Mauna Kea Technologies - 500 Beiträge pro Seite

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Mauna Kea Technologies, führender Hersteller von endomikroskopischen Geräten hat soeben die Resultate für das 4. Trimester 2011 bekanntgegeben. Der Umsatz ist im Vergleich zum letzten Jahr um 48% gestiegen.Mauna Kea hat ein revolutionäres Gerät (Cellvizio)entwickelt,welches es erlaubt endoskopische Untersuchungen im mikroskopische Bereich zu machen. Cellvizio erlaubt es auf die für den Patienten belastenden Gewebeentnahmen während der Untersuchung zu verzichten.
Der Vertrieb des Geräts ist jetzt erst in Nordamerika, Asien und Europa angelaufen so dass für 2012 eine sehr hohe Umsatzsteigerung zu erwarten ist.

http://www.maunakeatech.com/

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http://www.finanzen.net/nachricht/Mauna-Kea-Technologies-201…

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Hier noch ein interessanter Link:

http://www.4-traders.com/MAUNA-KEA-TECH-8296092/news/MAUNA-K…

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MAUNA KEA TECH : Admission of the Mauna Kea Technologies Share to the SRD "Long"

Regulatory News:

Mauna Kea Technologies (Paris:MKEA), leader in the endomicroscopy market, today announces the upcoming admission of its share to the "SRD Long-Only" of the Deferred Settlement Service.

Admission was granted following the quarterly revision of the NYSE Euronext Paris indices and as a result of the share's daily liquidity of over 100,000 euros. A regulated market service, the SRD "long-only" will enable investors to take long positions while buying shares or credit. Admission of the Mauna Kea Technologies share to the SRD "long-only" will take place at the opening of the stock market session February 24, 2012.

"We are delighted to be joining the SRD Deferred Settlement Service which will provide Mauna Kea Technologies' shares with better visibility and liquidity less than eight months after its first listing. This decision will allow a new category of investors to position themselves on the share," said Sacha Loiseau, founder and CEO of Mauna Kea Technologies. "On behalf of the entire team, I would like to take this opportunity to thank all of our shareholders for their interest in the Company."

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02/08/2012 | 11:50am
MAUNA KEA TECH : PERSEE Project Successfully Meets Key Milestone, Mauna Kea Technologies Obtains ?1.7 Million in Funding from Oseo

Regulatory News:

Major milestone paves way for real-time microscopy in cancer surgery

Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA, FR0010609263), leader in the endomicroscopy market, announced today that PERSEE, the consortium headed by Mauna Kea Technologies, has met a major milestone in its development and has obtained the second installment in funding from OSEO, a public sector institution dedicated to economic development in France.

The consortium has obtained a total of ?2.5 million, of which ?1.7 million will go to Mauna Kea Technologies for its role as project leader. The milestone payment was made possible by the successful completion of the first phase which included project definition, a feasibility study and a proof-of-concept demonstration. To date, Mauna Kea Technologies and its partners have received a total of ?4.2 million in funding for the project.

"The progress achieved in this first phase, exploring the abdominal cavity through the coupling of our probe-based Confocal Laser Endomicroscopy solutions with robotic devices, brings us a step closer to the development of surgical applications," commented François Lacombe, Chief Scientific Officer at Mauna Kea Technologies. "In addition to current endoscopic applications, we now envision expansion into fields, such as laparoscopic surgery, for an even more comprehensive treatment of patients with cancer".

PERSEE is a collaborative project led by Mauna Kea Technologies, and includes Endocontrol, the Intelligent Systems and Robotics Institute of the Pierre and Marie Curie University in Paris, France, the Gustave Roussy Cancer Institute in Villejuif, France, and the Mutualiste Montsouris Institute also in Paris, France. The objective of the PERSEE project is to develop new, real-time, pre- and per-operative diagnostic solutions by coupling endomicroscopy, robotics and telediagnostics. The 6-year-old project has been funded by OSEO's Strategic Industrial Innovation program since 2010 with a total grant-in-aid of ?7.6 million and an overall project budget of ?16.3 million. The next milestone is due to be reached at the end of this year.

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March 23, 2012 16:42 ET
Mauna Kea Technologies to Present at the American Gastroenterological Association's 2012 Fostering Innovation and Technology in Digestive and Metabolic Diseases Conference

PARIS--(Marketwire - Mar 23, 2012) - Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), the leader in the endomicroscopy market, announced today that Sacha Loiseau, PhD, founder and Chief Executive Officer, will present at the American Gastroenterological Association's (AGA) annual technology conference focused on "Fostering Innovation and Technology in Digestive and Metabolic Diseases."

