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Introducing the new eco-friendly range of Helapet Sterile Sharps Bins

helapet

Helapet are pleased to announce a major development in the range of Sterile Sharps Bins. The new “Eco” range of sharps containers are made from at least 40% recycled plastic, assisting the NHS drive to reach Net Zero by 2040.

The new Eco range will conform to HTM07-01 management and disposal of healthcare waste guidelines. This means they are still a standard yellow container with yellow or purple lids for cytotoxic /cytostatic waste. Due to the recycled material, the yellow will be a darker tone in contrast to the current model.

The new eco range of Sterile Sharps Bins contain a minimum of 40% high grade recycled material to help minimise the impact on our environment and the carbon footprint during its manufacture. This also means there is less dependence on crude oils used in the manufacture of virgin plastic.

The new Eco Sharps Bin range is fully compliant with UN 3291 and ISO 23907-1:2019 standards. Having a mainly yellow base with the appropriate coloured lid it is also in line with HTM 07-01 waste segregation guidance. They are also compatible with the same accessories, trolleys, and brackets as the current ones.

The new ECO range of Sterile Sharps Bins will be phased in from June 2022. Current customers will not need to change anything to begin receiving the new bins. Just place your order the usual way using the same product codes.

Reducing the amount of single use plastic is a challenge in our industry but it’s one that Helapet embraces. One of our key goals is to incorporate sustainability where possible across all areas of our business operations from facility management to work practices, delivering sustainable solutions that benefit the environment.

For additional information and latest prices on any of our listed products, please email sales@helapet.co.uk or call 01582 501980

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23.01.2023

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

(St. Louis, MO – March 23, 2021) - 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).



24.03.2021

The London Clinic is UK’s first independent hospital to introduce OncoSilTM – an innovative nuclear medicine to treat pancreatic cancer

The London Clinic, a leading independent hospital and charity located in London’s Harley Street Medical Area, is the first independent hospital in the UK to employ OncoSilTM, a breakthrough new treatment for pancreatic cancer.

The London Clinic

 

OncoSilTM is a single-use brachytherapy device (internal radiation) that delivers a pre-determined dose of beta-radiation directly into cancerous tissue. It is used in combination with chemotherapy to treat patients with locally advanced pancreatic cancer.

Pancreatic cancer occurs when abnormal cells in the pancreas grow out of control, with symptoms varying according to the tumour type and location. People often do not show symptoms in the earlier stages of the disease and so it is difficult to detect. Pancreatic cancer has the lowest survival rate of all common cancers, with a five-year survival rate of less than 7%.i

This new nuclear medicine therapy offers a new option for the treatment of locally advanced pancreatic cancer where the tumour is unresectable – meaning it is too large or infiltrative to be operated on.

The beta particles emitted by OncoSil™ cause damage to cancer cell DNA which renders them incapable of further cell division which can ultimately shrink the tumour mass.

oncosil_reduction_of_tumour

 

OncoSilTM has been shown in clinical studies to increase overall survival and lead to downstaging, allowing patients to undergo surgery to remove their tumours. This surgery statistically improves the five-year survival rate from ~7% to >20%.

Zarni Win

OncoSil™ implantation is an out-patient procedure which takes around 60 minutes. Dr Zarni Win, Consultant Radiologist and Nuclear Medicine Physician at The London Clinic, said:
“I am particularly excited about this new therapy, as it now offers a much higher chance for pancreatic cancer patients with locally advanced disease to undergo curative surgery following OncoSilTM therapy, compared to a pessimistic outcome with conventional treatment.”

Nigel Lange

 

Nigel Lange, CEO and Managing Director, OncoSil Medical President, EMEA said:
“I am delighted that The London Clinic will be the first institution in the United Kingdom to routinely offer patients with unresectable locally advanced pancreatic cancer, treatment with the OncoSilTM device. This provides patients and their clinicians with an encouraging new approach and hope, in a disease where there has been little advancement for decades.”

