Wednesday, March 3, 2010
Cardiva Medical, Inc. Announces Departure of Founder and CEO, Augustine Lien
Tuesday, March 2, 2010
Caddisfly larvae spun into surgical tape

SALT LAKE CITY – Often used as fishermen's bait, sticky caddisfly larvae may soon be used to suture wounds, according to researchers at the University of Utah.
The small, moth-like insect spins silk, much like butterflies and spiders, albeit underwater instead of on dry land. The chemical and structural properties of the larvae make it a probable and valuable adhesive tape during surgery because it could be used to hold together skin from the inside.
"I picture it as sort of a wet Band-Aid, maybe used internally in surgery – like using a piece of tape to close an incision, as opposed to sutures," said Russell Stewart, an associate professor of bioengineering at the U. and principal author of a new study of the properties of the fly's silk. The study will be published this week in Biomacromolecules, a journal of the American Chemical Society. He said gluing things together underwater isn't easy.
"Have you ever tried to put a Band-Aid on in the shower? This insect has been doing this for 150 million to 200 million years," he saidStewart studies natural adhesives at the U., including another he discovered made by sandcastle worms on the shore between high tide and low tide ocean waves. That type of natural "glue" has the potential to help repair small broken bones in humans by holding them together. He learned of the potential of the caddisfly larva from a Smithsonian Institution scientist who showed him several of the tube-shaped larval cases that caddisflies spin underwater. It was then that he put on his boots and waded through the Provo River, looking for larvae.
After growing them in his lab, researchers analyzed the silk fibers, finding that they stitched together glass beads from inside their shelters.
"It's like using Scotch tape on the inside of a box to hold it together," Stewart said. "It's really like a tape more than anything else – a tape that works underwater." Next up, they plan to study how strong the silk, or spun larva, can be and whether it can be reproduced synthetically and then used as a surgical adhesive.
In addition to caddisflies, the sandcastle worms, as well as mussels and sea cucumbers, are among the four categories of living organisms that have the ability to make adhesives under water.
And just as it took researchers a while to figure it out, the system of spinning something sticky enough to hold onto its eggs in the aquatic environment evolved independently for the flies, too, helping the creatures live and thrive, Stewart said.
Sunday, February 28, 2010
Medical Hemostat Statistics

I would like to offer you some statistics from this blog as provided by Google Analytics.
King Thrombin market yields lower results
Friday, February 12, 2010
ZymoGenetics, Inc. Q4 2009
The company proceed of $13.6 million profits for the quarter which resulted from a one set of recognition at differed revenue related to restructuring of the their agreement. It was the positive quarter financially was increased RECOTHROM sale further reductions in ongoing operating expenses. A $94 million of cash inflow is from milestone payments.
All of our financial goals for the year ending with the strong cash position strengthen further by the additional $91 million rate of last month. Net sales of RECOTHROM increased $10.6 million for the quarter including 1.4 million (inaudible) to try the clinic launch in Canada. For the year sales of (inaudible) firm within our range of guidance further in asset sales to be included. At the hospital level we continue to see increasing demand in Q4, we estimated the growth that approximately 18% compared to the third quarter. Cognition and license revenue for the quarter were $51.2 million and the largest component of this total was the acceleration of $34 million related to their agreement.
Baxter International Inc. Q4 2009
Sales in regenerative medicine which includes our bio surgery products, totaled $125 million and increased 24%. Sales excluding foreign currency grew 18% and continued to reflect robust growth of Floseal.
JnJ 2009 Earnings Call January 2010
As I mentioned earlier, Johnson & Johnson leads the industry in developing next-generation advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings, and we are very excited by the potential of the Fibrin Pad. With our human-plasma based biologics embedded directly into a proprietary matrix, the Fibrin Pad has the potential to uniquely and effectively address bleeding challenges that are hardly unmet by traditional hemostats. As Louise mentioned earlier, the BLI filing for the Fibrin Pad is now expected in the first half of this year.
And obviously, the best thing is to take the $7 billion we are investing and be able to generate products like Simponi or Stelara or Sedasys or the Fibrin Pad. Like, if we see other opportunities to license or to partner, partner may be an even more strategic investment than just a license. But, we will continue to take advantage of each of those in the areas where we see again the biggest opportunities for growth in the corporation.
