Synektik Group History

The registry court entered in the National Court Register the increase in Syn2bio’s share capital connected with the issue of demerger shares for Synektik SA shareholders – the formal completion of the spin-off process connected to R&D activity

Publication of the Division Plan of the Company by transferring a portion of its assets referring to the R&D activity to another company, Syn2bio

Dividend payment for the 2023 financial year in the amount of PLN 8.25 per share

Acquisition of 100% of shares in a medical IT software company, IT4KAN Sp. z o.o.

Establishment of the subsidiary SYNEKTIK Baltic SIA with headquarters in Riga

Extension of distribution agreement with Intuitive Surgical for da Vinci robots to include Lithuania, Latvia and Estonia

Collaboration with Hologic for exclusive distribution and servicing of mammography and biopsy systems in Poland

Extension of cooperation with Intuitive Surgical until December 31, 2029

Agreement with Medical Microinstruments for the exclusive distribution of Symani microsurgery and supermicrosurgery robots.

The cooperation covers the markets of Poland, the Czech Republic, Slovakia, Lithuania, Latvia and Estonia.

Agreement for exclusive distribution in Poland, Czech Republic and Slovakia of Qure.ai’s global artificial intelligence solution for radiology examination results assessment.

Dividend payment for the 2022 financial year in the amount of PLN 3.03 per share.

Extension of cooperation with Insightec until December 31, 2025 and expansion of the activity to the Czech Republic and Slovakia.

It concerns the exclusive distribution of products for neurosurgery using focused ultrasound guided by magnetic resonance imaging (MRgFUS, Exablate Neuro).

Obtaining a patent for a cardiotracer in Japan

End of FDA consultations on cardiotracer project

Dividend payment of PLN 0.60 per share

Obtaining marketing authorization for the radiopharmaceutical FLT (18F) Synektik

Obtaining a patent for a cardiotracer in Europe

Formal commencement of operations in the Czech Republic and Slovakia in the area of da Vinci robotic systems distribution

Signing of the contract for the first ZAP-X system in Poland.

The system for stereotactic radiosurgery of the brain, head and neck will be launched at the University Clinical Hospital in Olsztyn, pursuant to an agreement with the University of Warmia and Mazury.

Establishment of Synektik Czech Republic, s.r.o. based in Prague, Czech Republic

Signing of a cooperation agreement with Becton Dickinson Rowa Germany GmbH

Synektik becomes the sole distributor of BD Rowa robotic systems in Poland in the hospital pharmacy sector.

Obtaining a patent for a cardiotracer in Poland

Start of patient testing under the permit to conduct Phase III clinical trials of the cardiotracer.

Synektik obtains approval from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

The first system in Poland for performing neurosurgical operations using a concentrated ultrasound beam (FUS).

The Synektik Group, by means of its cooperation with Insightec, has become a distributor of an innovative system for treating essential tremor using ultrasound. The first device will appear in the Mazowiecki Szpital Bródnowski in Warsaw.

Change of registered office address

Synektik SA and its subsidiary Synektik Pharma Sp. z o.o. change their address from al. Wincentego Witosa 31, 00-710 Warsaw to ul. Józefa Piusa Dziekońskiego 3, 00-728 Warsaw.

Dividend payment of PLN 0.45 per share

Establishing cooperation with Genomtec

The agreement covers, among others, the commercialization of genetic tests for SARS-CoV-2 developed and produced by Genomtec.

Expanding the therapy offer with a radiosurgery system

Synektik is expanding its product portfolio with ZAP-X, an innovative system for stereotactic radiosurgery of the head and neck, manufactured by the American company ZAP Surgical Systems.

Payment of the first dividend from the generated profit

Report on the completion of phase II of the cardiotracer clinical trial

The report confirms the achievement of the intended primary endpoints defined in the study protocol.

Positive assessment of the European Commission for the report on the implementation of the cardiotracer project under the Horizon 2020 Programme funding

Synektik Group as the exclusive distributor introduces the APOTECA chemo robot to the Polish market

The system, used for automatic preparation of intravenous drugs applied in anti-cancer therapies, allows for reducing the costs of producing cytostatics and for minimizing the risks typical for their manual preparation, including the exposure of pharmacists to the influence of hazardous substances.

Completion of the patient observation phase in the Phase II clinical trial of the cardiotracer.

The end of the three-month follow-up period for patients who received a cardiotracer intended for PET imaging of myocardial perfusion.  No adverse events were reported in association with the investigational product.

