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Jan 04
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Cornerstone Therapeutics Acquires Cardiokine

By Cardiokine, Press Release
Press Release.

 

January 04, 2012 07:30 ET

Cornerstone Therapeutics Acquires Cardiokine

CARY, NC–(Marketwire – Jan 4, 2012) – Cornerstone Therapeutics (NASDAQ: CRTX)

•Cornerstone acquires worldwide rights to investigational therapy for hyponatremia
•Hyponatremia is one of the most common metabolic conditions affecting up to 6 million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually
•New Drug Application for lixivaptan filed Dec. 29, 2011; FDA approval expected in Q1 2013
•Expected launch of the product in the U.S. hospital market in 2013

Cornerstone Therapeutics (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital and respiratory markets, today announced that it has acquired Cardiokine Inc., a specialty pharmaceutical company focused on developing hospital products for cardiovascular indications. The merger was effective Dec. 30, 2011.

Under the terms of the agreement, Cornerstone will acquire all outstanding shares of Cardiokine which is located in Philadelphia. Cardiokine recently completed a series of phase III clinical trials for its lead compound, lixivaptan for treatment of hyponatremia, and filed a New Drug Application (NDA) with the FDA on Dec. 29, 2011. Lixivaptan is an orally active, selective vasopressin 2 receptor antagonist and has the potential to address a large unmet medical need as current treatment options have significant limitations that have impeded adoption by many hospitals.

“We are very excited about adding a hospital product to complement Curosurf, our neonatal lung surfactant. This is the first of several deals we hope to complete as we continue to execute the strategic plan that we initiated in 2011,”

said Craig A. Collard, Cornerstone’s Chief Executive Officer.

“The hyponatremia market is expected to grow significantly in the coming years and currently has limited treatment alternatives. The acquisition of Cardiokine allows Cornerstone to expand our pipeline into a new area of treatment and creates the potential to use our hospital specialty expertise to help meet the needs of patients with hyponatremia.”

Mr. Collard continued,

“Consistent with our stated strategic intent, we expect this transaction to be accretive within the first full year following launch. Additionally, we will continue the ex-U.S. licensing discussions initiated by Cardiokine, which present the opportunity for incremental revenue.”

“The clinical trials of lixivaptan were conducted in addition to current standard care in patients with hyponatremia associated with heart failure and the syndrome of inappropriate hormone secretion (SIADH), and comprise the largest placebo-controlled dataset to date in these populations,”

said Cesare Orlandi, MD, former Cardiokine Chief Medical Officer, who will continue his work on lixivaptan as a consultant to Cornerstone.

About Hyponatremia
Hyponatremia is a metabolic condition that occurs when there is not enough sodium (salt) in the blood. It is the most common electrolyte disorder among hospitalized patients affecting up to six million people in the U.S. and is often diagnosed in patients with heart failure. In the U.S. alone, there are five million heart failure patients, and each year one fourth of them develop hyponatremia. Other causes of hyponatremia include burns, diuretic medications, kidney disease, liver cirrhosis, and syndrome of inappropriate hormone secretion (SIADH).

About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing products for the respiratory, hospital and related specialty markets. Key elements of the Company’s strategy are to focus on identifying therapeutic niches within respiratory, hospital and related specialty markets to leverage existing business and create new opportunities; promote the Company’s current products to high prescribing physicians through the Company’s respiratory sales force and to hospital-based healthcare professionals through the Company’s hospital sales force; license or acquire rights to existing patent- or trade secret-protected, branded products, which can be promoted through the same channels to generate on-going high-value earnings streams; advance the Company’s development projects and further build a robust pipeline; and generate revenues by marketing approved generic products through the Company’s wholly owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of historical fact, including statements regarding the progress and timing of our product development programs and related trials, our strategy and our future operations and opportunities, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of preclinical studies and clinical trials with respect to our products under development, our ability to satisfy FDA and other regulatory requirements, our ability to enter into strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all, and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 3, 2011 and in our subsequent filings with the SEC. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release, and these statements should not be relied upon as representing our views as of any other date and do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise.

