Rhinomed, Inc  

41 Madison Avenue,
31st Fl.
New York,  NY  10010

United States
https://www.rhinomed.global/about-rhino-med/sample-collection/

• Booth: 4946

Rhinomed is a listed (ASX:RNO, OTCQB:RHNMF) medical technology company that specializes in wearable nasal technology as a novel way to address problems with breathing, sleep, and nasal congestion (e.g. due to sleep apnea, allergy, colds, and flu). Rhinomed’s existing FDA and TGA registered nasal products have been worn comfortably and safely since 2016, with 1.2 million users registering over 30 million positive user experiences. Rhinomed invests in furthering our knowledge of the role played by the nose, upper airways, and olfactory system in maintaining health and wellness, with our product pipeline now extending to sampling, diagnostics, and nasal drug delivery.

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 Press Releases

• Rhinoswab Junior Clinical Trial Results (Apr 25, 2022)

  MCRI/MCTC PRESENT RESULTS FROM RHINOSWAB FOR DIAGNOSIS
  OF RESPIRATORY VIRUSES IN CHILDREN CLINICAL TRIAL

  ● Clinical trial at Murdoch Children’s Research Institute (MCRI) /Melbourne Children’s Trial Centre completed with Rhinoswab JuniorTM meeting its primary efficacy endpoint and demonstrating laboratory equivalence (96.2% sensitivity) when compared to the current standard of care combined throat and nose swab.
  ● Trial also demonstrated a compelling preference for Rhinoswab Junior over the existing standard of care combined throat and nose swab.
          ○ 82% of children preferred the Rhinoswab Junior to the standard of care combined throat and nose swab.
          ○ 79% of parents would prefer their children to be tested with the Rhinoswab Junior.
          ○ 82% of nurses prefer to test children with the Rhinoswab Junior.

  21 December 2021: Rhinomed Limited (ASX:RNO OTCQB:RHNMF), a leader in wearable nasal and respiratory technology is pleased to announce the interim results in the world first “Rhinoswab for diagnosis of respiratory virus in children” trial, which was carried out by clinical scientists at the Murdoch Children’s Research Institute at the Melbourne Children Trials Centre (Royal Children’s Hospital.)

  
  The preliminary results were presented at a research briefing to both local and international key opinion leaders with the full results to be submitted to a medical journal early in the new year.

  
  The “Rhinoswab for diagnosis of respiratory virus in children” trial investigated the diagnosis of respiratory viruses in children with the novel Rhinoswab Junior, which is designed to collect a nasal sample from children without the discomfort and distress associated with the combined throat and deep nasal (CTDN) swabs. Rhinoswab Junior is a smaller version of the Rhinoswab device with child friendly features to engage children in the sampling process. Rhinoswab Junior’s design also allows for standardisation of the site of biological sampling as well as self collection, as compared with CTDN swabs, which are operator dependent.

  
  Methodology
  The trial recruited 254 symptomatic children, aged 4-18 years, who presented at the Respiratory infection Clinic at The Royal Children’s Hospital (RCH) Melbourne, Australia. Each child was sampled with the standard of care combined nose and throat swab and the Rhinoswab Junior with the order randomised. Samples were assessed on RT-PCR using an Ausdiagnostics respiratory pathogens 16-well multiplex panel that could identify multiple pathogens including SARS-CoV-2 (2 assays), Influenza A and B, RSV, Rhinovirus/Enterovirus Parechovirus, Parainfluenza 1,2,3,4, Adenovirus groups B,C,E some A,D, Metapneumovirus, Bordetella spp and Mycoplasma Pneumoniae.

  
  The objectives of the study were to investigate:
  1. The laboratory test performance of the Rhinoswab compared with the current standard of care CTDN swab
  2. The comfort and preference of Rhinoswab compared to the CTDN swab
  3. If laboratory handling of Rhinoswab is equivalent to the CTDN swab.
  The study also recruited nursing and laboratory staff to evaluate Rhinoswab against clinical, laboratory handling, process and workflow requirements.
  Laboratory performance results
  Across the 12 different targets on the Ausdiagnostics assay panel the Rhinoswab Junior achieved comparable sensitivity to the combined nose and throat swab.

