Clinical Papers - Bonewax, Oxidized Cellulose, Surgicel,

US FDA clears Abyrx's absorbable haemostatic bone putty for clinical use

Abyrx, Inc., a privately-held therapeutic device company, has received the United States Food and Drug Administration (FDA) clearance for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the state.

AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.

AHBP complements Abyrx’s existing surgical hemostat product offerings which currently include Hemasorb and Hemasorb Apply. With this new product, Abyrx is executing its strategy of vertically integrating within the surgical hemostasis marketplace.

Commenting on Abyrx’s portfolio approach to the marketplace, John J Pacifico, the Company’s president and chief executive officer, stated, “Our team is committed to providing the most comprehensive bone hemostat product line in the operating room. AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs.”

Richard Kronenthal, Ph.D., Abyrx’s chief scientific officer, offered his thoughts about the developmental challenge and the potential of the AHBP technology platform, “Our technical team evaluated dozens of subtle chemical and processing variables to specifically meet the surgical performance requirements of AHBP. Indeed, we continue to enjoy the challenge of further innovation by drawing on this new technology platform and our knowledge of the surgeon’s important needs.”

Abyrx’s surgical hemostat products are used by cardiothoracic, craniomaxillofacial, spine, orthopaedic, neurological, and trauma surgeons. The Company estimates that over 3.5 million patients undergoing surgical procedures each year could benefit from the intraoperative use of its products.

FDA: J&J Unit (Synthes) Recalls Potentially Flammable Bone Putty

The health regulator said certain lots of bone putty made by Johnson &Johnson unit Synthes were recalled as there was potential for the putty to catch fire if it came in contact with electrosurgical cautery systems during surgery.

The Hemostatic Bone Putty is used to stop bone bleeding by creating a physical barrier along the edges of bones damaged by trauma or cut during a surgical procedure.
The recall, which has been classified as Class I, or the most serious type of recall, was initiated on July 5.
Synthes had issued a medical device recall letter on July 5 requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the putty manufactured between July 6, 2011 and December 14, 2011.Synthes has been in the news for all the wrong reasons, Symthes is unusual in that it is one of a few cases in which company execs have been sentenced to a term of imprisonment for a misdemeanor violation of the Food, Drug and Cosmetic Act. The individual defendants, by virtue of their jobs, were “responsible corporate officers” at various time during the circumstances surrounding the clinical trial that was described in the indictment.


And what exactly took place? From May 2002 until fall 2004, a Synthes subsidiary called Norian, as well as Synthes and the former execs, ran unauthorized trials of their Norian XR and Norian SRS devices, which were bone cements used in surgeries to treat vertebral compression fractures of the spine, or VCR, a painful condition commonly suffered by the elderly, according to the feds.


The surgeries were performed despite a warning on the FDA labeling for Norian XR that cautioned against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine, according to the feds. But they apparently disregarded the warnings. For instance, the feds say that, before the marketing program began, pilot studies showed the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research conducted in a pig also showed that such cement-caused clots became lodged in the lungs.


Just the same, the Synthes gang marketed the device for VCFs without conducting testing that needed FDA approval, the marketing did not stop until after a third patient had died on the operating table.The trials were conducted at various US hospitals and selected surgeons were approached during so-called ‘Test Market Kick-Off’ meetings and a forum in 2003 and early 2004, according to the feds, who say about 52 spine surgeons were trained.


What’s more, after the death of that third patient in January 2004, they did not recall Norian XR from the market – which would have required them to disclose details of the three deaths to the FDA, according to the feds. Instead, they “compounded their crimes by carrying out a coverup in which they made false statements to the FDA during an official inspection in May and June 2004.” However since the purchase by J&J, it is J&J who now hold the legal burden.

To date:

2011 - Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. All four plead guilty to one misdemeanor count of shipping an adulterated and misbranded product in interstate commerce.Thomas Higgins, 55, a former president of the Synthes spine division, and Michael Huggins, 54, a former president of Synthes North America, were each sentenced to nine months. John Walsh, 48, who was director of regulatory and clinical affairs, was sentenced to five months. Richard Bohner, 57, sentenced at a later date to 8 months. Each must also pay a $100,000 fine. 