During the PanCO clinical study, which had participating sites in Australia, UK and Belgium, a total of 50 subjects were enrolled in the study with 42 subjects successfully implanted with the OncoSilTM device.ii

Our clinicians performed the largest number of implantations in the UK/EU during this study. The London Clinic will be the first centre in the UK to treat patients using this technology in 2021. 

FOR MORE INFORMATION, MEDIA INTERVIEWS AND IMAGES, CONTACT:
Daphne Power
Media Campaigns Officer
The London Clinic
07598 790732
d.power@thelondonclinic.co.uk

Notes to Editors

About The London Clinic

The London Clinic is the UK’s leading private charitable hospital, situated in Harley Street, the heart of London’s medical district. Opened in February 1932 by the Duke and Duchess of York (later becoming King George VI), The London Clinic has been at the forefront of healthcare for close to 90 years. Our services are provided across seven buildings housing ten theatres, 234 beds, consulting rooms and a wide range of diagnostic services, including the latest 3T MRI scanner. The Duchess of Devonshire Wing, The London Clinic’s custom-built cancer centre, spans eight floors, offering access to state-of-the-art radiotherapy and chemotherapy suites, along with Europe’s largest private stem cell collection and storage facility. We were the first independent hospital in the UK to gain the Joint Accreditation Committee ISCT Europe and EBMT (JACIE) accreditation in recognition of our quality standards in stem cell work. As a full-service hospital, The London Clinic offers the most comprehensive range of services of any UK private hospital, including a 13 bed, Level 3 Intensive Care Unit and in-house pathology laboratory. We employ over 1,300 expert nurses, allied healthcare professionals, doctors and support roles. Our 600 world-class consultants specialise in cancer care, digestive diseases, orthopaedics (including hips, knees, shoulders and fingers with on-site physiotherapy rehabilitation), neurology, cosmetic surgery, liver services, gastroenterology, urology, endoscopy, diabetes, haematology and endocrinology. As a charity, The London Clinic reinvests all profits to further our mission of advancing healthcare within our hospital and for the benefit of the healthcare community. We were the first private hospital in the UK to introduce robotic surgery for prostate cancer and SpyGlass technology for endoscopy, and are the only UK hospital supporting the phase three international clinical trial for Intra Operative Radiotherapy on glioblastoma multiforme. We continue to invest significantly in the education of our people, supporting nurses to complete their degrees and fellows to become consultants.

Find out more at www.thelondonclinic.co.uk

Follow us on LinkedIn and Twitter.

 

About OncoSil Medical

At OncoSil Medical we have one mission – to transform the prognosis for people with cancer.

Our first priority is pancreatic cancer. For 40 years the prognosis for this condition has remained almost unchanged. Less than 8% of patients with pancreatic cancer survive five years. The statistics have left patients and doctors little room for hope. Until now.

OncoSil Medical is an innovative Australian medical technology company focused on interventional oncology. We’re passionate about improving outcomes for people with cancer. We believe it’s time to change the conversation around cancers with poor prognoses and transform the approach to their treatment.

OncoSil™ is our breakthrough brachytherapy device. Unlike conventional external beam radiation therapy, OncoSil™ uses a targeted approach to deliver a calculated dose of radiation directly into the tumour. It enables doctors to target a greater radiation dose directly to the tumour, while sparing surrounding critical organs.

OncoSil™ is intended for intra-tumoural implantation into a pancreatic tumour via injection under EUS guidance. The OncoSil™ device is intended to be used in conjunction with gemcitabine-based chemotherapy.

ihttps://www.pancreaticcancer.org.uk/what-we-do/media-centre/pancreatic-cancer-statistics/#:~:text=Pancreatic%20cancer%20has%20the%20lowest,year%20survival%20less%20than%207%25.

iihttps://clinicaltrials.gov/ct2/show/NCT03003078



16.03.2021

Q BioMed Announces Strontium89 will be available as of September 2020 through Named Patient Program for Bone Metastases Pain Palliation in EU and Rest of World

