Isoray – Treating Prostate Cancer with Brachytherapy https://isoray.com Treating cancer with Cesium 131 Tue, 12 May 2020 20:10:27 +0000 en-US hourly 1 https://i1.wp.com/isoray.com/wp-content/uploads/2020/05/android-chrome-192x192-1.png?fit=32%2C32&ssl=1 Isoray – Treating Prostate Cancer with Brachytherapy https://isoray.com 32 32 117498881 Centers for Medicare and Medicaid Services Approves Isoray’s Application for Billing Codes for the Intraoperative Use of Cesium-131 https://isoray.com/2020/05/centers-for-medicare-and-medicaid-services-approves-isorays-application-for-billing-codes-for-the-intraoperative-use-of-cesium-131/ Tue, 12 May 2020 20:08:00 +0000 https://isoray.com/?p=8267 RICHLAND, WASHINGTON –  May 12, 2020 – Isoray, Inc. (NYSE American: ISR) today announced that the Centers for Medicare and Medicaid Services (CMS) has approved 64 ICD-10-PCS billing codes used for reimbursement of Cesium-131 (Cesium Blu™) for the hospital in-patient DRG setting. The codes allow hospitals to bill Medicare and other health insurers for specific […]

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RICHLAND, WASHINGTON –  May 12, 2020 – Isoray, Inc. (NYSE American: ISR) today announced that the Centers for Medicare and Medicaid Services (CMS) has approved 64 ICD-10-PCS billing codes used for reimbursement of Cesium-131 (Cesium Blu™) for the hospital in-patient DRG setting. The codes allow hospitals to bill Medicare and other health insurers for specific surgical procedures that would benefit from the addition of Cesium-131. DRG or diagnostic related groups are designed for Medicare and other health insurers to set payment levels for hospital in-patient services.

The 64 ICD-10-PCS codes are important for the growing surgical applications of Cesium-131 in treating a significant range of hard to treat cancers including brain, lung, head and neck, abdominal, breast, gynecological, pelvic, and colorectal cancers. The new codes take effect on October 1, 2020.

Isoray CEO Lori Woods said this is a key development in the use of Isoray’s proprietary isotope. “We view the creation of these new codes as a very positive step forward in promoting patient access to treatment with Cesium-131 and ensuring that hospitals receive fair and adequate reimbursement for providing brachytherapy services with Cesium-131. Isoray is committed to continuing to work with CMS officials, policymakers, health insurers and other stakeholders in the oncology community to promote patient access to brachytherapy with Cesium-131.”

Woods noted that the opportunities presented by the approval of these extensive billing codes come at a time when Isoray is seeing increased awareness and expanded use of Cesium-131 for a variety of hard to treat cancers throughout the body. “We believe that with the growing experiences of our customers in treating difficult to treat cancer tumors with our proprietary isotope, specific coding pathways will support further considerations of the use of Cesium-131 in a hospital in-patient setting,” she said.

Isoray is the world’s only supplier of Cesium-131. Brachytherapy (internal radiation therapy) with Cesium-131 seeds is high energy with a short half-life. Cesium-131’s energy is powerful, allowing it to attack the cancer being treated. Its short half-life means the radiation delivers its treatment dose quickly reducing other issues for the patient that can come from prolonged radiation exposure. Unlike external beam radiation, Cesium-131 internal radiation therapy is able to deliver a precise dosage and placement of Cesium-131 seeds avoiding healthy tissues and organs.

Contact

Media and Public Relations: Sharon Schultz (302) 539-3747
Investor Relations: Mark Levin (501) 255-1910

About Isoray

Isoray, Inc., through its subsidiary, Isoray Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook/isoray. Follow us on Twitter @Isoray.

Safe Harbor Statement

Statements in this news release about Isoray’s future expectations, including: the advantages of Cesium-131 and receiving billing codes for reimbursement for the “in patient” setting, whether demand for and use of Cesium-131 will occur as anticipated, continued positive industry data fueling renewed interest in brachytherapy patient results, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing Isoray, Inc. of the protections of the safe harbor provisions of the PSLRA.  It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as the extent to which the procedures are performed as “in patient” services, physician acceptance, training and use of our products, whether ongoing patient results are favorable, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, changes in laws and regulations applicable to our products, and other risks detailed from time to time in Isoray’s reports filed with the U.S. Securities Exchange Commission. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

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Isoray Announces Record Third Quarter Fiscal 2020 Financial Results https://isoray.com/2020/05/isoray-announces-record-third-quarter-fiscal-2020-financial-results/ Tue, 12 May 2020 20:05:00 +0000 https://isoray.com/?p=8257 Record Revenue and Gross Profit Revenue Increased 50% Year-Over-Year RICHLAND, WASHINGTON – May 12, 2020 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced its financial results for the third quarter fiscal 2020 ended March 31, 2020. Revenue for the […]

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Record Revenue and Gross Profit
Revenue Increased 50% Year-Over-Year

RICHLAND, WASHINGTON – May 12, 2020 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced its financial results for the third quarter fiscal 2020 ended March 31, 2020.

Revenue for the third quarter of fiscal 2020 grew 50% to a record $2.88 million versus $1.92 million in the prior year comparable period. The company’s core prostate brachytherapy revenue grew 42% when compared to the fiscal third quarter of 2019. Prostate brachytherapy represented 84% of total revenue for the third quarter of fiscal 2020 compared to 88% in the prior year comparable period. The majority of non-prostate brachytherapy revenue in the quarter was comprised of sales to treat brain cancer, including sales of GammaTile® Therapy.  Net new physician customer count for the twelve-month period ending March 31, 2020 increased 33% versus the prior year comparable period.

Gross profit as a percentage of revenues increased to 59.2% for the three months ended March 31, 2020, versus 45.7% in the prior year comparable period. Third quarter gross profit increased 94% to $1.71 million versus $0.88 million in the third quarter of fiscal 2019, largely attributed to increased sales and lower isotope unit costs compared to the prior year comparable period.

Isoray CEO Lori Woods said, “We are very pleased with the considerable progress we continue to achieve and the accelerated growth we realized in the quarter ended March 31st. This quarter generated the top three single highest revenue months in the company’s history. We believe this is an important indicator of enduring momentum and further advancement.”

As a result of the COVID-19 pandemic, Isoray did experience some impact from government guidelines that were issued prohibiting many non-emergency surgical procedures including brachytherapy. This led to the cancellation or postponement of treatments that were scheduled for late March and April.  As a result, preliminary sales for the month of April declined 20% versus April of 2019.

“While this did initially impact sales, we are hearing from many of our customers who tell us we should expect orders to pick-up from pent-up demand. Orders are already picking up. We began seeing growth in late April which has continued. We firmly believe that most, if not all, of the delayed procedures will take place over the next few months. We are optimistic about what is to come because we believe the resumption of procedures serves as a strong foundation for continued expansion,” Woods explained.

Driven by the 50% sales growth, total operating expenses increased 10% in the third quarter to $2.25 million compared to $2.04 million in the prior year comparable period. Total research and development expenses decreased slightly compared to the prior year comparable period. Sales and marketing expenses increased 25% versus the prior year comparable period. The increase in sales and marketing expenses was driven primarily by increased incentive compensation related to the increase in revenue as well as an increase in physician-led training expenses but was partially offset by a decrease in travel expenses due to COVID-19. General and administrative expenses increased 5% versus the prior year comparable period, primarily the result of increased payroll expenses due to increased headcount and incentive compensation, insurance premiums, and public company related expenses which were offset by a decrease in the company’s Washington State Hazardous Substance Tax, as well as reduced legal, travel, and employee hiring expenses.

The net loss for the three months ended March 31, 2020, was $0.55 million or ($0.01) per basic and diluted share versus a net loss of $1.13 million or ($0.02) per basic and diluted share in the comparable prior year period. Basic and diluted per share results are based on weighted average shares outstanding of approximately 67.6 million for the three months ended March 31, 2020, versus 67.3 million in the comparable prior year period.

For the first nine months of fiscal 2020 ended March 31, 2020, revenue increased 37% to $7.40 million versus $5.39 million in the prior year comparable nine-month period. Prostate brachytherapy represented 87% of total revenue for the first nine months of fiscal 2020 compared to 88% for the first nine months of fiscal 2019. Driven by the 37% sales growth, total operating expenses for the first nine months of fiscal 2020 increased 1% to $6.34 million, versus $6.28 million in the prior year comparable nine-month period. The net loss for the first nine months of fiscal 2020 was $2.26 million, or ($0.03) per basic and diluted share, compared to a net loss of $4.05 million, or ($0.06) per basic and diluted share, in the prior year comparable nine-month period. Basic and diluted per share results are based on weighted average shares outstanding of approximately 67.4 million for the nine months ended March 31, 2020, versus 66.9 million in the comparable prior year nine-month period.

Cash, cash equivalents, and certificates of deposit at the end of the third quarter of fiscal 2020 totaled $2.41 million and the company had no debt. Shareholders’ equity at the end of the third quarter of fiscal 2020 totaled $5.82 million.

Conference Call Details

The company will hold an earnings conference call today, May 12, at 4:30 p.m. ET/1:30 p.m. PT to discuss operating results. To listen to the conference call, please dial 844-602-0380. For callers outside the U.S., please dial 862-298-0970.

The conference call will be simultaneously webcast and can be accessed at https://www.webcaster4.com/Webcast/Page/2199/34448 by clicking on the link. The webcast will be available until August 12, 2020 following the conference call. A replay of the call will also be available by phone and can be accessed by dialing 877-481-4010 and providing reference number 34448. For callers outside the U.S., please dial 919-882-2331 and provide reference number 34448. The replay will be available beginning approximately one hour after the completion of the live event, ending at 4:30 pm Eastern Time on May 19, 2020.

