Fresenius Medical Care Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners

WALTHAM, Mass. ,  Oct. 24, 2019  /PRNewswire/ --  Fresenius Medical Care North America  (FMCNA), the nation's leading provider of kidney care products and services, announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to a new hemodialysis system, currently in development, that aims to prevent blood clotting without the use of blood thinner medication in most patients.

The antithrombogenic additive, Endexo ® , is being incorporated into the manufacturing process of dialyzers and bloodlines. Endexo is a polymer made of surface modifying molecules that are designed to inhibit the adsorption of protein and platelets, which in turn can potentially reduce clot risk and increase hemocompatibility. Citrasate ®   dialysate would be used with the new dialyzers and bloodlines as part of this novel system.

"Harnessing our innovational expertise, we continuously strive to make significant advances in our products and provide new solutions for people with chronic kidney disease worldwide," said Dr. Olaf Schermeier, Chief Executive Officer for Global Research and Development at Fresenius Medical Care. "Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients' well-being."

Many dialysis patients are currently prescribed blood thinners, like heparin, to reduce the risk of clotting as blood travels from their body, through bloodlines, and into the dialyzers that filter out toxins. The new technology aims to reduce the need for these blood thinners, which can have dangerous side effects. Fresenius Medical Care holds an exclusive worldwide license from Interface Biologics to apply the Endexo technology to various hemodialysis components, including dialyzers and blood lines.

"This new dialysis system builds on our commitment to innovate in ways that continuously improve patient safety and health outcomes," said   Mark Costanzo , president of FMCNA's Renal Therapies Group. "We are proud to be leading the way in designing the future of life-sustaining dialysis treatments."

"We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients," said Dr.   Robert Kossmann , chief medical officer for FMCNA. "The work to achieve this breakthrough has been years in the making and we are excited that the FDA has recognized the importance of bringing this technology to market as quickly as possible."

This FDA Breakthrough Device Designation is the second that the company has earned this year. In March, the FDA granted the designation to FMCNA's   computer-assisted ultrafiltration (UF) control software   currently in development to improve fluid management during hemodialysis and personalize treatments.

The FDA Breakthrough Device Program seeks to provide patients with faster access to technologies that provide more effective treatment or diagnosis of life-threatening or debilitating diseases by speeding up the development and review process. The FDA announced final guidance for the Breakthrough Devices Program on   December 19, 2018 . The program was established by the 21st Century Cures Act.

Research supporting the development of this new system will be presented at the American Society of Nephrology's   Kidney Week   in November.

About Fresenius Medical Care North America

Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world's largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at  https://fmcna.com.

Disclaimer

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

Media Contact:

Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com 
(781) 699-3331" data-reactid="39" id="1054653437"> Fresenius Medical Care North America

Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com 
(781) 699-3331" data-reactid="39" id="1219001020">Brad Puffer Corporate Communications

Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com 
(781) 699-3331" data-reactid="39" id="1505593461"> brad.puffer@fmc-na.com

Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com 
(781) 699-3331" data-reactid="39" id="1652593194">(781) 699-3331

Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com 
(781) 699-3331" data-reactid="39" id="1379797951"> ©   2019 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo and Fresenius Renal Technologies are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. Citrasate is a registered trademark of Advanced Renal Technologies used under license. Endexo is a registered trademark of Interface Biologics, Inc. used under license. All other trademarks are the property of their respective owners

Ripple Therapeutics Announces Evaluation and Licensing Agreements with Glaukos

October 15, 2024
TORONTO, CANADA / ACCESSWIRE / October 15, 2024 - Ripple Therapeutics Corporation, a clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants, is pleased to announce evaluation and licensing agreements with Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal disease. Ripple’s patented technology platform is based on a discovery that drugs can be chemically engineered into controlled release pharmaceuticals without the use of polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor both drug dose and duration. The advantages of this technology include lower molecular weight and higher drug loading allowing for smaller implants and a lack of degradation products which provides both a clearer regulatory path as well as an improved safety profile. With an extended duration of therapeutic benefit, this technology will also reduce the treatment burden for patients. These agreements enable Glaukos to leverage Ripple’s proprietary technology platform to create sustained release implants of targeted APIs for both glaucoma and retinal diseases. If the program is successful, the evaluation agreement will automatically convert into a licensing agreement with future milestone payments and royalties. “We believe Ripple has one of the most promising drug delivery technologies currently under development,” commented Tomas Navratil, PhD, Chief Development Officer, Glaukos. “We are pleased with the progress of our collaboration and have enjoyed working with the Ripple team as we work together to bring these much-needed sustained release products to patients with critical unmet needs.” “This is the first of what we believe will be a number of transactions using our technology platform in concert with partners’ APIs to create sustained release implants which will benefit patients with extended duration and improved safety”, commented Tom Reeves, President & CEO, Ripple Therapeutics. “We look forward to continued collaboration with the entire Glaukos team.” About Ripple Therapeutics Ripple Therapeutics Corporation is a privately held clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants. Ripple’s patented technology platform is based on a discovery that drugs can be chemically engineered into controlled release pharmaceuticals without the use of polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor both drug dose and duration. The advantages of this technology include lower molecular weight and higher drug loading allowing for smaller implants and a lack of degradation products which provides both a clearer regulatory path as well as an improved safety profile. With an extended duration of therapeutic benefit, this technology will also reduce the treatment burden for patients. www.rippletherapeutics.com Media Contact (Ripple) Julie Fotheringham, V.P. Marketing, People & Culture, Ripple Therapeutics M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

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