Zurich, Switzerland – 20 January 2026 – Piomic Medical, a leader in innovative wound care solutions, announces the successful initiation of the NAZARÉ trial, a prospective post-market clinical study evaluating the COMS® One Therapy System in patients with chronic ulcers of vascular origin.
NAZARÉ (Concurrent Optical and Magnetic Stimulation for chronic vascular ulcers) is an investigator-initiated trial (IIT) launched by a consortium of leading European wound care opinion leaders. The study reflects routine clinical practice, including outpatient care and treatment in patients’ homes, addressing the growing importance of home-based wound care within modern healthcare systems.
“I am very excited that NAZARÉ has now officially kicked off,” said Prof. Dr. Sebastian Probst, Past-President of the European Wound Management Association (EWMA) and Sponsor and Principal Investigator of the study. “Generating high-quality real-world evidence is essential in chronic wound care, and this study has the potential to provide valuable insights into the role of COMS in patients with hard-to-heal vascular ulcers.”

The randomized, controlled, assessor-blinded, real-world clinical study designed to evaluate wound healing outcomes in patients with difficult-to-heal vascular leg ulcers (ABI 0.5–1.3) and is expected to enroll approximately 122 patients across multiple European countries. Recruitment began in 2025, with the study planned to conclude in 2027, generating a comprehensive real-world evidence dataset to inform clinical practice, reimbursement discussions, and long-term market access strategies. Participating Swiss centers include specialized wound clinics and university hospitals, providing a broad and representative real-world patient population.

“The University Hospital Zurich is pleased to participate in the NAZARÉ study,” said Prof. Dr. med. Jürg Hafner, Investigator at the University Hospital Zurich and Past-President of the International Society for Dermatologic Surgery (ISDS). “We see strong clinical relevance in evaluating innovative, non-invasive therapies such as COMS in a real-world setting, particularly for patients with limited treatment options.”

“NAZARÉ represents an important step in generating robust real-world evidence for COMS therapy,” said Rejelle Williams, Head of Clinical Development at Piomic Medical. “Chronic vascular ulcers remain a major unmet clinical need, and high-quality post-market data from routine care settings are essential not only to inform clinical practice, but also to support reimbursement discussions and long-term market access. By demonstrating effectiveness, usability, and integration into standard care pathways across multiple European healthcare systems, NAZARÉ is designed to create meaningful value for patients, providers, and stakeholders alike.”

Expanding Across Europe
Following successful study initiation in Switzerland, first ethics approvals have now been obtained in other countries such as Austria, Germany, France and the United Kingdom with site activations underway. First patients are expected to be randomized in these countries shortly, further expanding the geographic footprint and clinical diversity of the NAZARÉ study.

The multinational design enables evaluation of COMS across diverse healthcare systems, increasing the relevance of findings for clinicians, regulators, and payers. In parallel, COMS is being evaluated in the U.S. in the MAVERICKS study, a pivotal FDA-regulated IDE trial. Together, NAZARÉ and MAVERICKS provide a complementary real-world and pivotal evidence package to support global regulatory, reimbursement, and market access strategies.
Full study details are available on ClinicalTrials.gov:
👉https://clinicaltrials.gov/study/NCT06528873

About the NAZARÉ Study
NAZARÉ is an investigator-initiated, post-market clinical study designed to assess the safety and effectiveness of concurrent optical and magnetic stimulation (COMS) in chronic vascular leg ulcers under real-world conditions. The study evaluates healing outcomes, usability, and integration into standard wound care pathways.

About Piomic Medical AG
Piomic Medical AG is a Swiss medical device company developing innovative, non-invasive therapies for hard-to-heal wounds. Its flagship technology, the COMS® One Therapy System, delivers concurrent optical and magnetic stimulation to support tissue repair across all phases of wound healing. Piomic combines strong scientific foundations, global IP protection, and deep clinical expertise to address one of healthcare’s most persistent challenges.

