IsoRay Continues To Make Waves In Cancer Treatment Market

IsoRay, Inc. (ISR – $1.57), our favorite medical technology Company, is an innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head, neck and gynecological cancers.

IsoRay is the exclusive manufacturer of Cesium-131, which allows for the precise treatment of many different cancers thanks to its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation). Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form.

A few weeks ago, the University of Pittsburg Medical Center (UPMC) released a peer-reviewed publication supporting the use of Cesium-131 for prostate cancer. The report covers a 9 year effort of using Cesium-131 for the treatment of low and intermediate prostate cancer. The conclusion was: Cesium-131 seed brachytherapy offers extremely high efficacy compared to other isotopes or treatment modalities used in treating prostate cancer, with the advantage of rapid return to pre-treatment urinary function and at lower cost.

This report follows on the heels of two other publications stating significant success in treating metastatic brain cancers and gynecological cancers with Cesium-131.

More Reports Proving Cesium-131 Efficacy

Standard treatment options for localized prostate cancer include radical prostatectomy, external beam radiotherapy, and prostate brachytherapy.

• Radical prostatectomy is an invasive procedure with the highest risk of urinary incontinence and erectile dysfunction of all treatments for localized prostate cancer.
• External beam radiation has a lower risk of these complications, but requires eight weeks of daily therapy.
• Prostate brachytherapy has a significantly lower risk of urinary incontinence and erectile dysfunction when compared to radical prostatectomy, but very similar cure rates. In addition, it’s an outpatient procedure with a much faster return to full activity than radical prostatectomy.

A drawback of prostate brachytherapy has been the bothersome urinary and bowel symptoms that can accompany the procedure. Previous studies, however, have demonstrated that by using the isotope Cesium-131, the duration of these symptoms is dramatically decreased when compared to men who undergo prostate brachytherapy with the other available isotopes.

Dr. Benoit at the University of Pittsburg Medical Center noted, “Our program began using Cesium-131 in 2006 in hopes of decreasing the duration of the bothersome lower urinary tract symptoms that accompany prostate brachytherapy. Our hope was that cancer control with Cesium-131 would be equivalent to the cancer control we achieved with Iodine-125 and Palladium-103. However, our intermediate term results demonstrate that in addition to decreasing morbidity, oncologic outcomes with Cesium-131 are actually exceeding those of Iodine-125 and Palladium-103.”

Next to the UPMC report, more abstracts, posters and medical journals describe significant success stories using Cesium-131 in treating metastatic brain, gynecological and prostate cancer. These published peer reviewed studies have created a rise in leading medical institutions preparing to duplicate these study results independently and/or participate in an existing multi-institutional study.

Outstanding medical centers continue to perform Cesium-131 cases following reports by Weill Cornell, University of Kentucky and UPMC of their experiences with Cesium-131. Some notable names now utilizing Cesium-131 in treating tumors in various body sites include Massachusetts General Hospital, Johns Hopkins, Harvard Affiliate Brigham and Women’s, Princeton, New York Presbyterian, Rutgers Medical School and Barrow Neurological Institute.

First Prostate Cancer Treatments in Russia

A few weeks ago, the first prostate cancer treatments using Cesium-131 took place at Neftyanik Hospital in the city of Tyumen, Russian Federation. The Neftyanik Hospital is a rapidly evolving, multi-specialty facility developing cutting-edge programs for cancer treatment, transplantation medicine and the treatment of neurological disease, among other medical necessities.

Dr. Ivan Popov, CEO of the Neftyanik Hospital, made clear that the availability of Cesium-131 in the Russian Federation offered real hope to Russian patients. “We plan to make our facility the prominent cancer treatment facility in the region. The advantages of Cesium-131 therapy will assist us in reaching our objective.”

Financials

Mid February, IsoRay announced financial results for its second quarter, ended December 31, 2014.

Seed brachytherapy sales for the prostate and non-prostate body sites remained materially unchanged in the three months ended December 31, 2014 when compared to the three months ended December 31, 2013. GliaSite Radiation Therapy System revenues decreased by approximately 30%, which was mainly due to the reduction in purchasing volume of a distributor.

	Three Months Ended December 31		Six Months Ended December 31
Amounts in $000’s	2014	2013	2014	2013
Net Sales	1,969	1,857	3,783	3,639
Net Income	503	431	942	824
Earnings Per Share	0.03	0.02	0.05	0.04
Most important income statement data for the quarters and six months ending June 30, 2014 and June 30, 2013. Source: Company Press Release

IsoRay’s management believes that the overall market for prostate brachytherapy has continued to receive increased pressure from other treatment options with higher reimbursement rates such as intensity modulated radiation therapy (IMRT) and robotics but management believes that combining treatments incorporating brachytherapy with other modalities in the prostate, the addition of new treatment facilities, and treatment of other body sites with brachytherapy have the potential to continue to increase revenue.

While the Company remains committed to expanding its presence in the prostate market, it will continue its strategic focus on promoting the use of Cesium-131 to combat cancers in numerous other body sites, such as brain, head and neck cancer, lung cancer, and gynecological cancers.

IsoRay’s cash position remains excellent with more than $20 million in cash on its balance sheet and no debt on December 31, 2014.

Conclusion

Convincing data continue to accrue in the United States from multiple centers describing the outstanding performance of Cesium-131 brachytherapy in cancer treatment throughout the body.

The clinical evidence provided through these protocols, performed by major medical centers, prove that utilizing Cesium-131 is either equal to or better than the current standard of care alternatives, with patients enjoying an improved quality of life, remains the key to IsoRay’s success.

This data will spur interest from physicians inside and outside the U.S. who feel strongly about offering highly effective, low impact cancer treatment to their patients.

With over $20 million cash in the bank and no debt, IsoRay won’t need to raise capital in the next few years. And with the anticipated addition of new studies being launched and the expectation of other study results being made public through future peer reviewed publications, management expects awareness of Cesium-131 to grow within the medical community.

We initially recommended IsoRay a little over a year ago at $0.75. Shares since then have seen a significant rally all the up to $3.77, for a profit of over 400%, but have since pulled back. If you don’t own shares yet, this remains an excellent entry point for an up and coming company with a revolutionary product in the cancer treatment market.

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