●
|
the Company is committed to developing its robotic surgical system with the objective of substantially improving upon minimally
invasive surgery;
|
● |
the Company intends to initially pursue focused surgical indications for the SPORT Surgical System, which may include one or more of
gynecologic, urologic, colorectal or general abdominal procedures;
|
● |
the SPORT Surgical System is being developed with the goal of inserting the interactive multi-articulating instruments and the 3D
high definition vision system into the patient’s body cavity through a single incision;
|
● |
the Company’s technology and research and development objectives and milestones, including such development milestones as achieving
design freeze, estimated costs, schedules for completion and probability of success;
|
●
|
the Company’s intention with respect to updating any forward-looking statement after the date on which such statement is made or to
reflect the occurrence of unanticipated events;
|
●
|
the Company’s expectation with respect to continuing animal and human cadaver studies;
|
●
|
the Company’s expectation that it can in a timely manner produce the appropriate preclinical and clinical data required for a 510(k)
application to the U.S. Food and Drug Administration, and Technical File for the CE Mark;
|
●
|
the Company’s expectation with respect to launching a commercial product in certain jurisdictions;
|
●
|
the Company’s intentions to develop a robust training curriculum and post-training assessment tools;
|
●
|
the Company’s plans to develop and commercialize the SPORT Surgical System and the estimated incremental costs (including the
status, cost and timing of achieving the development milestones disclosed herein);
|
●
|
the Company’s plans to design, create and refine software for production system functionality of the SPORT Surgical System and the
estimated incremental costs (including the status, cost and timing of achieving the development milestones disclosed herein);
|
●
|
the Company’s intentions to complete formative and summative human factors studies;
|
●
|
the Company’s belief that existing and planned prototype units will be suitable to support human factors studies, preclinical
evaluation and activities related to securing confirmatory human data during 2019;
|
●
|
the Company’s intentions with respect to initiating marketing activities following receipt of the applicable regulatory approvals;
|
●
|
the Company’s intention to continue to assess specialized skill and knowledge requirements and recruitment of qualified personnel
and partners;
|
●
|
the Company’s belief that the materials and parts necessary for the manufacture of a clinical-grade SPORT Surgical System will be
available in the marketplace;
|
●
|
the Company’s expectation that it will be able to finance its continuing operations by accessing public markets for its securities;
|
●
|
the Company’s intended use of proceeds of any offering of securities;
|
●
|
the Company’s intention with respect to not paying any cash dividends on Common Shares in the foreseeable future;
|
●
|
the Company’s intention to retain future earnings, if any, to finance expansion and growth;
|
●
|
the Company’s projected competitive conditions with respect to its products;
|
●
|
the Company’s technology and research and development objectives, including such development milestones as completing the
engineering confidence build and achieving design freeze, estimated costs, schedules for completion and probability of success;
|
●
|
the Company continues to explore in-licensing opportunities for technologies that may be used in conjunction with the Company’s
robotic surgical system;
|
●
|
the Company anticipates that it will continue its pursuit of key strategic relationships;
|
●
|
the Company’s continuing efforts to secure its intellectual property and expanding its patent portfolio by filing patent
applications as it progresses in the development of robotic surgical technologies and by licensing suitable technologies;
|
●
|
the Company’s plan to focus on the development and commercialization of the SPORT Surgical System at estimated incremental costs and
according to a given timeline; and
|
●
|
the Company intends to utilize a direct sales force and/or distribution partner(s) to initiate marketing the SPORT Surgical System
to hospitals.
|
|
• |
Florida Hospital Nicholson Center in Celebration, Florida;
|
|
|
|
|
•
|
Columbia University Medical Center in New York, New York; and
|
|
|
|
|
•
|
Institut Hospitalo-Universitaire de Strasbourg (“IHU Strasbourg”) in Strasbourg, France.
|
1.
