Medtech Wire

Kona Medical Secures $30 Million for a Renal Denervation System

noreply@blogger.com (Clyve Parker) — Wed, 30 May 2012 20:16:00 +0000

Kona Medical, today announced it has raised $30 million in Series C financing to advance its novel hypertension therapy. The company also announced that John Bowers, former Senior Vice President at SonoSite, Inc., has joined the company as Chief Operating Officer.

Kona Medical is developing an ultrasound-based approach to address severe high blood pressure (hypertension) through ablation of the renal nerves. Renal nerves are located proximal to the renal arteries, which provide blood flow to the kidneys. Renal nerves are part of the sympathetic nervous system and play a significant role in determining blood pressure.

Recent clinical data have shown that ablation of renal nerves can result in profound and lasting reduction in hypertension in patients whose blood pressure is not adequately controlled by medication. Industry analysts have forecast that the future market for devices to effect renal denervation may reach several billion dollars worldwide.

Kona’s proprietary technology, which utilizes externally delivered ultrasound energy to ablate the renal nerves, can enable non-invasive treatment for drug-resistant hypertension and has significant potential advantages over alternative methods.

“I am pleased to have leading healthcare investors recognize the tremendous potential of Kona’s therapy in addressing the hundreds of millions of people worldwide who have uncontrolled hypertension,” said Michael Gertner, MD, founder and Chief Executive Officer of Kona Medical. “We are also delighted to have John Bowers join the Kona team to provide additional leadership during this important period for the company.”

John Bowers is an experienced medical device executive who most recently was Senior Vice President for North America and Strategic Development at point-of-care ultrasound leader SonoSite, Inc. (recently acquired by Fujifilm). Previously, Bowers was CEO of Northstar Neuroscience and held various executive roles at Guidant Corporation and Eli Lilly and Company. While at Guidant, Bowers led the team that acquired enabling technologies for the XIENCE drug-eluting stent, which is now marketed by Abbott and is the worldwide market share leader.

Kona Medical will use proceeds from the financing to fund clinical trials and to add staff in both Bellevue and the San Francisco Bay Area as it advances its technology into commercial development.

Existing investors Essex Woodlands, Domain Associates, Morgenthaler Ventures and BioStar Ventures participated and the financing was led by a large-cap medical technology company. The terms of the financing provide for the potential inclusion of additional investors.

Synthetic Biology Accelerator Launched at Singularity University

noreply@blogger.com (Clyve Parker) — Thu, 17 May 2012 15:44:00 +0000

Singularity University Announces Inaugural Synthetic Biology Accelerator Program. Startup founders will develop and launch transformative companies in the emerging field of synthetic biology at new Silicon Valley SynBio Startup Launchpad.

Singularity University today announced the companies selected to participate in its inaugural synthetic biology accelerator program, SynBio Startup Launchpad. The program will nurture aspiring SynBio entrepreneurs seeking to apply the rapid-cycle, low-cost approaches employed by tech and biotech startups. Synthetic biology is genetic engineering using software-based design tools coupled with low-cost DNA synthesis and assembly.

The SynBio Program was conceived by Andrew Hessel, Co-Chair of SU’s Biotechnology and Bioinformatics track, and John Cumbers, Ph.D, a synthetic biologist working at NASA Ames Research Center. As Andrew Hessel explains, “advances in technology are allowing scientists to treat DNA, our genetic code, the same way people use code for software programming.”

The SynBio Startup Launchpad is Singularity University’s first formal initiative to support startups developing exponentially growing technologies. “The SynBio program brings together a powerful community seeking to support startups developing products from the emerging field of synthetic biology to address some of the world’s biggest challenges,” said Gabriel Baldinucci, Singularity University’s Vice President of Strategy and New Venture Development.

Three (3) companies have been selected for the SynBio Program: Evolutionary Solutions, Modern Meadow, and SoilGene. Evolutionary Solutions (founders Kettner Griswold and Paul Sebexen) is developing an oligo- to genome-scale synthesis device. Modern Meadow (co-founder Andras Forgacs) applies the latest advances in tissue engineering to produce a range of novel biomaterials for food and textile applications. SoilGene (founders Zachary Apte and Robert Lim) combines metagenomic and bioinformatic approaches to survey land opportunities for the natural resources and agriculture sectors.

A unique aspect of the SynBio program is its partnership with Triple Ring Technologies in Newark, California. The three selected companies will be based at Triple Ring to take advantage of its engineering and lab facilities, and their staff’s extensive expertise in life sciences innovation and commercialization. “We are excited to work with the SynBio entrepreneurs taking innovations to market in the emerging synthetic biology space,” said Joseph Heanue, Ph.D., president and CEO of Triple Ring Technologies.

The selected entrepreneurs will go through four months of comprehensive, customized mentoring and education in bringing their ideas to market. The companies receive close mentorship from a network of experienced advisors, weekly speakers on critical venture topics, networking with their peers, and valuable discounted services to launch their companies.

The first program will conclude in late August with the SynBio Companies pitching their ventures to investors and the community at “demo day” events.

About Singularity University

Singularity University’s mission is to assemble, educate, and inspire a new generation of leaders in business, science, finance, and government who strive to understand and use exponentially advancing technologies to address humanity’s grand challenges. Corporate Partners include Autodesk, Cisco, ePlanet Ventures, Genentech, Google, Kauffman Foundation, and Nokia. Since 2009, SU has hosted students and industry leaders from more than 60 countries at its campus at NASA Research Park, Moffett Field, CA.

SU offers a Summer Graduate Studies Program and numerous Executive Programs throughout the year focused on the impact and incubation of exponentially advancing technologies in the key areas of medicine and neuroscience, networks and computing systems, artificial intelligence and robotics, biotechnology and bioinformatics, nanotechnology, space and physical science, and energy and environmental systems. SU programs focus on the intersection of these areas with each other and with policy, law, and ethics; design; entrepreneurship; finance and economics; and futures studies and forecasting.

