Wound Care
The Business Unit Medical Devices (BUMD) develops innovative medical devices with a particular focus on Photodynamic Therapy (PDT).
BU MEDICAL DEFVICES (BUMD)
The Medical Devices Business Unit (BUMD) was established through the merger by incorporation of the spin-off company Molteni Therapeutics, which has been ISO 9001 and ISO 13485 certified since 2012, into its parent company Molteni Farmaceutici in December 2023.
The Business Unit is ISO 13485 certified for the design and development, production management, and commercialization of non-active medical devices for the treatment of skin lesions and ulcers. The certification also covers the design, production management, and commercialization of active devices for photodynamic therapy, as well as the production and commercialization of applicators for subcutaneous implants.
The quality system of the Medical Devices Business Unit (BUMD) ensures the consistent delivery of medical devices and related services that meet customer expectations and applicable regulatory requirements.
What is Photodynamic Therapy?
Photodynamic Therapy is an innovative technique successfully used to treat various skin conditions and disorders. It utilizes special photosensitizing substances activated by a light source at an appropriate wavelength. Once activated, the photosensitizer triggers a photodynamic reaction, producing therapeutic effects.
Depending on the nature and characterization of the compound, PDT can treat:
- Pre-cancerous lesions
- Skin imperfections and other dermatological manifestations
- Skin wounds and ulcers
- Post-trauma and post-surgical injuries
Molteni Farmaceutici offers a proprietary PDT platform designed to stimulate wound healing and tissue repair, effectively treating both infected and non-infected skin lesions and ulcers.
The Timeline of the BUMD
1991
Molteni establishes its Research and Development (R&D) department to develop two projects closely related to the field of pain therapy, the company's primary market.
1996
The research and development team began working on new potential applications of Photodynamic Therapy (PDT).
2006
The lead compound RLP068/Cl completes the preclinical phases, and the positive results achieved led Molteni Farmaceutici to spin off the project into a separate company: Molteni Therapeutics S.r.l.
2009
Molteni Therapeutics conducts the "first-in-human" study, which demonstrated the safety and tolerability of PDT treatment with RLP068/Cl formulated as a gel for topical administration.
2011
Molteni Therapeutics conducted the "Proof of Concept" study and demonstrated the efficacy and safety of the topical application of RLP068/Cl in patients with infected diabetic foot ulcers.
2012
The company transitions into a new phase focused on the development of innovative Medical Devices. Since 2012, Molteni Therapeutics has maintained a Quality Management System compliant with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards.
2013
In March 2013, Molteni Therapeutics obtained the CE Mark for the Medical Device VULNOFAST® gel.
2014
In 2014, Molteni Therapeutics obtained the CE Mark for two medical devices: in February for VULNOLIGHT®, a proprietary light source, and in December for VULNOFAST® plus, a dense liquid formulation.
2018
In 2018, Molteni Therapeutics obtained the CE Mark for two medical devices: in February for ELKOFAST® gel 0.3%, a non-sterile formulation, and in November for a device intended for subcutaneous implants.
2022
In September 2022, Molteni Therapeutics obtained the CE Mark for the Medical Device VULNOLIGHT® 4.0, a proprietary light source, in compliance with the requirements of the new Medical Device Regulation (MDR).
2023
In 2023, Molteni Therapeutics obtained the CE Mark upgrade for VULNOFAST® plus and ELKOFAST® gel 0.3% under the MDR Regulation. In December, all activities were integrated into Molteni Farmaceutici as the Medical Devices Business Unit.
2024
The journey of the Medical Devices Business Unit begins.