  	Rhinoswab Junior
  Sensitivity (95% CI)	96.2% (91.8, 98.3)
  Specificity (95% CI)	99.6% (99.6, 99.9)

  It is worthy of note in the current climate that the Rhinoswab Junior detected 100% of the patients who presented with SARS-COV-2.
  Preference results
  An online survey was completed on site. Children, parents and nursing staff were asked their opinions across a range of issues.
  82.2% of children preferred the Rhinoswab Junior, 6.7% had no preference and 11.5% preferred the standard swab. 79% of parents preferred the Rhinoswab while 82% of the nursing staff preferred the use of the Rhinoswab in the sample collection process. Further details will be discussed in the publication.
  The introduction of the Rhinoswab Junior into the laboratory does require changes to occur and some new workflows to be introduced. Specific details as to these changes are being incorporated into the pathology laboratory instructions and information packs that accompany the Rhinoswab Junior.
  Results from the use of the Rhinoswab published by NSWHealth Pathology https://www.pathology.health.nsw.gov.au/research-and-innovation/research-forum/christopher-kot support the introduction of these new works flows to not only provide a better user experience but also to “protect healthcare workers and improve result turnaround times.”

  
  Michael Johnson CEO of Rhinomed commented, “The results of this world first study come at a vitally important time. Testing of children has always been problematic with high testing reluctance due in no small part to the fear and anxiety families have toward the testing process. These results confirm that not only is the Rhinoswab Junior comparable to the highly invasive gold standard nose and throat swab in terms of lab performance, it is overwhelmingly preferred by children, parents and nurses.

  
  As we continue to deal with SARS-CoV-2 and its variants it is critically important that we enable mass, high frequency testing of children. The results of this trial and the previously published results from NSW Health Pathology provide clear evidence that we can easily and quickly test kids. These results provide confidence that the Rhinoswab Junior can, and will, make a significant difference across the global testing market.”

  For more information about the Rhinoswab Junior visit https://www.rhinomed.global/about-rhino-med/sample-collection/rhinoswab-junior/

  This report has been authorised for release to the market by the Board. Company Investor and Media Relations
  Michael Johnson,
  CEO & Director
  +61 (0) 3 8416 0900
  mjohnson@rhinomed.global
  Follow us on Twitter @rhinomedceo

  Rudi Michelson
  Monsoon Communications
  +61(0) 411 402 737
  rudim@monsoon.com.au

  About Rhinomed Limited (ASX: RNO, OTCQB:RHNMF)
  Rhinomed Limited is a Melbourne, Australia based ASX listed medical device company that has developed a novel wearable nasal technology platform that can improve air flow and provide both drug delivery and diagnostic capabilities.

• Rhinoswab Detects Covid-19 Virus in Doherty Study (Apr 25, 2022)

  RHINOSWAB DETECTS SARS-CoV-2 IN DOHERTY

  INSTITUTE RT-PCR STUDY

  ● Study undertaken at the Victorian Infectious Disease Laboratory (VIDRL), part of The Peter Doherty Institute for Infection and Immunity (The Doherty) met its key end point of establishing that the Rhinomed swab is comparable to standard of care nasal swabs.
  ● Study established 100% category detection of SARS-CoV-2 for the Rhinomed swab (Rhinoswab).
  ● No difference in the mean Ct value for detection of SARS-CoV-2 at both low and high virus burdens.
  ● Rhinoswab is comparable to standard of care swab in its ability to diagnose SARS-CoV-2 with RT-PCR. December 14, 2020 Melbourne, Australia.

