TransEnterix Completes Successful Pre-Clinical Robotic Surgical Procedures; Management Affirms FDA Timeline

SurgiBotTM system FDA 510(k) filing on track for mid-2015 submission

RESEARCH TRIANGLE PARK, N.C.-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the successful completion of four general surgery and urology procedures using its SurgiBot system patient-side robotic surgery system. Management also stated that the preparation of its FDA 510(k) filing is proceeding as planned, and affirmed prior guidance of its intention to submit the filing in mid-2015.

Philips to acquire Volcano to expand global leadership position in image-guided therapy market

- Philips to acquire Volcano for USD 18.00 per share; total transaction value of USD 1.2 billion (approx. EUR 1 billion), inclusive of Volcano's cash and debt
- Agreement to acquire Volcano, a global leader in catheter-based imaging and measurement solutions for cardiovascular applications, advances Philips' focused strategy in image guided therapy
- Volcano provides proven clinical development and commercialization capabilities for Philips' next generation of imaging and measurement technologies
- Philips expects the transaction to accelerate sales growth as combined business is optimally positioned to address unmet needs in EUR 4 billion image-guided therapy market
- Transaction expected to be accretive to Philips EPS by 2017 driven by revenue and cost synergies

EDAP Reports Continued Strong Growth in Third Quarter 2014


  • Revenues increased 27% year-over-year to EUR 20.3 million (USD 27.4 million) for the first nine months of 2014
  • HIFU revenue increased 114% year-over-year during first nine months of 2014
  • Positive operating income, excluding FDA-related costs, for three and nine months ended September 30, 2014
  • Solid financial profile with cash position of EUR 11.1 million (USD 14.0 million)
  • Three Focal One Systems sold during third quarter, demonstrates robust OUS demand for next-generation HIFU device
  • Recent FDA guidance on Ablatherm HIFU PMA submission provides clear U.S. regulatory path and opportunity.

University of Toledo Validates University Health Network In-Vitro Data

Toronto, Ontario - December 9 2014 / Theralase Technologies Inc. ("Theralase") (TSXV:TLT.V ) (TLTFF: OTC Pink(R)) announced today that the University of Toledo has conducted in-vitro Photo Dynamic Compound ("PDC") experimentation that replicates preclinical results obtained earlier by Princess Margaret Cancer Centre, University Health Network ("UHN"), thus validating the Theralase PDC technology at two world renowned institutions.

Theralase strategically partnered with the University of Toledo to confirm its in-vitro preclinical PDC results because of the expertise resident in the urology department led by Steve Selman, MD, FACS, Chair and Professor of Urology and Director of Urological Research, University of Toledo, Toledo, Ohio.

Cyberonics Reports Fiscal 2015 Second Quarter Results

Continued strong earnings growth -- Achievement of regulatory milestones -- New one million share buyback

HOUSTON, Nov. 20, 2014  -- Cyberonics, Inc. (CYBX) today announced results for the quarter ended October 24, 2014.

Quarterly highlights[1]

Operating results for the second quarter of fiscal 2015 compared to the second quarter of fiscal 2014, and other achievements, include:

  • Worldwide net sales of $73.4 million, an increase of 5%;
  • Continued growth in international net sales to $13.5 million, and increased by 13% on a constant currency basis;
  • U.S. net sales reached a new high of $59.9 million;