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Helsinki, Finland, October 17th 2016

Clinical study results reveal improved heart condition with Medtentia Annuloplasty Ring (MAR)

The statistical analysis of Medtentia’s proof-of-concept study evaluating the Medtentia Annuloplasty Ring (MAR) has recently been completed.

As previously expected based on preliminary data analyses, the main safety- and performance- related objectives of the study were successfully achieved. The newly analyzed results indicate that the MAR ring is well tolerated and induces improvement of heart condition in patients with mitral regurgitation. In the study, patients with mitral regurgitation underwent a surgery, in which their mitral valve was repaired with the MAR ring.

According to the cardiologist Dr. Tapio Aalto who conducted the central echo readings of the study, repair based on the MAR ring led to improved heart condition in all patients who were analyzed during the study. The coordinating investigator of the study, professor Kalervo Werkkala, states that although the 2-year follow-up time has ended, the study patients are still in good condition. Therefore also the long-term tolerability of the MAR ring seems promising so far. The study results strongly support the development of Medtentia’s second mitral repair product, the catheter-based CathHELIX, which is currently under preclinical investigation.

The MAR study was led by Professor Werkkala and the principal investigator of the study was Dr. Antti Vento, PhD. The study was carried out in the Lung and Heart Center of Helsinki University Hospital Finland, and the treatment time consists of over 600 patient care months gathered from 11 patients with a successful MAR implantation.

 


 

Helsinki, Finland, September 27th 2016

Hannu Syrjälä Appointed as New Chairman for Medtentia’s Board of Directors

Medtentia International Ltd is happy to announce the appointment of Hannu Syrjälä as the new Chairman of its Board of Directors. Mr. Syrjälä succeeds Tord Lendau as Chairman starting from the 14th of September, 2016.

Mr. Syrjälä has over twenty years of experience in different senior executive roles, including Head of Life Support Solutions Business in GE Healthcare. He is CEO and Partner of Berggren Group, one of the leading IP law firms in Scandinavia, and he currently serves as a board member in several tech start-up and private equity-owned companies.

 


 

Helsinki, Finland, August 22nd 2016

Data collection completed for the clinical study evaluating Medtentia Annuloplasty Ring safety and performance

The long-term data collection for the proof-of-concept study evaluating the Medtentia Annuloplasty Ring (MAR) has recently been completed. The prospective single-arm clinical study assessed MAR safety and performance in 11 adults who underwent mitral valve repair surgery. The collected data is currently being analyzed, and preliminary data analyses have yielded promising results.

“The preliminary results of the study have exceeded our expectations”, says Olli Keränen, the CEO of Medtentia. According to Keränen, all the main safety- and performance-related objectives of the proof-of-concept study were achieved. Medtentia aims to submit the results for publication during autumn 2016.

The MAR study was led by Professor Kalervo Werkkala and the principal investigator of the study was Dr. Antti Vento, PhD. The study was carried out in the Lung and Heart Center of Helsinki University Hospital Finland.

 


 

Helsinki, Finland, April 19th 2016

Medtentia’s Board of Directors elected

The Annual General Meeting of Medtentia International Ltd was held on April 19th 2016 in Helsinki, Finland. 

Tord Lendau was elected as Chairman of the Board of Directors and Markku Fagerlund; Lennart Hansson, PhD; Hannu Syrjälä; and Professor Hans-Reinhard Zerkowski were elected as members of the Board of Directors. Mr. Lendau is a businessman with extensive experience in international Corporate Governance, and he has held senior management positions at various life science companies, including Vice President and General Manager of Medtronic Synectics AB.

 


 

Helsinki, Finland, March 30th 2015

Medtentia raises €8M in new financing round

Medtentia International Ltd Oy has successfully completed a €8M financing round in March 2015. The round includes a total of €6M in equity from existing and new investors, while the remaining €2M consists of shareholder loans converted into capital.

The raised funds will be used mainly to support the development and testing of Medtentia’s catheter-based technology for minimally invasive mitral valve repair.

 


 

Press release
Helsinki, Finland, July 31, 2013

Medtentia Helix Ring for Mitral Valve Repair Continues to Achieve All Objectives in Approval Study

Medtentia International Ltd Oy today announced that the surgeons at Helsinki University Hospital led by Prof Werkkala have successfully continued to recruit patients for the official second phase of the clinical approval study evaluating the safety and efficacy of the “Medtentia Helix Ring in Adults Undergoing Mitral Valve Repair Surgery”.

After review and recommendation by Data Safety Monitoring Board and ethical authorities the competent authority has approved the study continuation. The second phase of the clinical study will commence as a multi-center study in several European countries in 2013.

The preliminary results after more than 85 patient months show consistent and sustained hemodynamic valve performance without adverse events and support the unique advantages of the helix ring technology. All the safety and performance study objectives have been achieved so far.

