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.


Technologies at Medtech Startups, May 2014

Below is a list of the new medical technologies under development at startups we identified in May 2014 and added to the Medtech Startups Database.

  • Patient positioning system for use in hip replacement and other orthopedic procedures.
  • Instrumentation to facilitate hip replacement surgery and other orthopedic instrumentation.
  • Drug-coated stent-valve designed to inhibit stenosis, obstruction or calcification of the valve.
  • Implants for the treatment of aneurysm.
  • Orthopedic implant technologies including a force sensor to measure performance of an orthopedic articular joint.
  • Insulin patch pump for treatment of insulin-dependent type 2 diabetes.
  • Undisclosed tissue vascular technology
  • Rapid, accurate, inexpensive diagnostic devices initially focused on malaria.
  • Device for diagnosis and management of diabetic retinopathy.
  • Tumor-targeted drug delivery.
  • Near infrared technology for blood glucose monitoring in diabetes.
  • Non-resorbable films for anti-adhesion.
  • Angioplasty double balloon for treatment of peripheral vascular disease.
  • Device to reduce the risk of ventilator-associated pneumonia.
  • Trocar, sleeve and tip for minimally invasive endoscopic surgery.

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

Tissue Engineering and Cell Therapy Market Outlook

The market for tissue engineering and cell therapy products is set to grow to nearly $32 billion by 2018. This figure includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies. The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

Tissue engineering and cell therapy may be considered comprised of bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The goal of stem cell research is to develop therapies to treat human disease through methods other than medication. Key aspects of this research are to examine basic mechanisms of the cell cycle (including the expression of genes during the formation of embryos) as well as specialization and differentiation into human tissue, how and when the differentiation takes place and how differentiated cells may be coaxed to differentiate into a specific type of cell. In the differentiation process, stem cells are signaled to become a specific, specialized type of cell when internal signals controlled by a cell’s genes are interspersed across long strands of DNA and carry coded instructions for all the structures and functions of a cell. In addition, cell differentiation may be caused externally by use of chemicals secreted by other cells, physical contact with neighboring cells and certain molecules in the microenvironment.

The end goal of stem cell research is to develop therapies that will allow the repair or reversal of diseases that previously were largely untreatable or incurable.. These therapies include treatment of neurological conditions such as Alzheimer’s and Parkinson’s, repair or replacement of damaged organs such as the heart or liver, the growth of implants from autologous cells, and even regeneration of lost digits or limbs.

In a developing human embryo, a specific layer of cells normally become precursor cells to cells found only in the central nervous system or the digestive system or the skin, depending on the cell layer and the elements of the embryo that direct cell differentiation. Once differentiated, many of these cells can only become one kind of cell. However, researchers have discovered that adult body cells exist that are either stem cells or can be coaxed to become stem cells that have the ability to become virtually any type of human cell, thus paving the way to engineer adult stem cell that can bring about repair or regeneration of tissues or the reversal of previously incurable diseases.

Another unique characteristic of stem cells is that they are capable of self-division and self-renewal over long periods of time. Unlike muscle, blood or nerve cells, stem cells can proliferate many times. When exposed to ideal conditions in the laboratory, a relatively small sample of stem cells can eventually yield millions of cells.

There are five primary types of stem cells: totipotent early embryonic cells (which can differentiate into any kind of human cell); pluripotent blastocyst embryonic stem cells, which are found in an embryo seven days after fertilization and can become almost any kind of cell in the body; fetal stem cells, which appear after the eighth week of development; multipotent umbilical cord stem cells, which can only differentiate into a limited number of cell types; and unspecialized adult stem cells, which exist in already developed tissue (commonly nerves, blood, skin, bone and muscle) of any person after birth.


Source: MedMarket Diligence, LLC; Report #S520, “Tissue Engineering & Cell Therapy Worldwide 2009-2018.”

Developmental Timescales

Tissue engineering and cellular therapy products take years of research and many millions of dollars (averaging about $300 million, according to some reports) before they make it over the hurdles of clinical trials and into actual market launch. More than one small biotech company has burned through its money too quickly and been unable to attract enough investment to keep the doors open. The large pharmaceutical and medical device companies are watching development carefully, and have frequently made deals or entered into alliances with the biotechs, but they have learned to be cautious about footing the bill for development of a product that, in the end, may never sell.

