ISR Stock: IsoRay Flies On FDA 510(k) Clearance

IsoRay, Inc. (NYSEAMERICAN: ISR) is screaming for the top in the market this morning, and for good reason. The company’s Cesium-131 brachytherapy seeds have received 510(k) clearance as part of C4 Imaging’s Sirius positive-signal MRI. Here’s what’s going on:

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ISR Stock Heads Up On 510(k) Clearance

In the press release, C4 Imaging LLC announced that IsoRay has received U.S. Food and Drug Administration 510(k) clearance for the use of its Sirius positive-signal MRI Markers with Isoray’s Cesium-131 brachytherapy seeds. 

In the release, the company said that Sirius is implanted during the treatment of prostate cancer with brachytherapy. The product is used to facilitate brachytherapy seed localization within the prostate through the use of a single post-implant MRI procedure. 

The company went on to explain that this process allows the benefits of MRI assisted brachytherapy to be made available to all prostate cancer treated patients with brachytherapy. 

Management Commentary

In a statement, Andrew Bright, President and CEO at C4 Imaging, had the following to offer:

This is a significant milestone. Sirius MRI Markers will enable Isoray’s customers to fully utilize the benefits of MRI seed localization. We’re delighted to partner with Isoray. They are leading innovators in the use of brachytherapy to treat prostate cancer, as well as other tumors, and recognize the potential of MRI to optimize treatment quality and patient care.

The above statement was followed up by Lori Woods, CEO at ISR. Here’s what she had to offer:

This achievement represents another step forward in Isoray’s leadership in providing effective prostate cancer therapeutic tools to patients and the doctors who treat them. We are excited to partner with C4 Imaging and bring together the benefits of their innovative technology and our proprietary isotope to achieve new strides in the ongoing fight against prostate cancer.

Why This Is Exciting News

The news released this morning is overwhelmingly positive for IsoRay and its investors. First and foremost, brachytherapy is a leading, cost-effective option for the treatment of prostate cancer. 

Importantly, ISR is the world’s only producer of Cesium-131, commercially known as Cesium Blu. These brachytherapy seeds are radioactive isotopes that deliver a minimally invasive and highly targeted treatment to the site of the cancer. Furthermore, the treatment attacks cancer cells while leaving healthy tissue and organs alone. 

With this treatment, patients benefit from the rapid resolution of their side effects, giving them the ability to return to normal lives quickly. 

So, it’s no surprise that investors are so excited about ISR stock this morning. After all, this 510(k) approval likely means that the company will see a substantial increase in revenue ahead. 

It’s also worth mentioning that the news seems to have triggered a short squeeze, leading to the gains in multiples that we’re seeing in the premarket hours this morning. 

What Analysts Think About ISR Stock 

According to TipRanks, three analysts currently cover ISR stock, and the overall opinion is a positive one. Of the three analysts that cover the stock, two rate it a Buy and one rates the stock a Hold. 

The average price target on the stock sits at $1.13, with the high price target being $1.25 and the low being $1. However, it’s important to remember that these price targets don’t take the 510(k) approval that was announced today into account. As such, when analysts re-review the stock, there’s a strong chance that price targets will be greatly increased. 

Nonetheless, it’s important to keep in mind that there may be a conflict of interest among analysts and other experts. So, always do your own research. Sure, it’s fine to use expert opinions to validate your own opinions, but you should never let them make up your mind for you.  

Risks to Consider Before Buying ISR Stock 

Any time you make an investment, there will be risks that should be considered. In the case of IsoRay, the most significant risks to consider include:

  • The Company Isn’t Making Money. While the news today will likely lead to tremendous revenue growth, it’s important to keep in mind that IsoRay currently operates at a loss. As a result, if the company can’t make it to profitability before its funds run dry, the company may raise money through the sale of newly issued ISR shares, leading to dilution for existing shareholders. 
  • Commercial Risks. The FDA approval this morning was overwhelmingly exciting news. However, now the company needs to be successful in commercialization. If the treatment doesn’t quite sell as well as believed, we could see significant losses ahead. 
  • Penny Stock Risks. ISR is a penny stock. As a penny stock, it is riddled with volatility and the company’s business model isn’t quite proven. As such, there are additional risks to consider before diving in. 

Final Thoughts

All in all, the news released by IsoRay this morning proved to be overwhelmingly positive and sets the stage for tremendous growth ahead. After all, the prostate cancer is a massive one, and this is a relatively non-invasive treatment option that will allow patients to return to their normal lives relatively quickly. All in all, if you’re not paying attention to ISR yet, you’re missing out!