Advanced Medical Solutions Group plc: Acquisition of Sealantis

Winsford, UK, 31 January 2019: Advanced Medical Solutions Group plc (AIM: AMS), the surgical and advanced wound care specialist company, today announces it has acquired Sealantis Limited (“Sealantis”), a developer of an alginate-based tissue adhesive technology platform, for $US 25m (approximately £19m) in cash with royalties due until December 2027 on sales of any of its products that are currently in development.

Overview of Sealantis
Sealantis is an Israeli-based medical device company with a patent-protected alga-mimetic sealants technology platform with a wide range of potential surgical indications under development. Its two most advanced surgical sealant products are Seal-G, an open surgery device already CE marked for reinforcement of the staple / suture line to minimise anastomotic leaks following gastrointestinal surgery, and Seal-G MIST (Minimally Invasive Spray Technology) the equivalent laparoscopic device for the same indication but performed through keyhole surgery.

For the year ended 31 December 2017, Sealantis reported gross assets of approximately £0.5m
(ILS 2.1m) and a net loss of approximately £1.5m (ILS 6.6m).   

Acquisition benefits
As well as a world class extension of our longer-term product development capability, strategically, the acquisition provides AMS with a technology platform and delivery systems that have significant potential across a range of applications in the high-margin internal surgery market which includes the $1 billion internal sealant market. These include the existing CE marked product to reinforce and protect gastrointestinal anastomoses, of which there are more than 6 million procedures performed annually worldwide1, with additional significant potential in Neuro, Orthopaedic, and Cardiovascular surgery indications.

Being alginate based, the technology and products have significant competitive advantages over existing market leading products in this space. Importantly, the products do not need refrigerated transport or storage, can be delivered by spreading or spraying, do not require advanced preparation and do not contain proteins so carry lower risk of infection or adverse reaction.

The Sealantis technology platform has multiple synergies with AMS, most notably within the sales, marketing, regulatory and operational areas, and the acquisition significantly strengthens the Company’s product portfolio for internal sealants and fixation devices, sitting alongside AMS’s LiquiBandFix8® laparoscopic and LiquiBandFix8® open fixation devices. The addition of the Sealantis products and indications will open up much larger parts of the surgery market for AMS to exploit commercially and significant sales synergies are anticipated once commercialisation commences from H1 2021.

AMS plans to rapidly maximise the value of the investment by continuing to invest in the existing Sealantis innovation centre and accelerate the commercialisation of the laparoscopic and open variants of Seal-G by running clinical trials for anastomotic leak prevention as well as obtaining approval for new indications. The Company expects to make a total investment of approximately £8m in R&D, regulatory and clinical costs which will be fairly evenly spread over the next three years, depending on clinical trial progress. Seal G will initially be targeted within Europe using AMS’s existing regulatory expertise and the Group’s extensive commercial footprint.

Sealantis operates a state-of-the-art innovation and manufacturing facility, which includes an ISO class 6 clean room, at the world-renowned Technion – Israel Institute of Technology, in Haifa, Israel. AMS intends to retain Sealantis’ team of 12 R&D staff, who will become a key part of AMS’s surgical R&D capability.

Terms of the transaction
AMS is acquiring Sealantis for an initial consideration of $US 25m (approximately £19m) in cash, to be funded from existing cash resources, which were £71m at 30 June 2018. In addition, AMS will pay royalties, in-line with market rates, on future sales of existing products in development until the end of 2027.

Until the commencement of product sales, which are expected in H1 2021, the acquisition is expected to be earnings dilutive due to the aforementioned investment in R&D, regulatory costs, and clinical studies.

Commenting on the acquisition, Chris Meredith, CEO of AMS, said: “This acquisition is in line with our strategy to acquire technologies that are complementary to our surgical portfolio as well as allowing us to leverage our global routes to market. The acquisition enhances our access to a significant and high-margin market in internal surgery, which includes areas of unmet need for effective and absorbable internal sealants, a market estimated at $1 billion. We are particularly excited to welcome Sealantis’ innovation team of R&D experts to AMS and look forward to working alongside them to develop the technology in a wide range of potential applications and indications. As we work towards the commercialisation of Seal-G Surgical Sealant over the next 18 months, we expect to maximise the full value of the platform and this innovative technology. AMS continues to actively monitor and evaluate other acquisition opportunities to capitalise on its strong financial and strategic position.”

BioCer Launch of HaemoCer Plus versus Arista, Perclot and unknown other as presented at EACTS in Vienna

Clearly demonstrated without question German technology continues to impress as "THE" device developer in the powdered plant based starch market. In the video you see from left to right Arista, Perclot, Unknown and the radical new polysaccharide agent HaemoCer Plus.

Medafor sells to Bard for $200 million, plus incentives that could add another $80 million.

Officials at Medafor Inc., a Brooklyn Center-based maker of a novel blood clotting product, said they’ve been looking for ways to enhance shareholder value — be it an initial public offering, new business relationships or just continuing organic growth. The one thing they weren’t looking for was a buyer, leaders said Monday.

Then the folks at C.R. Bard Inc., a New Jersey-based medical equipment maker, came calling.

Their offer — $200 million in cash now and up to $80 million more if revenue targets are hit in the next two years — proved too attractive to pass up, said Medafor CEO Gary Shope.

Medafor on Monday announced that it has an agreement to be purchased by C.R. Bard’s Davol Inc. division. The transaction has been approved by both companies’ boards of directors, but is subject to approval by Medafor’s shareholders and customary regulatory review.

“The premium price underscores what we have been building on,” Shope said in an interview Monday. “I think the shareholders are being rewarded with a great price.”

Medafor’s appeal has been its plant-based microporous polysaccharide hemospheres technology, which is used in its Arista MPH hemostat product. The product rapidly dehydrates blood and accelerates the body’s natural blood-­clotting process.

Sept. 24 is the target date for shareholder approval, Shope said. The deal values Medafor’s privately held shares at $6.37 per share. The revenue-based incentives are valued at up to $2.82 per share.

It’s a significantly better deal than the $2 per share that Atlanta-based CryoLife Inc. proposed in a takeover bid in 2010. At the time, the Medafor board called the bid “grossly inadequate.” CryoLife was an exclusive-rights distributor for Medafor’s blood-clotting technology in the United States and some international markets. It had also made offers for Medafor in 2008 and 2009, which Medafor also rebuffed.

C.R. Bard said Medafor will add approximately 1 percent to its 2014 revenue.

The company, a maker of vascular, oncology and surgical products, had revenue of about $3 billion last year. Scott Lowry, C.R. Bard vice president and treasurer, said he expects Medafor, which has 33 employees, to have annual revenue of $30 million to $40 million by the end of 2013. Medafor’s products will complement C.R. Bard’s hemostasis unit and broaden its product portfolio, he said.