  Rhinomed Limited (ASX:RNO OTCQB:RHNMF), a leader in nasal airway and respiratory technology, is pleased to report positive data from its lab-based spiking study of Rhinomed’s new Rhinoswab conducted at the Victorian Infectious Diseases Reference Laboratory (VIDRL), part of The Peter Doherty Institute for Infection and Immunity (The Doherty) in Melbourne.

  The study’s objective was to demonstrate efficacy in detecting the SARS-CoV-2 virus at both low and high viral loads.

  The study assessed how well the Rhinoswab performed in transferring a viral load for testing when compared to commercial comparators. It considered the amount of virus the swab was subjected to, as well as how well the swab could elute the acquired viral load for adequate testing by a PCR device.

  The eluted volume from the Rhinoswab was found to be comparable to the commercially available Copan eSwab when artificially dipped into a neat saliva solution spiked with inactivated SARS-CoV-2, at both high and low virus burdens. The relative maximal volume recovered was also comparable between the devices.

  The results showed that there were no statistical differences between the mean Ct values at the two viral concentrations obtained from both swabs when fully immersed in a viral solution, and that both swabs reported 100% accurate diagnosis of SARS-CoV-2. This indicates that the Rhinoswab is comparable to the comparator (the Copan ESwab) in terms of its ability to diagnose Covid-19 with a PCR from full saturation.

  Rhinomed CEO Michael Johnson commented, “We are delighted to have worked with VIDRL, the Doherty and Dr Julian Druce, Dr Mike Catton and their team to have confirmed that the Rhinoswab can detect SARS-CoV-2 using lab-based RT-PCR.”

  “This is a critical step in demonstrating that the Rhinoswab has a role to play in responding to the need for an easy to deploy, self-administered and effective sampling methodology.”

  “We are now reaching out to the many health systems, Covid Test developers and pathology groups for whom a comfortable, self-administered and effective swab will enable mass, high frequency testing. This response will be an important part of ensuring we can respond quickly and effectively to future Covid outbreaks.“

  Rhinomed is continuing its R&D program to optimise the swab and understand its utility with clinical sample collection. Further work is also seeking to assess its suitability across a range of other upper respiratory diseases including influenza.

  The Study
  The Doherty assessed the in vitro virus capture and recovery of virus signal of the Rhinomed dual-nostril swab device compared to the commercially available Copan eSwab using mock respiratory samples spiked with gamma-irradiated SARS-CoV-2 at two viral concentrations (low and high virus burdens). The Rhinoswab and Copan eSwab were artificially dipped into both the high and low virus burden spiked saliva solutions and eluted into 1mL of saline following maximal saturation.

  The results showed that both the Rhinoswab device and Copan eSwab performed equivalently following the artificial dipping into the SARS-CoV-2 solution and then eluted in 1mL saline. All negative Rhinoswab devices that were dipped into neat saliva gave negative results by RT-PCR as expected.

  The Doherty concluded that the eluted volume from the Rhinoswab device was comparable to the commercially available Swab when artificially dipped into a neat saliva solution spiked with inactivated SARS-CoV-2, at both high and low virus burdens.

  The average Ct values from the in-house RT-PCR targeting Helicase are shown in the table below.

  	Low virus Burden, 1mL elution CT Average	High virus Burden, 1mL elution CT Average
  Rhinoswab by Rhinomed	29.5	26.4
  Copan eswab	29.4	26.0

  In a second experiment a high virus burden solution was applied as 4 x 5μL (VT=20μL) onto both the Rhinoswab (n=10) and Copan eSwab (n=5) and eluted into 1mL, 2mL or 3mL saline. The results of this experiment showed that when 20μL of the same neat saliva high virus burden solution was applied directly to each device as 4 x 5μL amounts, the Copan eSwab eluted more efficiently across all elution volumes in saline. Better recovery from the Rhinoswab device was observed in the larger elution volumes, with the 3mL volume yielding the best recovery.

  Both swabs showed 100% detection of the virus at all media volumes when tested using rt-PCR.

