Laser-activated tissue repair trumps standard surgical closure

Boston — Photochemical tissue bonding, or laser-assisted nanosuturing, is a new cutting-edge technology that may rewrite the surgical books in terms of standard surgical closure procedures.This novel technique allows the surgeon to close the epidermal defect with laser following the application of a light-sensitive dye to the wound edges eliminating the need for epidermal suture placement. Led by Sandy Tsao, M.D., the human clinical trial is based on novel photochemical concepts developed at Massachusetts General Hospital, Boston, by scientists Min Yao, M.D., Robert W. Redmond, Ph.D., and Irene E. Kochevar, Ph.D."Traditional closure techniques work well, but there is always an issue of scarring. Dermabond adhesive liquid techniques also work, but these closure methods do not necessarily have the tensile strength to close wounds when compared to the laser-assisted nanosuturing technique, particularly in areas which may be more prone to keloid formation or unattractive scars," Dr. Tsao says.
Photosensitizing dyesPhotosensitizing dyes have already been utilized in conjunction with lasers in other therapies. Rose Bengal (RB), the ophthalmological dye used in this procedure, is approved by the Food and Drug Administration (FDA).When applied to the skin, RB is activated by light and cross-links proteins such as collagen and epidermal keratins. This non-thermal "stitching" of molecules restores the normal collagenous cross-links that are disrupted during surgery.
Clinical trialIn a recent trial, Dr. Tsao set out to determine the efficacy of wound closure using the photosensitizing dye coupled with laser irradiation and compared it to standard epidermal-interrupted suture closure.In the 28-patient study, Dr. Tsao performed 31 excisions of skin lesions that clinically needed to be removed including dysplastic nevi, SCC and BCC.All defects were closed with vicryl dermal sutures. Half of each epidermal wound was closed using standard interrupted epidermal sutures. The other wound half was closed with laser assisted nanosuturing by applying the rosebengal dye for one minute just to the incision edges of the wound followed by irradiation of this epidermal wound edge with a 308 nm KTP laser for 200 seconds. This way, each patient served as a built-in control in which the quality of closure of each part could be compared.
Results showed that a vast majority of the patients preferred the laser-assisted approach. In all cases, the tensile strength was comparable if not better than the traditional closure technique, and the scar appearance of the laser-treated side in many of the patients was near imperceptible.Though in a few cases, the scar was not clinically and aesthetically attractive, Dr. Tsao says, the laser-treated side was always the better appearing side. There were no complications, infections or dehiscence associated with either the traditional or the laser-assisted treated wound edges.Patients were evaluated at two weeks, three months and at six months. Study endpoints included efficacy of wound closure, vascularity, pigmentation, elevation, atrophy and scar appearance. The surgical sites were evaluated by two blinded physicians and patients were also asked to make an evaluation based on the same attributes."This novel technique provides a very effective means of providing epidermal wound closure with comparable if not markedly better clinical outcome compared to suture closure when evaluating scar erythema, pigmentation, atrophy, keloid formation and track mark formation," Dr. Tsao says.The excisions were attained from non-facial multiple body sites, including the shoulders, chest, back, abdomen, thighs and arms including keloid-prone areas such as the deltoid and sternal regions.Dr. Tsao says that one patient had an SCC in situ on the sternal region requiring a larger excision margin, and on the laser assisted treated side, there is simply no perceptible scar.
‘Next frontier’"With the current technology and knowledge, we still do not have the ability to close the deep dermis yet using this technique which is our next frontier. Eventually, suturing all together may become unnecessary and be a relic of the past."I think the utility beyond the necessity of removing the lesion is in areas where cosmesis is a really critical aspect of the outcome such as the face," Dr. Tsao says.According to Dr. Tsao, this revolutionary technique will save patients, as well as physicians, a lot of valuable time, because there are no sutures to be removed translating into less follow-up, a greater ease for the patient to take care of the area as well as less use of surgical materials.

