Spinal Sealant gets CE mark

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for Adherus^TM Spinal Sealant. Adherus^TM Spinal Sealant is used in spinal surgeries where a water tight seal is required to prevent cerebrospinal fluid leakage from the dural repair. Prevention of cerebrospinal fluid leaks should benefit the patient in shorter hospital stays and fewer post-surgical complications such as reduced pain and fewer infections. Adherus Spinal Sealant also acts as an adhesion barrier, thereby simplifying subsequent surgeries should the need arise. The unique, single use device is terminally sterilized and can be applied in both Open and MIS procedures through either a 100mm or 150 mm tip. The CE Mark provides regulatory approval for the company to begin sales in Europe and other countries outside the U.S.

“Adherus^TM Spinal Sealant is an easy to use device that complements HyperBranch’s neurosurgical sealant product line. Adherus^TM Dural Sealant, which was first launched in 2009, is currently marketed outside the U.S. for cranial surgery. Adherus^TM Spinal Sealant has negligible swelling, degrades slowly not only provides a watertight seal but also acts as an adhesion barrier to limit scarring, a major advantage if subsequent surgery is required,” said John Conn, President and Chief Executive Officer.

The Adherus^TM products are synthetic hydrogels which polymerize in a moist field, flow optimally depending on the application, and are bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure.HyperBranch Medical Technology, Inc. has now received CE Marks for ocular, cranial, and spinal sealants as well as a hernia mesh fixation product. The Company has completed a U.S. feasibility study and is starting the Pivotal portion of the study this month for the Adherus Dural Sealant. The Spinal product will follow the same approval path in the U.S. The company’s ophthalmic sealant is currently licensed to and marketed by BD Medical.

Surgical Device Company Wins 2010 NJTC "Best Early Stage Company" Award

At the 12th Annual New Jersey Technology Council (NJTC) Venture Conference in Somerset, NJ on March 26, Endomedix, Inc. (www.endomedix.com) unveiled a sprayable surgical hemostat that promises to change the way surgeons control bleeding during surgeries such as craniotomy and Ear, Nose & Throat (ENT) sinus procedures. The company’s proprietary technology will also lead to flowable hemostats for use in most other surgeries as well for military, first responder and ER applications. The Company’s product portfolio and business plans were key factors that led to the selection of Endomedix as the recipient of the "Best Early Stage Company" Award by judges at the Conference, where more than 65 companies showcased a broad spectrum of leading edge new technologies, products and services.

The Endomedix device sprays on the surgical site and forms a hydrogel in seconds, leading to the rapid formation of a mechanical clot. The hydrogel also contains a natural hemostat to amplify the natural cascade of coagulation. The device can produce effective hemostasis, or control of bleeding, much faster and is easier to use than competitive products. Since many surgeries require that bleeding be controlled many times during a procedure, the new device will save hospitals thousands of dollars per case in OR and anesthesia charges alone.

"Our technology is based on natural materials with a long history of use in FDA-regulated products, and our intellectual property is based on the innovative treatment and processing of these materials", explains Richard Russo, Chief Executive Officer. "Surgeons will be able to spray on our devices precisely, with almost immediate effect, so they can continue the surgery without having to wait a long time for bleeding to stop. Our product is also transparent, so unlike products currently available, the surgeon can see through it to confirm that bleeding has stopped."

Unlike many companies that try to invent something totally new, such as cure for a disease, Endomedix is developing products with improved performance and ease of use for procedures that surgeons perform every day. "It’s exciting to develop a device for a billion dollar plus market that both performs better and costs less to produce than the devices currently available," says Russo. "We’re in a strong position given what’s happening in medical care delivery systems around the world."

The daylong annual NJTC meeting is the largest of its kind on the East Coast. More than 65 companies showcased technologies and products from various sectors, including life sciences, information technology, energy/environmental management, telecommunications and nanotechnology. "Participants included a new crop of vibrant startup companies" said Aron Spencer, CEO of InVenture LLC, a firm that helps startups leverage inventions into viable companies, and Professor of Entrepreneurship at New Jersey Institute of Technology. "Selecting a single winner this year was not easy, but the combination of its experienced management, technology and business opportunity certainly qualifies Endomedix as the Best Early Stage Company of 2010".