For many of the products in development, product launch is likely to occur within five years. Exceptions include skin and certain bone and cartilage products, which are already on the market. Other products are likely to appear on the European market before launch in the United States, due to the presence of (so far) less stringent product review and approval laws in the European Union.

Even when the products are launched, take-up will be far from 100% of all patients with that particular condition. Initially, tissue engineering and cell therapy products will go to patients suffering from cancers and other life-threatening conditions, who, for example, are unable to wait any longer for a donor organ. Patients who seem to be near the end of their natural lives likely will not receive these treatments. Insurance coverage will certainly play a key role as well in the decision about who receives which treatments and when. But most importantly, physicians will be selecting who among their patients will be treated; the physicians learn about the treatments by using them, by observing the patient’s reactions, and by discussing their experiences with colleagues. In other words, the application of tissue engineering and cellular therapy will progress in a manner similar to the introduction of any new technology: through generally conservative usage by skilled, highly trained physicians dedicated to providing their patients with the best possible treatment without causing them additional harm.


Posted via email from medmarket’s posterous

Potential for neurological applications of sealants, hemostasis and closure treatments

neuro-sealantsThere is potential for new sealant, hemostasis and closure treatments designed to facilitate surgical treatments of neurological disorders; most existing alternative treatments are pharmological therapies limited to reducing symptoms and few cures exist. An important driver in this market segment is the increasing aging population, with a consequent growing prevalence of age-related disorders. Also, new improved systems for diagnosis promise the possibility of earlier intervention.

The major indications that will benefit from new sealant, hemostasis and closure products in neural tissue surgery are procedures to treat chronic stroke, spinal cord trauma, neurovascular defects, and brain tumor treatments.

There are an estimated 5.6 million Americans who may benefit from the use of closure and securement products for neurological disorders in 2008.

Excerpt from "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013," report #S175, published by MedMarket Diligence, LLC.

Medical technology platforms with high growth potential

Specific technologies and broad technology platforms have tremendous potential for market growth based on combinations of recent technology advancement, changes in clinical practice, current forces in the market and other criterial. 

  • Biotech solutions to traditional medical device technologies.  The thrust of medical technology is, and has been for a long time, to make it as effective as possible while being the least possible invasive.  Taken to the extreme, instead of implanting a device, such as a suture or a staple, the almost perfect solution would to be to close wounds with no device at all.  Hence, surgical sealants, fibrin glues and other medical/surgical adhesives, hemostats and related biologicals (and even non-biologicals like cyanoacrylates), having proven themselves clinically and offering very low adoption hurdles, represent a huge opportunity in the medtech market.
  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and their expansion to new clinical applications.
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are in applications too numerous to mention..
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.

(While the above list  is separately a White Paper that I have written, and periodically re-write to reflect new stuff being developed, I find it interesting and worthwhile to revisit frequently and discuss in this blog.)

The above topics are covered in various MedMarket Diligence reports.  See our list of titles.




Trends and drivers (continued) in medical technology

 More medtech trends

  • Nanotechnology advances.  The use of nanotechnology in medicine has faced as many overblown promises as any other application of nanotechnology. However, any realistic view of future medical technologies with big impact would be amiss if it did not consider the myriad applications of "nanotechnology", which we place in quotes to denote that there is no one technology called nanotechnology.  Rather, nanotechnology emcompasses a huge variation of technologies whose common denominator is only their design, manufacture or effects at a very small size.  Drug delivery, coatings technologies, angiogenesis and countless other unrelated technologies fall within the definition of nanotechnology.  Some, or many, may succeed hugely.
  • Developments in tissue engineering.  Setting aside, for the moment, the heated vitriol of the (current)  federal ban on funding for embrionic stem cell research, the continued developmet of cell biology applied to therapeutics in the broader category of cell and tissue engineering is a major trend that is creating new therapeutics.  Wound management, trauma treatments, organ repair/reconstruction, and others are established, rapidly growing markets.  Now, add back stem cell therapy (embrionic or otherwise) and you can see the enormity of this trend.
  • Gene therapy developments.  Forever an area of enormous potential, exceeded only by the overblown assessments of how soon developments will be commercialized, gene therapy developments continue to inch closer to reality.  While these technologies, too numerous in their diversity to mention, remain predominantly in the realm of research, the potential they hold and the rate of technology advance toward realizing that potential in virtually every organ system and clinical applications makes ignoring them a foolhardy consideration by any medtech manufacturer.