Zymogenetics - Recothrom Sales Climbing Q2 09

SEATTLE —ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported financial results for the second quarter ended June 30, 2009. In the second quarter of 2009, the company’s net loss improved to $27.0 million, or $0.39 per share, from $37.4 million, or $0.54 per share, for the second quarter of 2008. The improvement primarily resulted from increased product sales of RECOTHROM and higher collaboration and license revenues.

Revenues for the second quarter of 2009 were $22.6 million compared to $12.6 million for the prior year quarter. The increase resulted from higher collaboration and license revenues and higher sales of RECOTHROM in the United States.

RECOTHROM net sales were $6.0 million for the second quarter of 2009 compared to $1.4 million for the second quarter of 2008. The increase was attributable to increased market share as additional hospitals converted from bovine thrombin to RECOTHROM and existing customers increased their purchase volumes of RECOTHROM. Second quarter 2009 RECOTHROM hospital unit demand also increased from first quarter of 2009, growing by approximately 24%. Costs of product sales rose in line with sales.

RECOTHROM^®Thrombin, topical (Recombinant)

End user demand for RECOTHROM continued to increase in the second quarter. Overall hospital demand increased by approximately 24% in the second quarter of 2009 versus the first quarter of 2009. The company’s partner, Bayer Healthcare, continues to pursue approval in Europe, Canada and Australia.

Results from the Phase 3b RECOTHROM clinical trial were published in the June issue ofJournal of the American College of Surgeons. This study analyzed the safety of RECOTHROM in surgical patients with confirmed or highly likely prior exposure to bovine thrombin. One out of six patients in the Phase 3b study had antibodies to bovine thrombin at baseline. None of the patients in the Phase 3b study developed antibodies to RECOTHROM after topical application of the product in surgery, and adverse events were consistent with those typically observed in surgical patients, suggesting that RECOTHROM can be safely used in patients with pre-existing antibodies to bovine thrombin.

CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology

ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced it has received CE mark approval for its BioFoam((R)) Surgical Matrix (BioFoam). The CE mark allows immediate, unrestricted commercial distribution of BioFoam 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. BioFoam is the second product from the Company's protein hydrogel technology platform to receive a CE mark. CryoLife plans a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy to support its initial marketing efforts. Based on the number of liver and spleen procedures performed annually in the European Community, CryoLife estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million on a worldwide basis. "We are excited about securing our first approval for the use of BioFoam in organ resection surgery and look forward to continuing our development efforts to bring BioFoam into the U.S. market," said Steven G. Anderson, CryoLife president and chief executive officer. "Over the past four fiscal years, the U.S. Department of Defense has allocated approximately $5.4 million to CryoLife for the development of products containing a protein hydrogel, which is the primary component of BioFoam." In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process.

About BioFoam

BioFoam^® Surgical Sealant (BioFoam) is a two-component surgical sealant composed of purified bovine serum albumin (BSA) solution with sodium bicarbonate and glutaraldehyde solution with acetic acid. The two components of BioFoam are contained in a dual chambered syringe and, at the point of delivery, are mixed in a specially designed applicator tip. Upon delivery of the BioFoam, the sodium bicarbonate and acetic acid react with each other causing the material to foam to an approximate 5-fold expansion. The aldehyde groups of the glutaraldehyde react with the amine groups of the BSA and/or tissue surface proteins and generate chemical cross-links (covalent bonds). These chemicals cross-link together to form a mechanical seal at the site of application. The aldehyde groups are in slight molar excess over the amine groups, ensuring the cross-linking of the BSA molecules to each other and to the tissue at the application site. Polymerization of the BioFoam begins immediately upon application, sets up within 15-20 seconds and reaching full bonding strength within 2 minutes.

Scar-free surgery with nanotechnology sealant

(Nanowerk Spotlight) Much attention of nanotechnology researchers has recently been paid to the fabrication of free-standing, ultra-thin films. These systems have been developed for use in a wide variety of fields such as nano-separation membranes or nanosensors for electrochemical and photochemical applications. In a first report on the fabrication of free-standing nanosheets for biomedical applications, scientists in Japan have developed a biodegradable thin film of only about 20 nanometers thickness that could replace surgical stitches.

