Insightec
Private | |
Industry | Medical devices |
Founded | 1999 |
Headquarters |
Tirat Carmel, Israel Dallas, United States |
Area served | Worldwide |
Key people | Maurice Ferré, CEO |
Products | Exablate, Exablate Neuro |
Website | Insightec.com |
INSIGHTEC Ltd., is a privately held medical device company founded by Kobi Vortman, Elbit Medical Imaging, GE Healthcare in 1999 to develop magnetic resonance imaging guided focused ultrasound technology.[1]
The company obtained premarket approval (PMA) from the FDA in 2004 to market its ExAblate system to treat uterine fibroids in women who did not intend to get pregnant again;[2][3] and in 2015 it obtained a PMA to expand the marketing of the system to treat uterine fibroids in any woman.[4] In 2012 the company obtained a PMA from the FDA to market the system to treat pain from metastatic bone cancer who had failed other treatments.[5] In 2013 it won approval to market the system for uterine fibroids in China.[6]
In 2014 Insightec raised $59 million in a flat Series D round; as of that date it had raised $200 million and the valuation of the company was $200 million in the investment.[7]
In 2016 the company hired Maurice Ferré, the founder and former CEO of Mako Surgical, as its CEO.[1] Later that year, Insightec obtained a PMA from the FDA to market its Exablate Neuro system to treat essential tremor[8] and the next month published data from the pivotal trial in the New England Journal of Medicine[9] and signed an agreement with Siemens to integrate the device with Siemens' MRI systems.[10]
External links
References
- 1 2 Lawrence, Stacy (January 8, 2016). "Insightec raises $22M, brings on Mako Surgical co-founder as CEO". FierceBiotech.
- ↑ "PMA P040003 (ExAblate) index page". FDA. October 22, 2004.
- ↑ Altman, Lawrence K. (23 November 2004). "Treating Troubling Fibroids Without Surgery". The New York Times.
- ↑ "PMA P040003 Supplement 15 (ExAblate) index page". FDA. August 31, 2015.
- ↑ "PMA P110039 (ExAblate) index page". FDA. October 18, 2012.
- ↑ Garde, Damian (July 29, 2013). "InSightec takes to China with uterine fibroid device". FierceBiotech.
- ↑ Lawrence, Stacy (December 15, 2014). "GE-backed InSightec gets $59M for noninvasive surgical tool, adds ex-Mako CEO to board". FierceBiotech.
- ↑ "PMA P150038 (ExAblate Neuro) index page". FDA. July 11, 2016.
- ↑ Al Idrus, Amirah (August 24, 2016). "Pivotal data for Insightec's noninvasive essential tremor device published in NEJM". FierceBiotech.
- ↑ Al Idrus, Amirah (August 15, 2016). "Siemens, Insightec partner on novel essential tremor treatment". FierceBiotech.