Health Check: Amid headwinds, Nanosonics goes bells and whistles on core device
Amplia shares soar a further 36% on pancreatic cancer promise
Dimerix looks to broaden its repertoire
Nanosonics (ASX:NAN) has launched updated iterations of its medical probe sterilising device Trophon, pending rollout of its all-new tool called Coris.
The 'next generation' Trophon 3 has 40% faster cleaning cycles, with 'greater digital integration and the broadest traceability capabilities".
The company has also launched Trophon 2 Plus, a tweaked version of an existing software upgrade for users of earlier Trophons.
The company first commercialised the Trophons in 2009.
Trophons clean ultrasound probes much more safely and reliably than traditional manual techniques.
In mid-March the US Food & Drug Administration (FDA) approved the company's an all-new product Coris, for more fiddly flexible probes (such as for colonoscopies).
The company expects to launch Coris in the US later this year.
Nanosonics initially is launching the Trophon upgrades here and in the UK and Europe, with the FDA reviewing an approval submission.
What the analysts think
RBC Capital Markets analyst Craig Wong-Pan estimates only about 35% of the company's current US users have upgraded to a Trophon 2.
"Therefore we believe there is a reasonable runway for further upgrade sales.'
He's not sure whether the Trophon 3 features will convince enough hospitals to upgrade, given their budgetary pressures.
'Nonetheless, we believe the launch of these offerings is positive for Nanosonics, given the company has seen new competing products enter the ultrasound probe high level disinfection market.'
RBC rates the company a 'hold' with a target price of $5.
Meanwhile, broker Canaccord retains a 'buy' call, but has revised its target price from $5.74 to $5.15.
The firm cites the impact of a competitor, Lumicare, which is not FDA approved but looks to be winning market share here.
Canaccord expects Nanosonics to report 2024-25 revenue at the bottom of its cited $188.7 million to $193.8 million range.
Amplia continues its winning ways
One of the deadliest of tumours, pancreatic cancer is having its day in the sun courtesy of progress reports from Amplia (ASX:ATX) and OncoSil Medical (ASX:OSL).
Amplia shares today vaulted a further 36%, having soared 25%, on Friday. That was after the company confirmed a 16 th 'partial response' in its phase 1b/2a advanced pancreatic cancer trial, called Accent.
A confirmed partial response is when a tumour shrinks by more than 30% and the effect is sustained for two months or more.
More to the point, Amplia earlier recorded two 'pathological complete responses' (PCRs).
Rare in advanced pancreatic cancers, a PCR means there are no signs of cancer in tissue examined by a pathologist following surgical removal.
Accent is evaluating Amplia's drug candidate narmafotinib, in combination with standard-of-care chemotherapies.
Of the 55 patients enrolled, 20 of them remain on the trial so the company hopes for more positive responses.
The trial is being conducted at seven sites in Australia and five sites in South Korea.
Amplia shares have gained 330% since the start of the year.
Oncosil completes trial enrolment
Also on Friday, Oncosil said it had enrolled all 20 advanced pancreatic cancer patients in a phase I/II study of its eponymous targeted device.
A novel brachytherapy for pancreatic and liver cancers, the treatment involves irradiating tumours via a direct injection, using endoscopic ultrasound guidance.
Dubbed Pancosil, the study is investigating a novel percutaneous (through the skin) delivery for the spherical devices, guided by computed tomography.
As investigator, The Amsterdam University Medical Center is conducting the study.
Oncosil CEO Nigel Lange says the percutaneous approach could 'simplify administration and lower barriers to adoption, supporting wider market penetration and real-world clinical use'.
The idea is not to cure the cancer, but reduce the tumors to the point where they are operable.
Currently 30 countries have approved the device, including in the European Union, Britain, Turkey and Israel.
The company should release preliminary Pancosil data in late 2025.
Dimerix eyes other indications
While the cashed-up Dimerix (ASX:DXB) remains focused on its phase III kidney disease program, it's eyeing secondary activities to broaden its portfolio.
The company has raked in $65 million in upfront payments from four separate partnering deals for its lead indication, the regressive focal segmental glomerulosclerosis (FSGS).
But not all the cash is needed to support the 286-patient phase III trial.
'Now that the funds have come in, we are in a very strong position and can turn attention to our pipeline,' CEO Dr Nina Webster says.
She is working with the board on what program to pursue, but it will be 'in an area of high unmet need' and not too far from the company's expertise.
'Generally speaking, our competency is inflammatory disease and we understand rare diseases and kidneys well,' Webster says.
We know for sure it won't be something like oncology injectables.
Nor will it be diabetic kidney disease, which is much more prevalent than FSGS but a competitive field.
In the meantime, Dimerix hopes it might be able to win accelerated FDA approval for FSGS, which the agency classes as an 'orphan' disease.
… while PYC expands kidney disease trial
Still on the topic of spuds.
Following ethics approval, PYC Therapeutics (ASX:PYC) will advance to the second part of its safety and dosage study for polycystic kidney disease (PKD).
PYC hopes its drug candidate, PYC-003 will address the underlying cause of PYC, the most prevalent monogenic disease in humans marked by extreme swelling of the organ.
PYC will launch part B of the single ascending dose study of PKD patients, as well as escalating dosing to healthy volunteers.
By combining existing ribonucleic acid (RNA) drug design with its proprietary delivery platform, PYC is developing precision therapies for patients with genetic diseases that have no treatment options.
PYC's lead program is for the rare eye disease retinitis pigmentosa, but the company believes the kidney program shows much promise.
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