Chairmans address to AGM
Analytica Ltd. 222 Bazaar Street, Maryborough, QLD 4650 ABN 12 006 464 866 pericoach.com analyticamedical.com P E R I C O A C H ASX ANNOUNCEMENT Chairman’s Address at Annual General Meeting. 25 November 2021 . Good morning, Ladies and Gentlemen, and welcome to the 2021 AGM of your company, Analytica. My aim today is to give our shareholders an update on developments during the last 12 months and our strategy going forth to successfully commercialize the PeriCoach and the Enhanced Infusion System. It goes without saying the travel restrictions as a result of Covid-19 have once again, greatly restricted our ability to meet with overseas company executives. In spite of these obstacles, we announced in March of this year that Analytica had signed a deal to do a joint venture with Hebel Nacol Bio-Technology Co. Ltd (Nacol) and Shijiazhuang Biosphere Pty Ltd (Biosphere). This joint venture brings to the table highly experienced Chinese medical manufacturing and distribution companies with a national reach. Currently the joint venture is going through the regulatory process of registering the PeriCoach with the Chinese Food and Drug Administration (CFDA) as a class 2 medical device. Once CFDA clearance is obtained, the PeriCoach can be prescribed by the clinicians in China. The strategy is to distribute through the hospital networks as they have strong post-partum systems. This expansion into China is aimed at this rapidly growing postpartum rehabilitation market and the peri- menopausal market. This agreement allows the JV to manufacture the device in China with the software controlled by Analytica in Australia. The PeriCoach devices made in China will only work in China. The joint venture has been preparing the groundwork to manufacture the PeriCoach for the Chinese market. This agreement also builds upon our existing Middle East distribution partnership in 10 countries. While this work has been progressing the joint venture in combination with Analytica has been busy presenting clinical evidence on the PeriCoach at major medical, nursing and hospital conferences in China. On the 20/4/21 we announced to the market that Analytica had signed agreements to distribute our Enhanced Infusion System to Egypt, Bahrain, Iraq, Jordan, Kuwait, Lebanon, Saudi Arabia, United Arab Emirates and Iran. The Middle East is a significant market of close to 300 million people. Once the distributer has Egyptian Ministry of Health clearance, the plan is to distribute the Enhanced Infusion System through the hospital network in Egypt and then to extend it to the rest of the Middle East. Egypt with a population of 100 million people has 1,848 hospitals with over 131,000 beds. The Egyptian Government is rapidly improving the health system and has recently introduced Universal Health Insurance to cover all Egypt. In order to supply this market, we have chosen a new manufacturer in China to manufacture our Enhanced Infusion System. This company has the ability and the regulatory approvals to also supply our other target markets, the US and Europe. Analytica is also talking to other Chinese companies who have expressed interest in our Enhanced Infusion www.pericoach.com www.analyticamedical.com System for the Chinese market. These negotiations are going on as we speak. I will now address our Patent protection. On the 30th of April this year we announced to the market that Analytica Ltd had been granted a US Patent for the PeriCoach “intra vaginal device to aid in training and determining muscle strength” concerning the use of motion sensors in pelvic floor exercise devices. This patent gives Analytica intellectual property protection in the US market, the biggest market in the world. This invention has already been granted patent protection in Australia, China and Japan with other countries including Europe pending. Then fourteen days ago on the 11th of November we also announced to the market that Analytica had also been granted US Patent protection concerning the arrangement of force sensors in pelvic floor exercise devices. This with our previous patent granted in April gives Analytica an additional level of intellectual property protection in what will be our biggest market. The arrangement of the force sensors is a key technology allowing PeriCoach to target the pelvic floor muscles that matter, unlike other perineometers that measure intra-abdominal pressure, which only indirectly relates to pelvic floor muscle activity and hence is inaccurate. The PeriCoach technique feedback functionality uses inputs from our uniquely positioned force and movement sensors to assess the strength and technique used when contracting the pelvic floor muscles. As I said earlier both patent families have applications pending in other jurisdictions including Europe. Since the last AGM we have continued to work with our New York bankers. They too have experienced the very same Covid-19 related problems in North America and Europe as we have. However, the process of commercialization for the US and European markets has continued in-spite of the logistic difficulties Covid-19 has placed in front of us. On the back of the new evidence published from the independent clinical trial done at the University of New Mexico, the health economics report on the cost effectiveness of the PeriCoach in the US, the granting of our US patents, and the roll out of the PeriCoach in China and the Middle East, major multination medical device companies are once again in discussion with us concerning the PeriCoach. On April 23 this year we announced to the ASX that Analytica had done a $3.83 million share placement at 0.35 c per share subject to shareholder approval. 