GlobeNewswire

RadioMedix & Curium Announce Simplified Coding for DetectnetTM (copper Cu 64 dotatate injection)

Share

St. Louis, MO, March 23, 2021 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that the Centers for Medicare & Medicaid Services (CMS) has simplified the coding process for Detectnet.  Effective April 1, 2021, all sites of care will use code A9592 to submit for reimbursement for all patients.  While Transitional Pass-Through Status remains in effect for Detectnet, the current C9068 HCPCS code will be retired April 1, 2021.  For services performed prior to April 1st, C9068 should continue to be used for Medicare patients at Hospital Outpatient Department Imaging Facilities.  The descriptor for Detectnet remains: Copper Cu-64, dotatate, diagnostic, 1 millicurie. 

 “Once in effect, having one code for all patients regardless of the site of care will simplify the billing process for our customers,” said Curium Vice President of Sales, North America, Andy Farrow.  “We remain focused on helping physicians and patients in the neuroendocrine community and anticipate this change to positively impact coding and billing procedures for all sites.”

“The response to Detectnet from the neuroendocrine community is outstanding,” said Ebrahim Delpassand, MD, CEO of RadioMedix.  “The Phase III results demonstrate the clinical sensitivity, specificity, and accuracy of Detectnet.  Further, the 12.7-hour half-life of Detectnet enables it to be produced centrally and shipped to sites throughout the U.S.  The single HCPCS code is another step to simplifying the insurance billing process for imaging centers nationwide.”   

About Detectnet

INDICATIONS

Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. 

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

Radiation Risk

Diagnostic radiopharmaceuticals, including Detectnet, contribute to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Risk for Image Misinterpretation

The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors. Increased uptake might also be seen in other non-cancerous pathologic conditions that express somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas).

A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.

ADVERSE REACTIONS

In clinical trials, adverse reactions occurred at a rate of < 2% and included nausea, vomiting and flushing.  In published trials nausea immediately after injection was observed.

DRUG INTERACTIONS

Somatostatin Analogs

Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2). Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging.

USE IN SPECIFIC POPULATIONS

Pregnancy

All radiopharmaceuticals, including Detectnet, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of Detectnet.

Lactation

Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant.

Pediatric use The safety and effectiveness of Detectnet have not been established in pediatric patients.   Geriatric use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

OVERDOSAGE

In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered.

Please see Full prescribing information by clicking here.

About RadioMedix 

RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals.  RadioMedix has also established contract service facilities for academic and industrial partners: Full cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, and probe development and small animal Molecular Imaging Facility for pre-clinical evaluation of radiopharmaceuticals in animal models. To learn more, visit  www.radiomedix.com. For more information about this press release, please contact: media@radiomedix.com

About Curium

Curium is the world’s largest nuclear medicine company.  We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com.  For more information about this press release, please contact Janet Ryan, media contact for Curium: janet@ryan-pr.com.

About Neuroendocrine Tumors

Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract, pancreas and liver, but can also occur in other tissues including lung, thymus and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).      

CD0119 0321


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Stockwik completes a directed new share issue of approximately SEK 143 million13.4.2021 22:00:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE. Stockwik Förvaltning AB (publ) (”Stockwik” or the ”Company”) has, as communicated in the Company’s press release earlier today, resolved on a directed new share issue of 1,026,055 shares, corresponding to approximately SEK 143 million (the "Directed New Share Issue"). The subscription price of the shares in the Directed New Share Issue amounts to SEK 139 per share. A large number of Swedish and international institutional investors, including Handelsbanken Fonder and Joh. Berenberg, Gossler & Co. KG, participated in the Directed New Share Issue which was heavily over-subscribed.

Stockwik genomför en riktad nyemission om cirka 143 miljoner kronor13.4.2021 22:00:00 CEST | Pressemelding

EJ FÖR OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION, HELT ELLER DELVIS, DIREKT ELLER INDIREKT, I ELLER TILL USA, AUSTRALIEN, KANADA, NYA ZEELAND, HONGKONG, JAPAN, SINGAPORE, SYDAFRIKA, SYDKOREA ELLER NÅGON ANNAN JURISDIKTION DÄR SÅDANT OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION INTE SKULLE VARA FÖRENLIG MED TILLÄMPLIGA FÖRESKRIFTER ELLER KRÄVA REGISTRERING ELLER LIKNANDE ÅTGÄRDER. VÄNLIGEN SE VIKTIG INFORMATION I SLUTET AV PRESSMEDDELANDET. Stockwik Förvaltning AB (publ) (”Stockwik” eller ”Bolaget”) har, i enlighet med vad som offentliggjordes i Bolagets pressmeddelande tidigare idag, beslutat om en riktad nyemission av 1 026 055 aktier, motsvarande cirka 143 miljoner SEK (den ”Riktade Nyemissionen”). Teckningskursen för aktierna i den Riktade Nyemissionen uppgick till 139 kronor per aktie. Ett stort antal svenska och internationella institutionella investerare, däribland Handelsbanken Fonder och Joh. Berenberg, Gossler & Co. KG, deltog i den Riktade Nyemissionen som var kraf

NEP’s Solution for Aurora, North One and Extreme E Tests Its Metal In Some of the World’s Harshest Conditions13.4.2021 19:21:56 CEST | Press release

