We have had significant progress on our system and hence we thought it time to update you on our progress.

Transcription

1 January 16, 2018 Dear Investor Greetings! We have had significant progress on our system and hence we thought it time to update you on our progress. Some of you have been kind enough to refer us to funding sources and strategic partners. Please continue to pass on potential investors that would like to join us. Thanks so much and as always, Vanaja and I are happy to answer any questions. Sincerely Edward Peterson Global General Manager 3251 Progress Drive Orlando, FL

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3 DISCLOSURE THIS IS NOT AN OFFERING TO BUY OR SELL SECURITIES AND IS SOLELY AN INFORMATIONAL DOCUMENT. ALL ILLUSTRATIONS, PROJECTIONS AND FORECASTS ARE BASED ON CERTAIN ASSUMPTIONS AND EXPECTATIONS WHICH MAY OR MAY NOT OCCUR OR BE REALIZED. NO ASSURANCES CAN BE MADE THAT SUCH PROJECTIONS WILL OCCUR OR BE REALIZED, AND ACTUAL RESULTS MAY DIFFER MATERIALLY. THE INFORMATION, ANALYSIS, FORECASTS OR PROJECTIONS PROVIDED HEREIN WERE PROVIDED SOLELY FOR INFORMATIONAL PURPOSES. POTENTIAL INVESTORS MAY NOT RELY ON THE INFORMATION PROVIDED HEREIN BUT MUST ONLY CONSIDER THIS INFORMATIONAL DOCUMENT IN CONJUNCTION WITH ALL OF THE OFFERING MATERIALS, AND UNDERTAKE THEIR OWN DUE DILIGENCE INVESTIGATION REGARDING THE COMPANY, IN ORDER TO FULLY UNDERSTAND ALL OF THE IMPLICATIONS AND RISKS OF THE OFFERING. INVESTMENT IN THE COMPANY ENTAILS A HIGH DEGREE OF RISK AND POTENTIAL INVESTORS MAY LOSE THE ENTIRE AMOUNT OF THEIR INVESTMENT. INVESTMENT IN THE COMPANY WILL ONLY BE OFFERED TO ACCREDITED INVESTORS AS DEFINED IN RULE 501(A) OF REGULATION D UNDER THE SECURITIES ACT. 3

4 Vanaja V. Ragavan, M.D. From the Desk of the CEO Dear Investor, Welcome to our third newsletter. It s been a remarkable end of year as we now have a fully functioning working system and have demonstrated that we can detect the presence Lyme serology in preliminary studies. We will continue to work on the Lyme diagnostic and forward this product further with more data and a plan for regulatory work. We were indeed priviledged to have Dr. James Schumer, one of our investors, come to our lab and witness the actual data collection. He has kindly provided his own view of the technology and you can read this in the next page. Jim, thanks for the time you spent with us! We have also created an investor only page on our web and you will be receiving information on how to log in. We will try to update it with data on a regular basis and there should a place for you to post questions for discussion. In fact, we have asked Dr. James Schumer if he would like an opportunity to offer his ideas about the preliminary studies to date. Please contact me directly if you would like further information on any topic. Sincerely, Vanaja V. Ragavan, M.D. President and CEO (610)

5 A note from Dr. Schumer: Founder and Medical Director of ReVision LASIK and Cataract Surgery Center, Columbus, Ohio As a practicing physician, I understand the necessity for accurate and timely diagnosis in the pursuit of optimal patient care. I am often faced with the burden of collecting samples (blood or swabs of infected tissue); overseeing the procurement; handling and transport to a laboratory; only to have to wait days (or longer) for the results. I can only guess at the number of hands, processes and laboratory equipment needed to properly handle these specimens. In the meantime, I am faced with treating the patient empirically, often times with a broad spectrum antibiotics plus an antifungal and antiviral medications. This obviously leads to added expense and a delay in initiating the appropriate targeted treatment. I was thrilled to watch the Aviana prototype accurately measure, within several minutes, the presence of Lyme disease in just a drop of plasma. I was equally impressed with meeting the scientific team that Vanaja Ragavan, M.D. and Ed Peterson have assembled to help drive the development of this diagnostic device. Although startup companies carry significant risk from an investment perspective, I was willing to increase my investment in Aviana after witnessing what they have accomplished to date. Knowing how much a device like this can revolutionize Point of Care Diagnostics, I am excited to be involved in Aviana and be able to witness this type of advancement. 5

