• Auxogyn (New York) said the company's Eeva Test is now commercially available in the U.S. following its recent FDA clearance. This technology is designed to help fertility clinics select the best embryos during in vitro fertilization (IVF) to aid in their effort to provide the best chance of a successful pregnancy. The Eeva Test is a non-invasive predictive test that enhances the embryo selection process by taking images of the embryos during the incubation period. The test uses time-lapse image analysis software that was developed to take advantage of a scientific discovery at the Stanford University School of Medicine (Palo Alto, California) which identified specific cell division timings that can be used to predict embryo developmental potential. These automated, objective test results can now be used along with standard morphology grading to select the best embryos. This technology provides information to help clinicians move towards their objective of single embryo transfer. The traditional morphology grading process used to choose embryos for IVF involves visually examining them under a microscope, grading them based on several visual characteristics observed by the clinician, and then, based on this grading, selecting them for transfer into the woman's uterus. When there are several embryos that look similar, embryologists can have a difficult decision to make in selecting which embryo or embryos to transfer. The Eeva Test improves this process, providing clinicians additional information to aid in their embryo selection.

• Bioness (Valencia, California) said four patients have been implanted with the StimRouter Neuromodulation system, for an ongoing Canadian pilot study to evaluate device use in the treatment of overactive bladder symptoms. The StimRouter is already FDA cleared as a treatment for chronic, intractable pain of peripheral nerve origin. Now, this minimally invasive technology is being studied as an alternative treatment for the 35 million people in the U.S who suffer from overactive bladder symptoms and the 10 million who receive treatment for it, which contributes $66 billion in annual cost to the U.S. healthcare system. In the pilot study, subjects with documented refractory overactive bladder will receive tibial nerve stimulation via the StimRouter implantable lead and external pulse transmitter. The subjects will manage their treatment at home in accordance with the defined protocol, with periodic in-clinic outcome visits. The device is equipped with a feature to track usage and compliance during the six-month trial. StimRouter is designed to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of an implanted lead, external pulse transmitter and conductive electrode, controlled by a small hand-held wireless control unit.

• Bone Therapeutics (Gosselies, Belgium), the bone cell therapy company addressing high unmet medical needs in the field of bone fracture repair and bone fracture prevention, said the first four patients in the phase IIA proof-of-concept study for spinal fusion procedures have been treated with Bone Therapeutics' allogeneic osteoblastic (bone-forming) cell therapy product, Allob. This pilot Phase IIA study will enroll 16 patients with symptomatic degenerative lumbar disc disease who require interbody fusion surgery. Patients will be treated with a single dose of Allob combined with bioceramic granules to achieve bone formation and fusion of the vertebral bodies. Safety and efficacy of this treatment will be assessed over 12 months, using clinical and radiological evaluation. Spinal fusion is a procedure that eliminates pain and restores the normal life of a patient but, despite being a fairly routine surgery, is often associated with high failure rates. Bone Therapeutics' cell therapy product has been designed to accelerate the fusion process and reduce the failure rate of current surgeries. Today, the procedure has been performed in four patients without any complications or safety issues. The trial is currently running in four centers across Belgium: the Erasmus Hospital in Brussels, the University Hospital of Charleroi, Brugmann University Hospital in Brussels and the Hospital Oost-Limburg in Genk.

• Convergent Dental (Natick, Massachusetts) has released its new Ultraguide handpiece, along with the 15/400 hollow waveguide and automatic alignment system for Solea, a CO2 9.3 micron dental laser for hard and soft tissue. The new Ultraguide is a precision-engineered handpiece and the 15/400 hollow waveguide is specifically designed for access to the periodontal pocket and other hard to reach areas in the oral cavity. The 15/400 hollow waveguide gets its name from its dimensions which are a length of 15 millimeters and an inner diameter of 400 microns. The Ultraguide will be delivered with the industry's first automatic alignment system which will detect the center point of the laser's 0.25 mm beam and communicate wirelessly with Solea to precisely position it through the exact center of the hollow waveguide's opening.

• K2M Group Holdings (Leesburg, Virginia), a medical device company focused on making complex spine technologies, techniques and minimally invasive procedures, said it has received FDA approval to market the NILE Alternative Fixation Spinal System, the company's latest offering for addressing the most complex spinal deformity cases. K2M also received a CE mark for NILE, which allows the company to expand the global availability of the product. NILE features low-profile, robust implants and intuitive and light ergonomic instruments, intended to provide stabilization between the spine and the rod, and to allow for reduction, translation, compression and distraction while sparing the anatomy. The NILE implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods of various sizes and are also compatible with K2M's MESA Rail. The color-coded NILE Band is woven to provide strength and maintain structure, with exposed metal leaders attached on both sides. The low-profile NILE Clamps allow for compression and distraction along the rod, and provide versatility with independent band and rod locking mechanisms. The intuitive and user-friendly NILE Tensioner, inspired by K2M's patented Cricket technology, requires no assembly and also provides adjustable travel distance to allow for large reduction, as well as controlled, sequential reduction.