ASX Health Stocks: Polynovo leaps 12pc after coming out of trading halt, gets FDA approval
Health & Biotech
Health & Biotech
Polynovo (ASX:PNV) surged 12% after coming out of a trading halt.
The company announced that it has received FDA 510(k) clearance for its NovoSorb MTX, a new product innovation for soft tissue regeneration for the management of complex wounds.
MTX leverages the technology platform underpinning the clinical success of the company’s other product BTM, but without a sealing membrane.
It is expected that clinicians will use both products for the treatment of soft tissue deficits.
With MTX, the wound can be closed either with a skin graft or allowed to heal by contraction and formation of an epithelial layer.
This can simplify wound management and presents wider applications for common wound healing problems.
MTX is indicated for use in partial and full thickness wounds, pressure ulcers, venous ulcers, chronic and vascular ulcers, diabetic ulcers, and surgical and trauma wounds – offering clinicians greater versatility in wound management.
The MTX product portfolio expands PolyNovo’s addressable market in the US by an estimated $500 million.
“We are proud to bring MTX to US surgeons and patients, and believe a product specifically designed for use in a single-stage procedure will leverage and expand our penetration of the advanced wound care space,” said Polynovo CEO, Swami Raote.
“We expect clinicians to carry BTM and MTX and provide them a richer tool kit for patient care. We aim to quickly put MTX in the hands of Key Opinion Leader surgeons.”
Avecho Biotech (ASX:AVE) announced that interim results from studies conducted in the UK showed that Avecho’s oral cannabidiol (CBD) product under development has increased bioavailability compared to Epidiolex, the only FDA approved CBD product in the market.
“These formulations are now in clinical trials and will be entering Phase III clinical trials for an insomnia related indication,” said Avecho CEO, Dr Paul Gavin.
Anteris Technologies (ASX:AVR) says its DurAVR THV aortic valve demonstrated restoration of normal pre-disease flow when compared to other TAVRs (transcatheter aortic valve replacement) and SAVRs (surgical aortic valve replacement) at 6 months.
“Although preliminary, this data is remarkable and encouraging because it depicts a valve prosthesis, DurAVR THV, providing flow dynamics equal to that of a typical healthy native valve and is superior to current generation TAVR and SAVR haemodynamics,” commented CEO Wayne Paterson.
Imricor Medical Systems (ASX:IMR) has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial in Europe.
The study calls for treating 64 patients, and includes a six-month follow-up for each patient.
“This is a major milestone for Imricor that brings us one monumental step closer to treating ventricular tachycardia with ablation procedures guided by real-time iCMR,” says Imricor’s chair and CEO, Steve Wedan.
Imugene (ASX:IMU) announced that the Australian Government’s Office of the Gene Technology Regulator (OGTR) has granted Imugene the DIR licence required to expand its VAXINIA Phase 1 clinical trial within Australia.
Imugene’s multicentre Phase 1 VAXINIA trial has already commenced in May at US sites, delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment.
“We’re pleased to see this regulatory hurdle cleared on schedule which will allow the smooth progression of our VAXINIA Phase 1 trial as planned,” said Imugene CEO, Leslie Chong.
Medibio (ASX:MEB) announced the appointment of Dr Thomas R. Young as the company’s new CEO, with effect from today.
Dr Young is a family physician with more than 40 years of medical experience. He is recognised as an innovator and thought leader in the fields of Consumer Directed Health Care and Behavioral Health.
Meanwhile, Emyria (ASX:EMD) has engaged PsychoGenics, a leader in artificial intelligence (AI) enabled drug discovery and preclinical contract research services in neuroscience to help advance its MDMA-inspired New Drug Discovery program.
PsychoGenics will use its proprietary SmartCube(TM) platform to study novel compounds from Emyria’s MDMA-inspired drug discovery program developed with partner the University of Western Australia.