Loiseau will provide an overview of the company's flagship Cellvizio® probe-based confocal laser endomicroscopy (pCLE) system and the clinical and business milestones that led to the company's $70 million initial public offering on the NYSE Euronext exchange in July 2011. Loiseau will offer advice to private, GI-focused medical device companies weighing exit strategies, including decisions to go public in the U.S. or abroad.

Cellvizio, the world's smallest microscope, is the first system designed to provide live cellular-level images of internal human tissues during endoscopic procedures. Gastroenterologists across the U.S., Europe and Asia use the system to gain more information about their patients' GI and biliary conditions so they can make more informed treatment decisions at the bedside.

The conference runs from March 23 to 24 at the Four Seasons Hotel Silicon Valley in East Palo Alto, CA.

The AGA's Fostering Innovation in Digestive and Metabolic Diseases conference brings together medical device companies, reimbursement experts/consultants, policymakers, investors, inventors, physician innovators and key opinion leaders to examine the issues surrounding the development and delivery of new technologies to the GI market.

The program will identify unmet needs in GI as well as highlight new promising technologies, delivering vital information on what it takes to obtain approval, adoption, coverage and reimbursement in today's healthcare environment. Industry and regulatory experts will field questions from the audience through moderated panel discussions, allowing for engaging and open dialogue about the challenges presented by current requirements and how to best address these challenges.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.
For more information on Mauna Kea Technologies, visit www.maunakeatech.com

Disclaimer
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in Mauna Kea Technologies ("the Company") in any country. This press release contains forward-looking statements that relate to the Company's objectives. Such forward-looking statements are based solely on the current expectations and assumptions of the Company's management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company's products, new products or technological developments introduced by competitors, and risks associated with managing growth. Unfavorable developments in connection with these and other risks and uncertainties described, in particular, in the Company's prospectus prepared in connection with its IPO and on which the French Autorité des marches financiers ("AMF") granted its visa number 11-236 on June 20, 2011, could cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.

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Mauna Kea Technologies Appoints Medtech Expert to Top Sales Position in EMEA Region Georges Tabary Will Focus on Structuring an Elite Sales Force and Implementing the Company's Sales Strategy in the EMEA Region
Print article © Marketwire 2012
2012-03-27 19:44:04 -



PARIS -- (Marketwire) -- 03/27/12 -- Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the endomicroscopy market, today announced the appointment of industry veteran Georges Tabary as Vice President of Sales for the Europe, Middle East, and Africa (EMEA) region. Tabary will focus on structuring an elite sales force and implementing the company's sales strategy for its flagship Cellvizio® products in the EMEA region.



"We are delighted to welcome Georges to this key leadership position on our global sales team. He has a proven track record from a quarter century leading sales and marketing strategy for pioneering medical technology companies such as Leica Microsystems, Intuitive Surgical, Technomed International and ELA Medical," said Sacha Loiseau, Ph.D., CEO and founder of Mauna Kea Technologies. "At Intuitive Surgical, Georges not only led the sale of the first 50 da Vinci Surgical Systems outside the U.S. but also spear-headed the company's shift towards urology applications, leading to the company's overwhelming success in that market."





"I am delighted to be joining a bold and innovative team whose technology has tremendous potential to have a deep impact on how physicians diagnose and treat patients with digestive and respiratory diseases," Mr. Tabary said. "I'm very proud to be able to bring my experience to Mauna Kea Technologies, a company that is currently at the heart of a medical revolution within advanced endoscopy."



Mr. Tabary comes to Mauna Kea from Leica Microsystems where he was Director of Sales, Europe for 7 years, leading the company's surgical microscopy and histopathology businesses, overseeing strong growth in both areas.



Prior to Leica, Mr. Tabary served as Vice President and General Manager for Intuitive Surgical Europe. Mr. Tabary also spent almost 10 years in Japan where he was Managing Director for Technomed and Healthcare Business General Manager for Air Liquide Asia.

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Mauna Kea Technologies Reports 155% First Quarter Sales Growth


4/18/2012 11:22:24 AM

PARIS--(Marketwire - April 18, 2012) - Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), the leader in the endomicroscopy market, today announced its sales for the first quarter of 2012.

