BB&T < and Staff Reports

PARIS – Will healthcare organizations invest to capture $130 billion?

GE Healthcare (Chalfont, UK) estimates that worldwide there is a value pool of $130 billion in healthcare systems optimization market, bringing advisory services and technology solutions to optimize operational systems, improve clinical decision making and enable integrated healthcare organizations.

In June, GE reported the creation of a new global business unit called Performance Solutions to go broader and deeper into the advisory services and technology capabilities to improve healthcare systems.

Building on its reputation as one of the world's best-run companies, GE is ready to apply to hospitals what it practices in its own day-to-day operations with process improvement methodologies such as Six Sigma and LEAN.

The newly formed business group targets $1 billion in revenues by 2015 and represents a critical component of GE's growth strategy, according to John Dineen, president/CEO of the division.

The move follows last year's launch of the $6 billion “healthymagination“ initiative by Dineen to drive innovation in healthcare.

To reach the $1 billion goal in five years, Dineen told investors at a daylong meeting in New York City in June that revenues from both technology sales and advisory services will double each year.

Dineen includes revenues from companies GE is expected to acquire, such as in-country companies that will boost local capabilities.

In May, just weeks ahead of Dineen's announcement, GE acquired Sanesco (Paris), a French healthcare advisory services company with more than 600 public and private clients.

The revenue stream for GE Performance Solutions includes a mix of fees for advisory services and sales of proprietary technologies to support hospital administration, such as AssetPlus, AgileTrac and BlockOptimizer, for managing assets and patient flows.

Projected to account for one-third of sales, the Performance Solutions for Europe, the Middle East and Africa (EMEA) has emerged as a hot region for the new business unit.

Early successes in France and the UK indicate the company's offer resonates with beleaguered hospital administrators, and demonstrates the audacious goal of doubling revenues each year may not be out of line with the market potential.

Laurent Amiel, general manager for GE Healthcare Performance Solutions EMEA told BB&T a GE-led coalition of advisory and technology companies in France has been ranked as top provider for such services, winning four of eight contracts awarded to date by ANAP (Agence nationale d'appui à la performance des établissements de santé et médico-sociaux).

In 2009, France created the agency ANAP to accompany France's public healthcare providers through a change process aimed at improving the quality of care, the efficiency and increasing patient and staff satisfaction.

GE's EMEA group also is active in a similar program run by the UK's National Health Services (NHS).

Completing a three year program with the NHS Lothian hospital in Edinburgh, GE was praised for implementing LEAN principles throughout the organization and “genuinely empowering the front line staff,“ according to Lothian chief executive James Barbour, who added that staff know where the waste is and “it is they who have proposed the most radical ideas.“

GE is credited with a series of what Barbour called “cash releasing“ benefits including dramatic reductions in waiting times for colorectal cancer referrals and diagnostic scanning, as well as improved bed management.

Hospital inefficiency is not news to anyone, but until recently the urgency to address the problem has been accelerating, explained Amiel during an interview at the Performance Solutions EMEA office in Buc, France.

“Quite simply, there has not been an economic buyer for process improvement,“ he explained, adding, “The budgets invested in process improvement were not significant in many countries, this is now changing.“

Until the financial squeeze reached a tipping point, the focus in healthcare has been mainly on medical innovations, he said.

“For decades we have seen huge improvements in medical practice to the point where every day we are gaining 5 hours of life expectancy,“ he said, adding “that's about a 20% return, which is phenomenal.“

Cyberknife in expanded indication for Japan

Accuray (Sunnyvale, California), a developer of radiosurgery technology, reported that it received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the CyberKnife G4 robotic radiosurgery system to treat tumors non-invasively anywhere in the body, inclusive of head and neck. The system will be marketed in Japan as the CyberKnife radiosurgery system.

In June 2008, Accuray was granted Shonin approval of the CyberKnife system for use in Japan in the treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expanded the types of Japanese patients that could be treated with radiosurgery to include those with cancers of the spine, lung, liver, pancreas and prostate.

