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Paradigm Biopharmaceuticals presents patient-centric research at World MPS Symposium

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has presented its poster presentation for MPS VI, a rare autosomal lysosomal storage disorder, at the World MPS Symposium in Orlando, Florida.

The company presented outcomes from a patient focus group which aimed to identify and validate clinical endpoints thus producing the most clinically relevant endpoints for MPS subjects.

Paradigm chief medical officer Dr Donna Skerrett said: “Improving the lives of MPS patients requires a deep understanding of their medical condition, experiences, needs and priorities of both patient and caregiver.

“The patient-centric research conducted by the Paradigm team provides an opportunity to adopt and use these as a reference point for consistent patient engagement and to develop clinically meaningful endpoints, which is especially important in orphan indications”.

Current treatment includes enzyme replacement therapy (ERT) which acts to reduce non-neurological symptoms and pain, however, many patients conti..

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has presented its poster presentation for MPS VI, a rare autosomal lysosomal storage disorder, at the World MPS Symposium in Orlando, Florida.

The company presented outcomes from a patient focus group which aimed to identify and validate clinical endpoints thus producing the most clinically relevant endpoints for MPS subjects.

Paradigm chief medical officer Dr Donna Skerrett said: “Improving the lives of MPS patients requires a deep understanding of their medical condition, experiences, needs and priorities of both patient and caregiver.

“The patient-centric research conducted by the Paradigm team provides an opportunity to adopt and use these as a reference point for consistent patient engagement and to develop clinically meaningful endpoints, which is especially important in orphan indications”.

Current treatment includes enzyme replacement therapy (ERT) which acts to reduce non-neurological symptoms and pain, however, many patients continue to report ongoing issues.

Paradigm is focused on repurposing the injectable drug pentosan polysulphate sodium (iPPS) to treat inflammation.

Clarifying patient needs


The objective of the companys research was to engage patients with MPS VI, and their caregivers in the drug development process, to better understand the range of symptoms and the impact on function and activities of daily living.

A focus group was established with nine patients age 4-18 and their caregivers with a series of open-ended and polling questions to gain comprehensive understanding into the specific needs of patients suffering from the orphan disease.

MPS patients found the following activities most challenging:

  • 33.3% of patients/caregivers cited mobility and independence as their most challenging;
  • Fine motor tasks were reported by 78% as the most or second most challenging; and
  • 33.3% of patients/caregivers cited sleep as most or second most challenging.

Patient-centric development


Paradigm chief executive officer Paul Rennie said: “The research into the clinical unmet needs of MPS patients conducted by the Paradigm team and the presentation of the poster at the World MPS Symposium provides the company an important understanding of clinically meaningful end-points that will be incorporated into our clinical trial development program for iPPS in this orphan indication.

“This is Read More – Source

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Compumedics secures US Food and Drug Administration approval for Orion Lifespan™ technology

Compumedics Limited (ASX:CMP) has confirmed US Food and Drug Administration (FDA) approval of its Neuroscan Orion LifeSpan Magnetoencephalography (MEG) system.

The approval follows the successful installation and first phase commissioning of the system at the Barrow Neurological Institute in Arizona, USA.

MEG is a neuroimaging technique for mapping brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain.

Compumedics chairman and chief executive officer Dr David Burton said the company was pleased to achieve this milestone.

He said: “Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the R &D over many years.

“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory.”

The FDA clearance now allows for routine clinical use of the single MEG device, primarily for epilepsy and pre-sur..

Compumedics Limited (ASX:CMP) has confirmed US Food and Drug Administration (FDA) approval of its Neuroscan Orion LifeSpan™ Magnetoencephalography (MEG) system.

The approval follows the successful installation and first phase commissioning of the system at the Barrow Neurological Institute in Arizona, USA.

MEG is a neuroimaging technique for mapping brain activity by recording magnetic fields produced by electrical currents occurring naturally in the brain.

Compumedics chairman and chief executive officer Dr David Burton said the company was pleased to achieve this milestone.

He said: “Receiving 510(K) clearance from the FDA, whilst expected, it is nevertheless satisfying and validating after all the R &D over many years.

