The document provides information about a proposed self-powering pacemaker that aims to cure bradycardia by healing the natural pacemaker. It discusses: the team developing the product; the large market opportunity given the growing elderly population; the unique characteristics of the proposed pacemaker including being leadless, self-powering, and able to heal the natural pacemaker; the regulatory approval process through IDE and PMA trials; and a three phase plan to target the US, European, and Asia-Pacific markets.

2. “To join hearts by curing them”

3. Why to invest on our team?
Mr.Tony Stark
CEO,TJTech Inc.
MS (Biomedical engg.)
Mr. Chuck Burtowski
CTO (MS in Cardiac sciences)
Mr.Tapan Narulkar
Product Manager
Ms. Hermione Granger
CMO
Ms. Phoebe Buffay
Director, Regulatory Affair

4. 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

5. 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.

6. 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.

7. 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.

8. 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. Atrial
B. Atrioventricular nodal
C.Ventricular
D. Infantile

9. • 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.

10. • 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.

11. • 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.

12. • 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.e
if it is 10 , 20 ,30 degree.

13. 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.

14. 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.

15. 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.

16. 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

17. 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.

18. Advantages
• Leadless.
• Self-Powering (no maintenance)
• Small sized.
• Heal the natural pacemaker and blockades.

19. 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.

20. • 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?

21. 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.

22. 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.

23. Topic Description
CPT codes and payment 0387T- transcatheter insert or
replacement of leadless pacemaker
Total cost*- $ 15,500
0389T- evaluation of the leadless
implantable pacemaker
0388T- transcatheter removal of the
leadless pacemaker
Total cost*- $ 10,000
DRG, APC, and/or other codes and
payment amounts
MS-DRG 244- Permanent cardiac
pacemaker implant without MCC/CC
Cost*- $ 12532
MS-DRG 243- Permanent cardiac
pacemaker implant with CC
Cost*- $ 15,494
MS DRG 242- permanent cardiac
pacemaker implant with MCC
Cost*- $ 21,743
Facility Cost Average weighted hospital in-patient
cost- $15,843

24. • We are planning to grow our company in three phases to increase the
market share.
• Phase I:Target US
BY 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

25. • 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

26. • 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

27. ThankYou