A novel therapeutic approach, clinically proven to be safe and effective*

Concurrent Optical and Magnetic Stimulation for promotion of wound healing*

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.

  • Non-invasive, safe, effective
  • Lightweight & portable
  • Intuitive handling and training
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Chronic wounds

Driven by diabetes and the effects of an ageing population, hard-to-heal wounds remain a major challenge for modern healthcare systems.

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.

Ulcus Cruris

Ulcus Cruris

About 1% of population suffers from venous ulcers, arterial ulcers or mixed ulcers. Source.
Diabetic Foot Ulcer

Diabetic Foot Ulcer

Diabetic foot ulcers are a common complication of diabetes and affect approximately up to 25% of the diabetic population. Source.

Mechanism of Action

Advanced wound care through concurrent optical and magnetic stimulation

Optical stimulation

Optical stimulation

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

Magnetic stimulation

Magnetic stimulation is capable modify 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 intricated 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.

COMS® Technology

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 Investigations

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.

Further information on the MAVERICKS clinical trial
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