“We look at this as a growth opportunity,” Lowry said. “Our plan is to grow this business.”

He says it is premature to comment on status of Medafor’s management and employees since the deal still needs Medafor shareholder approval and to pass other regulatory requirements. Shope, the Medafor CEO, said he believes that Bard is considering keeping the Medafor organization intact but that “going forward, they will be making their own decisions.”

John Houston, an attorney at Fredrikson & Byron who served as Medafor’s lead legal counsel for the transaction, said: “This really was an offer that came out of left field. It was not solicited and it was not anticipated.”

Officials from Bard had met with two of Medafor’s senior officers at a conference in Spain less than a year ago, he said.

According to C.R. Bard’s statement on the acquisition, the global market for surgical hemostats is over $1.4 billion. “The Arista hemostat provides a great alternative to other commercially available hemostats while providing strong synergy with our Progel Sealant technology and sales channel,” said Timothy Ring, C.R. Bard’s chairman and CEO.

HaemoCer Instrumentation Advances Plant-sourced Hemostat Applications into Minimally Invasive Surgeries

BAYREUTH, Germany, May 31, 2012 /PRNewswire/ --BioCer Entwicklungs GmbH (BCE), a German based medical device manufacturer, announces the CE approval of its advanced HaemoCer™ Universal Applicator (UA). HaemoCer™ UA is a delivery configuration for applications of the HaemoCer™ Absorbable Polysaccharide Hemostat (APH) system in minimally invasive surgical procedures.

The HaemoCer™ UA system is a unique instrumentation for laparoscopic, ENT, spinal and other MIS procedures where precise delivery of APH particles to the bleeding site is mandatory. The delivery instrument is easily attached to the HaemoCer™ bellows dispenser and enables hemostat delivery under direct vision to the wound site for the control of capillary, venous and arteriolar bleeding. The initial HaemoCer™ 5 gram product range has also expanded to include multiple size configurations meeting the strong international market demand for HaemoCer™ in multidisciplinary procedures.

Dr. Markus Heinlein, Managing Director of BioCer, commented, "The clinical introduction of HaemoCer™ UA offers surgeons a delivery option within the expanding practice of minimally invasive surgery. Collaborating with leading laparoscopic surgeons and German engineers, our system has been designed for the controlled release of hemostatic particles. HaemoCer™ UA encompasses 3 unique advances, including a press-and-release locking system facilitating UA tip placement without uncontrolled discharge. Secondly the system features a tip design which minimizes tip blockage, both common difficulties with current particle delivery devices. Finally the new instrumentation is sold separately and the push-on coupling sheath will accommodate other devices allowing medical professionals and patients to immediately benefit from this new instrumentation while converting stocks to HaemoCer™."

BioCer Entwicklungs-GmbH, HaemoCer APH particles are manufactured utilizing a Polysaccharide Ultra-hydrophilic Resorbable Engineering (PURE) process.  HaemoCer™ contains no human or animal components and is developed and manufactured in Germany. For information, distribution inquiries, and licensing options, please visit http://www.biocer-gmbh.de or email info@biocer-gmbh.de.

GM plant proteins can hugely reduce the cost of new drugs, says professor who has got go-ahead to test HIV antibody on humans

Julian Ma is joint head of the infection and immunity research centre at St George's Hospital Medical School in London. He specialises in genetically modifying plants to produce useful drugs, a process called pharming, which he hopes will bring cheaper drugs to the developing world. His Pharma-Planta project was recently given permission by the UK medical regulator, the Medicines and Healthcare products Regulatory Agency, to carry out human trials of a monoclonal antibody, grown in tobacco plants, that can be used to prevent HIV infection.

How is a regular drug made?

The class of drugs we're dealing with are called recombinant proteins. What that means is a kind of protein that is made in a system that is not the host system for that original protein. Recombinant proteins have been made for decades using GM technologies – it started with GM bacterium E coli, which was used to make human insulin. Then we moved to GM yeast (an example of that is the vaccine against hepatitis B). More recently, the gold standard for making recombinant proteins, particularly monoclonal antibodies (Herceptin is a good example), is to use mammalian cells. The most commonly used one is a cell derived from the ovaries of a Chinese hamster (CHO). Those cells are grown in big fermenters as a liquid culture.

Why would using plant cells be better than these traditional methods?

These fermentation vats have to be kept absolutely sterile and the manufacturing facilities that are involved are very expensive. The thinking behind going to whole plants was: here we have a very simple and efficient protein-manufacturing system that simply uses sunlight, water and soil to make proteins. It's no coincidence that plants are at the bottom of the food chain, because it's the cheapest and most economical way of making proteins on a large scale.

How pure is the protein that comes out of your experimental plants?

There are many potential variables. The conditions under which you grow the plant inherently has some variability; daylight affects it, and there's variability of the environment around the greenhouse. And you've got soil in your greenhouse, the growth medium. What we've shown in our work is that, despite all the variations, what comes out of the plant can be made to very high quality; in fact, the quality we reached was even higher than had been previously achieved using the CHO system.

Can you use any plant for pharming?

There are some other species, such as maize, which would work very well – any plant that produces a seed would be a good target for us, because seeds are essentially dehydrated protein-storage bodies. We've chosen tobacco for several reasons: the most important is that it's not part of the food chain, and we were acutely aware that we needed to find a species that would not give us environmental issues about whether we might pass our product into the food chain. Tobacco is a major crop around the world, so, if you're looking at non-food crops, tobacco is the best-established one. And third, it produces a huge amount of biomass – if you want to create a very large-scale production system, biomass levels are important.

Where will this go in future?

One of the great areas for potential growth of plants is in making not just very complex molecules but also combinations of complex molecules, like antibodies. The product we're working on, the anti-HIV antibody, eventually will have to be used in combination with one or two antibodies: it's very unlikely it will be used by itself. The reason for that is that HIV is very good at mutating, so you need to provide two or three antibodies to prevent viral escape. That concept is applicable across the board for infectious diseases. Plants give you the option of making many molecules to add to a cocktail of pharmaceuticals, because the potential cost of making the molecules is much lower than conventional systems. You can now afford to make cocktails of two to three antibodies, whereas, up until now, we haven't been able to afford that.

Could you one day eat plants to extract the drugs, instead of processing them?

This suggestion has been around for quite a long time now and it is attractive, but there are some difficulties with that. The early suggestions of growing banana trees or tomato plants and having fresh produce as a delivery tool have been discarded, mainly because you can't control the dosage of your medicine very easily. That doesn't mean you can't take that sort of system and combine it with some simple food-processing technology. If you were able to produce a medicine in an edible fruit, like a tomato, you could do a simple food-processing step to stabilise the protein in the tomato product and also standardise the dose. That could be delivered by the oral route.