Dec 30
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Amsterdam Molecular Therapeutics Announces 2.5 Million Equity Raise

By Press Release
Press Release.

 

Amsterdam, The Netherlands – December 30, 2011 – Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that the Company has raised € 2.5 million in new equity by means of a private placement to three of its existing shareholders: Forbion Capital Partners, Gilde Healthcare Partners and Advent Venture Partners.

Under the terms of the transaction, AMT has agreed to issue 7,352,938 new shares at a price of € 0.34 per share, being the closing price on December 29, 2011, when the shares were placed. The proceeds of this issue will provide additional flexibility to further explore its strategic options to secure the financial stability of the Company. The proceeds do not eliminate the Company’s negative equity position, which will continue after completion of the equity raising, which is expected to take place on or around January 4, 2012, and the Company’s financial prospects remain as described in the announcement of December 15, 2011.

As a result of the private placement, the Company’s issued share capital will amount to 31,051,454 shares.

Pursuant to the Financial Supervision Act (Wet op het financieel toezicht) there is no obligation to publish a prospectus approved by the Netherlands Authority for the Financial Markets (Autoriteit Financiele Markten) in relation to the equity raising or the admission of the new shares to trading on NYSE Euronext in Amsterdam. The Netherlands Authority for the Financial Markets does not supervise the equity raising or the admission of the new shares to trading on NYSE Euronext in Amsterdam.

About Amsterdam Molecular Therapeutics
AMT is a world leader in the development of human gene based therapies. AMT has a product pipeline of several gene therapy products in development for hemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows AMT to pursue its strategy of focusing on this sector of the industry.  AMT was founded in 1998 and is based in Amsterdam. Further information can be found at www.amtbiopharma.com.

For further enquiries:
Jörn Aldag
CEO
AMT
Tel : +31 20 566 7394
j.aldag@amtbiopharma.com

Nov 18
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FDA approves Erwinaze to treat a form of leukemia

By EUSA Pharma, Press Release
Press Release.

 

The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

Acute lymphoblastic leukemia is a type of cancer in which the bone marrow makes too many lymphocytes, a type of white blood cell. White blood cells help the body fight infection and are formed in the bone marrow.

Erwinaze is injected directly into the muscle three times a week and works by breaking down one of the body’s protein building blocks (the amino acid, asparagine) that is present in the blood, and is necessary for the growth of all cells. Leukemia cells cannot produce this protein building block. When a patient is treated with Erwinaze the leukemia cells die. Normal human cells are able to make enough asparagine for their own needs through biosynthesis and will not be affected by treatment with Erwinaze.

“The approval of Erwinaze underscores the FDA’s commitment to the approval of drugs for conditions with limited patient populations with unmet medical needs using novel trial endpoints”

said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Erwinaze was evaluated in one clinical trial of 58 patients. Additional safety data was collected from the Erwinaze Master Treatment Protocol (EMTP), an expanded access program that enrolled 843 patients. Patients in both studies were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions.

In the trial to support efficacy, the main outcome (endpoint) was the measurement of the proportion of patients with sustained asparaginase activity levels that correlate with better leukemia control and survival. All evaluable patients were shown to have maintained the pre-specified threshold for asparaginase activity at 48 or 72 hours after dosing.

Side effects associated with Erwinaze treatment include serious allergic reactions (anaphylaxis), inflammation of the pancreas (pancreatitis), high blood levels of liver enzymes (abnormal transaminases and bilirubin), blood clotting, bleeding (hemorrhage), nausea, vomiting and high blood sugar (hyperglycemia).

Prior to Erwinaze’s approval there were two asparagine specific enzyme products – Elspar (asparaginase injection) and Oncaspar (pegaspargase) – approved by FDA to treat patients with ALL. Both of these products are E. coli derived.

Erwinaze has been designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the U.S.

Erwinaze is manufactured by EUSA Pharma Inc. of Langhorne, Pa.