  1mL elution	Mean Ct (+/- SD)
  Rhinoswab 20μL at Ct=26,	30.8 (+/- 0.61)
  E-Swab 20μL at Ct=26,	28.2 (+/- 0.06)

  2 mL Elution	Mean Ct (+/- SD)
  Rhinoswab 20μL at Ct=26,	30.6 (+/- 0.42)
  E-Swab 20μL at Ct=26,	28.5 (+/- 0.43)

  3 mL Elution	Mean Ct (+/- SD)
  Rhinoswab 20μL at Ct=26,	30.3 (+/- 0.26)
  E-Swab 20μL at Ct=26,	28.8 (+/- 0.13)

  Conclusions
  The eluted volume from the Rhinoswab device was comparable to the commercially available Copan eSwab when artificially dipped into a neat saliva solution spiked with inactivated SARS-CoV-2, at both high and low virus burdens. The relative maximal volume recovered was also comparable between the devices.

  The results showed that there were no statistical differences between the mean Ct values at the two viral concentrations obtained from both swabs when fully immersed in a viral solution, and that both swabs reported 100% accurate diagnosis of SARS-CoV-2. This indicates that the Rhinomed nasal swab is comparable and on par to the competitor, Copan ESwab in terms of ability to diagnose Covid-19 with a PCR from full saturation.

  This announcement has been authorised for release by the Board.

  Media Enquiries
  Michael Johnson, CEO & Director
  +61 (03) 8416 0900
  mjohnson@rhinomed.global
  Follow us on Twitter @rhinomedceo and @theturbinecom

  
  Rudi Michelson, Monsoon Communications
  +61 (0)411 402 737
  rudim@monsoon.com.au

  Rhinomed Global (https://www.rhinomed.global) is an Australian-based medical technology company with a patented nasal technology platform whose first products are used by consumers in the global sleep, respiration, and nasal congestion markets. These products, sold at major US retailers, support the development, acceptance, and adoption of a pipeline of future wearable, sensor, diagnostic, and drug delivery opportunities. The company has recently secured FDA class registration for its Rhinoswab, a dual nostril swab designed to collect nasal specimens for diagnostic testing for respiratory diseases, particularly COVID-19.

  Since its formation six years ago, Rhinomed has built the necessary foundation to accelerate its already increasing revenue growth. The company trades on the ASX:RNO and the OTCQB:RHNMF

• Rhinoswab Clinical Program Update (Apr 25, 2022)

  CLINICAL PROGRAM UPDATE: TWO KEY STUDIES
  CONFIRM RHINOSWAB SUPERIOR PERFORMANCE

  TOPLINE
  ● Nasal Swab Yield study (n=394) confirms Rhinoswab captures statistically significant larger sample than standard of care nasal swab
  ● Elution Efficiency study confirms Rhinoswab delivers superior elution efficiency when compared to standard of care nasal swab.

  May 13, 2021: Melbourne, Australia.
  Rhinomed Limited (ASX:RNO; OTCQB:RHNMF) a leader in wearable nasal and respiratory technology is pleased to report an important update on its RhinoswabÔ clinical program.

  
  In December 2020 the company established that the Rhinoswab was comparable to existing standardof care nasal swabs in detecting the SARS-CoV-2 virus in RT-PCR testing. This study wasundertaken at the VIDRL (Peter Doherty Institute).

  
  Since December the company has further refined the swab technology by improving the nylon flock used on the swab. Two studies have now been completed to assess the performance of the Rhinoswab against the current commercially available standard of care nasal swab (Copan eSwabÔ).

  
  Both studies have now confirmed that the Rhinoswab outperforms the standard of care nasal swab (Copan eSwabÔ) in two critical key performance factors: capture (yield) and elution efficiency.

