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Growth in Sealants, Glues, Hemostats, and Wound Closure is Absolute, Relative

Of late, I have needed to re-emphasize the difference between absolute and relative growth in medtech markets (and its importance). So, here it is again, this time regarding surgical sealants and other wound closure products.

The lowest relative rate of growth in this industry is the well-established sutures and staples segment. Sales of these products globally, even supported by innovations in bioresorbables and laparoscopic delivery technologies, are only growing at a 5.6% compound annual growth rate from 2013 to 2018. By comparison, growth of sales of surgical glues and sealants is at 9.4% for 2013-2018.

But from an absolute sales growth point of view, sales of sutures and staples will go from $5.2 billion to $6.9 billion, or absolute growth of $1.7 billion. Simultaneously, the relatively high growth in surgical glues and sealants translates to the absolute growth from 2013 to 2018 of only $0.9 billion.

Obviously, both absolute and relative growth are of interest.

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Source: MedMarket Diligence, LLC; Report #S192.

Bioactive Agents in Wound Sealing and Closure

Excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure 2013-2018″.

Screen Shot 2015-03-30 at 10.14.59 AMBiologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly.

Selected Biologically Active Sealants, Glues, and Hemostats 

CompanyProduct NameDescription/
(Status*)
Asahi Kasei MedicalCryoSeal FS SystemFibrin sealant system comprising an automated device and sterile blood processing disposables that enable autologous fibrin sealant to be prepared from a patient's own blood plasma in about an hour.
BaxterArtissFibrin sealant spray
BaxterTisseelBiodegradable fibrin sealant made of human fibrinogen and human thrombin. For oozing and diffuse bleeding.
BaxterFloSealHemostatic bioresorbable sealant/glue containing human thrombin and bovine-derived, glutaraldehyde-crosslinked proprietary gelatin matrix. For moderate to severe bleeding.
BaxterGelFoam PlusHemostatic sponge comprising Pfizer's Gelfoam hemostatic sponge, made of porcine skin and gelatin, packaged with human plasma-derived thrombin powder.
Behring/NycomedTachoCombFleece-type collagen hemostat coated with fibrin glue components.
Bristol-Myers Squibb/ZymoGenetics (Sold by The Medicines Company in the US and Canada)RecothromFirst recombinant, plasma-free thrombin hemostat.
CSL BehringBeriplast P/Beriplast P Combi-SetFreeze dried fibrin sealant. Comprised of human fibrinogen-factor XIII and thrombin in aprotinin and calcium chloride solution.
CSL BehringHaemocomplettan P, RiaSTAPFreeze-dried human fibrinogen concentrate. Haemocomplettan (US) and RiaSTAP (Europe).
J&J/EthiconEvicelEvicel is a new formulation of the previously available fibrin sealant Quixil (EU)/Crosseal (US). Does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, nor does it contain synthetic or bovine aprotinin, which reduces potential for hypersensitivity reactions.
J&J/EthiconEvarrestAbsorbable fibrin sealant patch comprised of flexible matrix of oxidized, regenerated cellulose backing under a layer of polyglactin 910 non-woven fibers and coated on one side with human fibrinogen and thrombin.
J&J/EthiconBIOSEAL Fibrin SealantLow-cost porcine-derived surgical sealant manufactured in China by J&J company Bioseal Biotechnology and targeted to emerging markets.
J&J/EthiconEvithromHuman thrombin for topical use as hemostat. Made of pooled human blood.
Pfizer/King PharmaceuticalsThrombin JMIBovine-derived topical thrombin hemostat.
Stryker/OrthovitaVitagel SurgicalBovine collagen and thrombin hemostat.
Takeda/NycomedTachoSilAbsorbable surgical patch made of collagen sponge matrix combined with human fibrinogen and thrombin.
Teijin Pharma Ltd/Teijin Group (Tokyo, Japan)KTF-374Company is working with Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) to develop a sheet-type surgical fibrin sealant. Product combines KAKETSUKEN's recombinant thrombin and fibrinogen technology with Teijin's high-performance fiber technology to create the world's first recombinant fibrin sealant on a bioabsorbable, flexible, nonwoven electrospun fiber sheet.
The Medicines Company (TMC)Raplixa (formerly Fibrocaps)Sprayable dry-powder formulation of fibrinogen and thrombin to aid in hemostasis during surgery to control mild or moderate bleeding.
The Medicines Company (TMC)In development: Fibropad patchFDA accepted company's BLA application for Fibrocaps in April 2014 and set an action date (PDUFA) in 2015. In November 2013, the European Medicines Agency agreed to review the firm's EU marketing authorization application. Status update in report #S192.
Vascular SolutionsD-Stat FlowableThick, but flowable, thrombin-based mixture to prevent bleeding in the subcutaneous pectoral pockets created during pacemaker and ICD implantations.

