ASX Health Stocks: US FDA approves ImpediMed’s newly designed bioimpedance thingy
Health & Biotech
Health & Biotech
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Brisbane-based medical software technology company, ImpediMed (ASX.IPD), announced that it has been given clearance by the US FDA for its SOZO Pro product.
SOZO Pro is the company’s next generation bioimpedance spectroscopy (BIS) system, providing personalised health metrics to quickly and reliably inform clinical decisions at the point of care.
Compared to SOZO, SOZO Pro offers a new, higher standing weight capacity (SOZO: 170kg; SOZO Pro: 220kg), and an updated stand design – allowing for easier transition between the standing and seated measurement positions.
ImpediMed believes these changes will improve clinical workflow, allowing for greater scalability of the SOZO Digital Health Platform.
The Special 510(k) FDA clearances cover substantial equivalence between SOZO Pro and SOZO for the lymphoedema and protein calorie malnutrition (body composition) indications.
ImpediMed says that achievement of this milestone clears the way to now submit a traditional 510(k) application to the FDA for the heart failure indication.
“FDA clearance of SOZO Pro is an important milestone in our product development and regulatory strategy,” commented Richard Valencia, CEO of ImpediMed.
“We continue to drive improvements in our product offering both with the SOZO system and its software to enhance the customer experience, and further keep ourselves well ahead of any potential competition.”
In March, ImpediMed surged over 60% in one day after the US National Comprehensive Cancer Network (NCCN) included BIS as part of its new guidelines.
The guidelines specifically named BIS as an objective measurement tool to identify early signs of lymphoedema. The inclusion is expected to help establish BIS to become standard of care, and will accelerate adoption by US private payors and providers.
“The recommendation in the NCCN Guidelines for the use of bioimpedance spectroscopy technology is a major validating moment for the company,” said Valencia at the time.
ImpediMed currently has the only FDA-cleared BIS technology for the assessment of lymphoedema.
The company’s SOZO Digital Health Platform is broadly accepted and recognised in the market for effective and accurate screening of lymphoedema.
Incannex Healthcare (ASX:IHL) announced that its subsidiary, Clarion Clinics, has entered a lease for riverfront premises in Abbottsford, Melbourne.
The premises will be used to provide psychedelic-assisted psychotherapy.
Fit out and commissioning of these premises will begin soon and is expected to be complete in August, facilitating the opening of the first clinic shortly thereafter.
The clinic is designed as a commercial scale prototype, which can be scaled up and replicated to other locations. It will have capacity to treat over 600 patients per year in normal working hours, and substantially more in extended hour operations.
Incannex has ordered an initial supply of psilocybin and MDMA, through an arrangement with Pharmala Biotech, to facilitate the commencement of clinical operations.
Incannex CEO, Joel Latham, said Clarion Clinics will be the first dedicated psychedelic-assisted psychotherapy business in Australia.
“We’re delighted to be at the forefront of an industry that has the potential to change the lives of thousands of people who have been living with conditions for which there have been no adequate treatment options,” he said.
The estimated Australian market for psychedelic-assisted psychotherapy is anticipated to be more than $2bn per annum and the global market closer to $60bn.
Incannex believes Clarion Clinics is uniquely placed to be a significant player in this market by being one of the first movers.
At Stockhead we tell it like it is. While Incannex Healthcare is a Stockhead advertiser, it did not sponsor this article.