Sealants, Glues, Hemostasis and Wound Closure Market, Size and Growth

The simple practice of closing wounds is not so simple, driven as it is by the fact that wounds can be the conduit for blood, infectious agents and every other liquid, gas or solid that should not enter or exit the wound.  The closure has to be readily accomplished, regardless of where the wound exists. The closure should not only prevent blood from being lost but ideally should actively stop the bleeding. The wound must stay closed despite the pressures exerted upon it. The closure should also have a minimal “footprint”, with the closure components being easily removed, absorbed or otherwise leaving the least possible trace of the closure, including scar tissue.

Hence, tapes, staples, sutures, clips, hemostatic agents, sealants, glues and other devices have been developed to get the job done.  The market for this range of closure options now reflects biologics, absorbable materials, devices and other products. Fundamentally, the market remains largely dominated by sutures and staples/clips, which have satisfied the demands of internal/external closure, easy of use, low cost, strength of closure and other considerations, not least of which is the evolving nature of surgical practice from the “open” to endo/laparoscopic. Nonetheless, tighter wound sealing, less bleeding and better outcomes in general have driven manufacturers to develop improvements.

Below is illustrated the 2014 market for the range of wound closure products along with their associated growth rates. The prospects for medical/surgical tapes are the exception to the rule, demonstrating a steady decline while better alternatives demonstrate steady growth.

Screen Shot 2015-05-20 at 10.08.13 AM

Source: MedMarket Diligence, LLC; Report #S192

Medtech Fundings in May 2015

Fundings for medical technologies in May 2015 came in at $757 million, led by the $96 million IPO of EndoChoice, Inc.

Below are the top fundings for the month thus far.

Company, funding Product/technology
EndoChoice, Inc., raised $96 million from a planned $115 million initial public offering according to the company Endoscopy imaging and instruments
Glaukos Corp. has set terms for a $75 million (previously filed for $86 million) initial public offering according to a regulatory filing Device-based treatment for glaucoma
Outset Medical, Inc., has raised $59.59 million of a planned $65.59 million round of funding according to a regulatory filing Dialysis technology
Shockwave Medical, Inc., has raised $40 million in a round of funding according to the company Balloon dilatation catheters integrated with lithotripsy for treatment of vascular and valvular lesions
Intact Vascular, Inc., has raised $38.9 million in a Series B round of funding according to the company Devices for minimally invasive peripheral vascular procedures
Autonomic Technologies, Inc., has raised $38 million in a Series D round of funding according to the company Microstimulator for treatment of autonomic disorders, including severe headache
AirXpanders, Inc., has filed for a $36.5 million initial public offering according to the company Breast tissue expander
AEGEA Medical, Inc., has raised $36 million in a Series C round of funding according to the company Connective water vapor treatment for menorrhagia (abnormal uterine bleeding)
Ceterix Orthopedics, Inc., has secured $35 million in debt funding according to the company Surgical instruments and other products for treatment of soft tissue injuries
Moximed, Inc., has raised $33 million of a planned $37.64 million round of funding according to a regulatory filing Extra-capsular and extra-articular knee implant for treatment of osteoarthritis

For the complete list of medtech fundings in May 2015, see link.

For a historical list of the individual fundings in medtech, by month, since 2009, see link.

Synthetic Surgical Sealants

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.

