TORONTO, May 19, 2016  -- Profound Medical Corp. (PRN.V), an emerging medical device company focused on prostate care, today announced that it has been granted Investigational Device Exemption (“IDE”) approval from the U.S. Food and Drug Administration (“FDA”), for a multicenter Pivotal Clinical Trial (“Pivotal Trial”). The objective of this trial is to evaluate the efficacy of the TULSA-PROTM System in patients with localized prostate cancer.

 

TULSA-PRO is a unique technology that combines real-time Magnetic Resonance Imaging (MRI) with transurethral robotically-driven ultrasound and closed-loop thermal feedback control providing a highly precise prostate treatment tailored to patient-specific anatomy.

 

“We are delighted to announce that TULSA-PRO has received IDE approval,” commented Profound CEO, Steve Plymale. “With this approval, clinicians participating in the study will be able to further validate the efficacy of this innovative technology. The commencement of this multijurisdictional Pivotal Trial is a significant milestone for Profound as it aims to establish TULSA-PRO as a minimally invasive alternative to other prostate care therapies. This study is expected to set the path to 510k regulatory approval and we look forward to working with the FDA to bring this unique technology to clinicians and patients across the United States.”

Data highlights promising results obtained from the AMIRST pilot study.

 

RANCHO CORDOVA, Calif., May 19, 2016  -- Cesca Therapeutics Inc. (KOOL), an autologous cell-based regenerative medicine company, today announced publication of data from a pilot study utilizing the company’s innovative technology for treatment of Acute Myocardial Infarction. The report was published in the “International Journal of the Cardiovascular Academy”, currently online*.

 

Results from the single-patient study titled, “Autologous bone marrow concentrate enriched in progenitor cells - an adjuvant in the treatment of acute myocardial infarction” were obtained using Cesca’s integrated point-of-care technology, Acute Myocardial Infarction Rapid Stem cell Therapy (AMIRST).

CAESAREA, Israel -- Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a leading developer of innovative bone mounted surgical robotic guidance systems, today entered into two strategic agreements with Medtronic plc (MDT). One agreement is a two-stage, multi-faceted, commercial agreement for co-promotion, co-development and, upon meeting certain milestones, potential global distribution of certain Mazor products. The second agreement is for an equity investment by Medtronic in Mazor.

 

Commercial Agreement

The commercial agreement has an initial U.S.-based co-promotion phase. If both organizations achieve their respective milestones by the end of 2017, then the companies will enter the second phase of the agreement, in which Medtronic will assume exclusive global sales and distribution rights for Mazor’s future spine products. 

Highlights:

Transaction values Symmetry Surgical Inc. at approximately $140.3 million

Pre-announces financial results for the first quarter ended April 2, 2016

Conference Call to Discuss Transaction Scheduled for 8:00 am ET on Tuesday, May 3, 2016

 

NASHVILLE, Tenn., May 02, 2016 - Symmetry Surgical Inc. (SSRG) (“Symmetry” or the “Company”), today announced that it has entered into a definitive agreement to be acquired with an equity value of $140.3 million by an affiliate of RoundTable Healthcare Partners (“RoundTable”), an operating-oriented private equity firm focused exclusively on the healthcare industry.  Under the terms of the agreement, Symmetry shareholders will receive $13.10 in cash for each share of Symmetry common stock, representing a 26% premium to the closing price of the Company’s common stock on April 29, 2016.  The agreement was unanimously approved by Symmetry’s Board of Directors.