“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory.”

The FDA clearance now allows for routine clinical use of the single MEG device, primarily for epilepsy and pre-surgical brain function mapping.

“The foundation for commercialisation”


With the FDA approval in place, Compumedics may now enter the lucrative US clinical market with its technology.

Burton added: “It represents a foundation for the commercialisation of our MEG technology.

"This market clearance will allow us to transition from product development to full commercialisation.

“Compumedics continues to actively pursue 40 identified MEG opportunities around the world, with four opportunities substantively advanced.”

Each system will typically sell for around US$3 million to US$4 million, depending on specification.

Additionally, sites using the system may now routinely bill both private and public insurance plans for MEG examinations.

Ground-breaking features


The MEG hardware approval comes in addition to tRead More – Source

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Cobalt Blue outlines strategy for cobalt processing and BHCP project

Cobalt Blue Holdings Ltd (ASX:COB) has outlined its near to mid-term strategy to develop the Broken Hill Cobalt Project (BHCP) alongside commercialising its proprietary cobalt processing technology.

This two-part strategy has been developed by the pure-play cobalt company which has recently secured 100% ownership of the BHCP, which is just outside the traditional mining centre of Broken Hill.

Chief executive officer Joe Kaderavek explains the key aspects of the strategy to Proactive.

PROACTIVE: Can you articulate the Cobalt Blue Holdings (COB) strategy?[hhmc]
CEO: COB has a two-part strategy:

Bringing the BHCP into production; and
Commercialisation of COBs proprietary technology through COB Partnerships

With regards to our second aim, COB is examining opportunities to apply the technology to third-party cobalt/copper resources. There are two third-party test work programs underway:

Millennium Project (100% Global Energy Metals Corporation – CVE:GEMX) – Cloncurry district, North Q..

Cobalt Blue Holdings Ltd (ASX:COB) has outlined its near to mid-term strategy to develop the Broken Hill Cobalt Project (BHCP) alongside commercialising its proprietary cobalt processing technology.

This two-part strategy has been developed by the pure-play cobalt company which has recently secured 100% ownership of the BHCP, which is just outside the traditional mining centre of Broken Hill.

Chief executive officer Joe Kaderavek explains the key aspects of the strategy to Proactive.

PROACTIVE: Can you articulate the Cobalt Blue Holdings (COB) strategy?


CEO: COB has a two-part strategy:

  1. Bringing the BHCP into production; and
  2. Commercialisation of COBs proprietary technology through COB Partnerships

With regards to our second aim, COB is examining opportunities to apply the technology to third-party cobalt/copper resources. There are two third-party test work programs underway:

  • Millennium Project (100% Global Energy Metals Corporation – CVE:GEMX) – Cloncurry district, North Queensland. COB is focused on the extraction of cobalt, copper and gold. This is an exciting opportunity as we are dealing with Mt Isa style mineralisation over a very large district. Positive test results will unlock a new territory for our technology, with final results expected shortly.
  • Carrapateena Mine (100% OZ Minerals Ltd – ASX:OZL). OZL has recently brought Carrapateena into operation to produce copper concentrates. OZL has engaged COB to evaluate the treatment of a secondary pyrite concentrate using the COB technology for recovery of cobalt sulphate (along with copper and gold). The test work program is expected to conclude by the end of May.

Why is the investment in a pilot and then demonstration plant so important?


CEO: A key stepping-stone on our development path is to build a metallurgical testing centre in Broken Hill. This centre will scale from an initial Pilot Plant operation producing ~100-300 kilograms of cobalt sulphate from 90 tonnes of ore and we expect commissioning in late Q2 with first operations mid-year.

This facility will then be upgraded to a larger-scale fully integrated Demonstration Plant, producing 1-2 tonnes of cobalt sulphate, by year-end.

The Demonstration Plant is aiming to deliver multiple production samples to leading battery facilities across Asia, Europe and North America.

Global industry uptake of our product requires extensive acceptance testing so that our commercial product can qualify as a precursor feedstock from the outset of BHCP operations.

