Heart Buddy

Christina Pothier
Parth Patel
Kevin Swift
Outline
○ Product introduction
○ Predicate devices
○ Business case
○ Design control timeline
○ Regulatory pathways
○ Clinical study
Wireless Ventricular
Assist Device (VAD)
VADs
○ Cardiovascular prosthetics
○ Assist the left or right
ventricle to maintain
circulatory blood flow
○ Fully or partially implanted
○ Powered percutaneously via
cable
Our Product
○ Wireless design reduces
rate of infection
○ Improves patient comfort
and mobility
○ Fully implanted
○ Powered transcutaneously
 Current VAD technology Wireless design
(powered percutaneously) (powered transcutaneously)
Competitive Products and Predicates

● No wireless models currently on the market

○ Thoratec/St. Jude Medical currently pursuing wireless technology
● Predicate LVADs:
○ HeartMate 3 by Thoratec
○ Impella by Abiomed
○ HeartWare by Medtronic
The Growing Market
● The LVAD market is estimated to exceed $2 billion by
20241 (a growth rate of 10.5%2)

● The number of patients needing heart transplants has

doubled in the last 15 years
→ 30% of these patients require an LVAD
HeartBuddy’s Competitive Advantage

● A wireless device is safer and more

comfortable for patients
→ 19% of patients with a traditional
LVAD developed a driveline
infection (DLI) within the 12 months
after implantation3
Projected Timeline
Jan 2019 July 2024
July 2023 Jan 2025
Design EU, Canada,
US PMA Australia
Phase Saudi Arabia
Submission Submission
Begins Submissions

Jan 2021 Jan 2025 Mar 2025

Jan 2024
Clinical Anticipated Anticipated
Anticipated US
Studies EU, Canada, Australia
Approval
Begin SA Approval Approval
Financial Projections4
Yearly project development costs $50 million

Post-approval yearly revenue $100 million

Post-approval yearly operating costs $25 million

Post-approval yearly earnings $75 million

Break-Even Point (Q1 Year 6) Feb 2024

Device Profit after Year 7: $265 million

(contingent on reg. approvals by Jan. 2023, 2024 & 2025)
Target Markets

United States European Union Canada

Australia Saudi Arabia

Regulatory Pathways
EU Regulatory Overview
● Anticipated classification:
Class III5
○ Implantable, long-term,
surgically invasive device
○ To be in direct contact
with the heart/central
circulatory system
● Declaration of Conformity
(DOC) to obtain CE Marking
○ Anticipated DOC by July
2024
● A Notified Body (NB) must
confirm that the device meets
the essential requirements of
the Medical Device Directive
(MDD)
EU Regulatory Overview

● Clinical trials to be pre-approved by European Competent

Authority
● Cost to obtain CE Marking
○ Up to $64,000 USD
● No physical location in Europe
○ Must appoint an EU Authorized Representative
US Regulatory Overview

● Anticipated classification: Class III

○ Supports or sustains human life; of substantial importance in
preventing impairment of human health
● Pre-Market Approval (PMA) required
○ Pre-submission guidance will be requested prior to a PMA
● FDA decision expected 180 after filing
● PMA Submission fee: $310,764
Canada Regulatory Overview

● Application for Medical Device License (MDL)

● Anticipated classification: Class IV
○ “A surgically invasive device intended to … correct
a defect of the central cardiovascular system”5
● Medical Device Establishment License (MDEL)
○ Mandatory license to distribute all medical
devices in Canada
Canada Regulatory Overview
● Class IV application materials:
○ Pre-clinical and clinical studies
○ Process validation studies
○ Software validation studies
○ Literature studies
● MDL Application
○ USD: $10,164 (CAN: $13,500)
○ Anticipated decision time: 75 days
Australia Regulatory Overview

● Classification: Class AIMD (Active Implantable Medical Device)

● Medical devices must be included on the Australian Register of
Therapeutic Goods (ARTG)
● Only Australian sponsors may apply to put a device on the ARTG
○ KCP Heart Solutions must distribute Heart Buddy through an
Australian med device company (sponsor)
Australia Regulatory Overview

● The application for a place on the ARTG will be reviewed by the

Therapeutic Goods Administration (TGA)
○ A division of the Australian government’s Department of
Health
● Anticipated fee: $1,310 (USD)
Saudi Arabia Regulatory Overview

● Must first be approved in ● Application for Medical

one of the following Device Marketing
markets: Authorization (MDMA)
○The EU ○ Submitted to the Saudi
○The US
Food and Drug Authority
○Japan
○Canada (SFDA)
○Australia
Saudi Arabia Regulatory Overview

● Conformity Assessment Body (CAB) appointed by SFDA

○ CAB is a third party that reviews the technical information in the
MDMA
● MDMA application is reviewed by SFDA and CAB
● A decision is anticipated 6 months after the submission of the
MDMA application
Clinical Study
● 50 participants
● Single group assignment interventional trial
○ All participants will receive the implant
● No masking (open label)
○ As with single group assignments, researchers will be aware that
all patients have the implant
● 2 year duration
○ Patient health will be regularly monitored and
potential adverse events recorded
 Thank You
We now welcome questions!
References
[1] Energias Market Research. “Advancements in Medical Devices Contributing to the Growth of Left
Ventricular Assist Device Market to Grow at a CAGR of 10.5% during 2018-2024 : Energias Market
Research Pvt. Ltd.” GlobeNewswire, 19 Mar. 2018.

[2] Wood, Laura. “Global Left Ventricular Assist Device (LVAD) Market Outlook to 2023: Profiles for
Thoratec, Terumo, Transonic, Berlin Heart, HeartWare International, and Many More.. -
ResearchAndMarkets.com.” Business Wire, 5 Oct. 2018.

[3] “Left Ventricular Assist Device Driveline Infections: Recent Advances and Future Goals.” Journal of
Thoracic Disease, University of Minnesota Department of Medicine, 7 Dec. 2015, doi:
10.3978/j.issn.2072-1439.2015.11.06.

[4] “Abbott Reports First-Quarter 2018 Results.” SEC Filing | Abbott Laboratories, 18 Apr. 2018,

[5] “Medical Device Directive 93/42/EEC, Annex 9”. Official Journal of the European Communities.
References
[5] Legislative Services Branch. “Consolidated Federal Laws of Canada, Medical Devices Regulations
(SOR/98-282).” Canada Occupational Health and Safety Regulations, Health Canada, 19 Nov. 2018.