CRYOSAVE NEWS 

 

Updated with Information related to SwissMedic and OFSP

Dear Clients, Dear Partners, Dear Stakeholders

We would like to share with you in complete transparency all information related to CryoSave’s news.

This information has been communicated in real time on www.esperite.com and with the publications of numerous Press Releases.

CryoSave has always strived to act in its client’s best interests and best practices.

 

Last update: 20/10/2019 20h19

 

CryoSave and SwissMedic

Communication with the authorities

Surprisingly and despite the constant and professional overview of CryoSave to be compliant with the regulation, SwissMedic has accused CryoSave of default of notification.

CryoSave would like to disclose all the available documents.

 

 

SwissMedic – OFSP (Federal Office for Public Health)

 5th February 2019 – Update on structural organisation of the company

Cryo-Save informs the SwissMedic of the creation of a new site for processing and storage. It is in fact the split of activities between commercial activities (wholesale, importation and exportation) and the laboratory for processing and storage.

Attachments :

Requête autorisation A : 2019.02.08 CS AG Pfaffikon 1er octroi file

Requête autorisation B : 2019.02.08 formulaire de base

Requête autorisation C : 2019.02.08 Requete autorisation – Nouveau site exploitation

 

7th March 2019 – Information to SwissMedic and OFSP on the transport of the samples.

Cryo-Save informs the SwissMedic and the OFSP about the recent agreement with PBKM and the imminent transport of all the samples from Switzerland to Poland.

This information is given to the authorities on due time and purely informative as Cryo-Save has an importation and exportation authorization given by the Swiss Authorities for the transportation of cord blood samples.

Attachments :

Letter of notification to SwissMedicLetter : 07 March 2019 – letter Swissmedic

Letter of notification to the OFSP: 07 March 2019 – letter OFSP

Importation and Exportation Authorisation : 2018.12 OFSP authorisation 

 

11th March 2019

Swissmedic confirms reception of all documents related to transfer of samples to Poland and requests for modification of the sites organisations.

Attachments :

Email flow declaration of establishments : Email Flow – Declaration of the establishment CS LB – nach Polen PBKM

 

15th March 2019

 CryoSave confirms and clarify the organization of the different sites. In addition, Cryo-Save resend more documents already communicated.

Attachments

Email flow declaration of establishment CS LB : mail Flow – Declaration of the establishment CS LB – nach Polen PBKM

 

22nd March 2019 – SwissMedic confirms reception of CryoSave notification of the transport of the samples.

SwissMedic confirms reception of Cryo-Save’s notification of the transport of the samples to Poland. The only request formulated is about the continuity of the activity in the laboratory of Plan les Ouates – Geneva, and if the authorization should be maintained.

Nothing at this stage could let Cryo-Save think that the obligation of notification is not fulfilled.

It is important to notice that the samples stored in Switzerland represent a small fraction of the total samples processed and stored by Cryo-Save.

The initiative consisting of transporting the samples to Poland is a global solution implemented for all the samples stored.

Attachments :

Confirmation of transport notification -SwissMedic confirms info polish transport : SwissMedic confirms info polish transport – Schreiben BAG 22.03.2019

Confirmation of transport notification -SwissMedic confirms info polish transport – Schreiben BAG 22.03.2019:  Email Flow – Clarification on authorization and Poland  

 

10th April 2019

CryoSave confirms by email to SwissMedic the activitities in the two respective locations:

 

Quote :

« Für den Standort Chemin des Aulx 12, 1228 Plan les Ouates (GE): Gesuch für

Namens.nderung, unter Beibehaltung von den folgenden T.agkeiten:

– Herstellung von TpP/GT/GVO

– Einfuhr von TpP/GT/GVO

– Grosshandel mit TpP/GT/GVO

– Ausfuhr von TpP/GT/GVO.

Für den Standort Churerstrasse 65b, 8808 Pf.ffikon (SZ): Gesuch für Betriebsaufnahme an

einem zus.tzlichen Standort:

– Einfuhr von TpP/GT/GVO

– Grosshandel mit TpP/GT/GVO

– Handel mit TpP/GT/GVO im Ausland “

End Quote

Attachments :     

email flow 10 may 2019 : email Flow 10 May 2019 – Authorization for storage, export and Import must be maintained

 

10th May 2019

CryoSave confirms the continuity of the laboratory operations and that the next inspection can be performed on the same site.

Attachments :

email flow declaration of establishment CS LB : email Flow 10 May 2019

 

Cryo-Save’s Certifications and Authorisations

Attachments :

ISO 9001 : ISO9001 CryoSave

Authorisation n* 500219 / Requête n* 102590193 : 2018.09.11 Licence Swissmedic valid until 10.20121 change of RP

Authorisation Storage, Importation and Exportation of human cells. N* BS2016-nTxZ111+112-NOV01 : 2018.12 OFSP authorisation

 

 

Background

During the summer 2018, Esperite, sole shareholder of CryoSave, took the decision to sell its stem cell activity. A process has been put in place and some potential buyers were contacted.

The main goal is to safeguard the integrity of ALL the samples processed and stored by CryoSave of the 18 years of activity.

CryoSave has put in place several measures in order to maintain the continuity of the activity, guarantee the storage of the samples until at least their initial contractual period of time. 

Despite several critics, CryoSave has communicated in real time and as soon as it was necessary, on the progress of this operation.

Since February, several press releases were issued in English and in other 12 languages. CryoSave has indicated on due time the different steps.

In addition, more than 500’000 emails were sent in order to increase the communication performance. (emails and press releases are attached and downloadable)

Reasons for this operation:

CryoSave has created and operated for more than 18 years one of the largest Cord Blood Stem Cell in Europe. Despite constant efforts and investments, two major parameters were to be taken in consideration.

 

  • Belgium: Private Processing and Storage is Forbidden

2011, 7th November: the Belgian government voted a new regulation which practically forbid the private storage of cord blood samples. 

2012, 1st December: the Cord Blood Samples, under the principle of solidarity should be available to everyone.

The company has fought against this decision and maintained the operation. This decision was not in agreement with the local authorities and subject to legal actions.

The FAGG, Federal Agency for public health, warned several times CryoSave and asked for a complete stop of the processing in Belgium. This happened in March 2015. The processing was transferred to Switzerland with all the related costs and increase of charges.

The FAGG, also asked for the termination of storage in Belgium which became illegal.

The CEO of the company negotiated and obtained a grace period until the end of 2018 and finally March 2019.

All the samples must go and were at risk of destruction by the Belgium Authorities.

Frederic Amar, CEO Quote : 

“Rapidly after my first days in the place, I discovered several reasons for emergency actions. This situation was totally unknown by me and most of CryoSave stakeholder. The previous management has voluntarily kept it silent.

 The urgent needed to relocate the processing laboratory to Switzerland. This had a massive impact on our organization. Huge investments were needed in addition to the cost for closing down a laboratory in Belgium.

The question of the samples was also critical. Negotiating with the FAGG was challenging as nothing could reasonably have help CryoSave. 

We had 42 tanks in Belgium which needed to be transported in another country where the regulation is stable and officially confirmed. None of the major countries in Europe as France, Italy, Germany, Spain were willing to accept the samples. Switzerland was an option but very costly and not entirely compatible with the European regulation. We also had the information that Switzerland will maybe not accept the renew the medical treaties with the European Union.

The transaction with PBKM came as the perfect solution to save guard all our samples.

Poland is a reputable European country and PBKM has an excellent track record.”

“Taking this decision has saved the samples and protected the interests of all our clients.”

 

Attachments : 

  • Maggy de Block , Minister of Health expresses her decision

 B&B – 121010 – Strikt vertrouwelijk – Voorbereidende nota vergadering 11 10 2012 FAGG – AR 7 Nov 2011 Sang cordon (3) Ministry of Health – 20160111 BE MoH – Mrs de Block

  • November 2011: The FAGG changes the rules on Cord Blood

 FAGG – AR 7 Nov 2011 Sang cordon (3)

  • Legal Opinion :

 B&B – 121010 – Strikt vertrouwelijk – Voorbereidende nota vergadering 11 10 2012

 

 

  • Decline of revenue and increase of losses

2011 2012 2013 2014 2015 2016 2017 2018 2019
Revenues 41.9 36.8 30.6 27.6 27.5 26.3 16.6 12.7
Results 2.3 -17.1 -3.5 -5.0 -7.2 -8.5 -12.9 -18.1

 

CryoSave has faced significant losses of revenue mainly due to the complex structure of its organization which was built on acquisition of a network which was not correctly integrated.

Losses were generated by a heavy organization with unjustified overhead and complex organization chart.

Frederic Amar, CEO Quote: 

“I joined the company in 2015 and invested an important amount into it based on publicly available and audited financial information. Nevertheless, the drop of revenue was already in motion and costly to reverse. In addition, most of the assets were overestimated and needed to be impaired.

From the beginning I have been focus on trying to restructure the company with the help of a limited numbers of efficient colleagues. I understand why the 2 founders who sold me their shares were so eager to get rid of their creation.

I also discovered too late that the Belgian operation was supposed to stop immediately.

The Belgian Government has officially requested the stop of any operation in Belgium and the transfer of the samples out of Belgium.

I invested and lost in CryoSave more than 7 million euros. Without my contribution, I believe that most of the samples located in Belgium would have been destroyed”

 

Storage Agreement with PBKM – Famicord

Initial Negotiations

After several weeks of negotiations, PBKM and Esperite agreed on a transaction which included the following actions. 

  • PBKM will immediately organize and take the responsibility of the transportation of the samples to their facility in Warsaw. Then PBKM will store the samples in perfect condition as long as the contract is in place.
  • PBKM will potentially acquire CryoSave’s activities and assets. This transaction was covered by an exclusivity until the end of June. Finally, PBKM’s supervisory board didn’t confirm its intentions.

PBKM is now in charge of the storage for all the CryoSave samples.

Attachments : 

      

 

Transportation of the Samples by PBKM

As agreed in the different documentation, PBKM and CryoSave have worked on a efficient calendar of operation.

PBKM mission was to perform the transportation from the CryoSave facilities.

The tanks were transported under the supervision, control and responsibility of PBKM who organized the entire process. 

A report has been established by PBKM. It records all the different phases and includes a complete and permanent monitoring of all the parameters including liquid nitrogen levels, temperature control and recording, traceability of the samples.

Pictures and integral movie have been taken all along the process.

We can without doubt consider that the transportation was conducted safely and didn’t affect the integrity of the samples. They were maintained in their original conditions without physical modification or environmental constraint.

*11th March 2019 :  11 tanks shipped from Switzerland to Poland

*18th March 2019 :  15   tanks shipped from Belgium to Poland

*1st April 2019 :        27   tanks shipped from Belgium to Poland

*21st May 2019 :         2  tanks shipped from Germany to Poland

*24th June 2019 :       4 tanks shipped from Switzerland to Poland

A total of 59 tanks have been shipped from the CryoSave locations to PBKM in Warsaw – Poland

In order to comply with the regulation, samples were shipped with all the related documentation. PBKM is also the custodian of all the files of all CryoSave customers. It represents several palettes of archive boxes.

A 60th tank remains stored at Linde Gas facility in the Netherland as it has always been. Myrisoph is in charge of this tank. 

A press release was issued in 12 different languages to inform all our clients.

In addition, we sent more than 350’000 direct emails to the contact we had in our database.

Practical information: The samples processed before March 2015 were stored in Belgium and are contained in the 42 Belgium tanks.

 

Communication on 1st July 2019

Attachments: 

  • Press release published on 1st July 2019 – all languages

ENGLISH – esperite confirm safety 2019-07-01

HUNGARIAN – esperite confirm safety 2019-07-01

ITALIAN – esperite confirm safety 2019-07-01

SERBIAN – esperite confirm safety 2019-07-01

HUNGARIAN – esperite confirm safety 2019-07-01

RUSSIAN – esperite confirm safety 2019-07-01

PORTUGUESE – esperite confirm safety 2019-07-01

POLISH – esperite confirm safety 2019-07-01

DUTCH – esperite confirm safety 2019-07-01

FRENCH – esperite confirm safety 2019-07-01

SPANISH – esperite confirm safety 2019-07-01

GERMAN – esperite confirm safety 2019-07-01

 

  • Emails sent to clients – all languages

 

PBKM published on Famicord.eu website the following:

Frequently Asked Questions regarding transfers of samples from CryoSave to FamiCord Laboratory

English: Frequently-Asked-Questions-regarding-transfers-of-samples-from-CryoSave.pdf

Hungarian: Gyakran-Ismetelt-Kerdesek-biologiai-mintak-Cryo-Save-tol-FamiCord-laborba-torteno-szallitasaval-kapcsolatban.docx.pdf

Spanish: Preguntas-frecuentes-sobre-la-transferencia-de-muestras-de-CryoSave-al-laboratorio-FamiCord..pdf

Italian: Domande-frequenti-riguardanti-il-trasferiemnto-dei-campioni-da-Cryo-Save-al-laboratorio-FamiCord.pdf

Bulgarian: Често задавани въпроси относно прехвърлянето на проби от в лаборатория на FamiCord.pdf

German: Haufig-gestellte-Fragen-zur-Ubertragung-von-Proben-aus-CryoSave.pdf

Identification and localization of the Samples

All samples have a perfectly identified location reported in the CryoSave DataBase (CryoDB). 

