By: David Groberman
CEO & Founder

HeraMED

HeraMED developed a unique, innovative product, that inspires confidence and peace of mind for pregnant women. Our solution, enables pregnancy monitoring and tracking the wellbeing of the fetus, in a reliable, simple and safe manner, anytime, anywhere. The technology, with 13 patents pending, has been proven effective, safe and accurate in extensive c

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Type: Equity  
Stage: Seed +
Category: Healthcare
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  • Campaign Highlights
  • Pitch
  • Team
  • Investors 34
  • Updates

Campaign Highlights

Breakthrough Innovative Technology

Pregnancy is one of the most exciting, complex and lifechanging events for women and their families. Despite technological advancements that characterize the healthcare industry, pregnancy monitoring has remained nearly unchanged since the 60’s.
Monitoring is available only in medical facilities, and require operation by trained professional medical staff. For many women, even in developed countries, quick access to real time fetal monitoring may be challenging and expensive, while in other parts of the world – it is practically impossible.

HeraBEAT is the company’s debut product, combining breakthrough fetal monitoring technologies, at an accuracy level akin the professional gold-standard systems used in hospitals.

These technologies provide the pregnant mother and her family peace of mind throughout the pregnancy stages, and may allow for early detection of potential complications, at a family-affordable price, without leaving the house.

Market Potential

There are 140 million births in the world every year. The pregnancy market is estimated at hundreds of billons of dollars per year, with sharp growth of 15-20% YOY.

HeraMED’s innovative technology will be made accessible to every home, with vast potential to penetrate the market.

 

Joining the moment before takeoff

HeraMED’s technology has jumped over many meaningful hurdles, and is equipped today with Medical CE approval that allows it to market its products throughout the EU and in many other countries, such as: Canada, India, Hong-Kong, Singapore, Australia and South Africa.  

Additionally, the company received the Israeli Ministry of Health approval (‘AMAR’), that paves the way to market HeraBEAT in Israel.
HeraMED is preparing to obtain the FDA approval during 2018.
The company has completed extensive clinical trials and pilots that prove the technology is ripe and ready create a dramatic impact on the pregnancy market.

 

A winning team of doctors, pregnancy experts, technology and marketing power

HeraMED’s development team is comprised of serial entrepreneurs, leading engineers, technology and regulation experts, senior doctors, product development and manufacturing experts, and proven track record in business development and marketing. 

 

Groundbreaking product

In the modern world in general, and among millennials in particular, women are interested in taking ownership of the health of their pregnancy, and managing it on their terms. They wish to be involved and engaged, to bond with their baby and feel connected to their pregnancy, in a simple and convenient way, without wasting money or time running around, commuting, and waiting in line. HeraBEAT combines an advanced smartphone-based user-friendly UI, with a sleek ergonomic and compact design – allowing for an easy-to-use solution that is reliable, safe and affordable for women and their families.?

Pitch

The Idea

The Problem

Pregnancy is one of the most prominent and meaningful events in life, with an unparalleled impact on the physical, emotional and socioeconomic health of women and their families. Monitoring the fetus’ physiological attributes is a genuine need throughout the pregnancy, and at times – crucial, in particular at the beginning and end stages of the pregnancy, as well as cases where the pregnancy is defined as a high-risk.
Despite technological advancements that characterize the medical ecosystem, existing solutions for pregnancy monitoring have remained nearly unchanged since the 60’s. Monitoring is available today primarily in medical facilities such as hospitals and clinics, and the pregnant mother is required to commute, wait in long lines, pay for the visit and service. Beyond this, in many locations women don’t have appropriate access to real-time fetal monitoring, which could result in complications and even tragedies.

 

The Solution

HeraMED developed a unique, innovative and revolutionary technology which allows a reliable, accurate and safe, home based pregnancy monitoring at a family affordable price. HeraBEAT is a comprehensive pregnancy monitoring solution which combines advanced sensing technologies with high-level quality design, safety and accuracy at the highest level of the medical requirements.

HeraBEAT was designed from the ground up to be used at home by the un-experienced expecting mother, thus requires no prior knowledge or training. The solution further integrates advanced Smartphone-based user interface with a straight forward, ergonomic and functional design.

HeraBEAT incorporates multiple unique and proprietary sensors developed in house by the company’s R&D team:

  • Innovative FHR transducer – accurately measures the Fetal Heart Rate (FHR) based on optimized and fine-tuned Ultrasound Doppler technology
  • An array of optical sensors (PPG) – for Maternal Heart Rate (MHR) measurement and to prevent any confusing or cross-talk between Maternal and Fetal Heartrate.
  • Motion detection sensors – measuring performance levels and providing real-time feedback and guidance for the user in a step-by-step approach.

 

How does it work?

