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Company History

2003

November 27, 2003 – Human Stem Cells Institute OJSC received its state registration (founded on November 3, 2003, on the base of the Cyrobank of Biomaterials of the Blokhin Cancer Research Center of the Russian Academy of Medical Sciences); Gemabank, a family cord blood stem cells  bank, was created.

2005

The first successful transplantation of cord blood hematopoietic stem cells and peripheral stem cells.

Successful transplantation from related partially compatible donors (brother and father) to a patient suffering from neuroblastoma (stage 4). The operation was carried out by specialists of the Pediatric Oncology and Hematology Research Institute of the Blokhin Cancer Research Center.

2006

HSCI founded its own publishing house, which became the publisher of Cell Transplantology and Tissue Engineering, a leading peer-reviewed scientific & analytical journal.

Together with the Blokhin Cancer Research Center, HSCI developed a technique for isolating and preserving hematopoietic stem cells which was officially confirmed by the Federal Medical-Biological Agency of Russia and recommended by the Russian Ministry of Healthcare.

2007

HSCI organized for the first time in Moscow an international symposium on current issues in cell-based technologies.

Since then, the event has been held on an annual basis and works presented at the symposium are published in Cell Transplantology and Tissue Engineering. The VI International Symposium “Current Issues in Cell-Based and Gene Technologies” was held on October 11-12, 2013 in Moscow.

2008

On December 12, 2008, HSCI’s patented method for isolating mononuclear  stem cells from cord blood was registered and approved in Russia. (The patent was issued on January 20, 2009, to HSCI with an expiry date of April 3, 2027).

This technique allows for the doubling of the number of hematopoietic stem cells isolated, thus providing a volume sufficient not only for transplantation into a child but also into an adult.

Construction was completed on Gemabank new laboratory.

The online version of Cell Transplantology and Tissue Engineering Journal was launched.

All issues of the journal are now available online.

2009

Clinical trials began for Neovasculgen – the first Russian gene-therapy drug developed by HSCI to treat Peripheral Arterial Disease (PAD).

HSCI held an IPO, becoming the first Russian biotech company to go public.

In December 2009 HSCI placed 15 million ordinary shares (20% of increased share capital) on the MICEX at 9.5 rubles per share (ticker: ISKJ). HSCI’s IPO opened trading on the IIM MICEX (Innovation & Investment Market) – a new exchange sector created  as a platform for innovative and growing companies. Today the MICEX is part of the Moscow Exchange (the ME MICEX-RTS).

2010

HSCI acquired a 50% stake in Hemafund, the largest family cord blood bank in Ukraine.

This acquisition was made with the aim of achieving synergies from joint business operations in the development of new cell-based technologies in Ukraine (as a part of the investment program unveiled ahead of HSCI’s IPO).

HSCI’s IPO was named Best IPO of an Innovative Company.

The award was presented based on research carried out by the Center for Stock Market Development and commissioned by the Institute for the Development of Financial Markets titled Ratings of the Effectiveness of IPO by Russian Companies in 2009-2010.

In response to a proposal by HSCI, RUSNANO’s Supervisory Board approved participation of RUSNANO in SynBio, a multilateral international project. The project company SynBio is intended to develop and produce new drugs for the Russian and world markets.

In December 2010, HSCI launched SPRS-therapy – the Company’s new cell technology service in aesthetic medicine.

SPRS-therapy – a comprehensive set of services for individual skin regeneration – is based on a technology for applying autologous dermal fibroblasts to correct the effects of aging and skin defects. This innovative technology was authorized by the Russian healthcare regulator in December 2009.

2011

HSCI acquired a control stake in Cryonix CJSC (St. Petersburg, Russia).

This acquisition was aimed at fully integrating the efforts of the two companies in the development of novel drugs, securing marketing authorization and provision of innovative medical services.

HSCI became co-investor in SynBio, a multilateral international project supported by RUSNANO.

Throughout the course of 2011, the final investment agreement for the SynBio project was signed by all parties and received HSCI’s corporate approval at a General Shareholders’ Meeting. In November 2011, following RUSNANO’s investment in the project company (41% stake), HSCI became its largest private co-investor (28%).

NextGen – HSCI’s new 100% subsidiary.

NextGen’s focus is R&D for gene and cell therapy, development of techniques for preventing inherited diseases using modern assisted reproductive technologies and the development of arrays for DNA diagnostics of inherited diseases and predisposition to them.