For more information about the SynBio program visit www.singularityu.org/synbio

SU Media contact: Diane Murphy (diane.murphy@singularityu.org)

SU Synbio Lab contact: Sandra Miller (Sandra.miller@singularityu.org)

EnligHTN Renal Denervation Technology Reduces Hypertension

noreply@blogger.com (Clyve Parker) — Wed, 16 May 2012 15:18:00 +0000

St. Jude Medical (STJ), a global medical device company, today announced that preliminary data demonstrated the company’s EnligHTN renal denervation system was safe and effective for the treatment of resistant hypertension. The study demonstrated that on average patients with resistant hypertension experience a systolic blood pressure reduction of 28 points after 30 days.

Renal denervation is a specialized ablation procedure that has been clinically proven to reduce blood pressure in patients with hypertension that is resistant to medical therapy. A typical normal blood pressure is below 120 systolic (the first number) and 80 diastolic (the second number), and is expressed as 120/80 mmHg. Hypertension, or high blood pressure, is a blood pressure greater than 140/90 mmHg.

Patients that enrolled in the trial had an average of 176 / 96 mmHg baseline blood pressure despite being on multiple medications to help control blood pressure. The results after 30 days demonstrated:

An average blood pressure of 148 / 87 mmHg, a 28 point reduction in systolic pressure
A reduction in systolic blood pressure to below 140 mmHg in 41 percent of patients

“The risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is,” said the trial’s Primary Investigator Prof. Stephen Worthley, Royal Adelaide Hospital in Australia. “From other clinical trials studying the impact of renal denervation we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients.”

Results from other clinical trials for competitive technologies studying the safety and efficacy of renal denervation demonstrated that results improve over time. After 30 days, a 14 point reduction in systolic blood pressure was noted in a competitor’s study, but this number improved to a reduction of 27 points of systolic blood pressure after one year. Compared to this competitive technology, the average 30-day results from the EnligHTN renal denervation trial showed double the reduction in blood pressure at 30 days. Further, the renal denervation treatment was successfully delivered with no serious complications related to the procedure or device.

Forty seven patients enrolled in the multicenter study. To be considered for enrollment, patients were required to have a systolic blood pressure above 160 (150 for patients with type 2 diabetes) and take at least three antihypertensive medications concurrently at maximally tolerated doses, including a diuretic.

“Hypertension accounts for millions of deaths every year, so it is encouraging that just ahead of World Hypertension Day, new data demonstrate that there is a safe and effective solution to help reduce blood pressure in patients where other treatments aren’t working,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division.

“The EnligHTN system is truly a unique technology that we believe has the potential to reduce a root cause of some of the world’s most burdensome cardiovascular diseases and help patients around the world live more healthy lives.”

Hypertension is a root cause of various life-threatening health problems, including heart disease, stroke, and kidney failure. It impacts more than 1 billion people globally, many of whom do not respond to conventional treatment with medication.

Vessix Receives CE MARK Approval for V2 Renal Denervation System

noreply@blogger.com (Clyve Parker) — Tue, 01 May 2012 09:50:00 +0000

Vessix Vascular, a developer of novel percutaneous radiofrequency (RF) balloon catheter technology for the treatment of hypertension, announced today that it has received Conformité Européenne (CE) Mark approval for its V2 Renal Denervation System for the treatment of hypertension.

Patented RF Balloon Catheter Delivers Treatment in Under One Minute

Renal denervation is a percutaneous, catheter-based therapy that uses RF energy to disrupt renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure.

The CE Mark enables Vessix to market its patented V2 System throughout the European Union. The CE certification was issued to Vessix by its notified body, BSI Group, also known as the British Standards Institution.

“Vessix offers a unique approach to treating uncontrolled hypertension that provides excellent clinical results and is faster, easier to use and less painful for patients than any renal denervation system currently available in the market,” said CEO Raymond W. Cohen. “After eight years optimizing RF balloon catheter and bipolar RF generator technologies, it is rewarding to see the V2 System working effectively in clinical practice to safely reduce patient blood pressures. As part of our commercialization strategy, Vessix has initiated a post-market approval surveillance study during which we plan to treat 120 patients at up to 20 international centers located across Western Europe."

Hypertension is the leading attributable cause of death worldwide. According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease and a 7 percent decrease in overall mortality. Renal denervation has shown in published clinical studies to be safe, durable and effective in reducing systolic blood pressure by approximately 20 percent.

Michael D. Gioffredi, Vessix’s Chief Commercialization Officer said, “Renal denervation is rapidly becoming one of the most important medical device developments in decades and we believe that our unique design will set a new standard for the treatment. In light of this regulatory clearance and the strong early clinical results from our multi-center European pilot study, we are moving forward with our commercialization plans in Europe and we look forward to sharing additional pre-clinical and human data at upcoming medical conferences in support of that launch.”

Vessix to Present Initial Clinical Study Results at EuroPCR Conference in Paris May 15-18

Vessix will present interim clinical results from its pilot REDUCE-HTN clinical study for patients with uncontrolled hypertension at EuroPCR 2012.

Professor Uta Hoppe, M.D., of Paracelsus Medical University in Salzburg, Austria, will present one-month post-treatment safety and efficacy data from her patients treated at Paracelsus and additional patients treated at Georges Pompidou Hospital in Paris, France and OLV Ziekenhuis in Aalst, Belgium. The presentation will be made during the “Emerging Interventional Technologies for Treatment of Resistant Hypertension” at 8:00 - 10:20 a.m. local time on Thursday, May 17 in Room 241 at the Palais des Congrès de Paris..

Find Vessix at EuroPCR 2012

Vessix will be exhibiting its V2 Renal Denervation System in booth M72.

Vessix CEO Raymond W. Cohen will also present at the Cardiovascular Innovation Pipeline on Renal Denervation to be held on Wednesday, May 16 at 15:00 local time in Room 351.