Zurich, Switzerland – August 15 2025 – Piomic Medical, today announced the publication of the clinical protocol for its pivotal MAVERICKS IDE (Investigational Device Exemption, NCT05758545) trial in the renowned peer-reviewed journal WOUNDS — The Trial Design of the Concurrent Optical and Magnetic Stimulation (COMS®) Therapy Study for Refractory Diabetic Foot Ulcers (MAVERICKS): A Multicenter, Randomized, Sham-Controlled, Double-Blind Investigational Device Exemption Clinical Study (WOUNDS. 2025;37(8):275-282. doi:10.25270/wnds/25037).The protocol was authored by nationally respected U.S. Key Opinion Leaders, reflecting the trial’s unparalleled scientific credibility and clinical relevance.

MAVERICKS — A Landmark Study Designed with Regulatory and Payer Alignment

The FDA approved MAVERICKS trial was designed with direct Medicare involvement, ensuring the results will be applicable to the Medicare beneficiary population. The trial received approval for Medicare Category B coverage, reimbursing not only standard of care (SOC) supplies and services but also the cost of COMS® therapy.

MAVERICKS will enroll 224 patients across up to 30 sites nationwide, spanning all major places of service, from outpatient wound clinics and physician offices to VA hospitals and including medical specialties such as vascular surgery, podiatry, endocrinology, plastic surgery, general surgery, internal medicine, and family medicine. Multiple participating study sites rank among the highest-performing wound care programs in the US.

Complexity and Bias Reduction at the Highest Level

The study is designed with rigorous methodology to address and reduce challenges frequently associated with wound care clinical trials, such as variability in wound assessment, inconsistent application of therapy, and bias from patient or clinician expectations. This is one of the most comprehensive and methodologically robust wound care device trials ever conducted:

• Sham-control arm to isolate true therapeutic benefit from potential placebo effect
• Double-blinding to eliminate patient and clinician expectation bias
• Centralized, blinded endpoint adjudication for objective wound healing measurement
• Extended 4-week run-in period to confirm non-healing (refractory) wound status and align with the latest CMS reimbursement guidelines for advanced therapies

The result is a trial designed to meet standards for market clearance and to produce payer-ready evidence for coverage and payment decisions, and to drive adoption with providers serving the Medicare population.

“With a long-standing research interest in wound care, I view the MAVERICKS trial as a groundbreaking and truly unique effort. Its rigorous methodology not only advances wound care research but also establishes a strong foundation for COMS reimbursement, paving the way for broader access to this innovative therapy,” said Aksone Nouvong, DPM, National Principal Investigator for MAVERICKS.

Reimbursement Environment Driving the Need for New Modalities

The U.S. wound care landscape is undergoing significant reimbursement reform. Proposed Local Coverage Determinations (LCDs) from Medicare Administrative Contractors (MACs) targeting cellular and/or tissue-based products (CTPs), including pricing caps, are set to reshape access to advanced wound therapies. This shift underscores the urgent need for novel treatment modalities that are clinically proven, cost-efficient, and deployable across a broader range of care settings.
COMS® therapy is uniquely positioned to meet this need. Unlike CTPs, platelet-rich plasma (PRP), or other advanced therapies that can be limited by cost, storage, or procedural complexity, COMS® is:

• Non-invasive and easy to administer in any setting
• Intuitive and mobile by design, enabling effective use across diverse care settings such as mobile wound care clinics and outpatient offices.
• Designed for consistent application without variability in tissue quality or operator technique.

In addition, the MAVERICKS trial specifically recruits refractory patients, which is a vulnerable, high-risk population due to the devastatingly high mortality rates observed when wounds fail to heal under standard of care and progress toward amputation. COMS® has the potential to significantly advance wound treatment, making it more accessible across diverse care settings and patient populations

Two Gold-Standard Trials to Drive Market Access

Piomic is conducting two gold-standard randomized controlled trials to support U.S. market clearance and global reimbursement for COMS® therapy:

• MAVERICKS — FDA IDE–approved and Medicare Category B–covered; a combined pivotal and reimbursement trial evaluating COMS® therapy in a high-mortality, refractory wound population.
• NAZARE — an investigator-initiated, real-world reimbursement trial in Europe evaluating COMS® therapy for vascular wounds in a home care setting.

Together, these studies form the evidence backbone for for U.S. market entry and continued global expansion.

“Publishing this protocol is a key step in delivering on our mission to make COMS® therapy accessible to patients who need it most,” said Christopher Hertz, CEO of Piomic Medical. “The trial’s design is not only clinically robust but also uniquely positioned to meet payer requirements and provider expectations from day one.”

