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Analytica Announces Expansion of Enhanced Infusion System into Middle East

  • Analytica signs agreement with Marwa for distribution, marketing and sales of the Enhanced Infusion System (EIS) in Egypt, Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Saudi Arabia and United Arab Emirates.
  • Patented IV add–in infusion system reduces infection and embolism risk and saves medical staff time for an overall lower total cost than existing equipment and practices.

BRISBANE, Australia, April 27, 2021 (GLOBE NEWSWIRE) — Analytica Limited (ASX:ALT), the Australian developer of the Enhanced Infusion System (EIS) and PeriCoach pelvic floor exercise system for the treatment of stress urinary incontinence, has entered into an agreement with Marwa's Office for Export & Import Medical Supplies (Marwa) to distribute, market and sell the EIS to hospital systems in Egypt, Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Saudi Arabia and United Arab Emirates.

The EIS technology was developed by Analytica under the project names AutoStart and AutoFlush and has been sold in Australia with the trade name FirstFlow, under limited license. EIS combines the AutoStart and AutoFlush patented technologies into a simple and inexpensive solution.

The patented float system automatically restarts IV fluid flow following medication delivery, thereby saving healthcare workers' time, reducing hospital costs and preventing the adverse events associated with air embolism and failure of Peripheral Intravenous Catheters (PIVC). The EIS reacts immediately, silently and without intervention or programming. It can be retrofitted to any existing infusion system design and can work in harmony with and improve the capability of any infusion pump or "bag' infusion system, regardless of sophistication.

Use of the EIS uniquely allows a completely closed infusion system, with integrity achieved by reducing the interactions believed to cause mechanical and vascular complications as well as good flushing and/or patency practice.

The EIS has an Australian TGA ARTG registration and USFDA 510(k) clearance. It is fully compliant with ISO 8536 infusion system and other relevant standards.

The EIS can markedly reduce legal risks by addressing multiple factors that can impact patients, clinicians and hospitals, including:

  • Air Embolism "" The EIS has a large and heavy float valve ensuring complete, long–term seal. The unique float maintains a seal even at extreme angles (up to 60 degrees from horizontal), making the device usable in ambulances, retrieval and military situations and reducing the risk of mortality and morbidity associated with air embolism.
  • Open/Closed Delivery System "" The needle–free access port is the only entry point, with only one syringe necessary per medication event. Using the existing 1L IV bag means replacement is less frequent than 100mL pre–mix bags, saving time and money and reducing the risk of contamination and infection.
  • Syringe Flush "" This feature eliminates the requirement to introduce an additional flushing syringe and bolus. Flushing prevents interactions between incompatible fluids/medications, thus reducing the risk of cross contamination and strengthening infection control.
  • Catheter Flush "" This feature reduces the risk of PIVC failure with the automatic, immediate restart of IV flow after medication delivery, which allows continuous maintenance flow to the flush line and catheter. This also maintains catheter patency by preventing internal luminal occlusion.
  • Medication Dilution "" The Interrupted Therapy feature allows the introduction of medication through EIS to accurately measure IV fluid mix rather than 3–way valve and bags.
  • Infection Risk "" Observational studies demonstrate high incidence of non–conformance to hand washing and flushing protocol. EIS limits access and infection opportunity.
  • Flushing pressure "" Bolus flush of catheter may vary based on syringe size and pressure. The proprietary float design ensures constant flushing pressure, reducing the risk of PIVC failure.

Given the health and legal risk–reduction features of the EIS, the home–based hospital care market represents a growth opportunity globally. The EIS is compact, rugged and does not require a pump or energy source, which makes it suitable for retrieval, military and third world needs without compromising risk.

To view a video about the operation and features of the EIS, please click here.

Marwa's Principal has extensive experience with the Egyptian health system, as a consultant and undersecretary of health for the Egyptian Health Insurance Organization Clinics (HIO) as well as leadership positions in the Egyptian Ministry of Health.

"Marwa has presented a compelling opportunity with experienced professionals to take Analytica's Enhanced Infusion System (EIS) into a large and growing market in the Middle East," said Dr. Michael Monsour, Chairman of Analytica Ltd. "We look forward to working with Marwa to expand the usage of our unique EIS technology."

For more information about Analytica and the Enhanced Infusion System, visit www.AnalyticaMedical.com

For investor or business inquiries, please contact: investorrelations@analyticamedical.com

For media inquiries, please contact: Annie Starr, astarr@6degreespr.com

About Analytica Limited

Analytica is a product development and commercialisation company based in Brisbane, Australia that is focussed on Class I and II medical device products.

Analytica is 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 decrease nursing monitoring costs, reduce embolism risk, improve infection control, and automatically restart flow after medication delivery during intravenous fluid infusion.

Analytica is also the manufacturer of 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 because of pregnancy, childbirth and menopause.

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Trademark of ICU Medical Australia.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d7af8a18–4b05–4cae–a8bb–71d578ab84fc


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Analytica Announces Expansion of PeriCoach® Pelvic Health Solution into China

  • PeriCoach will be distributed through extensive network of postpartum care centres, hospitals, pharmacy chains, and online platforms serviced by the joint venture partners.
  • Joint venture will also leverage extensive network of over 30,000 clinicians in 100 cities to distribute PeriCoach in China.
  • Agreement builds upon Analytica's existing Middle East distribution partnership to facilitate growth and manufacturing of PeriCoach in international markets.
  • Clinical trial confirms unsupervised PeriCoach treatment is on par with in–clinic pelvic floor physical therapy for treating stress urinary incontinence, at a much lower cost.
  • PeriCoach provides cost–effective solution to improve quality of life, ease burden of care and reduce incontinence pad expenditure in postpartum and aging populations.

BRISBANE, Australia, March 31, 2021 (GLOBE NEWSWIRE) — 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, CEO
investorrelations@analyticamedical.com


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