Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, has received marketing authorization in the Netherlands (RVG 130527)

Petach Tikva, Israel (ots/PRNewswire) - Isotopia Molecular Imaging Ltd. is
thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing
authorization in the Netherlands (RVG 130527). This landmark approval marks a
significant milestone in our ongoing commitment to improve healthcare and
patient outcomes across the globe.

Isotopia is a radiopharmaceutical focused company with proven expertise in
developing, manufacturing, and commercializing pioneering diagnostic and
therapeutic products, serving the nuclear medicine market. We appreciate Billev
Pharma support as our marketing authorization holder.

Isoprotrace® is designed to address prostate cancer patients. Isoprotrace® is
indicated* for positron emission tomography (PET) in patients with prostate
cancer, for primary staging of those with high-risk prior to primary curative
therapy and patients who have suspected recurrence based on elevated serum
prostate specific antigen (PSA) level.

Isoprotrace® is a single sterile vacuum - vial kit, intended for preparing
multi-patient doses of Gallium (68Ga) Gozetotide (PSMA -11) within only 5
minutes, saving precious decay time in comparison to a standard synthesis.

"Our isoprotrace® PSMA-11 represents a paradigm shift toward registered and GMP
products in nuclear medicine. We have reached this achievement after years of
dedicated research and navigating the complex regulatory landscape. It is with
immense pride and excitement to be part of this transition. We are humbled by
the opportunity and looking forward to our next challenges in this area. This is
a testimony to our relentless commitment to patients around the world to supply
radiopharmacy products in GMP standard," said Tzachi Levy, General Manager of
Isotopia's aseptic plant.

Isotopia Molecular Imaging Ltd, is committed to working closely with healthcare
providers, regulators, and the patient community in the Netherlands to ensure
that Isoprotrace® is accessible to all who can benefit from it. We are also
actively pursuing marketing authorizations in other countries (approval is
pending for Germany) aiming to make Isoprotrace® available across Europe.

*For detailed information, please refer to the product's SmPC.

Logo: https://mma.prnewswire.com/media/2337282/4537248/Isotopia_Logo.jpg

For more information, please connect with us:

Mail: mailto:[e-mail]

Nadav

View original content: https://www.prnewswire.co.uk/news-releases/isotopia-molec
ular-imaging-ltd-is-thrilled-to-announce-that-isoprotrace-has-received-marketing
-authorization-in-the-netherlands-rvg-130527-302102313.html

Contact:

[phone]

Additional content: http://presseportal.de/pm/171734/5745761
OTS: Isotopia Molecular Imaging