Latest news with #Optiscan
Sydney Morning Herald
01-07-2025
- Business
- Sydney Morning Herald
Melbourne breast cancer trial to test Optiscan imaging device
ASX-listed medical technology company Optiscan Imaging has started recruiting up to 50 patients for a Royal Melbourne Hospital clinical trial of its innovative precision surgery and digital pathology imaging devices, aiming to improve a common breast cancer surgery. The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients. The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices. Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed. Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge. 'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.' Optiscan Imaging chief executive officer and managing director Dr Camile Farah Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application. The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification. While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
The Age
01-07-2025
- Business
- The Age
Melbourne breast cancer trial to test Optiscan imaging device
ASX-listed medical technology company Optiscan Imaging has started recruiting up to 50 patients for a Royal Melbourne Hospital clinical trial of its innovative precision surgery and digital pathology imaging devices, aiming to improve a common breast cancer surgery. The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients. The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices. Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed. Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge. 'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.' Optiscan Imaging chief executive officer and managing director Dr Camile Farah Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application. The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification. While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
The Age
23-06-2025
- Business
- The Age
Optiscan teams up with US drugmaker to support FDA submissions
Optiscan Imaging has fired a major shot in a bid to expand into the lucrative United States medical imaging market by inking a blockbuster five-year deal with American pharmaceutical outfit Long Grove Pharmaceuticals. The exclusive collaborative agreement will see Long Grove's fluorescein sodium contrast dye, AK-FLUOR, supplied for use in Optiscan's InVue imaging system in clinical studies, starting with breast surgery. Long Grove was founded by US healthcare investor Water Street and is known for its high-quality, cost-effective drug formulations. The company is the legal manufacturer of AK-FLUOR dye. The contrast dye is used to highlight cellular structures for medical imaging during surgery. Optiscan already uses the dye with its InVue fluorescence-based endomicroscopic imaging technology. 'AK-FLUOR will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials.' Optiscan chief executive officer and managing director Dr Camile Farah The two companies have teamed up to explore and support new clinical uses for the injectable dye and will initially focus on breast surgery. The deal is expected to expand into gastrointestinal endoscopy, robotic-assisted surgery and laparoscopic procedures. The data generated from the trials will be used to fast-track United States Food and Drug Administration (FDA) approvals for both the device and the drug, potentially unlocking broader commercial use and a quicker route into the US market. As part of the deal, Optiscan will get valuable information about how AK-FLUOR works in the body and how it's manufactured. In return, Long Grove will receive support for new FDA applications if new therapeutic uses of its drug in microscopic imaging come to light from the trials. Optiscan chief executive officer and managing director Dr Camile Farah said: 'For Optiscan, the agreement gives us a supply of Long Grove's AK-FLUOR, which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials. The data flowing from these studies will be an invaluable resource for our regulatory submissions. For Long Grove, the collaboration should hopefully identify new uses for its drug.'
Sydney Morning Herald
23-06-2025
- Business
- Sydney Morning Herald
Optiscan teams up with US drugmaker to support FDA submissions
Optiscan Imaging has fired a major shot in a bid to expand into the lucrative United States medical imaging market by inking a blockbuster five-year deal with American pharmaceutical outfit Long Grove Pharmaceuticals. The exclusive collaborative agreement will see Long Grove's fluorescein sodium contrast dye, AK-FLUOR, supplied for use in Optiscan's InVue imaging system in clinical studies, starting with breast surgery. Long Grove was founded by US healthcare investor Water Street and is known for its high-quality, cost-effective drug formulations. The company is the legal manufacturer of AK-FLUOR dye. The contrast dye is used to highlight cellular structures for medical imaging during surgery. Optiscan already uses the dye with its InVue fluorescence-based endomicroscopic imaging technology. 'AK-FLUOR will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials.' Optiscan chief executive officer and managing director Dr Camile Farah The two companies have teamed up to explore and support new clinical uses for the injectable dye and will initially focus on breast surgery. The deal is expected to expand into gastrointestinal endoscopy, robotic-assisted surgery and laparoscopic procedures. The data generated from the trials will be used to fast-track United States Food and Drug Administration (FDA) approvals for both the device and the drug, potentially unlocking broader commercial use and a quicker route into the US market. As part of the deal, Optiscan will get valuable information about how AK-FLUOR works in the body and how it's manufactured. In return, Long Grove will receive support for new FDA applications if new therapeutic uses of its drug in microscopic imaging come to light from the trials. Optiscan chief executive officer and managing director Dr Camile Farah said: 'For Optiscan, the agreement gives us a supply of Long Grove's AK-FLUOR, which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials. The data flowing from these studies will be an invaluable resource for our regulatory submissions. For Long Grove, the collaboration should hopefully identify new uses for its drug.'