Delivering vaccines by the oral route has been the holy grail of vaccinologists for decades. There are some technical difficulties with it: some people don't respond well to oral vaccines and there are some immunological issues. But the potential is there. I think that is some way off, however, and what we've done at this stage – shown that plants are a viable manufacturing system for vaccines or antibodies – is the first step along a very long road that will ultimately lead to an edible vaccine. In the interim, this will give us many other valuable products which look much more like conventional pharmaceuticals.

Will your technique make drugs cheaper?

The real cost of pharmaceuticals is not down to the cost of the goods themselves, it's due to the many years it takes to develop a drug, and many other steps. Where I think the cost benefit does come in, though, is in the very early stages of drug development. In a plant system, the investment you have to make early on to test a new drug is much lower than if you wanted to make it by conventional systems. That could be 10- to 100-fold cheaper. We know that many drugs fail in the first few years of development, but if the cost of trialling each of those drugs is very high, very few people are able to enter the field. If you make the cost of entry into looking at new drugs much lower, using plant technologies, it allows you to bring underdeveloped countries in to look at drugs that they might find very important.

BioCer Release Test Data on "PURE"-ity of Latest Hemostat Innovation HaemoCer Vs. Perclot

A year ago Cryolife CEO Steve Anderson was embroiled in the meltdown of the CRY/Medafor relationship as the distribution agreement for first generation polysaccharide hemostat Arista came to a very bitter and public disintergration.......more HERE. Following this debacle CRY have entered into an agreement with merchant Starch Medical a San Diego based company with manufacturing facilities for Perclot (generation 2 of the polysaccharide powders) based in Beijing, China.http://www.docstoc.com/docs/60831472/PerClot-Arista Our 2009 Poll indicates concern, results HERE.

Now it's Q2 one year later and newly released test reports commissioned by German based BioCer, manufacturers of HaemoCer (conducted by a third party laboratory) offer compelling information supporting the contention their PURE (Polysaccharide Ultra-Hydrophilic Resorbable Engineering) process is much more than marketing hype. The report comparing CRY's Chinese Perclot with German made HaemoCer is available HERE or by clicking the thumbnail below.

Meanwhile video of HaemoCer shows the latest polysaccharide plant based hemostats formation of a powerful adhesive gelled matrix in comparison to generation 1 product Arista by Medafor Inc.

BioCer release video of HaemoCer the latest technology in powdered Plant based Hemostats from Germany using the DAPI application.

German Plant-based Hemostatic Innovation HaemoCer Receives CE Approval

BAYREUTH;Germany, December 16, 2010 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germany-based medical device manufacturer, are pleased to announce the CE approval of HaemoCer(TM), an Absorbable Polysaccharide Hemostat (APH). Introduction of HaemoCer(TM) APH will commence this month in the European Union and other selected international markets.

HaemoCer(TM) is an absorbable, surgical hemostatic technology created via a Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process. PURE processing utilizes sophisticated, plant-based polymer crosslinking that creates ultra-hydrophilic, biocompatible, polysaccharide compounds. The PURE technology format of HaemoCer(TM) is a powder; alternate novel product formats are planned for release Q2 2011. A family of customized, single-use application instruments will enhance the delivery of HaemoCer(TM) particles to the wound site for the control of capillary, venous and arteriolar bleeding in both open and minimally invasive surgical procedures. There is no thrombin, collagen, or other human or animal components in HaemoCer(TM) particles.

Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "In conjunction with clinical trial results due Q1 2011, the introduction of HaemoCer(TM) APH and its proprietary, integrated PURE technology represents the next generation of polysaccharide hemostatic agents. Complete production of HaemoCer(TM) is conducted in Germany and has been warmly received by multi-disciplinary surgical specialists. Our technology has been favorably received in multiple international markets and fields."

BioCer Entwicklungs GmbH is a privately held medical device company and develops novel materials and uses them to create new or modified medical devices and manufacturing technologies. BioCer Entwicklungs current solutions incorporate ceramic, polysaccharide, polymer and other composite materials developed with leading Bavarian scientific expertise in collaboration the University of Bayreuth. The proprietary, patent-pending technology platform for HaemoCer(TM) and PURE processing will focus on the worldwide, hemostasis, wound care, hernia repair and orthopedic marketplaces. For information, distribution inquiries, and licensing options, visit http://www.biocer-gmbh.de/en/ Contact:info@biocer-gmbh.de

German Company Biocer, Advances Plant Based Hemostatic Powder Technologies

BioCer Entwicklungs GmbH is a young and innovative company. Now on the basis of its comprehensive knowledge our developer team succeeded to provide health care with two seminal products according to the model of the nature.
With the help of a nanotechnological surface coating, implant materials are modified in a way that the medical devices grow in faster and more optimized. These biocom-patible coatings are now applied for the first time to polymer meshes, which are used as soft tissue reinforcement for hernia repair. In cooperation with experts from the textile branch BioCer Entwicklungs GmbH managed to develop a medical device which fulfills together with its optimized surface all demands of a modern mesh im-plant.
Also the development of our innovative hemostatic powder HaemoCer® was per-formed according to nature. HaemoCer® consists of plant based particles with an extremely high hygroscopicity, so that the natural coagulation cascade is accelerated. Hemostasis occurs within short time and HaemoCer® will be completely absorbed from the body within a few days.
With its new products BioCer Entwicklungs GmbH supports the surgeon as well as the patient in healing and restoration of the health.
Click Thumbnail Below for Presentation (note this presentation has been updated at the companies request)

BIOCER ENTWICKLUNGS-GMBH
Ludwig-Thoma Straße 36c
95447 Bayreuth
Telefone: +49 (0) 921 78 77 70 0
Telefax: +49 (0) 921 78 77 70 79
info@biocer-gmbh.de

FDA rules CollPlant wound dressing a device

The US Food and Drug Administration (FDA) has ruled that the CollPlant Holdings Ltd's (TASE: CLPT) wound dressing product, Vergenix, will undergo the certification process by the Center for Devices and Radiological Health (CDRH), which oversees medical devices.
Vergenix Wound Dressing is wound care sheet composed of pure recombinant human collagen scaffold that provides a moist wound healing environment. The product, a type I collagen, is produced by transgenic tobacco plants. It is designed to treat acute and chronic wounds, such as pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, abrasions, and second-degree burns.
US licensing procedures for medical devices are shorter than the procedure for pharmaceuticals. CollPlant believes that while Vergenix is based on human recombinant collagen produced through advanced biotechnological techniques, the FDA decision that the CDRH will review the product is very important for the company, as the regulatory procedures are significantly simpler, shorter, and cheaper than for biological and pharmaceutical products. This is a breakthrough since Vergenix will be a pioneering product for CollPlant's subsequent products.
CollPlant's share price rose 9.9% by mid-afternoon to NIS 1.20, giving a market cap of NIS 126 million.
Published by Globes [online], Israel business news - www.globes-online.com - on August 29, 2010

Hemostase: Medafor says its off...CryoLife its on.......

