“To join hearts by curing them”

Why to invest on our team?Mr. Tony Stark

CEO, TJ Tech Inc.MS (Biomedical engg.)

Mr. Chuck BurtowskiCTO (MS in Cardiac sciences)

Mr. Tapan NarulkarProduct Manager

Ms. Hermione GrangerCMO

Ms. Phoebe BuffayDirector, Regulatory Affair

Why cardiac disease?

• Our firm is passionate about the cardiac diseases and treatment of them for following reasons:

• Huge population with cardiac diseases: Wants to be a helping hand, to make patient self-confident.

• Profitable market size = high returns (we are doing business here)

• Personal vendatta

What is a healthy Heart

• Heart is one of the vital organs of the body which pumps the pure blood to organs and impure blood back to the lungs for purification.

• A healthy human’s heart rate is between 60 to 100 Beats per minute, and anything below 60 or above 100 is considered to be arrhythmic condition of heart.

• The EKG of normal heart shows this graph.

How heart works?

• Heart is a muscular organ which works like a pump in circulatory systems and arteries and veins acts as the

pipes to supply the blood to respective organs.

• A heart beat is consist of systole(contraction) and diastole (relaxation) cycle.

• This contraction in muscle is caused by the electric impulse generated through SA node and AV node

and bundle of HIS are responsible for its proper distribution.

Problem to be solved

• Heart rate of healthy heart is between 60-100 beats per minute (BPM).

• Bradycardia is a heart disease in which heart does not functions properly, causing irregularity in hear rate.

• When heart rate drops below 60 BPM.

• Depending upon the pathophysiological condition it may be of different types.

Bradycardia & Types of bradycardia

• The reduced heart rate of heart is known as Bradycardia.

• Bradycardia is a general term for arrhythmias where heart rate drops below 60 BPM, however, this condition may be developed in athletes after heavy exercises as a body’s adaptation capabilities.

• The following type of bradycardia are diseased state and a pathophysiological problem of heart muscles:A. AtrialB. Atrioventricular nodalC. VentricularD. Infantile

• Atrial:

• According to the symtoms it is further classified in three classes

1. Respiratory Sinus Bradycardia: Heart rate increases during inhalation and decreases during exhalation.

2. Sinus Bradycardia: Most commonly observed in athletes.

3. Sick Sinus Bradycardia: It is a diseased state which will result in sinoatrial blocades, sinus arrest followed by atrial fibrillation and cardiac arrest.

• Atrioventricular:

• It is a slow heart rate condition caused by the absence of electric impulse from sinus mode. AV junction remains absence leads to delayed heartbeat followed by bradycardia.

• This condition may be monitored through EKG and is appeared to be a normal QRS complex accompanied with inverted P curve.

• Ventricular Bradycardia

• It is also known as escape rhythm or idioventricular rhythm.

• In the case of this heart rate drpos below 50 BPM.

• It is a safety mechanism, which is adapted by our heart muscles to survive against loss of electrical impulse.

• It is a condition developed in response to abnormal electrical activity through atrium.

• The condition which leads to bradycardia are or slow heart rate are either malfunctioning of SA node, AV Node or Bundle of HIS.

• If by any reason these fails to work properly the patient may suffer from tiredness, weakness, fainting, cardiac arrest or even death.

• The degree of severity of condition depends on how bad the blockade is, i.eif it is 10 , 20 ,30 degree.

Answer to ailment

• There is only one answer to the question: How to treat bradycardia?

• Pacemakers

• Pacemaker are artificial devices which are used to generate the required electrical impulses to regulate the heart rate.

• Its primary purpose is to maintain the heart rate, either implanted to act as an SA node or to properly conduct the electrical conduction system which is not working due to blockade in heart.

Attractive market scenario

• The Bradycardia can be prevailed in children, adults and geriatric patients.

• However, sick sinus syndrome or atrioventricular bradycardia are most often in geriatric patients due to lack of muscle flexibility in old age.

• According to American Heart association one in every 600 patient is over 65 years of age.

• As per the study conducted by the AHS number patients who are in need of pacemaker will increase from 78,000 patients per year to 172,000 per year by the end of the year 2020. And this is just a fraction of world population.