Feb, 2012 - FDA Warning Letter 

Latest 2012 - FDA: J&J Unit Recalls Potentially Flammable Bone Putty

Baxter Acquires Ostene

August 17, 2011
Ceremed, Inc. (Los Angeles) announced today that it has entered into a definitive agreement to sell its Ostene® brand bone hemostasis product line to Baxter International Inc. The agreement provides for Baxter to acquire all rights to the Ostene® brand, including manufacturing.
Founded in 2002, Ceremed is a privately held medical device company focusing on the design and development of medical materials, utilizing their proprietary AOC PolymerBlend™ technology. Ceremed has successfully commercialized applications ranging from coatings and carriers to bone hemostasis. Based on the proven safety, efficacy and versatility of the AOC PolymerBlend™ technology, Ceremed looks forward to the continued development and innovation of products that meet the needs of today’s surgeons.
“We are very pleased that Baxter has agreed to acquire the Ostene® brand.” said Tadeusz Wellisz, M.D., chairman of Ceremed.
With the divestiture of both the marketing and manufacturing of Ostene®, Ceremed will free up assets needed to focus on bringing new products to market that will meet the demands of patients and device manufacturers alike. “This is a great opportunity for Ceremed to take the next step to becoming a major player in the biomaterials market,” noted Bill Lamm, president of Ceremed.

ORTHOCON Receives CE Mark and Health Canada Medical Device License for HEMASORB

IRVINGTON, New York, April 21, 2011 /PRNewswire/ - Absorbable Bone Hemostat Matrix Cleared For Clinical Use and Sale in Europe and Canada

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 http://www.orthocon.com.

Absorbable Bone Hemostat Is First Product To Incorporate Syntinate™ Technology Platform

IRVINGTON, N.Y., Feb. 17, 2011 /PRNewswire/ -- ORTHOCON, Inc., a developer of implantable products designed to stop the bleeding from and to deliver drugs to bone, today announced the U.S. launch of its first commercial product, the HEMASORB Absorbable Bone Hemostat Matrix.
The HEMASORB Absorbable Bone Hemostat Matrix is a ready to use, biocompatible, water resistant, and absorbable putty that is designed to rapidly stop bleeding when applied to damaged or cut bone. HEMASORB was cleared for market introduction by the U.S. Food and Drug Administration (FDA) via the 510(k) premarket notification process. In 2010, ORTHOCON conducted a limited market introduction of this product under its development name, ORTHOstat.
"We believe that HEMASORB is an innovative product that addresses a substantial market opportunity and has the potential to become a standard of care," said John J. Pacifico, President and Chief Executive Officer of ORTHOCON. "It is easy to use; it satisfies unmet needs and it is cost-effective."
Bleeding from cut bone is a common occurrence in many operative procedures. Excessive bleeding from bone 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 U.S. and Europe each year could benefit from the intra-operative use of HEMASORB.
"HEMASORB is the first commercial product that employs our proprietary Syntinate Technology Platform," commented Richard L. Kronenthal, Ph.D., ORTHOCON's Scientific Founder. "We are currently developing a pipeline of follow-on products that will complement Syntinate's utility as a bone hemostat by exploiting its unique potential to deliver drugs directly to bone."
The Syntinate Technology Platform incorporates biocompatible and absorbable solids and liquids to create a synthetic matrix that, when applied to bone, mechanically blocks bleeding. In addition, these constituents may act as drug reservoirs allowing for site specific and extended delivery of local anesthetics, anti-infective agents, and other drugs.
"We believe that our pipeline of products, beginning with HEMASORB, is very compelling and has the potential to create significant clinical and commercial value," concluded Mr. Pacifico. "We expect that the successful market launch of our HEMASORB Absorbable Bone Hemostat Matrix will prime the market for the future introduction of an array of innovative products."