Potential commercial partners will be able to visit the project mine site as well as the Demonstration Plant in 2020, providing inspection of the entire production chain.

What do you mean by flexible production at BHCP?


CEO: In order to take advantage of prevailing cobalt market conditions, the BHCP has a flexible production strategy. By developing a process that produces a range of commercially saleable products, the project will be able to optimise its suite of products at any one time. In simple terms – Capture the maximum cobalt margin across the price cycle for our shareholders.

The BHCP refinery will therefore produce:

  • An intermediate Mixed Hydroxide Product (MHP) containing ~25% cobalt and ~2% nickel. The high cobalt to nickel ratio is unique and is likely to command a premium payable content sale price, for blending with typical nickel rich MHPs.
  • A final Cobalt Sulphate will be produced from further refining the MHP. The target product specification is a >20.5% cobalt content sulphate crystal, suitable for use in cathode precursor manufacture.

COB is involved in various Federal Government initiatives, from the FBI CRC and the CRC-P, can you summarise this involvement?


CEO: COB has recently joined the Future Battery Industries Cooperative Research Centre (FBI CRC) (http://www.fbicrc.com.au/). The FBI CRC was granted A$25 million from the Australian Government and has received pledges from industry participants totalling A$100 million. COB will be taking an active role in the FBI CRC cathode precursor pilot plant, which is aiming to produce cathodes using Australian sourced raw materials (eg CoSO4.7H2O and NiSO4.6H2O)

COB has also been awarded A$2.4 million from the Cooperative Research Centre (CRC) – Project Round 8 Funding from the Australian Government, for applied research and development of the processing of cobalt-pyrite orRead More – Source

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Hexagon Energy Metals partner signs rare earth separation deal with Ucore

Hexagon Energy Metals Ltds (ASX:HXG) partner in the commercialisation of the RapidSX rare earth element (REE) separation technology, Innovation Metals Corp, has entered into an agreement with Ucore Rare Metals Inc (CVE:UCU).

Ucore will assess RapidSXs potential utilisation for the separation of REEs into high-purity REE oxides (REOs) using concentrate material from Ucores flagship Bokan-Dotsan Ridge REE Project in Alaska, US.

Hexagons management team in North America and Australia was instrumental in bringing the parties together and advancing the first binding Technical Services Agreement (TSA) signed for test processing the material.

Hexagon managing director Mike Rosenstreich said: “Ucores interest in and commitment to evaluating RapidSX is significant; they are a REE industry stalwart in the USA with an advanced project with US$145 million in designated financing from the Alaska Industrial Development and Export Authority (AIDEA).

“Ucore plans to develop heavy and light REE dow..

Hexagon Energy Metals Ltds (ASX:HXG) partner in the commercialisation of the RapidSX rare earth element (REE) separation technology, Innovation Metals Corp, has entered into an agreement with Ucore Rare Metals Inc (CVE:UCU).

Ucore will assess RapidSXs potential utilisation for the separation of REEs into high-purity REE oxides (REOs) using concentrate material from Ucores flagship Bokan-Dotsan Ridge REE Project in Alaska, US.

Hexagons management team in North America and Australia was instrumental in bringing the parties together and advancing the first binding Technical Services Agreement (TSA) signed for test processing the material.

Hexagon managing director Mike Rosenstreich said: “Ucores interest in and commitment to evaluating RapidSX is significant; they are a REE industry stalwart in the USA with an advanced project with US$145 million in designated financing from the Alaska Industrial Development and Export Authority (AIDEA).

“Ucore plans to develop heavy and light REE downstream processing capabilities through its planned Alaska Strategic Metals Complex to produce separated high-purity REOs.”

Third-party validation of a unique technology


“Ucore brings a tremendous amount of third-party validation to RapidSX, underscoring Hexagons focus on the commercialisation of this important technology.

“Over the past several years, Ucore has evaluated a range of alternative REE-separation processes, resulting in the selection of solvent-extraction chemistry, which led to their interest in the proprietary RapidSX REE separation technology, offering significant CapEx and OpEx savings compared to current conventional SX-based commercial REE separation.

Read More – Source

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