  
  Rhinomed’s new Rhinoswab has recently been approved for sale in the Australian market and is listed on the ARTG and in the US with the FDA. The Rhinoswab standardises the collection process and makes nasal sampling easy and comfortable for users. With production underway in Melbourne, Australia the company is seeking to scale up in order to meet demand. More information on the Rhinoswab is available at https://www.rhinomed.global/about-rhino-med/sample-collection/

  
  NASAL SWAB YIELD STUDY

  
  The objective of the Nasal Swab Yield Study was to compare the mean absorption/sample capture performance of the Rhinoswab against the commercially available standard of care nasal swab (Copan eSwabÔ) at various insertion time points.

  
  Methodology
  A randomised trial was conducted where 394 samples were collected from participants over a six week period. Participants were swabbed twice a day with a minimum of five hours between each sample collection. Participants were randomly assigned a nasal swab. Each swab was weighed prior to use and then weighed again post use using a calibrated Sartorius analytical scale.
            ● Participants were instructed to insert the standard of care nasal swab (Copan eSwabÔ) according to the manufacturer's Instructions for Use (15 seconds,                      each nostril).
            ● Participants were asked to insert the Rhinoswab according to the Rhinoswab Instructions for Use. Participants were randomly assigned one of three                             different time periods for insertion - 15 seconds, 60 seconds and 120 seconds.

  Results
  The results of the study are displayed below.

  Swab	Insertion time period	Mean (g)	95% CI range
  Standard of Care (Copan eSwabÔ)	15 secs each nostril	0.0278	0.0231	0.0324
  Rhinoswab	15 secs	0.0408	0.0341	0.0475
  Rhinoswab	60 secs	0.0437	0.0369	0.0506
  Rhinoswab	120 secs	0.0496	0.0417	0.0575

  
  Conclusion
  All Rhinoswabs captured a mean sample larger than the standard of care (Copan eSwabÔ) across all insertion time periods - 15 seconds, 60 seconds and 120 seconds.

  	Standard of Care (Copan eSwab)	Rhinoswab	Performance improvement
  15 seconds insertion each nostril	0.0278g
  15 seconds insertion		0.0408g	1.47 times greater than standard of care swab
  60 seconds insertion		0.0438g	1.57 times greater than standard of care swab
  120 seconds insertion		0.0496g	1.78 times greater than standard of care swab

  
  This study provides statistically powered evidence that the Rhinoswab, in addition to its comfort, ease of use and standardised sample collection procedure, captures a statistically larger sample from the nose than standard of care nasal swab (Copan eSwabÔ).

  
  EVALUATION OF RHINOSWAB ELUTION EFFICIENCY

  
  Independent laboratory, Gnomix (Adelaide, Australia) was engaged to compare the elution efficiency
  of the RhinoswabÔ compared to the standard of care nasal swab (Copan eSwabÔ).

  
  Methodology
  An aliquot of gamma-irradiated (inactivated) SARS-CoV-2 virus (strain VIC/01/202) was received from the Victorian Infectious Diseases Reference Laboratory (VIDRL) with a nominal CT value of 18 (assay dependent). The SARS-CoV-2 virus was diluted 1/200 in a stock solution of donated saliva to represent a high virus burden sample and 1/2000 in to represent a low virus burden sample.

  
  Two protocols were followed.

  
       1.      To reflect the standard of care, the high and low virus burden samples were applied as 4 x 5μl spots (20μl) onto 10 RhinoswabsÔ and 5 standard of care                      nasal swab (Copan eSwabÔ).
       2.      To evaluate the inherently greater potential capture area of the RhinoswabÔ in comparison to the standard of care nasal swab (Copan eSwabÔ) 4 x 8μl                        spots (32μl) were applied onto 10 RhinoswabsÔ.

  In both instances each swab was then placed into a 5ml tube containing 1ml of Saline, vortexed vigorously for 30 seconds and left to elute for 1 hour at room temperature. Standard curve samples were prepared by spiking 32μl, 20μl, 15μl, 10μl and 5μl of the respective high and low virus burden samples into a 5ml tube containing 1ml of Saline, vortexed vigorously for 30 seconds and left to sit for1 hour at room temperature.

