The COMS® One therapy system is intended to promote wound healing in chronic leg and foot ulcers, in addition to standard of care.* COMS® therapy is locally applied to the wound area for 16 minutes, approximately 2 times per week, over a recommended duration of 2 months.
*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. The photodisssociation of nitric oxide further increases tissue perfusion and acts like 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.
Magnetic stimulation is capable of modifing intracellular calcium through mechanosensitive ion channels. Calcium, a vital intracellular signal, modulates cellular function and gene expression during tissue repair. Mitochondria the biological power engine of humans, is essentially regulated by calcium. To empower the intricate processes of wound healing, enough intracellular energy is essential. Additionally the supply of nutrients and oxygen, provided by adequate perfusion supports these processes. Calcium additionally regulates the production of nitric oxide a potent mediator for vasodilation and subsequent tissue perfusion. This way the magnetic stimulation acts as a kick start especially for chronic wounds.
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.
Clinical research is being conducted to evaluate the safety and performance of concurrent optical and magnetic stimulation (COMS®) in patients with chronic wounds.
MAVERICKS (United States)
The MAVERICKS clinical trial focuses on the potential benefits of COMS® therapy in patients with therapy-refractory diabetic foot ulcers. This prospective, randomized, sham-controlled, double-blinded, pivotal clinical trial will enroll 224 patients across up to 30 clinical centers in the United States.
The MAVERICKS trial is intended to support regulatory approval in the United States and global reimbursement considerations for COMS® therapy.
NAZARÉ (Europe)
NAZARÉ is a prospective, investigator-initiated, post-market clinical study evaluating COMS® therapy in patients with chronic vascular leg ulcers under real-world conditions. Launched by a consortium of leading European wound care key opinion leaders, the study reflects routine clinical practice across outpatient and home-based care environments.
NAZARÉ is designed to generate real-world evidence to inform global reimbursement discussions and long-term market access strategies.
Important Regulatory Disclaimers
The COMS One therapy system has not yet received regulatory approval in the U.S. and Canada. Any statement on this website 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 the U.S.