Contacts

Investor Relations: Mark Levin (501) 255-1910
Media and Public Relations: Sharon Schultz (302) 539-3747

About Isoray

Isoray, Inc., through its subsidiary, Isoray Medical, Inc., is the sole producer of Cesium Blu brachytherapy seeds, which are expanding brachytherapy treatment options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium Blu by visiting www.isoray.com. Join us on Facebook and follow us on Twitter.

Safe Harbor Statement

Statements in this news release about Isoray’s future expectations, including: the anticipated continued growth in revenues in fiscal year 2020, the impact of COVID-19 on our financial results, suppliers, scheduling of procedures, and employees, lower isotope costs, advantages of our products including Blu Build and the GammaTile Therapy delivery system, whether interest in and use of our Cesium Blu  products will increase or continue, whether use of Cesium-131 in non-prostate applications will continue to increase revenue, whether further manufacturing and production process improvements will be completed or will result in lower costs, whether our market presence and growth will continue, the positive industry data fueling renewed interest in brachytherapy, strong patient results, the perception by patients of quality of life outcomes, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing Isoray, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, market acceptance and recognition of our rebranded products, our ability to successfully manufacture, market, and sell our Blu Build products and the success of the GammaTile Therapy, the length and severity of the COVID -19 pandemic, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released that support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards, the success of our sales and marketing efforts, changes in reimbursement rates, the procedures and regulatory requirements mandated by the FDA for 510(k) approval and reimbursement codes, changes in laws and regulations applicable to our products, the scheduling of physicians who either delay or do not schedule patients in periods anticipated, the use of competitors’ products in lieu of our products, less favorable reimbursement rates than anticipated for each of our products, and other risks detailed from time to time in Isoray’s reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ISR Q3 2020 Earnings Press Release_May 12 2020

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Isoray To Announce Third Quarter Fiscal 2020 Financial Results on May 12, 2020 https://isoray.com/2020/05/isoray-to-announce-third-quarter-fiscal-2020-financial-results-on-may-12-2020/ Mon, 04 May 2020 12:13:00 +0000 https://isoray.com/?p=7892 Conference Call is May 12 at 4:30 p.m. ET/1:30 p.m. PT RICHLAND, WASHINGTON – May 4, 2020 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in brachytherapy powering expanding treatment options throughout the body, today announced that it will host a conference call to discuss its financial results for the third […]

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Conference Call is May 12 at 4:30 p.m. ET/1:30 p.m. PT

RICHLAND, WASHINGTON – May 4, 2020 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in brachytherapy powering expanding treatment options throughout the body, today announced that it will host a conference call to discuss its financial results for the third quarter fiscal 2020 ended March 31, 2020 on Tuesday, May 12, 2020, at 4:30 p.m. Eastern Time. The Company will issue a press release announcing its financial results for the third quarter fiscal 2020 after the close of the U.S. stock markets on May 12, 2020.

To listen to the conference call, please dial 844-602-0380. For callers outside the U.S., please dial 862-298-0970.

The conference call will be simultaneously webcast and can be accessed at https://www.webcaster4.com/Webcast/Page/2199/34448 by clicking on the link. The webcast will be available until August 12, 2020 following the conference call. A replay of the call will also be available by phone and can be accessed by dialing 877-481-4010 and providing reference number 34448. For callers outside the U.S., please dial 919-882-2331 and provide reference number 34448. The replay will be available beginning approximately one hour after the completion of the live event, ending at 4:30 pm Eastern Time on May 19, 2020.

Contact

Investor Relations: Mark Levin (501) 255-1910

Media and Public Relations: Sharon Schultz (302) 539-3747

About Isoray

Isoray, Inc. is a medical technology company pioneering advanced treatment applications and devices to deliver targeted internal radiation treatments for cancers throughout the body.

Isoray, Inc., through its subsidiary, Isoray Medical, Inc., is the sole producer of Cesium-131 brachytherapy seeds. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook and follow us on Twitter.

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When is a change worth the trouble for brachytherapy? https://isoray.com/2020/04/when-is-a-change-worth-the-trouble-for-brachytherapy/ Tue, 07 Apr 2020 14:45:00 +0000 https://isoray.com/?p=7676 Gains in engagement, conformal coverage, seamless logistics, planning, and procedural efficiency drive Wisconsin brachytherapy program’s transition to Cesium Blu™.

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Gains in engagement, conformal coverage, seamless logistics, planning, and procedural efficiency drive Wisconsin brachytherapy program’s transition to Cesium Blu™.

“If it ain’t broke, don’t fix it.” The ageless axiom holds true in so many circumstances that it will almost certainly outlive us all.

The radiation oncology team at Aurora Health in Green Bay had built a successful brachytherapy program dating to 1998 using Palladium as their isotope of choice.  Why should they take a chance and change something that had a history of benefiting patients?

“We were seeing cure rates in the 90 to 95 percent range with Palladium for our low and intermediate-risk cases,” Dr. David Rohde, a Radiation Oncologist from Aurora Health, told us. “Toxicity, inclusive of lingering frequency and urgency in urination, was not a tremendous problem.”

Why make the change?