  • Named Patient Programs will allow Providers to treat patients with bone metastases pain palliation radiopharmaceutical treatment as of September, 2020
  • Named Patient Programs will remain in place until the treatment has been commercialised in EU and ROW, which is expected to be completed in 2021

NEW YORK, August 11, 2020 - Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today it is launching a Named Patient Program for its non-opioid bone metastases pain palliation drug, Strontium89 (Strontium Chloride Sr-89 Injection, USP). The Named Patient Program will be available to physicians and patients in the EU and throughout the world, and will be facilitated by Caligor Coghlan Pharma Services (CCPS).

Strontium89 is an FDA-approved, non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer, and is agnostic of the primary tumor. Common primary tumors that metastasize to the bone include prostate, breast, lung, as well as others. In several multicenter, placebo-controlled trials in cancer patients with pain from bone metastases, pain relief occurred in more patients treated with a single injection of Strontium89 than in patients treated with an injection of placebo. Strontium89 is administered intravenously once every three months and for some patients can reduce or even eliminate the need for opioid analgesics; pain relief lasts from 2 - 5 months in most patients.

Use of Strontium89 in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected, particularly in white blood cells and platelets. The extent of toxicity is variable but effects are generally transient. In randomized studies of Strontium89, the majority of hematologic toxicity was mild to moderate (Grade 2 or less) and white blood cell and platelet counts remained within approximately 70% of pretreatment levels. For more information including Important Safety Information please visit the Strontium89 page on Qbiomed.com.

Over ten million people around the world suffer from pain associated with metastatic cancer in the bone and may benefit from Strontium89. For nearly two years, there has been little to no access to this vital therapy, after manufacturing ceased in December of 2018. Q BioMed is pleased that the Named Patient Program will ensure immediate global patient access to an important therapy for this patient population. In the meantime, Q BioMed is actively pursuing full regulatory and marketing approval for Strontium89 in all major markets worldwide

Denis Corin, CEO of Q BioMed, said of the program, “We are very happy that Strontium89 is once again available worldwide, and that physicians have the ability to prescribe a safe, effective and non-opioid treatment to their bone metastasis pain patients regardless of their primary tumor type and notably beyond prostate cancer. We are actively working to ensure that Strontium89 is accessible to patients everywhere and to extend its relevance and use thorough additional clinical study.”
Any queries about the program and availability can be directed to info@qbiomed.com and at https://qbiomed.com/pipeline/sr89.

About Q BioMed Inc.

Q BioMed Inc is a biotech acceleration and commercial stage company. Q BioMed is focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
Please visit http://www.QBioMed.com and sign up for regular updates.
Media Contact Q BioMed:
Denis Corin
CEO
Investor Relations
+1(404) 995-6671
ir@qbiomed.com

About CCPS
Caligor Coghlan Pharma Services is a global company focused on changing the healthcare paradigm by supporting medical device and pharmaceutical companies from concept to commercialisation. Providing bespoke development consulting, regulatory and strategic services, packaging and labelling for clinical trial and initial commercial launch, early access and compassionate use programs, and medication/product management, storage, and logistics for hospitals, pharmacies and global healthcare systems. Ensuring patients have access to life enhancing treatments worldwide.



03.12.2020

Helapet Updates Syringe/Endcap Integrity Testing for Compliant Preparation of Injectable Medicines

Syringe Caps & Pharmapack® Press release

Helapet have announced that is has conducted new physical and microbiological integrity closure testing on their PharmaPack® range of sterile multi-pack BD syringes, in combination with a select range of syringe endcaps. The updated testing improves on existing compliances based on the recommended guidelines set down by the Pharmaceutical Aseptic Services Group (PASG) in their 2013 Yellow Document on the Protocols for the Integrity Testing of Syringes.