• Even during recession years, positive growth prospects are observed in artificial pacemaker industry.

Attractive market scenario

• Today the capture of artificial pacemaker in cardiac disease market is valued at US $6.5 billion per annum, which will significantly increase with increase in number of patients.

• Growth and strengthening of Asia-pacific economy is also a opportune market with a CAGR of 13.3% with market value of $5 billion per annum and is still increasing.

Competitior’s Overview

• The three most terrifying competitor’s in this market are Medtronic, St. Jude Medical and Boston Scientific capturing 90% of US pacemaker approvals.

• The biggest player in the game being Medtronic Inc., with a market share of 40%.

• Others being Biotronik (German) ,Sorin (Italian) having a little bit of capture in world market.

• Being highest contributor Medtronic is holding the winning flag and riding the tide up front with the help of leadless pacemaker, compact in size and ease in surgery which is approved recently.

• The technology our firm is working on is close to the currently marketed smallest and leadless pacemaker by Medtronic

Unique Product Characteristics

• Claim: An artificial, leadless self-powering pacemaker ensures that it does not need any power source for its operation, instead uses body’s own energy to charge with ability to heal the natural pacemaker eradicating the root cause of the disease, and makes the patient healthy by restoring the heart to normal condition.

• The most unique characteristic is it restores the natural conditions of heart due its healing properties to heal the heart muscles.

• It does not need any change of battery or maintenance as it is self-powering device.

• It can be implanted by using transcatheter surgery, however the device Medtronic developed can be implanted using the same method.

Advantages

• Leadless.

• Self-Powering (no maintenance)

• Small sized.

• Heal the natural pacemaker and blockades.

How will we get approval?

• It is a self-powering, permanent implantable device, which falls under Class III devices because it is a life supporting device.

• First of all we have to go for IDE and gather clinical data for its safety and effectiveness.

• After performing phase III trials our regulatory team will get a GUDID for the product and we will go for PMA.

• As soon as we will get PMA we will market it.

• After USFDA approval and successful marketing of the product we will target the whole world.

• Other targeted countries are EU, Britain, Asia-Pacific, Canada, Australia.

How will we get approval?

Sales & Distribution

• Our sales and distribution strategy will be to use a direct sales force.

• These are the reasons why we are going with this strategy:

1. Pacemakers are high value product with high number of population using it.

2. Our product is a high risk product, involving a non-traditional surgery for implantation, so the training of physicians is mandatory and should be done by company personnel.

3. Companies goal: To join hearts by curing them.

Revenue Modelling

• It is an implant which includes invasive surgery and need hospitalization and operating room.

• Although the stay in hospital is for very few days, maybe a day or two because this surgery only needs an hour or two.

• Invasion is through a small orifice hence no need of recovery period.

• The estimated cost for the full procedure including the cost of device is $25,000 per patient without any need of maintenance cost and repetitive surgery.

Topic Description

CPT codes and payment 0387T- transcatheter insert or replacement of leadless pacemakerTotal cost*- $ 15,5000389T- evaluation of the leadless implantable pacemaker0388T- transcatheter removal of the leadless pacemakerTotal cost*- $ 10,000

DRG, APC, and/or other codes and payment amounts

MS-DRG 244- Permanent cardiac pacemaker implant without MCC/CCCost*- $ 12532MS-DRG 243- Permanent cardiac pacemaker implant with CCCost*- $ 15,494MS DRG 242- permanent cardiac pacemaker implant with MCCCost*- $ 21,743

Facility Cost Average weighted hospital in-patient cost- $15,843

• We are planning to grow our company in three phases to increase the market share.

• Phase I: Target USBY using direct sales force, proper advertising and promotion, target to reach at the top of market.Estimated Profit per annum (till 2020): $55 million per annum.Market share (US only): 12 % of total artificial pacemaker.

Financial Planning

• Phase II: Invasion Europe

Use of direct sales force is must in case of Europe as medical care is different and physicians mostly trust on traditional open heart surgery.

Estimated Profit (upto 2025): $25 million

Financial Planning

• Phase III: Incredible Asia-Pacific

Hub of developing countries with immensely growing market and huge population.

Estimated Profit per year (till 2030): $50 million

Financial Planning

Thank You