“Remaining ‘out in front’ of new technology helps us keep our urologist partners interested in the program,” Dr. Rohde continued. “We were onboard very early with real-time dosimetry. The advent of the robotic surgery systems certainly created a lull in our program. But that system has not shown superior overall outcomes compared to radiation, including brachytherapy, especially for low-risk cases.”

“The opportunity to reduce patients’ urinary bother in half of the time thanks to Cesium Blu™’s energy and the short half-life is a benefit that merited investigation and ultimately a transition in isotopes for our practice.”

Adapting to a more efficient process for all

Cesium-131 became available for prostate brachytherapy in 2004. Encouraged in part by compelling new long-term outcomes data, Dr. Rohde’s team is part of a growing number of radiation oncologists transitioning to Cesium Blu as their isotope of choice for prostate brachytherapy.

A critical step in the transitioning process involved Medical Physicist Peter Heiberger’s visit with Dr. David Marshall’s Charleston, South Carolina practice. Dr. Marshall has been using Cesium Blu™ by Isoray for select prostate cancer cases and pioneering the advancement of the Blu Build real-time brachytherapy device from Isoray.

“Our experience with Dr. Marshall was fantastic,” Peter said. “Our techniques are quite similar to his making it very much an apples to apples transitioning experience. There are a few items we took away that we have already put into practice like capturing contours in smaller slices with higher levels of detail for example. But confirmation of what we are doing well in our program through Dr. Marshall, and what we could anticipate when transitioning isotopes, was of very high value.”

Early impressions of the power of Cesium Blu

Initial concerns about side effect severity have abated in the absence of observed and reported worsening urinary toxicity since switching to Cesium Blu. Dosimetry planning also happens more quickly, they report.

“Because of Cesium’s higher energy, fewer seeds are needed, which naturally reduces planning time,” Peter said. “Fewer seeds also means fewer needles are needed, which makes the entire implant procedure more efficient. Everyone is strapped for time. Shorter procedures mean a superior patient experience and benefits to clinicians as well.”

“Conformal coverage has been surprising,” Dr. Rohde said. “We are able to keep our distance from healthy tissues including the urethra while still getting great coverage with Cesium. It’s an ideal isotope for prostate brachytherapy.”

“When it comes to our isotope of choice, our urologists are mostly ambivalent. They are happy to place the needles where we want them. They are happy to place fewer of them per procedure, and they rely on us to keep our program at the forefront of treatment options that benefit all concerned.” Said Dr. Rhode.

Considering the Logistics of Brachytherapy

Some may think that navigating legal, order placement, shipping and safety protocols for brachytherapy seeds are arduous but necessary. How then did Dr. Rohde’s team mitigate the associated headaches?

“No one wants to go through those administrative, legal and safety requirements any more often than is necessary,” Peter said. “The Isoray team handled those elements directly in a very personal way that limited our requirements and kept our focus on our patients. Logistically the transitioning process has been seamless thanks in large part to our local sales representative and the balance of the associated Isoray team. It has been a ‘five-star’ experience.”

Just because it isn’t broken, doesn’t mean it can’t be better

“Don’t be afraid of change,” Dr. Rohde advises. “Given the benefits of efficiencies in planning, procedural delivery, dosimetry, safety and urethral sparing, I encourage my colleagues to take a deeper look at the data and potential for Cesium Blu to benefit their patients and their practice across the board.”

The views and opinions expressed in this article are those of the clinician and do not necessarily reflect the official policy or position of any other agency, organization, employer or company.

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The Big Reason Why One Team Switched to Cesium Blu Brachytherapy https://isoray.com/2020/03/the-big-reason-why-one-team-switched-to-cesium-blu-brachytherapy/ Tue, 10 Mar 2020 13:52:00 +0000 https://isoray.com/?p=7100  “The potential to smooth out our workflow and increase our potential candidate pool for the procedure given the ability to do brachytherapy with Cesium Blu prior to EBRT is a compelling motivation for adding it to our prostate cancer treatment arsenal,”- Dr. Bobby Koneru first in Eastern Iowa using Cesium Blu for prostate brachytherapy. Dr. […]

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 “The potential to smooth out our workflow and increase our potential candidate pool for the procedure given the ability to do brachytherapy with Cesium Blu prior to EBRT is a compelling motivation for adding it to our prostate cancer treatment arsenal,”- Dr. Bobby Koneru first in Eastern Iowa using Cesium Blu for prostate brachytherapy.

Dr. Bobby Koneru knew he wanted to be a doctor from a very young age. The son of a 30-year practicing anesthesiologist, Dr. Koneru credits his father as his inspiration for his medical calling. Bobby realized that dream when he earned his MD from the University of Missouri Medical School.

Having developed an affinity for surgery and the operating room, Dr. Koneru chose general surgery for his post-graduate internship at Northwestern University Hospital before settling on Radiation Oncology as his specialty.  This affinity for the operating room has proven beneficial for Dr. Koneru, as he has become one of the next generation of physicians who will carry the torch of brachytherapy pioneers like Dr. John Sylvester, Dr. Bradley Prestidge, Dr. Brian Moran, and others.