Neovasculgen® successfully passed the phase 2b/3 clinical trials and in December received marketing authorization in Russia. HSCI began active steps to launch this pioneering gene-therapy drug in the Russian market.

In Decemeber 2011 HSCI’s Board of Directors approved a new business plan and corporate strategy for 2012-2016.

2012

HSCI launched its Gemascreen service in Russia - Phase 1 of the Company project to provide nationally genetic diagnostics and consulting services with the aim of early identification, prediction and prophylactic treatment of genetic disorders.

Throughout 2011 HSCI developed a project to create its own Russia-wide network of advanced medical genetics centers for offering genetic diagnostics and consultation regarding: the monogenic inherited diseases most commonly found among the peoples of the Russian Federation; predisposition to the most widespread multifactorial disorders; chromosome abnormalities. 

In January 2012 the Company launched the nationwide Gemascreen program for the presymptomatic identification of the six most common inherited disorders in Russia or their carrier status through DNA screening using umbilical cord blood of a newborn. Through follow-up consultations with a physician geneticist the parents received information on prophylactic treatment of complications and prevention of the development of clinical symptoms of a disease (if discovered) or advice on approaches to planning the health of the child’s progeny (in the case that carrier status is identified). Gemascreen was offered on the Russian market through the end of 2013, when it was replaced by Ethnogene Neo.

Cell Transplantology and Tissue Engineering (CTTE) scientific and analytical journal founded and published by HSCI was included in the international bibliographic and abstract database EBSCO (www.ebsco.com).

HSCI began the process of obtaining marketing authorization for Neovasculgen® in Ukraine.

HSCI received marketing authorization for a device and is readying to begin distribution in Russia of the Celution® System produced by Cytori Therapeutics (USA).

This innovative medical technology allows for collection and processing of the patient’s own human adipose tissue for subsequent use in reconstructive and aesthetic medicine (injection of a patient’s own adipose-derived regenerative cells /ADRCs/). All laboratory and cell processing tasks are carried out by one device – the patient’s own cells are used with minimal manipulation, which simplifies the procedure and makes it effective and convenient for both the doctor and the patient (“Auto and Fresh” approach).

On June 30, 2012, at the 23rd Annual Conference of the Russian Society of Angiologists and Vascular Surgeons in St. Petersburg, a presentation was made of Russia’s first gene-therapy drug Neovasculgen®, developed by HSCI. The presentation was part of the launch program for the product in Russia.

On August 3, 2012, HSCI and Moscow bank of Sberbank of Russia completed signing of the set of agreements on financing in the amount of 75 million rubles for the construction and equipping of HSCI'S new laboratory and production complex.

The design and construction of this complex, which has no analogues in Russia, began in 2011. As a result (see year “2013” in this Company history section), the complex was built in a very short timeframe using HSCI’s own funds as well as financing from Sberbank of Russia.

The certification of Neovasculgen's first batches had been completed and the drug went on sales in Russia (in late September 2012).

RGMC HSCI LLC was established – a new 100% subsidiary of HSCI.

RGMC HSCI (Regenerative and Genetic Medical Center of the Human Stem Cells Institute) was created in October 2012 for the provision of medical services (with the aim of making use of tax allowance available for medical service providers).

General Director of HSCI Artur Isaev named Entrepreneur of the Year in high-tech.

The awards ceremony of the Entrepreneur of the Year Award in Russia, organized by Ernst & Young, was held in Moscow on November 29, 2012. The first Entrepreneur Of The Year® Award was held in the United States in 1986. Over the past 26 years the award’s geography has greatly expanded to include more than 50 countries worldwide. 

2013

SPRS-therapy becomes one of the Top-12 aesthetic medicine procedures in 2012.

In January 2013 the Russian journal Beauty & Health compiled its annual list of the top methods and procedures in aesthetic medicine. SPRS-therapy – a technology for applying autologous skin fibroblasts to repair skin damage due to aging or other structural changes introduced to the market by HSCI in December 2010 – was among the top 12 technologies which according to experts “proved their merits and won industry recognition” in the previous year.

HSCI receives marketing authorization for Neovasculgen® in Ukraine.

On February 26, 2013, the Ministry of Healthcare of Ukraine issued marketing authorization (Registration Certificate No.899/13-00200000) to HSCI for Neovasculgen®. The first deliveries of the drug to Ukraine began in the second quarter of 2013.