"We are moving steadily toward commercialization, and one of the key challenges that every firm in our situation must overcome is obtaining additional investment funds in this very difficult business environment", noted Russo. "We are making use of the experience and talents of the New Jersey Entrepreneurs Forum (www.NJEF.org) to provide insight on how to navigate the world of professional investors interested in private companies and startups. Their advice has helped us enhance our investment appeal, as evidenced by this Award."

HyperBranch Medical Technology To Market Surgical Sealants under Adherus Product Name

DURHAM, N.C.--(BUSINESS WIRE)--HyperBranch Medical Technology, Inc. announced today that it will begin to market their surgical sealants under a new product identity – Adherus Surgical Sealants. The Adherus name will soon appear on all Company literature but the total transition in the market place will likely take several months to complete. “The new identity brings continuity to our products and allows the end users - doctors, hospitals and nurses - to refer more effectively to our family of products. This is not an unusual change for companies like HyperBranch as they transition from a development company to an established organization in the market, ” said John Conn, President and CEO. HyperBranch’s Adherus product line is a family of synthetic hydrogels which polymerize in a moist field, set immediately upon application, and bio-degrades as the tissue heals. Adherus Surgical Sealants are CE marked and approved for sale outside the United States for ophthalmic, cranial, spine and hernia applications. The Company has also recently completed enrollment of a US FDA pilot study for its Adherus Dural Sealant in preparation for the expanded pivotal trial of the same product. The Durham, N.C. medical device company has also been developing advanced surgical sealants for cardiovascular, pleural (lung), plastic surgery and other related surgical applications. These products are all at various stages of clinical and pre-clinical development and complement the existing CE Marked products. HyperBranch Medical Technology, a privately-held company based in Durham, N.C., is developing innovative medical devices for the ophthalmology, general, and specialty surgery markets. The company is focused on the development of unique products based on its novel hydrogel technology. For more information visit:www.hyperbranch.com.

HyperBranch Medical Technology, Inc. Receives CE Mark for its NuSeal 30 Hernia Mesh Fixation Sealant Product

HyperBranch Medical Technology, Inc. announced today that it has received a CE Mark for its NuSeal 30 hernia mesh fixation sealant product. NuSeal 30 is used in hernia procedures to adhere the mesh. NuSeal 30 provides for secure mesh placement, minimizes pain caused by other fixation devices and gradually degrades as the body heals. The CE Mark for NuSeal 30 provides regulatory approval for the company to begin the registration process in countries outside the U.S. The unique, single use device is terminally sterilized and sets on contact after a spray application. The synthetic, biocompatible composition is stored at room temperature and is delivered through a custom applicator to meet the specific needs of the procedure. The intended users of NuSeal 30 are General Surgeons in a surgical environment. John Conn, President and CEO, said, "NuSeal 30 is a follow on product to the platform technology developed at Hyperbranch. NuSeal 30 is a major improvement to mesh fixation eliminating the need for staples and tacks while providing secure fixation, reducing pain and creating an anti-microbial environment. The Company will continue to introduce this technology in other indications." The Durham, N.C. medical device company recently announced the CE Mark approval of its NuSeal 100 for dural closure and the licensing of OcuSeal ophthalmic bandage to BD Medical. The company is currently conducting US clinical evaluations for the dural closure product and is in various stages of development for other indications of the platform technology. About HyperBranch Medical Technology, Inc. HyperBranch Medical Technology, a privately-held company based in Durham, N.C., is developing innovative medical devices for the ophthalmology, general, and specialty surgery markets. The company is focused on the development of unique products based on its novel hydrogel technology. Development work on HyperBranch`s surgical sealant platform has led to the recognition of several novel hydrogel properties that suggest significant utility in a variety of additional clinical applications. For more information visit www.hyperbranch.com.

Lifebond - Israel has developed a new surgical sealant

Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.

LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.

Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.

LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.