The Medtentia Helix Ring leverages the company’s proprietary helix-technology platform featuring a safe and intelligent mitral valve repair and replacement technique simplifying and shortening surgery. Medtentia’s helix based products may benefit patients by enabling small-incision surgical approaches and reduced operative times, leading to potentially reduced morbidity and faster recovery also for patients undergoing complex cardiac procedures. The Medtentia helix-technology provides also promising opportunities for catheter-based mitral valve interventions.

About Medtentia International Ltd Oy

Medtentia International Ltd Oy is a clinical-stage medical technology company developing innovative products for mitral valve repair and replacement based on the company’s proprietary helix technology. The company, located in Helsinki, Finland is backed by leading Nordic venture capital funds.

Additional company information can be found at www.medtentia.com.

Contact Information:
Olli Keränen, CEO +358 50 3567090
Prof Hans-Reinhard Zerkowski, COB +41 79 2767139



 

Press release
Helsinki, Finland, Oct 26, 2012

Medtentia Helix Ring for Mitral Valve Repair
Shows Promising Results

Helsinki, Finland, Oct 26, 2012 – Medtentia International Ltd Oy today announced that the investigators at Helsinki University Hospital have successfully completed the recruitment of patients for the first phase of the clinical study evaluating the safety and performance of the Medtentia Helix Ring in adults undergoing mitral valve repair surgery. The preliminary results after a total of 36 patient months in the clinical study show consistent and sustained hemodynamic valve performance and support the unique advantages of the helix ring technology. All the safety and performance study objectives have so far been achieved.

The second phase of the clinical study is planned to commence as a multi-center study in several European countries in Q1 2013.

The Medtentia Helix Ring leverages the company’s proprietary helix-technology platform featuring a safe and elegant mitral valve repair and replacement technique. Medtentia’s helix based products may benefit patients by enabling small-incision surgical approaches and reduced operative times, leading to potentially reduced morbidity and faster recovery also for patients undergoing complex cardiac procedures. The Medtentia helix-technology provides also interesting and promising opportunities for catheter-based mitral valve interventions.

About Medtentia International Ltd Oy

Medtentia International Ltd Oy is a clinical-stage medical technology company developing innovative products for mitral valve repair and replacement based on the company’s proprietary helix technology. The company, based in Helsinki, Finland, was established 2002 and is backed by leading Nordic venture capital funds.

Additional company information can be found at www.medtentia.com.

Contact Information:
Olli Keränen, CEO +358 50 3567090

 



Publications

Comparison of the novel Medtentia double helix mitral annuloplasty system with the Carpentier-Edwards Physio annuloplasty ring: morphological and functional long-term outcome in a mitral valve insufficiency sheep model
Moritz A Konerding1*, Jarmo Simpanen2, Leo Ihlberg2, Juha Aittomäki2, Kalervo Werkkala2, Vera Delventhal1 and Maximilian Ackermann1
* Correspondence: konerdin@uni-mainz.de
1. Institute of Functional and Clinical Anatomy, University Medical Center of the Johannes Gutenberg-University Mainz, 55099, Mainz, Germany.
2. Department of Cardiothoracic Surgery, Helsinki University Hospital, Helsinki, Finland.

 

Medtentia Double Helix Annuloplasty System Evaluated in Porcine Experimental Model; 
Henrik Jensen MD PhD1, Jarmo Simpanen MD2, Morten Smerup MD PhD1, Marianne Bjerre MS1, Morten Bramsen MS1, Kalervo Werkkala MD PhD2, Tiina Vainikka MD PhD2, 
Michael Hasenkam MD DMSc1 and Per Wierup MD PhD1, 
1. Dept. of Cardiothoracic Surgery, Skejby Hospital, Aarhus University, Denmark, 
2. Dept. of Cardiothoracic Surgery, Helsinki University Central Hospital, Finland; 
Innovations, Volume 5, Number 2, March/April 2010

 



Abstracts, Posters and Congress presentations

Nov 2012, IEEE Healthcare Innovation of the IEEE EMBS Houston, Texas USA;
Double Helix Mitral Annuloplasty System: A Comparative Flow Analysis;
Mika Nikander, Elomatic Oy, Turku, Finland

Jun 2010, ISMICS, San Fransisco; 
Kalervo A. Werkkala MD PhD, Helsinki University Hospital, Finland 

Aug 2009, Scandinavian Association of Thoracic Surgery (SATS), Stockholm; 
A New Medtentia Ring for Mitral Annuloplasty; 
Kalervo A. Werkkala MD PhD, Helsinki University Hospital, Finland

Jun 2008, ISMICS, Boston; 
The Minimally Invasive Medtentia Double Helix Mitral Annuloplasty System, 
Henrik Jenssen MD, Aarhus University, Denmark

Oct 2005, Milan; 
Key Ring Concept In Mitral Valve Reconstructions, 
Per Wierup MD PhD, Aarhus University, Denmark