The multi-sensor unit continuously measures the physio-logical signals extracted from the expecting mother’s abdomen and sends the data wirelessly to the native iOS or Android App. The software implements a unique signal processing algorithm that serves several goals:

  • Filtering and amplifying the Fetal Heart Rate signals.
  • Separation and cross-talk prevention of the Fetal and Maternal Heart Rate signals.
  • Neutralization, filtering and eliminating irrelevant abdominal and digestion or any other “noises”. 

The data is then transmitted via BLE – Bluetooth Low Energy to the smartphone where it is further analyzed, sorted and stored.

The unique user interface presents the results to the user in a simple and clear manner which gives a straight forward understanding regarding the wellbeing and status of the fetus.

The data can be digitally shared at the press of a button via a medical cloud (HIPAA compliant) with any authorized person or entity – a physician, a midwife or a call center (even a loved one or a family member) and immediately reflect the status of the fetus.

In cases of potential risk of fetal distress the expecting mother can receive an immediate and actionable response which might make the difference and may potentially save lives.

 

HeraMED submitted 13 patents to comprehensively protect the different aspects and innovation of our solutions.

 

The company holds a medical ISO 13485 quality system and HeraBEAT was approved by one of the strictest notified bodies BSI (British Standard Institute) as a Class IIa medical device.

These approvals and certifications allow HeraMED to market its products throughout the EU as well as additional geographies.

Additionally, the company received the Israeli Ministry of Health approval (‘AMAR’), for marketing HeraBEAT in Israel.
HeraMED is preparing to obtain the FDA approval during 2018.
The company has successfully completed extensive clinical trials and verified that the technology is ready to be launched to the market.

 

The Market

There are approximately 140 million pregnancies annually worldwide, with a constant and stable growth. HeraMED is targeting every one of them with an innovative solution that has the potential to empower women, impact, expand the pregnancy experience and even save lives.

The total estimated pregnancy-related market is valued at hundreds of billions of dollars annually.

Cross-referenced studies and market surveys indicate that the pregnancy monitoring market is valued at 3 billion Dollars and projected to rise at 7% CAGR.

HeraBEAT’s specific market of innovative and advanced home pregnancy monitoring is still considered a blue ocean and the estimations indicate its value at 1 billion dollars a year.

Since it is a flourishing yet very innovative and young market, that shares characteristics and parallel lines with the Wearables market, estimations are that the growth rates are expected to be at 15-20% CAGR.

 

 

World and US market facts

Macro:

  • In 2025 remote monitoring could create as much as $1.1 trillion a year in value by improving healthcare outcomes [Mckinsey & co]
  • Fast growing medical wearables market - The demand for wearable medical devices and remote patient monitoring systems is increasing, and the global market is expected to reach $612 billion in the next eight years; [2016, Grand View Research]
  • The cumulative annual cost related to childbirth in US alone is well over $50 billion [ACOG / The New York Times, 2013]

 

Micro:

  • Out-of-pocket costs rising X4 from 2004 to 2010 – Women with insurance pay an average of ~ $3400 [The New York Times, 2013]
  • In the US –  Insurance covers less than 10 total clinic visits through the course of pregnancy, thus the average American woman makes only 2 visits to a clinic for pregnancy monitoring, consensually deficient, among the lowest in OECD
  • “There's a severe shortage of Obstetricians, nearly half of US counties have no OB/Gyn’s, 56% have no Midwives” [ACOG, 2016]
  • While the average cost of a healthy baby born at full-term is ~ $3,000, the average cost for a premature baby is ~ $41,500;
    If the baby is born at 26 weeks, the costs rise to as much as $250,000.

 

Go To Market

The company focuses on two different case studies:

  • Normal, low risk pregnancies – In our modern society and specifically when considering the “Millennials”, women are eager to take more responsibility and manage their health and the course of their pregnancy. They strive to be able to connect and bond with their fetus and have the ability to understand the wellbeing of the fetus without the hassle and discomfort, and the waste of time and money associated with attending a monitoring session at the doctor’s office.
  • High risk pregnancies – women with a high-risk pregnancy (over 15% in developed countries) have a clear, immediate and genuine need to become early adopters and embrace new technologies enabling their pregnancies to be managed and monitored in a much easier, simple and safe manner.
    Typically, high risk pregnant women are required to frequently arrive at the hospital or clinic when the main purpose of the visit is to conduct a relatively short fetal monitoring session. Beyond the hassle and discomfort as well as the immense waste of time and work days, the actual arrival to a usually germ-rich environment is a clear and unnecessary threat that risks their own health as well as their pregnancy.