Monday, January 25, 2010
CryoLife Sends Letter to Medafor, Inc. Shareholders
ATLANTA -- CryoLife, Inc. (NYSE:CRY) , an implantable biological medical device and cardiovascular tissue processing company, announced today that it has sent the following letter toMedafor shareholders discussing its strategic proposal to purchase the outstanding shares of Medafor:
Important Information for Medafor Shareholders
January 21, 2010
Dear Fellow Medafor Shareholder:
You have probably seen the headlines regarding CryoLife's increased stake in Medafor and our proposal to the Medafor board of directors to combine our two companies. I wanted to take this opportunity to personally explain why we have taken this action, why our proposal is financially and strategically compelling, and what you can do to make your opinion heard.
We have great regard for Medafor's MPH® polysaccharide hemostatic technology, and we believe it has significant, untapped growth potential. CryoLife currently has the exclusive right to distribute this technology under the private label HemoStase® within the U.S. for use in cardiac and vascular surgery, and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions. As Medafor's largest distributor, CryoLife achieved $6 million in sales of HemoStase in 2009.
Unfortunately, we do not believe that Medafor has the resources to maximize the potential of this exciting technology on its own given the capital and other constraints facing the company. At the same time, we believe it is critical that Medafor fully develop this technology in order for Medafor shares to realize their full potential value. We have acquired a large stake in Medafor as a first step in our efforts to combine CryoLife and Medafor, drive additional growth of HemoStase and related products, and deliver earnings and revenue growth for CryoLife and Medafor shareholders.
CryoLife and Medafor: A Strong Strategic Fit
We believe that Medafor's hemostatic technology serves as a perfect complement to CryoLife's product portfolio, particularly our BioGlue® technology. A combination of our companies would allow us to offer surgeons a full range of products to assist them in controlling and preventing bleeding. CryoLife's financial strength (positive cash flow and positive earnings growth), strong direct sales force (45 direct sales representatives in the U.S. and direct sales forces in the United Kingdom and Germany), international distribution network, and experienced management team would allow us to drive additional growth of Medafor beyond its current capabilities, and create greater value for all shareholders.
Combination of CryoLife and Medafor: Our Proposed Offer
On January 13, 2010, we sent a letter to Medafor's board of directors proposing to acquire all of Medafor's remaining outstanding shares for $2.00 per share, to be paid in cash and stock, subject to completion of reasonable due diligence. We believe the price we are offering is full and fair. In fact, it represents a significant premium to that which we understand Medafor's management and board have recently offered to convert debt into equity, and is equivalent to the value at which recent stock transactions have taken place. It is also in line with the valuations of comparable public companies and with recent comparable publicly-disclosed M&A transactions.
While we believe our initial proposal is a strong one, we welcome further dialogue and are open to negotiation with the Medafor board. As we indicated in our recent communication to Medafor, we do not have the most current information regarding Medafor and its prospects, and we are willing to negotiate in good faith to determine Medafor's appropriate value.
Negotiations with the Medafor board would also allow us to determine the right mix of cash and stock. We believe a cash/stock offer is appropriate and attractive, as the cash component would provide Medafor shareholders with immediate and certain value, while the stock portion would allow shareholders to participate in future upside through continued ownership of the combined company. We think the prospects for CryoLife are strong and that Medafor shareholders will be able to realize additional value by owning our stock. It is also important to note that ownership of CryoLife stock would provide you with further liquidity, as you would be able to trade this stock on the New York Stock Exchange. That said, given the current economic climate, we recognize that cash may be more important to some shareholders, and we are therefore prepared to evaluate how to best address this.
Medafor's board has to date refused to enter into negotiations regarding our proposal. Their refusal to enter into discussions with us hurts Medafor shareholders as it impedes your ability to receive a fair price for your shares. The goal of this letter is simply to provide you with more information about our proposal and encourage you to contact Medafor's board to make your voice heard if you have an opinion about Medafor's future and our proposal.
WHAT YOU CAN DO NOW
As Medafor's largest shareholder, we believe that it is important for every shareholder to communicate with the Medafor board. If you have an opinion about anything we've discussed in this letter, please contact your board members today and let them know what you think. The phone numbers and addresses for the Medafor board and management are 877-633-2367 and 2700 Freeway Boulevard, Suite 800, Minneapolis, MN 55430. Make sure your board knows where you stand!
