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FocalTherics™ Expands Access to Focal One® Robotic HIFU for Veterans with Prostate Cancer through Agreement with MellingMedical

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FocalTherics (Nasdaq: FOCL) signed an agreement with MellingMedical to expand access to Focal One Robotic HIFU for prostate cancer treatment across VA and Department of Defense healthcare systems.

Through MellingMedical's VA Federal Supply Schedule, federal facilities can now acquire this incision-free, radiation-free robotic focal therapy for Veterans and active-duty personnel.

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  • Agreement with MellingMedical opens access to VA and DoD healthcare systems
  • Federal facilities can purchase Focal One Robotic HIFU via VA Federal Supply Schedule
  • Addresses Veterans population where nearly 500,000 receive prostate cancer treatment or care
  • Targets setting where prostate cancer represents about 30% of male cancer diagnoses

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  • None.

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FocalTherics™ Expands Access to Focal One® Robotic HIFU for Veterans with Prostate Cancer through Agreement with MellingMedical

AUSTIN, Texas, June 16, 2026 (GLOBE NEWSWIRE) -- FocalTherics (Nasdaq: FOCL) (the “Company”), the global leader in robotic focal therapy, today announced that it has entered into an agreement with MellingMedical, a leading SBA-Verified Service-Disabled Veteran-Owned Small Business (SDVOSB), to expand access to Focal One Robotic HIFU (High Intensity Focused Ultrasound) to federal healthcare providers and make its prostate treatment technology available to Veterans and active-duty military personnel throughout the VA and Department of Defense healthcare systems (“Veterans Healthcare System”).

Currently, nearly 500,000 Veterans are receiving prostate cancer treatment or care within the Veterans Healthcare System. Veterans are diagnosed with prostate cancer at two times the rate of the general population and prostate cancer accounts for approximately 30% of new cancer diagnoses among men in the Veterans Healthcare System.

Over the last four years prostate cancer care for Veterans has been an area of increased federal focus, anchored through the 2022 Cleland-Dole Act, which directed the Department of Veterans Affairs to advance comprehensive prostate cancer care for Veterans. Through MellingMedical's VA Federal Supply Schedule, federal healthcare facilities can now acquire Focal One Robotic HIFU, adding incision-free, radiation-free robotic focal therapy to the treatment options available across the Veterans Healthcare System.

"Bringing Focal One's revolutionary Robotic HIFU technology to our federal healthcare providers represents a significant advancement in prostate cancer care options for our Veterans," said Chris Melling, founder and CEO of MellingMedical. "This non-invasive treatment approach offers patients the possibility of maintaining their quality of life while effectively treating their condition, a perfect alignment with our mission to bring innovative healthcare solutions to those who have served our nation."

“FocalTherics is the leader in robotic focal therapy with a large and growing customer base in the United States,” said Ryan Rhodes, CEO of FocalTherics. “The Veteran population deserves access to the most advanced prostate cancer treatment options. This partnership reinforces our ongoing commitment to expand patient access to Focal One Robotic HIFU without the long-lasting effects of surgery or radiation.”

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About MellingMedical
MellingMedical, an SBA-Verified Service-Disabled Veteran-Owned Small Business (SDVOSB), holds a Medical Equipment and Surgical Federal Supply Schedule (Med/Surg), as well as a Pharmaceutical Schedule and ECAT capabilities, providing innovative and cost-effective healthcare solutions to all 172 VA Medical Centers and 1,138 VA Outpatient Clinics, all seven (7) VA CMOPs, 95 DoD Medical Facilities and Health and Human Services (HHS), including Indian Health Services (IHS) and the Center for Disease Control (CDC). To learn more, visit MellingMedical.com.

About FocalTherics
A recognized global leader in Robotic Focal Therapy, FocalTherics develops, manufactures, and markets minimally invasive medical devices worldwide to treat various conditions using proprietary focused ultrasound technology. The Company’s flagship platform, Focal One Robotic HIFU, combines advanced imaging, real-time treatment planning, robotic precision, and HIFU technology to deliver personalized focal therapy designed to optimize clinical outcomes while preserving quality of life. FocalTherics is committed to expanding the clinical adoption of its patented focused ultrasound-based robotic therapy platforms through continued innovation, clinical evidence generation, physician education, and global market development initiatives. For more information about FocalTherics, visit FocalTherics.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”), as amended and Section 21E of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices; the fact that the availability of Focal One through a Federal Supply Schedule does not guarantee purchase orders, adoption, or revenue, and that sales to U.S. federal healthcare systems, including the VA and Department of Defense, are subject to government budgeting, procurement, and policy factors outside the Company's control; risks associated with the intended discontinuation of the Company's ESWL and Distribution operating segments, including that the discontinuation may take longer or cost more than expected, may result in disputes with customers, distributors, employees or other counterparties, and may not produce the strategic benefits anticipated as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.

Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 10-K.

Forward-looking statements speak only as of the date they are made. Other than as required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

FocalTherics Investor Contact:
Louisa Smith - Gilmartin Group
investor.relations@focalone.com
MellingMedical Media Contact
Trina Barlow, President
Trina@OverflowCommunications.com

FAQ

What did FocalTherics (Nasdaq: FOCL) announce on June 16, 2026?

FocalTherics announced an agreement with MellingMedical to expand access to Focal One Robotic HIFU for Veterans. According to FocalTherics, the deal lets federal healthcare facilities acquire its incision-free, radiation-free prostate cancer treatment across VA and Department of Defense healthcare systems.

How does the MellingMedical agreement expand Focal One Robotic HIFU access for FOCL shareholders and Veterans?

The agreement enables federal healthcare facilities to obtain Focal One Robotic HIFU through MellingMedical's VA Federal Supply Schedule. According to FocalTherics, this brings its robotic focal therapy into VA and Department of Defense systems, broadening treatment availability for Veterans and active-duty military personnel with prostate cancer.

What is Focal One Robotic HIFU offered by FocalTherics (FOCL) for prostate cancer?

Focal One Robotic HIFU is a non-invasive, incision-free and radiation-free robotic focal therapy for prostate cancer. According to FocalTherics, this high intensity focused ultrasound treatment aims to effectively treat the condition while helping patients maintain quality of life compared with more invasive options.

How many Veterans with prostate cancer could be reached by FocalTherics’ (FOCL) new agreement?

Nearly 500,000 Veterans are currently receiving prostate cancer treatment or care in the Veterans Healthcare System. According to FocalTherics, its agreement with MellingMedical targets this population by making Focal One Robotic HIFU available across VA and Department of Defense healthcare facilities.

How does FocalTherics’ (FOCL) deal with MellingMedical align with the Cleland-Dole Act?

The Cleland-Dole Act directs the VA to advance comprehensive prostate cancer care for Veterans. According to FocalTherics, offering Focal One Robotic HIFU through federal channels supports this focus by adding a robotic, non-invasive prostate cancer treatment option systemwide.

Why is prostate cancer a key focus for the Veterans Healthcare System and FocalTherics (FOCL)?

Veterans are diagnosed with prostate cancer at about twice the rate of the general population. According to FocalTherics, prostate cancer accounts for roughly 30% of new male cancer diagnoses in the Veterans Healthcare System, making expanded treatment options an area of federal attention.