Diality Taps IPO Veteran as CFO to Drive Dialysis System to Market

IRVINE, CA – February 24, 2026 – Diality Inc., a medical device company poised to enter the lucrative kidney care market, has appointed Peter Donato as its new chief financial officer. The move signals a strategic shift from development to commercialization for the Irvine-based firm, which is advancing its recently FDA-cleared Moda-flx™ Hemodialysis System toward a planned 2027 market launch.

Donato, a seasoned financial executive with a formidable track record in the life sciences sector, joins Diality at a pivotal moment. The company is simultaneously enrolling patients in a clinical trial for home use of its device while preparing for its initial entry into professional care settings. His appointment is a clear indicator of Diality's ambition to secure a strong financial footing as it prepares to challenge established players in the multi-billion-dollar dialysis industry.

“Peter joins Diality at a pivotal time, as we prepare for the commercialization of Moda-flx to help more nephrologists and care teams improve the daily living of dialysis patients,” said Diality CEO, Osman Khawar, MD. “With his leadership, I am confident we will build and sustain profitable business models that enable us to make a long and meaningful impact in kidney care.”

A Financial Architect for Growth

Peter Donato brings nearly 35 years of financial leadership to Diality, with over two decades spent navigating the high-stakes world of public and private life science companies. His resume is distinguished by a history of steering companies through critical growth phases, including initial public offerings (IPOs) and high-value mergers and acquisitions.

This experience will be crucial for Diality, a privately held company that has raised $82.5 million to date, including a $28 million Series C round in 2023. Donato’s expertise in capital fundraising and scaling financial infrastructure is precisely what a pre-commercial company requires to manage its runway and prepare for the significant costs of market entry and expansion.

Prior to joining Diality, Donato served as CFO at heart failure device company Impulse Dynamics. His notable successes include co-leading the successful IPO of Neuronetics (NASDAQ: STIM) in 2018. He also played a key executive role in several major acquisitions, including the sale of surgical device firm Standard Bariatrics to Teleflex for approximately $300 million in 2022 and the $410 million sale of Assurex Health to Myriad in 2016. His extensive background also includes leadership roles at Zomedica (NYSE: ZOM), Bovie Medical (now Apyx Medical), and Cyberonics (now LivaNova), making him a veteran of the complex financial and regulatory landscape of the medical device industry.

Innovating in a Stagnant Market

Donato’s arrival coincides with Diality’s push to introduce what it calls long-overdue innovation to the renal care space. The global dialysis market, valued at over $92 billion in 2024 and projected to exceed $126 billion by 2029, is dominated by established giants like Fresenius Medical Care and Baxter International. However, it is also a field ripe for disruption, with a growing demand for more flexible, patient-centric treatment options.

Diality’s flagship product, the Moda-flx Hemodialysis System, aims to fill this gap. The system received U.S. Food and Drug Administration (FDA) 510(k) clearance in August 2024 for use in professional care settings such as hospitals and clinics. It is designed to be a user-friendly and mobile platform, featuring a compact footprint that allows for easy transport between different care environments.

Key features of the Moda-flx include a wide range of variable flow rates, allowing clinicians to customize treatments like Intermittent Hemodialysis (IHD) and Sustained Low Efficiency Dialysis (SLED) to individual patient needs. Its integrated reverse osmosis water filtration system and an intuitive graphical user interface are intended to simplify operation, combining the robust prescription capabilities of larger in-center machines with the ease-of-use promised by next-generation devices.

“The dialysis space has been overdue for innovation, and Diality is delivering it,” said Donato. “I look forward to joining the winning team at Diality and leveraging my experience in growing and scaling companies and financial infrastructure to bring much needed innovation to the renal/kidney space."

The Critical Push Toward Home Dialysis

While the initial 2027 launch will target professional settings, a significant part of Diality’s long-term strategy hinges on the rapidly growing home dialysis market. The company is actively enrolling patients in its PRESCRIBE Diality Home Hemodialysis Clinical Trial, a prospective, multicenter study conducted under an Investigational Device Exemption (IDE) from the FDA. The trial's success is critical for securing a home use indication for the Moda-flx system.

The push for home-based therapy is driven by substantial patient benefits, including greater autonomy, improved quality of life, and reduced travel burdens. Federal policy is also strongly encouraging this shift, with ambitious goals to have 80% of new kidney disease patients receive dialysis at home or receive a transplant by 2025. Despite these advantages, adoption remains low, with only about 13.7% of U.S. dialysis patients currently receiving treatment at home.

Significant barriers persist, including patient fear of performing the complex procedure without direct medical supervision, anxiety over self-cannulation, and logistical challenges like limited space for equipment and supplies. Many patients and providers also cite a lack of sufficient home support and training as major hurdles. Diality's Moda-flx, with its emphasis on user-friendliness and a simplified interface, is positioned to address some of these core challenges, but the company will need to navigate a landscape where patient confidence and robust support systems are paramount for successful adoption. Overcoming these obstacles will be key to unlocking the full potential of the home hemodialysis market.

A Strategic Play for Commercial Success

The appointment of a CFO with Donato’s pedigree is a well-established strategic play for a medtech company at Diality's stage. Moving from a research and development focus to a commercial one requires a different kind of leadership—one that can build scalable financial systems, manage investor expectations, and explore strategic pathways, including future funding rounds, partnerships, or even an eventual public offering.

With FDA clearance for professional use secured and a clinical pathway for home use underway, Diality is transitioning from a company that proves its technology works to one that must prove it can build a sustainable business. CEO Osman Khawar’s emphasis on building "profitable business models" underscores this new focus. Donato's role will be to provide the financial discipline and strategic vision necessary to translate the company's clinical and technological promise into market share and long-term profitability.

As Diality prepares for its limited market release in 2027, the addition of Peter Donato to its executive team provides a crucial piece of the commercialization puzzle. His experience in navigating the financial complexities of the life sciences industry will be instrumental as the company works to bring its innovative dialysis solution to patients and providers in a highly competitive and rapidly evolving healthcare sector.