In EUR k Q1 2012 Q1 2011 Growth %
IFRS 31 March 2012 31 March 2011
--------------- --------------- --------------- ---------------
Sales 1,611 631 +155%
--------------- --------------- --------------- ---------------
Mauna Kea Technologies reported a 155% growth in sales for the first fiscal quarter, ended March 31, 2012 which drove the company's overall sales for the period to EUR 1.61 million, from EUR 631,000 in the same period last year.

Clinical sales (sales to hospitals) more than doubled, rising 105% to EUR 1.24 million. This segment now accounts for 77% of the company's global sales. Sales to preclinical research laboratories were EUR 367,500 compared to EUR 24,300 last year.

Equipment sales -- or sales of Cellvizio systems -- rose 228% to EUR 1.20 million. The sale of consumables (miniprobes) also showed a significant increase of 160% to EUR 337,000, while the sales of services fell by 46% to EUR 72,000.

Sales from North America now account for 57% of the company's global sales, while the Europe Middle East and Africa (EMEA) and Asia Pacific regions account for 20% and 23% of sales, respectively.

"We are pleased with the sharp increase of product sales across the board, especially during a period which has been slower historically," Sacha Loiseau, Founder and CEO of Mauna Kea Technologies, said. "This very strong growth reflects our ongoing efforts to build highly effective marketing and sales activities worldwide."

About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.

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PARIS―Mauna Kea Technologies, a producer of endomicroscopy products, this week announced that the American Medical Association's CPT (current procedural terminology) editorial panel has approved three Category I codes to cover use of Cellvizio in the gastrointestinal tract. The company contests that customers will be able to use these codes to facilitate the claims and reimbursement process when utilizing Cellvizio.

Cellvizio, the world's smallest microscope, is the first system designed to provide live cellular-level images of internal human tissues during endoscopic procedures, according to Mauna Kea Technologies.

"The AMA CPT editorial panel's approval of Category I codes for Cellvizio represents an important step in our efforts to advance endomicroscopy and become a standard of care in gastroenterology," said Sacha Loiseau, founder and CEO of Mauna Kea Technologies.

"We believe that these new codes, once implemented early next year, will allow more patients with suspected GI disease to have access to our technology," Loiseau continued. "Studies have shown that with cellular level views of the GI tract, physicians have more information to help them identify early signs of disease and make more informed treatment decisions at the patient's bedside."


"We are confident that this positive development will help drive revenue and penetration into the U.S., the company's largest commercial market," said Thierry Thaure, CEO of Mauna Kea Technologies, North America. "We're incredibly pleased with the panel's vote and the fact that our customers will be able to use these codes to facilitate the claims and reimbursement process when utilizing Cellvizio."

The code request for optical endomicroscopy was presented at the February 2012 AMA CPT editorial panel meeting in Tucson, Ariz. The codes are currently scheduled for implementation in January 2013.

CPT codes are the most widely accepted medical nomenclature used to report medical procedures and services under public and private U.S. health insurance programs. Future panel actions may impact these items. Codes are not assigned, nor exact wording finalized, until just prior to publication. Release of this more specific CPT code set information is timed with the release of the entire set of coding changes in the CPT publication. A summary of the panel actions can be found here.

Mauna Kea Technologies is a global medical device company in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastrointestinal and pulmonary tracts.

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Artikel aus der französischen Tageszeitung "Le Figaro".

Sony sucht nach Ubernahmen im Bereich der medizinischen Industrie und möchte seinen Umsatz auf diesem Gebiet bis 2014 auf 470 Millionen Euro steigern. Vor allem möchte Sony sich auf den Schlüsselmärkten der medizinischen Bidgebung(zum Beispiel der Endoskopie) behaupten.

Sony cherche des acquisitions
Le géant japonais entend se faire une place sur les marchés clés de ce domaine d'activité.

L'industrie des sciences de la vie devient un secteur crucial pour Sony. Pour s'y renforcer, le groupe japonais a indiqué qu'il recourrait à «des fusions et acquisitions agressives». Sony est déjà propriétaire des fabricants de microéquipements pour l'analyse et le diagnostic iCyt et Micronics. Il prévoit, par ailleurs, de porter à 470 millions d'euros en 2014 son chiffre d'affaires sur le marché des caméras, imprimantes et moniteurs destinés à l'industrie médicale. Surtout, il entend se faire une place sur des marchés clés de l'imagerie médicale tels que l'endoscopie (coloscopie, etc.) où ses connaissances en imagerie numérique sont «des atouts».

