Medical Device Dailys

The French innovation funding agency OSEO is investing €8.5 million ($11 million) in a collaboration between two companies developing advanced ultrasound applications with the goal of creating a novel treatment for hyperparathyroidism with real-time imaging of the therapy.

The funding will be released over five years as the companies meet milestones for technology integration, proof of concept, product development and clinical studies.

OSEO awarded €6.9 million ($8.8 million) to Theraclion (Paris), which leads the project, and €1.6 million ($2 million) to SuperSonic Imagine (Aix en Provence).

The TUCE project (Traitement Ultrasonore Controllé Elastrographie) combines Theraclion's Thyrus stereotactic targeting for HIFU (high-intensity focused ultrasound) with the Aixplorer from Supersonic that measures tissue elasticity.

The resulting device is expected to provide instantaneous feedback on the efficacy of HIFU therapy for hyperparathyroidism rather than relying upon bloodwork ups and follow up exams with a patient to assess levels of parathyroid hormones, calcium and blood phosphorous.

The market potential for the initial indication of hyperparathyroidism is estimated at €600 million ($767 million) annually by Theraclion CEO Ismaël Nujurally.

Nujurally told Medical Device Daily that the opportunity for integrating the two technologies on a single platform are extensive and a closely guarded secret as competition for HIFU therapy intensifies.

HIFU has been shown to be effective against tumors in the liver, prostate, kidneys, uterus and breasts, he said, citing studies using devices from InSightec (Tirat Carmel, Israel and Dallas) and Focus Surgery (Indianapolis).

"I am not able to tell you where we want to go but bringing a precision measure for tissue elasticity during HIFU treatment, to have a precise image of the necrosis of the glands during treatment, creates a unique advantage and it is only a question of adapting the treatment head to other targeted organs to expand applications," he said.

"We have clinically proven that Thyrus can apply stereotactic targeting for very small nodules in a delicate area of the body, so we are confident and enthusiastic about applying the technology to larger targets," Nujurally said. (MDD, Feb. 12, 2008).

Reaching the first TUCE Project milestone for integrating the technology will release the first funding from OSEO of €900,000 for Theraclion and €800,000 for SuperSonic.

Once a prototype is built, the burden of clinical trials and clinical applications will be carried by Theraclion toward completion of the project in 2013.

This is the third OSEO financing for Theraclion from OSEO, possibly a record, while SuperSonic received a total of €1.4 million ($1.8 million) from the fund in two earlier financing rounds.

OSEO is dedicated to supporting French-based start-ups and Nujurally said the agency encouraged the collaboration of the two firms working in the ultrasound space to build a unique Made in France technology.

SuperSonic received €7 million in June, 2008 from the BioDiscovery III fund of Edmond de Rothschild Investment Partners (Paris).

Olivier Litzka, who manages the BioDiscovery portfolio, told MDD that SuperSonic is the first investment for the newly created fund , which raised €155 million in May, 2008, just ahead of the collapse of investor confidence.

SuperSonic showed its Aixplorer for the first time at the Radiological Society of North America meeting in Chicago early December, an ultrasound system for breast lesion imaging using the proprietary real-time ShearWave Elastography.

Palpation, pressing lightly on the surface of the breast to feel tissue underneath, is the first step in a clinical exam, the company points out.

Aixplorer takes this correlation of tissue elasticity to pathology to a new level with an platform capable of rendering tissue images 200 times faster than conventional ultrasound and producing a a color-coded map of breast lesions.

The Aixplorer superlinear transducer generates a shear wave within tissue by pulsing at supersonic speed forming a Mach cone and then acquiring images at speeds of up to 20,000 Hz.

Theraclion also showed its first-generation product, Thyrus, for the first time at RSNA 2008, and Nujurally said he expects to apply in 2Q09 for a 510(k) approval from the U.S. Food and Drug Administration for hypothyroidism therapy.

Truffle Capital (Paris) increased its investment in Theraclion in 2008, adding €1 million ($1.28 million) bringing its total investment to €5.1 million ($6.5 million).

Swedish firm adds obesity clinics

Global Health Partner (Gothenburg, Sweden) said it is further expanding its network of bariatric centers focusing on treating obesity via gastric bypass procedures.

The new clinics are established in Bergen, Norway; Birmingham, UK; and Cairo, Egypt. They join obesity clinics already in place in Stockholm and Lund, Sweden.

Global Health Partner noted that the prevalence of obesity is increasing "epidemically" in the western world. It said the World Health Organization (Geneva, Switzerland) estimates that close to 150 million people will suffer from obesity in Europe by 2010.

Obesity comes with a number of co-morbidities such as Type 2 diabetes, hypertension and infertility. The excessive weight, along with the co-morbidities, cause patient suffering and higher healthcare spending, the company said.

Bariatric Center Bergen has been opened in Vestnorsk Ortopedisk Sykehus in Bergen, Norway, where Global Health Partner also has a clinic focusing on spine surgery, Bergen Spine Center. Bariatric Center Bergen will primarily focus on the private market.

In Birmingham, Vita Clinics has started the first of several planned UK outpatient clinics. Initially, a number of publicly funded patients from Northern Ireland are treated under a wait-shortening agreement, but the UK clinics also will address the private market.

The third clinic, Bariatric Center Cairo, will treat private patients. The share of the Egyptian population suffering from obesity exceeds 20% and a large portion of these is also suffering from Type 2 diabetes.

Global Health Partner operates specialist clinics that focus on selected treatment areas — spine, dental, obesity and orthopedics — using a Swedish healthcare business model in which leading physicians become partners and shareholders.