Cryolife Q2 Biofoam and Hemostase MPH

CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that revenues for the second quarter of 2008 increased 18 percent to $27.2
million compared to $23.0 million in the second quarter of 2007.
During the Cryolife Q2 results mention was made of Biofoam which is being made with the help and funding of the Dept. of Defense (DOD). Biofoam is an expandable version of bioglue which expands to about 4 times its size as it leaves the syringe. BioFoam® Surgical Sealant (BioFoam) is a two-component surgical sealant composed of purified bovine serum albumin (BSA) solution with sodium bicarbonate and glutaraldehyde solution with acetic acid. The two components of BioFoam are contained in a dual chambered syringe and, at the point of delivery, are mixed in a specially designed applicator tip. Indications are for both Trauma and Surgical use. It appears suited to abdominal resections or lacerations and is ready to commence filing for regulatory submission. CE submission is planned for November 2008 and approval is expected late in Q1 2009 and product launch is expected 2-3 months after that, FDA IDE submission is planned for Q4 2008.
Sales of Hemostase MPH licensed from Medafor in early May have been "encouraging" and contributed $320,000 in the first 3 months including most of July. Steven G. Anderson, president and chief executive officer stated that internationally Hemostase MPH has had some success in the UK and Germany with launches in France and Canada set for September 1. Distribution throughout the rest of Europe, the America's, Australia and Asia-Pacific is scheduled for January 1 2009.
Analyst Matt Dolan enquired how long the sales force had sufficient product quantities to commence sales and was told orders only commenced in mid May but the US sales team now had full access to product. Cryolife also said new accounts and re-order rates are moving well for Hemostase MPH.
BioGlue(R) Surgical Adhesive revenues were $13.0 million for the second quarter of 2008 compared to $10.9 million in the second quarter of 2007, an increase of 19 percent. BioGlue revenues were $24.9 million for the first six months of 2008 compared to $22.1 million in the first six months of 2007, an increase of 13 percent.
U.S. BioGlue revenues were $9.1 million and $7.7 million in the second quarter of 2008 and 2007, respectively. U.S. BioGlue revenues were $17.7 million and $16.0 million in the first six months of 2008 and 2007, respectively. International BioGlue revenues were $3.9 million and $3.2 million in the second quarter of 2008 and 2007, respectively. International BioGlue revenues were $7.2 million and $6.1 million in the first six months of 2008 and 2007, respectively.
Other implantable medical device revenues for the second quarter of 2008 were $308,000, compared to $226,000 in the second quarter of 2007. Other implantable medical device revenues for the first six months of 2008 were $401,000 compared to $458,000 in the first six months of 2007. Other implantable medical device revenues in the second quarter and first six months of 2008 included $177,000 for Hemostase MPH(R), which was added to the CryoLife product portfolio in the second quarter of 2008.

CSMG Technologies Announces U.S. FDA 510(k) Clearance for Live Tissue Connect’s VAD System

CSMG Technologies, Inc., (OTCBB: CTGI), a technology management company, announced its subsidiary Live Tissue Connect, Inc. (LTC) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its LTC VAD System. The LTC VAD System consists of a LTC VAD.400 bipolar electrosurgical generator and two disposable sealing instruments. FDA clearance allows LTC to market these products in the USA.
The VAD.400 generator and the two disposable instruments are intended for use in open general surgical and gynecological procedures for the ligation of vessels and ducts as an alternative to mechanical clamping (clips or staples) and suturing. LTC’s new third generation bipolar system can be used on vessels (veins and arteries) up to 7 mm diameter, on ducts up to 2 mm diameter and tissue bundles as large as will fit in the jaw electrodes of the instruments.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased for our shareholders to be able to announce the most important and long awaited event in the history of LTC. By LTC receiving its first U.S. FDA 510(k) on the generator and the two instruments they are now able to start marketing in the U.S. market. I wish to publicly congratulate all the medical device professions involved with the LTC technology and the LTC team in Santa Barbara, California. I also want to personally thank as well all the CSMG shareholders who have believed in our potential and stayed the course waiting for this key corporate event."
Frank D. D’Amelio, President of LTC said, “The 510(k) clearance of our generator and disposable instruments marks the completion of a major milestone for LTC. The technology embodied within the VAD.400 generator and the interconnecting disposable instruments represents years of scientific research regarding the effects of RF energy on tissue. The LTC bipolar system has undergone extensive animal clinical testing; has been the subject to numerous peer-reviewed papers; and has passed all applicable quality standards. Having now obtained this clearance, we will next implement our USA sales representative recruitment plan and ramp up our production for distribution.”