Enclosed with this letter is a copy of CryoLife's 25th anniversary book, which provides information concerning CryoLife, its products and services, and the thousands of people who have been positively impacted by those products and services. If you would like more information about CryoLife and its proposal to acquire Medafor, please visit www.cryolife.com/medaforoffer or contact Nina Devlin at 212-704-8145. Additionally, if you would like to receive any future communications via email, please send an email request to medaforshareholderinfo@cryolife.com.
We are optimistic that you will be as enthusiastic as we are about what CryoLife and Medafor can accomplish together. I look forward to communicating with you again in the near future.
Sincerely,
Steven G. Anderson
Founder, CEO and President
Saturday, January 16, 2010
Cryolife Buying Up Medafor
CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has purchased approximately 1.6 million shares of Medafor's common stock from Medafor's founders and certain principal shareholders for approximately $2.00 per share. Based on the most recent information available to CryoLife, these shares represent approximately 8 percent ownership of Medafor. CryoLife currently has the exclusive right to distribute Medafor's MPH(R) polysaccharide hemostatic technology under the private label HemoStase(R) within the U.S. for use in cardiac and vascular surgery and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions. CryoLife achieved $6 million in sales of HemoStase in 2009. With its purchase of these shares of Medafor common stock, CryoLife believes that it is now the largest single shareholder of Medafor, in addition to being Medafor's largest distributor.
In addition, on January 13, 2010, CryoLife sent a letter to Medafor's management and board requesting to enter into discussions with them regarding a potential acquisition by CryoLife of the remaining outstanding common stock of Medafor for $2.00 per share in cash and CryoLife stock. A copy of this letter can be found near the end of this press release.
Steven G. Anderson, CryoLife's chairman, president and chief executive officer, said, "We have acquired this significant stake in Medafor as a first step in our efforts to acquire full control of HemoStase and the hemostatic technology on which it is based in order to help realize its significant, untapped growth potential. This technology serves as a perfect complement to our BioGlue(R) technology, allowing us to offer surgeons a full range of products to assist them in controlling and preventing bleeding. We believe this technology has tremendous untapped growth potential, provided Medafor is able to surmount the capital constraints currently facing the company, obtain the liquidity needed to invest in the technology's market rollout, and put in place the skilled management necessary to oversee the technology's development. We believe that a combination with CryoLife can help Medafor overcome these obstacles and create greater value for both companies and their shareholders."
Mr. Anderson continued, "We have presented Medafor with a proposal that represents full and fair value, reflecting both the upside from the growth potential of HemoStase and related products, as well as the downside presented by the IP restrictions on this product. We believe that our proposal also represents a significant premium to the price at which Medafor's own board and management have recently offered to convert debt into equity. We also believe that our offer would provide Medafor shareholders with certain value through a cash component, as well as the opportunity to participate in future upside through continued ownership of the combined company under CryoLife leadership. Our proposal would also minimize the dilution that would otherwise likely result from Medafor repeatedly accessing traditional capital markets in the absence of such a combination."
"CryoLife has made numerous past attempts to engage with Medafor's management and board about a potential value-creating acquisition of the company by CryoLife. To date, Medafor has summarily rejected all of our overtures and refused to negotiate with us. By providing our fellow Medafor shareholders with complete and timely information about our latest proposal, we hope to encourage Medafor's management and board to join CryoLife in negotiations," concluded Mr. Anderson.
Medafor shareholders can find additional information about CryoLife and its proposal to acquire Medafor at www.cryolife.com/medaforoffer.
The full text of CryoLife's most recent letter to the Medafor board of directors follows:
January 13, 2010
VIA FEDEX
Michael F. Pasquale, Chairman of the Board
Medafor, Inc.
Dear Michael:
I am writing to inform you that CryoLife has purchased approximately 1.6 million shares of Medafor common stock and, concurrently with this letter, has notified Medafor of this purchase and requested the issuance of those shares to CryoLife.
As you know, CryoLife has been interested for some time in negotiating an acquisition of Medafor by CryoLife, and we have made multiple past attempts to engage you in discussions about a potential combination.
CryoLife has great regard for your hemostatic technology and believes it has significant, untapped growth potential; however, we do not believe that Medafor has the resources to maximize this potential on its own given the capital and other constraints facing the company. I believe that our financial strength, strong direct sales force, international distribution network, and experienced management team would allow us to drive additional growth of HemoStase(R) and related products, beyond Medafor's capabilities, and deliver value to both CryoLife and Medafor stockholders. We believe that Medafor's hemostatic technology serves as a perfect complement to CryoLife's BioGlue(R) technology, and a combination of our companies would allow us to offer surgeons a full range of products to assist them in controlling and preventing bleeding.