6 Series B Fund Raising: We are focused on raising $3.5 to $ MM in Series B with a pre-money valuation of $1 MM to complete the biological data for limit of detection, standard curve and early clinical sample data. This will allow us to complete the development in preparation for regulatory clinical trials for FDA and CE Mark submission. For the latter activities, this will be the last round needed to get to market (Series C). Since we have a fully functioning system, we have the opportunity of working with several strategic partner to take us to market. We can provide more details to our current investors. You are all owners of this company and as such any assistance you provide is to the benefit of us all. Thank you for assistance you have already provided and any that you chose to provide in the future. Aviana could not exist without your help. Overview (Refresher) Aviana is an Orlando, FL-based diagnostic company developing a miniaturized, point-of-care biosensor capable of attaching to a smartphone. Aviana s finished diagnostic system will be a portable, simple-to-use, highly sensitive diagnostic platform that can quickly (< 20 minutes) and accurately detect a target infectious disease, biomarker, or protein in both clinical and scientific research settings. Aviana s vision is to provide highly sensitive and specific diagnostic capability to anyone with a smartphone or tablet (e.g., physician, medical technologist, or patient) and convey the results seamlessly to critical parties. Initial proof of concept studies using Aviana s proprietary biosensors have demonstrated accuracy similar to laboratory-based methods but with greater speed and portability. 6

7 GENERATION 2 READER Now that we have completed the first Generation prototype shown below, we are now working on our second generation reader, which will become our commercial reader. The concept is to miniaturize the working board on the Gen 1 reader to a small chip (shown in the center) and then attach this chip to a working android phone. Generation 1 Working Handheld Prototype Commercial Device: Dedicated smartdevice with miniaturized backpack As part of this process, we will plan to adapt a generic Android phone as our computing/wireless/cellular source. As part of our next funding milestones, we plan to work with one of our vendors to create the chip and another company to create the rugged casing and connection of our reader source to an Android phone. All functions of the Android phone not needed by us will be suppressed. We still have to create a cartridge that is simple and easy to use and we are working with a world class vendor to make this happen as part of our next funding milestones. FUNCTIONAL DATA: We have now stabilized the system and are obtaining functional, repeatable data on Lyme serology testing. Using a recombinant protein made in the labs of Dr. Mollie Jewett at UCF, we have been able to demonstrate that our system can detect Lyme serology (currently IgG containing serology) within 2-3 minutes. We have repeated this study using several serological samples with known Lyme titers and also compared it to know samples not containing any titers. In the latter, we have clearly established a clean baseline data. We will continue with this 7

8 work with more samples and also include IgM samples. We wish to establish a full data set for publication and to form the basis of our planned analytical studies. The graphs are shown below: Figure 1: Samples containing different titers of Lyme IgG when tested on our system and compared to the Elisa data provided by the source of samples: Lyme data EIA Titer (AU) Phase Shift (degree) Wampole EIA Certificate supplied by SecaCare Using Aviana System 0 (-)ve data LT 1 LT2 MT HT Different Human Plasma samples 0 Figure 2: Response Curve when a sample is diluted by addition of different volumes of the same high titer Lyme plasma. Phase Shift (degree) Lyme positive sample (-)ve controls Different volumes (µl) of HT lyme positive sample Wampole EIA titer

9 Figure 3: In this study, we demonstrate that whole blood provides the same background data as plasma, hence we will not need to do too much sample processing to activate our system, a major advantage in a point of care setting: 2.0 Phase Shift (degree) Plasma Whole blood Plasma or Whole blood from healthy donor Figure : Preliminary screening of healthy (negative control) plasma and Lyme positive plasma (procured from Seracare) using Pegasus system; data show no false negative data 12 Lyme diagnostic Phase Shift (degree) 8 0 Lyme Negative Zero false negative Lyme Positive We will continue to gather data for our Lyme product development FDA PRE-SUBMISSION MEETING: We are preparing to send a request for a pre-sub meeting to the FDA by the end of January. POTENTIAL LDT TESTING We have initiated work that will allow us to create an LDT for Lyme Disease and this could be both a source of income, albeit modest and also provide a basis for publicizing our technology. We will put this together in the next 3- months. 9