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.

See also the October 2015 report, “Worldwide Wound Management, Forecast to 2024:
Established and Emerging Products, Technologies and Markets
in the Americas, Europe, Asia/Pacific and Rest of World”, Report #S251.

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(Note: This report has been superceded by the August 2016 Report #S290.)

Medtech fundings in June 2015

Medtech fundings in June reached a very respectable $777 million. Below are the top fundings in medtech for the month so far, led by the planned $135 million IPO of ConforMIS.

Company, fundingProduct/technology
ConforMIS, Inc., has filed to raised $135 million in an initial public offeringKnee implants and customized orthopedics
Calhoun Vision, Inc., has raised $69 million from $52 million in new financing and $17 million in debt conversion, according to the companyLight adjustable intraocular lens
Invuity, Inc., plans to raise $48 million (downgraded from an initial expectation of $73.6 million) in an initial public offering according to the companySurgical lighting
Corindus Vascular Robotics, Inc., plans to raise $41 million in a initial public offering according to press reportsRobotic percutaneous angioplasty

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

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

New Medical Technologies at Startups, May 2015

Below is the list of technologies under development at medical technology companies identified in May 2015 and included in the Medtech Startups Database.

  • Nanotechnology-based diagnostic
  • Bone fixation devices, including for post-sternotomy closure
  • Devices and materials for bone lengthening
  • Nanopolymer drug delivery
  • Developing an artificial pancreas; combined blood glucose monitor and insulin pump
  • Terahertz radiation-based measurement of blood glucose
  • Patient-specific orthopedic implants
  • Undisclosed medical technology
  • Novel energy delivery-based medical technology
  • Device for early detection of cardiovascular disease based on endothelial dysfunction
  • Facet joint surgical instruments
  • Neuromodulation technology
  • Electric stimulation in wound healing
  • Mesenchymal stem cell treatment in cardiology, transplantation, and autoimmunity
  • Integrated blood glucose monitor, insulin dosing
  • Surgical instrumentation

For a historical listing of technologies at medtech startups, see link.

 

Absolute and Relative Growth in Wound Closure Product Sales Worldwide

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

Medtech manufacturers interested in “growth” markets need to consider the relative versus absolute. Nascent markets can growth from $1 million sales in year 1 to $2 million in year 2, obviously a 100% increase. But in multi-billion markets, a $1 million increase will elicit a yawn from all but the smallest manufacturers.

Just as an exercise, I ranked the growth rates for sales of wound closure products detailed in our Report #S192 by both the absolute sales growth from 2014 to 2018 and the compound annual growth rate over this period. To reveal the differences even further, I ranked all combinations of geographic area and wound closure product type. Partial results — just the top growth rankings, since the list is too long to show all — are shown side by side below (click on the chart to see a more legible version).

Wound Closure Sales Growth, Absolute and Relative, 2014-2018

Screen Shot 2015-05-25 at 9.40.11 AM

Source: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Even though tapes, sutures and staples have very modest growth rates in many geographic markets, their current dollar volume sales make such growth much more significant in absolute terms.

 

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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

 

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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, fundingProduct/technology
EndoChoice, Inc., raised $96 million from a planned $115 million initial public offering according to the companyEndoscopy imaging and instruments
Glaukos Corp. has set terms for a $75 million (previously filed for $86 million) initial public offering according to a regulatory filingDevice-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 filingDialysis technology
Shockwave Medical, Inc., has raised $40 million in a round of funding according to the companyBalloon 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 companyDevices for minimally invasive peripheral vascular procedures
Autonomic Technologies, Inc., has raised $38 million in a Series D round of funding according to the companyMicrostimulator for treatment of autonomic disorders, including severe headache
AirXpanders, Inc., has filed for a $36.5 million initial public offering according to the companyBreast tissue expander
AEGEA Medical, Inc., has raised $36 million in a Series C round of funding according to the companyConnective water vapor treatment for menorrhagia (abnormal uterine bleeding)
Ceterix Orthopedics, Inc., has secured $35 million in debt funding according to the companySurgical 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 filingExtra-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

[Editors note: The content in the May 2015 post below has been superseded by the July 2016 Report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”]


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


(This report has been superseded by the July 2016 Report #S290.)

  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, fundingProduct/technology
Intarcia Therapeutics has raised $225 million in a round of funding according to the companySubcutaneous, 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 filingGenetically based treatments for cardiomyopathies
Scanadu has raised $35 million in a Series B round of funding according to press reportsDevice that enables patients to scan and upload diagnostic information
Neuronetics, Inc., has completed a $34.3 million Series F funding round, according to the companyTranscranial magnetic stimulation for the treatment of depression
Lombard Medical, Inc., has raised $26 million in financing from Oxford Finance, LLCStent grafts for treatment of abdominal aortic aneurysm
EBR Systems, Inc., has raised $20 million in a round of funding according to the companyWireless 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.