- Polynovo share price rises after FDA approval announcement
- Avecho says its CBD product is more potent than Epidiolex
- Medibio announces new CEO
Polynowo (ASX:PNV) rose 12% after emerging from a trading halt.
The Company announced that it has received FDA 510(k) clearance for its NovoSorb MTX, a new soft tissue regeneration product innovation for the treatment of complex wounds.
MTX leverages the technology platform that underpins the clinical success of the company’s other product, BTM, but without the sealing membrane.
It is anticipated that clinicians will use both products to treat soft tissue deficits.
With MTX, the wound can either be closed with a skin graft or left to heal by contraction and formation of an epithelial layer.
This can simplify wound management and offer broader applications for common wound healing problems.
Indicated for use in partial and full wounds, pressure ulcers, venous ulcers, chronic and vascular ulcers, diabetic ulcers, and surgical and traumatic wounds, MTX offers physicians greater versatility in wound management.
The MTX product portfolio adds an estimated $500 million to PolyNovo’s addressable market in the United States.
“We are proud to make MTX available to US surgeons and patients and believe that a product specifically designed for use in a one-step procedure will leverage and expand our market penetration in the advanced wound care space,” said Swami Raote, CEO of Polynovo.
“We expect clinicians to carry BTM and MTX with them and provide them with a more comprehensive toolkit for patient care. Our goal is to quickly get MTX into the hands of Key Opinion Leader surgeons.”
Polynovo share price today:
More ASX healthcare announcements on Monday
Avecho Biotech (ASX:AVE) announced that interim results from studies conducted in the UK showed that Avecho’s investigational oral cannabidiol (CBD) product has increased bioavailability compared to Epidiolex, the only FDA-approved CBD product on the market.
“These formulations are now in clinical trials and will enter Phase III clinical trials for an indication related to insomnia,” said Dr. Paul Gavin, CEO of Avecho.
Anteris Technologies (ASX:AVR) says his DurAVR THV aortic valve compared to other TAVRs (transcatheter aortic valve replacement) and SAVRs (surgical aortic valve replacement) has demonstrated recovery of normal pre-disease flow at 6 months.
“While these data are preliminary, they are remarkable and encouraging as they represent a valve prosthesis, DurAVR THV, that offers flow dynamics equivalent to a typical healthy native valve and is superior to the hemodynamics of the current generation TAVR and SAVR” , commented CEO Wayne Paterson.
Imricor Medical Systems (ASX:IMR) has applied for approval to initiate a clinical trial of iCMR-guided real-time ventricular tachycardia (VT) ablation in Europe.
The study requires the treatment of 64 patients and includes a six-month follow-up for each patient.
“This is an important milestone for Imricor that brings us a tremendous step closer to treating ventricular tachycardia with ablation procedures guided by real-time iCMR,” said Steve Wedan, Chairman and CEO of Imricor.
Imugen (ASX:IMU) announced that the Office of the Australian Government Genetic Technology Agency (OGTR) has granted Imugene the DIR license required to expand its Phase 1 VAXINIA clinical trial in Australia.
Imugene’s multi-center Phase 1 VAXINIA trial, which began in May at US sites, is administering a low dose of VAXINIA to patients with metastatic or advanced solid tumors who have received at least two prior standard lines of treatment.
“We are pleased that this regulatory hurdle has been cleared as planned, which will allow our VAXINIA Phase 1 trial to proceed as planned,” said Leslie Chong, CEO of Imugene.
Medibio (ASX:MEB) announced the appointment of Dr. Thomas R. Young as the company’s new CEO effective today.
dr Young is a family doctor with more than 40 years of medical experience. He is recognized as an innovator and thought leader in the fields of consumer directed health care and behavioral health.
In the meantime, Emyria (ASX:EMD) has engaged PsychoGenics, a leading artificial intelligence (AI) company enabling drug discovery and preclinical contract research services in the neurosciences, to advance its MDMA-inspired 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 a partner, the University of Western Australia.
Stock prices today: