Insightec

INSIGHTEC Ltd.
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]

References

  1. 1 2 Lawrence, Stacy (January 8, 2016). "Insightec raises $22M, brings on Mako Surgical co-founder as CEO". FierceBiotech.
  2. ↑ "PMA P040003 (ExAblate) index page". FDA. October 22, 2004.
  3. ↑ Altman, Lawrence K. (23 November 2004). "Treating Troubling Fibroids Without Surgery". The New York Times.
  4. ↑ "PMA P040003 Supplement 15 (ExAblate) index page". FDA. August 31, 2015.
  5. ↑ "PMA P110039 (ExAblate) index page". FDA. October 18, 2012.
  6. ↑ Garde, Damian (July 29, 2013). "InSightec takes to China with uterine fibroid device". FierceBiotech.
  7. ↑ Lawrence, Stacy (December 15, 2014). "GE-backed InSightec gets $59M for noninvasive surgical tool, adds ex-Mako CEO to board". FierceBiotech.
  8. ↑ "PMA P150038 (ExAblate Neuro) index page". FDA. July 11, 2016.
  9. ↑ Al Idrus, Amirah (August 24, 2016). "Pivotal data for Insightec's noninvasive essential tremor device published in NEJM". FierceBiotech.
  10. ↑ Al Idrus, Amirah (August 15, 2016). "Siemens, Insightec partner on novel essential tremor treatment". FierceBiotech.
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