NOT SO FAST, MY FRIEND!

The continued quagmire that is the CryoLife/Medafor relationship appears set to continue according to This latest Press Release from CryoLife.

Background

After a failed takeover bid by CryoLife they encouraged Medafor shareholder's to withhold their votes at a recent Medafor shareholder meeting. This was rejected by 95% of the 70% of attendee's and one disappointed shareholder will no doubt be Jim Karerchersuch who commented "I say get rid of CryoLife and let investors make some money,".

Expenses in the tussle continue to escalate for both companies with Medafor CEO Shope stating... "The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, ."

and another online source stating ...."Anderson, who launched the hostile takeover attempt of Medafor in 2009 and chose several public venues to prosecute his case, spent approximately $6 million in the effort."

Conclusions

For those on the sidelines this extremely public battle has been an intriguing insight. Lately barely concealed personal attacks are now appearing in certain news articles relating to CryoLife CEO Steven Andersons, age and absence from the shareholder meeting despite his residence in MN. Meanwhile Medafor management were brought under the spotlight with the CryoLife claim "that Medafor's CEO and chief financial officer earned a combined $700,000 last year." Medafor management also denied any issues related to the fact that Medafor senior executives, and Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. With Pasquale claiming it isn't necessary to live locally.

Investors and Distributors must be feeling unsettled by the lack of clarity in terms of supply, and without any public statement from Medafor or the courts (where both companies appear more comfortable communicating) the status quo appears confusing.

One positive indication from this mess is that plant-based hemostatic technology is certainly worth fighting for. Medafor partner Orthovita must have an eye on these occurences, as will other key China manufacturer Starch Medical.

Scientist has succeeded in producing a replica of human collagen from tobacco plants

A scientist at the Hebrew University of Jerusalem's Robert H. Smith Faculty of Agriculture, Food and Environment has succeeded in producing a replica of human collagen from tobacco plants – an achievement with tremendous commercial implications for use in a variety of human medical procedures.

Natural human type I collagen is the most abundant protein in the human body and is the main protein found in all connective tissue. Commercially produced collagen (pro-collagen) is used in surgical implants and many wound healing devices in regenerative medicine. The current market for collagen-based medical devices in orthopedics and wound healing exceeds US $30 billion annually worldwide.

Currently, commercial collagen is produced from farm animals such as cows and pigs as well as from human cadavers. These materials are prone to harbor human pathogens such as viruses or prions (mad-cow disease). Human cadaver is scarce, and for certain indications possesses serious ethical issues.

Producing human recombinant type I pro-collagen requires the coordinated expression of five different genes. Prof. Oded Shoseyov of the Robert H. Smith Institute of Plant Sciences and Genetics in Agriculture has established the only laboratory in the world that has reported successful co-expression all the five essential genes in transgenic tobacco plants for the production of processed pro-collagen. For this work, Shoseyov was one of the recipients of a Kaye Innovation Award during the Hebrew University Board of Governors meeting in June.

Shoseyov's invention on has been patented, and the scientific findings behind it were published recently in the journal Biomacromolecules. A company, CollPlant Ltd ., has been established based on patents and technology that were developed in Shoseyov's laboratory. It has raised US$15 million to establish the first commercial molecular farming company in Israel and is already manufacturing collagen-based products that have attracted collaborative commercial interest from companies in the US, Japan Europe and Israel.

Yissum, the technology transfer company of the Hebrew University, is one of the shareholders of CollPlant.. CollPlant is a public company traded in "TASE", and the potential revenue for the Hebrew University from this invention is estimated to reach into the multi-million dollar range.

The Kaye Awards have been given annually since 1994. Isaac Kaye of England, a prominent industrialist in the pharmaceutical industry, established the awards to encourage faculty, staff, and students of the Hebrew University to develop innovative methods and inventions with good commercial potential which will benefit the university and society.

Biotechnology a boon to Textile Industry

The biotechnology has prefabricated rapid developments in genetic engineering with a possibility of ‘tailoring’ organisms in order to optimize production of established or novel metabolites of commercial importance and of transferring genetic material (genes) from one organism to another. It has economized developing industrial processes with less energy and renewable raw materials thus it is an effective interdisciplinary and integrate natural and engineering sciences. Few textile industrial uses are focused here.

Fibers and Biopolymers: Cotton, wool and silk natural textile fibers are an calibre but biotechnology producing one-of-a-kind fibers and improve yields of existing fibers. Cotton is leading worldwide textile fiber with ca 20 million tons grown/year by about 85 countries but it is vulnerable to many insects, and to maintain yields, massive amounts of pesticides are in use. Cotton is prone to infestation by weeds under intense irrigation conditions and needs throughout its growth cycle, and has poor tolerance to any of the herbicides. Hence biotechnologists have place forward short-term objectives on genetically engineering insect, disease and herbicide resistance into cotton plant along with modification of fiber calibre and properties to have high performance cottons. Naturally colored cottons are attracting the world market hence transgenic intensely colored cottons (blues and vivid reds) is dream of the day that can replace bleaching and dyeing.

Biotechnology has largely influenced animal fiber production, in vitro fertilization and embryo transfer, diagnostics, genetically engineered vaccines and therapeutic drugs are other catchments of it. CSIRO, Australia’s national research organization is place up efforts for genetic modification of sheep to resist attack from blowfly larvae by engineering a sheep that secretes an insect repellent from its hair follicles and ‘biological wool shearing’’. And is expected to artificial epidermal growth bourgeois which on injection into sheep disturbs hair growth, within a month, it breaks up in wool fiber and fleece can be pulled off whole in half the time it takes to shear a sheep.