Study shows use of superglue in chest surgery cuts recovery time in half

Victor Haddad used Krazy Glue in his woodworking shop for years to mend his accidental wounds. Then last year, as he awaited a heart operation, he discovered on the Internet that a Calgary doctor was using a superglue to fuse bones together after chest surgeries.
The minute he read about the experimental procedure, he says, “I wanted it.”
He became a patient of Paul Fedak, a cardiac surgeon who pioneered the technique in 2009 at Calgary’s Foothills Hospital Medical Centre. In June of this year, Dr. Fedak replaced Mr. Haddad’s aortic valve and joined his sternum using steel wire, and then sealed the bones with a sticky paste called Kryptonite.
Mr. Haddad was out of the hospital in seven days. Within six weeks, the 59-year-old resident of Milk River, Alta., was back to work as a real-estate broker. Mr. Haddad didn’t bother to fill his prescription for pain meds, he says. “I’ve been pain free since before I left hospital.”
His surgery was standard except that Dr. Fedak took a few minutes to apply adhesive to the ends of the chest bones before stitching up the soft tissue. According to Dr. Fedak, breastbones heal much faster when secured with wire as well as Kryptonite glue.
Instead of it taking six to eight weeks for the bone to fuse back together, “we do it in 24 hours.” The glue makes it rock solid within a day.
A study released Sunday suggests the use of adhesive in chest surgery reduces the normal recovery time by half. Patients have less physical disability in the first six weeks after surgery and can breathe deeply sooner, Dr. Fedak reports. He adds that patients are able to cough with less discomfort and require significantly less medication such as narcotics to manage pain.
No complications or side effects from the glue were reported among the 55 patients in the randomized controlled trial.
The procedure has the potential to improve post-operative care for an estimated 1.4 million open-chest surgeries performed worldwide each year, according to the Heart and Stroke Foundation of Canada.
Dr. Fedak has applied to the Canadian Institutes of Health Research to fund a larger clinical trial involving 2,000 patients throughout North America, which should start in six months, he says.
Although medical adhesives are widely used in hip replacements and other procedures, most bone cements contain toxic ingredients that are dangerous for use in the chest, notes Dr. Fedak. In contrast, Kryptonite is an adhesive polymer composed of calcium carbonate and fatty acids derived from castor bean oil. It is “bio-compatible” and turns into a porous bonelike substance as it cures, he says.
Dr. Fedak doesn’t recommend the adhesive for patients at high risk for internal bleeding and other complications after surgery, because doctors might need to re-enter the breastbone and the procedure would take longer if the breastbone is well-bonded. Otherwise, he says, “you could use this on almost any patient.”
Regulators in Canada and the United States have approved the use of Kryptonite, which is made by the Doctors Research Group in the United States.
The glue is expensive, adding $700 to $1,000 to the cost of performing surgery. The need for public funding is a barrier to routine use, Dr. Fedak says. But he suggests that using Kryptonite could result in net savings to the health-care system by reducing recovery time and major post-op complications, including breastbones that separate after surgery.
“If a patient leaves the hospital a day early, that would be thousands of dollars of savings,” he points out.
Patients from around the world have contacted him, seeking repairs to sternums that didn’t heal properly after surgery, Dr. Fedak says. Although he is cautious about expanding the use of Kryptonite prematurely, he adds, reconstructions to damaged sternums “work very well.”
Mr. Haddad says he’s been the envy of his friends since he was glued back together with Kryptonite. He mentions a neighbour who took more than six months to bounce back after recent heart surgery.
“He is absolutely annoyed that he wasn’t in the [Kryptonite] study.”

Ceremed's AOC® Awarded Best New Technology in Biomaterials for Spine Care in 2010

ORLANDO, Fla., Oct. 5 /PRNewswire/ -- Ceremed's patented implantable polymer material known as AOC® won Orthopedics This Week's annual award for Best New Technology for Spine Care in 2010 in the Biomaterials category. AOC® was selected winner by a panel of neurosurgeons, orthopedic surgeons and veteran clinical buyers, based on the technology's originality, clinical relevance, and the likelihood that it will improve current standards of care.
"I am proud of AOC®'s success," said Ceremed's chairman, Tadeusz Wellisz, M.D. "AOC® is a versatile technology that has been well received by physicians and scientists. This award serves as continued validation for AOC® as Ceremed strives to develop more products that aid the surgeon and improve the patient's quality of care."

About AOC®:

AOC® is Ceremed's proprietary implantable polymer material. It is composed of a blend of Alkylene Oxide Copolymers that are commonly used in the medical field. This unique blend is an ideal carrier because it dissolves without swelling and is eliminated from the body within 48 hours. Unlike most resorbable polymers, AOC® does not require metabolic or inflammatory processes to break down.  AOC® is synthetic and can be formulated in a range of consistencies with a unique combination of properties, including anhydrous formulations, making it an ideal carrier for compounds that are not stable in aqueous solutions. The material is proving to be a versatile, soluble carrier that delivers a broad range of therapeutics to the surgical site without compromising the healing process.
AOC® is already used in spinal fusion products, as a soluble coating system for orthopedic and neurosurgical implants, and for bone hemostasis. Ceremed is able to custom-manufacture compounds using any OEM proprietary material in combination with the AOC® biomaterial.
About Ceremed:

Ceremed, Inc. is a privately held medical device corporation founded in Los Angeles, California in 2002.  Ceremed's mission is to utilize its proprietary implantable polymer formulations to enhance the "Standard of Care" by replacing aging and possibly harmful materials with safe and effective materials and devices that provide for better patient outcomes by improving healing and reducing post-surgical complications.  The company manufactures a variety of surgical implantable devices marketed both directly and through partnership licensing and manufacturing arrangements. Ceremed's signature product is the highly successful Ostene® Bone Hemostasis material (www.ostene.com).

