SalivaPod - Novel Saliva Sample Collection for a New Era of Diagnostics

Conceptomed, an innovative Norwegian based medtech company, has created SalivaPOD™ for easy-to-use saliva sample collection. SalivaPOD™ is now sold throughout Scandinavia by a leading distributor of laboratory supplies and equipment. Conceptomed looks to expand its distribution and partnering network in Europe, the US, Asia, Latin America, Australia, and elsewhere. The Sage Group is advising Conceptomed on business development in respect of partnering and licensing globally.

Stimulated by the Covid pandemic and the breadth of analytes which can be detected in saliva (SARS CoV2, HIV, hepatitis, numerous biomarkers for disease, drugs of abuse, therapeutic drugs, etc.), SalivaPOD™ addresses the need for a reliable, reproducible, safe, low cost and easy-to-use saliva collection device that can be made widely available. The wide range of diagnostic tests for analytes in saliva has created a growing demand for a state-of-the-art saliva collection device.

The SalivaPOD™ is a single-use device, intended for use by a lay person for the collection and short-term storage of oral fluid specimens. The lay person may perform, or the healthcare professional performs, the transfer of the specimen into a transport culture medium, a buffer solution or one or more diagnostic reagents for further transport to a testing laboratory, or for immediate analysis and diagnostic use.

SalivaPOD™ is CE marked and approved for sale in Europe. Conceptomed believes that FDA approval will be gained shortly. SalivaPod™ is designed to be a low-cost, easy-to-use, device which delivers superior saliva samples for accurate diagnostic testing. SalivaPod™ addresses several problems with existing saliva collection kits at the market:

· High viscosity of saliva

· Problems with robotic pipetting

· Too much or too little saliva compared to transport medium

· Risk of contaminating the sample

The key benefits of SalivaPod™ are summarized below. Please also see the attached product sheet for details. SalivaPod™ is available as a single unit or 100 unit packages.

· By controlling the amount of the sample to 1mL to maximum of 1.5 mL, with arrows and a 360○ Fill-to-Line mark to guide the user to collect 1 mL, SalivaPOD™ optimizes and standardizes the sample-to-media ratio thus controlling viscosity of the sample, avoiding inaccurate or questionable test results, and improving assay reproducibility. · By its structural filtering design, SalivaPOD™ reduces influx of oral cavity lumps, food particles, or other contaminants from the sample thus yielding a clean sample without bubbles, froth, or mucous and further protecting against inaccurate or questionable results – and eliminating the need for pre-analytical process steps. · By the design and integration of the SalivaPOD™ mouthpiece or “sample straw” into the SalivaPOD™ unit and the transfer/ejection of saliva after the initial collection procedure, any contamination on the outside surface of the laboratory tube is eliminated – the saliva transfer step is a closed system, where the encapsulated saliva is “pushed directly into” the laboratory tube. · By the comprehensive simplicity of SalivaPOD’s™ Instructions for Use (IFU) in both paper format and through the eIFU SalivaCODE™ App with optional voiceover available in the App Store and Google Play, SalivaPOD™ can be easily and safely used by patients and individuals without further instruction to allow for reliable test results. The present IFU is in 13 languages. Additional ones can be easily added · SalivaPOD™ has a label prepared with printed TWIN Unique QR code for integration with eHealth systems · These features make SalivaPOD™ ideal for consumer use as well as sample collection in a medical facility, clinic, physician’s office, hospital or screening center, to analyze nucleic acids, proteins, or small molecules for clinical or research purposes.

· These features reduce the need for lab workers to spend time to further prepare samples for testing. They also improve test and trace compliance specifically for Covid.

· These benefits have been experienced by the Norwegian Armed Forces which has used SalivaPOD™ on over 3000 samples without problems related to the collection or “cleanliness” of the sample nor the resulting test results. The same has been experienced by the daily use in Trondheim Municipality and St. Olavs Trondheim University Hospital where 100% of the more than 40,000 SalivaPOD™ samples have been analyzed without issue. SalivaPOD™ samples for PCR is now the preferred and PCR testing method for the population 6-65 years of age in Trondheim.

· SalivaPOD™ is covered by design patents pending in all major markets

· By virtue of its design and materials and Conceptomed’s substantial investment, SalivaPOD™ can be made widely available due to its highly competitive pricing.”

We would be pleased to arrange an introductory call with Conceptomed management to present the SalivaPOD™ product and answer any questions you may have in relation to a future commercial relationship.

Dr. Bill Mason & Wayne Pambianchi

The Sage Group

wtm@sagehealthcare.com

+44 7785 950134