Fermentation is developing biopolymers at large-scale i.e. bacterial storage compound polyhydroxybutyrate (PHB) is developed by Zeneca Bioproducts and is as produced ‘Biopol’. It high molecular weight linear polyester and thermoplastic (melts at 180°C) and can be melt spun into biocompatible and biodegradable fibers suitable for surgical use where human body enzymes slowly degrade sutures. Biopol is being used as conventional plastics for shampoo bottles but it is not economic, research is on to produce Biopol from plants, probably from genetically engineered variety of rape. Polysaccharides chitin, alginate, dextran and hyaluronic acid biopolymers are of interest in wound healing as chitin and its derivative chitosan are important components of fungal cell walls, at present manufactured from sea food (shellfish) wastes. Patents taken out by Asian Unitika cite a use of fibers prefabricated out of chitin in wound dressings. At BTTG, research has been directed for use of intact fungal filaments as a direct source of chitin or chitosan fiber to produce affordable wound dressings and other novel materials. Tests are carried out at Welsh School of Pharmacy indicate that these products have wound healing acceleration properties. Wound dressings based on calcium alginate fibers have already been developed by Courtaulds and are marketed as ‘Sorbsan’. Present supplies of this polysaccharide rely on its extraction from brown seaweed’s. However, a polymer of similar structure can also be produced by fermentation from certain species of bacteria. Dextran, which is manufactured by fermentation of sucrose by Leuconostoc mesenteroides or related species of bacteria, is also being developed as a fibrous non-woven for specialty end-uses such as wound dressings. Additional one-of-a-kind biopolymers are now coming onto market thanks to biotechnology e.g. hyaluronic acid a polydisaccharide of D-glucuronic acid and N-acetyl glucosamine found in connective tissue matrices of vertebrates and is also present in capsules of some bacteria. The original method of production by extraction from rooster combs was very inefficient requiring 5 kg of rooster combs to wage 4 g of hyaluronic acid. Fermentech, a British biotechnology company, is now producing hyaluronic acid by fermentation. The same amount of high calibre purified hyaluronic acid can be obtained from 4 liters of fermentation broth as opposed to 5 kg of rooster combs.

Different biotechnological routes for cellulose production are being worked out globally, cellulose is produced as an extra cellular polysaccharide by several bacteria in form of ribbon-like micro fibrils, and can be used to produce moulded materials of relatively high strength. Sony, a Asian electronics company has patented a way of making hi-fi loudspeaker cones and diaphragms from bacterial cellulose. An substitute route to cellulose, still at a very primeval stage of development, concerns in vitro cultivation of plant cells. Culturing cells of various strains of Gossypium can produce cotton fibers in vitro include a more uniform product displaying particularly desirable properties. Plant tissue culture can wage a steady, all year supply of products without climatic or geographic limitations free of contamination from pests. Proteins are interesting biopolymers for utilizing new genetic manipulation techniques where animal and plant proteins genes (e.g. collagen, various silks) can now be transferred into suitable microbial hosts and proteins produced by fermentation. US army is taking up spider silk as a high performance fiber for bulletproof vests.

Enzymes

Chemical reactions by catalytic proteins (enzymes) are a central feature of living systems, living cells makes enzymes even though the enzymes themselves are not alive and we can encourage living cells to make more enzymes than they would normally make. Or to make a slightly different enzyme (protein engineering) with improved characteristics of specificity, stability and performance in industrial processes and operate under mild conditions of pH and temperature. Many enzymes exhibit great specificity and stereo selectivity. With a notable exception of starch-size removal by amylases, however, scant attention is given to application of enzymes in textile processing for preparation textile fibers e.g. flax and hemp by dew retting involves action of pectolytic enzymes from various microorganisms, which degrade pectin in middle lamella of these plant fibers. Yet no attempts appear to be taken to use isolated enzyme preparations for desired effects even though their effectiveness has been demonstrated in the laboratory.

Use of isolated enzymes to remove fats and waxes, pectin’s, seed-coat material and colored impurities from loom say cotton and cotton/polyester fabrics, leading to a novel, low-energy fabric-preparation process, (replace scouring and bleaching) is investigated at BTTG. Only partial success is prefabricated using existing commercial enzyme preparations due to the recalcitrant nature of some of components and process was found to be too slow and therefore uneconomic for current applications. Enzyme that is being applied in textile processing for removal of hydrogen peroxide prior to dyeing is catalase. Undoubtedly, use of microbial enzymes can be expected to expand into many other areas of textile industry replacing existing chemical or mechanical processes in not too distant future.

Contrary to textile processing enzymes are used in detergents since their inception in 1960’s, and washing powders are referred to as ‘biological’, and degrade stains with milder washing conditions at lower temperatures saving energy and protects fabric. Cellulose enzymes could replace pumice stones used to produce ’stone-washed’ denim garments, stones can alteration clothes, particularly the hems and waistbands, and most manufacturers are now using enzyme treatment. Cellulose enzymes are in biopolishing, a removal of fuzz from surface of cellulosic fibers, which eliminates pilling making fabrics smoother and cleaner looking. Similarly protease enzymes are developed for wool.

Interesting uses of enzymes are in biotransformation with biocatalytic transformation of one chemical to another. In practice, either intact cells, an extract from such cells or an isolated enzyme might be used as the catalyst system of a specific reaction. Concentration of individual enzymes in cells is typically less than 1 per cent this can now be increased using gene increment techniques. Bulk chemical production by oil-based processes is being replaced by biotransformations, biotechnology competes with chemical synthesis. For example, optical activity of chemicals as of polymer precursors is likely to grow and biotransformation has a particular edge over traditional chemical methods.

Textile Auxiliaries: These are dyes produced by fermentation or from plants in future in the nineteenth century many of colors used to dye textiles came from plants e.g. woad, indigo and madder. Many microorganisms produce pigments during their growth, which are substantive as indicated by permanent staining and associated with mildew growth on textiles and plastics. Some species produce up to 30% of their dry weight as pigment, such microbial pigments are benzoquinone, naphthoquinone, anthraquinone, and perinaphthenone and benzofluoranthenequinone derivatives, resembling in some instances the important group of vat dyes. Microorganisms offer great potential for direct production of novel textile dyes or dye intermediates by controlled fermentation techniques replacing chemical synthesis. Production and evaluation of microbial pigments as textile colorants is currently being investigated at BTTG. Another biotechnological route for producing pigments for use in food, cosmetics or textile industries is from plant cell culture, e.g. red pigment shikonin (cosmetics) is being commercially produced since 1983 in Japan. Shikonin was extracted from roots of five-year-old Lithosperum erythrorhiz plants where it makes up about 1 to 2 percent of dry weight of roots. In tissue culture, pigment yields of about 15 percent of dry weight of root cells have been achieved.

New Analytical Tools: Work on molecular biology at BTTG has led to development of species-specific DNA probes for animal fibers to detect adulteration of high value specialty fibers such as cashmere by much cheaper fibers e.g. wool and yak hair. Rapid methods are being evolved to assist in primeval detection of biodeterioration of textile and other materials. BTTG have shown that presence of viable microorganisms on textiles can be assessed using enzyme luciferase isolated from firefly (Photinus pyralis), which releases light (bioluminescence) in combination with ATP produced by the microorganisms.