Bonewax Granuloma

Specialty Medical Products Company Enters $10 Billion Orthopedic Biomaterials Market with Patented Technologies

FORT WORTH, Texas, Oct. 1 /PRNewswire-FirstCall/ -- Wound Management Technologies, Inc., (OTC Bulletin Board: WNDM) a rapidly growing provider of specialty medical products, announced today it has closed on its acquisition of Resorbable Orthopedics LLC, a private company with patented technologies including a resorbable bone wax and a delivery system for orthopedic bone void fillers, among others.Under the terms of the agreement, Resorbable Orthopedics has become a wholly owned subsidiary of Wound Management Technologies in a stock transaction.
Scott Haire, CEO of Wound Management Technologies, said, "This highly significant acquisition adds complementary orthopedic biomaterials products to our existing CellerateRx wound care products. Wound Management Technologies, through two subsidiaries, is participating in one of the fastest growing medical markets worldwide. The total global biomaterial market is currently $28 billion and is expected to exceed $58 billion in the next five years. The orthopedic biomaterials market is approximately $10 billion alone, driven by improved patient benefits, a shorter FDA approval cycle and an aging population ever more aware of biomaterial benefits."
"Wound Management Technologies is executing our strategy for rapid growth. The building blocks are coming together and the acquisition of Resorbable Orthopedics is another accomplishment for Wound Management Technologies. We are executing on our strategy to broaden our platform technologies that target a growing patient population. Diabetes and orthopedic disorders are expanding internationally and we are responding by establishing global distribution channels," said Haire.
Barry Constantine, founder of Resorbable Orthopedics LLC, said, "The patents offer innovative, safe and effective resorbable orthopedic products. The bone wax and delivery system address issues such as 'bone wax granuloma' and the delivery of materials that manage bone wound healing in a cost effective manner. At a time when there is a great need for safer and more affordable health care products, these are well timed solutions."

Ceremed Announces Collaborative Effort to Produce ApaTech's New Spinal Implant Actifuse(TM) Shape

LOS ANGELES, Oct 14, 2008 /PRNewswire via COMTEX/ -- Ceremed Inc. announced today that its collaborative effort with ApaTech Limited, a London based manufacturer of products for bone grafting, has resulted in the launch of ApaTech's latest product, Actifuse(TM) Shape, a novel, formable bone grafting solution. The new product combines Ceremed's AOC(TM) Biosoluble(TM) polymer with ApaTech's proprietary Actifuse(TM) microgranules. The resulting product's biostimulative properties are optimized by AOC's ability to be molded or cut to the contours of the grafting site.
The synthetic blend of alkylene oxide copolymers in AOC(TM) is water soluble allowing them to dissolve. The unique properties of the product include the dissolution of the product without swelling or inflammation as seen with some implant materials. The dissolved product is then eliminated from the body without further breakdown.
The launch of Actifuse Shape represents the culmination of a two year collaborative effort between the companies. The product will be manufactured in Ceremed's Los Angeles facility and shipped to ApaTech's distribution points in the UK and US. Ceremed has licensed the AOC(TM) technology to ApaTech Limited as the first of many projects in which the AOC(TM) technology is used as a passive carrier for bioactive materials and therapeutic agents. Several other derivative products related to the AOC(TM) technology are planned for release in the coming year. Ceremed currently distributes its Ostene(TM) bone hemostasis product in the United States and Europe.
"Ceremed is committed to the design and development of unique medical polymers to enhance the effectiveness of surgical procedures," says Tadeusz Wellisz, M.D., CEO of Ceremed. "We are actively seeking strategic alliances that greatly expand the impact of our products on the medical market. Ceremed's ability to rapidly bring products to market combined with the expertise in developing unique polymer blends makes us an exceptional partner for co-development."