Life After the CE Mark Certification. Folks,
Post# of 1609
Posted On: 08/28/2013 2:05:18 PM
Life After the CE Mark Certification.
Folks,
I haven't forgotten you guys in InvestorsHangout. For what it is worth, this is one company that enjoyed the benefits of CE Mark certification after July 20, 2011 to increase sales growth with a new customer base in the EU and Asia. By the way, the company has FDA approved products, too, as Solos. The PPS in 2011 traded higher in 2013. Basically, Solos is following this company's foot steps. Cheers!
Minimally Invasive Devices, Inc. Awarded CE Mark for FloShield
Certification paves way for sale of innovative FloShield laparoscopic visualization system throughout the European Union
COLUMBUS, OH - JULY 20, 2011
PRNewswire -- Minimally Invasive Devices, Inc., (MID) has been awarded CE Mark Certification for its FloShield laparoscopic visualization system. This certification is mandatory for sale of certain medical devices in the European Union.
The FloShield system provides for an uninterrupted clear view during laparoscopic procedures. FloShield uses airflow from the insufflator to defog and deflect debris from the lens of the laparoscope without removing the scope from the abdominal cavity for cleaning. Surgeons have to interrupt surgery as often as ten times per hour to remove the scope and manually clean it. FloShield dramatically reduces, and often eliminates, interruptions to clean the lens. FloShield is the only medical device that prevents optics from becoming obscured.
"The advent of HD ten years ago was the last breakthrough in laparoscopic vision," says Wayne Poll, M.D, FloShield inventor and CEO of MID. "FloShield represents the last hurdle in laparoscopic visualization."
The FloShield system, which received FDA 510(k) approval in 2008, is in early distribution within the U.S., and in use at approximately 40 hospitals throughout the country. The system was certified ISO 13485 compliant in December of 2010, clearing the path for CE Marking.
"We have been contacted by several European and Asian distributors who are interested in FloShield," says Poll.
FloShield is manufactured in Franklin, OH. Poll says the company has more than tripled employment over the last two years from four full time employees to 14.
About Minimally Invasive Devices, Inc.
Minimally Invasive Devices, Inc. (MID) was founded in 2007, by Wayne Poll, M.D., a laparoscopic surgeon . MID's first market offering is the FloShield system of laparoscopic visualization devices. The FloShield franchise will soon add Flo-X, the first biocompatible agent with 510(k) clearance for washing the lens of the laparoscope in situ. The company is also developing complimentary technology that manages the entire air space in laparoscopic surgery , which will improve the environment and experience for laparoscopic surgeons.
Funding for the company was led by the Ohio TechAngel Funds with additional funding from three other Ohio-based angel funds including Queen City, NorthCoast and ECOTAF. MID has received venture funding from Charter Life Sciences and Reservoir Partners. The company is headquartered at 1275 Kinnear Rd., Columbus, OH in the TechColumbus technology business incubator. For more information, visit www.midsurgical.com
SOURCE Minimally Invasive Devices, Inc.
Folks,
I haven't forgotten you guys in InvestorsHangout. For what it is worth, this is one company that enjoyed the benefits of CE Mark certification after July 20, 2011 to increase sales growth with a new customer base in the EU and Asia. By the way, the company has FDA approved products, too, as Solos. The PPS in 2011 traded higher in 2013. Basically, Solos is following this company's foot steps. Cheers!
Minimally Invasive Devices, Inc. Awarded CE Mark for FloShield
Certification paves way for sale of innovative FloShield laparoscopic visualization system throughout the European Union
COLUMBUS, OH - JULY 20, 2011
PRNewswire -- Minimally Invasive Devices, Inc., (MID) has been awarded CE Mark Certification for its FloShield laparoscopic visualization system. This certification is mandatory for sale of certain medical devices in the European Union.
The FloShield system provides for an uninterrupted clear view during laparoscopic procedures. FloShield uses airflow from the insufflator to defog and deflect debris from the lens of the laparoscope without removing the scope from the abdominal cavity for cleaning. Surgeons have to interrupt surgery as often as ten times per hour to remove the scope and manually clean it. FloShield dramatically reduces, and often eliminates, interruptions to clean the lens. FloShield is the only medical device that prevents optics from becoming obscured.
"The advent of HD ten years ago was the last breakthrough in laparoscopic vision," says Wayne Poll, M.D, FloShield inventor and CEO of MID. "FloShield represents the last hurdle in laparoscopic visualization."
The FloShield system, which received FDA 510(k) approval in 2008, is in early distribution within the U.S., and in use at approximately 40 hospitals throughout the country. The system was certified ISO 13485 compliant in December of 2010, clearing the path for CE Marking.
"We have been contacted by several European and Asian distributors who are interested in FloShield," says Poll.
FloShield is manufactured in Franklin, OH. Poll says the company has more than tripled employment over the last two years from four full time employees to 14.
About Minimally Invasive Devices, Inc.
Minimally Invasive Devices, Inc. (MID) was founded in 2007, by Wayne Poll, M.D., a laparoscopic surgeon . MID's first market offering is the FloShield system of laparoscopic visualization devices. The FloShield franchise will soon add Flo-X, the first biocompatible agent with 510(k) clearance for washing the lens of the laparoscope in situ. The company is also developing complimentary technology that manages the entire air space in laparoscopic surgery , which will improve the environment and experience for laparoscopic surgeons.
Funding for the company was led by the Ohio TechAngel Funds with additional funding from three other Ohio-based angel funds including Queen City, NorthCoast and ECOTAF. MID has received venture funding from Charter Life Sciences and Reservoir Partners. The company is headquartered at 1275 Kinnear Rd., Columbus, OH in the TechColumbus technology business incubator. For more information, visit www.midsurgical.com
SOURCE Minimally Invasive Devices, Inc.
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