Read all posts on TISSUE WELDING

Baxter get FDA warning for Feiba VH claims

The FDA have warned Baxter for making misleading claims for Feiba VH. There are many points made such as :
"the following adverse events, but not limited to, that are reported in the referenced studies1-5 to support the safety claim are inconsistent with the term “well-tolerated”:
“Seven minor adverse reactions, including minor chest pain and tightness, drowsiness, and discomfort in breathing” and “evidence of liver dysfunction was seen in three patients.”2
“chills, fever, nausea, dizziness, and an unusual taste in the mouth” 3
“Three patients contracted clinically overt hepatitis.”4
“For FEIBA there were 40 total reports [MedWatch Reports], of which 11 [>25%] were thrombotic events.” 1
“…a myocardial infarction occurred one hour after the second infusion of FEIBA in a 41-year-old hemophilia B patient…The second dose …increased the circulating Factor IX level until 58%. The combination between this increase in plasma coagulant activity and pre-existing risk factors…might have been responsible for the thrombotic complication.” 5
As a result, the above statements promote the potential unsafe administration and use of FEIBA. If you have adequate and well controlled data to support such claims, please submit the data to FDA to review."

The full letter is posted on the FDA website HERE
BackgroundAccording to the FDA-approved prescribing information (PI), FEIBA VH is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity and is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors. FEIBA VH is contraindicated in patients who are known to have normal coagulation mechanism.

Fleas study provides insights for surgical sealant

A long term study of fleas, ticks and other insect pests in the livestock industry has led to the development of a new and highly efficient wound sealant following soft tissue surgery. Dr Chris Elvin, from CSIRO Livestock Industries, outlines how this medical breakthrough evolved. The sealant, known as PhotoSeal™, was developed through recent research by Dr Elvin and Dr Alan Brownlee, who revealed a unique way of gluing together some naturally occurring proteins.
This work evolved from previous studies concerned with the synthesis of resilin, the elastic protein which allows fleas to jump and improves the flight efficiency of flying insects.
The blood protein fibrinogen is used to make protein adhesives and hydrogels with super-fast bonding and sealing characteristics.
PhotoSeal™ has been trialled on animals with encouraging results, and the next step is the operating theatre.
Read more about Photomedical technologies
These images demonstrate surgical application of PhotoSeal™ in repairing a 16G needle puncture wound to the common left iliac artery in an anaesthetised pig. The upper image shows xenon light (endoscope light source - illumination for 20 seconds) of the wound site following addition of liquid PhotoSeal™. The lower image shows the repaired wound site 30 minutes after repair. There was good pulsatile flow and no loss of blood.

Here's how they define the Market opportunity
The fundamentals of the biomedical materials market are excellent with substantial patient populations, and growing need for surgical sealants, haemostat adjuncts and tissue engineering solutions:
PhotoSeal™ market
Deficiencies (confirmed by surgeons) in existing products have constrained market growth.
There is interest from the industry to partner on product development.
This will generate medium term cash flow for PhotoSealTM and provide a path to market.
The tissue sealant market is estimated to be A$600 million of which A$400 million is fibrin sealants, and growing at 10-15 per cent.
PhotoSeal™ will require a strong distribution network as the key purchasing decisions are made by surgeons.

PEAK Surgical Receives 510(k)

PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System combines the PULSAR(TM) Generator, which supplies pulsed plasma radio frequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month."With the introduction of the PlasmaBlade, general surgeons now have access to a single surgical tool that cuts tissue as precisely as a scalpel and controls bleeding as effectively as traditional electrosurgery without causing extensive collateral thermal damage to tissues," said John Tighe, chief executive officer of PEAK Surgical.
PlasmaBlade
PEAK Surgical’s first cutting and coagulation tool, the PEAK PlasmaBlade, is a disposable device that offers the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage.The PEAK PlasmaBlade is based on proprietary pulsed plasma technology. This technology represents an evolutionary leap in the advancement of radiofrequency surgical technologies, which originated with traditional electrosurgery and progressed to plasma-mediated energy devices.