Given the strategic logic for this transaction, we are proposing to acquire all of Medafor's remaining outstanding shares for $2.00 per share in cash and stock, subject to completion of reasonable due diligence. We believe our offer is both fair and generous and provides an opportunity for Medafor shareholders to receive immediate and certain value through a cash component, as well as the opportunity to participate in future upside through continued ownership of the combined company.
The price we are offering represents a significant premium to that which we understand Medafor's management and board have recently offered to convert debt into equity and is equivalent to the value at which recent stock transactions have taken place. It is also in line with the valuations of comparable public companies and with recent comparable publicly disclosed M&A transactions.
In the course of a negotiated transaction, and as part of our due diligence efforts, CryoLife will of course be willing to take into consideration any factors that we may not have accounted for when undertaking our valuation analysis, including any updated financial information.
This is a great opportunity for both our companies, and I urge you and your board to begin a dialogue with us as soon as possible so that we can begin to share our vision with you. We believe that the sooner the parties are able to reach agreement on a combination, the easier the transaction between the parties will be and the sooner we will be able to create value for both Medafor and CryoLife shareholders.
We believe that we can achieve much more together than Medafor will be able to achieve on its own, and regardless of our prior history, as your largest shareholder, we must now work together to realize the greatest value for our shareholders. Please contact me as soon as possible to discuss this proposal.
I look forward to speaking with you soon, and I feel certain that we can reach a mutually beneficial agreement.
Very truly yours,
Steven G. Anderson,
President, CEO and Chairman of the Board
cc: Board of Directors of Medafor
Gary J. Shope
ADDITIONAL IMPORTANT INFORMATION
This announcement is provided for informational purposes only and is not an offer to purchase nor a solicitation of an offer to sell shares of Medafor or CryoLife. Subject to future developments, CryoLife may file a registration statement and/or tender offer documents and/or proxy statement with the SEC in connection with the proposed combination. Shareholders should read those filings, and any other filings made by CryoLife with the SEC in connection with the combination, as they will contain important information. Those documents, if and when filed, as well as CryoLife's other public filings with the SEC, may be obtained without charge at the SEC's website at www.sec.gov and at CryoLife's website at www.cryolife.com.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company's CryoValve(R) SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft(R) technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. The Company's CryoPatch(R) SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company's BioFoam(R) Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. BIOGLUE Aesthetic(TM) Medical Adhesive is CE marked in the European Community for periosteal fixation following endoscopic browplasty (brow lift) in reconstructive plastic surgery and is distributed by a third party for this indication. CryoLife distributes HemoStase, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding our efforts to acquire full control of HemoStase and Medafor's hemostatic technology, our belief that such an acquisition would enable us to drive additional growth of HemoStase and related products, and deliver earnings and revenue growth for CryoLife and Medafor shareholders. These future events may not occur as and when expected, if at all, and, together with our business, are subject to various risks and uncertainties. These risks and uncertainties include that any transaction with Medafor may not occur due to circumstances and events beyond our control, including legal impediments, we may not be able to realize the anticipated benefits of a transaction with Medafor, our plans to acquire Medafor may change, and Medafor's management may act in ways that differ from our current expectations. Also, the success of any transaction between CryoLife and Medafor is subject to risks facing both companies. These risks include that CryoLife is significantly dependent on revenues from BioGlue and there are a variety of risks affecting BioGlue, CryoValve SG pulmonary heart valves and other SynerGraft processed tissues and products may not be accepted by the marketplace, the CryoValve SG pulmonary heart valve has a one year shelf life, the CryoPatch SG has a one year shelf life, we are dependent on the availability of sufficient quantities of tissue from human donors, the CryoValve SG pulmonary heart valve post-clearance study requested by the FDA may not provide the expected positive results, our products and tissues we process and preserve have allegedly caused and may in the future cause injury to patients, and we have been and may be exposed to tissue processing and product liability claims and additional regulatory scrutiny as a result, the possibility that the FDA could impose additional restrictions on our operations, issue a 483, or warning letter, or require a recall, or prevent us from processing and distributing tissues or manufacturing and distributing other products, our failure to adequately comply with government regulations could result in loss of revenues and customers as well as additional compliance expense, our ability to borrow under our credit facility may be limited, the credit facility limits our ability to pursue significant acquisitions, the financial and credit liquidity