About the Market for Renal Denervation

Industry analysts suggest that there are more than 12 million patients worldwide whose blood pressure remains uncontrolled despite taking three or more anti-hypertensive medications representing a global market opportunity for renal denervation that could ultimately grow to $30 billion.

About the Vessix V2 Renal Denervation System

    The V2 System for the treatment of uncontrolled hypertension is an over-the-wire balloon catheter with an array of RF electrodes mounted in a precise pattern designed to deliver a modest dose of RF energy to disrupt the renal nerves located in the adventitia that surround the renal artery. The patented RF balloon catheter connects to a proprietary bipolar RF generator specifically designed and optimized for the renal denervation clinical application.

    Therapy is delivered via a balloon catheter that is quite familiar to interventional cardiologists and other physicians, thereby increasing the usability and safety profile of the device.

    The V2 balloon catheter occludes blood flow to the renal artery during the 30-second RF therapy delivery allowing for a directed and highly controlled flow of heat energy to the target nerves. Consequently, the V2 is significantly faster – by an order of magnitude – than other renal denervation systems currently marketed.

    Rapid RF treatment time greatly increases the efficiency of the denervation procedure and additional safety benefits to the clinician conducting the procedure and the patient in terms of less use of contrast dye and lower exposure to radiation.

About Vessix Vascular, Inc.

Founded in 2003, Vessix is a private company developing novel RF balloon catheter and bipolar RF generator technology. The Company is backed by world-class European and U.S. venture capital firms including NeoMed Management, Edmond de Rothschild Investment Partners and OrbiMed Advisors LLC. For more information on Vessix Vascular, please visit the Company’s website at www.vessixvascular.com or contact Matt Clawson at Allen & Caron Inc at +1-949-474-4300 or via email at matt@allencaron.com .

# # # #

Amgen and UCB Initiate Sclerostin Antibody Phase 3 Program in Patients with Postmenopausal Osteoporosis

noreply@blogger.com (Clyve Parker) — Wed, 04 Apr 2012 08:00:00 +0000

UCB and Amgen announced today the start of their sclerostin antibody (CDP7851/AMG 785) Phase 3 clinical trial program for the treatment of postmenopausal osteoporosis.

"We look forward to working with UCB on the CDP7851/AMG 785 Phase 3 program," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis."

"Our sclerostin antibody project with Amgen is one of the most exciting pipeline programs in UCB's portfolio. Data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis," said Prof. Dr. med. Iris Loew-Friedrich, Chief Medical Officer of UCB and Executive Vice-President Global Projects and Development.

"We are delighted about the start of the Phase 3 program. The progress made to date encourages and motivates us as we work toward providing a new treatment option for women living with postmenopausal osteoporosis."

The Phase 3 program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. Initial results from the Phase 3 program are expected by the end of 2015.

CDP7851/AMG 785 is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, CDP7851/AMG 785 is designed to increase the amount of bone in the skeleton. With more than 75 million people worldwide suffering from osteoporosis, there is a serious patient need for therapeutics that help build bone. Amgen and UCB are collaborating on the development of CDP7851/AMG 785 for the treatment of bone-related conditions, including postmenopausal osteoporosis and fracture healing.

Osteoporosis is the most common disorder of bone metabolism. Osteoporosis, or porous bone, is a chronic, progressive and systemic disease marked by low bone mass, deterioration of bone tissue and low bone strength, leading to bone fragility and an increased risk of fractures.

The rate of bone loss is accelerated in women during and after the menopause as a result of estrogen deficiency associated with the loss of ovarian function at menopause. The risk of fracture increases exponentially with age. The prevalence of osteoporosis is estimated to be 64.6 million people in the seven major markets; women are four times more likely than men to develop osteoporosis

Biomet to Acquire DePuy Trauma Business

noreply@blogger.com (Clyve Parker) — Tue, 03 Apr 2012 14:57:00 +0000

Biomet, a global leader in the manufacture of musculoskeletal medical products, announced today that it has made a binding offer to acquire the worldwide trauma business of DePuy Orthopaedics.

Under the terms of the offer, which is subject to exclusivity protection, Biomet will pay approximately $280 million in cash. The binding offer was made in order to permit DePuy Orthopaedics to comply with its consultation obligations with various European works councils prior to entering into a negotiated, mutually binding purchase agreement.

“This transaction will provide Biomet with a much stronger presence in the global trauma market and greatly expands our Sports, Extremities and Trauma business, which is a meaningful growth driver for Biomet,” said Jeffrey R. Binder, President and CEO of Biomet, Inc.

“The DePuy Trauma team has done a great job of building a successful business. We look forward to welcoming them as Biomet team members and working alongside them to fulfill our commitment to providing customers with outstanding products and service, as well as continued innovation.”

The binding offer expires on June 1, 2012 but can be extended under certain circumstances. The transaction is subject to receipt of regulatory approvals, completion of required employee consultation procedures and other customary closing conditions.

Mammography Screening Can Lead to Overdiagnosis of Breast Cancer

noreply@blogger.com (Jen) — Tue, 03 Apr 2012 03:54:00 +0000

According to recent results from the Norwegian Screening Program reveal that overdiagnosis of breast cancer may be higher than thought and that mammography screening can over estimate the incidence of invasive Breast Cancer.

The study, which compared invasive breast cancer incidence with and without screening in a population of Norwegian women concluded that mammography screening entails a substantial amount of overdiagnosis.

A total of 39, 888 patients with invasive breast cancer were included, 7,793 of whom were diagnosed after the screening program started. The researchers concluded that the overdiagnosis rate of breast cancer in Norway is between 18% (one in six) and 25% (one in four).

"Overdiagnosis" is a term many are unfamiliar with. In cancer medicine, it refers to a tumor that fulfills all laboratory criteria to be called cancer but, if left alone, would never cause harm. This is a tumor that will not continue to grow, spread and kill. It is a tumor that can be cured with treatment but does not need to be treated and/or cured.

Many clinicians reject the idea that there is such a thing as a cancer that does not kill and does not need treatment. Indeed, it is impossible for a physician to tell whether an individual patient with a small localized cancer has an overdiagnosis cancer.

