- The FDA has granted a new 510(k) clearance to RenovoRx Inc's RNXT RenovoCath Delivery System.
- The RenovoCath Delivery System is the device component of the Company's initial product, RenovoGem.
- The drug/device combination used in RenovoRx's Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform is a dual-balloon infusion catheter delivering chemotherapy directly to tumors via arteries.
- The new design provides more targeted therapy delivery, translating into more effective treatment with fewer side effects.
- RenovoRx received it's initial 510(k) for the RenovoCath delivery system in 2014.
- RenovoRx is conducting a Phase 3 trial utilizing the RenovoTAMP platform to evaluate RenovoGem in pancreatic cancer.
- The study has reached 44% patient enrollment and is expected to involve approximately 200 participants.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: RNXT shares are up 64.9% at $13.01 during the premarket session on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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