Health Check: Woundcare house tackles overlooked women’s cancer sector | Stockhead
Closing the gap: With its hydrogel spacer to prevent radiation damage, Tetratherix aims for happier gynaecological surgery results. Pic: Getty ImagesTetratherix will launch an expanded local and US trial to. . .
Closing the gap: With its hydrogel spacer to prevent radiation damage, Tetratherix aims for happier gynaecological surgery results. Pic: Getty ImagesTetratherix will launch an expanded local and US trial to test its protective spacer for gynaecological cancersBroker highlights reimbursement issues for heart disease tearaway Echo IQWell, well, well! Imagion goes to the funding wellFollowing ethics approval, woundcare device developerTetratherix (ASX:TTX)will launch a broader pivotal trial to cater for the overlooked gynaecological cancer segment. Targeting both local and US Food and Drug Administration (FDA) clearance, the circa 240-patient study expands on a 15-patient local effort, Tutela. The trial pertains to Tutelix, a hydrogel spacer that fills in bodily gaps post-surgery. Tetratherix is developing the product via a joint venture with Koda Health. To date, the JV has focused on protecting the rectum from radiation in prostate cancer procedures. “Women receiving radiotherapy for cervical, uterine and vaginal cancers face a similar anatomical problem to men treated for prostate cancer,” the company says. This limits the radiation dose that can be safely delivered and may cause injury during and after treatment. With gynaecological sites, the weight of the abdominal mass puts greater pressure on the spacer, relative to the prostate site. Tetratherix chief technology officer Dr Ali Fathi says the study shows that Tutelix “maintains its structure and holding space under sustained anatomical pressure”. This provides the company’s impetus “to pursue a gynaecological indication where no commercially approved product has existed. ”The company expects half the patients to be recruited here and the remaining 50% in the US. Local recruitment should start in the September quarter, with US enrolment subject to FDA clearance. A capital raise, Imagion thatThen there’s the need to mitigate radiation exposure in cancer diagnosis procedures. That brings us to medical imaging innovatorImagion Biosystems (ASX:IBX), which today requested a trading halt pending a capital raising. It’s not hard to guess where the company will deploy the funds. Earlier this month, the FDA cleared Imagion to undertake a phase Ib/2 clinical trial for its flagship device Magsense. This is for detecting Her2-positive breast cancer. The study will be under the FDA’s Investigational New Device regimen. Magsense is a new class of magnetic resonance imaging that improves cancer detection compared to conventional imaging – but without the radioactivity. The company expects to start recruiting in the September quarter, while clinical site contracting already is underway. The three-part study involves an initial Part A safety cohort on a low dose, followed by a further Part B trial of the optimised protocol. The larger Part C stanza covers actual diagnostic performance. Imagion expects the trial to take 18 to 24 months, with interim analyses after part A and part B. Echo IQ ‘faces US pay headwinds’Brokers usually initiate research coverage on a stock in a highly supportive vein, often bordering on fawning. But to its credit Petra Capital takes an even-handed line on heart device tearawayEcho IQ (ASX:EIQ), citing the need for better US reimbursement. The firm plonks a $1. 09 ‘target price’ on the stock compared with this morning’s price of $1. 22. Echo IQ uses AI to analyse cardiac ultrasound measurements to improve structural heart disease diagnosis. The company already has an FDA-cleared software product in Echosolv AS (as in aortic stenosis). Echo IQ awaits clearance for Echosolv HF, which tackles heart failure more broadly. It’s a much bigger market. So, what’s the problem?“The current price is factoring in a high level of commercial success, underappreciating the reimbursement headwind to adoption and monetisation,” opines Petra. The company relies on a miscellaneous US reimbursement code “with high claim denial rates”. The company lodged its Echosolv HF application with the FDA last December and has guided to clearance in the June half. Hey! It’s June 24 – so stay tuned. Reimbursement doubts aside, Petra dubs Echosolv HF as an “excellent asset”. “We view the FDA clearance of Echosolv HF as highly likely … and the key to unlocking the US commercial opportunity. ”Meanwhile, Echo IQ today announced the appointment of Matthew Dodds as its new chief financial officer. Dodds was a Wall Street medical analyst and senior executive at Livanova PLC and Johnson & Johnson Medical Devices. Echo IQ shares have vaulted 375% calendar year to date and are up a heart-stopping 460% over the past 12 months. Island has its time in the sunMeanwhile, local capital markets firm Prenzler Group saysIsland Pharmaceuticals (ASX:ILA)is getting to the pointy end with its acquired Galidesivir program, “a medical countermeasure for some of the world’s highest-consequence viral threats”. These hazards include the Marburg and closely related Ebola viruses. Prenzler says Island is on an unusual development path, in that it is availing of the FDA’s Animal Rule. This enables a drug to be approved with animal-only studies, in cases where testing on humans would be too dangerous. These primates will be treated either 24 or 48 hours after Marburg exposure, with twice-daily intravenous administration over 14 days. The trial’s primary endpoint is survival to 28 days, post exposure. The firm adds that Island is producing Galidesivir under Good Manufacturing Principles (GMP), with PI Health Sciences. This “establishes the manufacturing, analytical and quality systems needed for pivotal studies, potential FDA submission and future procurement discussions”. Prenzler says a GMP manufacturing announcement “may not read as dramatically as a [trial] efficacy result” – and how true is that?But good manufacturing is kinda important. “For a biodefence countermeasure, the value proposition is not simply that the drug works in an animal model,” the firm says. “Governments and regulators also need confidence that the product can be manufactured, tested, stored, supplied and potentially procured. ”Island recently expanded a research collab with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Geneva Foundation. USAMRIID is the US Army’s primary research institute for studying highly hazardous pathogens and a leading high-containment infectious disease research organisation. Prenzler expects results in the September quarter, with topline results by the end of the year. At Stockhead, we tell it as it is. While Island and Imagion are Stockhead advertisers, the companies did not sponsor this piece.