HSCI Board of Directors approves business plan for 2013-2017.

On March 20, 2013, the Board of Directors of HSCI approved the “Business Plan of OJSC HSCI and its Subsidiaries According to Projects (2013-2017)”.

HSCI receives prize for innovative work.

On March 22, 2013, at the Mid-Cap-2013 forum in Moscow the Human Stem Cells Institute received a special prize for innovation.

Completion of the technical and clinical validation of HSCI’s proprietary Ethnogene DNA array and launch of Ethnogene medical genetics consultations based on this array.

In February 2013 HSCI announced the completion of the technical validation and in April - the clinical validation of its own DNA array for the provision of genetic screening and consulting services as a part of the Company’s socially significant project to create a Russia-wide network of Genetico medical genetics centers for the identification and prophylactic treatment of genetic disorders among various age groups. HSCI’s Ethnogene DNA allows to simultaneously test for the presence or carrier status of more than 60 monogenic inherited diseases and also predisposition to the development of several prevalent multifactorial disorders. The uniqueness of this DNA array, in contrast to others offered on the market, is that it reflects the specific spectrum of inherited diseases that are most commonly encountered among residents of Russia and the CIS.

Starting in the second half of April 2013, HSCI began using this array to provide its new Ethnogene services – medical genetics consultations for a broad range of consumers: for children and adults (identification of genetic features and determination of genetic load for the purpose of forecasting and evaluating risks), as well as a tool in pregnancy planning (preconception screening).

Neovasculgen® was included in the National Recommendations for treating patients with vascular diseases.

The new version of the National Recommendations for treating patients with Peripheral Arterial Disease was presented in June 2013 at an international conference of vascular surgeons in Novosibirsk. The National Recommendations were amended to include broader use of modern noninvasive technologies for treating patients with vascular diseases, which is key to reducing the incapacitation of patients. In particular, the recommendations have been expanded with a new section on gene-therapy drugs which includes information about the first Russian gene-therapy drug Neovasculgen® for therapeutic angiogenesis.

Opening of the new laboratory and production complex of the Regenerative and Genetic Medical Center of the Human Stem Cells Institute (RGMC HSCI).

HSCI’s new laboratory and production complex for the creation of new products and the provision of services in the fields of regenerative medicine and medical genetics was officially opened in June 2013. The facility was designed in accordance to GMP standards. It includes cleanroom laboratory and production premises totaling 360 square meters and a modern automated cryogenic storage facility. The complex consists of a molecular genetics lab, cell culture lab, pharmaceutical block, cord blood stem cell bank and reproductive tissue bank (Reprobank). Its creation is a strategically important step not only for HSCI but for the Russian biotech sector as a whole. In addition to supporting HSCI’s products and services, the complex offers contract-based services for the small-batch production of biomedical products and drugs of other Russian and international companies.

Using the new laboratory and production complex, RGMC HSCI began to offer the spectrum of preimplantation genetic diagnosis (PGD) services and is also opening a reproductive cell and tissue bank called Reprobank (personal storage, donor bank).

In September 2013, the Molecular Genetics Laboratory and Reproductive Tissue Bank of RGMC HSCI received licenses for provision of these medical services under the new regulations of the Russian Ministry of Healthcare.

HSCI shares were included in the Broad Market Index and the Second-Tier Index of the Moscow Exchange.

HSCI ordinary shares were added to the forenamed indices for the first time. Therefore, starting December 17, 2013, HSCI ordinary shares have been employed in the calculation of three Moscow Exchange indices: the Broad Market Index, the Second-Tier Index and the MICEX-Innovation Index.

Russian Ministry of Industry and Trade issues HSCI with a license for Pharmaceutical production.

The license “To engage in the production of medicinal products” (No.12785-LS-P dated 31 December 2013) allows HSCI to manufacture, store and sale of sterile cell-based drugs in form of liquid for injections. Thus the Biopharmaceutical production facility within the new HSCI’s laboratory and production complex has begun functioning for the development, manufacturing and quality assurance of the drugs (including contract small batch manufacturing for the use in preclinical and clinical trials by Russian and foreign R&D companies).