To be continued…




Medical Technology Market Analysis, MedMarkets (April 2008)

Below is the coverage in the April 2008 issue of MedMarkets.

Ablation:  An Energized Market

Demand for Hip and Knee Implants Expected to Increase

MedMarket Outlook: Beyond Technology Innovation: Current and Future Market Forces and Trends

Early Stage Companies: Evalve, ES Vascular, Cardiorobotics, TriVascular

Early Stage Company Financings: Alure Medical, Arbel Medical, Breathe Technologies, CoAxia, IDev Technologies, IlluminOss Medical, Lanx, Pathway Medical Technologies, Tryton Medical

Recent Medtech Startups

Biotechnology Update: Self-Assembling Nanofibers Show Promise for Spinal Cord Injury

Drivers: Sluggish Economy Slows Venture Capital Market

Leading Clinical Edge
Nanovalve Useful for Drug Delivery
Molecular Machine Serves as Remote Control
Progress Made on Biosensing Nanodevice
Mutant Proteins Stimulate Heart Cell Growth
Specialized MRI Identifies Brain Cancer Early
New Therapy for Pediatric Retinoblastoma
Eye Drops Monitor Brain Tissue Repair
Nanoengineered Gel for Spinal Cord Injury
Cell-Sorting System May Detect Cancer

FDA Approves OrNim’s Monitoring Device
Study Challenges Aspect Medical’s Device
Kinetic Concepts to Acquire LifeCell
Promising Results for Evalve’s MitraClip
U.S. Patient Receives CardioKinetix Heart Implant
Medtronic Improves Talent Stent Graft
FDA Reports Medtronic AneuRx Deaths
Medtronic CRT Clinical Trial Fails
Positive Results for Echo Therapeutics’ Symphony
Abbott’s Glucose Monitor Approved
Datascope to Sell Business to Mindray
Philips Completes Respironics Acquisition
ArthroCare’s Ablation Device Successful
Benefits from Genzyme’s Carticel Sustained
J&J Considers Design Changes for Charité
LifeNet Health Launches Cervical Implant
BioMimetic Refutes FDA Comments
AngioDynamics to Buy Diomed

Complete content available to subscribers only.  For coverage in all past issue of MedMarkets, see link.

See Reports from MedMarket Diligence.

“High Growth Medical Technologies” 2008

We have just updated our “High Growth Medical Technologies” white paper, as we expect to continually do in the immediate future, since the areas with growth keep changing, and new areas keep appearing.

As all white papers should be, it’s free.  Here’s the link so you can download it.

MedMarket Outlook: High Growth Medical Technologies

(From the September 2007 issue of MedMarkets)

Drawing upon the clinical and technology sectors we have addressed in MedMarkets and the Market and Technology Reports of MedMarket Diligence, we have previously identified a number of areas where we see substantial growth in medical technology markets. In our white paper, High Growth Medical Technologies, we note those areas we consider high growth due to their “likely success in clearing technology hurdles, the size of their respective current/potential caseloads or target markets and their reasonably short (<5 year) timeline to achieve considerable realization in measurable (or even sizeable) commercial terms.” We highlight them here and note additional areas worthwhile to watch.

Nanotech and MEMS. Applications of [tag]nanotech[/tag] in medical/healthcare are incredibly diverse, from device coatings to complex drug delivery, sensors and other diagnostics. Applications are seemingly limited only by imagination: drug delivery, gold nanoshells for heat-killing cancer cells, diagnostics, nanobatteries for artificial retinas, nanosensors for pathogens, etc. [tag]MEMS[/tag] (microelectromechanical systems) applications include implantable pumps, hearing aids, defibrillators, lab-on-a-chip and other biomedical research.