"We have developed a free-standing PLLA nanosheet with a thickness of 20nm and an area in centimeter order, fabricated by a simple combination of a spin-coating method and a peeling technique with PVA as a supporting film,"

Shinji Takeoka tells Nanowerk. "We found that our ultra-thin nanosheet has an excellent sealing efficacy for gastric incision as a novel wound dressing that does not require adhesive agents. Furthermore, the sealing operation repaired the incision completely without scars and tissue adhesion. This approach would constitute an ideal candidate for an alternative to conventional suture/ligation procedures, from the perspective not only of a minimally invasive surgical technique but also reduction of operation times."Takeoka is a professor in the Department of Department of Life Science and Medical Bioscience at Waseda University in Tokyo. With collaborators from the National Defense Medical College and members of his group he reports his findings in a recent paper in "Free-Standing Biodegradable Poly(lactic acid) Nanosheet for Sealing Operations in Surgery"

Macroscopic and microscopic observations of the stomach seven days after treatments. Sealing with the PLLA nanosheet (a,c). Conventional suture/ligation (b,d). Letters F, M, and S show fibroblasts, mucosa, and submucosa, respectively. Sealing surgical incisions with this nanosheet instead of performing the traditional suture and ligation procedures is more than just a godsend for Hollywood's plastic surgeons. In cases where internal organs or other tissue has been severely damaged, repair by suture and ligation may become technically difficult and unreliable. Also, internal scarring can lead to sometimes dangerous adhesions, with areas of tissue that should remain separate become joined by scar tissue.Researchers have already been working on novel glue-type (see for instance: Gel-based glue fastens snails to wet surfaces, model for surgical adhesive and sheet-type biomaterials for wound dressing. "Ideally" explains Takeoka, "desirable properties of a novel wound dressing material should incorporate the advantages of both types, that is, not only sufficient adhesive strength to cover the wound site as with a sheet-type structure, but also compatibility with the site as with a glue-type structure."The nanosheet developed by the Japanese team fits that bill – it has very interesting features such as high adhesiveness, high flexibility, and high transparency at the same time. PLLA and other polyesters have been clinically applied in drug delivery and as degradable stitches before, but not as nano-thin sheets. Interestingly, the mechanical properties of the nanosheets are very different from the conventional thin film of the same components.

tPreparation of PLLA nanosheets and appearance. (Image: Dr. Shinji Takeoka, Waseda University)

Takeoka explains that his and his team's scientific backgrounds are bio-related macromolecular chemistry and molecular assembling science and engineering." We have studied platelet substitutes, which are biodegradable nanoparticles such as phospholipid vesicles and polymerized albumin particles carrying platelet membrane proteins and peptides for ten years" he says. "We noticed that the nanoparticles specifically accumulated at sites of vascular injury and had hemostatic ability. Moreover, in order to enhance their hemostatic abilities, we proposed the idea of sheet-shaped carriers having a larger contact area for a targeting site than spherical nanoparticles." To demonstrate the suitability of their nanosheets as a novel wound dressing material that lacks adhesive reagents, the researchers repaired incisions on mouse stomachs with them instead of sutures. They found that the PLLA nanosheet has an excellent sealing efficacy and the healed wound showed neither scar nor tissue adhesion. Although it will be several years before this material is developed enough to enter clinical trials, Takeoka expects that the nanosheet will be applied not only in the field of surgery as a wound dressing instead of conventional suturing operation but also in the field of plastic surgery, endoscopic surgery, regeneration medicine, and external use (skin etc.). He also sees applications in the fields of material science, material engineering, and surface science.

Cryolife Q2 '09 - Edited

Product revenues which consists primarily of BioGlue and HemoStase increased 5% in the second quarter of '09 compared to the second quarter of '08 and increased 6% in the first half of '09 compared to the first half of '08. We had a very difficult prior year quarterly comp for BioGlue as the second quarter of last year was by far our best quarter during 2008.

