• ASX medical devices to make inroads with FDA after a good year for drug developers
  • FDA is reviewing Allegra’s Spinal Cage Device made from 3D-printed Sr-HT-Gahnite
  • Stockhead reached out to Allegra’s board member, Dr Nick Hartnell


It’s been a good year for ASX biotechs from a regulatory perspective, with the likes of Neuren (ASX:NEU), Lumos Diagnostics (ASX:LDX), and Chimeric Therapeutics (ASX:CHM) all getting nods from the US FDA in 2023.

But whilst these drug development biotechs have been hogging all the limelight, ASX medical device companies have also kept the regulator busy.

On Monday for example, respiratory imaging tech company, 4DMedical (ASX:4DX), jumped by 15% after receiving clearance for its CT-based ventilation product (CT LVAS) from the US FDA.

Earlier this year, Nova Eye Medical (ASX:EYE) also achieved FDA clearance for its next generation iTrack surgical device to treat glaucoma.

Another ASX medical device company that could achieve FDA status soon is Allegra Medical Technologies (ASX:AMT), which is bringing its unique orthopaedic device to the market.

Allegra’s flagship product is the Cervical Spinal Cage device, which is made from a 3D-printed Sr-HT-Gahnite material.

The versatile Sr-HT-Gahnite is a unique material that could be used not only in areas such as orthopaedics, but also in wider medical applications like dental.

“We believe it’s going to be a game changer as far as this material is concerned,” said Dr Nick Hartnell, a non executive director and board member at Allegra.

“There’s a massive orthopaedics market worldwide, worth in the tens of billions of dollars. And our target is obviously America first, that’s why we’ve submitted an application to the FDA.”


Spinal Cage Device

Allegra is the exclusive owner of the breakthrough Sr-HT-Gahnite material along with its associated patents obtained from the University of Sydney.

“The beauty of this material is it’s made from ceramic, and it’s bone-like – in other words, it has very similar characteristics of the bone,” Hartnell told Stockhead.

“It’s also sprayable, meaning that you can spray it onto implants on uneven surface, so you could make it into any any shape you like.”

The first product Allegra will bring to market from this material is the Cervical Spinal Cage device, which is a scaffold used in orthopaedic surgery.

Hartnell explained that when a patient has a disc that’s protruding into the neck’s spinal cord, the first thing a surgeon would do is take the pressure off the cord.

Next, the surgeon would put a cage, which is normally made out of metal, around the disc.

“But what we’ve got now with our Spinal Cage device is, instead of metal, it’s essentially a bone graft substitute, which is integrated into the vertebral structures,” Hartnell explained.

“This cage is 3D-printed, meaning that you can print it into any size and will behave just like the human bone.”

The beauty of this product, says Hartnell, is that it is tough enough that if you put the implant in, you don’t have to restrict any movement or limit the range of motion of the patient.

“It’s also biologically active. What that means is that the body reacts to it, and will essentially accept it as its own, and will grow new bone around it.

“And that’s when you’ve got your biological strength, and that’s when when you’re completely healed,” Hartnell said.


FDA pathway

In March this year, Allegra announced the submission of its US FDA 510(k) pathway application for the Sr–HT–Gahnite Spinal Cage Device.

The FDA has reviewed the device, and has requested additional information.

“We’ve gone through the vast majority of our application with the FDA, and they have questions related to our CT findings, and our claims on how Allegra’s bone fusion is faster than other bone fusions,” explained Hartnell.

“All these questions are very fair and are all about patient safety, because obviously the FDA’s priority is safety.”

Hartnell said Allegra will submit an informal response to the FDA within the next couple of weeks, with the formal response expected to be in the new year.


Market has taken eye off Allegra

As an innovation company, Hartnell said Allegra doesn’t want to be just a one trick pony.

“Apart from the Sr–HT–Gahnite, a large part of what I’m doing is working on soft tissue reconstruction – so ACL reconstruction, rotator cuff, repairs, all of those reconstruction options,” said Hartnell.