Drug Device Hybrids. Drug-coated stents are only the most obvious. Demarcations between drugs, devices, biotech and biopharm have become almost arbitrary as the products are now more often defined by their functions than their composition, pitting widely different technologies against each other or combining them into products that are far more than the sum of their parts. These include bioresorbables, drug coatings for biocompatibility, [tag]drug delivery[/tag], tissue ingrowth and myriad other possibilities.

Atherosclerotic plaque reversing drugs. Take an established, invasive device market, or markets ([tag]angioplasty[/tag], [tag]stent[/tag]ing, coronary artery bypass technologies. etc.) and penetrate it with a drug — the word “growth” would be inadequate in describing the potential.

Rational therapeutics. Both drugs and device markets, of virtually all types, are at best symptomatic, arguably with high efficacy, but symptomatic nonetheless. Any clinical intervention, however, that directly addresses the root cause of disease or at least moves further upstream in the pathogenic pathway (e.g., insulin for diabetes is a far better clinical solution than dialysis for end stage renal disease), will have substantially more potential. Pharmaceutical development in general, and biotechnology in even more specific terms, recognizes the value in this. However, many a venture capital dollar has been spent overestimating this value while underestimating the technical challenge.

RFID — Radiofrequency Identification. The integration of information technologies with medical devices is inevitable, given the value of information that can be exploited by identification of devices using [tag]RFID[/tag], from ensuring surgical instrument count in the OR, identifying implants in patients, tracking product inventories, etc.

Infection control. The global population and its increasing capacity to migrate brings pathogens from, and to, all corners of the globe. The overuse of antibiotics has stimulated a startling number of drug resistant bacteria. Nosocomial infections represent a huge cost in healthcare systems. These reasons are enough to point to the huge potential for products in infection control.

Obesity Drugs. Effective drugs to treat [tag]obesity[/tag], and preempt all the downstream healthcare complications of obesity, represent potential recognized by a growing number of pharmaceutical companies, even in spite of the recent failure of Accomplia (rimonabant) by Pfizer. High volume caseload with high healthcare costs are strong drivers in support of continued obesity drug development.

To these high growth areas previously identified, we add a number of additional ones, due to the emerging potential seen as high volume potential is matched with achievements in technology development:

Apoptosis. “Programmed cell death” is a normal part of an organism’s life cycle, encompassing necessary functions of cellular differentiation, but also orepresents an area of tremendous study for its potential in areas as diverse as cancer therapeutics and other disease treatments due to the normal or even dysfunctional role it plays in those diseases.

Gene-driven drug development. The mapping of the human genome was a major stumbling block for the development of gene-based medicine, but it is not the only hurdle. The complex interactions of the human genome as it operates in molecular biology, resulting in either healthy or pathogenic tissue systems, are a gargantuan puzzle more complex than the genome mapping goal itself. However, we predict that the progress made in understanding the genetic basis of disease will yield dramatic successes in the development of drugs created based on this knowledge or, in the least, screened against genetic profiles that will dictate the likely success of pharmaceutical candidates.

Neuromodulation. In the September issue of MedMarkets, we highlight some of the developments in [tag]neuromodulation[/tag] and [tag]neurostimulation[/tag]. While applications are diverse, the apparent commercial successes in this field have been limited, but certainly significant to have been noticed (or created) by companies like Medtronic. The human nervous system has an architecture and function that make it innately less amenable to yielding its secrets than are other organ systems, yet advances in implantable devices have converged with the huge unmet need of chronic pain management to create enormous opportunity in the market.

As we have noted previously, the potential markets for advanced medical technologies appear to be limited only by imagination. Manufacturers have demonstrated time and again their ability to create product types, product combinations, applications and all their various customized variations in order to capitalize on the convergence of technical achievement and umet market demand.

Surgical Procedures Worldwide with Potential for Use of Hemostats, Med/Surg Glues & Sealants and Adhesion Prevention

Sealant, Glues, Hemostats Potential ProceduresSurgical wounds are projected to increase in number at an annual rate of 3%, but overall the severity and size of surgical wounds will continue to decrease over the next five years as a result of the continuing trend toward minimally invasive surgery.