On the other hand, most who study epidemiology and cancer treatment outcomes have accepted that overdiagnosis is a problem in breast cancer.

Research and Markets: Global Blood Plasma Market Report

noreply@blogger.com (ai) — Sun, 01 Apr 2012 13:55:00 +0000

Recent scientific studies are leading to the discovery of new proteins in the blood plasma and their uses to treat hitherto unresolved medical conditions. The market for blood plasma products has shown continuous growth in the past years growing at a CAGR of around 10% during 2001-10 and is projected to expand steadily in the years to come.

With scientific and technological advances in medical research both in developed and developing countries, there is now much room for increased usage of IVIG. New indications are being explored whereby various blood plasma products are being put to new uses for treatment of old and new diseases.

Furthermore, the entry of new recombinant products, which compete with existing blood plasma products, have started a price competition creating a downward pressure on prices. The deficiency of A1PI is still an undiagnosed and untreated disease in North America which provides significant scope and potential for the increased use of blood plasma products in the treatment of the affected people.

Besides this, bleeding disorders and related diseases are growing requiring increased usage of blood plasma products. Ageing population is on the constant rise worldwide and the aged people are prone to develop diseases requiring more demand of blood derivatives. Furthermore, the economic growth is also responsible for higher utilization of blood plasma derivatives. Also, new proteins are being discovered in blood plasma, which are being put to new uses for treatment of various diseases.

Despite several factors suggesting future growth of the market, the high prices of blood plasma products continues to be a significant challenge.

The leading players of the blood plasma market compete mainly on the basis of product pricing and performance, supply of the products, and continuous offering of new and innovative plasma derivatives. The existence of several players operating at a domestic level, entry of new players, and agreements with government agencies, academic and research institutions make the plasma market landscape intensely competitive.

ABOUT THIS REPORT

The report provides an analysis of the global blood plasma market. It also discusses the major trends, growth drivers and potential markets for blood plasma market. The report presents the competitive structure of the industry and profiles major players in the market with a discussion of their key business strategies.

Key Topics Covered:

- Overview

- Blood Plasma Market Overview

- Market Dynamics

- Competitive Scenario

- Company Profiles

- Market Outlook

Companies Mentioned

- Baxter International

- CSL Limited

- Grifols

- Octapharma

For more information visit http://www.researchandmarkets.com/research/c6b1afa9/global_blood_plasm
Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): 353-1-481-1716
Sector: Healthcare and Medical Devices

Biobank to Pinpoint Disease Causes

noreply@blogger.com (Clyve Parker) — Sat, 31 Mar 2012 09:57:00 +0000

The UK Biobank is open for business. Medical, lifestyle and genetic information from 500,000 middle-aged British people is now available to medical researchers around the world to help in the hunt for the causes of and treatments for disease.

"It's the biggest, most detailed collection of data that's ever been put in place," says Rory Collins, UK Biobank's founder. Its impact on dissecting the causes of disease, he says, will be as profound as the invention of the telescope was to astronomy, or the microscope to microbiology.

"If you're born, you will get sick and die, and there's no escape from that," says Barbara Collins, a 57-year-old Londoner who is a UK Biobank volunteer. "But if there's anything I can do to make a difference in someone else's life, I'm more than happy to do that. I hope what I'm doing will speed up research to find treatments for cancer, diabetes, heart disease and dozens of other illnesses."

Collins is one of the half-million Britons aged between 40 and 69 who have donated their DNA, medical history and details of their lifestyle to the UK Biobank. The volunteers will be followed for the next 30 years, and by comparing those who remain healthy with those who develop illnesses, researchers hope to be able to isolate the causes of disease.

In particular, UK Biobank will help measure the extent to which diseases have genetic or environmental causes. "For years, people have asked about nature versus nurture but now, with the data we have, we can tease out the contributions of what you're born with versus the environment you grow up in," says Wendy Ewart of the UK Medical Research Council, one of several backers of the project.
Public interest

First approved in 2006, UK Biobank officially launched on 30 March. Researchers applying for access to the Biobank must show that their work is in the interests of public health, and that its results will be published in peer-reviewed journals. Proposals will be assessed by UK Biobank's board.

The National Institutes of Health in Washington DC are apparently keen to use the UK Biobank – a resource that they considered too expensive and unwieldy to set up in the US, despite initial plans to do so.

"Francis Collins, the director of the NIH, would love to do what we've done, but came to the conclusion it would be too expensive, costing about $2 billion," says Rory Collins. "They can't afford it, and they don't have anything like the National Health Service which tracks everyone's medical records and details."

China has a similar database, called the China Kadoorie Biobank, which also contains the health details of 500,000 volunteers, but Rory Collins says that the UK version has more information on each volunteer. The two are complementary, and could be the focus for joint studies, he says.

The Chinese project hints at the kind of results the UK Biobank might turn up. It has found, for example, that thinner men are more at risk of developing chronic obstructive pulmonary disease in China, and that major risk factors for heart attacks include diabetes and psychosocial stress.
Future growth

There are more than 1000 categories of information for each of the UK participants, ranging from whether they use cellphones and how often they see friends and relatives to the usual spectrum of physiological measurements, including hand grip strength, bone density, blood pressure, lung function, body fat profile, and even scores on standard tests of cognitive ability.

Plans are afoot to add more, including fMRI scans of a fifth of the participants. Many will also be given accelerometers to wear on their wrists for a week, allowing physical activity to be measured accurately. Other ideas include ultrasound scans, and X-rays of bones and joints.

Around 20,000 volunteers will be completely retested every two to three years, and updates on the health of all UK Biobank participants will be automatically fed in from family doctors, hospital records and death registries.

Rory Collins says that all data given to researchers will be coded, so that no individuals can be identified. There will be no feedback to participants about changes in their health status, a condition to which all volunteers consented to at the outset.

