Piomic Medical receives unconditional FDA IDE approval for U.S. pivotal trial
Piomic Medical receives unconditional IDE approval from the FDA for MAVERICKS, the pivotal study for the COMS® One Therapy System in patients with refractory diabetic foot ulcers.
MAVERICKS clinical trial focuses on the effects of COMS® therapy in patients suffering from therapy-refractory diabetic foot ulcers.
Zurich, Switzerland – 01 December 2022 – Piomic Medical, a medical device company at the forefront of innovation in the treatment of hard-to-heal wounds and management of surgical site infections, today announces that the U.S. Food and Drug Administration (FDA) has fully approved its Investigational Device Exemption (IDE) application for MAVERICKS, the COMS® One therapy system pivotal trial in patients with therapy refractory diabetic foot ulcers. The trial is intended to support marketing and reimbursement of COMS® therapy in North America.
“This is another significant milestone for Piomic and a result of a multi-year R&D program that delivered comprehensive pre-/clinical data, meeting the very high standards of the U.S. FDA”, added Martin Walti, COO of Piomic. “We are very pleased with the high level of market acceptance we are experiencing in Europe and look forward to approaching the U.S. market following the successful completion of this clinical trial and FDA granting our De Novo Classification request. With U.S. site selection already initiated, we look forward to enrolling the first U.S. patients early next year. This trial has the potential to address a huge unmet medical need and simplify the way advanced wound care is performed, especially for diabetic patients around the world.”
The MAVERICKS clinical trial focuses on 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 in 224 patients at up to 20 centers throughout the United States. Hard-to-heal wounds pose a particular challenge for patients and therapists, but also have severe economic implications for healthcare systems, and society as a whole. Every 20 seconds, a leg of a diabetic patient is amputated, remaining the leading cause of major amputations in our modern health care system1. In the U.S. alone, it is estimated that the cost of chronic wound care ranges from 28 to 97 billion USD per year2.
Piomic previously demonstrated significant clinical benefits of COMS® treatment in therapy-refractory wounds of different etiologies in a multicenter, prospective, comparative clinical study in Switzerland3. “In this study, the COMS® therapy significantly reduced the time to wound closure for hard-to-heal wounds when compared with SOC alone, and could therefore lead to substantial savings in healthcare time and costs. In addition to its clinical effectiveness, it can enable patient self-management and fasten the timely transfer of patients with persistently high-cost conditions towards a more cost-effective treatment setting.” – Reinboldt-Jockenhöfer et al.
The COMS® One therapy system was awarded CE Mark Approval in May 2020 and is commercially available in selected global advanced wound care markets during an initial soft launch phase. Over 5,500 treatments have been performed in routine clinical practice or as part of clinical trials with more than 500 patients successfully being treated, making clinicians and nurses impressed by the effectiveness and ease of use of COMS® therapy.
About Piomic Medical
There are about 50 million reported cases of patients suffering from hard-to-heal wounds, which has created a severe cost burden on global healthcare systems. The timely transfer of patients from stationary settings to less expensive post-acute care settings, such as the outpatient or home care setting, has become a top priority to reduce health care costs in developed countries. Piomic develops innovative medical devices for the treatment of hard-to-heal wounds, based on the proprietary COMS® therapy, which incorporates the technology for concurrent optical and magnetic stimulation. COMS® treatment requires minimizing training efforts and fits seamlessly into the workflow of healthcare professionals. As an adjunctive treatment, the application does not require any changes to standard of care protocols and fits well into a phase-adapted wound-healing concepts. The simplicity of use of COMS® therefore allows it to be used easily across the continuum of care, from in-patient clinic to home care. Along with the possibility for self-administration, the COMS® One device offers optimal conditions to enable patient self-management in a cost-effective manner. A market need that could not have been demonstrated more clearly than during the COVID-19 pandemic.
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.
1. Armstrong D.G., Boulton A.J.M., Bus S.A. Diabetic foot ulcers and their recurrence. N. Eng. J. Med. 2017;376:2367–2375.
2. Nussbaum SR, Carter MJ, Fife CE, et al. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Value Health. 2018;21(1):27-32.
3. Reinboldt-Jockenhöfer F, Traber J, Liesch G, Bittner C, Benecke U, Dissemond J. Concurrent optical and magnetic stimulation therapy in patients with lower extremity hard-to-heal wounds. J Wound Care. 2022;31(Sup6):S12-S21.