Medical Device Daily Correspondent

ZICHRON YAAKOV, Israel – Tactile Technologies (Rehovot, Israel), developers of the Implant Location System (ILS), a disposable micro-robot for accurate, efficient dental implant procedures, obtained FDA marketing approval for its 3-D surgery planning and implant locator software.

The company, not yet two years old, was founded by serial entrepreneurs and physicists Zvika Slovin, company CEO; Uriel Weinstein, vice president of R&D; Haim Tal, chairman of the periodontology department and chairman of the dental implants department at Tel Aviv University and head of Tactile Technologies’ Clinical Advisory Board; along with attorney Amichai Ben-David, chairman of the board, founder and manager of the Israeli investment company DCL Technologies.

Tactile Technologies will begin marketing the software package in the U.S. while planning clinical trials for its integrated, disposable micro-robot to begin in July at various leading medical research centers, including Vienna General Hospital, Boston University Hospital and New York University.

Slovin told Medical Device Daily, “Dental system manufacturers have been seeking a solution that minimizes the risks and simplifies the implant procedure, but current devices still suffer from inaccuracy, high procedural complexity and high prices. We leveraged recent technological advances in tactile sensing technology, 3-D radiological visualization and miniaturized robotic control to create Tactile Technologies’ unique bone-sensing technology that enables precision measurement of bone tissue covered by soft tissue, without invasive surgery.”

The company’s tactile sensing technology provides a mechanical image of the bone contour without removing any gum tissue. Bone contour measurements are compared to pre-operative radiological images that are used to determine the exact location of the system on the patient’s anatomy.

The sensor uses a matrix of ultra-thin micro-needles inserted through the gum tissue until contact with bone is attained. The needles’ specially designed geometry en-sures negligible trauma while bone contours are measured using miniature position encoders and digital signal processing electronics.

“The result is unprecedented, exceptionally high measurement accuracy,” Slovin said.

The founders of Tactile Technologies created the firm following their previous successful associations. Slovin, Weinstein and Ben-David founded RDC Communications, which was sold to Marconi Communications for $39 million in 1999, and also Gnome, which was sold to BBRS for $10 million in 2001, then later sold to Marconi.

Tactile Technologies’ president, implant pioneer Gerald Niznick, provided the start-up funding. He invested $4 million in the company last year. He is known as the founder of the dental device company Paragon Implant, which was sold to Sulzer Medica in 2002 for $102 million.

Other applications planned for the Implant Location System and related tactile sensing devices are in spinal surgery and a variety of fine orthopedic procedures.

FDA approval for new ECG technology

BSP Biological Signal Processing (Tel Aviv, Israel) received FDA approval for marketing and sales of its HyperQ System, a high-frequency ECG (HF ECG) proprietary signal-acquisition and signal-processing technology that the company says will revolutionize the early detection and monitoring of ischemic heart disease, the leading cause of death in the developed world.

Irit Yaniv, BSP’s vice president of clinical and business development, explained that the HyperQ System is the first PC-based stress ECG device that records, analyzes and displays both conventional stress ECG and HF ECG, then creates a physician-friendly interface – numerical readout of the results, as well as self-explanatory graphs, that detect myocardial ischemia.

BSP recently concluded a study on 1,000 patients showing that critical changes in certain high frequency components of the QRS complex are consistently present with acute myocardial ischemia, and, more so, are reversed by reperfusion, Yaniv said.

“HyperQ technology can show if reperfusion is successful with unmatched accuracy,” said Amir Beker, BSP’s CEO, who founded the company in 2000. “[Our] first FDA approval is an essential milestone on the road to global recognition of our technology.”

He added that, with the company now holding ISO certification, the CE mark and FDA approval, “we are ready to bring our products to the U.S. and European markets.”

BSP is developing at-rest and activity monitoring systems, telemedicine devices and application for implantable cardiac devices, said the company’s chief scientist, Shimon Abboud, a Tel Aviv University professor who pioneered cardiac implications of HF ECG more than 25 years ago, and is about to take his own start-up, CardioInspect, on a U.S. road show of Israel life science companies.

Lumenis partners with

Lumenis (Yokneam, Israel), a global maker of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications, reported its plans to partner with to distribute its clinical management software with each new Lumenis aesthetic laser sold in the U.S.

Avner Raz, president and CEO, said, “AestheticPC is a software company focused on web-based applications specifically designed for aesthetic practices and provides the platform needed to seamlessly manage patient accounts, clinic scheduling, resource allocation and treatments for aesthetic service providers.”