Nov 18
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EUSA Pharma Announces FDA Approval Of Orphan Drug ERWINAZE™ For Treatment Of Acute Lymphoblastic Leukemia

By EUSA Pharma, Press Release
Press Release.

 

Langhorne, PA and Oxford, UK – 18 November 2011 – EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE™ (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase. ERWINAZE will be available to patients throughout the United States immediately.

ALL is the most common form of childhood cancer, with approximately 2,900 patients under the age of 20 diagnosed in the USA each year [1]. It is also one of the most curable forms of cancer,with remission rates in treated children of over 95% and 75 – 85% surviving at least five years without recurrence of leukemia [1]. Treatment involves a number of stages and drugs, and typically includes asparaginase as an essential component of current protocols. ERWINAZE isindicated as an integral part of a multi-agent regimen for the treatment of ALL patients who develop hypersensitivity to current products derived from E. coli, and is therefore the first and only approved treatment option available for patients with hypersensitivity to standard-of-care treatment with pegaspargase. An estimated 15 – 20% of ALL patients develop hypersensitivity to E. coliderived asparaginase, representing approximately 450 – 600 children in the United States eachyear [2].

“Treatment with asparaginase is a vital and life-saving therapy for thousands of patients, mostly children, with acute lymphoblastic leukemia each year. Unfortunately, a number of these patients develop hypersensitivity to asparaginases derived from E. coli, including pegaspargase, and are unable to complete the recommended course of treatment. The approval of ERWINAZE is an important advance because it is the only treatment option that can enable these patients to continue and complete their full course of therapy,”

said Stephen E Sallan MD, Chief of Staff,Dana-Farber Cancer Institute and Professor of Pediatrics, Harvard Medical School.

“Today’s approval of ERWINAZE highlights EUSA’s ongoing commitment to the oncology field, and the treatment of patients affected by orphan diseases. We are grateful to our partners at the UK Health Protection Agency, our investigators and employees, and to the Food and Drug Administration for their dedication to this effort and for helping us make ERWINAZE available to the hundreds of patients who can benefit from it each year,”

said Dr Tim Corn, EUSA Pharma’s Chief Medical Officer.

Commenting on the news, Bryan Morton, President and Chief Executive Officer of EUSA Pharma, said, “The approval of ERWINAZE marks a major milestone for EUSA, and represents the culmination of many years of work. Launching ERWINAZE to sit alongside our existing portfolio of specialty products is also a major strategic milestone for the company, as this is the first treatment EUSA has developed internally. This achievement represents a transformation for the company, signaling our transition into a specialty development as well as commercialization organization.”

The ERWINAZE approval is based on the results of clinical studies in 630 ALL patients. In the pivotal efficacy study conducted in 58 subjects, 100% of evaluable patients achieved the asparaginase activity primary endpoint.

EUSA will offer a patient assistance program to help expand access to ERWINAZE for patients who lack health insurance or meet certain other criteria. For further information about ERWINAZE and full prescribing information visit www.erwinaze.com.

About ERWINAZE

ERWINAZE is an asparaginase enzyme that depletes the level of asparagine in the bloodstream.

Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Asparaginase products are derived from bacteria,and approximately 15 – 20% of patients develop hypersensitivity to modern products derived from Escherichia coli, preventing their continued treatment [2]. ERWINAZE, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments. ERWINAZE was originally discovered by the UK Health Protection Agency, and the assays for the US Biologics License Application were conducted by AIBioTech, Richmond, Virginia.

Selected Important Risk Information
Contraindications: History of serious hypersensitivity reactions, including anaphylaxis, to Erwinaze; History of serious pancreatitis, thrombosis or hemorrhagic events with prior Lasparaginase therapy.

Warnings and Precautions: Discontinue Erwinaze if serious hypersensitivity reactions, includinganaphylaxis, or severe or hemorrhagic pancreatitis occur. Warnings include: monitor glucose(intolerance may not be reversible; insulin may be needed for hyperglycemia); thrombosis and hemorrhage: discontinue until resolved. Do not use in lactating women and use in pregnant women only if clearly needed.

