ASX Biotech Stocks: Nuheara secures historic FDA clearance for its over-the-counter hearing aid – Stockhead





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Medical device manufacturer Nuheara (ASX:NUH) has received historic – and first of its kind – US Food and Drug Administration (FDA) clearance for its self-fitting Over The Counter (OTC) hearing aid.
The company plans to launch its self-fitting OTC hearing aid as the HP Hearing PRO, which it says “brings superb medical grade hearing aid technology combined with highly desired features of wireless ear buds into a multifunctional device” that will be sold in the US online and in retail stores, including Best Buy, Crutchfield, and Amazon for US$699.
 The device offers a 30% improvement in focusing on speech in noise with the use of directional microphones, and an improved ability to follow conversations and reduce background noise. 
It’s a big milestone for the company and also for the OTC hearing aid market and the estimated 38 million Americans who experience some hearing loss and do not own a hearing aid due to access and affordability barriers.
Historically in the US, hearing aids are sold at an average cost of US$4,672 per pair and can be as much as US$10,000 or more per pair through licensed audiologist and licensed hearing aid retailers.
Nuheara co-founder and MD Justin Miller says the company is well placed to “take immediate and significant advantage of the regulation changes” with its affordable hearing device ready for market.
 


 
 
IMUGENE (ASX:IMU)
Oncology company Imugene has dosed the first patient in its Phase 1 metastatic advanced solid tumours (MAST) study dosed with VAXINA, the novel cancer-killing virus CF33-hNIS.
A Phase 1 MAST study has to date delivered a low dose to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. 
The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
The trial is anticipated to run for approximately 24 months and is funded from existing budgets and resources. 
 
EMYRIA (ASX:EMD)
The company has completed a $3m placement to accelerate Ultra-Pure cannabinoid registration programs with the TGA, and advance multiple preclinical screening programs for Emyria’s novel MDMA-inspired drug discovery program being developed with the University of Western Australia.
The company nabbed a $1m cornerstone investment received from lead manager, Sixty Two Capital and a follow-on $500k investment from Tattarang’s Tenmile Ventures. 
The placement is being conducted at an offer price of $0.18 per share, representing a 14.3% discount to the last traded price on 26 October 2022 ($0.21). 

BOTANIX (ASX:BOT)
Another cannabis player Botanix has secured commitment for $5 million at at $0.063 per share via an institutional placement – and announced an SPP for $3 million.
Funds raised will be used to progress development of the company’s pipeline of assets in light of the recent successful BTX 1702 rosacea clinical study, for costs associated with preparing for the FDA approval and commercial launch of Sofpironium Bromide and for general working capital purposes.
 
 
 
 
NITRO SOFTWARE (ASX:NTO)
The company received an unsolicited takeover bid on Friday by Technology Growth Capital, LLC – a special purpose vehicle managed by Potentia Capital Management Pty Ltd (Potentia) – to acquire all the fully paid ordinary shares in Nitro on issue it does not already own at $1.80 cash per share.
“Following careful consideration, including advice from its external advisers, the Nitro board has concluded the Potentia takeover bid undervalues Nitro and unanimously rejects the Potentia takeover bid as not being in the best interests of shareholders,” the company said.
Probably because there’s a better offer in the works.
Cascade Parent Limited (trading as Alludo) has made a proposal through one of its subsidiaries to acquire 100% of Nitro at $2.00 cash per share. 
Alludo has also indicated it is willing to proceed with an off-market takeover bid with a 50.1% minimum acceptance condition, offering $2.00 cash per share.
To explore whether a definitive transaction can be agreed, Nitro and Alludo have entered into a Process Deed, with Nitro granting Alludo a 21-day period of exclusivity for the purposes of confirmatory due diligence and negotiation of definitive agreements.
 
SCHROLE GROUP (ASX:SCL)
Edtech company Schrole has been engaged by Rio Tinto (ASX:RIO) to assess capabilities and governance of selected universities and vocational education schools in Guinea to support Rio’s Simandou iron ore project.
The company has previously collaborated with Rio in Mongolia between 2007-2015, focusing on upskilling vocational teachers to Australian standards. 
Schrole has now issued an invoice for ~US$225,000 as part of the commencement of the engagement, with specialists from Schrole Develeop to travel to Guinea in November 2022 to assess capabilities across the universities and vocational education schools. 
After the initial assessment, the company will recommend actions to support the training of the proposed workforce for its Simandou iron ore project and improve literacy standards in Guinea. 
The company has also assessed and developed training programs for mining projects in Ghana, Ivory Coast and Australia. 
“We have proven our expertise in curriculum standards and methodology development across international jurisdictions including Mongolia, Australia, Ghana, and Ivory Coast, delivering customised accredited training solutions to create the best possible outcomes for those communities,” MD Rob Graham says.
 
IXUP (ASX:IXU)
The data collaboration platform has entered into a new product develop and commercialisation agreement with Melbourne-based Cipher Sports Technology Group which will see the creation of a joint venture sales and marketing vehicle (JVCo) to jointly develop and sell a number of new technology products aimed at the global sports affiliate industry, with an initial focus on the US digital sports wagering and gaming sector, where Cipher is already operational from its offices in New York City.
The parties have already started to design and build several products aiming to see them in market by 1QCY23. 
 
BLUEBET (ASX:BBT)
Another one in the gaming and wagering space, BlueBet has made a US$500,000 strategic investment in UK-based sports gamification platform provider Low6.
Low6 provides white-labelled gamification services to global betting operators, enabling them to create personalised and branded gaming experiences for their customers to drive customer acquisition and engagement.
BlueBet expects to leverage its investment in Low6 to expand its product offering into free to play games, to assist in onboarding and engaging its customer base. 
 
 
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