Diagnostics & Imaging Week European Editor and Staff Reports

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 Diagnostics & Imaging Week 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.

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 D&IW 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 in 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).

IONM introduced in Pakistan hospitals

Faisal Jahangiri, a senior neurophysiologist with Impulse Monitoring (IMI; Columbia, Maryland), a provider of intraoperative neurophysiological monitoring (IONM) services to hospitals, recently introduced IONM at medical centers in four cities in Pakistan.

IONM assesses neurological function involving the brain, spinal cord and related nerve structures during surgery. Its use facilitates the surgical process and can reduce surgical risk by providing alerts to surgeons of potential harm to spinal cord or neural structure, according to IMI.

Jahangiri visited Pakistan at the invitation of the government of Pakistan to tour several medical centers and hospitals across the country, with the objectives to monitor several high-risk surgeries, as well as deliver education sessions on IONM.

IMI provides monitoring and support services to hospitals and other facilities that include intraoperative neuromonitoring for spinal, nerve and brain-related surgeries, and autotransfusion.

Greek/Cyprus distributor for WacSTAT

SpectraScience (San Diego) said it has established a distribution partnership for the Greek and Cyprus markets through M.S. Jacovides Hellas, an Athens-based firm specializing in the marketing and distribution of innovative medical devices.

Michel Vaudry, SpectraScience VP of sales and marketing, said, "M.S. Jacovides is a respected and well-established medical distribution company and its decision to add the WavSTAT Optical Biopsy System to their portfolio is a strong validation of our technology.

M.S. Jacovides Hellas' President/Managing Director Aris Jacovides said, "We ... believe there is significant market potential for this innovative GI cancer diagnostic system. We see important benefits to our physicians, enabling them to quickly distinguish between normal and precancerous tissue in the GI tract and allowing for physical biopsy at exactly the same site and time that the optical biopsy is performed.

He added, "More importantly, the WavSTAT objectively identifies the borders of tissue during surgery to determine if all cancerous tissue has been removed. This will prevent a second surgery."

Breastlight debuts at MD&M West

New life sciences company PWB Health (Dumbarton, Scotland) introduced at last week's MD&M West conference in Anaheim, California, the Breastlight, a home-use device that makes it easier to perform self-examinations by literally shining a light on breast tissue to illuminate internal changes.

To optimize the performance and durability of the Breastlight, SABIC Innovative Plastics' (Pittsfield, Massachusetts) Lexan and Cycoloy healthcare resins are used in the housing and lens of the device. These medical-grade materials, combined with technical and design services provided by SABIC Innovative Plastics, helped PWB Health bring the Breastlight to market quickly, thus giving women a new tool as part of their regular breast awareness routine.

The Breastlight was being exhibited for the first time in the U.S. at SABIC Innovative Plastics' booth at MD&M West.

To create the Breastlight, PWB Health had a number of application requirements, beginning with the device's housing. Because the product is typically used in the bathroom where it might drop onto a hard tile floor, the company wanted a tough, impact-resistant resin.

For ease of use, PWB Health wanted relatively thin walls (2 mm) to make the housing lightweight, which required a high-flow resin. For the Breastlight lens, the company wanted a crystal-clear material with excellent impact resistance and the ability to be ultrasonically welded.

Breastlight has been approved for sale in Europe and Canada and is currently under review by the FDA for sale in the U.S.

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