Some of the participants already have illnesses, including 26,000 with diabetes, 50,000 with joint disorders and 11,000 who have had at least one heart attack. By 2022, some 40,000 are expected to have diabetes, and 28,000 to have had heart attacks. But Barbara Collins is undaunted by the prospect of ill health to come: "Even if I can't benefit from the results personally, I know my children, my children's children and perfect strangers will."

Research and Markets: Analysis of European Biosimilars Market

noreply@blogger.com (Clyve Parker) — Fri, 30 Mar 2012 09:19:00 +0000

Research and Markets announced today the addition of Frost & Sullivan's new report "Analysis of European Biosimilars Market" to their offering. Impending Patent Expiries of Blockbuster Biologics Spells Good News for Biosimilars

The biosimilars manufacturing industry is at a nascent stage. However, the impending patent expiries of biologics are anticipated to result in the introduction of several new biosimilars and provide impetus to market development.

The expiration of patents and other intellectual property rights of biological innovators over the next decade opens up opportunities for biosimilars to enter the market and increase industry competition, notes the analyst of this research. Price reduction strategies will ensure increased adoption among physicians and patients alike, spurring market advancement.

While the market offers lucrative growth prospects, the need for sizeable investments will pose a serious challenge to smaller firms. Complex production processes, expensive biological and chemical materials, and rigorous clinical trials as well as mandatory safety, efficacy and quality tests require significant investments. The need for considerable financial outlays will hinder the entry of small biotech firms in particular, cautions the analyst.

On the other hand, specialty pharmaceutical companies with biotech expertise and financial capabilities are well positioned to venture into the biosimilars market. High manufacturing costs are another major barrier to market entry. However, there are viable prospects for licensing agreements between companies.

Effective Sales and Marketing Strategies Critical to Successful Commercialisation

The uncertainties and risks for biosimilars manufacturers persist. Companies need to have strongly integrated research and development (R&D), production, sales and marketing processes to ensure market success.

Access to sales and marketing capabilities can be achieved through collaborations between pharmaceutical companies and specialty biotech firms with technical expertise, advises the analyst. Companies can build sales and marketing capabilities in-house and ensure effective marketing support for the commercialisation of biosimilars.

Effective sales communication to the scientific community, coupled with continuous promotional activities as well as close and constant interaction with doctors and pharmacists, will promote greater uptake of biosimilars.

For more information visit :

http://www.researchandmarkets.com/research/459fc936/analysis_of_europe

Source: Frost & Sullivan
Contacts

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): 353-1-481-1716
Sector: Biotechnology

TriVascular Receives FDA HDE for Ovation Abdominal Aortic Stent Graft

noreply@blogger.com (ai) — Wed, 02 Nov 2011 19:56:00 +0000

TriVascular, Inc. Receives U.S. Humanitarian Device Exemption Approval for the Ovation Abdominal Stent Graft System. First of its kind approval expands access to minimally invasive aortic repair

MEDTECHWIRE, November 2, 2011

TriVascular, Inc. today announced the approval of the Ovation™ Abdominal Stent Graft System by the US Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). This is the first HDE granted by the FDA in the field of Abdominal Aortic Aneurysm (AAA) treatment. With this approval, patients previously ineligible for Endovascular Aneurysm Repair (EVAR) will gain access to a minimally invasive therapy.

“The design and available sizing of the Ovation Abdominal Stent Graft are well suited to treat
patients with small aortic anatomy who are currently left without less invasive treatment
options,” said Michael Dake, MD, Professor of Cardiothoracic Surgery and Medical Director,
Catheterization and Angiography Laboratories, Stanford University Hospital. “Coupled with
Ovation’s extremely low profile, 14F OD delivery system, this Humanitarian Use Device will
expand treatment options for patient groups currently underserved by EVAR, such as
women.”

At 14F OD, Ovation is the lowest profile commercially available AAA device. The innovative,
low profile system separates and optimizes the two most important elements of EVAR,
fixation and seal, and is designed to expand the pool of treatable patients by addressing a
wider range of diseased anatomy.

“We are thrilled to receive the first-ever HDE approval in EVAR and are excited to partner
with physicians across the United States,” said Michael Chobotov, Ph.D., President and CEO
of TriVascular, Inc. “This represents an important step in expanding access to minimally
invasive treatment for patients with aortic disease.”

TriVascular’s Ovation Abdominal Stent Graft System was launched commercially in Europe in
January 2011. In the United States, the pivotal study of the Ovation Abdominal Stent Graft
completed enrollment in March 2011. Enrollment in the Continued Access study is ongoing.
Under the HDE, Ovation is approved for use in patients with access vessels of less than 7mm
in diameter and aortic necks with lengths of at least 7mm and diameters between 15.5mm
and 17.4 mm.

About TriVascular, Inc. - TriVascular’s initial product offerings are novel endovascular
grafts focused on significantly advancing EVAR. Building upon partnerships with thought
leading clinicians worldwide, TriVascular’s products are designed to address unmet clinical
needs and expand the pool of patients who are candidates for EVAR. Based in Santa Rosa,
California, TriVascular offers highly talented, motivated individuals the opportunity to
positively impact global healthcare.

Media Contact: Vivek Jayaraman 707-543-8804

Edmond de Rothschild Investment Partners - EdRIP

noreply@blogger.com (mw) — Tue, 09 Aug 2011 17:47:00 +0000

Edmond de Rothschild Investment Partners (EdRIP) is dedicated to investments into privately owned companies. It has currently more than €800 million under management invested primarily as life sciences venture capital and growth capital.

The life sciences team consists of seven professionals bringing together over 30 years of experience in the life science industry and more than 50 years of private equity and venture capital experience. The team has approximately €220 million under management, and raised its most recent fund, €150 million BioDiscovery 3 fund, in 2008. Edmond de Rothschild Investment Partners is part of La Compagnie Financière Edmond de Rothschild.

