Orthovita Q2

Product sales for the three months ended June 30, 2008 increased 30% to $19.3 million as compared to $14.9 million for the same period in 2007. Product sales for the six months ended June 30, 2008 increased 27% to $35.5 million, as compared to $28.0 million for the same period in 2007.

Sales growth for the reported periods in 2008 was primarily attributable to increased sales of our VITOSS(R) FOAM and VITAGEL(R) product portfolios in the U.S. as we further develop our U.S. field sales network. Approximately 60% of our product sales during the three and six months ended June 30, 2008 and 2007, respectively, were from products based upon our VITOSS FOAM platform co-developed with Kensey Nash Corporation. VITAGEL contributed approximately 25% of product sales for the three and six months ended June 30, 2008, as compared to approximately 19% and 20% of our product sales during the three and six months ended June 30, 2007, respectively.

King Pharmaceuticals shares dive after 2Q report

Shares of King Pharmaceuticals Inc. tumbled Thursday after the specialty drugmaker issued a disappointing second-quarter earnings report. King Pharmaceuticals has reported it saw a drop in revenue in the second quarter of the year.Total revenues for April to June were $397 million, compared with $543 million in the same period last year.King said the main reason for its decreased revenue was the arrival to the market of generic substitutes for its Altace drug.
However, Brian Markison, chairman, president and chief executive officer of King, said the firm is pleased with the continued strong performance of its Thrombin-JMI drug.
When asked for more detail on pricing and background on the thrombin market they again reiterated the perception of an "account by account fight" with a "fair amount of pressure on pricing". There was also a "a lot of pressure on the margin".

Thrombin - Recothrom Q2 sales

Bruce L.A. Carter, Ph.D., CEO of ZymoGenetics highlighted the laborious process of attaining hospital approval for the product "First, we have to enlist the support of surgeons, nurses, and pharmacists. Then we have to get RECOTHROM on the agenda for upcoming pharmacy and therapeutics committee meetings. Then we need to get the P&T committee to endorse RECOTHROM either as the addition to the formulary or a commitment to completely convert to RECOTHROM. Then we have to work with hospital pharmacists and surgical departments to process conversions and circle back to surgeons and nurses to encourage the use of RECOTHROM...........Of the 169 meetings that have taken place as of late June, decisions were made at a 103 meetings, with 66 where decision was still pending. Of the 103 meetings with decisions, 77 approved either complete conversion to RECOTHROM from bovine, or addition of RECOTHROM. 26 P&T committees declined to add RECOTHROM at this time, but many of those of course occurred before the GPO pricing agreements were in place, and before we had a full line of products.
So we need to circle back and get more surgeons at these hospitals. So through late June, the decisions were; 30% to completely convert so RECOTHROM is the only approved product, 45% of the time to add, and 25% to decline at this time.
As of mid-July, a 130 hospitals have now purchased RECOTHROM, and we are pleased to say that approximately 60% have reordered, and a third are already doing so on a routine basis.
So to reiterate; RECOTHROM is being well received by surgeons consistent with our expectations, and I think this is evidenced by a 75% positive response from decisions made to-date. The selling process in this market is long, and in some cases it is taking longer than we anticipated. We have put GPO contracts covering a large portion of the marketing place, and we now have a full line of RECOTHROM product, which will help build sales in the second half of the year, and we are confident that RECOTHROM will become the market leader in the coming years, and that our commercialization strategy is sound."
Bruce also discussed Zymo’s interpretation of the hospitals consideration in terms of facing a coagulation issues and also the threat of possible complications due bovine thrombin. Discussing price sensitivity he asserted that while not fully aware of the cost involved with Thrombin JMI, Recothrom was unlikely to be produced as cheaply as King Pharmaceuticals bovine Thrombin JMI but Omrix manufactured (Ethicon distributed) human sourced Evithrom was likely to be associated with higher costs. Bruce said "I don’t know the precise cost associated with the production of bovine thrombin -- but I would guess that it would be difficult for us to match the cost of goods of bovine thrombin. However, the other, when it comes to human thrombin in collecting plasma from humans, then I think that's a different issue. That's going to much, much more expensive." I guess Ethicon negative publicity for King's bovine product will work to Zymo's advantage...........

Interestingly many of us expected hospitals to use bovine (King), human (ethicon/Omrix) or Zymo (Recothrom)............but when queried....by Kevin DeGeeter - Oppenheimer
"Okay. And maybe two more quick questions if I may. It looks like we continue to see about 45% of these P&T committees leaving bovine on formulary base, quite putting both products on formulary, which I think is very different than what everyone was expecting previous to launch. I think we expected hospital either be bovine, human, or recombinant. First, I guess, just answer that the way which you think about the overall market, or is there something different in these early adopters that may suggest they have a different attitude towards single product on formulary versus multiple? And if it's going to be half the market, give or take, it's going to have multiple products on formulary. How does that change the sales message here?"
Bruce Carter
"I think that what we believe, as you're seeing, is that some people fully convert. Others, and I don't think it's at all surprising, say, look, you guys are new. We'd like to put you on the formulary. We're going to try you out on the formulary. We want to make sure that you can consistently supply us, so we don't want to remove the other product. So we feel comfortable that you can consistently supply us. And we believe that over a matter of time, people will convert to just one, and we believe that will be RECOTHROM.
As we've said before, we see this as a ratchet mechanism. In addition, of course, remember that a number of these people are putting us on the formulation time when we didn't have the full complement, we didn't have the 20000-unit, we didn't have the spray. So they would feel that converting completely to RECOTHROM was not appropriate at that particular point in time. So we're not surprised. We would also, as I've said once before, expect full conversion eventually."

Hemostasis Big Week for Results - Omrix, King, Zymo, Orthovita

It's a big week for Q2 results for the big 3 in the thrombin sector with Omrix 11th, King 7th and Zymogenetics Aug 5th.

According to IMS, the market research firm, hospitals purchased $440,000 of Recothrom during June. In a research report, Kevin DeGeeter, an analyst at Oppenheimer & Co., said he forecast sales would be $750,000 for the month. DeGeeter said that stockpiling by wholesalers (which is not counted in the IMS numbers) should "largely offset weak user demand" by hospitals. He expects second-quarter Recothrom sales to be only slightly below his initial estimate of $3.3 million.

Orthovita will also hold a conference call on Thursday, August 7, 2008, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2008. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.

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