Funding for work on 18F-fluorothymidine

Under the agreement between Synektik Pharma Sp. z o.o. and the National Centre for Research and Development, the Group receives funding for development and pre-implementation work under the project entitled “Market introduction of a new radiopharmaceutical 18F-fluorothymidine (FLT) for targeted oncological diagnostics and assessment of therapy progress”.

Completion of Phase II of cardiotracer studies

As part of the second phase of clinical trials, the tested molecule was administered to the last patient. This means that the stage of administering the cardiotracer for PET-CT examinations to patients in the recruited group has ended, as planned.

First Da Vinci System Sold

Thanks to the signing of the first contract for the sale of a robotic surgery system, Da Vinci X type is delivered to the Mazovia Hospital in Warsaw.

Synektik is the exclusive distributor of innovative da Vinci® robotic systems in Poland

Based on the agreement with Intuitive Surgical, a pioneer and leader in the global market of robotic systems for surgery, Synektik is responsible for, among other things, the sale and service of robots, instruments and accessories for devices, as well as training of operating physicians.

Synektik Pharma and Iason merge to form Synektik Pharma

Subsidiaries of Synektik SA – Synektik Pharma Sp. z o.o. (previously named Monrol Poland Ltd Sp. z o.o.) and Iason Sp. z o.o. – become one entity called Synektik Pharma Sp. z o.o.

Collaboration with Blue Earth Diagnostics in the production of Axumin® – a new radiopharmaceutical in Poland designed for the prostate cancer diagnosis.

Iason sp. z o.o., part of the Synektik Group, has reached an agreement with Blue Earth Diagnostics Ltd, a leader in molecular diagnostics, to introduce the radiopharmaceutical Axumin® (fluciclovine 18F), used in prostate cancer diagnostics, to the Polish market.

Based on this agreement, production of Axumin® will begin at the Mszczonów plant in 2018, and Iason will be the exclusive supplier of Axumin® to the Polish market.

Purchase of Monrol Poland and a new radiopharmaceutical production plant in Mszczonów

Synektik Group buys 100% of Monrol Poland shares from Eczacbaş Monrol and Monrol Europe. This increases again the number of plants where radiopharmaceuticals are produced and Synektik now has modern manufacturing centres in Kielce, Warsaw and Mszczonów.

Positive opinion of the Bioethics Committee regarding the Phase II of clinical trials of the cardiotracer

The positive decision of the Bioethics Committee regarding the cardiotracer clinical trial enables the commencement of the active phase of the clinical trial involving patients as part of Phase II of the innovative cardiotracer clinical trials.

Publication of the Synektik Capital Group Strategy for 2017-2021

The company has indicated the strategic directions of the Group’s development until 2021, according to which it plans to use the acquired competences in the field of intelligent medical solutions and focus on three key medical fields with the greatest commercial potential: oncology, cardiology and neurology.

At the same time, Synektik announced the expansion of the field of activity from the area of ​​diagnostics to the area of ​​therapy, where the largest expenditures in the field of health care are concentrated.

Signing an agreement to conduct Phase II clinical trials of a cardiotracer

Signing an agreement with ClinMed Pharma based in Warsaw for the provision of services related to conducting Phase II of clinical trials related to a cardiotracer intended for myocardial perfusion imaging (MPI) using the PET method.

The aim of Phase II clinical trials is, among others, to select the dose range and confirm the safety of the cardiotracer for PET imaging to assess myocardial perfusion in patients with known or suspected coronary artery disease.

Completion of Phase I of the clinical trial of cardiotracer for myocardial perfusion diagnostics.

The primary goal of Phase I clinical trials was to determine the safety and tolerability of the cardiotracer in a group of healthy patients. The results of the clinical trial were consistent with the goals set for the Phase I trial and allowed the initiation of Phase II trials involving patients.

Signing a partnership agreement with Carl Zeiss in Poland regarding the distribution and servicing of the INTRABEAM oncology radiotherapy system.

Under the contract, Synektik becames the exclusive representative of Carl Zeiss in the distribution and servicing of technologically advanced radiotherapy equipment used in the cancer treatment.

Obtaining a prestigious grant under the SME Instrument Horizon 2020 program

Approval of the ranking list of projects recommended for funding under Phase 2 of the European Union’s SME programme Horizon 2020

The Company’s project was presented under the Horizon 2020 framework program in the Health category and the subcategory Supporting clinical trials of new biomarkers and medical devices.

The aim of the project is to conduct Phase I and II clinical trials for a marker for the diagnosis of coronary artery disease during positron emission tomography (PET) examination.

Commencement of export of IASOcholine® radiotracer to the Czech Republic and Slovakia.