Vessix Vascular

noreply@blogger.com (mw) — Wed, 03 Aug 2011 12:29:00 +0000

Vessix Vascular, founded in 2003 and formerly known as Minnow Medical, is a private company developing a novel percutaneous radiofrequency (RF) balloon cathetercatheter and a bipolar RF generator technology for the treatment of resistent hypertension.

Vessix Vascular is backed by world-class European and U.S. venture capital firms including Edmond de Rothschild Investment Partners (EdRIP), OrbiMed, NeoMed and Christopher Weil & Company.

NeoMed

noreply@blogger.com (mw) — Wed, 03 Aug 2011 09:46:00 +0000

NeoMed is an international investment firm that exclusively invests in emerging companies in the pharmaceutical, medical device and diagnostics industries. NeoMed has total committed capital exceeding $200 million and invests in early-stage companies with outstanding growth prospects.

NeoMed was founded in 1997 and has offices in Norway and Switzerland. To date the company, has established four fund and has successfully invested in more than 30 companies in Scandinavia, Switzerland, Germany and the UK, and North America.

NeoMed’s experienced investment team works closely with its entrepreneurs and a broader industry network to support the growth of its portfolio companies.

In each of its funds, NeoMed builds a balanced portfolio of highly selective investments in young and in more mature private companies. Investments may also be made in privately negotiated transactions involving emerging yet public companies.

NeoMed principally invest in minority positions. Consequently, most investments are syndicated transactions with participation of other investors. In early stage companies, NeoMed may lead or co-lead investments and in more mature companies, NeoMed may lead individual financing rounds in co-operations with other investors.

Portfolio companies are expected to have a clear path to creating value and to achieving a sustainable competitive advantage that will enable an exit for NeoMed within a period of three to five years from the time of investment.

Ablynx Receives €5 Million For Alzheimer's Research

noreply@blogger.com (mw) — Mon, 27 Jun 2011 10:43:00 +0000

Ablynx [ABLX] today announced that it has earned a €5 million milestone payment following Boehringer Ingelheim's decision to initiate development with its lead Nanobody candidate that was selected in May 2010.

In January 2007, Boehringer Ingelheim and Ablynx announced a worldwide research and licensing agreement to discover and develop new therapies for Alzheimer's disease using Ablynx's Nanobodies against a single disease target.

The collaboration has a potential value of $265 million in upfront and milestone payments plus undisclosed royalties on product sales.

"We are delighted that Boehringer Ingelheim is making further progress with the Nanobody lead candidate which has the potential to be a first-in-class therapy for Alzheimer's disease and we look forward to this product advancing into the clinic in 2012." said Dr. Edwin Moses, Chairman and CEO of Ablynx. "This programme illustrates the wide applicability and advantages of our Nanobody platform in addressing diseases as complex as Alzheimer's." He added.:

This is the second milestone payment that Ablynx receives as part of our Alzheimer's research collaboration with Boehringer Ingelheim,

For more information, please contact Ablynx:
Dr Edwin Moses
Chairman and CEO
t:   +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
     +32 (0)473 39 50 68
e: edwin.moses@ablynx.com

Marieke Vermeersch
Investor Relations Manager
t:   +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch@ablynx.com

Carotid Stent Systems Market to Double by 2015

noreply@blogger.com (Clyve Parker) — Mon, 20 Jun 2011 15:21:00 +0000

The world market for carotid stent systems, which was valued at $150 million in 2010, is expected to double by 2015, according to a new Medtech Report titled:

Carotid Stent Systems Market - Current Status & Future Outlook

Despite the fact that carotid stents were available in Europe since 2000, and with over a decade of clinical experience with carotid stenting as an alternative to surgery, the market is still in its early stages of development.

Carotid artery stents were approved by the FDA in 2004 for high surgical risk patients and the first procedure specific carotid stent was approved in Japan in 2008.

The market for carotid stent systems serves primarily older people with progressive atherosclerotic disease, so based on demographics alone demand for a minimally invasive catheter-based treatment option should continue to grow.

Recent results from the CREST trial coupled with extending indication, by the FDA, to include standard-risk surgery patients will propel growth.

Abbott Vascular, Cordis, Boston Scientific, Medtronic and Covidien have transformed the competitive landscape of the market by bundling their carotid stents with their embolic protection devices as complete Carotid Stent Systems.

However, the competitive landscape is about to experience further change as companies in the neurovascular space embrace the technology in an effort to broaden their offering to their client base with comprehensive stroke management solutions.

This should open windows of opportunities for innovative stents and embolic filters design and development companies to license their technologies and spin off their in-development products.

Carotid Stent Systems Market - Current Status & Future Outlook report offers an overview of the state of both the technology and the market. It profiles current market landscape for carotid stent systems and explores market potential for the devices with global forecast to 2015.

Covidien Receives FDA Premarket Approval for Pipeline Embolization Device

noreply@blogger.com (mw) — Wed, 06 Apr 2011 10:33:00 +0000

Covidien today announced that it received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the Pipeline Embolization Device.

The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

Pipeline is a new class of embolization device designed to divert blood flow away from the aneurysm in order to provide a complete and durable aneurysm embolization while maintaining patency of the parent vessel.

"The Pipeline Embolization Device is a breakthrough and life-saving endovascular treatment for large or giant wide-neck brain aneurysms." said Joe Woody, President, Vascular Therapies, Covidien.

The Pipeline Embolization Device PMA application was based on the results of the PUFS (Pipeline for Uncoilable or Failed Aneurysms) clinical study, a single-arm study of large and giant, wide-neck or fusiform aneurysms that included safety and efficacy data on 108 patients.

The Pipeline Embolization Device has received CE Mark approval in Europe and has been sold outside the United States since July 2009. The Pipeline device will be available at the existing clinical sites in the U.S. beginning this quarter.

Sanofi-Aventis Wins Control of Genzyme

noreply@blogger.com (mw) — Mon, 04 Apr 2011 09:45:00 +0000

Sanofi-Aventis SA, France’s biggest drug maker, has won control of Genzyme Corp. in an acquisition worth at least $20 billion.