Selected Nonactive Synthetic Surgical Sealants and Glues1  2

CompanyProduct NameDescription/Status
BaxterCoSealSynthetic, 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 MedicalTissuGlu Surgical AdhesiveSynthetic, 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 MedicalSylys Surgical SealantSynthetic 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/DavolProgel (obtained via BardÕs 2012 acquisition of Neomend)Hydrogel sealant made of human serum albumin and PEG.
CryoLifeBioGlueBovine serum albumin (BSA)-based surgical adhesive delivered in dual-chamber system.
CryoLifeBioFoam Surgical MatrixDual-action sealant and hemostat. Delivered as liquid and sets into soft foam for difficult to access spaces.
EndomedixN/AIn 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/ABiodegradable, 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 TechnologyAdherus Dural SealantHydrogel 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*DuraSealAbsorbable hydrogel dural sealant comprised of synthetic PEG ester solution and trilysine amine solution. Delivered via double barrel system.
Integra LifeSciences*VascuSealSimilar in composition to DuraSeal but intended for use in arterial and venous reconstruction procedures to seal suture lines.
J&J/EthiconOmnex Surgical SealantCyanoacrylate sealant for prevention of leakage along suture lines in vascular reconstruction procedures.
LifeBond (Israel)LifeSeal/LifePatch Surgical SealantsCrosslinked gelatin sealants applied as an adhesive hydrogel matrix. In development for internal wounds and staple-line reinforcement.
Medical Adhesive Revolution GmbH (Aachen, Germany)N/AIn development with a high-strength, biodegradable surgical adhesive that can be used instantaneously to stop bleeding within seconds..
Ocular Therapeutix (formerly I-Therapeutix)ReSureHydrogel 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 SystemProprietary 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 LtdSeal-VProtein-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 SealantBioresorbable, 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 PatchFirst 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

  1.  Covidien divested its Confluent Surgical product line – including DuraSeal, DuraSeal Exact/Xact, VascuSal and SprayShield – to Integra LifeSciences in January 2014.
  2. Status of product approval and market introduction detailed in Report #S192.

New technologies at medtech startups, April 2015

Below is a list of the technologies under development at medical technology startups identified in April 2015 and added to the Medtech Startup Database.

  • Therapeutic drug monitoring device.
  • Artificial pancreas for diabetes.
  • Automated, 3D ultrasound for breast cancer diagnosis.
  • Products for the treatment of facet joint syndrome.
  • Fractional laser with applications in aesthetics and gynecology.
  • Undisclosed surgical technology.
  • Antimicrobial implants and other devices in orthopedics to reduce surgical-site and hospital-acquired infection.
  • Developing a portable artificial lung.
  • Technologies to reduce infections and improve efficiency of patient ventilation.
  • Small molecule drugs for treatment and prevention of atrial fibrillation.
  • Vascular access device.
  • Stem cell technology.
  • Development, marketing, and distribution of medical technology equipment in urology, aesthetics.
  • Technology for securing a medical device combined with a hemostasis valve.
  • Embolic protection devices.
  • Head-mounted neurostimulation system for the treatment of migraine.

For a historical listing of medical technologies at startups since 2008, see link.

Medtech fundings in April 2015

Fundings for medical technologies in April 2015 reached $615 million, led by the huge $225 million funding of Intarcia Therapeutics.

Below are the top fundings for the month.

Company, funding Product/technology
Intarcia Therapeutics has raised $225 million in a round of funding according to the company Subcutaneous, osmotic pump for drug delivery in type 2 diabetes
Mesoblast has raised $58.5 million in a round of funding by Celgene Corp. Precursor and stem cells for cell therapy
MyoKardia, Inc., has raised $46 million in a round of funding according to a regulatory filing Genetically based treatments for cardiomyopathies
Scanadu has raised $35 million in a Series B round of funding according to press reports Device that enables patients to scan and upload diagnostic information
Neuronetics, Inc., has completed a $34.3 million Series F funding round, according to the company Transcranial magnetic stimulation for the treatment of depression
Lombard Medical, Inc., has raised $26 million in financing from Oxford Finance, LLC Stent grafts for treatment of abdominal aortic aneurysm
EBR Systems, Inc., has raised $20 million in a round of funding according to the company Wireless cardiac pacing

For the complete list of medtech fundings in April 2015, see link.

For a historical list of the individual fundings in medtech, by month, since 2009, see link.

Sealants/Glues, Hemostats, Other Wound Closure Markets, Size and Growth

Products in wound closure include sutures/staples, tapes, vascular closure devices, surgical hemostats, and surgical sealants/glues.