2014

HSCI changed the form of participation in SynBio project

On 14 February 2014 HSCI signed an agreement on the transfer of its share in the charter capital of SynBio LLC (28.18% with a nominal value of RUB 613,078,000) in the form of an additional contribution to the charter capital of IceGen LLC.

This move has been made by HSCI to execute the conditions of the Investment Agreement for the SynBio project, signed on 4 August 2011 (see press release here) and approved together with its associated transactions by the Extraordinary General Shareholders’ Meeting on 31 August 2011 (see press release here).

As a result, SynBio LLC will have only two participants: RUSNANO (41%) and the holding company (59%), which represents the interests of all other partners in the project, including HSCI. The holding company is IceGen LLC, established on 9 August 2011, with HSCI’s share of this company’s charter capital amounting to RUB 144,000 out of the total of RUB 300,000. Thus HSCI’s stake in IceGen LLC amounted to 48.07% stake.

Therefore, as of the date of the notarization of the transaction, HSCI relinquished the ownership of its stake in SynBio LLC and beginning from the moment of the official registration of the transfer of ownership rights (record in Unified State Register of Legal Entities as of 21 February 2014 ) has ceased to be a participant in SynBio LLC and indirectly owned a share in this company through its stake in IceGen LLC, which following state registration of the charter capital increase of IceGen LLC to RUB 1,275,697,000 remained equal to 48.07% but increased in nominal value to RUB 613,222,208.74.


HSCI and RVC Biofund signed investment agreement on implementation of joint project in medical genetics and reproductive medicine

The agreement was signed in Moscow on 17 February 2014 with the aim of implementing a project to create in Russia a network of Genetico medical centers for the development of personalized medicine based on the principle of an individualized approach to the prevention, diagnosis and treatment of genetic disorders. This project also entails the development of services based on a reproductive cell and tissue bank (personal storage and donation).

The project is being implemented through a subsidiary of HSCI – the Regenerative and Genetic Medical Center of the Human Stem Cells Institute (RGMC HSCI LLC) – in which RVC Biofund becomes a participant.

The investment agreement signed by HSCI and RVC Biofund took effect after receiving the relevant corporate approval by the EGM on March 27, 2014.

Moscow Life Sciences Investment Day – 2014 organized by HSCI attracts more than 250 participants

Moscow Life Sciences Investment Day is the first conference in Russia to be fully dedicated to investment opportunities in healthcare, biotechnologies, biopharmaceuticals, medical equipment and devices, medical services, diagnostics and digital health, as well as the exchange of information and introduction of companies seeking to attract investment in projects related to human health.

The conference supported by Moscow City Government, Moscow Exchange and Russian Venture Company took place on June 18, 2014. Among participants there were more than 40 Russian and foreign LS companies, around 100 investors, and also a number of international LS scientists, pharma industry professionals and market research analysts.

Artificial chromosome for the treatment of genetic disorders was developed by HSCI

HSCI researchers in cooperation with Institute of Cytology RAS (Russian Academy of Sciences) and National Institutes of Health (Bethesda, USA) have developed a human artificial chromosome (HAC) for the correction of inherited (genetic) Limb-Girdle Muscular Dystrophy and Hemophilia. The Company is actively working on further development of this technology conducting further trials using cell cultures and animals.

Development of Russian innovative drug for Peripheral Arterial Disease was supported by the Council of Maryland Biotech Companies (USA)

According to the Council’s resolution, made on May 1, 2014, the drug Neovasculgen® developed by Human Stem Cells Institute has been approved as a necessary treatment supporting the health of American citizens. The Germantown Incubator welcomed the development of groundbreaking drug Neovasculgen® in the USA and decided to provide full cooperation in developing the company and bringing this and other potential drugs to the American consumers.

HSCI launched program in the name of Adam Nash to treat children with inherited diseases

Adam Nash is the first baby born in in 2000 in the United States using the preimplantation genetic diagnosis (PGD) procedure to save the life of an older sibling. Adam’s sister, Molly Nash, had the genetic disease - Fanconi Anemia. Without a stem cell transplantation, Molly would not have lived to see her 10th birthday. As Molly’s parents failed to find a fully compatible donor match for her, they decided to undergo in vitro fertilization using PGD to choose an embryo free of the genetic mutation casing Fanconi Anemia and also histocompatible . Upon birth, cord blood stem cells from Adam were transplanted to Molly and saved her life. The procedure was completely safe for Adam – the blood was taken from his umbilical cord before its disposal.