“Brachytherapy presents a great blend of radiation delivery and hands-on procedure time in an operating room environment that has always been attractive to me,” Dr. Koneru told us.

Dr. Koneru is president and founder of the Paramount Oncology Group with practices and affiliations in Cedar Rapids, Ia., Dubuque, Ia. and Freeport, Il.

Until recently Dr. Koneru and his urologist colleague Dr. Thomas Richardson used Iodine-125 for their brachytherapy procedures. But given Iodine’s 59-day half-life, the team was forced to offer prostate brachytherapy solely following EBRT, constraining their workflow, patient options, and opportunities.

A programmatic approach to workflow refinement and patient convenience – The key to urology’s “buy-in”

“Brachytherapy outcomes for prostate cancer treatment are excellent for candidates regardless of the energy source, though Iodine does bring inconveniences,” he said. “Given its quite long half-life compared to Cesium Blu, residual side effects of Iodine for prostate brachytherapy remain with patients for months on end. Many prostate cancer patients have grandchildren they want to be near. Iodine delays that opportunity.”

Dr. Koneru added that brachytherapy with Iodine must be done following EBRT because of longer half-life. This restricts patient treatment opportunities and workflow refinement limiting the care team’s ability to administer the optimal therapy or package of therapies. Some patients experience side effects from EBRT that delay or potentially eliminate their candidacy for brachytherapy and its benefits when using Iodine.

“The potential to smooth out our workflow and increase our potential candidate pool for the procedure given the ability to do brachytherapy with Cesium Blu prior to EBRT is a compelling motivation for adding it to our prostate cancer treatment arsenal,” said Dr. Koneru.

“We are fortunate to have an excellent working relationship with our urology group, including Dr. Richardson, which is based on trust,” Dr. Koneru said. “He embraces brachytherapy as a modality and is a key reason our group is able to provide it as a benefit of prostate cancer patients throughout eastern Iowa and beyond.”

Transitioning process, training, team and results

In mid-2019, Dr. Koneru and his team including Dr. Richardson and Todd Steinberg, their medical physicist, traveled to Longview, Texas to learn about the nuances in procedural techniques and isotope transition nuances of progressing from Iodine to Cesium brachytherapy with Dr. Bill Taylor.

“Overall our experience with Dr. Taylor was fantastic,” Dr. Koneru said. “His team is exceptional. He is a fantastic teacher and he has a very straightforward technique, some elements of which we have already incorporated into our own. For example, we adjusted our implant technique after our training, which significantly improved the efficiency of our implant.  ”

Dr. Koneru described the travel and training process burdens as relatively painless when one considers the value of the outcome: a differentiator for the practice, an opportunity for patients to move beyond their cancer and its impact on their lives more quickly and adding a tool that significantly increases our brachytherapy opportunities and reduces procedure time by 50 percent or more.

Dr. Koneru said his practice is now able to complete brachytherapy procedures in an out-patient setting within 30 minutes. Prior to the team’s transition to Cesium Blu, procedures ran between 45 and 60 minutes.

In all combination therapies, the team now uses Cesium Blu brachytherapy first followed by EBRT in four to six weeks thanks to Cesium Blu’s short half-life and side effect resolution within four to six weeks.

The team is the sole provider of Cesium Blu brachytherapy in eastern Iowa and is focused on building their practice into a leading institution for the treatment of prostate cancer with brachytherapy.

About

Bobby Koneru, MD, is president and founder of  Paramount Oncology Group (POG). He is also an adjunct faculty at Loyola University Chicago Stritch School of Medicine.  Based in Dubuque, Iowa, Paramount Oncology Group provides radiation therapy to patients in Iowa, Wisconsin, and Illinois through multiple modalities across a range of cancer indications including prostate, breast, brain, lung, rectum, head and neck.

The views and opinions expressed in this article are those of the clinician and do not necessarily reflect the official policy or position of any other agency, organization, employer or company. 

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The fight to raise awareness and the patient-friendly nature of brachytherapy. https://isoray.com/2020/03/the-fight-to-raise-awareness-and-the-patient-friendly-nature-of-brachytherapy/ Tue, 03 Mar 2020 19:38:53 +0000 https://isoray.com/?p=7095 Welcome to the Isoray’s Prostate Cancer Connect Podcast! Each episode of the series, Dr. John Sylvester and featured guests will be talking in-depth about the current status and advancements in brachytherapy for prostate cancer treatment. How do we find the right awareness vehicle at the right time for patients? How do we respond to shifting […]

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Welcome to the Isoray’s Prostate Cancer Connect Podcast! Each episode of the series, Dr. John Sylvester and featured guests will be talking in-depth about the current status and advancements in brachytherapy for prostate cancer treatment.

How do we find the right awareness vehicle at the right time for patients? How do we respond to shifting or urgent demands for the procedure and the associated resources?