“So once we’ve got approval from the Spinal Cage, then we’ll really be able to expand on our innovation products.

“I believe the market probably has lost a bit of focus on Allegra, and hasn’t really been watching us because FDA approvals take time and investors do get bored.

“But I honestly believe that once we’ve got FDA approval, that’s when other other big players in the market strike and come in to look for an acquisition,” says Hartnell.


Some other ASX medical device stocks

4D Medical (ASX:4DX)

4DMedical surged over 50% last week after announcing that its XV LVAS scanning device has been included into the US Centers for Medicare & Medicaid Services (CMS).

The inclusion today means that from 1 January 2024, XV LVAS scans conducted in a US hospital outpatient facility for Medicare patients can be billed to CMS.

CMS has accepted the reimbursement request and finalised assignment of the Category III CPT code for XV LVAS to the rate of US$299 per scan.

A few days later, the company said it has received clearance for its CT-based ventilation product, CT LVAS, from the US FDA.

The clearance will expand and broaden patient accessibility of functional lung imaging in the US, following the recent CT LVAS rollout in Australia.

4DX’s XV LVAS uses X-rays to create detailed images of lung movement and function during breathing. It gives clinicians a clearer picture of lung health for pulmonary disorders including asthma, COPD, cystic fibrosis, and even cancer.


Micro-X (ASX:MX1)

Micro-X is is developing cathode X-ray technology which has applications for the health sector, but they’re also doing work with bomb detection and airport security self check-in.

The company’s technology revolves around the miniaturisation of x-rays, and has already received a TGA approval for its Rover x-ray imaging machine.

Recently, Micro-X announced that it has received CE Mark Certification under the European Medical Device Regulation (MDR) for its Class IIb medical device – the Rover and Rover Plus mobile x-ray system.

This allows the device to be sold for medical use in the European Union (EU) and other countries that recognise the certification.


OncoSil Medical (ASX:OSL)

The OncoSil device is a breakthrough single-use brachytherapy device that comprises phosphorous-32 microparticles.

It could be used to inject drugs directly into a pancreatic tumour, to deliver an absorbed dose of 100 Gy in 81 days.

In June, OncoSil announced that ethics committee approval has been received for the PANCOSIL clinical trial.

The study involves the treatment of 15 patients with the OncoSil device, which will be delivered percutaneously (by inserting a needle directly through the skin into the pancreatic tumor, under CT guidance) rather than endoscopically guided by ultrasound.

The study is intended to develop a feasible and safe standardised approach for a percutaneous application of the OncoSil device, which will subsequently be confirmed in a larger group of patients.


EmVision (ASX:EMV)

EMV makes portable brain scanners which can detect stroke and other brain injuries.

EMvision says it does not aspire to replace the current stroke imaging methods: computer tomography (CT) or magnetic resonance imaging (MRI) scans.

Based on electromagnetic microwave imaging, EMvision’s devices are intended to be used in hospitals as an adjunct to these accepted methods.

In October, EMV said that an advanced 28-antenna prototype of its 2nd Gen ultra-light weight helmet scanner, designed for road and air ambulance deployment, has been assembled for bench testing.

The company says this complementary product suite will address a huge unmet clinical need in both bedside (1st Gen, which is currently undergoing multi-site clinical trials), and first responder (2nd Gen) brain imaging.


Painchek (ASX:PCK)

The PainChek App uses artificial intelligence (AI) and facial recognition to detect pain in those who cannot self-report, giving a voice to those who cannot verbalise pain.

For those who can self-report, PainChek Universal also includes access to the Numerical Rating Scale, a well-established standard used to document pain levels amongst these individuals.

The company reported on Tuesday that the European Patent Office (EPO) has issued a Notice of Acceptance for its patent application.

Entitled “A Pain Assessment Method and System”, the patent will enable PainChek to safeguard the intellectual property of its pain assessment and monitoring technology within the European market.

This includes exclusive rights to the commercialisation of its technology across the 39 member states of the European Patent Organisation, until 2035.


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