  
  Assay
  Following elution, 140μl of eluate was extracted using the QIAamp Viral RNA Mini Kit (QIAGEN) according to the manufacturer's instructions. The QuantiNova IC RNA was included in all samples as an extraction control. Reverse transcription and qPCR were performed using the QuantiNova Pathogen +IC Kit (QIAGEN) in combination with the SARS-CoV-2 N1+N2 assay kit (QIAGEN) according to the manufacturer's instructions. A 6μl volume of input viral RNA was used in the QuantiNova Pathogen Assay and thermal cycling was performed on a Rotorgene Q qPCR instrument using the conditions in the QuantiNova Pathogen +IC Kit handbook. The QuantiNova IC RNA, extraction negative control and PCR negative control were included on each run.

  
  Results:
  Standard load

  1.  20μl at High Virus burden
       Sample loading of 20μl of the high virus burden sample yielded an average of 16.34μl recovery (82%) for the RhinoswabÔ and an average of 14.5μl (73%) for           the comparable standard of care nasal swab (Copan eSwabÔ). This suggests a superior elution efficiency for the RhinoswabÔ when comparing identical                     initial loadings of the high virus burden sample.

  	High Virus Burden 20 μl (1ml Elution) Average Ct	Average μl recovered
  RhinoswabÔ	25.45 (+/- 0.24)	16.34 μl (82%)
  Standard of Care nasal swab (Copan eSwabÔ)	25.75 (+- 0.43)	14.50 μl (73%)

  
  20μl at Low Virus burden
  Sample loading of 20μl of the low virus burden sample yielded an average of 21.8μl recovery (~100% taking into account experimental deviation) for the RhinoswabÔ and an average of 14.5μl (73%) for the comparable standard of care nasal swab (Copan eSwabÔ). This suggests superior elution efficiency for the RhinoswabÔ when comparing identical initial loadings of the low virus burden sample.

  	Low Virus Burden 20 μl (1ml Elution) Average Ct	Average μl recovered
  RhinoswabÔ	29.15 (±0.24)	21.80 μl (~100%)
  Standard of Care nasal swab (Copan eSwabÔ)	30.39 (±1.03)	17.33μl (87%)

  2. Greater load potential
      32μl at High Virus burden A sample loading of 32μl of the high virus burden on the RhinoswabÔ was also tested to evaluate the inherently greater potential                capture area of the RhinoswabÔ in comparison to the standard of care nasal swab (Copan eSwabÔ). This yielded an average of 21.0μl recovery (66%) for the            RhinoswabÔ. This indicates that it is possible to recover more virus from the extra loading capacity, although there appears to be slightly diminished overall              efficiency.

  	High Virus Burden 32 μl (1ml Elution) Average Ct	Average μl recovered
  RhinoswabÔ	24.94 (±0.17)	21 μl (66%)

  
  32μl at Low Virus burden
  A sample loading of 32μl of the low virus burden on the RhinoswabÔ was also tested to evaluate the inherently greater potential capture area of the RhinoswabÔ in comparison to the Standard of Care nasal swab (Copan eSwabÔ). This yielded an average of 28.7μl recovery (90%) for the RhinoswabÔ. This indicates that it is possible to recover more virus from the extra loading capacity, although there appears to be slightly diminished overall efficiency.

  	Low Virus Burden 32 μl (1ml Elution) Average Ct	Average μl recovered
  RhinoswabÔ	28.5 (±0.49)	28.7 μl (90%)

  Conclusion
  Under the conditions tested and with the materials supplied, the RhinoswabÔ demonstrated not only a comparable but also a superior elution efficiency to the commercially available Standard of Care nasal swab (Copan eSwabÔ).

  
  This report has been authorised for release to the market by the Board.