Omrix recieve positive news on Evicel

Omrix announced today that it has received a positive opinion for EVICEL(TM) Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.
CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for quality, safety and efficacy. The CHMP's positive opinion for Evicel will now be forwarded to the European Commission for marketing authorization, which is expected by the end of the third quarter of 2008 (3Q08). The CHMP's opinion also stated that the approved indication for EVICEL would read as follows, "Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery."
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a general hemostasis in surgery indication.
Upon its anticipated approval, EVICEL will be licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix and ETHICON's supply and distribution agreement, ETHICON has the marketing rights for the EU.

About EVICEL:

Omrix say "We have been developing our next generation fibrin sealant, Evicel™, in collaboration with Ethicon. Evicel™ differs from Quixil® in that it does not contain an antifibrinolytic stabilizing agent in the Biologically Active Component. The presence of this agent resulted in Quixil® being contraindicated for surgical procedures involving direct contact with Cerebro Spinal Fluid and/or Dura Mater. "
EVICEL(TM) is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL(TM) is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing. On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.
The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.
“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
Evicel contains fibrinogen and thrombin, two proteins involved in the production of fibrin. Fibrinogen and thrombin are found in human plasma, the liquid portion of blood. The plasma used to manufacture the product is collected from donors who have been screened and tested for blood-transmitted infections. The fibrinogen and thrombin also undergo a two-step process to further reduce the risk for the transmission of potentially contaminating bloodborne viruses. While the potential risk for infectious disease transmission is remote, it cannot be eliminated.
A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.
FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.

Evicel Prep video HERE

King Pharmaceuticals Announces Date for Release of Q2 results

King Pharmaceuticals, Inc. reported today that the Company plans to announce its financial results for the second quarter ended June 30, 2008, prior to the market open on Thursday, August 7, 2008. The Company also plans to provide a live conference call which may include discussion of the Company's marketed products, pipeline, strategy for growth, financial results and expectations, and other matters relating to its business beginning at 11:00 a.m., E.D.T., that same day. Interested persons may listen to the webcast by clicking on http://www.kingpharm.com/web_casts.asp. King will archive the webcast at this same link for not less than 14 days following the webcast for those unable to participate during the live webcast.

Cold Plasma Technologies with Medical Potential Get Licensed

Drexel University’s plasma medicine technologies were licensed to Plasma Technologies, Inc.(PTI), a Texas-based company that intends to design, patent and market medical devices related to wound healing and care, prevention of hospital borne infections, and other medical applications. The technology may have near term impact not only in civilian healthcare settings, but also on the U.S. military applications.
“We are pleased to have PTI as a partner to commercialize the plasma medicine technologies,” said Dr. Ken Blank, vice provost for research at Drexel. “PTI has the expertise to bring the technology through clinical trials and FDA approval so that this breakthrough technology can be used to benefit patients.”
Found in fluorescent light bulbs and high-end televisions, non-thermal or cold plasma can also be used in medicine, as Drexel researchers discovered. Part of what makes this technology so desirable is that small amounts of energy are used instead of chemicals in the medical process.
The researchers found that cold plasma can kill bacteria (including B. anthracis which is a causing agent of anthrax, E.Coli, Streptococci and Staphylococci) on living tissue within seconds without causing side effects. Cold plasma can also stop bleeding, making it effective in some surgical procedures and in treating intestinal ulcers and persistent nosebleeds. For example, a severe wound that might bleed for 10-20 minutes was stopped after only 15 seconds of plasma exposure and with no tissue damage. Initial findings also show cold plasma can promote the growth of some human cells at doses slightly greater than those needed to kill bacteria.
Cold plasma produces medical effects by enhancing biochemical processes that would either occur slowly or not at all, researchers in the Plasma Institute say. For the same reasons, cold plasma has already found many uses in fuel conversion and hydrogen production, energy systems and aerospace engineering, environmental control and material and waste treatment.
Prototype medical devices have been designed with the participation of PTI’s surgeons to address needs in trauma and plastic surgery, and to augment healing in acute and chronic wounds. These devices have immediate applications in the battlefield, emergency rooms, rehabilitation centers and cancer treatment centers in the military as well as international and US civilian markets.