CryoLife Announces First Clinical Use of BioFoam

ATLANTA and LONDON, Sept. 10 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced the first clinical implant of its BioFoam(R) Surgical Matrix, which received CE mark approval in August 2009. BioFoam was used in a liver resection procedure following tumor removal as a supplemental measure to promote hemostasis (a complex process that stops bleeding) by sealing vessels. "Despite advances in surgical technique, bleeding complications continue to be a problem in liver resection surgery and can be life-threatening," said Professor Brian Davidson, MD,

FRCS, Professor of Surgery, Department of Surgery, Royal Free Hospital in London who performed the procedure on September 9. "We are very hopeful that BioFoam will reduce the time required to achieve hemostasis during liver resection surgery and will reduce the number of complications following surgery."

CryoLife is conducting a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. The objectives of this 45-patient controlled launch, in which BioFoam is used as a surgical hemostatic adjunct in the open repair of liver parenchyma following liver resection and/or liver transplant surgery, are to (1) collect additional clinical data supporting the safety and performance of BioFoam and (2) further refine the optimal application technique. "The clinical availability of BioFoam is another milestone in the company's corporate objective of providing world-class surgical options for the control of intraoperative bleeding," said Steven G. Anderson, CryoLife president and chief executive officer. "We believe the unique adherence and expansion characteristics of this product make it useful for organ sealing and other future surgical applications. It is a wonderful complement to our existing hemostasis products, BioGlue(R) and HemoStase(TM)." 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 and expects to start enrollment in Q4 2009. During the European Association of Cardio-Thoracic Surgery (EACTS) annual meeting in Vienna, Austria Oct. 17-21, booth 43, CryoLife will be soliciting input from the attendees on potential future clinical applications for the use of BioFoam in cardiothoracic surgery. About BioFoam BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and can be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future reoperations in liver resections. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE mark approval 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.

BioSyntech

Established in 1995 and traded on the TSX Venture since 2004, BioSyntech has created and developed innovative biotherapeutic thermogels for regenerative medicine (tissue repair) and therapeutic delivery, which appeal to large unsatisfied markets.
BST-DermOn™ is a topical therapy, which conforms well to the wound and may help stimulate the natural healing process. It may maintain the wound’s moist environment while allowing gas exchange. The wound healing, as well as inherent hemostatic and bacterio-static properties of the chitosan component of BST-DermOn™ has well-documented in the scientific literature. Our animal studies have shown that it stimulates and supports the intrinsic healing process of slow or non-healing wounds.
Claude LeDuc President and CEO BioSyntech Inc. said "As part of the implementation of the streamlined business plan we will concentrate and focus our efforts and resources on advancing BST-CarGel® through the clinic. While we continue to believe strongly in the market opportunity of our other programs, given the current limited financial resources at BioSyntech, enrollment for the BST-DermOnTM clinical trial and development work on BST-InPodTM has been suspended at this time."

Neomend Inc.

IRVINE, Calif., June 17 /PRNewswire/ -- NeoMend, Inc. today announced that its ProGEL(TM) Surgical Sealant has received a recommendation for approval from the U.S. Food and Drug Administration's (FDA) Anesthesiology andRespiratory Therapy Devices Advisory Panel.The panel's recommendation will be considered by the FDA during completion of its review of the Premarket Approval (PMA) for ProGEL. The panel's recommendation for FDA approval was conditioned principally on NeoMend conducting a post approval study to gather more safety data.

While Neomend products are for sealing, and anti-adhesion they also are conducting trials of a vascular closure product ProGEL-VS

Covidien Introduces the VascuSeal

Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the VascuSeal™ Vascular Sealant System throughout Europe and in select Middle East markets. VascuSeal™ offers surgeons a unique advanced hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period. VascuSeal™, which is CE-Marked, is intended for use as a surgical sealant during arterial and venous reconstructions to seal suture lines.
Unlike a hemostatic agent, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully. The VascuSeal™ Sealant System offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding.
The VascuSeal™ sealant technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. VascuSeal™ sealant polymerizes within seconds when sprayed on the suture line and is blue in color which provides the vascular surgeon visualization of coverage and thickness of the material upon application. Postoperatively, VascuSeal™ sealant continues to seal the suture line as healing progresses under the gel. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.
“The VascuSeal™ Vascular Sealant System represents another innovative product in the BioSurgery marketplace,” said Scott Flora, President, Surgical Devices, Covidien. “We expect VascuSeal™ to be well-received by surgeons looking to improve patient outcomes, save time and reduce blood loss during surgical procedures,” added Flora.