On this episode, Dr. Sylvester is joined by Isoray’s Vice President of Sales and Marketing Mike Krachon as they discuss brachytherapy from an industry standpoint. Krachon provides an in-depth discussion on how he and other industry professionals are striving to raise awareness of brachytherapy among men as a viable treatment and increase training among physicians. They also discuss ways to address challenges including declining use of brachytherapy despite strong outcomes data, swift side effect resolution and the future they envision for the treatment.

Listen Now:

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iHeartRadio

SoundCloud

Disclaimer: The content of this podcast should not be taken as medical advice, is for informational purposes only, and cannot be used in any legal capacity.

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Isoray Announces Second Quarter Fiscal 2020 Financial Results https://isoray.com/2020/02/isoray-announces-second-quarter-fiscal-2020-financial-results/ Tue, 11 Feb 2020 21:05:00 +0000 https://isoray.com/?p=7030 Revenue Increased 16% Year-Over-Year Gross Profit Increased 45% Year-Over-Year RICHLAND, WASHINGTON – February 11, 2020 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced its financial results for the second quarter fiscal 2020 ended December 31, 2019. Revenue for the […]

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Revenue Increased 16% Year-Over-Year
Gross Profit Increased 45% Year-Over-Year

RICHLAND, WASHINGTON – February 11, 2020 – Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced its financial results for the second quarter fiscal 2020 ended December 31, 2019.

Revenue for the second quarter of fiscal 2020 grew 16% to $2.21 million versus $1.90 million in the prior year comparable period. The company’s core prostate brachytherapy revenue also grew 16% when compared to the fiscal second quarter of 2019. Prostate brachytherapy represented 89% of total revenue for the second quarter of fiscal 2020 compared to 89% in the prior year comparable period. The majority of non-prostate brachytherapy revenue in the quarter was comprised of sales to treat brain cancer, including sales of GammaTile® Therapy.

Gross profit as a percentage of revenues increased to 50.4% for the three months ended December 31, 2019, versus 40.2% in the prior year comparable period. Second quarter gross profit increased 45% to $1.11 million versus $0.77 million in the second quarter of fiscal 2019, largely attributed to increased sales and lower isotope unit costs compared to the prior year comparable period.

Isoray CEO Lori Woods said, “We are pleased to announce another strong quarter of growth and progress. We see continued growth of market share this quarter and we find that particularly rewarding given that we believe topline growth would have been greater had it not been for the timing of the holidays at the end of the quarter. Clearly, our momentum is enduring as preliminary sales for the month of January 2020 increased about 45% versus December 2019 and about 30% versus January 2019. With our growing share of the core prostate market and the increasing use of Cesium Blu™ to treat other hard to treat cancers, we are excited about the prospects for expanding opportunities as we continue to evolve our position as an industry leader and innovator.”

Total operating expenses in the second quarter decreased 8% to $2.01 million compared to $2.19 million in the prior year period. Total research and development expenses decreased 33% versus the prior year comparable period. The decrease in total research and development expenses was primarily the result of decreased protocol expenses, decreased development expenses related to the Blu Build delivery system, and a year-over-year decline in collaborative research expenses related to GammaTile Therapy compared to the prior year comparable period.  Sales and marketing expenses decreased 5% versus the prior year comparable period. The decrease in sales and marketing expenses was driven primarily by lower travel and tradeshow related expenses versus the prior year comparable period largely due to a calendar shift of the ASTRO Conference to September 2019. General and administrative expenses decreased 3% versus the prior year comparable period. The decline was primarily the result of a decrease in legal and public company expenses compared to the prior year comparable period.

The net loss for the three months ended December 31, 2019, was $0.90 million or ($0.01) per basic and diluted share versus a net loss of $1.41 million or ($0.02) per basic and diluted share in the comparable prior year period. Basic and diluted per share results are based on weighted average shares outstanding of approximately 67.4 million for the three months ended December 31, 2019, versus 67.3 million in the comparable prior year period.

For the first six months of fiscal 2020 ended December 31, 2019, revenue increased 30% to $4.52 million versus $3.47 million in the prior year comparable period. Prostate brachytherapy represented 89% of total revenue for the first half of fiscal 2020 compared to 89% for the first half of fiscal 2019. Total operating expenses for the first six months of fiscal 2020 decreased 4% to $4.09 million, versus $4.24 million in the prior year comparable period. The net loss for the first half of fiscal 2020 was $1.71 million, or ($0.03) per basic and diluted share, compared to a net loss of $2.92 million, or ($0.04) per basic and diluted share, in the prior year comparable period. Basic and diluted per share results are based on weighted average shares outstanding of approximately 67.4 million for the six months ended December 31, 2019, versus 66.7 million in the comparable prior year period.

Cash, cash equivalents, and certificates of deposit at the end of the second quarter of fiscal 2020 totaled $3.18 million and the company had no debt. Shareholders’ equity at the end of the second quarter of fiscal 2020 totaled $6.14 million.

Conference Call Details

The company will hold an earnings conference call today, February 11, at 4:30 p.m. ET/1:30 p.m. PT to discuss operating results. To listen to the conference call, please dial (844) 602-0380. For callers outside the U.S., please dial (862) 298-0970.