About Piomic Medical
Piomic develops innovative medical devices for hard-to-heal wounds, based on its proprietary COMS® therapy (Concurrent Optical and Magnetic Stimulation) designed to enhance tissue regeneration in both chronic and acute wounds. Next-generation applications target infection management and soft tissue repair. COMS® therapy has been applied in over 2,000 patients in Europe, showing promising results across multiple wound types, including severe pressure injuries, for which it received the EPUAP Most Innovative Product Award in 2024.

Important Regulatory Disclaimers
The COMS® One therapy system is currently investigational in the U.S. and Canada and has not yet received regulatory approval in either region.

Zurich, Switzerland – 14 March 2025 – Piomic Medical, proudly announces that its new research and development project, COMS® Blue, has been awarded funding through Eureka and the Eurostars program. Eurostars is Europe’s largest international funding initiative for collaborative R&D projects driven by highly innovative SMEs, supporting the creation of new products, processes, or services for commercialization.

As one of 25 Swiss companies selected, Piomic Medical will collaborate closely with Fraunhofer IZM – a leading Research Institute for Reliability and Microintegration – and reanmo – a forward-thinking software company focused on user-centric digital solutions.
The goal of this project is to complement Piomic Medical’s COMS® treatment pipeline with an innovative solution for treatment and prevention of chronic and acute wound infections. COMS® Blue leverages real-time diagnostics, paired with digital health applications, ensuring a more targeted and personalized treatment of infections in wound care.
A pressing trend in recent years is the rise of antimicrobial Resistance (AMR) and Surgical Site Infections (SSI). Drug-resistant bacteria are increasingly common causes of SSIs, complicating treatment and outcomes.¹

“We are honored by Eurostars’ recognition of our commitment to advancing both the treatment and diagnosis of infected wounds,” said Jari Kruth, CTO of Piomic Medical. “By combining our innovative platform technology with Fraunhofer IZM’s engineering expertise and reanmo’s software capabilities, we’re enhancing patient care while also taking direct aim at the urgent threat of AMR and rising incidence of SSIs.”

Recent global analyses put the pooled incidence of SSIs around 2.5% of surgical procedures, adding an average of 10 days to the postoperative hospital stay and more than $20,000 in hospital costs per admission.^2,3 SSIs are associated with to a 2- to 11-fold increase in the risk of mortality with 75% of SSI-associated deaths directly attributable to the infection.^3,4 These sobering statistics underscore the urgency for advanced, antibiotic-independent treatment options like COMS® Blue.

This project has received funding from Innosuisse and Bundesministerium für Bildung und Forschung through Eureka and the Eurostars program, which is co-funded by the European Commission as part of the European Partnership on Innovative SMEs. More information on Eurostars and Eureka can be found at eurekanetwork.org.

Important Regulatory Disclaimers
COMS® Blue is still under development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between COMS® Blue therapy and investigations with the COMS® One therapy system in Europe or the United States.

Literature References
1. Monk EJM, Jones TPW, Bongomin F, Kibone W, Nsubuga Y, et al. (2024) Antimicrobial resistance in bacterial wound, skin, soft tissue and surgical site infections in Central, Eastern, Southern and Western Africa: A systematic review and meta-analysis. PLOS Global Public Health 4(4): e0003077.
2. Zimlichman, E, Henderson D, Tamir O, et al., “Health care-associated infections. a meta-analysis of costs and financial impact on the US health care system”. JAMA Intern Med, 173(22):(2013): 2039-46.
3. Ban, KA, Minei JP, Laronga C, et al., “American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update”. J Am Coll Surg, 224(1): (2017): 59-74.
4. Awad, SS, “Adherence to surgical care improvement project measures and postoperative surgical site infections”. Surgical Infect (Larchmt), 13(4): (2012): 234-7.

Zurich, Switzerland – 04 October 2024 – Piomic Medical, a leader in innovative wound care solutions, is proud to announce that the COMS® One Therapy System has been awarded the Most Innovative Product Award at the European Pressure Ulcer Advisory Panel (EPUAP) 2024 conference. This prestigious award highlights the significant potential of COMS® therapy in advancing the treatment of severe pressure ulcers, a leading cost driver in wound care with very limited treatment options.

