Polynovo (ASX:PNV)  jumped 18.53% in early morning trade today.

PNV develops innovative medical devices utilizing the patented bioabsorbable polymer technology Novosorb, and said released its unaudited results for the half year ending 31 December – with US sales for December at a record US$2.43 million ($3.4 million) which is up 76% on the same time last year.

The company recorded US Q2 results of US$5.86 million (AU$8.06 million) – an increase of 105%.

Plus, monthly US sales for December exceeded US$2 million for the first time, and quarterly US sales exceeded US$5 million for the first time.

Plans to expand the sales team

The company added 16 new accounts in Q1 and a further 19 added in Q2 bringing total US accounts to 154 – with plans to increase its US sales team to expand coverage across key cities and regions.

Sales to the rest of the world have been patchy, the company said, but Polynovo had its first sale in Cyprus and Poland, as well as repeat orders in Denmark, Italy and Germany.

“While US sales are very encouraging, there is more to achieve as we still have new sales staff being onboarded and more staff to be employed,” chairman David Williams said.

“In addition, we are retraining existing staff to follow surgeon leads using the product in new indications.

“While the US is the engine room of our growth in the immediate future, there are many opportunities in the rest of the world where we are just starting out.”



Creso Pharma (ASX:CPH)

Creso Pharma rose 2.4% today after reporting its wholly-owned psychedelics subsidiary, Halucenex Life Sciences Inc., was invited to become a Special Access Program (SAP) drug supplier following favourable legislative changes in Canada.

A range of previously restricted drugs, including psilocybin, can now be used in patient treatment, with medical professionals able to request access for the purposes of emergency treatment.

If Halucenex becomes a supplier, its expected to unlock a number of near term revenue generating opportunities, CPH said.

The regulatory shift signals a near term opportunity for Halucenex to supply psilocybin to a growing patient population in Canada, and could generate revenue if Halucenex becomes a SAP supplier – as the PTSD therapeutics sector is a potential major market opportunity for Creso with the sector expected to grow to US$10.5Bn in value by 2025, the company said.

Psychedelic medicines on a ‘strong upward trajectory’

“Psychedelic medicines remain on a strong upward trajectory for both research and compassionate use purposes and this recent shift from Health Canada shows the potential direction towards more liberal policies as public demand increases,” Halucenex founder and CEO Bill Fleming said.

“Halucenex is well positioned to capitalise as a supplier to the SAP upon regulatory approval . If successful in the application process, Halucenex has a large supply of GMP grade, synthetic psilocybin which can be sold to doctors and patients.

“We continue to work through growing protocols for botanical psilocybin, which can also be supplied in the future.

“Post approval, we anticipate a number of revenue generating opportunities to materialise as Halucenex progresses its transition to a leading drug development and supply company.”


Avita Medical (ASX:AVH)

Regenerative medical company Avita was up 1.59%, also announcing unaudited results for the December quarter.

Revenue increased 35% to $6.9 million, compared to $5.1 million for the previous corresponding period.

As of December 31, 2021, Avita had around $55.5 million in cash and cash equivalents and $49.3 million in short-term and long-term marketable securities, and no debt.

The company has now completed enrollment in two clinical trials with the goal of submitting premarket approval (PMA) supplements in 2022 – including the RECELL® System for the repigmentation of stable vitiligo lesions and RECELL System for soft tissue reconstruction (trauma).

“Our recent successes in getting two pivotal clinical trials fully enrolled, and also demonstrating proof of concept in two other potential indications, underscore our commitment to further growing the market opportunities for the RECELL system,” CEO Dr. Mike Perry said.

“Looking ahead, we will be preparing our vitiligo and soft tissue dossiers to submit PMA supplement applications to the FDA in late 2022 for commercial launches for those indications in 2023.”