Sony suit ainsi les traces de General Electric, Philips et Siemens, leaders de l'imagerie médicale, avec environ 23 % de parts du marché mondial chacun. Ou encore de Samsung, Toshiba et Canon. Ces fabricants d'électronique grand public se convertissent peu à peu à l'imagerie médicale, bénéficiant de la convergence technologique entre deux secteurs utilisateurs d'images visualisées sur écrans plats. «Le marché de l'imagerie médicale est beaucoup moins volatil que celui des téléphones, tablettes et autres produits grand public. On ne change pas de scanner tous les ans», souligne Jacques Souquet, PDG de Supersonic Imagine. Enfin, il est devenu valorisant pour ces groupes de relever du domaine de la santé, au développement inéluctable.
PME françaises

La croissance du marché de l'imagerie médicale est de 4 % à 7 % par an. Dans le secteur plus spécifique de l'endoscopie, dominé par l'américain J & J et le japonais en difficulté Olympus (que Sony aurait approché sans succès il y a quelques mois), la croissance annuelle approche même 7 % à 10 %. Le marché global de l'imagerie médicale s'élève, selon les estimations, entre 20 et 30 milliards de dollars. Autre atout, les marges y sont «meilleures que celles des activités traditionnelles de Sony», estime Michael On de Beyond Asset Management. «Ces équipements médicaux sont fabriqués en petites séries mais les frais de distribution et de marketing sont beaucoup plus faibles que pour les produits grand public», note Marc-Olivier Bévierre, du cabinet de conseil Cepton. Depuis la ­cession de la CGR de Thomson à General Electric en 1988, aucun Français ne figure parmi les grands de l'imagerie médicale. Mais des PME très innovantes s'installent sur ce marché. C'est le cas du champion de la rupture technologique en imagerie médicale ultrasonore (échographie) Supersonic Imagine, du pionnier de l'imagerie médicale en 3D Eos Imaging ou encore de Mauna Kea. Ce spécialiste de l'endomicroscopie «place le microscope dans le corps du patient au lieu de prélever des tissus du patient pour les amener sous le microscope», explique Sacha Loiseau, son fondateur.

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http://www.invive.in/wp-content/uploads/2012/04/PR_MKT.pdf

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Mauna Kea Technologies Reports New Data Demonstrating Cellvizio(R)'s Potential as a Tool for the Characterization of Pancreatic Cysts
Adding Cellvizio's AQ-Flex(TM) 19 Confocal Miniprobe Could Improve Care of Patients With Suspected Pancreatic Cancer

PARIS, May 23, 2012 (MARKETWIRE via COMTEX) -- Mauna Kea Technologies (nyse euronext:MKEA)(nyse euronext:FR0010609263), the leader in the endomicroscopy market, today reported new data showing that utilizing Cellvizio, the world's smallest microscope, during needle-based procedures is safe and may help physicians more accurately differentiate benign and cancerous pancreatic cysts to determine with more certainty if the patient needs immediate surgery.

"Pancreatic cysts are abnormal pockets of fluid on or within the pancreas. While most of these lesions are benign, some pancreatic cysts need to be surgically removed because the risk of harboring or developing a malignancy is high," said Kenneth J. Chang, Professor and Chief, Division of Gastroenterology and Executive Director of the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine School of Medicine. "Needle-based Confocal Laser Endomicroscopy provides a real time view of the cells inside pancreatic cysts, which may provide physicians with additional information to help them decide if a patient needs surgery. If larger studies confirm these promising early results, we expect this to lead to a significant change in how physicians diagnose and rule out pancreatic cancer."

Used during endoscopy procedures, this new miniprobe known as the AQ-Flex(TM) 19 is comprised of a fiber-optic microscope that is small enough to thread through a needle with a diameter of 1mm.

Dr. Chang and his colleagues presented the results of the "Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound, Through-the-needle confocal laser Endomicroscopy and Cystoscopy Trial (DETECT)" (abstract L4575) at an American Society of Gastrointestinal Endoscopy (ASGE) Topic Forum at Digestive Disease Week(R) (DDW) 2012, which took place May 19 to 22 in San Diego.

The investigators identified key features seen in Cellvizio images that were taken from inside pancreatic cysts in 21 patients. The investigators then correlated the presence of structures to clinical results and concluded that nCLE procedures improve the sensitivity for the diagnosis of malignant cysts.

