BEVERLY, Mass. Nov. 18, 2024 Quanta Dialysis Technologies, a leader in transforming kidney care through its award-winning Quanta™ Dialysis System, has successfully closed its oversubscribed Series E Preferred Stock financing round, raising more than $60 million of additional capital.

Led by Novo Holdings, Glenview Capital and b2venture, with broad participation by existing shareholders, this latest funding round underscores strong investor confidence in Quanta’s market potential to revolutionize the treatment of kidney disease across a variety of settings.

With the newly secured capital, Quanta will expand its commercial presence in the US and continue to invest in cutting-edge innovation within the sector.

“Our commitment to delivering innovative solutions for acute care has never been stronger,” said Alejandro Galindo, Quanta’s Chief Executive Officer. “This financing round provides the resources to solidify Quanta as the best-in-class solution across the care continuum, to significantly expand our commercial operations, while continuing to introduce enhancements that will strengthen our long-term competitive position.”

“Quanta’s compelling product-market fit within the $1.5 billion acute care segment is demonstrated by its ability to win contracts over well-established legacy CRRT and IHD competitors,” said Robert Ghenchev, Managing Partner of Growth Investments at Novo Holdings. “The recent FDA clearance for the home setting is transformational for patients and significantly expands Quanta’s addressable market into the chronic and sub-acute segments.”

“The team at Quanta continues to deliver on their plan to offer the market a next generation dialysis system that provides exceptional quality care to patients, is easy to use and can provide substantial savings to providers,” adds Lloyd Mandell, Managing Director of Glenview Capital. “We are confident this funding will allow more patients to have access to the Quanta Dialysis System, while allowing the company to achieve their goals of reaching more customers and driving down the cost of their products.”

This milestone marks a significant step towards revolutionizing kidney care and improving patient outcomes. Furthermore, as Quanta advances its growth strategy this latest capital injection will ensure both customers and industry partners can continue to rely on the company’s robust financial foundations.

View source version on prnewswire.com: QUANTA DIALYSIS TECHNOLOGIES CLOSES OVERSUBSCRIBED SERIES E FUNDING ROUND

BEVERLY, Mass. Nov. 4, 2024 Award-winning medical technology innovator, Quanta Dialysis Technologies®, has confirmed the US Food and Drug Administration (FDA) has given 510(k) clearance for the use of its Quanta Dialysis System in the home setting. With this clearance, Quanta becomes the only company to offer a high dialysate flow (500 mL/min) system across the entire care continuum for end stage renal disease (ESRD) patients.

This significant step in Quanta’s US commercialization efforts follows another recent milestone in which the company received clearance for the first, and only, FDA-cleared device able to perform intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.

Based on 2022 data from the United States Renal Data System, of the 550,000 prevalent ESRD patients in the country on dialysis therapy, just 2.4% receive home hemodialysis (HHD). The Quanta Dialysis System (previously known as the SC+ Hemodialysis System) addresses this gap by providing patients access to a high-flow system in the home, the same offering as routinely provided in hospitals, post-acute facilities and in-center clinics.

 “The 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta,” said Quanta Chief Executive Officer Alejandro Galindo. “We recruited and executed this pivotal trial during the height of COVID-19 and have now achieved an FDA clearance few other products have obtained. As the US continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing complications and re-admissions.

“Our product is designed to help those patients seamlessly transition to the home and remain there as long as possible. We are currently planning our home launch with customers who have successfully implemented Quanta into acute and sub-acute settings first.”

Decades-Long Troubles with HHD Adoption

Across the US more than 70% of dialysis facilities are currently not certified to offer HHD, and almost half of those with certification have no active HHD patients. Much of this is attributed to the lack of FDA-cleared technologies, alongside challenges associated with the cost-of-therapy and patient ‘burnout’, caused by dialyzing with low flow technologies requiring frequent treatments.

 “Many patients prefer the flexibility of home hemodialysis – a flexible schedule, no commute, and with more frequent therapies they feel better and need less medication,” said Quanta Chief Medical Officer Dr. Paul Komenda, MHA, FRCPC, FASN. “Expanding treatment into the home is something we are constantly asked about by clinicians, advocacy groups, providers and patients. One of our major commitments as a business is to make kidney care more accessible, and with an easy-to-train, easy-to-maintain device that accommodates a high-flow HD prescription, Quanta is poised to become the best option for the home.”