  Company	Investor and Media Relations
  Michael Johnson, CEO & Director +61 (0) 3 8416 0900 mjohnson@rhinomed.global Follow us on Twitter @rhinomedceo	Rudi Michelson Monsoon Communications +61(0) 411 402 737 rudim@monsoon.com.au

  Follow us on Twitter @rhinomedceo and @theturbinecom
  Rhinomed Global (https://www.rhinomed.global) is an Australian-based medical technology company with a patented nasal technology platform whose first products are used by consumers in the global sleep, respiration, and nasal congestion markets. These products, sold at major US retailers, support the development, acceptance, and adoption of a pipeline of future wearable, sensor, diagnostic, and drug delivery opportunities. The company has recently secured FDA class 1 registration for its Rhinoswab, a dual nostril swab designed to collect nasal specimens for diagnostic testing for respiratory diseases, particularly COVID-19. Since its formation six years ago, Rhinomed has built the necessary foundation to accelerate its already increasing revenue
  growth. The company trades on the ASX:RNO and the OTCQB:RHNMF

• Nasal-swab-registered-with-US-FDA-(20 Nov 2020).pdf (Apr 26, 2022)

  RHINOMED’S NEW NASAL SWAB SUCCESSFULLY

  REGISTERED WITH US FDA

  20 November 2020 Melbourne, Australia.
  Rhinomed Limited (ASX:RNO OTCQB:RHNMF), a leader in nasal airway and respiratory technology, is pleased to announce that it has successfully registered its novel nasal swab with the US FDA as a Class 1 device to collect samples from the nose to detect upper respiratory tract diseases including influenza and coronavirus strains.

  
  The successful registration and conformity with the relevant standards means that Rhinomed’s novel nasal swab is now able to be sold in the US market.

  
  The new nasal swab is an extension of Rhinomed’s nasal technology platform and intellectual property patent portfolio using the company’s depth of experience as a world-leading developer of nasal devices. Rhinomed’s existing nasal products have been worn comfortably and safely since 2016 and are sold in more than 20,000 pharmacies worldwide.

  
  Rhinomed’s nasal swab is:

  
            ●    Less invasive and more comfortable than standard nasopharyngeal swabs;
            ●    Unique as it collects samples from both nostrils simultaneously.
            ●    Able to collect samples from a far greater surface area of the nose than normal swabs;
            ●    Able to be self-administered easily, anywhere, reducing the risk of infection of healthcare
                   workers; and
            ●   Able to be used by a wide number of people every day.

  
  Rhinomed’s nasal swab is designed for self-collection in the home, workplace or in a clinical setting under supervision and is expected to address the problems withcurrent nasopharyngeal swabs that are highly invasive and uncomfortable. Most existing nasal swabs require a healthcare worker to collect the sample, which places the healthcare worker at risk of infection. The use of healthcare workers and the requisite personal protection equipment (PPE) also comes with significant cost.

  
  The new Rhinomed swab is designed to be able to collect a larger sample, be worn for a predetermined time (it remains snugly in place) and collect a sample from both nostrils simultaneously, thus offering the potential for a more effective diagnostic sample. The swab has been designed to fit into existing vials and work with existing pathology workflows.

  
  The Company is now rapidly scoping manufacturing and is assessing additive manufacturing (3D printing) solutions, existing offshore manufacturing resources and assessing the viability of local manufacturing.

  
  Rhinomed is advancing discussions with potential commercial partners in respect to the program. Further details on the clinical and commercial program will be announced as further progress occurs.

  
  This announcement has been authorised for release by the Board.

  Media Enquiries
  Michael Johnson, CEO & Director
  +61 (03) 8416 0900
  mjohnson@rhinomed.global
  Follow us on Twitter @rhinomedceo and @theturbinecom

  
  Rudi Michelson, Monsoon Communications
  +61 (0)411 402 737
  rudim@monsoon.com.au

  
  About Rhinomed Limited (ASX: RNO, OTCQB:RHNMF)
  Rhinomed Limited is a Melbourne-based ASX-listed airway technology company that has developed a novel nasal and respiratory technology platform.