Separately, Irving Waxman, MD, Professor of Medicine and Surgery and Director of the Center for Endoscopic Research and Therapeutics at the University of Chicago School of Medicine, presented similar results from a 65-patient, multi-center study known as INSPECT (abstract Mo1204) during an American Gastroenterological Association (AGA) poster session earlier this week.

Investigators were able to identify 100% of the pancreatic cystic neoplasms in these patients.

"We are dedicated to developing and rigorously evaluating advanced endoscopic imaging tools that provide physicians with more real-time, cellular-level information than they've ever had before," said Sacha Loiseau, CEO and founder of Mauna Kea Technologies. "The AQ-Flex 19 miniprobe extends Cellvizio's clinical reach into a new type of organ for the first time and represents a significant milestone for the company."

Over 40 abstracts and presentations demonstrating the clinical utility of endomicroscopy as a tool to improve outcomes in digestive disease were featured at DDW 2012.

* The nCLE probe has received the European CE Mark and clearance in Israel. The company is working on getting 510(k) clearance in the U.S.

About Pancreatic Cancer Pancreatic cancer is one of the rare cancers for which chemotherapy and radiotherapy have disappointing results. The best patient outcomes are achieved with surgery in which the surgeon must remove all the cancerous cells, including those in the primary tumor, as well as those hidden in the surrounding pancreatic tissue and lymph nodes. The American Cancer Society (ACS) estimates that approximately 43,920 people (22,090 men and 21,830 women) will be diagnosed with pancreatic cancer this year and about 37,390 people (18,850 men and 18,540 women) will die of the disease. Since 2004, rates of pancreatic cancer have continued to steadily increase by 1.5% each year, according to the ACS.

About Digestive Disease Week Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org .

About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and help detect abnormalities in the gastro-intestinal and pulmonary tracts. Its flagship product, Cellvizio(R), a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.

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MAUNA KEA TECHNOLOGIES REPORTS 93% SALES INCREASE IN FIRST HALF OF 2012
PARIS, July 11, 2012 – Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the
endomicroscopy market, today reported topline sales results for the second quarter and frst half of 2012,
ended June 30.
In K€
IFRS standards
2012 2011 Change %
Q1 (to March 31) 1,611 631 +155%
Q2 (to June 30) 1,907 1,189 +60%
First Half 3,519 1,820 +93%
Sales Increase 93% During First Six Months of 2012
Driven by a strong increase in sales of Cellvizio® systems and probes to hospitals, the company’s key target
market, sales grew 93% to €3.52 million during the frst half of 2012 from €1.82 million in the same period
last year.
“The robust increase in sales of Cellvizio systems and miniprobes during the frst half of 2012 reinforces our
new sales and marketng strategy and initatves to strengthen our sales team,” said Sacha Loiseau, Founder
and CEO of Mauna Kea Technologies.
During the frst half of 2012, clinical sales (sales to hospitals) rose 76% to €2.86 million from €1.63 million
during the frst half of 2011. This segment now accounts for 81% of the company’s global sales. Sales to
preclinical research laboratories, which represented 19% of overall sales, rose to €657,000 from €191,000.
Equipment sales – or sales of Cellvizio systems – rose 119% to €2.45 million the frst half of 2012. The sale of
consumables (miniprobes) also shows a signifcant increase of 119% to €849,000, while the sales of services
fell by 29% to €223,000 during the frst six months of 2012.
Geographical sales distributon refects the company’s eforts to strengthen its business strategy and direct
sales teams in the U.S. and part of Europe. As of June 30, sales from the Americas now account for 60% of
the company’s global sales, while the Europe Middle East and Africa (EMEA) and Asia Pacifc (APAC) regions
account for 25% and 15% of sales, respectvely.
Second Quarter Growth Exceeds 60% Year over Year
Sales during the second quarter of 2012 grew by more than 60% to €1.91 million from €1.19 million in the
same period last year, with clinical sales up 58% to €1.62 million and pre-clinical sales up 73% to €289,000.
Equipment sales rose 66% to €1.245 million during the second quarter, while the sales of consumables
doubled to €512,000. Sales of services fell by 16% to €151,000 during the second quarter of 2012.
The company plans to announce its full fnancial results for the frst half of 2012 afer the NYSE Euronext
closing bell in Paris on August 30, 2012.