BioGlue revenues were 12.4 million and 24.1 million for the second quarter in the first six months of '09 compared to 13 million and 24.9 million for the corresponding periods in '08. BioGlue revenues in the second quarter of '09 did improve over the first quarter of '09 with an increase of 5%.

Excluding the effects of changes in foreign currency exchange rates year-over-year which reduced BioGlue revenues by 331,000 and 639,000 in the second quarter and first six months of '09, BioGlue revenues would have been 12.7 million and 24.8 million.

HemoStase revenues for the second quarter and first six months of '09 were 1.5 million and 2.6 million. HemoStase was added to our product portfolio in the second quarter of '08.

Tissue processing and product gross margins were 63 and 64% for the second quarter and first six months of '09 compared to 66 and 65% for the corresponding periods in '08. We expected to see this decrease in gross margins as HemoStase sales which carry a lower gross margin than our recent aggregate gross margins continue to grow. And with some pricing pressure that we've seen as a result of the economy and it's effect on hospital purchasing patterns.

Tissue processing and product gross margins were 63 and 64% for the second quarter and first six months of '09 compared to 66 and 65% for the corresponding periods in '08. We expected to see this decrease in gross margins as HemoStase sales which carry a lower gross margin than our recent aggregate gross margins continue to grow. And with some pricing pressure that we've seen as a result of the economy and it's effect on hospital purchasing patterns.

Once we receive final IDE approval, our clinical study will evaluate BioFoam as an adjunct on cessation of bleeding by ligature or conventional methods is ineffective or impractical on liver parenchyma. This is a two part investigation including a feasibility phase followed by a pivotal phase. Both phases will be prospective, multi-center, randomized and controlled.

The feasibility phase of the investigation will be conducted at a maximum of two investigational sites. And we'll enroll 20 eligible subjects. The pivotal investigation will include a total of 164 eligible subjects, 82 subjects and each treatment group enrolled across a maximum of 10 investigational sites.

We believe that we can obtain commercial approval in approximately two to three years. We think the annual worldwide market opportunity for a product like BioFoam used for the sealing of abdominal parenchymal tissues is over a 100 million. We continue to evaluate other potential uses for BioFoam including its clinical utility in the treatment of traumatic injuries and in cardiovascular surgery.

Hemostat IFU and Brochure Downloads

For your information currently including J&J, Baxter, Vascular Solutions, Orthovita, SMI, Cryolife, further materials are welcomed along with updates (please send to hemostatguy@gmail.com) , all materials provided are and sent must be freely available online and from a verifiable email address. You may download or share by clicking on the thumbnails below..........Please Do view the sidebar Disclaimer also displayed below this post as all information is subject to change and is not for clinical use, always review the company/product information directly. No liability is accepted by this Author.

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Orthovita schedule Q2 date

Orthovita, Inc, a leading orthobiologics and biosurgery company, will hold a conference call on Thursday, August 6, 2009, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2009 and update full year guidance. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.

The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 18137278. Participants should dial in ten minutes prior to the scheduled start time for the conference call.

A replay of the conference call will be available for two weeks beginning August 6, 2009, at 11:30 a.m. Eastern Time, and ending August 20, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 18137278.

Vascular Solutions - Q2

Net revenue from hemostat products (primarily consisting of the D-Stat(r) Dry, D-Stat Flowable and D-Stat Radial products) was $6.4 million during the second quarter, an increase of 6% over the second quarter of 2008. "The two principal reasons for our sales growth in hemostat products were the exit of a competitor's patch product from the market and the growing sales of our new 'Wrap' version of the D-Stat Dry," commented CEO Mr. Root.

Blood Transfusion and Blood Conservation in Cardiac Surgery - Clinical Paper

Another Reader supplied article Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery - Society of Thoracic Surgeons and Society of Cardiovascular Anesthesiologists.

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Thrombin - Presentation

Courtesy of a reader....

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