 

Track Record

Agreements

The company has made its primary goal to become an innovative and dominant player in the home pregnancy monitoring market. The company already signed several meaningful agreements such as:

  • Israel – a signed agreement with an Israeli and international distributer with specific knowledge and proven track record in marketing and sales of similar products.
  • US – a comprehensive revolutionary clinical trial lead by one of the most acknowledged healthcare systems in the industry, was defined and agreed. This will further be used to provide the necessary data to be submitted to the FDA. The company is currently wrapping and closing the legal and commercial details of the agreement.
  • Germany – advanced discussions with several prominent distributers as well as leading medical centers.
  • Canada – advanced discussions with 2 major retail and online networks – Best Buy and Walmart.
  • UK - advanced discussions with several prominent distributers as well as leading medical centers, NHS included.
  • Turkey – HeraBEAT was chosen by the ministry of health to be the solution for a nationwide mother and child service, expected to expand to an estimated 100,000 end points.
  • India – similar to Turkey – HeraBEAT was chosen as the solution to allow remote monitoring for rural areas.

 

Sales

  • HeraMED generated preliminary revenues
  • HeraMED successfully finished the first manufacturing batch of several hundreds
  • HeraMED is moving forward to the next stage to produce thousands of units

 

Clinical Tests

The company successfully concluded several clinical trials and pilots including dozens of pregnant women. The results have clearly proven the maturity and readiness of the technology, which has been further optimised and fine-tuned to mass production. Further, a set of bench and clinical trials showed very high level of accuracy and reliability of the HearBEAT device as compared to the industry’s gold standard - hospital monitors such as Philips and GE - at a fraction of the price.

 

Medical Approvals

  • HeraMED received a medical ISO 13485 by BSI (British Standards Institute)
  • HeraBEAT is class IIa medical CE approved.
  • HeraBEAT is AMAR (Israeli Ministry of Health) approved
  • FDA submission is planned for 2018 

 

Opportunities

  • HeraMED is about to sign several extensive agreements for commercial and R&D cooperation with major US leading healthcare entities.
  • HeraMED is planning a strategic penetration to the MEDC (More Economically Developed Countries) including EU, US and others.
  • In parallel, HeraMED plans to start evaluating and looking for penetration strategies to the emerging markets, with China and India in focus.

 

Competitors

Competition is split into two major sectors:

  • Professional solutions targeted exclusively at hospitals and clinics – These are high-end, high-quality solutions, however not suitable at all for home use. They require high level of experience and professionalism and regulation explicitly limits use to clinical settings. The cost of such devices starts at $1000-2000 and can get as high as $8,000-10,000
  • Low-end “toy” solutions – mostly very low-quality devices made in China and positioned as a “bonding” tool and no more. The focus of these solutions is low price while accuracy and medical reliability is not even a claim. Though we should consider it as presenting some form of competition, they are considered no more than a “Life style” product.

 

Competitor Analysis

Exit Strategy

Business model

Three phase action plan

  1. Phase A – Initiate sales
    • Build HeraBEAT Brand Credibility as the most reliable, and safe go-to product for pregnant mothers.
    • Obtaining stamp of approval through cooperation with medical brand names:
      Specialty hospitals | KOL physicians | Healthcare systems | Tele-health providers
    • Start sales through the above channels in parallel with commerce mid-size B2B2C,
      Consumer Electronics, and Mother & Baby retailers.
    • Focus on online and “guerrilla” marketing, social networks and sales via local small to medium size partners and distributors.
    • Sales goal for first year 7,000-8,000 devices.
       
  2. Phase B – start scaling sales
    • Expanding sales activities by cooperating with substantial distributors with international footprint.
    • The numbers will grow with the commercial heavyweights as sales gain momentum and scale, and the spillover to HeraMED’s own online channel.
    • Penetration to speciality brick and mortar networks and retailers.
    • Pursuing Pharma companies’ cooperation, complementing the “beyond the pill” trend.
    • Relentlessly expanding the cooperation with the medical community with the goal of proving the medical and financial advantage of the solution.
    • Sales goal for second year  25,000-30,000 devices.
      ?
  3. Stage 3 – Boost Sales
    • As HMOs, insurance companies and employers provide reimbursement, sales are expected to rise significantly.
    • In Israel, most of the leading HMOs already offer 75% reimbursement.
    • This will reduce any remaining cost barriers for mothers.

 

 

Exit Strategy

Next Steps

 

Use of Proceeds

See budget file.

 

Team

David Groberman
CEO and Founder 
Biography
David been developing multi-disciplinary medical devices for the last 15 years. Prior to founding HeraMED, spent over 8 years as Co-Founder and CTO at Meytar R&D – one of the leading R&D service provider firms in Israel. Some of Meytar’s most prominent clients are GE Healthcare, Philips Healthcare, Bayer, Teva, ST Electronics, HP-Indigo, Orbotech, Stratasys (Objet), Mazor Robotics, Pluristem and many others. During that time, David gained extensive, hands-on knowledge and capabilities, leading some of the most challenging projects in the field of multi-disciplinary medical and high-tech devices, ranging from implants to invasive mechanical, electro-mechanical and opto-mechanical instruments, surgical apparatuses and applicators, monitoring, diagnosis and scanning equipment. David is an alumnus of the IDF elite computer science unit MAMRAM. David holds B.Sc. cum laude from the faculty of Mechanical and bio-medical engineering in TAU.

