Periodic Reporting for period 1 - Heart Function Support (Innovative, minimally invasive device to support the natural movement of the heart in heart failure patients)
Periodo di rendicontazione: 2022-09-01 al 2024-02-29
This is the final report by Syntach AB as the company has ceased operations on July 6, 2023, as result of not being able to raise capital to fund ongoing operations. Syntach AB was started in 2012 with the mission to develop the Syntach Cardiac Support System (Syntach CS), a device implant intended to restore left ventricular function in patients with advanced heart failure. The company does not have any other product and was dependent on the success of this project.
Since receiving the EIC grant on September 2022 and in addition to focussing on developing Syntach CS in accordance with this project plan, Syntach AB has spent considerable time on raising additional capital to complement EIC funding and to expand its team to meet operational challenges ahead. This included the successful application and award of a €15 million EIB grant for the development of the Syntach CS System (On January 11, 2023, the Company signed the “EIB Fund Indicative Term Sheet) and appointment of Mr. Patrick N.J. Schnegelsberg as the company’s CEO, and Mrs. Cansel Isikli as VP of RA/Q, effective December 1, 2022.
Since then and up until ceasing its operations on July 6, 2023 (all staff were let go effective that day), management, and the board, together with financial advisors have reached out to over 100 investors in the EU, and the United States. In early 2023 it became clear that virtually all potential investors were looking for a complete series of animal data (proof of concept) and human clinical data from first in human studies. To address the former the company invested considerable time and resources to generate comprehensive animal data set demonstration proof of concept. This was completed by June 2023 (see attached deck “Syntach CS Animal Data”). With these data, the company re-approached potential investors it had NDAs with, However, none showed interest, and expected to see human clinical data from first in human studies.
In addition to reaching out to investors, beginning in Q1-2023, Syntach also reached out to potential strategic partners in China and Japan. While some of these discussions advanced to term sheet level, they failed to materialize (downturn of Chinese equity market, and for potential strategic partners in Japan, the lack of human clinical data).
Finally, the company was in talks with a Mexico-based family offices that had committed $2 million in funding but did not follow thought, despite several attempts to close the investment.
Up until ceasing its operations on July 6, 2023, the company has completed the work packages summarized in the table below (Table 1, Work Progress). As reported in February of 2023, Syntach faced issues related to durability of certain device components (WP3) which resulted in delays of planned design transfer (WP4). This resulted in an extension of the overall project to 76 months from the originally planned 55 months. The remainder of the work packages contemplated under this project, however, was not completed. As described above, much of our effort has been focused on task T2.5 “Capure Investment” and on generating proof of concept data. These sub tasks took most of the effort for the team during the first half of 2023.
Since receiving the EIC grant on September 2022 and in addition to focussing on developing Syntach CS in accordance with this project plan, Syntach AB has spent considerable time on raising additional capital to complement EIC funding and to expand its team to meet operational challenges ahead. This included the successful application and award of a €15 million EIB grant for the development of the Syntach CS System (On January 11, 2023, the Company signed the “EIB Fund Indicative Term Sheet) and appointment of Mr. Patrick N.J. Schnegelsberg as the company’s CEO, and Mrs. Cansel Isikli as VP of RA/Q, effective December 1, 2022.
Since then and up until ceasing its operations on July 6, 2023 (all staff were let go effective that day), management, and the board, together with financial advisors have reached out to over 100 investors in the EU, and the United States. In early 2023 it became clear that virtually all potential investors were looking for a complete series of animal data (proof of concept) and human clinical data from first in human studies. To address the former the company invested considerable time and resources to generate comprehensive animal data set demonstration proof of concept. This was completed by June 2023 (see attached deck “Syntach CS Animal Data”). With these data, the company re-approached potential investors it had NDAs with, However, none showed interest, and expected to see human clinical data from first in human studies.
In addition to reaching out to investors, beginning in Q1-2023, Syntach also reached out to potential strategic partners in China and Japan. While some of these discussions advanced to term sheet level, they failed to materialize (downturn of Chinese equity market, and for potential strategic partners in Japan, the lack of human clinical data).
Finally, the company was in talks with a Mexico-based family offices that had committed $2 million in funding but did not follow thought, despite several attempts to close the investment.
Up until ceasing its operations on July 6, 2023, the company has completed the work packages summarized in the table below (Table 1, Work Progress). As reported in February of 2023, Syntach faced issues related to durability of certain device components (WP3) which resulted in delays of planned design transfer (WP4). This resulted in an extension of the overall project to 76 months from the originally planned 55 months. The remainder of the work packages contemplated under this project, however, was not completed. As described above, much of our effort has been focused on task T2.5 “Capure Investment” and on generating proof of concept data. These sub tasks took most of the effort for the team during the first half of 2023.
This is also part of the technical report - see appendix and its appendix
WP 1: Project Management and coordination
All Tasks progressing according to plan until the revised project plan. This was under discussion with the potential investor.
See further below
D1.6 D1.7 and D1.9 delivered.
Syntach participated in several congresses, including ICI2022 (Tel Aviv), CRT 2023 (selected to compete for CRT 2023 Top Innovation Award), and THT2023 (selected to compete in “Shark Tank”), and published a paper in the Journal of the American College of Cardiology (Schnegelsberg PNJ, Solem K, Solem JO. Minimally Invasive Fully Implantable Cardiac Support System to Restore Left Ventricular Function in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):392-393.)
Discussions with strategic partners included: Abbott, Edwards Life Sciences (United States), Magas’s, Century Medical, Terumo, Core Medical, Nepro and Heka Bio (China & Japan).