  
  With its initial product Turbine, Rhinomed has established a leading position in emphasizing the role of breathing in sport and exercise. With its Mute variant, the company has also entered the sleep sector to tackle the global snoring market, while its third product, the Pronto range, tackles nasal congestion and sleep disturbance issues. The company is developing applications for the delivery of medical cannabis and for conditions including anxiety, pain, allergies, nausea, anxiety and coughs and colds.

  
  Rhinomed’s devices are sold in over 20,000 stores worldwide including Walgreens, CVS, Boots and online with Amazon; and are approved in major markets including the US, Europe, Canada and Australia.

• BTNS supply agreement.pdf (Apr 26, 2022)

  BTNX AND RHINOMED FINALISE SUPPLY AGREEMENT

  FOR RHINOSWAB

       ●    24 month Rhinoswab and Rhinoswab Junior supply agreement with BTNX Inc. – one of Canada’s largest rapid antigen test (RAT) kit                                     manufacturers.

  
       ●   Agreement on an exclusive basis for the Canadian market and non-exclusive in other markets.

  
       ●   Rhinomed will supply a minimum of 22.5 million swabs over the course of the term.

  
  7th April 2022: Melbourne, Australia.
  Rhinomed Limited (ASX:RNO OTCQB:RHNMF), a leader in wearable nasal and respiratory technology, is pleased to confirm that it has entered into a supply agreement with BTNX Inc. – one of Canada’s largest manufacturers of rapid antigen test kits.

  
  The supply agreement is for a period of 24 months and covers the supply of Rhinoswab and Rhinoswab Junior for inclusion in BTNX’s range of Covid-19 Rapid Response antigen test kits. This includes supply of Rhinoswab Junior for inclusion in the new Rapid Response COVID-19 Antigen Rapid Test Cassette - Junior Home Test Featuring Rhinoswab Junior – one of the world's first rapid antigen test kits designed for children.

  BTNX is a world leader in rapid, point of care diagnostics across a range of markets. BTNX is the largest supplier of rapid antigen test kits to the Canadian government where it has supplied over 315 million rapid antigen tests to date.

  
  BTNX and Rhinomed can advise that the supply agreement contains standard terms for an agreement of this nature and provides for a minimum binding commitment of 22.5 million swabs over a 24 month period. The agreement is exclusive in the Canadian market and non-exclusive in all other markets. BTNX has informed Rhinomed orders will commence in July 2022.

  Pricing remains commercial in confidence however investors should note that the revenue associated with this arrangement has the potential to represent approximately 465% to 475% of reviewed H1FY22 revenues of $3.75m.

  
  Michael Johnson CEO of Rhinomed said, "The completion of this supply agreement with BTNX is an indicator of the strong market feedback BTNX has received and the impending completion of the Canadian regulatory approval process. The BTNX Rapid Response with Rhinoswab Junior has the potential to transform the way children in Canada are tested. We look forward to a long and successful partnership with BTNX.”

  BTNX CEO Iqbal Sunderani said “In the completion of this agreement with Rhinomed, we are pleased to have progressed one step closer to our shared goal of improving the testing experience for children and parents alike. We look forward to our continued collaboration with Rhinomed as we bring this exciting new product to our key markets.”

  This report has been authorised for release to the market by the Board. This announcement discloses all material details as required under section 4.1 of ASX Guidance Note 8 in respect of the Supply Agreement.

  Company	Investor and Media Relations
  Michael Johnson, CEO & Director +61 (0) 3 8416 0900 mjohnson@rhinomed.global Follow us on Twitter @rhinomedceo	Rudi Michelson Monsoon Communications +61(0) 411 402 737 rudim@monsoon.com.au

  
  About Rhinomed Limited (ASX: RNO, OTCQB:RHNMF)
  Rhinomed Limited is a Melbourne, Australia based ASX listed nasal and airway technology company that has developed an innovative nasal technology platform that can improve air flow and provide both drug delivery and diagnostic capabilities.

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