Tuesday, January 28, 2014

Baxter sues Johnson & Johnson over FloSeal patents

Baxter (NYSE:BAX) accused Johnson & Johnson (NYSE:JNJ) of infringing 6 patents covering its FloSeal line with the Ethicon SurgiFlo line of competing surgical hemostasis products.

In a lawsuit filed last week in the U.S. District Court for Northern Illinois, Baxter said the alleged infringement is willful and asked Judge Sharon Johnson Coleman for triple damages, pre- and post-judgment interest, legal costs and a jury trial.

"Defendants' SurgiFlo products directly compete with Baxter's biosurgery products, including the Floseal family of products, which practice the Patents-in-Suit. On information and belief, defendants are aware of Floseal's established position in the hemostatic products market and carefully track Baxter's marketing and other activities related to the Floseal products in the United States and worldwide. For example, one or more of Defendants have repeatedly communicated with Baxter regarding competitive marketing issues in the United States and abroad pertaining to Floseal and SurgiFlo," Baxter alleged, according to court documents. "Defendants have infringed and will continue to infringe Baxter's intellectual property rights by making, using, selling, offering for sale within the United States and/or importing into the United States delivery products for hemostasis such as the SurgiFlo family of products."

Thursday, January 9, 2014

Sealant Inspired By Beach Worm Could Become Surgical Superglue

Remember that wacky glue commercial from the 1980s? "Krazy Glue, you crazy rat," the narrator says. "Strong enough to hold this man suspended in mid-air." He promises the stuff can bond almost anything: a plastic knob, a plastic plug, a rubber boot, a door knob, and even a flashlight case.

Heck, a version of the everlasting adhesive is even approved by the Food and Drug Administration to seal skin wounds.
But superglue can't fix a broken heart — or even a torn artery. Yet.
Now a team of doctors and engineers at Brigham and Women's Hospital in Boston are getting close to changing that. Their unlikely inspiration is a 3-inch worm that lives off the coast of California.
Cardiac surgeon Pedro del Nido and his colleagues have developed a biodegradable adhesive that can patch a hole in a pig's heart or artery. The experimental glue is nontoxic and is strong enough to hold up under the high pressures in the human heart, the team report Wednesday in the journal Science Translational Medicine.
So far, they've tested the glue only in animals. So the sealant is far from reaching the operating room or battlefield. But del Nido hopes the adhesive will eventually replace traditional sutures and staples for some operations, especially heart surgery.
"A glue is the holy grail for repairing hearts," del Nido tells Shots. "Right now we use sutures. Every time the needle and thread enter normal tissue, they do a little bit of damage. Usually it doesn't matter. But I repair children's hearts. For those, this damage can really be a problem."
Regular superglues don't work well inside the body. "It's a skin glue," del Nido says. "You can't use it internally because it hardens as soon as it comes into contact with water." And the glues are made from a compound called cyanoacrylate, which can be toxic.
To find a safe adhesive that could work on hearts, arteries and other organ surfaces, del Nido teamed up with bioengineer Jeffrey Karp, also at Brigham and Women's Hospital.
"In our lab, we look to nature for inspiration in designing materials," Karp tells Shots. "Solutions are really all around us." Karp's lab has been looking at porcupine quills for insights that could lead to better surgical needles.
The barbs on porcupine quills make it easier from them to penetrate the skin.
For the heart glue, Karp and his team turned their attention to critters that stick to slippery surfaces, such as slugs, spiders and a bristly little worm that glues itself rocks in tidal pools, called thesandcastle worm.
To eat, chitons use their teeth, which look like black bulbs with bluish highlights, to grind up rock.
"We started looking at how creatures, like the sandcastle worm, could attach to wet surfaces," Karp says. After years of experimenting with various chemical cocktails, he and his team finally stumbled upon an adhesive that's biodegradable and nontoxic.
"Cells and tissues can grow over the material and into it," he says. Eventually it just dissolves into the body. And the glue only hardens when UV light shines on it. So a surgeon can put the glue in exactly the right place before it seals up.
Although Karp and del Nido haven't tested the experimental glue on people yet, they've put the adhesive through a whole battery of tests in animals.
"We made a hole in the heart of a living rat and showed that we can seal it up without removing the blood," Karp says. "The animals were fine six months later."
They also patched a pig's heart and carotid artery with the glue. Even after the pig was given a shot of adrenaline and its heart pressure shot through the roof, the patched stayed on the tissue.
Of course, humans are more complicated than pigs and rats. And the glue has to be safe for decades in people, not months.
But Karp is so confident that the adhesive will one day reach surgeon's toolbox that he has procured $11 million to start a company to manufacture and test the glue. "It appears that the glue is safe," he says. "But we do need to do more studies. We'll repeat the animal tests and then move forward in humans."

Arch Therapeutics to Webcast Live From the Biotech Showcase Investor Conference

WELLESLEY, MA--(Marketwired - Jan 8, 2014) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), a life sciences company and developer of AC5(TM), a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to announce that Terrence W. Norchi, M.D., CEO of Arch Therapeutics will present at The Biotech Showcase(TM) 2014 conference on Monday, January 13th, at 5:00PM PST. Attendees will find the presentation scheduled for "Track C" in the Mission II room at that time. Dr. Norchi's presentation will provide insights into the Company's ongoing activities to commercially develop novel technologies into a suite of new products targeting markets of unmet clinical need.
A live webcast of Dr. Norchi's Biotech Showcase presentation can be accessed at the following URL: http://www.media-server.com/m/p/8hcwd8zu.
The Biotech Showcase(TM) 2014 Conference (www.ebdgroup.com/bts) takes place January 13-15, 2014 at the Parc 55 Wyndham Hotel, located at Union Square, San Francisco, California. The Biotech Showcase(TM) is an investor and partnering conference devoted to providing private and public biotechnology and life sciences companies an opportunity to present to, and meet with, investors and pharmaceutical executives during the course of one of the industry's largest annual healthcare investor conferences. Now in its sixth year, Biotech Showcase is expected to attract upwards of 1,500 attendees.
About Arch Therapeutics, Inc. (OTCQB: ARTH)
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate, known as AC5(TM), is being designed to achieve hemostasis in minimally invasive and open surgical procedures. Find out more at www.archtherapeutics.com.

Tuesday, January 7, 2014

Z-Medica Signs HealthTrust Agreement

WALLINGFORD, Conn., Jan. 6, 2014 -- /PRNewswire/ -- Z-Medica, a leading developer and marketer of hemostatic agents, announced it has signed an agreement with HealthTrust, a group purchasing and total cost management solutions company,  to provide its healthcare member facilities access to QuikClot® products under a vascular closure patch category, effective January 1, 2014.

"Controlling bleeding in a hospital setting is essential for minimizing the length of procedures, reducing the risk of complications, reducing the cost to patients and medical facilities and improving overall patient outcomes," said Jack McCarthy, vice president of U.S. healthcare sales at Z-Medica. "We are very pleased to be working with the experienced HealthTrust team in this important effort to bring QuikClot products to more healthcare providers and patients who can benefit from them." 

QuikClot products are impregnated with a mineral called kaolin that has been clinically shown to accelerate the body's natural coagulation cascade, helping healthcare professionals, first responders, law enforcement officers, consumers and adventure and outdoor sports enthusiasts rapidly control bleeding. Kaolin is a naturally-occurring, inorganic mineral that does not contain any botanicals, biological material or shellfish products and does not cause any exothermic reaction or vascular complications. QuikClot products are credited with helping thousands of people survive traumatic blood loss every year.