Following the release of the 2013 Yellow Document it is now necessary for NHS Aseptic Production Units (APU’s) to assess the integrity of the applied syringe/endcap combinations when preparing injectable medicines. Using both microbiological and physical integrity testing, a comprehensive assessment of the luer-lock closure can be made and evidence used to approve the use of that syringe/endcap combination for the sterile preparation of patient medications.

Two test methodologies were undertaken by a commissioned NHS Laboratory, involving a suitable number of test samples of syringe/endcap combinations subjected to microbiological and physical integrity testing. The microbial integrity evaluation involved sterile filling each sample, which was then challenged by immersion in a culture of Brevundimonas Diminuta and incubated at 30-35°C for 14 consecutive days. Physical integrity testing involved the samples being subjected to a dye intrusion test to determine whether any dye appeared to have entered the syringe barrel whilst under conditions matching those used for patient products.

The results concluded that the selected syringe/endcap combinations demonstrated the suitable durability required to pass both integrity tests, delivering compliant syringe closure and secure protection against physical leakages and external microbial contamination.

About Helapet

Helapet has been a respected supplier to the NHS for over 30 years, supplying sterile single-use consumable products to meet the high standards and requirements of healthcare professionals working in aseptic working environments.

Helapet is a member of the respected CliniMed® (Holdings) Group, comprising of eight specialist companies dedicated to supporting patient care through the supply of vital products into the healthcare industry.

Further reading:

https://www.helapet.co.uk/downloads/Integrity_Testing_of_Syringes_2013_2nd_Edn.pdf
NHS Method: Protocols for the Integrity Testing of Devices; 2nd Edition, revised April 2013

https://www.helapet.co.uk/downloads/29098_PharmaPack_Integrity_Testing_Summary_Datasheet.pdf
PharmaPack® Sterile Multi-Pack Syringe/Endcap Integrity Test Summary, 2019

 

Contact:
Chris Steng info@helapet.co.uk



07.04.2020

Curium Announces Approval of Pulmotech™ MAA (kit for the preparation of technetium Tc 99m albumin aggregated injection) by the U.S. Food and Drug Administration

(St. Louis, MO – March 24, 2020)- Curium announced today that the U.S. Food and Drug Administration (FDA) has approved Pulmotech MAA. When labeled to technetium Tc 99m, Pulmotech MAA is a single-photon emission agent for lung imaging as an adjunct in the evaluation of pulmonary perfusion and, in adults, to aid in the evaluation of peritoneovenous shunt patency. Curium has marketed a similar version of MAA (macroaggregated albumin) in Europe for more than a decade and expects to begin selling product to U.S. customers in April 2020.

“We are excited to bring Pulmotech MAA to the market,” said Dan Brague, Curium CEO, North America. “Our customers have been asking us to expand our product portfolio to include an MAA product for several years. I am happy to share that we have listened and we are now able to help supply the needs of clinicians and their patients. This is the first in a series of anticipated approvals over the next two years in which Curium will bring solutions to the market.”

“I am excited to bring a second MAA product to the U.S. market and look forward to engaging with customers on Pulmotech MAA immediately. This brand offers our customers significant value and is a tremendous addition to our growing portfolio of products in the U.S.” said Andy Farrow, VP of Sales, North America.

 

About Pulmotech MAA

Curium offers customers the flexibility to purchase vials in either a pack of 5 or in a box of 30. To order any product in Curium’s portfolio, please contact Customer Service at 1-888-744-1414.

 

Indication

Technetium Tc 99m Albumin Aggregated Injection is a radioactive diagnostic agent indicated for:

  • Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
  • Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.

 

IMPORTANT RISK INFORMATION

Contraindications

  • Patients with severe pulmonary hypertension
  • Persons with a history of hypersensitivity reactions to products containing human serum albumin

 

Warnings and Precautions

  • Serious adverse reactions have been reported in patients with pulmonary hypertension
  • Serious hypersensitivity reactions have been reported

 

Adverse Reactions

  • Deaths after administration to patients with severe pulmonary hypertension and serious hypersensitivity reactions have been reported.