Severe stage IV pressure ulcers account for only around 13% of pressure ulcers but are responsible for nearly 59% of the total wound care costs associated with pressure ulcers.² These ulcers are notoriously difficult to treat and pose a significant burden on healthcare systems. The COMS® One Therapy System, while not yet cleared for treating pressure ulcers, has shown promising initial data in severe cases. An abstract presented at EPUAP 2024 demonstrated an average Wound Surface Area Reduction (WSAR) of 77% and a 42% complete closure rate in stage IV ulcers, which are typically difficult to treat and represent a substantial healthcare cost burden.¹

Martin Walti, Chief Operations Officer at Piomic, commented: “We are honored to receive this recognition from EPUAP. It underscores the potential impact of our COMS® therapy in revolutionizing the treatment of severe pressure ulcers, where few options exist today. This award inspires us to continue innovating and pushing forward to bring this solution to patients globally.”

The award comes at a crucial time as Piomic Medical continues to validate the efficacy of COMS® therapy through clinical investigations. The Medicare-approved FDA IDE trial MAVERICKS is currently evaluating the potential beneficial effects of COMS® treatment in patients suffering from therapy-refractory diabetic foot ulcers. Additionally, the NAZARE trial in Europe will investigate Concurrent Optical and Magnetic Stimulation (COMS) for the treatment of patients with chronic ulcers of vascular origin in a real-world setting. These prospective, randomized, controlled clinical trials will help provide a strong foundation for future regulatory approvals and commercialization strategies across key markets.

About Piomic Medical
Piomic develops cutting-edge medical devices designed to treat hard-to-heal wounds based on its proprietary COMS® therapy, which utilizes concurrent optical and magnetic stimulation. COMS® therapy is intuitive, fits within existing clinical workflows, and offers a promising solution for healthcare professionals dealing with ulcers that do not respond to standard care. With its innovative approach, Piomic aims to reduce healthcare costs while improving patient outcomes.

Important Regulatory Disclaimers
The COMS® therapy system has not been cleared or approved by regulatory authorities for the treatment of pressure ulcers. Any statements regarding the safety and effectiveness of the system for this indication are not applicable, as regulatory clearance or approval has not yet been obtained.

Literature References
1. Sarmiento K, Casela AM, Gamboa JF, Siton VAG, Granada MJ, Ratilla J. A first-in-human evaluation of concurrent optical and magnetic stimulation in severe hard-to-heal pressure ulcers.
2. Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. International Wound Journal. 2019;16(3):634-640. doi:10.1111/iwj.13071

In the August edition of the Journal of Wound Care (JWC), a new study led by Jacques Neyens and his team in the Netherlands has further substantiated the promising outcomes of our initial research on COMS. This case series, involving 27 patients treated with COMS at the Expertise Centre for Wound Care (ECW) in Oosterhout, reinforces the positive results observed in our original pivotal trial and in real-world usage, demonstrating the effectiveness of COMS beyond the clinical setting:

”…COMS showed positive effect on wound healing in all etiologies of the wounds treated…”1

”The overall mean wound surface reduction was 69+-36%. Of the participants wounds: 12 were classified as complete wound closures in 12 weeks (50%); four as likely-to-heal (17%); four as improved healing (17%) and four as non-healing (17%).”1

“The mean value of feasibility was 9.3 +- 0.9, on a scale of ‘very hard to use’ =0 to ‘very easy to use’ =10. The confidence in the application was rated with a mean of 8.7+-1.0, on a scale of ‘very insecure application’ =0 to ‘very confident application’ =10.”1

In addition, several new findings presented by the authors stand out and deserve particular attention:

“The potential of COMS as a debridement tool in cases where sharp debridement is not feasible.”1

“The potential use of COMS for wound bed preparation (WBP) for subsequent skin grafting or skin replacement procedures.”1

“The best results were achieved in PUs and VLUs (respectively 100% and 62% categorized as completely healed).”1

1Neyens, J., Heusden, W. V., Veenendaal, D. V., & Schols, J. (2024). Effects of concurrent optical and magnetic stimulation in hard-to-heal wounds: a real-world evidence case series. Journal of Wound Care, 33(8), 560-568.

