Navigation Links
Incept BioSystems Completes First Human Clinical Trial of the SMART Start™ Embryo Culture System and Submits 510(k) Application to the FDA
Date:10/12/2010

ANN ARBOR, Mich., Oct. 12 /PRNewswire/ -- Incept BioSystems, Inc. ("Incept"), a privately-held biomedical device company using patented, microfluidic technology developed at the University of Michigan, announced today the completion of the first U.S. human clinical trial of its proprietary, SMART Start Embryo Culture System, and the recent submission of a 510(k) application to the U.S. Food & Drug Administration ("FDA").  A decision as to market clearance for the device is expected from the FDA sometime in 2011.

As compared with the current in vitro fertilization ("IVF") practice of culturing embryos in a static environment (i.e. a microdrop in a culture dish), Incept's SMART Start Embryo Culture System is a device that enables a continuous, refreshable culture microenvironment while using industry-standard IVF culture medium.

The objective of the clinical trial, for patients undergoing IVF, was to assess the impact on a) morphological embryo development (structural characteristics), and b) embryo survival rates, when embryos are subjected to a refreshable culture microenvironment. A total of 496 embryos from 36 couples who were diagnosed with infertility, and were planning to undergo IVF and embryo transfer, were enrolled in the prospective, randomized performance study, which took place at four investigational sites. Data from the study (P=0.0145) showed that Incept's SMART Start Embryo Culture System met the primary endpoint and was non-inferior to the conventional static dish culture, based on the number of embryos that reached the 8-cell stage at 72 hours of culture.

Commenting on today's news, Christopher Bleck, President and Chief Executive Officer of Incept, noted, "We are pleased with the trial results, which confirmed the safety of the SMART Start Embryo Culture System. This is the first time that any microfluidic technology has been used successfully to help treat infertility patients and is, therefore, a key milestone for our company, and potentially, for the future of IVF.  We anticipate initiating a second study in 2011 to evaluate implantation and pregnancy rates using the system."

Dr. Joseph Conaghan, Ph.D., H.C.L.D. of the Pacific Fertility Center in San Francisco and a trial investigator, stated, "With only a fraction of IVF cycles in the U.S. resulting in a live birth using today's methods, the successful development of Incept's novel, SMART Start Embryo Culture System, could have broad ramifications for the future of IVF and potentially represent a new standard of care. We were honored, therefore, to have been able to take part in this important clinical trial and look forward to working with Incept on the continued development of this product."

About In Vitro Fertilization

IVF is a technique in which eggs are retrieved from a woman's ovary and inseminated, resulting in fertilized eggs which are then cultured in specialized laboratory conditions. It is the primary treatment for infertility today, common when other methods of achieving conception have failed.  According to the Society for Reproductive Technology, in 2008, women underwent approximately 140,800 IVF cycles in the U.S., and over 1,000,000 cycles, worldwide.

About The SMART Start Embryo Culture System

The SMART Start technology platform is designed to provide a continuous, refreshable culture microenvironment while using industry-standard IVF culture medium. Mouse and bovine studies conducted by researchers at the University of Michigan, and at the Company, have demonstrated that the use of this system improves the rate of embryo development so that a greater percentage of embryos achieve advanced stages of development.

The System is comprised of an electro-mechanical device, consisting of the SMART Start pump, power pack, cable hub, and associated cabling and; the polystyrene, microfluidic SMART Start cartridge -- a single-use disposable component that attaches to the pump and is configured to contain wells and channels to provide a dynamic, microfluidic culture environment up to the time of embryo transfer.

About Incept BioSystems

Incept BioSystems, Inc., based in Ann Arbor, Michigan, is a privately-held medical device company leveraging its proprietary, microscale SMART Start technology (System of Microfluidics for Assisted Reproductive Technology) platform to provide the in vitro manipulation, performance, and viability of high-value cells for the treatment of patients undergoing in vitro fertilization. The device is a cell culture system that can mimic in vivo conditions and is the first microfluidic system that will address the demanding user requirements of fertility professionals while reproducing physiologic conditions for embryo and oocyte culture in the Assisted Reproduction lab.  For additional information about Incept BioSystems, visit the Company's website at: http://www.inceptbio.com.


'/>"/>
SOURCE Incept BioSystems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Incept BioSystems Initiates First Human Clinical Trial of its SMART Embryo Culture System for In Vitro Fertilization (IVF)
2. Biosystems International Merges With Microbiochips
3. NEXUS Biosystems Completes Acquisition of REMP Sample Management Business From Tecan Group
4. NEXUS Biosystems Acquires Tecan Groups REMP Sample Management Business
5. InfraReDx Completes $21 Million Equity Financing
6. Ocular Therapeutix Completes Proof of Principle Study with Moxifloxacin-Loaded Punctum Plugs
7. Apollo Endosurgery Completes First Clinical Case with Newly-Launched FlexShears™ Endoscopic Scissors
8. Randomized Clinical Trial of OrbusNeichs Genous™ Bio-engineered R stent™ in China Completes Patient Enrollment
9. DiFUSION Technologies Completes Successful Antimicrobial Implant Animal Trial
10. IDEV Technologies Completes $46 Million Preferred Stock Financing With Piper Jaffray and Additional Strategic Investor
11. SAFC® Completes Expansion of High-Potency Fermentation Capabilities at Israel Site
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/18/2017)... -- Two Bayer U.S. Pharmaceutical leaders received top awards from ... th Woman of the Year event ... mission of furthering the advancement and impact of women ... Powell-Steffen , senior director of brand activation and inside ... Howe , a regional business manager for New England ...
(Date:5/11/2017)... 2017  Thornhill Research Inc. ( Toronto, ... $8,049,024 USD five-year, firm-fixed-priced, indefinite-quantity/indefinite-delivery contract by the ... Corporation (CCC) ( Ottawa, Ontario, Canada ... general anesthesia to patients requiring emergency medical procedures ... Marine Corps have been a longtime partner with ...
(Date:5/10/2017)... Md. , May 10, 2017 CSSi, ... solutions for the clinical research industry, is proud to ... www.CSSiEnroll.com . The new website features both enriched content ... user experience and enhances the company,s already well-established position ... industry. "After many months of hard ...
Breaking Medicine Technology:
(Date:5/26/2017)... ... May 26, 2017 , ... Leading CEOs from biotech, pharmaceutical, ... and 31st at The Four Seasons Hotel Boston. , The Boston CEO ... offering exclusive access to key decision makers who influence deal making and investment. ...
(Date:5/26/2017)... ... May 26, 2017 , ... Somnoware, ... NOX-T3 portable sleep monitor with its Somnoware Sleep Device Interface (SDI). Somnoware SDI ... diagnostic device operations. With this platform, initializing devices and importing studies are just ...
(Date:5/26/2017)... ... May 26, 2017 , ... via seating ... mesh back 24/7 task chair specifically designed for clinical areas. Genie Copper Mesh ... to partner with Cupron® to provide customers with a game changing chair that ...
(Date:5/26/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, Texas, ... being discussed by President Donald Trump and the rest of the world. Donald Trump ... peace talks in the continuous battle between Israel and Palestine. The world’s eyes are ...
(Date:5/26/2017)... ... May 26, 2017 , ... Dr. Alex Rabinovich, a highly-skilled oral ... new, informational blog post on insurance options. If a Bay Area patient has to ... save time and money. Visiting an in-network provider for a second opinion can ensure ...
Breaking Medicine News(10 mins):