Obtaining a grant from the National Center for Research and Development for research related to a cardiotracer for the diagnosis of myocardial perfusion

Approval of the ranking list of projects recommended for funding under the competition announced by the National Centre for Research and Development.

In accordance with the aforementioned list, the Company’s project entitled “Development of a new cardiotracer, labeled with 18F, for the assessment of myocardial perfusion and diagnosis of coronary artery disease in PET (Positron Emission Tomography) examination” was positively verified in terms of feasibility, substantive (horizontal and detailed) and strategic assessment, thus qualifying for funding for its implementation.

Implementation of a comprehensive operating room project for the Neurosurgery Clinic of the Bródnowski Hospital in Warsaw.

Implementation of a contract for the Mazowiecki Bródnowski Hospital in Warsaw for a total amount of almost PLN 21 million net. The project included the delivery of specialist diagnostic equipment, design and execution of construction works and the delivery of other medical equipment for the Neurosurgery Clinic related to the construction of an integrated operating room.

Start of Phase I clinical trial of radiotracer for myocardial perfusion diagnostics

Conclusion of an agreement with Hadasit Medical Research Services and Development Ltd based in Israel to conduct the first phase of clinical trials related to a cardiotracer intended for myocardial perfusion imaging (MPI) using the PET method.

Commencement of IASOcholine® manufacturing at the production plant in Warsaw

Synektik is the only entity in Poland with two commercial production plants producing three different radiopharmaceuticals (IASOEfdege®, IASOflu® and IASOcholine®).

Zakończenie przedklinicznej fazy badań nad radioznacznikiem do diagnostyki perfuzji mięśnia sercowego

Successful completion of preclinical studies related to the MPI cardiotracer intended for cardiac examinations using Positron Emission Tomography (PET), conducted in cooperation with Hadasit Medical Research & Development Ltd – the commercial branch of Hadassah Medical Center.

Acquisition of ownership rights for the products EFDEGE®, IASOflu®, IASOdopa® and IASOcholine® from IASON GmbH

Company’s debut on the main market of the Warsaw Stock Exchange.

Approval of the Company’s prospectus in connection with the planned transfer of listings from NewConnect to the main market of the Warsaw Stock Exchange.

Opening of the Research and Development Center in Warsaw

Obtaining a permit to manufacture the medicinal products IASON Efdege and IASOflu at the production plant in Warsaw.

Introduction of E series shares to the alternative trading system on the NewConnect market

Registration of the increase in the Company’s share capital by series E shares.

Obtaining exclusive rights to manufacture and sell worldwide radiotracers for myocardial perfusion diagnostics.

Conclusion of an agreement for conducting joint research and purchase of a license with Hadasit Medical Research & Development Ltd based in Jerusalem (Israel) – owned by Hadassah Ein-Karem Medical Center.

Obtaining exclusive rights to manufacture and sell worldwide radiopharmaceuticals based on ammonium salt, which are innovative markers for performing diagnostic tests of heart diseases in the field of myocardial perfusion. The agreement also stipulates that the companies will conduct joint research and development work and clinical trials on radiotracers based on ammonium salt.

Introduction to the alternative trading system on the NewConnect BBB series shares market.

Registration of the Company’s share capital increase by BBB Shares

Qualification for the NCX Life Science index

The NCX Life Science index includes companies from the medical and biotechnology sector listed on the NewConnect market, whose operations and development take place with a high share of intellectual capital and modern technologies.

The Issuer’s qualification to the NCX Life Science index was influenced by the significant expansion of the Issuer’s Capital Group’s operations since its debut in the Alternative Trading System of the NewConnect market, and in particular the commencement of commercial production of radiopharmaceuticals in August 2012.

Obtaining authorization to manufacture the medicinal product IASOflu

Obtaining a building permit for a radiopharmaceutical production plant in Warsaw

Conclusion of an agreement with the Ministry of Economy to co-finance the establishment of the Synektik Research and Development Centre from the European Union funds.

Synektik’s qualification to the NewConnect Lead market segment

A segment that brings together the leaders of the NewConnect market, i.e. companies with the greatest potential to transfer listings to the regulated market. On the day of the Issuer’s qualification, 8 companies were classified to the segment, and the Issuer was one of two representatives of the medical and life science industry.

Belonging to this segment is a distinction and an indication of great development potential.

Introduction of D series shares to the alternative trading system on the NewConnect market

Signing the agreements on the commencement of construction of a radiopharmaceutical production plant and a Research and Development Center in Warsaw.