Common Adverse Reactions 1%: Serious hypersensitivity including anaphylaxis, pancreatitis, and abnormal transaminases, coagulation abnormalities (thrombosis, hemorrhage), nausea, vomiting, and hyperglycemia.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the US, a pan-European presence and a wider distribution network in numerous additional territories. EUSA currently has a total of 10 specialist hospital products,which are sold in over 80 countries globally*. These include Erwinase®/Erwinaze™ and Kidrolase®for the treatment of acute lymphoblastic leukemia, Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp® G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. The company also has several products in late-stage development.

Nov 17
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Biocartis completes EUR 71 million (USD 100 million) Series C Fund Raising

By Biocartis, Press Release
Press Release.

 

Lausanne (Switzerland) – November 17, 2011. Biocartis, a company developing and commercializing compact molecular diagnostic (MDx) systems designed to drive the widespread adoption of personalized medicine and other applications including the improved diagnosis of infectious disease, announced today the completion of EUR 71 million (USD 100 million) Series C equity fund raising backed by existing investors, new investors and industrial collaborators and partners. Investors in the round were Debiopharm Group™, Philips, Johnson & Johnson Development Corporation (JJDC), the Wellcome Trust, Korys (investment holding of the Colruyt family), Valiance, Biovest, the family office of Dr Paul Janssen, IHL SA (Luc Verelst), PMV, New Rhein Healthcare, certain members of the Biocartis senior management team and the family office of founder Rudi Pauwels (Benaruca).

Rudi Pauwels, the founder and CEO of Biocartis, commenting on today’s announcement said,

“Completing one of the largest life science fundraisings this year, against the background of the current turbulent financial background, is testament to the quality of Biocartis’ technology, its team and the attractive market opportunity for a transformational molecular diagnostics platform which can change the face of global healthcare. We have succeeded in attracting a broad and diverse group of investors who have recognized our potential and the progress we have made towards our goal of becoming a fully integrated global diagnostics company commercializing molecular diagnostics systems that will make personalized medicine an everyday reality.”

Biocartis’ first system, codenamed Apollo, is expected to be launched in 2013. Apollo takes its inspiration from the consumer electronics industry, being designed for everyday use by a broad range of customers in a wide range of settings. The Apollo system has been established in close collaboration with Philips Corporate Technologies, which is the key development partner of the platform. Apollo is a compact, scalable, core system that allows multiple assays to be performed anywhere, anytime, simply, rapidly and without the need for a specialist laboratory environment and trained technicians. Apollo can deliver results as accurate as those generated in a specialized clinical laboratory setting in as little as one hour from sample preparation to read out.

Apollo is highly versatile with regard to sample types and assay types and can analyze multiple disease parameters in one assay. Apollo has also been designed to be easily integrated into healthcare IT systems and to benefit from lower capital requirements and running costs.

Biocartis is using a collaborative business model to help drive the build-up of the shared installed base of its Apollo system once launched and to broaden the menu of infectious disease and personalized medicine assays required to meet the needs of the growing MDx market. Biocartis’ key collaborators include bioMerieux and Janssen Pharmaceutica (J&J). Biocartis’ aim is to rapidly create a widely adopted platform that is accessible to both the Company and other developers of new MDx assays.

Rudi Pauwels further commented,

“Today’s financing is a key step in enabling Biocartis to deliver its broader vision for diagnostics, to enhance each patient’s quality of life by offering better treatments based on better and more personalized diagnostics. With the backing of our investors, the drive and experience of the Biocartis team and the support of collaborators I am confident we can achieve this ambitious and important goal.”

Following the fundraising, the Biocartis Board will be enlarged. Current Board members, Rudi Pauwels (Benaruca), Rudi Mariën (Biovest), Domenico (Dinko) Valerio (Aescap), Pietro Scalfaro (Debiopharm), Greg Parekh (New Rhein), Jean Deleforge (bioMerieux) will be joined by new Board members, Vincent Vliebergh (Korys), Alex Dittmair (Valiance), Christine Deuschel (Debiopharm) and Staf Van Reet (J&J). Current Board members Ruth Devenyns (KBC Private Equity) and Shahzad Malik (Advent Venture Partners) will stand down having greatly contributed to the Company’s development to this stage.