News.com.au
23-06-2025
- Business
- News.com.au
Health Check: It's ‘nothing personal' as major US biotech fund calls time on Syntara
San Francisco's BVF Partners has exited all its ASX investments because they are too small for the fund's mandate Alcidion shares soar 15% on earnings upgrade Optiscan enters 'win-win' supplier collab Syntara (ASX:SNT) CEO Gary Phillips says the exit of a long-term US backer should not be seen as a judgment on the company's late-stage myelofibrosis drug program. In a block trade the San Francisco BVF Partners has disposed of its $5 million, 6%, Syntara stake. The shares were taken up by some of Syntara's existing institutional holders. BVF's exit last week sent Syntara shares down by 25%, despite the company's previous Friday's positive update on its phase II myelofibrosis trial update. Phillips says the trial news created a 'liquidity event' which BVF availed of. But it was not a case of BVF (as in Biotech Value Fund) spurning Syntara's drug program. Rather, the fund grew to the extent where it can't justify a minimum investment below US$30-50 million. 'They always liked our science,' Phillips says. 'They have visited our labs and were always encouraged, but they just got bigger and bigger.' With US$9 billion of assets, BVF has called time on all its ASX investments. In May BVF divested its $3 million in Actinogen Medical (ASX:ACW), also via a block trade. The fund had also invested in Opthea (ASX:OPT), but got off before the eye drug developer's' trials went pear shaped. BVF also invested in immune-oncology drug developer Viralytics, famously taken over by Merck for an eyebrow-raising $500 million in 2018. Syntara's blood cancer program looks the goods Syntara's 'liquidly event' stemmed from further data from its phase II myelofibrosis trial, evaluating its drug candidate SNT-5505 in combo with the standard-of-care drug ruxolitinib. The patients had been treated with ruxolitinib, so had symptoms such as enlarged spleen size and blood counts 'indicative of high disease burden'. The results showed eight of 11 evaluable patients (73%) achieved a reduction of more than 50% at 24 weeks, as measured by a standard gauge called TSS50. Four out of nine patients (44%) had a spleen volume reduction of 25% at week 24 or beyond. The ongoing trial enrolled 16 patients with intermediate or high-risk myelofibrosis, for 52 weeks of treatment. However, five dropped out by the 24-week mark. This is a 'withdrawal rate consistent with that seen in other myelofibrosis studies of patients with similar disease severity." Eight patients reaching 38 weeks showed and average 56% reduction in symptoms, while five reaching 52 weeks exhibited a 63% decline. Syntara intends to chat with the FDA in the September quarter about the design of a pivotal phase 2c/3 study. Too much of a good thing for Immutep? With four trial updates on separate programs in less than two months, immunology drug play Immutep (ASX:IMM) must also feel underappreciated. Immutep stock has fallen around 10% in this period and trades at close to five-year lows, despite the upbeat clinical vibes. Too much activity from the multi-tentacled Immutep confusing investors, perhaps? Today, Immutep said a phase I autoimmune study showed 'significant T-cell suppression', thus highlighting potential efficacy of its candidate IMP-761. Initial data from placebo-controlled, double-blinded effort also showed good safety at the highest dosing level to date. By stimulating the LAG-3 (lymphocyte-activation gene-3) agonist antibody, IMP-761 promises to treat conditions including rheumatoid arthritis, Type 1 diabetes and multiple sclerosis. Since May 5 Immutep also has updated investors on its head and neck cancer, lung cancer and soft tissue sarcoma trials. Miya My! Alcidion has upgraded earnings Hospital patient management software supplier Alcidion (ASX:ALC) has upped its full-year earnings outlook, with strong take-up of its flagship Miya prompting clients to adopt its broader wares. 'Over the past few months this has resulted in several customers of varying size seeking extensions or module upgrades," CEO Kate Quirke says. "This has contributed to our improved financial position." Having guided to earnings before interest, tax depreciation and amortisation of $3 million, the company now expects the number to exceed $4.5 million (for the year to June 30 2025). The company earlier guided to revenue of at least $40 million. Alcidion provides to more than 400 hospitals and 87 healthcare organisations in the UK, here and New Zealand. In the UK, the most capacious market, the beloved National Health Service (NHS) is being merged with Department of Health and Social Care. This poses both threat to – and opportunities for – Alcidion, given it sells to NHS organisations. In April, Quirke said the push for more NHS productivity with fewer staff was likely to mean greater demand for Alcidion's digital platforms. 'I see the opportunity increasing,' she said. 'But we are waiting to see what the ten-year plan indicates in terms of where the priority areas are.' PYC gets FDA OK PYC Therapeutics (ASX:PYC) has provided evidence that the FDA continues to function, with the agency approving the company's proposed trial design at a preliminary (Type B) meeting. The company currently is undergoing a phase 1-2 trial of its drug candidate VP-001, to treat the blinding eye disease retinitis pigmentosa type 11 (RP11). With positive data to date, PYC wants to progress to a phase2/3 study pitched at FDA approval. The FDA says PYC can use similar endpoints and says trial design features (such as use of a sham arm and inclusion exclusion criteria) are OK as well. The company will use this guidance to finalise its proposed registrational study design. Tryptamine study aims to put binge eating disorder to BED Meanwhile, Tryptamine Therapeutics (ASX:TYP) has won ethics approval for the world's first trial, to test intravenously infused psilocin for binge eating disorder (BED). BED is the most common eating disorder in the US and second most common here. BED results in multiple other conditions including depression, anxiety, PTSD (post-traumatic stress disorder) and compulsive behaviours. A collaboration with Swinburne University, the local trial will enrol 12 patients and administer them with with Tryptamine's drug candite TRP-8803. They will be given two doses 14 days apart and also undergo psychotherapy. The trial has started recruiting, with first dosing expected in the September quarter. Investors can expect top-line results before the year is out. The good OIL on a 'win-win' collab Optiscan (ASX:OIL) has entered a five-year collaboration agreement with the US based Long Grove Pharmaceuticals, which provides a contrast agent for Optiscan's fluorescence-based endomicroscopic imaging systems. The idea of the collab is to use Long Grove's fluorescein drug, AK-FLUOR, with Optiscan's imaging technology in clinical studies. This potentially will identify new applications for the drug and expedite regulatory submissions. On the Optiscan side of things, the data should support the company' efforts to win FDA approval for its Invue device. Invue enables surgeons to gain real-time pathology insights and make on-the-spot decisions. Optiscan CEO Dr Camile Farah dubs the agreement a 'clear-cut win-win for both companies' development strategies'.
