The COMS® One therapy system is intended to promote wound healing in chronic leg and foot ulcers, in addition to standard of care.* The device is locally applied to the wound area for 16 min, 2-3 times per week, over a recommended duration of 6-8 weeks.
*The COMS® One therapy system is not cleared in the US.
Chronic cutaneous ulcers are defined as wounds which fail to proceed through phases of wound healing in an orderly and timely manner to produce a durable structural functional and cosmetic closure. Macro and microvascular disorders are some of the most frequent causes for a delayed wound healing process.
Photobiomodulation is a non-thermal process which involves endogenous light absorbing molecules that elicit photo-physical events at biological scale. Light in the far red to near infrared spectral range using low energy light emitting sources is reported to be especially bio-modulative. Triggering phase transitions in the active centre of Cytochrome C oxidase, facilitates the substrate to product conversion and augments the turnover rates of the enzyme. A kick-start for cellular respiration. Photobiomodulation has now accumulated evidence of a positive action on all phases of wound repair from the first inflammatory phases to the remodelling phase. Source.
In healthy tissue, the body's endogenous electric fields guide the wound healing processes. In chronic wound situations, where the surrounding tissue is poorly perfused, such endogenous electric currents are found to be reduced. Via time varying magnetic fields, small electric currents can be induced in biological tissue. Feigning these endogenous electric currents in a chronic wound situation is promising to restore tissue integrity and promote wound healing.“Magnetic fields have been associated with an intense anti-inflammatory action, mediated by the shift in the production of cytokines from a pro-inflammatory pattern to an anti-inflammatory pattern. This can speed up the movement from the chronic inflammatory phase, which is typical for chronic wounds, to a more pro-reparative phase of tissue repair. Source.
The COMS® One therapy system incorporates the technologies for optical and magnetic stimulation. The optical stimulation component of the COMS® One Therapy System is designed to emit light by two types of LEDs in the wavelength of 660 nm (red) and 830 nm (near infrared) range of the electromagnetic spectra. The magnetic stimulation component is generated by a coil emitting pulse modulated magnetic fields in the extremely low frequency (ELF) range of the electromagnetic spectra.
Piomic is conducting clinical research to investigate the safety and efficacy of concurrent optical and magnetic stimulation in chronic foot and leg ulcers.
The MAVERICKS clinical trial focuses on the possible beneficial effects of COMS® treatment in patients suffering from therapy-refractory diabetic foot ulcers. The prospective randomized, sham-controlled, double-blinded, pivotal clinical trial will be conducted on 224 patients at up to 20 centers throughout the United States.
The trial is intended to support the marketing and reimbursement of COMS® therapy in North America.
Important Regulatory Disclaimers
The COMS One therapy system has not yet received regulatory approval in the U.S. and Canada. As such, use is limited to investigational use only in these regions. Any statement in this press release about safety and effectiveness of the system does not apply to the U.S. and Canada because the device is currently undergoing clinical investigation in these geographies.