Waste Management: Microbes or their enzymes are being used to degrade toxic wastes instead of traditional processes, thus waste treatment is useful industrial calibre of biotechnology. In textile industry color removal from dyehouse effluent, toxic heavy metal compounds and pentachlorophenol used overseas as a rot-proofing treatment of cotton fabrics but washed out during subsequent processing in the UK pose a challenge for disposal. Currently efforts are on to resolve such problems perhaps biotechnology would appear to offer the most effective solutions.

Conclusions: Biotechnology is being treated as upcoming science with enormous commercial implications for many industrial sectors in years to come. It has successfully developed new products, opened up new doors, expedited production and helped to clean up environment. Mainly biotechnology is contributing a lot to textile industries but it current awareness is low. Michael Heseltine recently launched ‘Biotechnology Means Business’ initiative in the UK to inform companies about biotechnology and place them in touch with experts to deploy biotechnology to give a competitive edge to their business to win new markets. E.g. downstream processing after fermentation accounts for at least 70 percent of production costs in biotechnology and there is the need for improved filtration and separation techniques. Hollow fibers and membranes, which separate molecules according to size, are finding increased application in this area.

Enzymes are used in detergents e.g. protease removes stains caused by proteins such as blood, grass, egg and human sweat. Amylase removes starch-based stains such as those prefabricated by potatoes, pasta, rice and custard. Lipase breaks down fats, oils and greases removing stains based on salad oils, butter, fat-based sauces and soups, and certain cosmetics such as lipstick. Cellulase brightens and softens the fabric, and release particles of dirt trapped in the fibers. Briefly biotechnology improves plant varieties used in production of textile fibers and in fiber properties, and derives fibers from animals and health care of the animals along with novel fibers from biopolymers and genetically altered microorganisms. The survismeter is a effective tool to characterize broth fermentation.

References

Biotechnology Means Business: say of the art report on ‘The Textile & Clothing Industries’, 1995, The Biotechnology Unit, DTI, LGC, Queens Rd., Teddington, Middlesex, TW11 0LY, UK. Tiny Book on Enzymes and the Environment, 1993, NovoNordisk A/S, DK – 2880, Bagsvaerd, Denmark.

Glossary: Biotechnology: Use of living organisms or their cellular, sub cellular or molecular constituents to manufacture products and establish processes. DNA: Deoxyribonucleic acid, chemical molecule to carry hereditary information to pass from parent to offspring. DNA Probe: Single DNA strand used to detect a presence of complementary strands of DNA. Enzymes: Protein molecules that speed up specific chemical reactions and remain unchanged. Gene: Unit of heredity composed of DNA.

Genetic Engineering: A range of techniques for manipulating DNA and thereby modifying the genetic structure of living organisms. Transgenesis: Stable incorporation of foreign DNA from one species into another. For example, incorporating genes from a bacterium has developed insect resistant transgenic plants.

Cryolife close offer while Medafor Management adopt a Nero fiddle strategy

ATLANTA, March 18, 2010 /PRNewswire via COMTEX/ -- CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has sent the following letter to Medafor's Board of Directors:

March 18, 2010

VIA FEDEX

Michael F. Pasquale, Chairman of the Board

Medafor, Inc.

Dear Michael,

As Medafor's largest shareholder, CryoLife is deeply concerned about the rationale for and transparency surrounding Medafor's recent agreement with Magle Life Sciences announced on March 12, 2010.

As we predicted, you have again diluted existing Medafor shareholders without providing adequate value in return. We are deeply dismayed that you have seemingly given away almost 10 percent of Medafor, in addition to an undisclosed amount of much-needed cash, for the rights to a technology to which we believe you already have exclusive access. Given the absence of any other compelling business rationale, and your failure to provide your shareholders with an explanation of the substance of the transaction, we can only conclude that the sole purpose of the Magle Life Sciences ("Magle") transaction is to further entrench Medafor's management and board and prevent a combination between CryoLife and Medafor. In addition, the issuance of this significant block of stock is contrary to comments that your management and board have made to shareholders regarding Medafor's significant improvement in operating results and cash flow, which you indicated would be sufficient to fund your operations and growth strategy.

CryoLife has attempted in earnest for over the past 16 months to engage Medafor in friendly, good faith negotiations to arrive at a transaction that would enable HemoStase and related products to reach their full potential, and create value for Medafor and CryoLife shareholders. Unfortunately, every attempt we have made to create value for Medafor shareholders has been frustrated by a value-destructive action or response from Medafor's management and board.

As you know, we anticipated that Medafor management would be required to continue to engage in dilutive financings in order to fund its operating plan, and we have expressed our concerns in this regard to you and to our fellow Medafor shareholders. Nonetheless, we did not believe that Medafor's management and board would act in direct conflict with their fiduciary duties and inflict material dilution upon their shareholders, without obtaining any cash investment in return, in what appears to be an obvious effort to deny existing Medafor shareholders the right to choose whether or not to enter into a business combination with CryoLife.

We believe the dilutive share issuance to Magle was undertaken for the sole purpose of diluting CryoLife's holdings and therefore making any subsequent action to acquire Medafor significantly less likely to succeed. Unfortunately, this share issuance is clearly harmful to all Medafor shareholders, and further demonstrates the lengths to which Medafor's management and board will go in order to entrench themselves and preserve their excessive compensation.

Given the impact of the recent additional dilution on the value of your stock, and our concerns that Medafor's management and board will continue to cause intentional additional harm to shareholder value, CryoLife will withdraw its $2.00 per share proposal in 5 business days. During this time period, we will urge Medafor shareholders to contact the Medafor board and impress upon them the need to uphold their fiduciary responsibilities, including providing all Medafor shareholders with sufficient details regarding the Magle transaction so that we can all understand the impact it has on the value of Medafor common stock. We remain willing to enter into discussions with you about a combination; however, after 5:00 p.m., March 24, 2010 our current proposal to acquire Medafor will terminate.

In the event that you fail to provide your shareholders with adequate information regarding the Magle transaction and we withdraw our proposal for the reasons discussed above, we will remain Medafor's largest shareholder, and we intend to pursue all actions necessary to preserve the value of our investment, including the exercise of our right to call a special meeting of shareholders or pursue litigation in defense of our rights.

Sincerely,

Steven G. Anderson

President, CEO and Chairman of the Board

cc: Board of Directors of Medafor

Gary J. Shope

IMPORTANT

This letter is provided for informational purposes only and is not an offer to purchase nor a solicitation of offers 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 athttp://www.sec.gov/ and at CryoLife's website at http://www.cryolife.com/.