Wound types have not changed over history, with a slight exception being the emergence (several decades ago) of femoral punctures associated with catheterization procedures. But what has changed, and what continues to evolve, is the practice of closing those wounds. Sutures, staples and tapes are a mainstay of medical practice, representing uncomplicated methods to secure wounds. And while innovators continue to change the form and function of these products to improve performance, the more recently introduced surgical hemostats, vascular closure, and surgical sealants/glues have seized significant shares of wound closure caseload and are growing marginally faster than sutures/staples and tapes. The result is and will be an erosion of traditional wound closure technology shares.

Below is illustrated the size/growth of segments in the global wound closure market.

Screen Shot 2015-04-13 at 7.05.33 AM
Source: MedMarket Diligence, LLC; “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, Report #S192.

The Five Biggest Medical Technology Forces

There are five fundamental forces driving change in virtually every medical technology market. (There are many other forces, of course, that impact these markets, such as regulation, reimbursement, etc., but here I speak of forces driven by technology and the innovators employing them.) They represent challenges and opportunities — depending merely upon how companies perceive and respond to them.

Devices are no longer devices (only).

An inert medical or plastic device is likely to present little competitive threat. The device that succeeds stretches the boundaries of what a device is. Devices can be:

  • Biocompatible
  • Bioresorbable
  • Bioactive
  • Shape-shifting (e.g., nitinol)
  • Hybridized with drugs, cells, other biologics
  • Integrated with RFIDs and sensors
  • Combinations of the above

Competition comes from all directions. And so does opportunity.

Competition in medical technology has long since been defined by the device, having been replaced by the definition of the specific problem solved. And that problem is the disease state and the costs of managing and/or eliminating it. (An angioplasty catheter’s competition is not just angioplasty catheters, but also drug-eluting and/or bioresorbable coronary stents, drug-coated balloons, atherectomy, minimally invasive coronary artery bypass graft, atherosclerotic plaque-reducing drugs, etc.) Successful innovators consider all possible alternatives to solving the disease state need and define themselves by the solution, not the product. The only limitation a manufacturer has is its willingness to pursue all avenues to solving the problem.

Zero invasiveness.

Any technology that is not focused on the ideal of zero collateral damage, zero complications, and zero adverse side-effects will be threatened by those that do. The advances in materials technologies, medical/surgical techniques and understanding of pathology, among other advances, are sufficient to challenge manufacturers to pursue the goal of zero invasiveness. Just as open surgery has evolved to incisionless surgery, medical technologies increasingly take on the potential to be more like drugs, or better — treating the disease on a one-time basis with no complications whatsoever.

Decentralized, point-of-care technology.

Capital equipment is expensive, big and lethargic. A handheld imaging — ultrasound, even MRI — performed at the patient’s bedside or doctor’s office, offers enormous potential to reduce cost and increase clinical utility. But decentralization is not limited to diagnosis, since treatment is the ultimate goal and its incentives are the same. Of course, the trend moving diagnostics and therapeutics from the centralized to the point-of-care is not a new idea, but the reality is that a whole range of therapeutic devices (e.g., numerous ablation modalities) have been developed that no longer require OR suites, general anesthesia and their associated costs, and imaging systems have been shrinking to the point that words like “handheld” and “MRI” can be used in the same sentence (see Butterfly Network).

Research and development tools eliminate excuses.

R&D is inevitably challenged to evaluate ideas thoroughly, considering difficult to anticipate obstacles and rapidly evaluating ideas to reveal the best prospects and bring them to manufacturing, let alone market. But multiple technologies have been developed and put into use that can accelerate the iterative cycles of development and yield prime product candidates to bring to market — biotech, pharma, biopharm, device, drug/device and others.  Computer modeling of hemodynamic blood flow, computer simulation of drug candidates (hybridized with devices or not), 3D printing (prototypes, custom implants) and many other advances rapidly accelerate and improve the efficiency of product development of products that more perfectly fit the need and eliminate excuses for unforeseen costs and patient complications. R&D is also far more well informed — integrating more complete understanding of systems biology and the consequent downstream benefits and costs of intervening in any particular way. What is left is the ability to more rapidly evaluate and test (more) ideas and bring them to market.