Note: Status of products detailed in Report #S192.

Source: MedMarket Diligence, LLC

Wound Sealant and Securement Procedure Volumes by Clinical Area and End-Point

Sealants, glues, hemostats, and other products in wound closure and securement offer benefits that vary by clinical area, but the nature of that benefit also varies by the type of end-point (benefit) the product achieves — does it provide a life-saving benefit? A time-saving? Cost-savings? A cosmetic or aesthetic benefit?

Accordingly, by examining the volume of procedures for which closure and securement products provide which kind of benefit is crucial to understanding demand, especially between competitive products.

Below is a categorization of benefits ranging from the critical (I) to the aesthetic (IV).

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

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Source: MedMarket Diligence, LLC (Report #S192)

Considering these different categories, below are the volumes of procedures distributed by category across each of the major clinical disciplines.

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Wound Closure Products, Worldwide (Millions), 2014

 

 

 

 

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Source: MedMarket Diligence, LLC (Report #S192)

Classification of Wounds by Morphology

Wounds may be classified according to their depth and whether underlying tissues are damaged. Partial-thickness wounds do not intrude through the dermis and can heal by regeneration; full-thickness wounds involve both the epidermis and dermis, and sometimes underlying tissues as well. They generally heal by scar formation. Wound classification by morphology is shown below:

TypeTissue CharacteristicsEtiologyPrognosis for Healing
Partial thicknessInvolves entire epidermis and portions of dermis.Friction, pressure, small cuts, minor burns.Heal within 10-18 days, epidermal element germinates and migrates up to the epithelial layer. Heals without significant scarring or functional impairment.
Deep partial thicknessInvolves entire epidermis and almost entire dermis.Friction, cuts, significant burns.Healing within 20-35 days.
Full thicknessInvolves epidermis and dermis; may extend into subcutaneous tissue. Sweat glands and hair follicles are destroyed.Severe deep cuts, surgical incisions, most chronic wounds, and third-degree burns.Heals by granulation, formation of new blood vessels, new biomaterial deposition, and new cells over many weeks. Scarring usually results.
Underlying tissue damageConsidered more extensive than full- thickness wounds. Involves subcutaneous tissue, muscle, fascia, bone, and other organs.Surgery of organs, electrical burns and certain thermal burns, such as molten metal or severe scalding, massive traumatic injury, and untreated chronic damage.May require debridement or removal of all necrotic tissue to expose viable bleeding tissue. Systemic antibiotic therapy and grafts/flap skin replacement.

Source: MedMarket Diligence, LLC

The global wound management market is the subject of Report #S249.

The global market for surgical sealants, glues, hemostats, vascular closure devices, sutures/staples, and tapes is the subject of Report #S192.

Manufacturers of sealants, glues, hemostats

Sealants and glues also are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use. For the purposes of this analysis, the market is broken down by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats. The market for sealants, glues, and hemostats, while largely controlled by J&J/Ethicon and Baxter, nonetheless has many active players, many of whom have demonstrated staying power (and growing share) in the global market.

Below is illustrated the manufacturers in bioactive products, non-active natural or synthetic agents, and non-active materials.
Hemostats

Source: MedMarket Diligence, LLC; Report #S192.

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.

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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 May.

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.

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.

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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.