Cryolife Q3 - Edited...Offers Multiple Hemostatic Platform

Cryolife are offering a multi-Hemostatic platform which will challenge their competitors and offer surgical alternatives, please find below edited comments from Q3, for full info click the link at the bottom of this post. A visit to the CRY site is worthwhile HERE

Ashley Lee - EVP, CFO and COO

We saw evidence that the cardiac business continued to improve during the third quarter. Cardiac revenues for the third quarter of '09 increased 4% compared to the corresponding period in '08 and increased 13% compared to the second quarter of '09. The increase in the third quarter compared to the prior year was primarily due to a 7% increase in unit shipments partially offset by a decrease in average service fees. We believe factors contributing to the cardiac improvement include our efforts in physician training, including the Ross Summit and monthly aortic allograph workshops, the efforts of our new specialized cardiac technical representative sales force, anticipated seasonal increases with respect to the increase over the second quarter and increased shipments into international markets in particular, Germany and Austria. Also positively affecting the cardiac business during the quarter was our 510(k) clearance of CryoPatch SG used for cardiac reconstructive surgeries. We anticipate

that this will be a growing part of our cardiac business in the coming quarters. The vascular preservation service business continues to do well. Vascular revenues for the third quarter and first nine months of '09 increased 8% and 10% compared to the corresponding periods of '08. These increases resulted from an 8% and 10% increase in unit shipments for the third quarter and first nine months of '09 compared to the comparable periods of '08. Surgeons are seeing the benefits of using our preserved vascular tissues, especially for prevention of amputation of lower limbs and in actively infected surgical sites. We believe that this will continue to be a very attractive market for us and we believe that we have significant room for growth in this business. Product revenues which consist primarily of BioGlue and HemoStase increased 5% in the third quarter of '09, compared to the third quarter of '08 and increased 6% in the first nine months of '09 compared to the first nine months of '08. The increase year-over-year primarily reflects the growing usage of HemoStase in cardiac and vascular surgical indications. HemoStase revenues for the third quarter and first nine months of '09 were $1.6 million and $4.1 million.

Steve Anderson - President and CEO

On August 4, we announced that we had received a CE mark for BioFoam surgical matrix as an adjunct in the ceiling of abdominal parenchymal tissues, specifically liver and spleen when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The CE mark allows for unrestricted commercial distribution of BioFoam in the European community. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed, and becomes our second product from the company's protein hydrogel technology platform to receive a CE mark. The company has been developing BioFoam in conjunction with the United States Department of Defense which has provided the company with most of the funding for advancing this product. We continue to evaluate the potential for using BioFoam to seal penetrating wounds such as gunshot injuries as well as for other types of surgery. Today, the Department of Defense has granted about $5.4 million to CryoLife for the development of this surgical sealant. The controlled clinical launch of BioFoam began in Europe in early September with initial clinical uses occurring in Germany, the UK and France. Based on the number of liver and spleen procedures done annually in Europe, we estimate that this is a $30 million annual market opportunity with a worldwide annual market of about $100 million. As of yesterday, we had completed 21 BioFoam applications in 19 patients with the longest follow up now beyond 30 days in the controlled clinical launch. The product has worked well and provided homeostasis in all of the cases. All of these initial patients will have completed their 30 day follow-up by the 21st of November. We anticipate a full commercial launch in Europe to begin in January of 2010. Additionally, we have begun feasibility animal studies evaluating the use of BioFoam in cardiovascular procedures. One acute and two chronic animals were recently completed with BioFoam applied to the aorta, femoral veins and aortic jump graft. The BioFoam stop bleeding in all cases demonstrating the product's potential utility in these applications. The chronic animals will be evaluated at 30 days. We anticipate that BioFoam would be useful in cardiovascular procedures for external bleeding and suture line sealing. BioFoam is easily visualized in the surgical field and initial studies indicate that it biodegrades more quickly than BioGlue. We expect to conduct a pivotal animal study and file for a cardiovascular CE mark application towards the end of the first half of next year. If BioFoam proves to be valuable in controlling active bleeding in cardiovascular applications, we believe the market opportunity in Europe for BioFoam could be significantly larger than the market opportunity for BioGlue. Initial estimate suggests this expanded opportunity could approach $100 million annually. Earlier this week, we announced that the FDA had approved our Untied States IDE to conduct a human clinical trial for BioFoam for use in sealing liver parenchymal tissue on cessation of bleeding by ligature or other conventional methods, is ineffective or impractical. The approved IDE is for our perspective, multi-center randomized, feasibility study evaluating safety outcomes of BioFoam as compared to standard topical haemostatic agents. We will now seek approval from the United States Department of Defense which will be the final step necessary to begin this trial. Following DoD approval, the feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. Upon successful completion of the feasibility study and subsequent FDA and DoD approval, a follow-on perspective multi-center randomized controlled pivotal study will be conducted. It is currently anticipated, that the pivotal investigation will enroll a total of 164 eligible subjects. 82 subjects in each treatment group across a maximum of 10 investigational sites. The successful completion of the BioFoam US clinical trial which we anticipate will take about three years, would give the company a technology platform of three products to control surgical site bleeding that would in the aggregate, address active bleeding sites in vascular and cardiac reconstruction surgeries as well as the sealing of parenchymal tissues such as liver and spleen surgical procedures. Management believes that the total annual worldwide market for surgical adhesives and glues approaches $900 million.

Ashley Lee

As detailed in our press release this morning, we expect total revenues and preservation service revenues for the full year of '09 to be near the lower end of our previous range of guidance, BioGlue revenues to be slightly below our previous range of guidance and HemoStase revenues to be near the higher end of our previous range of guidance. We expect other revenues for '09 to be approximately $1 million primarily related to funding received from the DoD in connection with the development of BioFoam. The amount of other revenues is largely dependent upon actual expenses incurred related to the development of BioFoam. We currently plan to issue our initial 2010 financial guidance at the Piper Jaffray Health Care Conference in New York on either December 1 or 2. Although we are currently in the process of finalizing our 2010 plans, we will say that we certainly expect 2010 to be another record year in both revenues and operating income. There are a few items that we would like to comment on that we believe could be positive developments for the company in the future. As Steve mentioned earlier, we expect to begin enrolling patients in our BioFoam IVE either late this year or early next year under an FDA approved clinical trial. This will be the first step in getting a commercial approval to distribute BioFoam in the United States. We are still optimistic that we will get approval to sell BioGlue in Japan. Progress continues to be made on this matter. We are in the process of completing our second large animal study for the use of ProPatch our FDA cleared, SynerGraft processed tissue patch, for use in general surgery indications and specifically ventral hernia repair. If the studies are concluded successfully, we expect to ramp up our efforts to secure a commercialization partner in general surgery. We continue efforts on the business development front to find complementary products or companies that we can acquire to leverage our existing infrastructure and sales force to deliver more value to our shareholders.

