Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScan™ (Kit for the Preparation of Technetium Tc 99m Succimer Injection)

• NephroScan is now US FDA approved for the preparation of Tc-99m DMSA
• NephroScan aids in the detection of kidney cortical defects in adult and pediatric patients, including term neonates
• GE Healthcare to commence distribution in the US
• Manufactured by ROTOP Pharmaka in Germany

LONDON, Feb. 23, 2022 /PRNewswire/ -- Theragnostics announces that NephroScan, its radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patients, including term neonates, has received Marketing Approval by the US Food and Drug Administration ("FDA").

NephroScan, a proprietary kit for the preparation of technetium Tc 99m succimer injection, is Theragnostics' first FDA approved drug.  It is manufactured by ROTOP Pharmaka GmbH in Germany. GE Healthcare, a global leader in molecular imaging, serves as the exclusive distributor of the product in the United States and the product is now available for ordering.

Greg Mullen, President and Chief Executive Officer of Theragnostics, said: "The FDA approval of NephroScan is a significant milestone for Theragnostics and for patients who are affected by kidney disease. NephroScan enables the detection and diagnosis of kidney disease, enabling physicians, patients, and their families to help make informed treatment decisions. The approval has been a remarkable team effort in collaboration with the regulatory development group at Facet Life Sciences and the specialists for radiopharmaceutical development and manufacturing at ROTOP Pharmaka GmbH."

Dr. Ted Treves, Professor of Radiology at Harvard Medical School and former Chief Division of Nuclear Medicine at Boston Children's Hospital said: "The value of Tc-99m DMSA is well established in the assessment of disorders affecting the kidneys in children and adults. The approval in the US means that Tc-99m DMSA imaging will be brought back as a useful tool for the evaluation of adult and pediatric patients affected by renal diseases. Efforts are underway for renewed education of referring physicians about its value and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) practice guidelines have recently been updated¹."

Important Safety Information: Radiation Risks: Technetium Tc 99m succimer injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

Advanced Renal Failure: Some patients with advanced renal failure may exhibit poor renal intake of technetium Tc 99m succimer injection. It has been reported that satisfactory images may be obtained in some of these patients by delaying imaging for up to 24 hours.

About Theragnostics

Theragnostics is a private clinical-stage pharmaceutical company developing precision oncology products for diagnostic medical imaging and targeted radionuclide therapy. The Company has completed several proof-of-concept phase I and II clinical trials for several radionuclide diagnostics and targeted therapies. For more information, please visit www.theragnostics.com.

About NephroScan

Following intravenous administration, the radiopharmaceutical agent Tc-99m dimercaptosuccinic acid (Tc-99m DMSA) principally binds to the cortical regions of the kidneys. Its biodistribution makes it a logical imaging agent for renal scintigraphy. It is imaged by different methods such as planar and pinhole imaging and SPECT. Tc-99m DMSA imaging during acute renal infection has been used to identify patients that are at risk for later development of permanent sequalae such as parenchymal scarring, hypertension, and even chronic renal failure. Tc-99m DMSA imaging can also be used for the determination of split renal function, kidney shape, size, position, and homogeneity¹.

About ROTOP Pharmaka GmbH

ROTOP Pharmaka is a leading radiopharmaceutical company with over 20 years of experience that produces cGMP compliant cold kits and radiopharmaceuticals in Germany and supplies to over 30+ countries. Apart from development, manufacturing, and registration of radiopharmaceuticals, ROTOP offers a broad range of CDMO Services. For more information visit: www.rotop-pharmaka.de.

About GE Healthcare

GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. www.gehealthcare.com

¹ SNMMI Procedure Standard/EANM Practice Guideline on Pediatric [99mTc]Tc-DMSA Renal Cortical Scintigraphy: An Update (https://s3.amazonaws.com/rdcms-snmmi/files/production/public/FileDownloads/ProcedureStandards/SNMMI%20EANM%20DMSA%20guideline_final.pdf)