crisis may adversely affect our ability to borrow money or raise capital, the current economic crisis and future economic crises may adversely affect our business and financial condition, there are limitations on our use of net operating loss carry-forwards that could result in our inability to use them fully or at all, adverse regulatory action outside of the U.S. could affect our business, physicians have been and may be reluctant to implant or use our preserved tissues or products, our existing insurance policies may not be sufficient to cover our actual claims liability, current economic conditions may impact demand for our tissues and products, intense competition may affect our ability to operate profitably, we may be unable to obtain adequate insurance at a reasonable cost or at all, uncertainties related to patents and protection of proprietary technology may adversely affect the value of our intellectual property, uncertainties related to patents and protection of proprietary technology for products distributed by us may adversely affect our ability to distribute those products, we are dependent on key personnel, we may not be successful in obtaining necessary clinical results and regulatory approvals for products and services in development, and our new products and services may not achieve market acceptance, we may be unable to effectively leverage our existing sales force to sell HemoStase, the lawsuit we filed against Medafor regarding our distribution agreement with Medafor may continue to adversely impact our relationship with Medafor and could hamper or prevent us from distributing HemoStase, Medafor may in the future attempt to terminate our distribution agreement, rapid technological change could cause our services and products to become obsolete, extensive government regulation may adversely affect our ability to develop and sell products and services, we have experienced operating losses and negative cash flows in the past, and we must continue to address the underlying causes in order to continue to operate profitably and generate positive cash flows, investments in new technologies and acquisitions of products or distribution rights may not be successful, if we are not successful in expanding our business activities in international markets, we will be unable to pursue one of our strategies for increasing our revenues, continued deflation of foreign currencies relative to the U.S. dollar could materially and adversely impact our foreign revenues, and future healthcare policies, healthcare reimbursement methods, and healthcare reimbursement policies may affect the availability, amount, and timing of our revenues, financial condition, and profitability. These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K filing for the year ended December 31, 2008, our Form 10-Q filing for the quarter ended March 31, 2009, our Form 10-Q filing for the quarter ended June 30, 2009, our Form 10-Q filing for the quarter ended September 30, 2009, and the Company's other SEC filings. Medafor's business is also subject to a number of risks, including the risk that HemoStase does not have adequate intellectual property protection, that additional regulatory approvals may not be obtained in a timely fashion, if at all, and that product liability lawsuits could be filed in connection with the use of HemoStase. In addition, the acquisition of Medafor by CryoLife, if it occurs, could result in unexpected costs or liabilities to CryoLife due to potential non-compliance by Medafor under applicable laws and regulations, although CryoLife is currently not aware of any material non-compliance, or due to other factors that we are not currently able to predict, as we have not had the opportunity to perform a due diligence review with respect to Medafor. The Company does not undertake to update its forward-looking statements. In addition, the calculation of the estimated percentage of Medafor's outstanding shares owned by CryoLife is based on 20,340,314 shares outstanding, the number of outstanding shares shown in Medafor's audited financial statements for its fiscal year ended December 31, 2008. This calculation does not take into account any shares that may have been repurchased or issued by Medafor since that date, including any shares issued in connection with the conversions of debt attempted by Medafor in late 2009. As a result, CryoLife's actual percentage ownership of Medafor's outstanding common stock may be greater or less than 8%. If the debt conversions were successful, it is possible that our actual percentage ownership is significantly less than 8%.
For additional information about the company, visit CryoLife's Web site:
www.cryolife.com.
Wednesday, January 13, 2010
Development of a new class of hemostat that may replace thrombin
Haemostatix Ltd www.haemostatix.com has completed preliminary pre-clinical studies demonstrating that its new class of topical hemostat, PeproStatTM, is effective, with the potential to replace thrombin. PeproStat is based on albumin coated with a short peptide that effectively polymerises fibrinogen into a fibrin-like clot. This novel mode of action, based on peptide:protein recognition, is faster than the enzyme thrombin, leading to faster clot formation and less ‘wash-off’ from the wound. Unlike thrombin, it is not affected by anti-coagulants. The composition of the new active ingredient offers the prospect of stable, ready-to-use, formulations in a market dominated by products that require preparation prior to use, a key issue for surgeons. Additional advantages include an improved safety profile and low manufacturing costs. Haemostatix’s CEO, Dr Nichols, commented “the multiple benefits of this radically new approach to hemostasis creates tremendous opportunities for new product development for both surgical and trauma markets”