Question-and-Answer Session

Matt Dolan - Roth Capital

First question on Bio, may be you can give us some detail there. We haven't seen a level quite as low for a year or two. What's happening there with pricing or competition or may be something at the hospital level? Just some more commentary would be appreciated.

Ashley Lee

Yeah Matt there are few factors that are playing into what we saw with BioGlue, First of all, we have seen some recent product approvals in recent meaning within the last couple of years. In areas where BioGlue had been used on an off-label basis, so we think that we've seen some of that business go away. We also continue to see hospitals challenge the use of products and surgical procedures, including seamless and haemostatic agents and we think that that's had a small effect on our business. We're also seeing some of our large competitors become very diligent in enforcing hospital purchasing requirements under their contracts. Again, that hadn't affected our business to a huge extent but again, it has had some effect. We've also seen hemostats actually be used in a small amount of procedures where BioGlue has currently been used. We don't think it's a significant issue for the BioGlue business going forward, but again, we did see we did see a little bit of that recently in the last couple of quarters. We still see a little bit of respect on pricing and for the nine months number, foreign currency exchange rates had an effect on the revenues year-to-date although to a lesser extent in the third quarter in this year. So, again there are several issues that we see there none of which I think, stands out anymore than the other. We hope that a lot of these issues are transient and that they will go away, especially factors relating to the economy. We think others will probably run their course in 2009 and going forward, we're still optimistic that we're going to be able to grow the business. Its a major focus of the sales force going into 2010 and if all goes according to plan and what we see, we still believe, that that long term, we're going to be able to grow this business at a rate consistent with growth in cardiac and vascular surgical procedures which is in the mid single digit range.

Matt Dolan - Roth Capital

So, if I look at the guidance, what it implies for Q4, for pushing down towards the lower end of things, it's still a sequential increase but, not significant. I know last year, you saw a sequential decrease in Q4, but for the most part, it seems like Q4 is one of your bigger quarters of the year. Is that guidance related primarily to the BioGlue situation or maybe is there a more general comment you could provide on hospitals and destocking and some of the issues we saw earlier this year, what's the rationale there?

Ashley Lee

I'll comment on BioGlue specifically and we certainly expect to see fourth quarter be sequentially better than the third quarter. If you look at where we are in the month of October right now, October is on track to be better, provide good revenues than any particular month, any single month in the third quarter, and we expect that to continue into the fourth quarter. So, a couple of things there, we expect BioGlue to increase sequentially. We also think that that will have the effect of increasing gross margin sequentially in the fourth quarter compared to the third too, because it was a little bit lower than what we wanted it to be in third quarter and because BioGlue has such high gross margins, it effected margin in the third quarter and we fully expect gross margin in the fourth quarter to increase sequentially over the third.

Matt Dolan - Roth Capital

So may be just a general, I know you gave a kind of a synopsis of what's going to drive growth, but if we think of a base business growing in the mid-single digits, how are you going to provide growth or accelerate growth from what we've seen here in 2009, whether it be adding to the sales force or some of the initiatives you hit on. Are any of those something we should start to rely on?

Ashley Lee

Well, I am talking about tissue specifically, we continue to see year-over-year growth there, the cardiac business has certainly rebounded and we're seeing year-over-year growth in the vascular business. We expect that to continue into 2010. For BioGlue again, it's a major focus of the sales force right now. There are a few things that we are working on there from a marketing standpoint. We're really looking at marketing BioGlue in combination with HemoStase as a perfect partnership to really address like 90% of the needs that the operating room has to control blood loss. So, we're really focusing on marketing the two products together. We've always marketed their speed, simplicity and ease of use. We also are taking a different approach with product approval committees; especially as it relates to HemoStase and we are focusing on the economic story using BioGlue and the cost savings with the reduction in blood products. So, we fully expect to be able to grow BioGlue. And then HemoStase again, we're only getting into our second full year of the launch in 2010 and we expect that business to increase significantly.

Greg Brash - Sidoti & Company

And then just on the BioFoam expectations, you talked a little bit about potentially using in cardiac procedures, may be where you are using BioGlue. How long until those studies are completed. When can we realistically may be expect an indication [assumption] in that margin?

Ashley Lee

BioFoam will have a full launch in international markets at the beginning of next year. The initial work that we have been doing for sealing organs indicates that it is very effective. It can provide hemostasis and a liver reception under one minute, which is superb. And then the animal studies that we have recently been doing to evaluate the effectiveness for cardiovascular surgery would indicate that it can effectively hold cardiac pressure, which is extremely encouraging. And I am very encouraged about that because, there has been some criticism of BioGlue's long degradation time and the studies that we've been conducting, showed us that BioFoam pretty much is gone after six months in the body, and I think the doctors will find that very helpful to them. It's also very easily seen once it's applied in the body. You can see it more easily in the surgical field than you can see BioGlue and it isn't as runny. I think its going to be very user friendly, that's what I am leading up to there. But it's effectiveness as a haemostatic agent is very encouraging to us and that is going to end up being a significant product for us. That will give us three sealants adhesives, call them what you wish, had act in significantly different ways and have very different uses, whereas the HemoStase isn't very strong. BioGlue is very strong. And to refresh people's memory, BioGlue can withstand 500 millimeters of mercury blood pressure, within two minutes of being applied and BioFoam will fit right in the middle of those two products. It be very nice product, very versatile product and I am looking forward to that making a significant contribution in international growth next year.

Greg Brash - Sidoti & Company

And just one more on BioGlue, you mentioned several issues that have been impacting sales. Did you believe it's more a function of just hospitals cutting back on using sealants in a way to cut costs or a competitor out there just really taking on a share?

Ashley Lee

We really think it's just a conglomeration of all the factors that we mentioned Greg. We don't see any one of those factors contributing significantly more than the others. Just a lot of little things at this point, but we think that we're on our way to addressing several of those and again, we expect revenues to certainly increase sequentially in the fourth quarter and we expect the growth in 2010.

Ashley Lee

We have about 12 cardiac specialists throughout the United States and we're going to be adding to that in 2010 and we have between 40 and 45 sales representatives that handle vascular tissues. Vascular tissue sales reps handle vascular HemoStase and BioGlue and the cardiac specialists who focus primarily on cardiovascular surgeons would be handling the three products as well. That's how it's sorted out but, it takes a more sophisticated sales run to effectively interact with the cardiovascular surgeons. I think you have to know a lot more about cardiac reconstruction to be able to communicate effectively with them and that's why last year we took the top salesmen in the company and put them over into that new sales job and its turning out to be very effective.

The full transcript is available at Seekingalpha