Since the 2008 regulatory approval, there has been significant interest in the treatment of tumors throughout the body using CyberKnife radiosurgery and the availability of the CyberKnife G4 System in Japan further expands the planning, application and throughput capabilities of the system. The company believes the system addresses the unique challenges of random and excessive target motion by using intelligent and adaptive image guidance, which minimizes dose to surrounding healthy tissue and critical structures, ultimately minimizing treatment complications and side effects.

Gore DrySeal Sheath used in Australia

W.L. Gore & Associates (Flagstaff, Arizona) reported the first clinical cases in Australia involving its Gore DrySeal Sheath. The sheath aids in minimally invasive treatment of patients with abdominal aortic aneurysms (AAA) utilizing the Gore Excluder AAA Endoprosthesis and thoracic aortic aneurysms (TAA) utilizing the Gore Tag Thoracic Endoprosthesis.

The first procedures were performed by Thomas Daly, MD, at Westmead Hospital (New South Wales), Alan Bray, MD at Newcastle Private (New South Wales), and Michael Denton, MD, at Epworth Private Hospital (Victoria).

The Gore DrySeal Sheath, which was recently released in Australia, is comprised of a hemostatic valve attached to the introducer sheath. The valve is pressurized to create a seal, thereby minimizing blood loss and accommodating multiple wires and catheters simultaneously. The valve consists of a silicone outer tube and an inner film tube that create an effective hemostatic seal that easily adapts to the profiles of the inserted devices. The sheath is available in profiles from 12 to 26 Fr, in 2 Fr increments, and has a working length of 28 cm.

DNA Electronics inks agreement

DNA Electronics (London), a developer of semiconductor solutions for healthcare, reported that it has signed a non-exclusive, worldwide license agreement to provide Ion Torrent (Guilford, Connecticut), the semiconductor sequencing company, access to its intellectual property. No further details about the agreement were disclosed.

DNA Electronics is a provider of scalable semiconductor solutions for real-time nucleic acid detection which enable faster, simpler and more cost-effective DNA analysis platforms. The company's IP portfolio includes techniques for monitoring nucleotide insertions using solid-state biosensors on standard CMOS chip technology, enabling label-free electronic DNA sequencing and diagnostics platforms.

DNA said its Genalysis portfolio of silicon-based point-of-care solutions delivers handheld gene tests with all the appeal of consumer electronics: anytime, anywhere. Interchangeable, disposable “lab-on-chip“ cartridges can be tailored to any sequence of interest, making this a customizable semiconductor technology amenable to a wide variety of applications and markets. The ability to accurately detect a gene sequence in real-time using a standalone, fully portable, low power electronic readout presents disruptive new opportunities in diagnostics, data capture and therapy.

Miraculins to buy PreMD's skin cholesterol test

Miraculins (Winnipeg, Manitoba) said it has executed a definitive agreement to acquire from PreMD (Toronto) all relevant assets, including intellectual property, licenses and regulatory approvals, inventories, data and marketing materials required to commercialize the Prevu skin cholesterol test.

Miraculins will acquire the Prevu test in exchange for a combination of cash, stock and ongoing royalties.

The product has received regulatory clearance in th U.S., Canada and Europe with successful test marketing in U.S. and Canada.

At closing, Miraculins will pay PreMD the purchase price of C$250,000 in cash and issue to the company 1,822,158 common shares from treasury. After closing, Miraculins will pay PreMD a 10% ongoing royalty on its gross revenue associated with Prevu, with Miraculins retaining the right to buy-out the royalty at anytime for a one-time payment of C$1 million.

The test has received regulatory clearance in Europe and Canada as a general part of coronary artery disease (CAD) risk assessment. In the U.S., the test has received clearance as an adjunct to current risk assessment procedures for patients already considered at risk for CAD.

Beckman Coulter signs Canadian contract

Beckman Coulter (BC; Brea, California) reported it has signed a record contract with CML HealthCare (CML; Toronto). According to the company, the deal represents the largest contract of any Canadian diagnostics company for a single testing site.

Valued at an estimated $25 to $30 million over five years, BC will deliver nine of its flagship immunoassay (UniCel DxI 800) instruments, six chemistry (AU5421) systems and three full automation lines to CML. The new chemistry systems are upgrades to the existingBC systems already installed at CML.