The Series C financing round was led by Biocartis’ senior management and Peter Verhaeghe, managing partner at VVGB in Brussels, Belgium.

About Biocartis (www.biocartis.com)

Biocartis aims to transform the global diagnostics market by making personalized medicine an everyday reality. The challenge Biocartis addresses is to enable the broadest possible access to new technologies that will allow individual diagnoses to be made quickly based on a systematic analysis of the wealth of rapidly emerging biomarkers rather than solely on physiological symptoms as they are today. Ending the ‘one drug fits all’ paradigm will empower physicians to make better diagnoses based on better information and help tackle efficacy failings and increasing healthcare costs. Biocartis intends to become a fully integrated provider of novel, broadly applicable molecular diagnostics and immunodiagnostics solutions (instruments, analytical techniques, chemistries, sample preparation and other innovative tools) with high-value clinical assay menus. These solutions are designed to be compatible with deployment in a wide variety of health care settings, providing rapid, high-quality care close to the patient. Biocartis’ vision is shared by its current collaborators which include bioMerieux and Janssen Pharmaceutica (J&J).

Biocartis is currently developing two innovative systems that share a common user interface and design philosophy:

– Apollo, a system designed for the MDx market, comprising an instrument, communication console and single use, disposable cartridges. This system can detect and quantify multiple DNA- or RNA-based biomarkers in a wide variety of patient sample types with truly minimal user intervention.
– A second system that has been built around disposable, microfluidic cartridges with digitally encoded micro carriers for the rapid and sensitive detection of a broad range and number of biomarkers. The first product from this technology will focus on protein-based biomarkers and will allow Biocartis to enter the immunoassay market.

Biocartis was founded in 2007 by Dr. Rudi Pauwels (Co-founder of Tibotec, Virco and Galapagos Genomics), Prof. Philippe Renaud (Prof. at EPFL), and Nader Donzel (Co-founder of Scitec laboratory Automation). The company has raised more than 100 million euro in equity funding. Biocartis SA is based at the EPFL’s Innovation Square in Lausanne, Switzerland; it has a fully owned Belgian subsidiary in Mechelen and a Dutch subsidiary at the High Tech Campus in Eindhoven.

Contacts
Rudi Pauwels, CEO
Tel: +41 21 69 39 051
pr@biocartis.com
Hilde Windels, CFO
Tel: +32 15 632 663
pr@biocartis.com
Citigate Dewe Rogerson
David Dible/Chris Gardner
Tel : +44 (0) 20 7638 9571
david.dible@citigatedr.co.uk/chris.gardner@citigatedr.co.

Oct 18
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Cellnovo receives 2011 Best MedTech Fundraiser Award

By Cellnovo, Press Release
Press Release.

 

LONDON, UK – October 18, 2011 – Cellnovo was named Best Medtech Fundraiser at the recent 2011 OBN Bioscience Awards, an honour that recognises Cellnovo’s success in raising £30m to advance mobile diabetes management.

“Cellnovo has developed a game changing diabetes management system, and was featured at OBN’s 2011 BioTrinity Conference,”

said Jon Rees, Chief Executive Officer of OBN.

“Cellnovo was an obvious choice to receive the Best MedTech Fundraiser Award and we wish them every success in the commercialization of their system around the world.”

“Cellnovo is very proud of this accomplishment because we added some of the premier investors in Europe to our syndicate, and they are equally passionate about Cellnovo,”

said William McKeon, Chief Executive Officer of Cellnovo.

“They recognised our vision and capability to move beyond convention as we deliver the world’s first mobile diabetes management platform.”

The OBN Annual Bioscience Awards seek to highlight the many great achievements of the bioscience sector in raising funds, making deals and supporting innovation. This year’s Awards placed particular emphasis on the achievements of nominees, like Cellnovo, succeeding despite the challenges of the current financial climate.