Genzyme holders tendered 225 million shares, or 85% of the outstanding stock in Sanofi’s takeover offer.

Sanofi is paying $74 in cash plus one contingent value right for each Genzyme share. Under the terms of the CVR, Genzyme holders may receive as much as $14 a share in additional payments, depending on the performance of the multiple-sclerosis drug Lemtrada and production levels of two other products.

Remaining Genzyme holders have four days to tender their shares. After that, any remaining Genzyme shares will be canceled and converted into the right to receive the same terms as those that were tendered.

With the acquisition, Sanofi gains treatments for rare illnesses such as Fabry, Gaucher, and Pompe diseases.

FDA Advisory Committee Recommends Approval of Pipeline Embolization Device

noreply@blogger.com (Ron) — Fri, 18 Mar 2011 11:48:00 +0000

Covidien announced today that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Panel voted to recommend approval for Pipeline Embolization Device, intended for the endovascular treatment of large or giant wide-necked intracranial aneurysms.

Pipeline is a new class of embolization device designed to divert blood flow away from the aneurysm in order to provide a complete and durable aneurysm embolization while maintaining patency of the parent vessel.

At its meeting today, the FDA Advisory Panel discussed the Premarket Approval (PMA) application for the Pipeline Embolization Device. Following its review of the PMA data, the Panel voted unanimously to recommend approval. Although the FDA is not required to follow Panel recommendations, it often does.

The Pipeline Embolization Device PMA application is based on the results of the PUFS (Pipeline for Uncoilable or Failed AneurysmS) clinical study that included safety and efficacy data on 108 patients. PUFS is a single-arm study of large and giant, wide-neck or fusiform aneurysms typically not coilable, with six-month safety and effectiveness endpoints.

"Safe and effective treatment of large and giant, wide-neck or non-saccular aneurysms remains a significant unmet clinical need," said Aaron Berez, M.D., General Manager, Neurovascular, Covidien. "Clinical experience suggests that the Pipeline Embolization Device may represent a valuable alternative to current endovascular or surgical treatment options for these types of aneurysms."

"The Pipeline Embolization Device represents a breakthrough endovascular treatment for large, giant and wide-neck aneurysms that are very difficult or impossible to treat with existing therapies such as surgery or coiling," said Joe Woody, President, Vascular Therapies, Covidien. "We believe strongly that the PMA data that was submitted from the PUFS clinical study supports the safety and efficacy of this device."

The Pipeline Embolization Device has received CE Mark approval in Europe and has been sold outside the United States since July 2009.

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4 billion, Covidien has approximately 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

SOURCE: Covidien

Covidien
Rachel Bloom-Baglin, 508-261-6651
Vice President, Communications
Vascular Therapies
rachel.bloombaglin@covidien.com

or

Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com

or

Cole Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com

or

Todd Carpenter, 508-452-4363
Director
Investor Relations
todd.carpenter@covidien.com

Serge Tailler Named CEO of The Pharmaceutical Strategist

noreply@blogger.com (Clyve Parker) — Thu, 17 Mar 2011 12:51:00 +0000

BRUSSELS (MEDTECH WIRE) The Pharmaceutical Strategist (TPS) announced today the appointment of Serge Tailler to the position of President and CEO of TPS Global.

Serge will apply his extensive experience in Integrated communication, branding and strategic planning to solidify the company’s market position as the leading foresight think tank in the life-science industry.

Before joining The Pharmaceutical Strategist, Serge was Global Business Director at Polygone Group, Business Director at Mc Cann Healthcare Worldwide, Partner at 4MED Belgium and Business Development Manager at Nelson Communications.

“With roots in both life-science industry executive level strategic planning roles and digital age communication skills, Serge is the perfect person to lead The Pharmaceutical Strategist into a leading board level advisory role in the life science industry. said Al Sheikh, Senior Partner at TPS.

Mr. Tailler role would span strategic and marketing planning as well as integrated post-modern digital communication campaign design and implementation. He has a great understanding of what the industry needs and will continue to build TPS presence globally. Serge has already put forward solid proposals to re-position the think tank for a new generation of corporate audience.”

About The Pharmaceutical Strategist:

The Pharmaceutical Strategist (TPS) is a global long range planning think tank specialized in the life-science industry. TPS has spearheaded the introduction of cutting edge scenario planning techniques to the pharmaceutical industry, has refined the techniques to fit the long-range planning cycles typical of the life-science industry and has pioneered their application to the level of the global business unit.

Contacts:

Serge Tailler
President & CEO
The Pharmaceutical Strategist
+32 (0475) 605511http://www.pharmastrategy.com

or

Clyve Parker
Medtech Wire
pr@medtechwire.com

Medtronic Completes Acquisition of Ardian

noreply@blogger.com (mw) — Thu, 13 Jan 2011 11:00:00 +0000

Medtronic, (MDT), today announced that it has completed the acquisition of privately-held Ardian, Inc., a developer of catheter-based therapies to treat hypertension and related conditions. Under the terms of the agreement announced on Nov. 22, 2010, the purchase price is $800 million in cash up front, plus additional cash payments equal to annual revenue growth through the end of Medtronic’s fiscal year 2015.

Medtronic had previously invested in Ardian and, prior to completion of the acquisition, held an 11.3 percent ownership stake in the Company. Medtronic expects to recognize a one-time gain on its ownership stake of approximately $80 million, which will be partially off-set by one-time transaction and acquisition costs in fiscal year 2011. Excluding the one-time gain, it is estimated the acquisition will be approximately $0.02 dilutive in Q4 fiscal year 2011, and between $0.05 to $0.06 dilutive in fiscal year 2012.

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. Hypertension is estimated to have a direct cost to the global healthcare system of more than $500 billion annually.

Ardian’s flagship product, the Symplicity® Catheter System™, addresses uncontrolled hypertension through renal denervation, or ablation of the nerves lining the renal arteries. It has received the CE (Conformité Européene) mark and Australia’s Therapeutic Goods Administration (TGA) listing, but is not yet approved by the U.S. Food and Drug Administration (FDA).