Encouraging Clinical Trial Results

An FDA Investigational Device Exemption (IDE) trial of the Quanta Dialysis System was completed in October 2023, including a multi-center, open-label assessment of efficacy and safety. The trial saw 32 patients receive standard in-center hemodialysis while training to use the Quanta Dialysis System, before transitioning to perform HHD four times per week for eight weeks. The study demonstrated the device to be safe and effective, with more than 90% of patients electing to continue using the device after completing the trial.

Study results were presented at the American Society of Nephrology meeting in 2023 and the manuscript is now under review at the Clinical Journal of the American Society of Nephrology.

“Our IDE study has clearly demonstrated best in class dialysis adequacy and high patient satisfaction. Our device gives sufficient dialysis in 3x per week therapy and the option of better outcomes with higher frequency,” added Dr. Komenda.

About the Quanta Dialysis System:

As a compact device with performance comparable to larger traditional machines, the Quanta Dialysis System provides the clinical versatility needed to deliver kidney replacement therapy across multiple care settings. With an intuitive user interface and only once-weekly hot rinse requirement, the device is designed to be operated by a broad range of users to bring dialysis directly to patients.

The Royal Academy of Engineering announced Quanta Dialysis Technologies as the recipient of the 2022 MacRobert Award (the UK’s longest running and most prestigious award for UK engineering innovation), joining the ranks of Rolls-Royce, Arup and Raspberry Pi.

To learn more about Quanta and its products, visit www.quantadt.com.

The SC+ Hemodialysis System is now known as the Quanta Dialysis System.

Indications for Use – 510(k) K242269

The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription, by a trained clinician who is competent in the use of the device. The SC+ Hemodialysis System is also indicated for use in the home by trained patients in tandem with a trained care partner.

The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.

View source version on prnewswire.com: QUANTA™ DIALYSIS SYSTEM RECEIVES FDA CLEARANCE FOR HOME HEMODIALYSIS

Quanta Dialysis System becomes first-in-class to perform three standard-of-care dialysis modalities in one device

BEVERLY, Mass., Aug. 3, 2023 /PRNewswire/ — Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). Under the new 510(k), the Quanta Dialysis System is the only dialysis device FDA-cleared to provide intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED) or bagless CRRT which creates dialysate on demand – all in a single machine.

The Quanta Dialysis System was originally designed to serve the more than two million people with end-stage kidney disease (ESKD) worldwide who receive treatment with dialysis or a kidney transplant. The latest addition of its Trinal Kidney Therapy™ (TKT) software provides a treatment solution for critically ill patients diagnosed with acute kidney injury (AKI) who require dialysis. It features dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery.

“This clearance is a true game-changer for acute care settings,” said Quanta Chief Executive Officer, Alejandro Galindo. “Hospitals are often constrained with limited space and nursing staff. The Quanta Dialysis System with TKT software provides an all-in-one solution for hospitals with an intensive care unit (ICU) looking to reduce their device footprint, maximize their operational efficiencies, reduce burden on nurses and substantially lower consumables expenses.”

Mortality for ICU patients with severe AKI who need dialysis has been reported to exceed 50% in patients often requiring intravenous life support to maintain a minimum blood pressure. CRRT offers a slower and gentler alternative to conventional dialysis; continuous dialysis runs 24 hours a day as compared to traditional hemodialysis which occurs over a four-hour period enabling better real time management of volume and biochemistry for patients.

“Critically ill patients that are hemodynamically unstable, such as those with severe AKI, are more challenging to manage in the ICU balancing volume status, inotropic support and ventilation requirements. Because of its slower rate of fluid removal, CRRT may cause less stress for the patient and enable more real-time decision making for clinical teams on a minute-to-minute basis,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “However, once the hemodynamic status of the patient has improved, a transition to IHD or SLED may be the best option. A device than can perform all three modalities in one is ideal.”

Quanta is ready to commercialize the Quanta Dialysis System with TKT software and expects to officially launch the product at the 2023 American Society of Nephrology Annual Meeting.