Monitoring women throughout the course of pregnancy is a vital part of pregnancy management and crucial for the safety of both the mother and child.
The medical community is of the view that that the best indicator of foetal wellbeing is heart rate monitoring.
Today, foetal heart monitoring is a standard part of every pregnancy check-up. Sometimes, it is combined with additional tests to determine whether the pregnancy is high-risk or has potential complications. Foetal heart rate can further assist and provide an indication for an onset of premature labour.
However, prenatal care in modern society has become a complex regimen of at least 14 clinical appointments - many more if the pregnancy is high-risk - often only to confirm the expectant mother and her foetus are healthy.
Current technologies are expensive, bulky, limited and designed for professional use only.
The result is that pregnancy monitoring almost always requires a clinical setting, a nurse or doctor to conduct the measurement and the careful attention of a trained obstetrician-gynaecologist for a subjective, time-consuming, visual interpretation of FHR pattern recognition and assessment.
Expectant mothers pay a high price for unnecessary appointments in the form of time away from work and associated lost wages or personal days, child care costs, and so on.
HeraMED was incorporated in 2011 in Israel as a technology start-up developing innovative, connected pregnancy monitoring solutions.
Its first commercial product, HeraBEAT™ is a medical-grade, clinically validated foetal heart rate monitor mainly for home use.
HeraBEAT is simple to use and wirelessly communicates with any smartphone (iOS/Android) via Bluetooth Low Energy.
HeraMED offers comprehensive hardware solutions supported by software applications focused on foetal well-being and parental assurance.
HeraBEAT is accurate, user-friendly, safe and affordable. It combines unique sensing technology, electronic hardware, embedded software, smart algorithms and a mobile app to advance foetal health and prenatal maternal care. HeraBEAT is the subject of several pending patents.
Led by a team of medical professionals, skilled engineers, product developers and marketing experts, HeraMED Israel has set out to redefine the pregnancy experience.
Non Executive Chairman Dr Ron Weinberger is the former Executive Director and Chief Executive Officer of Nanosonics Limited (ASX: NAN), a $950 million market cap healthcare company, and has over 20 years’ experience in developing and commercialising medical devices.
HeraMED’s aim is to become a world leader in innovative, accessible, technology-driven products which change the way practitioners and expectant mothers approach and monitor the miracle of pregnancy.
HeraMED’s products have the potential to impact the lives of many people.
HeraMED Limited (ACN 626 295 314) is offering up to 30,000,000 shares at an issue price of $0.20 each to raise up to $6 million, with a minimum subscription requirement to raise at least $5 million.
At 20c per share, the market capitalisation on completion of the offer will be $17,240,000 assuming the minimum subscription of $5 million is raised, and $19,240,000 assuming the maximum of $6 million is raised.
Raisebook is accepting bids of between $2,000 (minimum) and $5,000 (maximum) per entity registered with Raisebook.
The offer of the securities are made in the Disclosure Document, a copy of this document can be obtained by clicking on the "ACCESS DISCLOSURE DOCUMENT" button on this page.
Anyone who wants to acquire the securities will need to complete the application form that will be in or will accompany the Disclosure Document.
Before making an investment decision, potential investors should read the Disclosure Document entirely, and seek professional financial advice.
Investors should note that the company is in the early stages of its growth. Accordingly, any investment made in the company should be considered highly speculative.
|Min. Subscription||Max. Subscription|
|Shares under Public Offer||25,000,000||29%||30,000,000||32.89%|
|Shares to Vendors||37,400,000||43.4%||37,400,000||41.01%|
|Shares to Corp Advisers||6,600,000||7.7%||6,600,000||7.24%|
|Shares to Noteholders||17,200,000||20%||17,200,000||18.86%|
|Deferred Consideration Shares to Vendors||19,550,000||14.72%||19,550,000||14.19%|
|Deferred Consideration Shares to Corporate Advisers||3,450,000||2.6%||3,450,000||2.50%|
|New Options to Noteholders||8,600,000||6.5%||8,600,000||6.24%|
|New Options to Lead Manager||7,500,000||5.6%||7,500,000||5.44%|
|New Options to Executive Directors||7,500,000||5.6%||7,500,000||5.44%|
|Fully Diluted Share Capital||132,800,000||100%||137,800,000||100%|
|Closing Date for the Offer (from Disclosure Document)||16 November 2018|
|Issue of Securities under the Offers||29 November 2018|
|Completion of the Acquisition||29 November 2018|
|Holding statements sent to Shareholders||29 November 2018|
|Shares commence trading on the ASX||4 December 2018|
More about HeraBEAT™
HeraBEAT is a compact, smart, connected, medical grade, self-operated ultrasound doppler device for monitoring foetal heartbeat. It is self-operated by a pregnant woman and transmits and displays data on her smartphone.
