Cohera Medical Completes Enrollment of Sylys™ Surgical Sealant Clinical Trial

PITTSBURGH, May 30, 2013 -- /PRNewswire/ -- Cohera Medical, Inc.^®, a leading innovator and developer of absorbable surgical adhesives and sealants, today announced the completion of enrollment of its clinical trial for Sylys, the first and only resorbable synthetic sealant specifically designed to significantly reduce anastomotic leakage in bowel procedures.

Currently underway in Europe, the study is evaluating the safety of Sylys on the reduction of anastomotic leakage following bowel repair. The study included patients enrolled at two sites in the Netherlands.

"We are excited to conclude enrollment in this significant safety trial for Sylys, which has the potential to help reduce anastamotic leakage following colorectal procedures," said Dr. Consten of the Meander Medical Center, Amersfoort.  "We look forward to following the enrolled patients and reporting the findings of this study." 

"Cohera appreciates the fast enrollment by both Dr. Bemelman, at AMC Hospital and Dr. Consten at the Meander Medical Center" said Chad Coberly, JD, VP of Clinical, Regulatory and Legal Affairs of Cohera Medical.  "We also greatly appreciate the assistance of the team at Factory CRO, in the Netherlands, to help us reach our timeline objectives on this important first in human study.

Anastomotic leaks, on average, occur in 3 – 15% of colorectal procedures and are the cause of one third of the mortalities following colorectal surgery. Sylys has the potential to make an enormous impact on an industry estimated as a $1 – 4B market.

"Enrollment completion of this study is monumental for Cohera Medical, as this is our second class III product in humans," said Patrick Daly, President and Chief Executive Officer of Cohera Medical.  "It is an indication of the remarkable surgeons we work with, who recognize the value of this sealant, and its ability to enhance standard closure techniques, supporting the healing process and reducing post-operative complications."

Read more here: http://www.sacbee.com/2013/05/30/5457988/cohera-medical-completes-enrollment.html#storylink=cpy

Chinese Starch Medicals Perclot Patent Claims Denied - Impact for Cryolife predicted

Recently denied claims for China based Perclot manufacturer Starch Medical have seen Starch re-file a dramatically reduced set of claims revised patent application published May 16, 2013 (see HERE). 
The original 2009 filing which includes "Inventors" Ji Xin (James Ji), previously Chinese Distributor of Medafor's Arista, has now dropped Jianping Chen (Jane Chen) as an "Inventor".

 Of more critical importance the patent has now shrunk in respect of claims made. Currently claims 1-53 have now been cancelled and it seems likely this patent is less than secure.

The EU search indicates denial regarding incorrect claims and scope of the claims regarding novelty, and inventive steps. Comments such as "the skilled person knows....this method does not support an inventive step" amongst others is available in the embedded document below.

  European Search Report Starch Medical PCT_US2009000227

In the meantime it will be interesting to see the reaction from Cryolife Shareholders who, having been subjected to the Medafor - Cryolife debacle, may now have serious due diligence queries of executives. The millions spent already on the CRY-Starch marriage may be a concern, but continued investments highlighted in the last quarterly report by executives such as Ashley Lee who announced Q1 2013 the intention of (after initial denial of the Perclot IDE) re-filing the IDE with the FDA in May. Ashley also stated further investment in Perclot with "a 320 patient study, randomized 1:1 with a 30-day follow up over across several medical specialties". CEO Steve Anderson commented when questioned about Perclot manufacturing "I think we’ve already spent the money that we’re going to spend to build out our manufacturing facility that frankly is up and ready to go".

RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age

PARSIPPANY, NJ--(Marketwired - May 9, 2013) -  The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for RECOTHROM®, Thrombin topical (Recombinant) to include use in pediatric patients, following completion of a post-approval pediatric clinical trial commitment. RECOTHROM is a recombinant topical thrombin now indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adult and pediatric populations greater than or equal to one month of age. RECOTHROM provides patients greater than one month of age an alternative to bovine or human plasma derived thrombin. 

"Pediatric patients, in various surgical settings, have an increased chance of repeat surgeries. RECOTHROM has been studied in pediatric patients and shown to have a low rate of immunogenicity, and offers an important tool for use in this patient population," said Kevin N. Foster, MD, MBA, FACS, Chief, Burn Services, The Arizona Burn Center at Maricopa Medical Center.

The recent FDA approval is based, in part, on data from a completed Phase 4, open-label, single-group safety and immunogenicity study. This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates.

"Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Officer of The Medicines Company. "There are several hundred leading hospitals in the United States that conduct thousands of surgical procedures in pediatric patients each year. We believe the expanded pediatric indication for RECOTHROM provides an opportunity to make this topical hemostat available to a broader range of surgical patients."

About The Medicines CompanyThe Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.