A Medical Device Daily

In Veritas Medical Diagnostics (IVMD; Inverness, Scotland) reported signing a commercial agreement on a joint project with the Ness Foundation, a Scottish-based neuro-developmental research organization.

IVMD said it would apply its low-cost measurement systems together with the foundation’s intellectual property to develop a rapid, non-invasive diagnostic product for the early detection of mental illness.

The company said the joint development would focus in the area of phospholipid spectrum disorders and the breakdown in communication between brain cells to evaluate simple, quantitative and diagnostic tests.

John Fuller, president and CEO of In Veritas, said, “Our technology is already proven to measure blood parameters and was the subject of a recent patent application for non-invasive measurement. There is tremendous synergy between our measurement techniques and the type of diagnosis required by the scientists at the Ness Foundation.”

Ness Foundation Chairman Douglas Mundie said, “We hope that by using IVMD’s technology with our own intellectual property, we can further the understanding and effective treatment of neuro-developmental disorders.”

In Veritas, known as In Vivo Medical Diagnostics prior to a name change earlier this spring (Medical Device Daily, April 25, 2005), said the process currently in use is imprecise, requires skilled interpretation and is costly, preventing any widespread use. It has been estimated that one in six people worldwide will suffer from a medically identified neuro-developmental illness with one in 100 having a serious condition.

World Health Organization (Geneva, Switzerland) statistics show 24 million people worldwide suffer from schizophrenia (0.7% of the adult population), and the cost of treatment alone is $1.44 billion per year.

The Ness Foundation’s mission is to improve the quality of life of individuals with neuro-developmental disorders and other related conditions, by conducting research to discover safer, more effective diagnostics and treatments. The conditions that its research is focused on include schizophrenia, bipolar disorder, autism spectrum disorder, dyspraxia, dyslexia, depression and ADHD.

In Veritas Medical Diagnostics consists of two wholly owned subsidiaries based in the UK – IVMD (UK) Ltd. and Jopejo Ltd. IVMD (UK) is in the final stages of developing its first medical device for the cardiovascular market, with other applications of its technology to include the diabetes market and other areas where imaging is essential.

Jopejo is in the late stages of developing new monitoring devices that utilize signal processing for the late-term pregnancy market.

French reimbursement for Physio-Stim

Orthofix International (Huntersville, North Carolina) said it has received reimbursement approval from France’s Ministry of Health for the Physio-Stim bone growth stimulator.

Physio-Stim is indicated for the treatment of an established non-union acquired secondary to trauma. A non-union is considered to be established when the fracture site shows no visible progressive signs of healing.

The product is a single-piece, self-contained, battery-powered, non-invasive, low-energy, pulsed electromagnetic device. It contains an integrated microprocessor-based control unit that generates programmed current pulses for the treatment transducer, which delivers a uniform, low-amplitude pulsed electromagnetic field (PEMF) to the fracture site. The device is powered by a single 9-volt disposable battery.

“While bone growth stimulation products are well-established in the U.S., stimulation is a relatively new technology in Europe,” said Charles Federico, group president and CEO of Orthofix, “thus offering an attractive level of potential growth, due in part to increasing procedure volumes, but also due to the significant competitive advantages of our stimulation product family.”

Federico said Orthofix anticipates that it can grow its second-place market share in France now that Physio-Stim has received reimbursement approval. “In addition, we will continue to be aggressive in seeking reimbursement for our stimulation products in other European countries. Orthofix has the broadest line of clinically proven and FDA-cleared stimulation products, and we believe this presents us with significant competitive advantages.”

Francoise Havez, general manager of Orthofix SA, said “We are proud to be the first PEMF treatment reimbursed in France for pseudoarthosis and delayed union The recommendation of the CEPP [Commission d’Evaluation des Produits et Prestations] placed Physio-Stim ahead of a second surgery or ultrasound treatment.”

Havez said Physio-Stim “enables quantifiable public healthcare cost savings and will allow patients to come back to work earlier.”

Hospital adds two Elekta accelerators

Elekta (Stockholm, Sweden) said Centre Hospitalier de Rodez’s (Rodez, France) new radiation therapy unit has acquired two new Elekta Precise linear accelerators with Multileaf Collimators & iViewGT imaging system, together with the integrated Oncology Information System (OIS) developed by Impac Medical Systems (Mountain View, California), an Elekta subsidiary.

The hospital has chosen the Impac OIS to provide core Image-Enabled Oncology electronic medical record functionality, along with integrated tools designed for radiation oncology treatment management, resource scheduling and procedure management.

The OIS was designed, the company said, to help radiotherapy centers “manage the entire spectrum of cancer care with process automation tools that improve workflow efficiencies while simultaneously reducing the risks of medical errors.”

Impac said that with a vendor-independent infrastructure, its Oncology Information System “allows for best-of-breed hardware configurations and ensures interoperability of multi-vendor radiotherapy equipment, including treatment planning systems, imaging devices, simulators, and linear accelerators.”

Dr. Alain Marre, head of the radiation therapy department at Centre Hospitalier de Rodez, said the Impac OIS “provides a real management tool [and] . . . optimizes verification and traceability of treatments.”