RenovoRx (RNXT) Stock Climbs On FDA Clearance

RenovoRx Inc (NASDAQ: RNXT) is screaming for the top in the premarket hours this morning, and for good reason. The company announced that it has received 510(k) clearance from the FDA. Here’s what’s happening:

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RNXT Stock Climbs On FDA Clearance

In the press release, RenovoRX said that it received a new 510(k) clearance from the United States Food and Drug Administration (FDA). The clearance surrounds the company’s proprietary RenovoCath Delivery System. 

In the release, the company explained that the RenovoCath Delivery System is the device component of the Company’s initial product, RenovoGem. This 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. 

This new design provides more targeted delivery of therapy which the Company believes can translate into more effective treatment with fewer side effects. RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014.

Management Commentary

In a statement, Shaun Bagai, CEO at RNXT, had the following to offer:

Our novel RenovoTAMP therapy platform isolates the region of disease enabling delivery of the optimal dose of targeted chemotherapy to the tumor location. We believe this new design cleared through the FDA 510(k) process will further improve RenovoTAMP’s targeted delivery. Our focus is maximizing patient survival while minimizing side effects for cancer patients.

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Final Thoughts

All told, this is incredible news for the company. After all, the clearance gives the company the ability to actively market the device in the United States. As the company continues to work on trials for this drug/device combination, it is getting closer and closer to market approval for both sides of the equation, with the device side now under its belt. 

Should all continue to go well, RNXT has a real possibility of becoming a key player in the treatment of pancreatic cancer, an indication that’s met with extreme difficulty in the medical community. 

All in all, the stock is one to watch closely. 

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