A Medical Device Daily

SpineVision (Paris) reported that it has initiated a limited European release of FlexPLUS, a posterior lumbar pedicle screw-based system that is the first new product developed by its wholly owned subsidiary, FlexSpine (Singapore), spun off from SpineVision's New Technologies Business Unit in December 2005 for the purpose of developing innovative motion preservation technologies.

The FlexPLUS product addresses what SpineVision cited as two critical clinical needs – the dynamic stabilization of the spine without fusion and protection of the adjacent levels in a lumbar fusion.

FlexPLUS offers various degrees of stabilization – rigid, hybrid and dynamic – and is complementary with the recently launched X-PLUS instrumentation system. The FlexPLUS system enables spine surgeons to apply FlexSpine's Selective Segmental Stabilization technology during the procedure and therefore adapt to multiple disc-degeneration stages.

FlexPLUS also is complementary with SpineVision's PediGuard device, which the company says is the first wireless, hand-held instrument capable of accurately detecting changes in tissue type, “thus alerting surgeons to pedicular or vertebral breaches during pedicle screw site preparation.” Real-time feedback is provided to surgeons via audio and visual signals, giving them additional new information.

SpineVision said accuracy of pedicle screw placement still is an issue in spine surgery, with published rates of intraoperatively “misplaced” pedicle screws ranging from 10% to 40%, some of which result in pathological consequences such as spinal cord damage, including paraplegia or quadriplegia.

“We are very excited about this important milestone in the evolution of SpineVision,” said Gérard Vanacker, CEO and founder of the company. “FlexPLUS, like PediGuard, is a unique technology. It will allow spine surgeons to have more options in the treatment of lumbar disc diseases.”

FlexPLUS offers several types of rods composed of titanium and polymer, all fully compatible with PLUS and X-PLUS screws and instruments.

Vanacker said the first 10 cases performed by European thought leaders in the spine sector “have confirmed the versatility of our system and suggest promising perspectives in terms of patient outcomes.”

The company said that prior to clinical use, bench tests demonstrated that the device withstands 15 million cycles under high loads and large displacements, without any mechanical alteration.

“FlexPLUS will soon be followed by other innovative spine motion-preservation technologies currently being developed by FlexSpine,” Vanacker said.

SpineVision said it will be demonstrating FlexPLUS, along with PLUS, X-PLUS, Uni-Thread with its new high-grade Spondylolisthesis instrumentation, and the next-generation of PediGuard at the 13th International Meeting of Advanced Spine Techniques (IMAST) in Athens, Greece, in mid-July.

The global market for non-fusion spinal devices, the focus of the FlexSpine subsidiary, was estimated to be about $200 million in 2005 and is expected to grow to some $7 billion by 2010.

Urgent PC system gets CE mark

Uroplasty (Minnetonka, Minnesota) said its next-generation Urgent PC Neuromodulation System has received the CE mark and been approved for sale in Europe. Notice of the approval came from AMTAC Certification Services, Uroplasty's European Notified Body.

The Urgent PC system is a minimally-invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to the symptoms of overactive bladder.

The new model of the Urgent PC system is for the treatment of overactive bladder symptoms and for the treatment of fecal incontinence. The company said the system was redesigned to provide enhanced ease of use and visual and auditory feedback during device operation.

Regulatory clearance from the FDA is pending, Uroplasty said.

David Kaysen, president and CEO, said European sales personnel expressed enthusiasm for the new design during their pre-launch training program. “We have a highly motivated sales group, including our Uroplasty sales managers, our direct representatives in the UK, and our partnership with distributors in 40 countries around the world,” he said. “In addition, the therapeutic efficacy of the Urgent PC is well documented in European publications.”

Uroplasty has wholly owned subsidiaries in the Netherlands and UK.

Skin cancer firm gets new investor

SciBase (Stockholm, Sweden), developer of a proprietary method for quick, simple and accurate detection of skin cancer, has added Investor Growth Capital as a new investor.

Investor Growth Capital is the wholly owned venture capital arm of Investor AB, the largest industrial holding company in the Nordic region.

Investor Growth Capital, together with previous investors SEB Foretagsinvest and Capman, control 80% of the Swedish medical technology company. CapMan and SEB have provided SEK 50 million of the SEK 100 million total investment in the firm.

The latest investment was done as a new share issue.

“Getting the Investor Growth Capital as a new owner is additional proof that our method and technology have a lot of potential,” said SciBase CEO Christer Wallin.

“There is an enormous interest for early, safe and simple detection of skin cancer, and SciBase's method has been welcomed. It can mean saving lives, suffering, time and money. Our ambition is to deliver results in each of these areas, and thereby making SciBase a world leader in the fight against skin cancer,” said Wallin.

“SciBase represents an inspiring medical device investment for us at Investor Growth Capital,” said Jakob Lindberg of that firm. “There is a large clinical need that is unmet, a market potential in the multibillion SEK range, and a proprietary product with extremely good sensitivity and specificity.”

He added: “Skin cancer is one of the fastest-growing types of cancer in the world and as experts in the field already know, the available diagnostic tools are highly unsatisfactory.”

The research behind the SciBase product development has been conducted at Karolinska Instititute (also Stockholm), under the direction of Associate Professor Stig Ollmar.

With the SciBase technology, it is possible to discover skin cancer within just a few minutes. The area of skin in question can be examined quickly and simply with the help of a probe. At the end of the probe is a disposable sensor that is connected to a computer that interprets the information.

Seven clinical studies have been conducted on more than 1,200 people. Another 700 people are currently participating in clinical studies. The market launch for the product is planned for 2007-2008. Among the potential customers are hospitals, as well as individual clinics.