  • Founder
Dr. Yosef Tovbin
Chief Medical Advisor 
Biography
Dr. Tovbin is currently Head of Labor and Delivery Ward at Assaf Harofeh Medical center one f the largest hospitals in Israel with over 10K births a year; He is a specialist in obstetrics, gynecology, infertility and ultrasound. A member of the Israeli Society of Obstetrics and Gynecology, the Israeli Society of Ultrasound in Obstetrics and Gynecology and the International Society of Ultrasound in Obstetrics and Gynecology – ISUOG. Dr. Tovbin graduated from the Sackler Faculty of Medicine - TAU.

Michael Nenner
VP R&D
Biography
Michael brings a combination of professionalism and creativity. Coming from a diverse background of serving as a high ranked marine officer in the IDF’s navy submarine flotilla, and an arts and music enthusiasts as a professional drummer. During his service in the IDF Michael became an expert in advanced weapons technology and specifically focused in Sonar technology. Michael holds a B.Sc in Engineering at TAU, and has been working in R&D and management of Multi-Disciplinary medical and monitoring devices for 4 years before joining HeraMED.

Dganit Littinsky
Director of Regulation and Quality
Biography
Dganit has Over 14 years of experience in Regulatory Affairs and Quality Assurance in medical device companies. Expertise in ISO13485 and worldwide regulatory submissions including CE & FDA.Prior to joining HeraMED Ltd., Dganit served as VP RA & QA at Hip Hope Technologies Ltd., a company specializing in medical wearable protective devices for the elderly. and at Pollogen Ltd., a company specializing in medical and aesthetic devices for variable dermatological treatments. Dganit also held QA and RA management position at Radiancy. Dganit holds a B.Sc. in Materials science engineering, BGU.

Sivan Barnea
Chief Commercial Officer
Biography
Sivan is a seasoned Business and Marketing leader with proven track record of high impact negotiations of multi-million dollar deals and game-changing initiatives, collaborative vendor partner and customer management, strategy development, product management, leading new product roll out, generating revenue, and reducing costs. Known for unique blend of strategic thinking with knack for meticulous execution. Energetic, creative and passionate, with extensive work experience spanning B2B and B2C products and companies, in both large organizations and startups, complemented by an MBA from Kellogg and a BSc in engineering.

Prof. Shmuel Einav
Chief Scientific Advisor
Biography
Prof. Einav is a world-distinguished expert in the field of biomedical engineering and specifically cardiovascular circulatory system. He is currently a University Research Professor at the State University of New York at Stony Brook and the Co-Director of their Center of Excellence. He is best known for his studies on blood flow through heart valves, coronary circulation, blood-tissue interaction, and flow and turbulent characteristics in occluded arteries. Shmuel has been elected as a Fellow of the American Institute for Medical and Biological Engineering (AIMBE), the International Federation for Medical and Biological Engineering, European Alliance for Medical and Biological Engineering & Science, Biomedical Engineering Society and a Fellow of the American Society of Mechanical Engineers (ASME). Prof. Einav is also a Distinguished Scholar in Residence at Caltech – California Institute of Technology. During his tenure at Tel Aviv University, under his supervision, the Department of Biomedical Engineering was established, a Graduate Program in Biomedical Engineering was successfully implemented, and in 2001 the first class of Undergraduate Biomedical Engineering students began its studies. He is the Founding Director of the Slezak Super Center for Cardiac Research and Biomedical Engineering, the Founding Director of the Kodecz Center for Medical Engineering and Physical Sciences, the Founding Director of the Austrian Laboratory for Cardiovascular Flow Dynamics, and the Founding Director of the California Friends Laboratory for Biomedical Computing and Parallel Processing. Prof. Einav has published more than 130 scientific articles, reviews and invited chapters, and a multitude of abstracts in the biomedical engineering, fluid mechanics and medical fields. He is a member of the editorial board of three leading journals. He is the Principal Investigator in a number of research projects and grants, awarded from Israel, Europe and United States sources, including

  • Advisor
Ady Jakubovitz
VP Marketing and Sales
Biography
Experienced serial entrepreneur with a demonstrated history of working and leading sales and marketing tea. He was HP‘s country sales manager and served as Executive VP at Matrix a leading software integration house and iMER Co-founder and CEO. Skilled in Strategic planning, out-of-the-box approach, Entrepreneurship, and Business Development. Strong leadership personality. Ady graduated from Technion - Israel Institute of Technology.

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