A pregnant woman attaches HeraBEAT to her abdomen to monitor FHR in the comfort and privacy of her home. The multi-sensor unit communicates wirelessly through a Bluetooth low-energy connection with any smartphone, where the results are presented on a clear and user-friendly display.
HeraBEAT automatically differentiates between foetal and maternal heart signals and filters out other noises and interferences. HeraBEAT integrates HeraMED Israel’s proprietary ultrasound doppler technology which has been optimised for home use, with compact design and cost-effectiveness while maintaining rigorous medical grade quality and accuracy.
HeraBEAT’s smartphone app provides step-by-step guidance which helps the expecting mother find an optimal location on her abdomen for the sensor. The device then captures FHR signals, filters, sorts and categorises the collected sounds and confirms that their pattern, intensity and other characteristics match those of a typical FHR signal.
HeraBEAT includes an optical sensor which uses photoplethysmography (optics which illuminates the skin and measure changes in light absorption) to capture maternal heart signals which are evaluated by an embedded algorithm to prevent confusion or cross talk between foetal and maternal heart sounds. This proprietary technology allows HeraBEAT to avoid the interference, distracting noises and confusion which plague other self-operated foetal monitors.
Once the FHR signal is captured, HeraBEAT automatically switches from search mode to track and measure mode where it collects data for audio and visual presentation. The collected data is stored on the expecting mother’s smartphone where it can be easily shared with a medical professional for further analysis and consultation.
The HeraBEAT ecosystem solution:
HeraBEAT has been approved for use in the EU by the British Standards Institute (BSI) and has received CE Class IIa certification as a home use medical device for over-the-counter sales. Its accuracy, reliability and safety have been proven through rigorous laboratory testing, clinical trials and extensive field use.
HeraBEAT is further certified by the Israeli Ministry of Health (AMAR). HeraMED Israel is certified by BSI as ISO13485:2016 compliant and operates according to the strictest levels of quality assurance and standardisation which the medical industry requires.
HeraMED has already started preparations for its 510K FDA submission. HeraBEAT has been defined and categorised as a class II device; approved for home use with the approval of a physician.
- HeraBEAT is uniquely positioned as the only medical grade, foetal monitor designed to meet the needs of self-monitoring home users. Only HeraBEAT interfaces directly and wirelessly with a user’s smartphone to share data, provide guidance, display data and use phone-based data storage capabilities. An expectant mother can easily and quickly use her smartphone to send collected data to a health care professional who can provide instructions, information or just assurance.
- HeraBEAT’s compact construction, sophisticated technology and reliance on the smartphone’s display and processing power make it highly accurate, comparable only with the most professional, expensive hospital equipment yet also price-competitive even with low-end devices.
- Its filtering technology and ease-of-use provide results comparable to more expensive devices which require extensive training and experience. HeraBEAT’s proprietary algorithms have a critical function as part of the embedded software, making the device’s readings robust and stable even in earlier gestational stages, and they are a crucial part of HeraMED’s innovation.
- In developed markets, HeraBEAT is a complementary solution targeted at millennial mothers; empowering them and unleashing control over their pregnancy. In emerging markets, HeraBEAT provides an affordable, hospital-grade solution to under-resourced populations.
Other Products and Services in Development
Service model and cloud based support
HeraMED is developing a service-based model leveraged predominantly by the automated transmission of collected data but expanding beyond this.
In this premium model, the expectant mother would send her collected data to a remote, cloud-based server and from there to a healthcare provider who will be able to remotely monitor and assess the measurements.
Orion – AI powered pregnancy monitoring
HeraMED conceived its “Orion” project which is currently being developed in cooperation with Mayo.
Orion is the result of HeraMED’s latest research achievements in pregnancy monitoring analysis.
HeraMED is applying the multiple analytical capacities of big-data along with machine learning functionalities to develop a superior alternative to the current pregnancy monitoring which requires human intervention by a trained obstetrician-gynaecologist for a subjective, time-consuming, visual analysis of FHR pattern recognition and wellbeing assessment.
HerMED considers that Orion could be a superior alternative to current manual, paper and expert-based analysis.
Purposes of the Public Offer
The principal purposes of the Public Offer are to:
- Accelerate the commercialisation of the HeraBEAT product;
- Expand sales through signing of additional distribution agreements in UK, Germany and other European countries, as well as India and other regions;
- Exploit the opportunities under the Cooperation Agreement;
- Accelerate the development of Company’s next generation Orion solution.
- Expand and establish further production lines whether inside or outside of Israel;
- Prepare FDA and TGA regulatory filings for HeraBEAT;
- Provide funding for the purposes set out in Section 1.6 of the Disclosure Document;
- Complete the Acquisition;
- Facilitate HeraMED’s listing on the ASX;
- Provide HeraMED with access to equity capital markets for future funding needs; and
- Enhance the public and financial profile of HeraMED to facilitate its growth.