“The size of the round and calibre of investors speaks volumes about Cellnovo, the company’s leadership team and its unique offering,”

said Raphael Wisniewski, Partner at Edmond de Rothschild Investment Partners.

“We look for companies that have the potential to transform an industry,”

said Philippe Peltier,Partner at Auriga Partners.

“We feel that Cellnovo is set to bring enormous benefit to diabetics,clinicians, and to health systems worldwide.”

About OBN
OBN is a not-for-profit business network that provides comprehensive support for its member biotech and medtech companies in the Oxford and South-East England biocluster and the rest of the UK.

Through its delivery of Europe’s fastest growing biopartnering and investment conference, BioTrinity,OBN generates more R&D-company-to-investor interactions than anyone else in Europe.

About Cellnovo
Cellnovo, an innovative UK-based mobile health company, is committed to bringing greater freedom and ease-of-use to people living with diabetes. The company has developed the industry’s first mobile diabetes management system, which includes a patch pump, a mobile handset with a built-in blood glucose monitor, and an extendable applications set. For more information, please visit www.cellnovo.com.
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Oct 04
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Frost & Sullivan has announced Cellnovo the winner of its 2011 European Technology Innovation Award in Diabetes Care

By Cellnovo, Press Release
Press Release.

 

LONDON, UK – October 4, 2011 – Frost & Sullivan has announced Cellnovo
the winner of its 2011 European Technology Innovation Award in Diabetes Care. Cellnovo, a UK-based company, is pioneering the use of mobile technology for easier, more effective diabetes management.

The Cellnovo diabetes management system integrates an insulin patch pump with a mobile touch screen handset that monitors blood glucose and activity levels. This information is then wirelessly transmitted to a secure site that performs analysis for patients and caregivers to use.

“We are extremely proud to win this prestigious award,”

says William McKeon, Chief Executive Officer of Cellnovo.

“It not only acknowledges our visionary use of technology, but,more importantly, the value it delivers to people with diabetes, clinicians and payers.”

“The Cellnovo solution can help patients control their diabetes more effectively,”

says Frost & Sullivan Research Analyst Arjunvasan Ambigapathy.

“Physicians can access in-depth data on each patient, reviewing data trends for valuable insights on aberrant readings. Such tools offer the flexibility of managing increasing patient loads in a shorter time span and at lower costs.”

“The Frost & Sullivan award recognizes Cellnovo’s position as a leading medical technology innovator at the forefront of the convergence of medical devices, IT and mobile connectivity,”

says John E. Milad, Investment Manager at NBGI Ventures.

“The award reflects the exciting potential of the Cellnovo system to provide a paradigm shift in the management of diabetes,thereby empowering patients, their families and clinicians.”

Cellnovo has harnessed the power of technology to make insulin therapy more convenient and accurate than ever before. Continuous mobile connectivity provides as much or as little data as the physician or caregiver needs. For example, it is expected that parents of children with newly diagnosed diabetes will initially use the web and text-based system extensively as they learn to manage the disease. Once parents’ confidence and knowledge increases, they will most likely transition to more casual monitoring.

Unlike traditional devices, the Cellnovo system is future-proofed by the ability to install new apps and system updates through an SD card integrated with the handset. This approach means that patients with the Cellnovo system will have the ability to keep their system updated with the latest innovations.

About the Frost & Sullivan European Technology Innovation Award
The Frost & Sullivan European Technology Innovation Award is presented to the company that has excelled in the following criteria: uniqueness of technology, impact on new products/applications, impact on customer value, and relevance of innovation to industry.

About Cellnovo
Cellnovo, an innovative UK-based mobile health company, is committed to bringing greater freedom and ease-of-use to people living with diabetes. The company has developed the industry’s first mobile diabetes management system, which includes a patch pump, a mobile handset with a built-in blood glucose monitor, and an extendable applications set. For more
information, please visit www.cellnovo.com.
###

Sep 19
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Cellnovo Receives CE Mark Approval for World’s First Mobile Diabetes Management System

By Cellnovo, Press Release
Press Release.