Surgical procedures generate a large number of uncomplicated acute wounds with uneventful healing, and a lower number of chronic wounds such as those generated by wound dehiscence or post-operative infection. On the skin surface, surgical wounds are most often closed by “primary intent”, using products such as sutures, staples, or glues, where the two sides across the incision line are brought close and mechanically held together. The use of glues for closure has rapidly become adopted for treatment of minor cuts and grazes over the last decade, and products in this category are now being promoted for use in theatre where they offer certain advantages over sutures. Benefits for use on the skin surface include reduced need for anesthesia, reduced infection, and reduced scarring.

A growing number of wounds created as part of the surgical procedure are becoming infected by pathogens that exhibit some resistance to antibiotics. Recent figures indicate that an average of 8% of wounds are infected in the hospital during surgical procedures. Adjunctive surgical closure and securement products have been shown to reduce infection levels, and, for example, cyanoacrylate adhesives have been approved in the USA for use to prevent post surgical infections.

Surgical hemostats, [tag]tissue sealant[/tag]s, and glues are used for a spectrum of surgical procedures ranging from closure of skin wounds to significant hemostasis to prevent blood replacement during major surgical procedures.

Hemostats are used to reduce bleeding during surgical procedures. These products work by coagulating blood quickly and accelerating the normal clotting mechanisms. Blood clotting is part of the body’s natural defense mechanism. After tissue damage, blood invades the damaged area. Platelets are activated to convert prothrombin into thrombin, which converts fibrinogen in the blood to form viscous polymers of fibrin. The fibrin is subsequently cross-linked by activated factor XIII to further bind the fibrin polymers into a viscous three-dimensional mat of fibrin. This is the basis of a blood clot which prevents further bleeding. Later in the healing process the fibrin clot is acted on by the enzyme fibrinolysin which breaks up fibrin as this material is no longer required. Fibrinolysis begins a cascade of healing by releasing fibrino-peptides which act to stimulate angiogenesis and cell-activated-repair.

The natural clotting process has been used by manufacturers to design new products that can mimic the body’s hemostatic action. Hemostatic products have been developed using collagen and degraded collagen (gelatin) to stimulate the hemostasis cascade. These hemostatic products depend on a cascade of blood factors to initiate and drive the full clotting process; they therefore tend to be slower-acting than products based on fibrin and thrombin which act later in the cascade to produce immediate hemostatic results. In addition, synthetic polyanionic materials (such as Johnson & Johnson/Ethicon’s Surgicel) and some naturally occurring biological polymers (such as calcium alginate and chitosan) have been developed to stimulate the same cascades; companies have recently evolved these simple hemostatic materials to develop hemostasis products that can also seal bleeding tissues.

[tag]Fibrin sealant[/tag]s and synthetic [tag]sealants[/tag] offer a significant advantage over pure hemostats because they do not rely on the full complement of blood factors to produce hemostasis. Sealants provide all the components necessary to prevent bleeding and will often prevent bleeding from tissues where blood flow is under pressure, and the damage is extensive.

In addition to [tag]hemostats[/tag] and sealants, a number of companies have developed tissue glues to reduce (and in some cases replace) the requirement for sutures. These products are capable of providing a degree of repair strength which is at least an order of magnitude greater than that achieved with [tag]fibrin[/tag] and synthetic sealants.

It is recognized that these products have potential to replace sutures in some cases where speed and strength of securement are priorities for the surgical procedure. Tapes, sutures and staples are also applicable to a growing range of procedure-specific internal securement cases

Approximately 70 million surgical and procedure-based wounds are created annually worldwide that offer potential for use of adjunctive surgical closure and securement products; over 20 million of these wounds are created during surgical procedures in the USA.

Although healing of all these wounds might be improved through use of adjunctive surgical closure and securement products, it is likely that increased usage of these products will be limited, on economic grounds, to a fraction of procedures. It is realistically estimated that some 10-15% of these procedures would benefit from increased use of newly-developed adjunctive surgical closure and securement products.

Tags: sealant, fibrin, hemostat, wound

See Report #S145: “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007.” Description and table of contents here.