WP 2 Market activities: Sales capacities, CE and FDA market approval, IP management & dissemination.
Task 2.3 2.4: Progressing according to plan
Task 2.5: Very much focus of the work has been to fulfil this task. Additional animal test was done.
See further below.
Conclusion: It was not possible to find investment needed.
In early December, the Company started reaching out to qualified investors (venture capital funds): (1) Personal network, (2) Conferences, (3) Referrals, introductions, and (4) Advisory firms (success fee, finder’s fee based). In total the company (re)-contacted and updated over100 investors. Several NDAs signed, but no term sheets signed. Task 2.3 2.4: Progressing according to plan, Task 2.5 Capturing Investment: Very much focus of the work has been to fulfil this task. Furter animal test data was needed in communication with potential investors. Additional animal testing was performed and prototypes to perform the test were manufactured. The result of the animal testing can be seen in the attached deck “Syntach CS Animal Data”.
Syntach CS Animal data 20230530 (Attached)
WP3 Development: Technical verification of the device
Tasks 3.1 and 3.2: Paused since January
• Durability testing did not meet requirements.
• Initiated design and material revisions.
See further below
Extension of project was needed. New time plan never established as it was under discussion with potential investors. A preliminary time plan indicating an extension up to 76 months.
Partially completed; Tasks 3.1 and 3.2: During December 2022 durability testing of Syntach CS (linear bearings inside drive unit) failed to meet product requirements, and the company began design and material revisions. Further development work was carried out (WP3B) but no completely new generation of prototypes was finalized.
WP 4- Design Transfer and manufacturing
Work with prototypes both internally and externally was performed both as part of the development work and also manufacturing of prototypes that were used in the animal testing.
Prototypes used in the animal testing. D4.2
Several “part prototypes” not complete- D4.3 (partly)
WP 5 Preclinical trial - Never started
WP6- Pilot Study ( First in Human )- Never started
WP7 Pivotal trials- Never started
WP 8- Ethics Requirements
Animal test performed had the ethical approval needed.OK according to the stage of the project.
WP 1: Project Management and coordination
All Tasks progressing according to plan until the revised project plan. This was under discussion with the potential investor.
See further below
D1.6 D1.7 and D1.9 delivered.
Syntach participated in several congresses, including ICI2022 (Tel Aviv), CRT 2023 (selected to compete for CRT 2023 Top Innovation Award), and THT2023 (selected to compete in “Shark Tank”), and published a paper in the Journal of the American College of Cardiology (Schnegelsberg PNJ, Solem K, Solem JO. Minimally Invasive Fully Implantable Cardiac Support System to Restore Left Ventricular Function in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):392-393.)
Discussions with strategic partners included: Abbott, Edwards Life Sciences (United States), Magas’s, Century Medical, Terumo, Core Medical, Nepro and Heka Bio (China & Japan).
WP 2 Market activities: Sales capacities, CE and FDA market approval, IP management & dissemination.
Task 2.3 2.4: Progressing according to plan
Task 2.5: Very much focus of the work has been to fulfil this task. Additional animal test was done.
See further below.
Conclusion: It was not possible to find investment needed.
In early December, the Company started reaching out to qualified investors (venture capital funds): (1) Personal network, (2) Conferences, (3) Referrals, introductions, and (4) Advisory firms (success fee, finder’s fee based). In total the company (re)-contacted and updated over100 investors. Several NDAs signed, but no term sheets signed. Task 2.3 2.4: Progressing according to plan, Task 2.5 Capturing Investment: Very much focus of the work has been to fulfil this task. Furter animal test data was needed in communication with potential investors. Additional animal testing was performed and prototypes to perform the test were manufactured. The result of the animal testing can be seen in the attached deck “Syntach CS Animal Data”.
Syntach CS Animal data 20230530 (Attached)
WP3 Development: Technical verification of the device
Tasks 3.1 and 3.2: Paused since January
• Durability testing did not meet requirements.
• Initiated design and material revisions.
See further below
Extension of project was needed. New time plan never established as it was under discussion with potential investors. A preliminary time plan indicating an extension up to 76 months.
Partially completed; Tasks 3.1 and 3.2: During December 2022 durability testing of Syntach CS (linear bearings inside drive unit) failed to meet product requirements, and the company began design and material revisions. Further development work was carried out (WP3B) but no completely new generation of prototypes was finalized.
WP 4- Design Transfer and manufacturing
Work with prototypes both internally and externally was performed both as part of the development work and also manufacturing of prototypes that were used in the animal testing.
Prototypes used in the animal testing. D4.2
Several “part prototypes” not complete- D4.3 (partly)
WP 5 Preclinical trial - Never started
WP6- Pilot Study ( First in Human )- Never started
WP7 Pivotal trials- Never started
WP 8- Ethics Requirements
Animal test performed had the ethical approval needed.OK according to the stage of the project.
The work on Syntach CS was published a paper in the Journal of the American College of Cardiology (Schnegelsberg PNJ, Solem K, Solem JO. Minimally Invasive Fully Implantable Cardiac Support System to Restore Left Ventricular Function in Heart Failure. JACC Basic Transl Sci. 2023 Apr 24;8(4):392-393.).
At CRT 2023 the company as selected to compete for CRT 2023 Top Innovation Awards, and at THT2023 Syntach was selected to compete in “Shark Tank” competition.
At CRT 2023 the company as selected to compete for CRT 2023 Top Innovation Awards, and at THT2023 Syntach was selected to compete in “Shark Tank” competition.