SHOWCASING CUTTING EDGE TECHNOLOGY & SUSTAINABILITY WORKING TOGETHER LONDON, April 13, 2021 (GLOBE NEWSWIRE) -- Last weekend marked the first event for Extreme E, a new all-electric off-road racing series designed to highlight the climate crisis. NEP Group, the leading technical partner for content producers around the globe, worked with Extreme E and host broadcaster Aurora Media Worldwide and North One, to create a cutting-edge, sustainable broadcast solution that brought the first race, in AlUla, Saudi Arabia, into homes in 180 countries around the globe. Designed to mirror Extreme E’s goals of marrying the latest technology with sustainability and building solutions to meet the rigors of the world’s harshest conditions, NEP’s innovative broadcast services will be used by Aurora and North One at races in Senegal, Greenland, Brazil and Patagonia as the series continues. NEP’s complete end-to-end broadcast package includes a custom IP flypack, remote production solutions, crewing, sat

Annual General Meeting 2021: Tecan shareholders endorse all motions proposed by the Board of Directors13.4.2021 17:45:00 CEST | Press release

Votes cast exclusively through the independent proxy in line with COVID-19 Ordinance 3 of the Swiss government to combat the pandemicIncrease in the dividend from CHF 2.20 to CHF 2.30 per share Lukas Braunschweiler, Heinrich Fischer, Oliver Fetzer, Karen Huebscher, Christa Kreuzburg and Daniel R. Marshak re-elected as members of the Board of DirectorsLukas Braunschweiler confirmed by shareholders as Chairman of the BoardChrista Kreuzburg, Oliver Fetzer and Daniel R. Marshak confirmed as members of the Compensation CommitteeAll proposals relating to compensation approved Männedorf, Switzerland, April 13, 2021 – The Annual General Meeting of the Tecan Group (SIX Swiss Exchange: TECN) endorsed all motions proposed by the Board of Directors on April 13, 2021. The Annual General Meeting was held at the headquarters of the company, without personal attendance by shareholders. Voting rights could only be exercised through the independent proxy in line with the Federal Act on the Statutory Pri

Stockwik offentliggör avsikt att genomföra en riktad nyemission om upp till 1 026 055 nya aktier13.4.2021 17:31:00 CEST | Pressemelding

EJ FÖR OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION, HELT ELLER DELVIS, DIREKT ELLER INDIREKT, I ELLER TILL USA, AUSTRALIEN, KANADA, NYA ZEELAND, HONGKONG, JAPAN, SINGAPORE, SYDAFRIKA, SYDKOREA ELLER NÅGON ANNAN JURISDIKTION DÄR SÅDANT OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION INTE SKULLE VARA FÖRENLIG MED TILLÄMPLIGA FÖRESKRIFTER ELLER KRÄVA REGISTRERING ELLER LIKNANDE ÅTGÄRDER. VÄNLIGEN SE VIKTIG INFORMATION I SLUTET AV PRESSMEDDELANDET. Stockwik Förvaltning AB (publ) (”Stockwik” eller ”Bolaget”) offentliggör avsikt att genomföra en riktad nyemission om upp till 1 026 055 nya aktier till svenska och internationella institutionella investerare (den ”Riktade Nyemissionen”). Bolaget avser att genomföra den Riktade Nyemissionen med avvikelse från aktieägarnas företrädesrätt med stöd av bemyndigandet från årsstämman den 8 maj 2020. Stockwik har gett Pareto Securities AB (”Pareto Securities”) i uppdrag att utreda förutsättningarna för att genomföra den Riktade Nyemissionen genom

Stockwik announces intention to carry out a directed new share issue of up to 1,026,055 new shares13.4.2021 17:31:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. PLEASE REFER TO IMPORTANT INFORMATION AT THE END OF THE PRESS RELEASE. Stockwik Förvaltning AB (publ) (”Stockwik” or the ”Company”) hereby announces intention to carry out a directed new share issue of up to 1,026,055 new shares directed to Swedish and international institutional investors (the “Directed New Share Issue”). The Company intends to carry out the Directed New Share Issue with deviation from the shareholders' preferential rights pursuant to the authorization granted by the annual general meeting on 8 May 2020. Stockwik has engaged Pareto Securities AB (“Pareto Securities”) to investigate the conditions to carry out the Directed New Shar

Norsk Hydro: Innkalling til generalforsamling 202113.4.2021 16:27:22 CEST | Pressemelding

Aksjeeierne i Norsk Hydro ASA innkalles til ordinær Generalforsamling torsdag 6. mai 2021 kl. 10:00. Generalforsamlingen vil i år gjennomføres digitalt med elektronisk stemmegivning som følge av Covid-19 situasjonen. Se vedlagt guide for online deltakelse. Det er også mulig å forhåndsstemme eller gi fullmakt før møtet. Fullstendig innkalling, agenda og vedlegg er vedlagt. Alle relevante dokumenter ligger på www.hydro.com/generalforsamling Investorkontakt Line Haugetraa +47 41406376 Line.haugetraa@hydro.com Denne opplysningen er informasjonspliktig etter verdipapirhandelloven §5-12 Vedlegg Arsberetning og arsregnskap 2020Guide for digital deltakelseHydros lonnspolitikkInnkalling til ordinaer generalforsamling 2021Innstilling fra Valgkomiteen 2021Moteseddel