ALT Analytica Limited

Analytica Announces Expansion of PeriCoach® Pelvic Health Solution into China
Analytica Limited (ASX:ALT), the Australian manufacturer of the PeriCoach pelvic floor exercise system for the treatment of stress urinary incontinence, has entered into a joint venture (JV) agreement to manufacture, distribute and market the system in China, Macau, Hong Kong and Taiwan. Analytica partners with Hebei NACOL Bio-Technology Co., Ltd (Nacol) and Shijiazhuang Biosphere Pty Ltd (Biosphere), based in Hebei Province.

Nacol key shareholders include two highly experienced Chinese medical manufacturing and distribution companies, Heibei Aineng Biological Technology Co., Ltd and Shijiazhuang YST Medical Supplies Co. Ltd.

The JV will register PeriCoach with the Chinese Food and Drug Administration (CFDA) as a class II medical device. With CFDA clearance, PeriCoach can become a prescription treatment, initially covering the hospital network in the North China area.

Expansion into China will support the distribution of PeriCoach to both the rapidly growing postpartum rehabilitation market and the early-stage preventative senior market, as one in three women worldwide suffer from stress urinary incontinence. The agreement furthers Analytica’s strategy to bring PeriCoach into global markets, building upon growth in the Middle East with partner Motion Egypt LLC, and pursuit of other partners in North America, Europe and Southeast Asia outside of China.

PeriCoach is comprised of a medical device, smartphone app and the PeriVault, the largest pelvic floor muscle exercise database in the world. PeriCoach includes biofeedback technique guidance technology that helps women correctly perform pelvic floor exercises, also known as “Kegel” exercises, while the device and app are being used. Real-world data from PeriCoach patients1 shows that nearly 60% of women do not know how to engage these hidden muscles when they first use the device. PeriCoach technique guidance means “Kegels” can be done correctly and confidently by any woman in the privacy of her own home.

A recent independent, peer-reviewed, randomized controlled clinical trial2,3 performed at the University of New Mexico and published in the Journal of Female Pelvic Medicine & Reconstructive Surgery concluded that the PeriCoach biofeedback system, with no formal instruction, is non-inferior and on par with in-clinic pelvic floor physical therapy in a pelvic floor centre of excellence, making this system the most cost-effective4 form of treatment for stress and mixed urinary incontinence. Watch Video Here.

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/1d7fc4b0-f47e-4dae-819d-b5db59eb359f

Currently manufactured in Australia, the new PeriCoach manufacturing line for the Chinese market only is located in the Shijiazhuang Free Trade Zone and will be listed as one of the major projects in the free trade zone and high technology zone.

PeriCoach will be distributed through the existing extensive network of hospitals and postpartum organisations serviced by the JV partners. The JV partners have collaborated with a leading postpartum care service platform in China with coverage of 100 cities and more than 30,000 clinical professionals.

In China, 15 million babies are born each year.5 With the rapid development of the modern economy, the postpartum rehabilitation industry has grown to 3.95bn yuan pa (US$608M) in 2018, with a compound annual growth rate of 43.9%.6

Furthermore, China, as with Western countries, has an aging population among which 31% of older women experience urinary incontinence, but only 25% of those currently seek medical assistance.7 The JV sees a large public health opportunity for conservative treatment of incontinence in women aged 50-70 years, reducing the quality-of-life impact along with the longer-term economic burden of aged-care.

The CEO of Aineng, Mr LanJu Xu, will lead the JV and comments: “We have strong confidence in Analytica’s R&D capabilities and do believe that Analytica and Nacol can take advantage of each parties’ strengths from this Joint Venture and achieve a win-win situation. Bringing together Analytica’s leading technology and Nacol’s extensive industry resources in China, we are looking forward to witnessing PeriCoach enter this huge market.”

Mr Xu has a strong background in medical devices and materials, including a track record of 17 class II medical device approvals and completed clinical trials of two class III medical devices. He is also the Team Lead for Key Research & Development (R&D) Program of the Ministry of Science and Technology in China, which is operated by four leading universities and one of the top three hospitals in China. Additionally, Mr Xu is the lead of the medical material R&D Center in Nankai University.

Analytica Ltd Chairman, Dr Michael Monsour, comments: “Entering the China market with such nimble, experienced operators is a major milestone for Analytica. China is leading the world in recognising the need for effective postpartum care and is facing the challenge of caring for its large aging population by using the PeriCoach system to assist women with managing incontinence. PeriCoach is a proven cost-effective solution that will dramatically improve quality of life and burden of care for women. We look forward to the continued exploration of our strategic options to expand the availability of PeriCoach globally.”

Analytica has recently moved its Australian manufacturing operations and is looking to re-establish online sales in the US, UK/Ireland, Australia and New Zealand in the near future. PeriCoach has USFDA 510(k) clearance, Australian ARTG registration, and CE-marking.

For more information, please contact: investorrelations@analyticamedical.com

For more information about the PeriCoach System, visit: www.PeriCoach.com

For more information about Analytica, visit: www.AnalyticaMedical.com

References

1. Data on file.
2. Analytica Announcement: https://www.analyticamedical.com/downloads/2020/20201120-ASX-ALT-UoNM-FPMRS.pdf
3. Barnes, Kara Lauren MD*; Cichowski, Sara MD, FACOG, FPMRS†; Komesu, Yuko M. MD, FACOG, FPMRS*; Jeppson, Peter C. MD, FACOG, FASC, FPMRS*; McGuire, Brenna MD*; Ninivaggio, Cara S. MD, FPMRS*; Dunivan, Gena C. MD, FACOG, FPMRS* Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence, Female Pelvic Medicine & Reconstructive Surgery: November 16, 2020 - Volume Publish Ahead of Print - Issue - doi: 10.1097/SPV.0000000000000993: https://journals.lww.com/jpelvicsurgery/Abstract/9000/Home_Biofeedback_Versus_Physical_Therapy_for.99288.aspx
4. White Paper: Health Economics of PeriCoach for Management of Stress Urinary Incontinence: https://www.analyticamedical.com/downloads/2020/20201124-ASX-ALT-deWinterWhitepaper.pdf
5. National Bureau of Statistics of China: https://data.stats.gov.cn/easyquery.htm?cn=C01&zb=A03060D&sj=2020
6. Compound Growth: Overview of China's postpartum rehabilitation equipment industry in 2019 (report code: 19RI0824) by leadleo Academy
7. Che, X. Y., Wu, S. L., Chen, Y. K., Huang, Y. B., & Yang, Y. (2019). Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences, 51(4), 706–710. https://doi.org/10.19723/j.issn.1671-167X.2019.04.019: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7433489/

About Analytica Limited

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 for urinary incontinence in Australia and has CE mark and USFDA 510(k) clearance.

PeriCoach also has clearance in Australia, and CE Marking in Europe for the treatment of pelvic organ prolapse, a condition that affects up to 1 in 5 women during their lifetime.

Contact:Geoff Daly, CEOinvestorrelations@analyticamedical.com