All the tanks are clearly identified and their location perfectly known.

Some clients have requested a confirmation for the storage of their samples.

Myrisoph and PBKM will be soon able to confirm formally the identification and location for ALL samples without exception.

The lack of immediate answer and only transitory and will be solved very soon.

There is no reason to worry as the processing and storage performed by CryoSave has always been performed according to the best possible standards.

Every sample is in it own canister, has a specific place in a rack, the rack, correctly referenced and placed in its tank. Every location and reference has been entered in CryoDB.

 

Licence Agreement with Myrisoph

Once the transaction with the polish partner fell short and was cancelled twice, CryoSave had the need to secure the continuity of business and maintain the clients support in a proper way.

CryoSave and Myrisoph, who is linked to CryoSave Dubaï, came to an agreement on 20th August 2019.

Basis for the agreement:

Myrisoph and its subsidiary in Switzerland, CSG-Bio SA, are now in charge of the continuity of the commercial activity as well as performing the technical support for the existing customers.

The following items have been transferred from CryoSave to Myrisoph and CSG-Bio SA :

  1. CryoSave websites , www.cryosave.com and www.cryo-save.com with all their existing local extensions as for example cryo-save.it, cryo-save.es, …
  2. Social network pages, Facebook, Instagram, Linkedin, …
  3. CryoSave Database, called CryoDB, administrates laboratory results and medical history. 
  4. Email addresses and Phones numbers
  5. Myrisoph is now the exclusive licensee of the trade marks CryoSave and all the derivatives and connected trade marks like Salveo.
  6. Myrisoph is the director of the CryoSave Stichting which owns all the tanks were the samples are stored.

 

  • Myrisoph is committed to financially and operationally guarantee the storage of all the CryoSave samples. 

 

Myrisoph has agreed to replace CryoSave in its obligation to pay the annual fees of the PBKM Storage Agreement.

 

Since 20th August 2019, CryoSave communication, activity and sales are exclusively controlled by Myrisoph and CSG-Bio SA. 

The former CryoSave team does not have the right to operate any activity any more. 

Nevertheless we took the initiative to publish this communication in order to clarify the situation

CSG-Bio SA

12, rue de Hesse

PO Box 5322
1211 Geneva 11
Switzerland

Certificate of registry : CSG-Bio – Registre du Commerce du Canton de Genève

Myrisoph Capital Inc

2140 S.Dupont Highway, Camden

DE 19934, County of Kent 

USA

Frederic Amar, CEO Quote : 

“We have all the reasons to believe that with Myrisoph agreement, in complement with the PBKM agreement, CryoSave has acted and worked for the best interests of CryoSave clients and for the protection of their samples.”

 

Information on the Samples

  • Myrisoph

Myrisoph and its branch in Switzerland have access to the entire information with the CryoSave Database. 

The usual email addresses are functioning and the new licensees must be able to communicate all relevant information. 

The former CryoSave team has maintain constant their effort to guarantee the integrity of the Data.

You must be able to receive an answer sending your messages now to :

  • info@cryo-save.com
  • Info@cryosave.com

In case of lack of proper reaction, the former CryoSave team could organize a support team.

 

  • PBKM

PBKM is the custodian of the entire samples inventory in Poland.

It includes all the physical documentation.

PBKM is entitled to communicate information to the clients who would formulate a request. 

PBKM has also obligation per contract to support the CryoSave clients and communicate all information in its role of processor of the client personal data.

 

Continuity of Services to CryoSave Clients

Cryosave has choosen with PBKM the best option for a long term quality storage of the samples. PBKM as Processor of the clients information is able to physically access all the samples in its custody and to deliver the relevant information contained in the accessible database and the physical files.

It could require some limited time before the service runs optimally due to the large quantity of information to process. 

Myrisoph and its branch in Switzerland are now the legitimate licensees of the CryoSave brands and have under their control, databases, websites, emails, phone number and social medias. It is a matter of few days before they should be able to re-activate a proper communication. 

In addition Myrisoph committed to guarantee financially the cost of all CryoSave samples.

To be continued.