CML HealthCare is a community provider of laboratory services with 121 licensed specimen collection centers and one licensed lab that process over 140,000 tests daily. The CML HealthCare network includes 110 medical imaging centers in five provinces across Canada. CML HealthCare's business also includes 23 medical imaging centers in the U.S. Northeast.

Medibord gets £75K investment from Mobius

Medibord (Nottingham, UK) has received a £75,000 ($119,251) investment from the Mobius Life Sciences Fund Medibord designs patient positioning boards for use in MRI scanners and radiotherapy treatments. The company's first product is a radio-translucent, MR compatible composite which was developed in response to oncologists' need for greater treatment accuracy, especially for prostate cancer. With positive feedback from UK users, the company said it is planning to expand sales into the Middle East, followed by the U.S. and European markets.

The investment in Medibord is in the form of equity and debt, with the debt component being provided through Mobius' collaboration with Nottingham City Council.

Mobius provides seed level equity investment into early stage bioscience, pharmaceutical, medical technology and healthcare businesses.

Bioventirx reports first-in-man milestone

BioVentrix (San Ramon, California), developer of the PliCath HF system for use in epicardial catheter-based ventricular reconstruction (ECVR), reported achievement of its first-in-man milestone, performed on a 52-year-old male heart failure patient in Krakow, Poland.

The PliCath HF system is designed to treat heart failure (HF) by reducing the enlarged left ventricle (LV) through an anchoring system that is delivered across the cardiac chambers with the use of a catheter. By pulling non-adjacent walls of the heart into contact, intervening scar tissue that resulted from a previous heart attack is excluded.

Lead surgeon Prof. Jerzy Sadowski, of the Pope John Paul II Hospital, Jagiellonian University (Krakow, Poland) expressed great optimism about the device. “The BioVentrix PliCath HF device performed as it was designed. This technology allowed us to perform major reconstruction of the LV on a beating heart in a matter of minutes without incisions. The patient is recovering well. This device has great promise and should help improve the quality of life of our patients suffering from heart failure.“

The patient's heart size was decreased by 40%, while the ejection fraction (EF), the percentage of blood volume ejected from the ventricle after contraction, increased by 15%. In extensive animal studies, the PliCath HF system improved the EF by 13%; the end diastolic volume (the relaxed part of the cardiac cycle) by 18%; and the end systolic volume (the fully contracted part of the cardiac cycle) by 35%. Based on the outcome of this first procedure, it appears that similar results can be achieved in humans.

MDS Nordion in Cobalt-60 agreement with OPG

MDS Nordion (Ottawa), a provider of products and services to the global health science market, reported that it has extended its existing agreement with Ontario Power Generation (OPG), the Canadian-based electricity generation company, until 2020 for the secure supply of cobalt-60 used in gamma sterilization technologies around the world.

OPG will continue to supply raw materials to MDS Nordion for use in their medical sterilization and sealed source products. The agreement provides MDS Nordion with additional long-term supply for its global customer base.

“Executing on this agreement demonstrates to our current and prospective customers that the company remains committed to securing long-term supply of cobalt-60,“ says Jill Chitra, senior VP, strategic technologies and regulatory affairs. “It also enables MDS Nordion to continue building on its strong market position in the sterilization industry.“

Approximately 40% of single-use medical devices produced worldwide are sterilized using gamma sterilization technologies. These include disposable medical devices and supplies such as surgeon's gloves, syringes, sutures and catheters, as well as pharmaceuticals. In addition, it can be used to sterilize cosmetic products and to enhance the material properties of polymers.

“We continue to build on our solid partnership with MDS Nordion,“ said Bill Robinson, executive VP, Nuclear Refurbishment, OPG.

InspireMed introduces new MGuard system

InspireMD (Tel Aviv, Isrsael) reported the availability of a new delivery system for its MGuard coronary stent system. The new delivery system, which has already been introduced in selected regions around the world, was launched in South America, during SOLACI 2010 in Buenos Aires, Argentina.

“We are very pleased with the flexibility and performance of the new delivery system. In our testing we have experienced a 15% improvement in crossing profile and 45% improvement in pushability resistance. These improvements will directly benefit coronary patients in Latin America and throughout the world,“ said Eli Bar, CTO and VP of R&D at InspireMD.