|
Multi-disciplinary applications
of a new robotic platform by Barbara Seeliger, MD and Lee Swanstrom, MD (IHU Strasbourg), accepted and presented as a poster at the Society of American Gastrointestinal and Endoscopic Surgeons Meeting, Seattle, WA. (April
2018);
|
2.
|
Single-port prostatectomy using
SPORT Surgical System by Eric Barret, MD (Institut Mutualiste Montsouris, France), accepted and presented as a poster at the EAU Section of Urology Technology Meeting, Modena, Italy, May 2018;
|
3.
|
Multispecialty single port
robotic technology applied in the live animal model: proof of concept by Travis Rogers, MD, Eduardo Parra Davila, MD, Vipul Patel, MD (all from Florida Hospital), Ricardo Estape, MD (South Miami GOG) and Armando Melani, MD
(IRCAD Brazil), accepted and presented as a poster at the Society of Robotic Surgery Meeting, Stockholm, Sweden (June 2018);
|
4.
|
Feasibility of single-port
partial nephrectomy using SPORT surgical system by Eric Barret, MD (Institut Mutualiste Montsouris, France), accepted and presented as a poster at Society of Robotic Surgery Meeting, Stockholm, Sweden (June 2018);
|
5.
|
Single-port robotic partial and
hemi nephrectomy using a novel single port robotic platform by Sebastien Crouzet, MD (University of Lyon, France) and Barbara Seeliger, MD (IHU Strasbourg), accepted and presented at EAU Robotic Urology Section Meeting,
Marseille, France (September 2018);
|
6.
|
Reverse Objective Structured
Assessment of Technical Skills (Reverse-OSATS) as a means of measuring the capability of the Titan Medical SPORT Surgical System on core surgical principles by Chetna Arora, MD, Arnold P. Advincula, MD (both from Columbia
University Medical Center) and William B. Burke, MD (Stony Brook Cancer Center), accepted and presented at Society of European Robotic Gynecologic Surgeons Meeting, Milan, Italy (September 2018);
|
7.
|
Multispecialty single port
robotic technology applied in the live animal model: proof of concept by Travis Rogers, MD, Eduardo Parra Davila, MD, Vipul Patel, MD (all from Florida Hospital), Ricardo Estape, MD (South Miami GOG) and Armando Melani, MD
(IRCAD Brazil), accepted and presented at World Congress of Endourology Meeting, Paris, France (September 2018);
|
8.
|
Feasibility of single-port
partial nephrectomy using SPORT surgical system by Eric Barret, MD (Institut Mutualiste Montsouris, France) Accepted and presented at World Congress of Endourology Meeting, Paris, France, September 2018; and
|
9.
|
Reverse Objective Structured
Assessment of Technical Skills (Reverse-OSATS) as a means of measuring the capability of the Titan Medical SPORT Surgical System on core surgical principles by Chetna Arora, MD, Arnold P. Advincula, MD (both from Columbia
University Medical Center) and William B. Burke, MD (Stony Brook Cancer Center), accepted at American Association of Gynecologic Laparoscopists World Congress, Las Vegas, NV (November 2018).
