The ASX’s smallcaps have dropped a raft of positive (and a minority of negative) news on investors today, as the FDA gives a device the all-clear and data comes in proving that several technologies do, in fact, work.

Zoono (ASX:ZNO)

Up 92 per cent. That is what Zoono’s latest news has done to their share price.

The miniature anti-microbial company signed a deal with US partner MicroSonic to sell a bespoke antimicrobial “system” to car care company Turtle Wax, developed specially for the business over the last 12 months.

MicroSonic has to buy a minimum of $US23m ($33m) worth of the Zoono Z-71 Microbe Shield by 2023. That’s enormous for a company that only has a market cap of $24m.

Somnomed (ASX:SOM)

Sleep breathing device maker Somnomed has the a-OK from the all-powerful US FDA for a new sleep apnea product.

Sleep apnea is when the walls of the throat come together during sleep and block off the airway. At best it causes broken sleep, at worst it can lead to life-threatening illnesses such as high blood pressure or diabetes.

The treatment options are surgery or, more commonly, a CPAP (continuous positive airway pressure) mask and machine. Somnomed is one of the ASX companies making alternatives — theirs is a kind of mouth guard.

The latest version has FDA 510k clearance, a premarket approval that the device is at least as safe and effective as a legally marketed device. The company says it’ll offer a more precise fit and shorter delivery times.

Somnomed shares did not budge from $1.75 on the news.

Volpara (ASX:VHT)

A study has confirmed the company’s AI-based breast density analysis works better than a visual assessment by a human radiologist.

Breast density is increasingly understood to be a major risk factor for breast cancer. Volpara’s tech analyses mammograms to generate a “volumetric breast density” score for the physical measurement of the breast tissue.

The paper, “A case-control study to add volumetric or clinical mammographic density into the Tyrer-Cuzick breast cancer risk model”, concluded that adding density measures to regular breast cancer risk factors gave a better overall risk figure, and an AI-based volumetric analysis “has some practical advantages because it is fully automated and has excellent agreement with 3D breast MRI.”

Volpara shares ticked up 4 per cent on the news as this is but a step change in the company’s trajectory, one that has been helped by statements such as the FDA introducing mandatory reporting of breast density in mammograms.

Living Cell Technologies (ASX:LCT)

It wasn’t all good news, however, as LCT revealed a mixed bag of results around its Parkinson’s treatment, NTCELL.

The company’s drug NTCELL works by coating choroid plexus cells from newborn pigs — the cells that produce cerebrospinal fluid in the brain — and turning that into a capsule that can be implanted into the brain.

In January, four-year results from the phase 1 and phase 2a studies showed it mostly worked and was safe.

This study was supposed to confirm the most effective dose of NTCELL, define any placebo component of the response and further identify the initial target Parkinson’s disease patient sub group.

But LCT stock plunged 40 per cent to 2.2c after sharing results from the middle group in its phase 2b study that showed people who had 40 capsules implanted in their brains showed no difference from the placebo.

Furthermore, while the four people in the middle group who had 80 capsules in their heads continued to show some benefit two years in compared to the two people taking placebos their group, their results weren’t significantly better when compared to all six placebos across the whole study.

The company did not discuss results from the third group with 120 capsules.

BTC Health (ASX:BTC), Admedus (ASX:AHZ)

BTC is buying Admedus’ infusion business for $6.3m as part of a restructure, but is yet to find a buyer for the legacy immunotherapy/vaccines business.

Infusion equipment, for the confused, are the machines, pumps and tubes that allow medical professionals to infuse a patient with everything from painkillers to catheters and syringes.

After a near-death experience in 2017, Admedus has been increasingly focused on its bioscaffolds business ADAPT which are designed to prop up heart valves and other biological tissues.

It tried and failed to sell the immunotherapy arm in April to Constellation Therapeutics in an attempt to bump off the vaccines division, which they then had to put into administration to sort out its financial woes.

But they did manage to put its aortic valves in five sheep earlier this year.

AirXpanders (ASX:AXP)

Embattled breast implant maker AirXpanders has landed investors with more bad news.

Today it said full year revenue won’t hit guidance of $US11.5m-14m, but it can’t say by how much it will miss as it works through a restructure.

It will also breach loan conditions in April for a debt taken out with Oxford Finance. They say they’re in talks about how to deal with this latest breach as well as the breach for the previous quarter.

The US company hit the ASX in 2015 with a device still in development to improve breast reconstruction after mastectomies. By late 2017 it was in the early stages of selling — and calling itself a promising takeover target — and had moved the factory to Costa Rica, for cost saving purposes.

But by early 2018 it had run into serious financial problems: sales were not hitting the ambitious targets offered in 2017 and the stock was plunging.

They dumped the CEO and started cutting costs to try to get the company’s books under control.

By mid-2018, analysts were saying the company was still salvageable.

But their efforts have not yet worked. The company was suspended from the ASX in late March and a restructure was announced in early May to cut almost half of the workforce and spending by another third.

Featured Companies

You might be interested in