While implementing the radiopharmaceutical production development strategy of the Issuer’s Capital Group, in 2011 a decision was made to go ahead with an investment comprising the construction and launch of a second radiopharmaceutical manufacturing plant and a Research and Development Centre in Warsaw.

The company Międzynarodowe Centra Medyczne Inwestycje Sp. z o.o., in which the Issuer acquired 50% of shares, was responsible for organising the process of building the production plant from the formal and legal side.

On December 15^th, 2011, this company concluded a sublease agreement with Euromedic Diagnostic Polska Sp. z o.o. for land in Warsaw, on which construction of a plant to produce radiopharmaceuticals for the needs of Euromedic Diagnostic Polska Sp. z o.o. and for external entities was commenced.

It was decided to locate the Research and Development Centre on the premises of the new radiopharmaceutical production plant.

Completion of the investment process and obtaining a permit for the production of radiopharmaceuticals.

Obtaining by IASON Sp. z o.o. a permit from the General Pharmaceutical Inspector for the production of a medicinal product. At the same time, IASON Sp. z o.o. was added to the Register of Pharmaceutical Manufacturers/Importers under number 256.

Introduction of C series shares to the alternative trading system on the NewConnect market

Introduction of A, B and BB series shares to the alternative trading system on the NewConnect market

Registration of increases in the Company’s share capital by series B, series BB and series C shares

Transformation of Synektik Sp. z o.o. into a stock exchange company

On February 4, 2011, Synektik Spółka Akcyjna was entered into the register of entrepreneurs of the National Court Register. Synektik S.A. was registered under number: 0000377574.

Acquisition of 100% of shares in IASON Sp. z o.o.

In connection with the acquisition of shares from IASON GmbH, active steps were taken to enable the production and sale of radiopharmaceuticals used in positron emission tomography examinations (so-called PET devices).

Signing a license agreement with IASON GmbH

Acquiring the knowledge necessary to produce radiopharmaceuticals IASON Efdege (fluorodeoxyglucose labeled with the 18F isotope) and IASOflu (sodium fluoride using the 18F isotope), in accordance with the principles of Good Manufacturing Practices.

Signing a lease agreement for space in the Świętokrzyskie Oncology Center for the production of pharmaceuticals

Obtaining a lease of premises in Kielce, which is part of the real estate in which the Świętokrzyskie Oncology Center is located. Commitment of IASON Sp. z o.o. to use the leased premises for the production of short-lived radiopharmaceuticals and to adapt the leased premises for the needs of this activity.

Signing of a distribution agreement for the sale of Siemens Group products.

Extension of cooperation with Siemens Group in the sale of their products. Within the scope of their operations, the Company offers such products as: computed tomography (CT), X-ray machines, magnetic resonance imaging (NMR), mammographs, angiographs.

Obtaining the Accreditation Certificate as the first private laboratory

Obtaining the Accreditation Certificate of the Polish Center for Accreditation, enabling the performance of acceptance and specialist tests. PCA accreditation No. AB 703 confirms the competence of the Company’s laboratory to conduct the tests listed in the scope of accreditation using strictly defined and supervised methods.

Establishment of a research laboratory for medical imaging diagnostics equipment

Decision to establish a laboratory to perform acceptance tests of radiological equipment with ionizing radiation, necessary to start using the newly installed X-ray set, and specialist tests of X-ray equipment, which all healthcare entities using ionizing radiation for medical purposes are required to perform once a year.

Establishment of IT solutions department

Organization of a department responsible for creating IT solutions, intended as a uniform environment allowing for archiving of various medical data related to the patient. Among the Company’s IT products there is the ARPACS software recognized on the market, responsible for archiving and distributing images, descriptions of tests and patient service processes, flow of information on procedures and settlements as well as administrative data of the patient.

Eatablishing assembly and service departments and signing an agreement with Siemens.

The first organized service department was established, performing assembly and installation, as well as servicing highly specialized equipment. The company cooperated with both equipment and spare parts manufacturers and equipment users, constantly step ahead of the expectations. The company provided services both in Poland and in Europe, in countries such as Italy, Germany, Austria, Norway, Russia, and Ukraine. An agreement was concluded with Siemens for the provision of maintenance services.

Establishing the Company

Synektik Sp. z o.o.  (limited liability company) was established on 4 October 2001 by means of a notarial company establishment deed, drawn up by Maria Alicja Janowska, a notary in Warsaw, Repertory A No. 7060/2001. The Company was entered into the register of entrepreneurs of the National Court Register on 23 March 2002. The company was registered under number 0000102600.