We thank Dr. J. Neyens, W. van Heusden, Dr. D. Van Veenendaal, and Prof. J. Schols for their work and dedication!
Link to free-access publication

Zurich, Switzerland – 01 March 2024 – Piomic Medical, a pioneer in the treatment of hard-to-heal wounds and management of surgical site infections, today announces that the American Medical Association (AMA) has approved the creation of two new Category III Current Procedural Terminology (CPT) codes for the COMS® One therapy system. This milestone marks an important step in facilitating reimbursement for the Company’s innovative medical device currently undergoing U.S. clinical investigations for the treatment of refractory diabetic foot ulcers.

CPT codes are used in the U.S. by physicians and public and private health insurance programs to identify specific medical services and procedures for reimbursement. Category III CPT codes, specifically designated for emerging technologies, procedures, and services, provide a temporary coding system for novel advancements. The two codes will become effective January 1st, 2025 for procedures related to the COMS® One therapy system, including application, wound assessment, dressing care and instructions for ongoing care.

This development closely follows the Centers for Medicare & Medicaid Services (CMS) Category B designation for Piomic’s pivotal IDE study called MAVERICKS. This robustly designed clinical study, poised to become the most comprehensive investigation in the wound care device industry over the past decade, will not only support the Company’s FDA De Novo submission but also establish a solid foundation for reimbursement and commercialization endeavors.

Martin Walti, Chief Operations Officer at Piomic Medical, commented: “We are delighted with the issuance of two new Category III CPT codes by the American Medical Association for our COMS® One therapy system, which is a further important step in our U.S. commercialization strategy. The introduction of CPT III coding is a pivotal development, enabling future utilization of COMS® therapy to be accurately reported. Upon FDA approval, healthcare professionals will be able to submit claims for the COMS® One therapy system, paving the way for broader adoption and supporting our commercial roll-out in the U.S.”

Bernard Laurel, President at Piomic Medical U.S., added: “Today’s announcement marks another important milestone in our U.S. commercial strategy for the COMS® One system. We are intensifying preparations for the U.S. commercial launch of this groundbreaking therapy targeting refractory diabetic foot ulcers — a patient population in dire need of innovative, advanced treatment options due to increased prevalence, elevated amputation rates and substantial morbidity. We are confidently taking steps to ensure that the introduction of COMS® therapy will be widely accepted by U.S. clinicians, while also enhancing patient quality of life and delivering meaningful benefits to payors and healthcare systems alike.”

About Piomic Medical
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. Treatment with COMS® is intuitive and conforms to the established workflow of healthcare professionals. As an advanced treatment for therapy-refractory ulcers, COMS® adds to the therapeutic armamentarium of wound care clinicians challenged with ulcers that do not sufficiently respond to standard of care regimens. With diabetes reaching epidemic levels globally, innovative therapies are essential to preventing amputations, improving patient quality of life, and minimizing the deleterious clinical and economic impacts of non-healing ulcers. COMS® was developed with input from virtually all clinical environments, allowing for its application across the full continuum of care, from in-patient facility to home care.

Important Regulatory Disclaimers
The COMS® therapy system has not yet received regulatory approval in the U.S. and Canada. As such, use is limited to investigational use only in the U.S. Any statement in this press release about the 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.

Zurich, Switzerland – 03 September 2023 – Piomic Medical, a medical device company at the forefront of innovation in the treatment of hard-to-heal wounds, announces the enrollment of their first patients in the company’s MAVERICKS U.S. pivotal clinical study sites (NCT05758545).

MAVERICKS will investigate potential beneficial effects of COMS® treatment in patients suffering from therapy-refractory diabetic foot ulcers. COMS® is the company’s proprietary technology that delivers concurrent optical and magnetic stimulation to accelerate healing of chronic 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. Recently, the Centers for Medicare & Medicaid Services (CMS) designated the MAVERICKS trial Category B designation, approving coverage for the COMS One therapy system along with associated and standard items and services.

Piomic Medical received an investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA) in November 2022. This robustly designed clinical study will support a De Novo regulatory submission for novel medical devices, and if successful in achieving FDA marketing authorization, will provide a solid foundation for reimbursement and commercialization efforts.

