Navigation Links
ORTHOCON® Receives CE Mark and Health Canada Medical Device License for HEMASORB®
Date:4/21/2011

IRVINGTON, N.Y., April 21, 2011 /PRNewswire/ -- ORTHOCON, Inc., a privately-held therapeutic device company, today announced that DEKRA and Health Canada have cleared its HEMASORB Absorbable Bone Hemostat Matrix for clinical use and sale in Europe and Canada.

HEMASORB is a ready-to-use, biocompatible, water resistant, and absorbable putty designed to rapidly stop bleeding when applied to damaged or cut bone. Control of bleeding from cut bone is a problem in many operative procedures including spine, orthopedic, cardiac, and craniomaxillofacial surgeries. Excessive bleeding during surgery may impair the surgeon's view of the operative field, may result in the need for blood transfusions, and may be associated with post-operative complications. ORTHOCON estimates that over 3.5 million patients undergoing surgeries in the United States, Europe, and Canada each year could benefit from the intra-operative use of HEMASORB.

"We are pleased that HEMASORB has been cleared for clinical use and sale in Europe and Canada," said John J. Pacifico, President and Chief Executive Officer of ORTHOCON. "We are confident HEMASORB will provide surgeons in Europe and Canada with an innovative and cost-effective tool to assist in their management of intra-operative bone bleeding, and we fully expect HEMASORB to become the standard of care for bone hemostasis."

HEMASORB, previously cleared by the Food and Drug Administration (FDA) via the 510(k) premarket notification process, was first introduced in the U.S. in 2010. The product has been approved for sale at leading hospitals throughout the United States and is used successfully by hundreds of surgeons. ORTHOCON will continue to focus its efforts on increasing adoption of HEMASORB in the U.S. and is actively pursuing product distribution partnerships in Europe and Canada to ensure HEMASORB becomes widely available to surgical patients in these markets.

About ORTHOCON

Founded in 2005, ORTHOCON develops, manufactures, markets, and sells implantable products that stop bone bleeding. ORTHOCON's technology platform is also being developed to enable controlled, local drug delivery to the treatment site.

ORTHOCON is funded by leading international venture capital investment firms. The company occupies 8,000 square feet at its state-of-the-art facility in Irvington, New York. For more information, please visit www.orthocon.com.


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

Related medicine technology :

1. ORTHOCON® Announces U.S. Market Launch of HEMASORB®
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
7. CryoCor Receives FDA Approval for Right Atrial Flutter
8. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
9. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
10. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
11. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical Services, ... solutions for injectable drug administration, today shared the results ... Adapter for improving the intradermal administration of polio vaccines. ... Vaccination Summit in May 2017 by Dr. Ondrej ... Department, World Health Organization (WHO), and recently published in ...
(Date:10/4/2017)... , Oct. 4, 2017  South Korean-based healthcare product ... training aide "cprCUBE" on Kickstarter. The device will educate ... cardiac arrests with better efficiency compared to the dated ... real-time feedback on efficacy of the compression for a ... has a goal to raise $5,000. ...
(Date:10/2/2017)... Mich. , Oct. 2, 2017 Diplomat ... 8th Day Software and Consulting, LLC , and ... 8th Day Software, based in Tennessee ... LLC. 8th Day expands EnvoyHealth,s service offerings for health ... development. "In an ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... advisory services for healthcare compliance program management, will showcase a range of technology ... Association for Assisted Living (NCAL) Convention and Expo to be held October 14–18, ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has ... today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula ... the highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... a leader in post-acute health care, have expanded their existing home health joint ... Health. , AccentCare has been operating a joint venture home health company with ...
(Date:10/12/2017)... PA (PRWEB) , ... October 12, 2017 , ... ... is the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B ... York City on October 11, 2017. , The annual award competition recognizes editorial and ...
Breaking Medicine News(10 mins):