The conference call will be simultaneously webcast and can be accessed at https://www.webcaster4.com/Webcast/Page/2199/33012. The webcast will be available until May 11, 2020, following the conference call. A replay of the call will also be available by phone and can be accessed by dialing (877) 481-4010 and providing reference number 58363. For callers outside the U.S., please dial (919) 882-2331 and provide reference number 58363. The replay will be available beginning approximately 1 hour after the completion of the live event, ending at 4:30 pm ET on February 18, 2020.

Contacts

Investor Relations: Mark Levin (501) 255-1910
Media and Public Relations: Sharon Schultz (302) 539-3747

About Isoray

Isoray, Inc., through its subsidiary, Isoray Medical, Inc., is the sole producer of Cesium Blu brachytherapy seeds, which are expanding brachytherapy treatment options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium Blu by visiting www.isoray.com. Join us on Facebook and follow us on Twitter.

Safe Harbor Statement

Statements in this news release about Isoray’s future expectations, including: the anticipated continued growth in revenues in the quarter ending March 31, 2020, and in fiscal year 2020, lower isotope costs, advantages of our products including Blu Build and the GammaTile Therapy delivery system, whether interest in and use of our Cesium Blu  products will increase or continue, whether use of Cesium-131 in non-prostate applications will continue to increase revenue, whether further manufacturing and production process improvements will be completed or will result in lower costs, whether our market presence and growth will continue, the positive industry data fueling renewed interest in brachytherapy, strong patient results, the perception by patients of quality of life outcomes,  and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing Isoray, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, market acceptance and recognition of our rebranded products, our ability to successfully manufacture, market, and sell our Blu Build products and the success of the GammaTile Therapy, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released that support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards, the success of our sales and marketing efforts, changes in reimbursement rates, the procedures and regulatory requirements mandated by the FDA for 510(k) approval and reimbursement codes, changes in laws and regulations applicable to our products, the scheduling of physicians who either delay or do not schedule patients in periods anticipated, the use of competitors’ products in lieu of our products, less favorable reimbursement rates than anticipated for each of our products, and other risks detailed from time to time in Isoray’s reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ISR Q2 2020 Earnings Press Release__February 11 2020

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Isoray Collaborates with MIM Software to Deliver an Advanced Treatment Solution for Recurrent Head and Neck Cancers https://isoray.com/2020/02/isoray-collaborates-with-mim-software-to-deliver-an-advanced-treatment-solution-for-recurrent-head-and-neck-cancers/ Wed, 05 Feb 2020 13:13:00 +0000 https://isoray.com/?p=6630 Bundled Treatment Program Provides New Opportunities For Treating Physicians and Patients Facing Limited Options RICHLAND, WASHINGTON – February 5, 2020 – Isoray, Inc. (NYSE American: ISR) today announced an executed agreement with MIM Software to deliver a novel one-stop-provides-all program to treat head and neck cancer. The new offering bundles MIM’s software technology and Isoray’s […]

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Bundled Treatment Program Provides New Opportunities For
Treating Physicians and Patients Facing Limited Options

RICHLAND, WASHINGTON – February 5, 2020 – Isoray, Inc. (NYSE American: ISR) today announced an executed agreement with MIM Software to deliver a novel one-stop-provides-all program to treat head and neck cancer. The new offering bundles MIM’s software technology and Isoray’s industry leading Cesium BluTM, also known as Cesium-131, brachytherapy expanding treatment options and access for physicians and patients. Cesium Blu brachytherapy delivers a highly targeted treatment to the site of the disease, preserving healthy tissue and organs.

Bringing together Isoray’s Cesium Blu brachytherapy seeds in mesh with MIM Software’s powerful brachytherapy treatment planning software provides physicians with all the anatomical information they need to effectively place the Cesium Blu seeds exactly where they are needed to treat the patient’s cancer. Available now, the inclusive offering streamlines adoption of both the Cesium Blu brachytherapy treatment and MIM’s planning software to deliver an economically feasible option for facilities and physicians treating head and neck cancers.

Isoray CEO Lori Woods said this is an important development in the treatment of head and neck cancers. “Our initiative with MIM Software represents another step forward in the treatment of hard to treat cancers. As the industry leader in brachytherapy, we are committed to providing the best ways to bring new and efficient treatment solutions to clinicians and the patients they treat. We believe this new brachytherapy treatment package will make an important contribution to achieving that goal because it expands physician and patient access to a cutting-edge approach to the treatment of head and neck cancers.”

MIM Software is committed to enhancing patient care by providing customer-focused and innovative solutions. MIM Software Chief Scientific Officer Jon Piper said, “This agreement represents an exciting opportunity to reach more clinicians performing emerging brachytherapy head and neck treatments. We remain committed to developing software that enhances patient care and helps make optimal treatment options available to patients and the physicians who treat them.”

Cesium Blu brachytherapy attacks targeted cancers aggressively. It features a short half-life and a shorter treatment duration than other isotope treatments, potentially reducing complications for the patient that can come from prolonged radiation exposure. The short duration of radiation also contributes to a rapid resolution of side effects and allows patients to return to their normal lives quickly.

