Nuwellis (Nasdaq:NUWE) announced today that it entered into a supply and collaboration agreement with DaVita (NYSE:DVA).
The agreement enables Nuwellis — formerly CHF Solutions — to pilot its Aquadex ultrafiltration therapy within selected U.S. markets. Aquadex, which removes excess fluid from patients suffering from hypervolemia (fluid overload), treats congestive heart failure and related conditions.
DaVita offers extracorporeal therapies like continuous renal replacement therapy and apheresis. The company recently launched a joint dialysis venture with Medtronic called “Mozarc Medical.”
Pairing Aquadex with DaVita’s care team could expand access to ultrafiltration therapy, Nuwellis said. The company also aims for this deal to reduce related healthcare costs for providers and payers.
“We are honored that DaVita is collaborating with Nuwellis to pilot a services model alongside Aquadex,” said Nestor Jaramillo, Jr., president and CEO of Nuwellis. “We believe DaVita’s clinical infrastructure could potentially help accelerate the clinical adoption of ultrafiltration when first-line medical treatments are ineffective. Our clinical and commercial teams are excited and ready to begin working together on the pilot program to introduce ultrafiltration to a broader patient population.”
More details on the agreement between Nuwellis and DaVita
Nuwellis and DaVita expect their pilot program to launch by the end of the third quarter. They plan for it to extend through May 31, 2024.
Through the pilot, the companies plan to make Aquadex available at a combination of DaVita’s hospital customers and outpatient centers. Both companies intend to collaborate on the therapy’s rollout, clinician training and patient support. The agreement includes an option for DaVita to extend its supply agreement with Nuwellis for up to 10 years.
In conjunction with the agreement, Nuwellis issued DaVita a warrant for approximately 1.3 million shares of its common stock. The warrant remains subject to certain vesting milestones and a blocker that prevents the exercise of the warrant for a number of shares totaling greater than 19.9% ownership in Nuwellis.
Nuwellis also granted DaVita registration rights to participate in future equity financings. In each case, the rights are conditioned on DaVita electing to extend the agreement upon completion of the pilot.
“Ultrafiltration therapy using Aquadex is a novel solution for patients suffering from fluid overload – a key driver of negative outcomes in heart failure patients. It offers clinicians the opportunity to restore fluid balance and alleviate heart failure symptoms precisely and gently,” said Dr. John Jefferies, chief medical officer of Nuwellis. “We believe the pilot with DaVita can support the role ultrafiltration can play in heart failure patient management and could enable accelerated commercial expansion of this therapy.
“Near-term, there’s value in providing these services in acute settings for hospital patients. Nuwellis also sees a future path to treating heart failure patients earlier, in outpatient settings.”