 

LONDON, UK – September 19, 2011 – Cellnovo today announced that it has received CE Mark approval for the world’s first mobile diabetes management system, a significant milestone for the company and for people living with diabetes.

“This is Cellnovo’s first step in a journey to bring this mobile diabetes management system to the world,”

says William McKeon, Chief Executive Officer of Cellnovo.

Cellnovo is a complete diabetes management system built around the principles of mobile, wireless technology. The system includes an insulin patch pump, a wireless, touch screen handset with a built-in blood glucose monitor, and an extendable applications set.

“Cellnovo has created the first insulin pump that brings innovation and combines form with function, essential qualities in a device that patients have to interact with 24/7,”

says Dr.Pratik Choudhary, Clinical Lecturer in Diabetes at King’s College London.

Cellnovo’s groundbreaking technology means that diabetes therapies can now be managed more easily, accurately and intuitively. The patch pump is the smallest and most precise everdeveloped, and the touch screen, wireless handset is instantly familiar to those who have used other mobile devices such as Apple’s iPhone.

“Cellnovo has combined advanced mobile and medical technology which may create a
paradigm shift in diabetes care,” says Irl B. Hirsch, Professor of Medicine, University of
Washington, Seattle, USA. “For the multitude of patients who could benefit from pump therapy, Cellnovo could be a game-changer.”

The most exciting feature of the Cellnovo handset is that it wirelessly receives and transmits real-time data to a portal for patients and caregivers to use. This means that patients nolonger have the burden of keeping meticulous journals, and that the data collected isincredibly accurate and consistent, ensuring optimal monitoring and treatment of the disease.

“The ability to see real-time data of patients who may be hundreds of miles away provides the opportunity to redefine our care model,”

says Dr. Mark Evans, Lecturer and Honorary Consultant at the Institute of Metabolic Science at the University of Cambridge.

About Cellnovo
Cellnovo, an innovative UK-based mobile health company, is committed to bringing greater freedom and ease-of-use to people living with diabetes. The company has developed the industry’s first mobile diabetes management system, which includes a patch pump, a mobile handset with a built-in blood glucose monitor, and an extendable applications set. For more information, please visit www.cellnovo.com.
###

Sep 13
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Cellnovo forms worldwide technology alliance with LifeScan

By Cellnovo, Press Release
Press Release.

 

LONDON, UK – September 13, 2011 – Cellnovo, developer of the first mobile diabetes management system, today announced a technology alliance with LifeScan, Inc. that will bring new portability and control to diabetes patients worldwide.

Under the global agreement, Cellnovo will integrate LifeScan’s blood glucose monitoring technologies into the handset of its mobile diabetes management system. The Cellnovo system, the first of its kind, consists of an insulin patch pump and a touch screen handset that wirelessly transmits real-time data to a secure portal for patients and healthcare providers to use.

“We wanted superb blood glucose monitoring technology inside our mobile handset and LifeScan is a market leader,”

said William McKeon, Chief Executive Officer of Cellnovo.

“Through our partnership with LifeScan, our combined technologies will advance care through connectivity.”

With Cellnovo, diabetes therapies can now be managed with a system that is mobile,
compact, highly accurate and intuitive. In addition, a real-time data tracking and reporting feature means that patients no longer have the burden of keeping meticulous journals – the process is entirely automated for them.

“Cellnovo has the potential to break new ground in bringing the first mobile diabetes management system to market,”

said Dr. David Kerr, Consultant Physician and Diabetologist at the Bournemouth Diabetes and Endocrine Centre.

“It is clear that new technologies for diabetes care, such as Cellnovo’s mobile health solution, are going to forever change the way we practice medicine and more effectively manage diabetes long into the future.”

 

About Cellnovo
Cellnovo, an innovative UK-based mobile health company, is committed to bringing greater freedom and ease-of-use to people living with diabetes. The company has developed the industry’s first mobile diabetes management system, which includes a patch pump, a mobile handset with a built-in blood glucose monitor, and an extendable applications set.

Sep 01
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Biocartis named as a Technology Pioneer 2012 by the World Economic Forum

By Biocartis, Press Release
Press Release.