 

Use In Specific Populations

  • Lactation: Temporarily discontinue breastfeeding and discard breast milk for 13 hours after administration.

 

Please see Full Prescribing Information at https://www.curiumpharma.com/pulmotech-maa

 

About Curium

Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.

With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a 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



24.03.2020

RadioMedix and Curium Announce copper Cu 64 dotatate injection Was Granted Priority Review by the U.S. FDA

(Houston, TX and St. Louis, MO – March 11, 2020) - RadioMedix Inc. and its commercial partner Curium announced the U.S. Food and Drug Administration (FDA) has granted copper Cu 64 dotatate injection a priority review. Copper Cu 64 dotatate is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). Curium is preparing to launch copper Cu 64 dotatate in Q3 of this year.

“If approved, we expect that copper Cu 64 dotatate injection will have a significant impact on physicians, neuroendocrine tumor patients and their caregivers as this will help alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents,” said Ebrahim Delpassand, MD, CEO of RadioMedix.

“We are preparing for the full-scale commercialization of copper Cu 64 dotatate injection and are excited to introduce a new product and a new isotope into the market. We are pleased that our significant efforts will result in helping neuroendocrine tumor patients receive a specific, sensitive and timely diagnosis,” said Curium CEO, North America, Dan Brague.

About RadioMedix

RadioMedix, Inc. is a clinical-stage biotechnology company, based in Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and targeted alpha and beta-emitter therapy. RadioMedix has research and contract service facilities for academic and industrial partners: the cGMP Dose Manufacturing and Analytical suites for the investigational clinical trials, and the Drug Discovery and Pre-clinical Core Facility for pre-clinical evaluation of drugs, both located in Houston, TX. Also, a second new state of art commercial manufacturing facility located in Humble, TX, has been recently established. To learn more, visit wwww.radiomedix.com. For more information about this press release, please contact:media@radiomedix.com. Follow us on social media: LinkedIn https://www.linkedin.com/company/radiomedix-inc-/ Facebook: https://www.facebook.com/RadioMedix-Inc/

About Curium

Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.

With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a 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 and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).



12.03.2020

Vent-Medis High Volume Crucible

Xiel Ltd have been requested to cease all commercial activities with the Vent-Medis High Volume Crucible whist the MHRA legal team review if the product can be registered as both a pharmaceutical and medical device. Please see more details in the attached letter.

As communicated in the attached letter and should you wish, we are offering to accept the return of all products sold since 19.11.19 for a full refund. Please confirm if this is an option you wish to explore and we will arrange collection of your Purchase order 200726889 at a convenient time, and issue a full credit against our invoice 253 dated 17.12.19.

Please note that Xiel can continue to offer Servicing and Maintenance of Technegas Generators which are not impacted by the current MHRA request.

Xiel ltd apologise for any inconvenience caused but can assure you we are working with the correct authorities to have this resolved as soon as possible and as soon as more information is received we will of course keep you updated.



23.01.2020

RadioMedix and Curium Announce FDA Filing of copper Cu 64 dotatate injection New Drug Application

(Houston, TX and St. Louis, MO – January 7, 2020) - RadioMedix Inc. and its commercial partner Curium announced today that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection.

“If approved, we expect that copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. In addition, this drug will provide an exciting new imaging agent for NET physicians, patients and caregivers,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “Copper Cu 64 dotatate injection will be the first neuroendocrine PET diagnostic agent available to all medical centers with PET capability across the country. This will alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents. We are currently pursuing a Priority Review with the FDA to expedite commercial availability.”

“If approved, the clinical utility of this new agent will allow Curium to enhance patient care in the U.S. by bringing the accuracy of PET SSTR to all hospitals and imaging centers,” said Curium CEO, North America, Dan Brague. “Our ability to manufacture copper Cu 64 dotatate injection at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued focus on patients with neuroendocrine tumors. We are excited to be bringing Cu 64, an exciting new isotope for PET imaging, to the market. We look forward to exploring additional applications that can help patients and physicians.”

