• Truscreen granted approval in Mexico
  • The company can now gain direct access to Mexico’s public health sector
  • Neurotech reports results from its Phase I/II cannabis clinical trial


TruScreen gets approval in Mexico

Medical device company, TruScreen Group (ASX:TRU), has received a Cofepris approval in Mexico, giving it access to the country’s public health sector.

The Cofepris is Mexico’s regulatory body equivalent to the US FDA.

The approval allows TruScreen to expand its cervical cancer screening, currently, in the private health clinics, to the wider public health sector.

A 2020 census identified that only 2.3% of the Mexican population have private healthcare, while 70.9% of the population accessed the public health system.

Mexico meanwhile has an addressable market of 65 million women. Of that, 9,400 women are diagnosed annually with cervical cancer with a mortality rate of 46% – or 4,300 deaths.

Cervical cancer has now become the second most prevalent cancer amongst women in Mexico.

“The Cofepris approval highlights the accelerating acceptance of the TruScreen technology globally,” said TruScreen’s CEO, Dr Beata Edling.

“I am delighted that women in Mexico will have access to faster, more efficient, and reliable cervical cancer screening with TruScreen.”

TruScreen’s cervical screening technology, TruScreen Ultra, could detect abnormalities in the cervical tissue in real-time, via measurements of the low level of optical and electrical stimuli.

The device is CE Marked/EC certified, ISO 13485 compliant, and is registered for clinical use with the TGA (Australia), MHRA (UK), NMPA (China), SFDA (Saudi Arabia), Roszdravnadzor (Russia), and now COFEPRIS (Mexico).

It also has Ministry of Health approval for use in Vietnam, Israel, Ukraine, and the Philippines, among others and has distributors in 29 countries.


Neurotech’s Phase 1/2 results

Neurotech (ASX:NTI) has provided an update on the progress of the 11 autism spectrum disorder (ASD) patients who were part of the company’s world-first Phase 1/2 clinical trial.

The trial originally examined the daily use of Neurotech’s proprietary broad spectrum cannabinoid drug therapy, NTI164, out to 52 weeks of treatments.

All patients have now crossed 90 weeks of daily oral therapy with NTI164.

Results show that NTI164 continues to exhibit a safety and tolerability profile, with all patients showing stable blood chemistries and normal liver and kidney function over 90 weeks.

Although no further quantitative efficacy analysis has been collected since week 52, caregiver and clinician reports remain positive with symptomatic improvement maintained at the 90-week mark.

The trial was the longest ever study in ASD, examining the safety of a broad spectrum cannabinoid drug treatment.

Data from this trial will support future regulatory interactions and filings for NTI164.

Following the conclusion of this study, Neurotech says it’s now on track to report the next phase – Phase 2/3 ASD clinical trial data – in late Q1 to early Q2 this year.


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