This is an excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, published by MedMarket Diligence, LLC.
Compared to biologically active sealants containing fibrin and other human- or animal-derived products, synthetic sealants represent a much larger segment of the sealant market in terms of the number of competitors, variety of products, and next-generation products in development. Non-active synthetic sealants do not contain ingredients such as fibrin that actively mediate the blood clotting cascade, rather they act as mechanical hemostats, binding with or adhering to the tissues to help stop or prevent active bleeding during surgery.
Synthetic sealants represent an active category for R&D investment in large part because they offer several advantages over fibrin-based and other biologically active sealants. First and foremost, they are not derived from animal or human donor sources and thus eliminate the risks of disease transmission. Moreover, they are typically easier to use than biological products, often requiring no mixing or special storage, and many of these products have demonstrated improved sealing strength versus their biological counterparts. Synthetic products also have the potential to be more cost-effective than their biologically active counterparts.
Leaders in the synthetic surgical sealants space include Baxter International Inc., CryoLife, CR Bard, and Ethicon/J&J; however, there are many up-and-coming competitors operating in this segment of the market with some interesting next-generation technologies that could gain significant traction in the years ahead. Moreover, unlike the fibrin sealants segment, where most products have more general indications for surgical hemostasis, a good number of competitors in the synthetic sealant field are focused on specific clinical applications for their products, such as cardiovascular surgery, plastic surgery, or ophthalmic surgery.
|Baxter||CoSeal||Synthetic, translucent gel for cardiovascular and peripheral vascular surgery applications. Consists of two polyethylene glycol (PEG) polymers that rapidly crosslink with proteins in the tissues, forming a covalent bond. Also mechanically adheres to synthetic graft materials. Intended for adjunctive use to seal areas of leakage.|
|Cohera Medical||TissuGlu Surgical Adhesive||Synthetic, resorbable adhesive based on companyÕs proprietary lysine-derived urethane polymer technology. Used for surgeries involving large flap tissue approximation, such as mastectomy and abdominoplasty, to reduce wound drainage and reduce or eliminate the need for wound drains and lower the risk of seroma formation.|
|Cohera Medical||Sylys Surgical Sealant||Synthetic sealant designed specifically to help reduce leaks at the anastomosis in gastrointestinal surgery procedures. Used in conjunction with standard closure techniques to protect suture or staple line during first few days of healing.|
|CR Bard/Davol||Progel (obtained via BardÕs 2012 acquisition of Neomend)||Hydrogel sealant made of human serum albumin and PEG.|
|CryoLife||BioGlue||Bovine serum albumin (BSA)-based surgical adhesive delivered in dual-chamber system.|
|CryoLife||BioFoam Surgical Matrix||Dual-action sealant and hemostat. Delivered as liquid and sets into soft foam for difficult to access spaces.|
|Endomedix||N/A||In early-stage development with a surgical sealant designed to help control bleeding during brain surgery procedures. Product is a hydrogel comprised of two biocompatible polysaccharides that are simultaneously mixed and sprayed onto the surgical site.|
|Gecko Biomedical (France)||N/A||Biodegradable, biocompatible hydrophobic light-activated adhesive made by combining glycerol and sebacic acid. Applied in liquid form and solidifies into leak-proof, flexible seal after a few seconds exposure to UV light.|
|Hyperbranch Medical Technology||Adherus Dural Sealant||Hydrogel comprised of two synthetic components: activated PEG and polyethyleneimine. Designed for adjunctive use with standard methods of dural repair during neurosurgery and spinal surgery.|
|Integra LifeSciences*||DuraSeal||Absorbable hydrogel dural sealant comprised of synthetic PEG ester solution and trilysine amine solution. Delivered via double barrel system.|
|Integra LifeSciences*||VascuSeal||Similar in composition to DuraSeal but intended for use in arterial and venous reconstruction procedures to seal suture lines.|
|J&J/Ethicon||Omnex Surgical Sealant||Cyanoacrylate sealant for prevention of leakage along suture lines in vascular reconstruction procedures.|
|LifeBond (Israel)||LifeSeal/LifePatch Surgical Sealants||Crosslinked gelatin sealants applied as an adhesive hydrogel matrix. In development for internal wounds and staple-line reinforcement.|
|Medical Adhesive Revolution GmbH (Aachen, Germany)||N/A||In development with a high-strength, biodegradable surgical adhesive that can be used instantaneously to stop bleeding within seconds..|
|Ocular Therapeutix (formerly I-Therapeutix)||ReSure||Hydrogel sealant designed specifically for use during ophthalmic surgery (such as cataract surgery) as an alternative to sutures.|
|Sapheon Inc. (being acquired by Covidien)||VenaSeal Sapheon Closure System||Proprietary catheter-based system that delivers a specially formulated cyanoacrylate medical adhesive to embolize and close the saphenous vein in patients with venous reflux disease. Eliminates the need for surgery, thermal ablation, sedatives, tumescent anesthesia, post-procedure compression stockings, and chemical sclerosants.|
|Sealantis Ltd||Seal-V||Protein-free, biodegradable vascular surgery sealant made with Alga-Mimetic Adhesive Technology: mimics algae underwater adherence mechanism.|
|Tenaxis Medical (being acquired by The Medicines Company)||ArterX Vascular Sealant||Bioresorbable, gluteraldehyde-based prophylactic synthetic sealant with unique, noninflammatory crosslinking agent that mechanically seals human tissue and artificial grafts in wet or dry field.|
|Xcede Technologies Inc. (subsidiary of Dynasil Biomedical Corp.)||Xcede Patch||First product based on platform of ready-to-use, high-strength, fast-acting combination of hemostat/sealant technology initially invented by Dr. Daniel Ericson and acquired by Dynasil in 2011.|
Source: MedMarket Diligence, LLC