|
2018
|
2017
|
2016
|
||||||||||
Net Sales
|
-
|
-
|
-
|
|||||||||
Net and comprehensive loss for the year
|
$
|
22,639,272
|
$
|
33,586,984
|
$
|
23,323,496
|
||||||
Basic & diluted loss per share
|
$
|
1.36
|
$
|
4.25
|
$
|
4.80
|
||||||
Total long-term liabilities
|
-
|
-
|
-
|
|||||||||
Total Assets
|
$
|
21,915,164
|
$
|
29,674,610
|
$
|
7,192,496
|
||||||
Dividends
|
-
|
-
|
-
|
Research and Development Expenditures
|
Year Ended
December 31, 2018
|
Year Ended
December 31, 2017
|
||||||
Intellectual property development
License and royalties
Product development
|
$
|
14,540
-
32,843,799
|
$
|
25,704
43,575
12,831,576
|
||||
Total
|
$
|
32,858,339
|
$
|
12,900,855
|
Three
Months
Ended
December
31, 2018
|
Three
Months
Ended
September 30, 2018
|
Three
Months
Ended
June 30,
2018
|
Three
Months
Ended
March 31,
2018
|
Three
Months
Ended December 31, 2017
|
Three
Months
Ended
September 30, 2017
|
Three
Months
Ended
June 30,
2017
|
Three
Months
Ended
March
31, 2017
|
|||||||||||||||||||||||||
Net sales
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||||
Net and Comprehensive Loss (gain) from operations
|
$
|
8,410,702
|
$
|
7,534,456
|
$
|
5,885,415
|
$
|
808,699
|
$
|
12,829,980
|
$
|
13,902,817
|
$
|
1,865,913
|
$
|
4,988,274
|
||||||||||||||||
Basic and diluted loss per share
|
$
|
0.41
|
$
|
0.41
|
$
|
0.47
|
$
|
0.07
|
$
|
1.20
|
$
|
1.80
|
$
|
0.30
|
$
|
0.90
|
Issue Date
|
Expiry Date
|
Number Issued
|
Number Outstanding
|
Exercise Price (CDN $)
|
||||||||||
TMD.WT.F
|
November 16, 2015
|
November 16, 2020
|
233,740
|
233,740
|
$
|
48.00
|
||||||||
TMD.WT.G
|
February 12, 2016
|
February 12, 2021
|
389,027
|
386,694
|
$
|
30.00
|
||||||||
TMD.WT.G
|
February 23, 2016
|
February 12, 2021
|
58,226
|
58,226
|
$
|
30.00
|
||||||||
TMD.WT.H
|
March 31, 2016
|
March 31, 2021
|
501,831
|
501,831
|
$
|
36.00
|
||||||||
TMD.WT.H
|
April 14, 2016
|
March 31, 2021
|
75,275
|
75,275
|
$
|
36.00
|
||||||||
TMD.WT.I
|
September 20, 2016
|
September 20, 2021
|
569,444
|
569,444
|
$
|
22.50
|
||||||||
TMD.WT.I
|
October 27, 2016
|
September 20, 2021
|
67,667
|
67,667
|
$
|
22.50
|
||||||||
NOT LISTED
|
March 16, 2017
|
March 16, 2019
|
357,787
|
135,824
|
$
|
12.00
|
||||||||
NOT LISTED
|
March 16, 2017
|
March 16, 2021
|
357,787
|
355,253
|
$
|
15.00
|
||||||||
NOT LISTED
|
June 29, 2017
|
June 29, 2022
|
1,612,955
|
75,810
|
$
|
6.00
|
||||||||
NOT LISTED
|
July 21, 2017
|
June 29, 2022
|
370,567
|
370,567
|
$
|
6.00
|
||||||||
NOT LISTED
|
August 24, 2017
|
August 24, 2022
|
563,067
|
563,067
|
$
|
6.00
|
||||||||
NOT LISTED
|
December 5, 2017
|
December 5, 2022
|
1,533,333
|
1,533,333
|
$
|
18.00
|
||||||||
NOT LISTED
|
April 10, 2018
|
April 10, 2023
|
1,126,665
|
1,126,665
|
$
|
10.50
|
||||||||
NOT LISTED
|
May 10, 2018
|
April 10, 2023
|
168,889
|
168,889
|
$
|
10.50
|
||||||||
*NOT LISTED
|
August 10, 2018
|
August 10, 2023
|
7,679,574
|
7,679,574
|
$
|
4.15
|
||||||||
TOTAL
|
15,665,834
|
13,901,859
|
Milestone Number | Development Milestones | Estimated Cost (in U.S. million $) | Schedule for Milestone Completion | Comments |
Milestone 1
|
Prototype, test and procure surgeon feedback on revised workstation controls
Complete software and hardware change requirements and finalize computer and software architecture for production systems
Complete revisions to instrument and lens wash system and demonstrate performance
|
Q2 2018
|
Completed
|
|
Milestone 2
|
Complete Camera Insertion Tube (CIT) engineering confidence build based on improved design
Complete design of SPORT Surgical System surgeon workstation and patient cart for engineering confidence build