Dr. Heliodoro Ruiz, Principal Investigator at Clever Medical Research in Miami, FL, enrolled first patients in August. “I am honored to participate in the MAVERICKS clinical trial to evaluate the use of COMS® treatment for non-healing diabetic foot ulcers. We were excited to see previous positive results from European studies for this pioneering technology and hope to improve upon those outcomes in this U.S. trial,” said Dr. Ruiz. “It is vital for patients suffering from chronic ulcers that their wound clinicians have effective treatment options when standard of care fails. Absent such options, physicians are often limited to surgical procedures that are known to ultimately increase rates of morbidity and mortality for these compromised patients.”

Christopher Hertz, CEO of Piomic Medical, commented, “This is an important milestone for the company, and I would like to personally thank Dr. Ruiz and his entire research team for their diligent recruitment and enrollment efforts.” Mr. Hertz added, “Our partnership with all our principal investigators is highly valued and instrumental in our efforts to bring COMS® to the U.S. market. We look forward to working with the participating study sites as we gain traction and enrollments for ongoing clinical validation.”

About Piomic Medical
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. Treatment with COMS® is intuitive and conforms to the established workflow of healthcare professionals. As an advanced treatment for therapy-refractory ulcers, COMS® adds to the therapeutic armamentarium of wound care clinicians challenged with ulcers that do not sufficiently respond to standard of care regimens. With diabetes reaching epidemic levels globally, innovative therapies are essential to preventing amputations, improving patient quality of life, and minimizing the deleterious clinical and economic impacts of non-healing ulcers. COMS® was developed with input from virtually all clinical environments, allowing for its application across the full continuum of care, from in-patient facility to home care.

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 the U.S. Any statement in this press release about the 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.

A significant milestone has been reached in the United States regarding MAVERICKS, the COMS® One therapy system pivotal study in patients with therapy-refractory diabetic foot ulcers (DFUs).

On June 20, 2023 the Centers for Medicare & Medicaid Services (CMS) determined that our COMS device, along with associated and standard items and services, has been approved for Medicare coverage purposes during Piomic’s IDE study – Category B.

Since CMS has approved our study for coverage across all Medicare Administrative regions, study sites will no longer require separate approval from local Medicare Administrative Contractors (MACs). This will enable all Piomic study sites, regardless of their location in the US, to immediately recruit Medicare patients upon site activation.

Doran Edwards, MD, former Medical Director for the Palmetto GBA Pricing, Data Analysis and Coding (PDAC) contract, and COO of Advanced Healthcare Consulting, stated, “CMS’ positive coverage decision for Medicare patients enrolled in Piomic’s IDE study is significant. It will allow study sites to enroll Medicare patients more quickly and in potentially greater numbers, while also generating valuable clinical evidence from the Medicare population. Beneficiary-specific evidence of safety and effectiveness is prioritized by CMS – and is traditionally required – when making coding, coverage and payment decisions for new technologies.”

Chronic, non-healing wounds present a significant challenge for caregivers and patients, and they have profound economic implications for healthcare systems. Through our development of the innovative and user-friendly COMS therapy system, Piomic aims to streamline the complex care delivery system for chronic wound patients in all care settings.

Zurich, Switzerland – 27 April 2023 – Piomic Medical at the forefront of innovation in the treatment of hard-to-heal wounds, today announces it has received certificates according to Medical Device Regulation (MDR) from its Notified Body, TÜV SÜD, ensuring continuous market access in the European Union (EU). The COMS One® therapy system is estimated to be within the first 10% of medical devices to be certified according to MDR.

Piomic Medical was granted the EU Quality Management System (QMS) Certificate and the EU Technical Documentation Assessment Certificate confirming that the Company’s QMS and the COMS® One therapy system are compliant with the latest regulatory standards required for medical devices in Europe. This announcement follows the recent unconditional FDA IDE approval for the MAVERICKS U.S. pivotal trial, demonstrating Piomic Medical’s compliance with the high standards of medical device regulations internationally.