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, in addition to small animal Molecular Imaging Center for the pre-clinical evaluation of new targets in vitro and in vivo. To learn more, visit www.radiomedix.com. For more information about this press release, please contact:media@radiomedix.com

About Curium
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.

With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a 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 and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).



07.01.2020

Curium Acquires Finnish Radiopharmaceuticals Company
MAP Medical Technologies Oy

(London and Paris – December 02, 2019) — Curium has successfully completed the acquisition of Finnish radiopharmaceuticals company MAP Medical Technologies Oy. The acquisition of MAP Medical will further expand Curium’s footprint in Europe, providing direct access to Nordic and Baltic countries for its broad portfolio of life saving diagnostic solutions.

MAP Medical operates three GMP manufacturing sites across Finland, two in Helsinki and one in Tikkakoski, and has been supplying critical radiopharmaceutical agents to customers across Nordics and Baltics since 1991. The Company employs c.50 people and offers a range of PET diagnostic agents. It is also a distributor of Curium’s SPECT product portfolio in Finland.

“We are looking forward to integrating MAP Medical into our network of 25 PET sites across Europe” says Benoit Woessmer, CEO of PET EUROPE at Curium. “This acquisition complements our current geographical footprint and enables us to offer our broad range of products and future pipeline of innovative agents to customers and patients across Nordics and Baltics.”

“The MAP Medical team is excited to be part of a global nuclear medicine platform” commented Mika Nyyssönen and Jarmo Haukka, co-founders of MAP Medical. “We are confident that, in Curium, they have found the right home to further build their careers in this exciting field, developing and commercializing lifesaving diagnostic and therapeutic solutions to patients globally”.

About Curium
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.

With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a 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 MAP Medical Technologies Oy
MAP Medical Technologies Oy, founded in 1991, is an independent Finnish company focused on developing and manufacturing radiopharmaceuticals which improve the quality and length of human life as well as serve the needs of nuclear medicine professionals. The company operates three facilities in Finland and distributes a broad range of PET and SPECT products to customers across Nordics and Baltics.



02.12.2019

Hermes Medical Solutions receives 510(k) FDA clearance for Voxel Dosimetry

Hermes Medical Solutions has received 510(k) FDA clearance for its Voxel DosimetryTM product. The product has previously been CE-marked.

Voxel DosimetryTM provides estimates (deterministic) of absorbed radiation dose at voxel level as a result of administrating one of the supported radionuclides and providing a 3-dimensional dose map.

Hermes Medical Solutions´ Voxel DosimetryTM supports the 7 most common isotopes; Ga68, I123, I131, In111, Lu177, Tc99m and Y90.

The Voxel DosimetryTM workflow consists of the following steps:
• SPECT/CT or PET/CT DICOM data loading from the data manager (e.g. PACS)
• Registration of different time-points to a common reference study
• Generation and integration of voxel-level time-activity curves
• Voxel-level absorbed dose calculation using a Monte Carlo method
• Saving of the absorbed dose map back to the data manager (e.g. PACS) in DICOM format

“This is an important step towards the holy grail in medical imaging, Theranostics”, says Hermes Medical Solutions´ CEO Tom Francke. “Voxel DosimetryTM is the most advanced dosimetry product on the market, which was also recognized by the FDA. It supports all the most commonly used isotopes. It is now both CE-marked and FDA-approved”.


