Autonomous Defibrillation System: Invention of Dr. Shamir Israel Leibovitz
|Personal Detection and Defibrillation For Sudden Cardiac Death||
Shamir Leibovitz, Founder & CEO
Phone: +972-52-790-3203 or +972-54-537-5565
City: Tel-Aviv, Israel
Sudden Cardiac Death (SCD) is the second leading cause of death (after all cancers combined together) claiming the lives of about 400,000 people in the US alone. Even though it occurs, in most cases, to patients with prior cardiac history, it cannot be predicted in advance. Clinical studies have shown that when symptoms occur, immediate defibrillation is the only way to save the patient’s life. Out of hospital survivability from SCD is only about 5%. This is due to the fact that state of the art solutions are not good enough or available readily enough.
| Dr. Israel Shamir Lebovitz, M.D., F.C.O.G – CEO Dr. Lebovitz is a specialist gynecologist and a seasoned entrepreneur. He is the founder owner and CEO of the Bio-Term startup – the developer of novel therapeutics for the treatment and prevention of pre-term labor and for the induction of labor
Rani Shifron, Business Development, Sales & Marketing – 30 year medical device sales, marketing & business development strategic professional. Launched dozens of products into global markets with billions of $$ in sales to date: Oridion, BreathID, Direx, Medirex and consulted many more
Prof. Zvi Vered, Director Department of Cardiology, Assaf Harofeh, Past President Israel Heart Society
Prof. Fausto J. Pinto, MD, PhD, FESC, FACC, FSCAI, FASA, FASE, President of European Society of Cardiology Professor of Medicine and Cardiology, Senior Fellow of New Westminster College, UK
ü CE approved elements – obtained
ü FDA 510K process – to be initiated upon investment
ü Short time to market
ü Short ROI
ü Product design freeze
ü Pilot studies to be performed shortly
ü Market sizing studies completed
ü Business pilot – in process
ü In discussion with OEM’s and multiple distributors
ü Key opinion leaders chosen for medical advisory board
ü Insurance companies
|A full diagnosis and treatment system including an ECG chest belt attached to the patient, which continuously monitors heart rate and ECG. The integrated proprietary software issues an alert when pre SCD signals are detected thus allowing for the immediate activation of a small format defibrillator, which runs an accurate ECG test of its own prior to administering the electric shock.|
|ECG Chest Belt||Small format mini AED|
|The system can operate in a completely autonomous mode, or can transmit the ECG data to a medical call center which evaluates it and eventually sends a defibrillation command. In addition, it supports the assistance of a care taker, who attaches the mini defibrillator electrodes and operates the system and can talk with the medical call center. The system can also transmit GPS data to enable follow-up treatment by a CPR team.|
Business model: sell system on a monthly usage basis – to be paid within 5 years – (60 payments X $70 = $4,200)
ü Initially through distributors & call centers
ü Later stage through the big OEMs
Market Potential: In the US alone 30M Americans live with CHD, or are at high risk
Seeking an investment of $2 million for completing pilot studies, getting regulatory approvals and launching the product to market in key countries as well as conducting clinical studies with key opinion leaders to influence insurance co’s.
§ Q2 15: Complete software development
§ Q3 15: CE/FDA + manuf. of 1000 units
§ Q4 15: Launch in Israel and the UK
§ Q1 16: Launch in 3 additional countries
§ Q2 16: Reach partnership with key strategic player
US Patent Application Publication, 10/18/2012
Current Business Plan
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The solution consists of a lightweight and comfortable personal monitoring and defibrillation system that is activated in a very short time after occurrence of SCA, and which is independent of the presence of anybody else operating the system.
The system is comprised of 3 modules:
- An ECG sensing module, that is permanently attached to the patient and continuously transmits the data to the defibrillator module. The uniqueness of this module is that it is lightweight, comfortable and suitable for an indefinte period of use.
- The defibrillator module -the main module – that can be either attached to the patient or rest on the charging module – in standby for immediate attachment and activation. This module receives the ECG data in wireless mode, evaluates it and then either applies defibrillation directly or sends the data to a medical call center that eventually sends back a defibrillation command. The module has additional voice communication features and automatic transmission of the location of the patient (to be used by follow-up team summoned to the patient).
- A charging and testing module which charges all batteries and periodically tests the other 2 modules.
The system operation is very flexible, taking into account the patient’s risk level, his or her activity and whereabouts and the optional presensce of an aid-person.
Hospitals and large clinics are of course equipped with all necessary resuscitation modalities.Patients recognized to be at very high risk are advised to get an ICD – Implantable Cardiac Defibrillator. This however has only a very limited effect on the statistics, because:
- The procedure is costly – about $ 30,000 – 40,000 (including operation).Therefore, only a very small percentage of CHD patients are offered to undergo implantation.
- Implantation candidates must wait about 3 months, from incurring event, till they are actually operated on. In this period they are the most prone to SCA.
Automatic External Defibrillators (AEDs) are deployed in public places, such as airplanes, malls, trains. The AEDs are preferably operated by designated trained people but in emergency may eventually be operated by anyone. Survivability in those public places has been shown to increase by a factor of 3-5. Despite the growing trend, AEDs in public places can only save a very small fraction of SCA victims.
Life Vest Defibrillators are small AEDs permanently attached to the patient. They are offered as interim solutions before ICD implantation. They are cumbersome and uncomfortable to wear in worm weather, sleep and washing.
As can be seen, there is no satisfactory solution for the treatment out-of-hospital SCA victims, which explains the low survivability.
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