Adrian Meier, Head of Quality and Regulatory at Piomic Medical, commented: “Achieving MDR certification is another major milestone and the result of our early adaptation strategy formed in 2019 to the new and more stringent regulatory requirements in Europe. Considering the actual situation, where many medical device companies still struggle to implement the new requirements, this achievement would not have been possible without the extensive and diligent work of the entire Piomic Medical team. According to EU commission information, in October 2022 approximately 10% of the existing certificates were transferred to MDR. Consequently, the transitional provisions were again extended in March 2023. We are very thankful for the opportunity to become a new customer of TÜV SÜD, our competent Notified Body and we look forward to continuing working with them.”

Christopher Hertz, Chief Executive Officer at Piomic Medical, added: “Without doubt, MDR has raised the standards for medical device regulation, and we are excited to be among the first Class II active medical device companies to receive this certification. It shows our strong commitment to complying with the highest regulatory standards for medical devices and is a demonstration of our progress in meeting the standards required for approval of the COMS® One therapy system in the U.S.”

About European Medical Device Regulation (MDR)
The MDR 2017/745 came into effect in April 2017, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovation. MDR has significantly increased the requirements in respect of technical documentation, benefit-risk evaluation, Unique Device Identification (UDI), Economic Operators, clinical data and post-market surveillance, with more stringent scrutiny of Competent Authorities and Notified Bodies. It represents the biggest change in European medical device compliance standards in more than 20 years.

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 the U.S. Any statement in this press release about the 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.

M&A experienced advanced wound care leader appointed as President of US Subsidiary Piomic Medical Inc.

Zurich, Switzerland – 02 February 2023 – Piomic Medical, at the forefront of innovation in the treatment of hard-to-heal wounds and management of surgical site infections, today announces the appointment of Bernard Laurel as the President of Piomic Medical Inc. Mr. Laurel. is a highly experienced global business executive with an exceptional track record of managing, scaling and supporting the acquisition of market leaders in the wound care industry.

“Bernard will be a critical member of our Executive Management team as we prepare for the potential commercial launch of COMS® in North America.” states Bertrand Hughes, Chairman of the Board at Piomic Medical. “His extensive experience in scaling emerging medtech companies and guiding them to successful strategic transactions will be invaluable as we initiate further clinical investigations in the US. Bernard’s previous experience in supporting clinical investigations for De-Novo technologies seeking FDA approval is very important to improve commercial readiness before Piomic Medical enters the US market. With his wealth of knowledge and experience, Bernard is sure to make a significant impact on the success of the company.“

Mr. Laurel adds: “I am excited to collaborate with the Piomic Medical Board and management team to bring COMS® therapy to patients and caregivers who need cost-effective, proven wound healing modalities. COMS® therapy is an innovative and promising intervention, especially for patients with diabetic foot ulcers that have not responded well to standard-of-care treatments. These wounds are difficult to heal and adversely impact U.S. society, most notably through the decreased quality of life, increased morbidity and mortality, and rising healthcare expenditures. Estimates suggest that chronic wound care costs the U.S. between 28 to 96 billion USD annually¹. I am eager to support Piomic’s first pivotal clinical trial MAVERICKS in the U.S. to evaluate the benefits of COMS® therapy for recalcitrant DFUs. This trial represents one of the largest undertaken for medical devices in the advanced wound care industry during the past decade.

Mr. Laurel was President & CEO of Anodyne Medical Device (initially VP Sales & Marketing) from 2013 through 2018, a leading U.S. manufacturer and global supplier of pressure ulcer treatment and prevention devices. Success during his tenure across the P&L helped facilitate a lucrative acquisition by Hill-Rom in 2016. Prior to this, he was VP of Sales & Marketing with Sanuwave, a wound care company using sonic energy, where he supported a multicenter pivotal RCT in diabetic foot ulcers while expanding international distribution. At Medela, a Swiss-based leader in breast pumps and neonatal equipment, he supported the creation and growth of the company’s new wound care division. This startup business unit focused on negative pressure wound therapy (NPWT), with Mr. Laurel playing a key role in litigation that ended a multibillion-dollar monopoly in the advanced wound care space.

Mr. Laurel holds a BS in Biology from Duquesne University and an MBA in Business Administration from the Tepper School of Business at Carnegie Mellon University.

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 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 the 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.

Reference List
1. 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.