HSCI opened the unique Genetico center, featuring a PGD laboratory, in Moscow in 2013. Today the center provides a wide range of genetic tests and counsels families on early identification, prediction and prophylactic treatment of genetic disorders. The Genetico medical genetics centers HSCI has been opening throughout the country starting 2013 actively cooperate with IVF clinics in Russia and offer expectant parents the opportunity, if necessary, to use PGD.

Parents who go to Genetico centers to take advantage of PGD so as to give birth to a healthy baby and treat an older child with an inherited disease thereby become members of the Adam Nash program in Russia. As part of this program, the first Russian child was born in 2014 with the aim of saving his elder sister diagnosed with Shwachman-Diamond syndrome.

Cell Transplantation and Tissue Engineering scientific and analytical journal published by HSCI was renamed to Genes and Cells

HSCI announced the renaming of the journal in September, 2014.

The decision to rename the journal was due to the fact that HSCI has significantly widened the scope of its research interests and activities: in addition to regenerative medicine and cell technologies, the company became active in such areas as gene therapy and medical genetics.

As of now, Genes and Cells is the leading specialized peer-reviewed scientific and analytical journal recommended by the Higher Attestation Commission of the Ministry of Education and Science of the Russian Federation for the publication of the of doctoral thesis abstract. The journal has a high citation index, and is included in the eLIBRARY and Scopus databases, and EBSCO, and has a broad target audience. The journal’s website, the updated version of which was launched in 2011, is an independent media outlet with a diverse news line and online diaries (blogs) of the leading Russian and foreign specialized professionals.

HSCI was Ranked among the Top 10 Russia's Most innovative companies under TechUspeh ('Tech Success') Third National Rating

For the first time, the “TechUspeh” rating was conducted in 2012 by the Russian Venture Company (RVC) in partnership with the Association of Innovative Regions of Russia (AIRR), PwC and SME Bank. The rating determines the leading fast-growing high-tech companies in Russia which are capable of playing a key role in the future development and modernization of Russian technological industries.

The results of the “TechUspeh” (‘tech success’) third national rating of Russia’s fastest-growing high-technology companies were tallied on October 15, 2014 in Moscow at the “Open Innovations” international forum. A total of 110 companies took part in the rating in 2014, of which 80 successfully passed the qualification criteria.

HSCI for the second year in a row was included in the TOP-10 innovative companies of the rating in terms of the technological level of its products, their originality, the company’s intellectual property, as well as expenditures on R&D and technological modernization.

The results of the Company’s law suit against “Russian Reporter” magazine and its founder - CJSC Expert Media Holding

On October 28, 2014, the Moscow Arbitration Court ordered CJSC Expert Group and CJSC Expert Media Holding to pay a total of 44.4 million rubles (or about 1 million US dollars) as compensation to HSCI for financial losses reputational harm caused by a publication in Russian Reporter magazine entitled “Money Made on Children’s Blood” dated January 24, 2013. The court also ordered to remove the magazine web pages with the published article.

The article contained false information about the Gemabank (largest family cord blood stem cell bank in Russia and CIS) belonging to HSCI and about cord blood banking in Russia in whole, discrediting HSCI’s business reputation. “Russian Reporter” magazine was established by CJSC Expert Media Holding.

Previously, the Moscow Arbitration Court fully upheld HSCI’s legal claim as of June 25, 2013 and ordered Expert Media Holding to publish HSCI’s response to the publication in Russian Reporter magazine as complied with the Russian legislation.

According to Artur Isaev, General Director of the Human Stem Cells Institute: “This article was a journalistic mistake in which the author did not understand the details, groundlessly accusing an entire industry of non-existent crimes, and thereby causing considerable damage to the company and the cell technologies sector in general. Development of this sector is for the benefit of society and the people... We sought to be heard – we asked the respected journalists to publish our opinion, because we wanted justice. The court carefully reviewed the case and made an honest and fair decision. Despite winning in all courts during the case, we are ready to settle with Russian Reporter magazine and the defendants and reach an amicable agreement, even at this stage. If this isn’t possible, then we will donate all 44.4 million rubles given to us for compensation of damages and reputational harm to charities for the treatment of children with leukemia and inherited diseases. It is precisely for these patients and for creating treatments for similar diseases that Gemabank and the entire team of the Human Stem Cell Institute work”. See press release for details.