Further reading: https://www.hermesmedical.com/products/oncology-dosimetry-olinda-theranostics/

Hippeläinen ET, Tenhunen MJ, Mäenpää HO, Heikkonen JJ, Sohlberg AO. Dosimetry software Hermes Internal Radiation Dosimetry: from quantitative image reconstruction to voxel-level absorbed dose distribution. Nuclear Medicine Communications 2017; 38:5:357-365 Gustafsson J, Brolin G, Cox M, Ljungberg M, Johansson L, Gleisner KS. Uncertainty propagation for SPECT/CT-based renal dosimetry in Lu-177 peptide receptor radionuclide therapy. Phys Med Biol. 2015;60(21):8329–8346

Contact:
Tom Francke, info@hermesmedical.com

21.10.2019

Curium Announces Revised Pricing for Technescan MAG3TM (kit for the preparation of technetium Tc 99m mertiatide)

(St. Louis, MO – September 4, 2019) – Curium announced today that it is implementing a new pricing model for Technescan MAG3. Curium is phasing out its pay per dose sales model, in which Curium supplies a vial of Technescan MAG3 to a nuclear pharmacy and the nuclear pharmacy pays Curium a designated price for each dose that it compounds and dispenses to its customers. Curium is transitioning to a price per vial approach. The average price per vial currently being established is approximately $625 for most U.S. customers. This change provides a simplified approach that customers tell us will benefit their operations.

“After careful review of our sales approach, we are making this change to simplify the tracking and reporting demands of our customers and provide them a clearer picture of their supply costs,” said Curium CEO, North America, Dan Brague. “The transition will likely take several months to implement but will be a focal point for our sales team during the second half of 2019. We look forward to partnering with our customers on this new approach and continuing to learn how we can better serve their needs.”

About Curium
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.
With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a 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


04.09.2019

Serac Imaging Systems to develop a compact, hybrid optical/gamma camera which will be portable, smaller, easier to use and more cost effective than anything that exists on the market today

Please find below and attached a press release announcing the formation of a new molecular imaging company, Serac Imaging Systems, which has been established to develop a highly innovative, miniature, hybrid gamma/optical camera (HGC) which will be portable, cheaper, smaller and easier to use than anything that exists on the market today. The IP for the HGC has been exclusively licensed from a group of universities led by the University of Leicester.

SIS Press Release

27.06.2019

Theranostics: New hope for late stage prostate cancer patients with an innovative UK-first treatment

Dr Yong Du, Clinical Director Theranostics; Julie Martin, Business Development Theranostics; Emma Spellman Head of Theranostics and Imaging UK and Dan McGowan, Research Physicist – Nuclear Medicine.
Dr Yong Du, Clinical Director Theranostics; Julie Martin, Business Development Theranostics; Emma Spellman Head of Theranostics and Imaging UK and Dan McGowan, Research Physicist

The first patients in the UK have now received an innovative theranostics treatment for advanced prostate cancer at GenesisCare, giving new hope for men who have exhausted other treatment options. The UK’s largest private cancer care provider, GenesisCare, announced today that the service is now available at its centre in Windsor for the first time in the UK.

Press Release

03.06.2019

Blue Earth press release

Blue Earth Diagnostics continues to expand access to Axumin (fluciclovine (18F)) in Europe

Blue Earth Diagnostics continues to expand

09.05.2019

Blue Earth Diagnostics’ latest press release

Announcing the addition of Axumin® (fluciclovine (18F)) to the EAU guidelines for imaging in patients with biochemical recurrence in Prostate Cancer.

The aim of the EAU Guidelines is to assist practicing clinicians in making informed decisions in a given circumstance; taking the highest quality scientific data, their patient’s personal circumstances, values and preferences into account. This is great news for BED as it’s a clear recognition of the clinical value of Axumin in Europe.

Press Release

17.04.2019

Blue Earth Diagnostics celebrates 5 year anniversary

Press Release - Blue Earth Diagnostics celebrates five years

Press Release

06.03.2019

Blue Earth Diagnostics’ Latest Press Release

Blue Earth Diagnostics’ latest press release announcing the first production and administration of Axumin® (fluciclovine (18F)) in Italy. This news demonstrates our continued commitment to maximize access to Axumin across Europe.

Press Release

12.02.2019

Brexit Update From Curium - Updated

Please find the most recent information surrounding our Brexit contingency plans

Feb 2019 Curium Brexit Contigency updated

18.02.2019    

 

 

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