Contact

Media and Public Relations: Sharon Schultz (302) 539-3747
Investor Relations: Mark Levin (501) 255-1910

About Isoray

Isoray, Inc., through its subsidiary, Isoray Medical, Inc., is the sole producer of Cesium-131, also known as Cesium BluTM, brachytherapy seeds, which are expanding brachytherapy treatment options throughout the body. The medical technology company is an innovator in seed brachytherapy powering expanding treatment options throughout the body for difficult to treat head and neck, brain, gynecological, lung, esophageal, and abdominal wall cancers in addition to prostate cancer. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium BluTM by visiting www.isoray.com. Join us on Facebook and follow us on Twitter.

About MIM Software, Inc.

MIM Software, Inc. provides practical imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging. MIM is a privately held company that sells its products globally to imaging centers, hospitals, specialty clinics, research organizations, and pharmaceutical companies. Learn more by visiting www.mimsoftware.com/ .

Safe Harbor Statement

Statements in this news release about Isoray’s future expectations, the advantages of our products and their delivery systems, the advantages of our collaboration with MIM Software and the ultimate utilization by physicians and patients, whether interest in and use of our products will increase or continue, whether use of Cesium-131, also known as Cesium BluTM, in non-prostate applications will continue to increase revenue, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing Isoray, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released that support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards, the success of our sales and marketing efforts, changes in reimbursement rates, the procedures and regulatory requirements mandated by the FDA for 510(k) approval and reimbursement codes, changes in laws and regulations applicable to our products, the scheduling of physicians who either delay or do not schedule patients in periods anticipated, the use of competitors’ products in lieu of our products, less favorable reimbursement rates than anticipated for each of our products, and other risks detailed from time to time in Isoray’s reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Episode 3: How brachytherapists are partnering with urologists and readying the next generation of practitioners. https://isoray.com/2020/02/episode-3-how-brachytherapists-are-partnering-with-urologists-and-readying-the-next-generation-of-practitioners/ Tue, 04 Feb 2020 12:00:00 +0000 https://isoray.com/?p=6543 While brachytherapy continues to demonstrate positive outcomes with swift side effect resolution for prostate cancer treatment, the modality remains underutilized. In this episode, Dr. John Sylvester is joined by radiation oncologist Dr. Alex Hsi to discuss why the use of brachytherapy is declining, the need for training the next generation of practitioners and some of […]

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While brachytherapy continues to demonstrate positive outcomes with swift side effect resolution for prostate cancer treatment, the modality remains underutilized. In this episode, Dr. John Sylvester is joined by radiation oncologist Dr. Alex Hsi to discuss why the use of brachytherapy is declining, the need for training the next generation of practitioners and some of the ways they have worked to raise awareness for the value of brachytherapy across the entire healthcare continuum, particularly patients, throughout their careers.

Listen Now:

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SoundCloud

Disclaimer: The content of this podcast should not be taken as medical advice, is for informational purposes only, and cannot be used in any legal capacity.

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Isoray To Announce Second Quarter Fiscal 2020 Financial Results on February 11, 2020 https://isoray.com/2020/01/isoray-to-announce-second-quarter-fiscal-2020-financial-results-on-february-11-2020/ Fri, 31 Jan 2020 14:35:26 +0000 https://isoray.com/?p=6640 Conference Call is Tuesday, February 11, 2020 at 4:30 p.m. ET/1:30 p.m. PT RICHLAND, WASHINGTON – January 31, 2020– Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced that it will host a conference call to discuss its financial results for […]

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Conference Call is Tuesday, February 11, 2020 at 4:30 p.m. ET/1:30 p.m. PT

RICHLAND, WASHINGTON – January 31, 2020– Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and innovator in seed brachytherapy powering expanding treatment options throughout the body, today announced that it will host a conference call to discuss its financial results for the second quarter fiscal 2020 ended December 31, 2019 on Tuesday, February 11, 2020, at 4:30 p.m. Eastern Time. The Company will issue a press release announcing its financial results for the second quarter fiscal 2020 after the close of the U.S. stock markets on February 11, 2020.

To listen to the conference call, please dial 844-602-0380. For callers outside the U.S., please dial 862-298-0970.

The conference call will be simultaneously webcast and can be accessed at https://www.webcaster4.com/Webcast/Page/2199/33012. The webcast will be available until May 11, 2020 following the conference call. A replay of the call will also be available by phone and can be accessed by dialing 877-481-4010 and providing reference number 58363. For callers outside the U.S., please dial 919-882-2331 and provide reference number 58363. The replay will be available beginning approximately 1 hour after the completion of the live event, ending at 4:30 pm Eastern Time on February 18, 2020.

Contact

Investor Relations: Mark Levin (501) 255-1910

Media and Public Relations: Sharon Schultz (302) 539-3747

About Isoray

Isoray, Inc., through its subsidiary, Isoray Medical, Inc., is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy treatment options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook and follow us on Twitter @Isoray.

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