180 Markets Pty Ltd acted as sole lead manager to this Placement. To support this placement, I contributed $750,000 of the $3.83 million. This fund raising was then approved at an Extraordinary General Meeting on June 18. I thank 180 Markets Pty Ltd for their support. I would now like to talk to you about other developments that have been ongoing over the last twelve months. We have continued to engage with both State and Federal Governments at all levels with view to funding to support Analytica. As a result of these ongoing discussions the Queensland Government announced on September 6 that it would support Analytica through grant funding under the Advance Queensland Industry Attraction Fund. This would allow a phased manufacturing expansion over 5 years. Previously we have outsourced the manufacture of the PeriCoach. This funding will help Analytica bring manufacturing in house which will be www.pericoach.com www.analyticamedical.com important once we start supplying the Middle East, European and US markets. The benefits of bringing the PeriCoach production under Analytica’s control includes better supply chain management and regulatory compliance. We also have continued to work with Government based health systems around Australia in an effort to convince the Health Departments that the use of the PeriCoach post childbirth could rehabilitate pelvic floor muscles, improve women’s lives, save unnecessary pelvic floor surgery, keep women out of nursing homes and save State and Federal Government’s money. If we are successful, we will see the PeriCoach used in Obstetric Hospitals post childbirth as is currently being planned in Middle Eastern and Chinese Obstetric hospitals. I would like to make mention and thank the Analytica staff, especially Geoff, Chelsea Megan , Rebecca and Rebecca who have worked so hard on the PeriCoach and our Enhanced Infusion System. I also would wish to take this opportunity to thank our shareholders who have supported us over the long years of development. Our focus continues, make the best in class, gather evidence that the product performance is exceptional and actively pursue partnering opportunities. As a board we are conscious of the need for sales to make Analytica a successful company. It has not been an easy road. As obstacles are put in our way, we have had to change our strategy numerous times to get around these obstacles. I know the board is grateful for your support. Before I finish I would like to thank my fellow board members Ross, and Peter, who also have worked hard to re position our company. I believe we have made real progress during the last year. I will finish by saying once again that I believe we will be successful. Dr Michael Monsour For more information, please contact: email@example.com For more information about the PeriCoach System, visit: www.PeriCoach.com For more information about Analytica, visit www.AnalyticaMedical.com www.pericoach.com www.analyticamedical.com About Analytica Limited Analytica is a product development and commercialisation company, based in Queensland, Australia, focussed on Class I and II medical device products. Analytica’s lead product is the PeriCoach ® System – an e-health treatment system for women who suffer Stress Urinary Incontinence. This affects 1 in 3 women worldwide and is mostly caused by trauma to the pelvic floor muscles as a result of pregnancy, childbirth and menopause. PeriCoach comprises a device, web portal and smartphone app. The device evaluates activity in pelvic floor muscles. This information is transmitted to a smartphone app and can be loaded to a cloud database where physicians can monitor patient progress via web portal. This novel system enables physicians to remotely determine if a woman is performing her pelvic floor exercises and if these are improving her condition. Strengthening of the pelvic floor muscles can also potentially improve sexual sensation or satisfaction and orgasm potential in some women. PeriCoach has regulatory clearance in Australia and has CE mark and USFDA 510(k) clearance for the treatment of urinary incontinence. PeriCoach also has clearance in Australia, and CE Marking in Europe for the treatment of mild to moderate pelvic organ prolapse, a condition that affects up to 1 in 5 women during their lifetime. Analytica is also the developer of the Enhanced Infusion System (EIS), a combination of patented technologies developed under the project names AutoStart and AutoFlush. The EIS is a simple and inexpensive IV add-in technology to reduce nursing monitoring costs, reduce embolism risk, improve infection control, and automatically restart flow after medication delivery during intravenous fluid infusion.