Complete and demonstrate full suite of simulation software for beta test
|
Q3 2018
|
Completed
|
|
Milestone 3
|
Complete SPORT Surgical System capital equipment engineering confidence build based on improved design
|
Q4 2018
|
Completed
|
|
Milestone 4
|
Document results of confidence build unit testing, implement subsystem design improvements and schedule preliminary audit of quality
system by European Notified Body
|
16.0(1)
|
Q1 2019
|
|
Milestone 5
|
Update system design and related hardware and software documentation
Verify production system operation with clinical experts under rigorous formal (summative) human factors evaluation under simulated
robotic manipulation exercises
Initiate SPORT Surgical System Design Freeze
Initiate preclinical live animal (swine) and cadaver studies according to final protocols for FDA submittal
Submit Investigational Device Exemption (IDE) application to FDA
|
16.9(2)
|
Q2 2019
|
|
Submit draft protocols to FDA in Q-submission(s) for comment
|
Completed
|
|||
Milestone 6
Milestone 7
|
Complete and document preclinical live animal (swine) and cadaver studies according to final protocols for FDA submittal
Obtain ISO 13485 Certification
Receive IDE approval from FDA
Complete and document human confirmatory studies under IDE protocols for FDA submittal
Submit Technical File to European Notified Body for review for CE Mark
Submit 510(k) application to FDA
|
16.1(3)
15.1(4)
|
Q3 2019 –
Q4 2019
|
|
TOTAL
|
64.1
|
(1) |
Includes research and development costs estimated at approximately US $14.6 million, and general and administrative costs estimated at approximately US $1.4
million.
|
(2) |
Includes research and development costs estimated at approximately US $15.5 million, and general and administrative costs estimated at approximately US $1.4
million.
|
(3)
(4)
|
Includes research and development costs estimated at approximately US $14.7 million, and general and administrative costs estimated at approximately US $1.4
million.
Includes research and development costs estimated at approximately US $13.7
million, and general and administrative costs estimated at approximately US $1.4 million.
|
Proceeds from the Offering
|
Proceeds from the Offering
|
Total
|
||||||||||
as outlined in the short-form
|
as outlined in the short-form | |||||||||||
prospectus dated April 3, 2018
|
prospectus dated August 7, 2018 | |||||||||||
(including the May 10, 2018
|
||||||||||||
overallotment)
|
||||||||||||
Ongoing
|
||||||||||||
development and
|
||||||||||||
commercialization
|
||||||||||||
of the SPORT
|
||||||||||||
Surgical System
|
$
|
6,649,246
|
$
|
13,971,769
|
$ | 20,621,015 | ||||||
General working
|
||||||||||||
Capital requirements
|
1,662,312
|
3,492,942
|
5,155,254 | |||||||||
Total Net Proceeds
|
$
|
8,311,558
|
$
|
17,464,711
|
$
|
25,776,269
|
Type of Securities
|
Number of Common Shares issued or issuable upon conversion
|
Common Shares
|
22,295,455
|
Stock options(1)
|
925,782
|
Warrants
|
13,282,253
|
Broker warrants(2)
|
786,183
|
(1) |
The Company has outstanding options enabling certain employees, directors, officers and consultants to purchase Common Shares. Please refer to note 4(b) of
the Interim Financial Statements for terms of such options.
|
(2) |
Pursuant to the agency agreement in respect of the March 2017 offering, in addition to the cash commission paid to the agents, 50,005 broker warrants were
issued to the agents. Each broker warrant entitles the holder thereof to acquire one Common Share at the price of CDN $10.50 for a period of 24 months following the closing date.
|
(a)
|
Stock Options
|
(b)
|
Warrant Liability
|