Acquiring Ardian offers Medtronic the opportunity to lead the development of renal denervation for the treatment of uncontrolled hypertension. The acquisition augments Medtronic’s existing interventional therapies and complements the company’s expertise in catheter design and ablation technologies.

CardioSonic TIVUS System

noreply@blogger.com (mw) — Fri, 07 Jan 2011 13:02:00 +0000

CardioSonic TIVUS system uses high-intensity, nonfocused ultrasound to facilitate percutaneous transluminal renal artery denervation. The system components are as follows: the 0.014-inch guidewire-based TIVUS catheter equipped with the CardioSonic proprietary ultrasound transducer, the TIVUS control console, and the 6-F flexible introducer sheath.

The single-use TIVUS catheter, which is highly flexible and torqueable, is advanced into the renal artery under fluoroscopic guidance and positioned within the vessel lumen. Real-time US feedback is provided to the operator, allowing for accurate positioning of the TIVUS device to avoid contact with the arterial wall. At the desired longitudinal position within the renal artery, ultrasonic ablation is performed at specific circumferential locations.
The TIVUS catheter is then removed and positioned in the contralateral renal artery, and the procedure is repeated. The total treatment time is anticipated to be < 10 minutes, and recovery time should be rapid. The anticipated outcome is a significant and sustained reduction in blood pressure.

Preclinical Results

A total of 80 acute and 20 follow-up studies on pigs have been performed to date, aimed at determining the optimal treatment parameters of energy delivery duration and intensity. Studies of kidney tissue NE concentrations at 30- and 90-day follow-up have demonstrated successful renal denervation as witnessed by a 50% or more decline in tissue NE.

Several TIVUS ablation points were performed along the same longitudinal arterial location; at 30 and 90 day follow-up, no stenotic intimal lesions were evident on angiography or histopathology and demonstrated ablation of renal nerves.

Clinical Advantages

TIVUS is a percutaneous catheter-based technology, which may offer substantial ease of use and shortened procedure times compared to currently available modalities. Total treatment duration is estimated at five minutes per renal artery.

According to CardioSonic, TIVUS catheter is easy to navigate and position, which provides immediate online safety feedback (eg, ultrasonic energy is not applied if vessel wall contact is present); precise control on the thermal effect location and application of variable levels of thermal modulation of the target tissues; real-time information on the direction and location of the applied energy and spatial orientation of the therapeutic catheter tip; treatment of early bifurcating renal arteries with short treatment segments; and real-time blood temperature feedback (energy application is terminated if blood temperature is unsafely elevated). The localized damage to the nervous tissue at the treatment site suggests that minimal pain may be caused by this treatment.

TIVUS is a potential platform technology that could be applied to other clinical applications requiring directional and localized tissue thermal modulation/ablation, without damage to the blood vessel wall.

CardioSonic

noreply@blogger.com (mw) — Fri, 07 Jan 2011 12:56:00 +0000

CardioSonic is an Israel-based privately owned medical device company developing the TIVUS (Therapeutic IntraVascular UltraSounds) system, a high-intensity, nonfocused ultrasonic catheter system, for endovascular renal denervation.

According to CardioSonic, applying ultrasonic energy, the TIVUS technology enables remote, localized, controlled, and repeatable thermal modulation of the renal vessel wall tissue, resulting in safe renal nerve ablation.

The remote thermal effect is located in the adventitia and perivascular region, with no thermal damage to the endothelium and media, therefore, preventing the development of vessel injury processes.

People:

Ariel Svertdlik
Chief Technology Officer and Cofounder

Medtronic Signs Agreement to Acquire Ardian

noreply@blogger.com (mw) — Mon, 22 Nov 2010 11:05:00 +0000

Medtronic, Inc. (NYSE: MDT) and privately-held Ardian, Inc. announced today that they have entered into a merger agreement whereby Medtronic will acquire Ardian. The agreement calls for Medtronic to make an up front cash payment of $800 million, plus commercial milestones equal to the annual revenue growth through the end of Medtronic’s fiscal year 2015. Medtronic had previously invested in Ardian and currently holds an 11 percent ownership stake in the Company.

Based in Mountain View, Calif., Ardian develops catheter-based therapies to treat hypertension and related conditions.

“Hypertension (high blood pressure) is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death,” said Sean Salmon, Vice President and General Manager of the Coronary and Peripheral Business at Medtronic. “We view renal denervation for the treatment of uncontrolled hypertension as one of the most exciting growth markets in medical devices. Ardian’s investigational catheter-based treatment for uncontrolled hypertension through renal nerve denervation complements Medtronic’s expertise in catheter design and ablation technologies, and augments Medtronic’s interventional therapies.”

Data from a clinical study of Ardian’s flagship product, the Symplicity® Catheter System™, were recently released at the American Heart Association 2010 Scientific Sessions in Chicago and published in The Lancet. It was reported that patients treated with the Ardian device experienced a 33 mmHg greater reduction in systolic blood pressure at six months (p<0.0001) than the control group. The Symplicity Catheter System has received CE mark and Australia TGA listing, but is not approved for sale in the U.S.

“Ardian brings to Medtronic the Symplicity Catheter System and a growing body of evidence to support its clinical use for patients whose hypertension remains uncontrolled despite optimal medical management,” said Andrew Cleeland, President and CEO of Ardian. “Our integration into Medtronic creates a tremendous opportunity to leverage Medtronic’s global scale and scope to advance the treatment of uncontrolled hypertension.”

The transaction is expected to close in Medtronic’s third fiscal quarter of 2011, and is subject to customary closing conditions, including U.S. and foreign regulatory clearances.

Genzyme Courts Takeda

noreply@blogger.com (Clyve Parker) — Mon, 15 Nov 2010 09:07:00 +0000

Genzyme initiates talks with Takeda in a bid to sell itself for more than the $18.5 billion Sanofi is offering.