuries, using high-frequency technology.
Treatment of conditions such as lymphedema and upper extremity disorders, particularly after surgery, is a clinical challenge with limited conventional therapeutic approaches. Traditional methods, such as manual lymphatic drainage, require a significant commitment of time and resources, often with unsatisfactory results.
Through the project, Focusmed was able to increase the effectiveness of electromedical therapies by upgrading the Pronexibus Plus® electromedical device, increasing radiofrequency power and refining treatment protocols. Clinical trials have been conducted on patients with lymphedema, upper limb disorders, and muscle-tensive headaches.
The project resulted in significant reduction of edema and pain in treated patients, improving quality of life and upper limb function. Clinical trials, conducted on more than 100 patients, demonstrated the effectiveness of its device in treating these complex conditions, without recording significant side effects.
Focusmed’s technological innovation helps to increase treatment options for patients, but it also has reduced operational costs for healthcare facilities.
The Pronexibus Plus® device is now ready for commercialization, with prospects for deployment in the international market as well, marking an important step forward in the field of electromedical devices.
The amount of public support granted is €79,754.00.
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Focusmed Srl
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Mail: admin@focusmed.it
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Legislative Decree of 24 February 1997, No 46 Article 21
1. It is forbidden to advertise to the public devices that, according to provisions adopted by decree of the Minister of Health, may be sold only on prescription or may be used with the assistance of a doctor or other healthcare professional.
2. Advertising to the public of devices other than those referred to in paragraph 1 is subject to authorization by the Ministry of Health. On the requests for authorization expresses opinion the Commission of experts provided for by article 6, paragraph 3, of the legislative decree 30 December 1992, n. 541, which for this purpose is supplemented by a representative of the Department of the Ministry of Health responsible for medical devices and one of the Ministry of Industry, Commerce and Crafts.