Vascular Solutions Announce Hemostasis Products Highest Earner Q2

Reporting on Q2 results Vascular Solutions, CEO Howard Root today announced "Our highest sales product category in the second quarter was our hemostat products, with $6 million in net revenue in the second quarter, a decrease of 11% from the second quarter of 2007, but an increase of 2% over the first quarter of 2008.
In the second quarter of 2007, our partner King Pharmaceuticals placed a $725,000 stocking order for their initial launch of the ThrombiGel and ThrombiPad products, which is the primary reason for the reduction in revenue year-over-year.
In the second quarter of 2008, King purchased $246,000 of ThrombiGel and ThrombiPad, as they continue to ramp their sales into the surgical and trauma markets, consistent with our long-term plans.
To assist in growing D-Stat Dry sales, in the second quarter we initiated new programs with our direct sales force to maintain our focus on the D-Stat Dry, and to expand into new accounts to address the competitive challenges, with good results to date."

Discussing lower International results Howard repeatedly pointed to "lower percentage sales growth in international markets, as a result of the transition from hospital pricing to distributor pricing in Germany in the second quarter. " and the finalising of a series of litigations including "a $4.5 million jury verdict in our trial against Marine Polymer Technologies. Following the verdict, the court has now dismissed all of Marine Polymer's post-trial objections, and has entered judgment, including interest, at $5.1 million. The court also issued a permanent injunction against Marine Polymer's representatives for making slanderous statements about our D-Stat Dry. "

James Hennen CFO discussing Thrombin VSI said "We currently have remaining approximately $400,000 inventory of Thrombin-VSI in vials, and approximately $810,000 in bulk Thrombin. We expect to consume the supply of Thrombin-VSI over the next several years in hemostatic products sold in European markets."

During the Q&A Howard pointed to "aggressive sampling" by competitors in Q4 & Q1 and explained labs tend to use the free product first until they "see that it doesn't work, and then come back to something else."

He further claimed "we are the clear number one patch in the US market, which is the vast majority of that market. When you are number one, it's hard to grow more."

Source: seekingalpha

J & J Woundcare Sale and Omrix - rumour and conjecture abound

Market sources suggest a number of hypotheses about Omrix. One is that Johnson & Johnson (NYSE: JNJ), which markets Omrix's fibrin surgical sealant in the US, wants to buy the company. This hypothesis is not news to Omrix shareholders, but it has never been proved and seems unlikely given the tense relations between the companies. At Omrix's most recent conference call, founder president and CEO Robert Taub implied that Johnson & Johnson was not doing enough to market Omrix's products.

Another recent hypothesis is that that Johnson & Johnson might sell its own wound treatment business. Investors have worried that Omrix's products might be sold together with the division, but Omrix says that its business of surgical sealants would get even greater exposure after a sale. Johnson & Johnson may be seeking a new source of growth for the division.
Taub, who owns 25% of Omrix, is a strong believer in the company and its strength. If that Johnson & Johnson does not buy it, the anticipated "big thing" might be Taub increasing his stake in Omrix, and possibly even delist it.


Pictured: Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc., rings The NASDAQ Stock Market Opening Bell
Taub has told associates that Omrix will achieve a value of $1 billion, more than triple its current market cap of $300 million. The company has $82 million in cash and no debt, so Taub would need a net $143 million of his own money to buy out the other shareholders in the company. Obviously, if Taub makes a move on the company, its share price will presumably rise, possibly considerably, but the amount would still be within Taub's means with suitable leverage. He would also probably bring in a partner to any deal.
Omrix will publish its financial report for the second quarter on August 11, and the company's financials might also give its share a boost.
Published by Globes [online], Israel business news - http://www.globes-online.com/ - on July 20, 2008