 

Mechelen, Belgium. 1st September, 2011 – Biocartis today announces that it has been selected as a Technology Pioneer 2012 by the World Economic Forum. Technology Pioneers comprise 25 of the most innovative young companies from around the world, companies poised to have a critical impact on how business and society work.

The Technology Pioneers 2012 will be recognized for their work at the Annual Meeting of the New Champions in Dalian, People’s Republic of China, from 14 to 16 September 2011.

“The Technology Pioneers program recognizes companies whose cutting-edge technologies are transforming business and society and we are very proud to have been selected by the judging panel. At Biocartis our vision is for people to have quick access to personalized medicine anywhere and anytime. We want to enhance the quality of life through better diagnosis and better treatments with modern diagnostics available in the widest possible variety of healthcare settings,”

said Rudi Pauwels, Biocartis’ CEO.

Olivier Schwab, Director, Head of Technology Pioneers, World Economic Forum, said,

“One particular aspect to highlight this year is the large number of companies that are focusing on having a social impact, such as providing health or financial services to underserved populations, while revolutionizing the business paradigms in their industries. This year’s companies showcase the diversity in which innovative technology can be deployed.”

The identification of the Technology Pioneer companies is the result of a rigorous selection process, for which the Forum received hundreds of applications from around the world, and that were evaluated by over 50 global technology experts. The selection committee includes leading academics, journalists, technologists and venture capitalists.

About Biocartis
Biocartis is a company that focuses on the development and commercialization of versatile and compact molecular diagnostic solutions that will make molecular diagnostic testing easier to perform in a wider range of healthcare settings. The Company was founded in 2007 by Dr. Rudi Pauwels (Co-founder of Tibotec, Virco and Galapagos Genomics), Prof. Philippe Renaud (Prof. at EPFL), and Nader Donzel (Co-founder of Scitec laboratory Automation).

At this moment the Company is developing two innovative systems that share a common user interface and design philosophy:

  • A system for molecular diagnostics of nucleic acids (DNA/RNA) that is composed of an instrument, communication console and single use, disposable cartridges. This system can detect and quantify multiple DNA- or RNA-based biomarkers in a wide variety of patient sample types with truly minimal user intervention.
  • A system built around disposable, microfluidic cartridges with digitally encoded micro carriers for the rapid and sensitive detection of a broad range and number of biomarkers. The first product from this technology will focus on protein-based biomarkers.

The ultimate goal is to carry out diagnostic tests rapidly and cost-effectively when and where key clinical decisions need to be made.

Biocartis SA is based at the EPFL’s Innovation Square in Lausanne, Switzerland; its Belgian fully owned subsidiary in Mechelen and the Dutch subsidiary at the High Tech Campus in Eindhoven.

About the Technology Pioneers Program
Since 2000, the World Economic Forum has recognized the work of young companies who hold the promise of significantly transforming the way business and society operate. More than 400 innovative companies from five continents have been selected as Technology Pioneers. Among them, approximately 60% are still independent and 20% have been acquired by industry leaders. Previous Technology Pioneers include Monitise (2006), Mozilla Corporation (2007), Nanosolar (2007), Gridpoint (2008), Mint.com (2009), BloomEnergy (2010), Takadu (2011) and NetQin (2011).

Technology Pioneers are selected on a yearly basis. Candidate companies are nominated by Members, constituents and collaborators of the World Economic Forum, as well as by the larger public. A selection committee, comprised of top technology and innovation experts from around the world, reviews all candidate companies and makes a recommendation to the World Economic Forum, which then takes the final decision.

 

About the World Economic Forum
The World Economic Forum is an independent international organization committed to improving the state of the world by engaging business, political, academic and other leaders of society to shape global, regional and industry agendas.

Incorporated as a not-for-profit foundation in 1971 and headquartered in Geneva, Switzerland, the Forum is tied to no political, partisan or national interests (www.weforum.org).

Rudi Pauwels, CEO
Tel: +41 21 694 04 30
pr@biocartis.com
www.biocartis.com