In the Medtech Startups Database, we identify newly formed medical technology companies and capture as much data as possible on these sometimes secretive, “stealthy” companies. Â The companies we include are those that are predominantly, though not exclusively, device-intensive, but may also include those developing drug-device hybrids, biomaterials, biotech, drug or other technologies that are evolving to serve areas once served fairly exclusively by devices.
Below is an illustration of a select distribution of companies by their area(s) of clinical focus. Note plese that the trend indicating an increase in the number of companies is only partially attributable to our growing capability to identify heretofore hidden startups — there has been a true upward trend in company formation. (It is also worth noting that we anticipate 2008 to illustrate a drop-off in numbers of companies formed, based on numbers identified thus far, and this is likely to continue through 2009 with the current credit crisis taking place in fourth quarter 2008.)
For more information about the Medtech Startups Database, see link.
Another sampling of new technologies in various stages of development at recently founded medical technology startups:
Surgical drain and other technologies
Novel wound healing and drug delivery based on unique hydrogel
Nitric oxide coatings for blood-contacting medical devices
Bioresorbable implants for a range of surgical applications
Device to block transmission of pathogens via intravenous catheters
Self-expanding stent for femoral and popliteal applications
Device for treatment of chronic obstructive pulmonary disease (COPD)
Wound closure device to improve aesthetics without sacrificing strength
These technologies and details on the companies developing them are provided in the Medtech Startups Database.Â Unlike other sources of “emerging medical technologies” or meetings focused on investment and in “innovation” (you know the ones), which often have companies upwards of ten or more years old (and apparently spent all that time attending more investment meetings than actually “innovating”), the companies in the Medtech Startups Database are true startups, some only weeks (or days) old, some up to a year or two old and some up to a few years old who may have stayed in “stealth mode”, were it not for our efforts!
Below please find a list of recent MedMarket Diligence reports.
Excerpt from MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016.” See link for more information. Available for purchase online.
Technologies developed and in use for the management of acute and chronic wounds have diversified from traditional dressings, bandages and wound closure techniques to include an increasing number of diverse technologies ranging from tissue engineering, growth factors, physical therapies (e.g., negative pressure) and others.Traditional dressings and bandages have evolved to contain more active elements contributing to wound healing, with products including films, hydrocolloids, foams, alginates, hydrogels, non-adherents and antimicrobials. Wound closure is a specific area of intense development and market growth beyond traditional suturing and more recent stapling technologies and has seen proliferation and high market growth for surgical sealants, glues and hemostasis products.
The size of the worldwide wound management market is ultimately driven by the clinical need for advanced wound management products. That need is most clearly reflected in the prevalence of chronic wounds and burns. Current estimates put the total annual incidence of chronic wounds at almost 9 million worldwide, and there are 177 million cases of diabetes worldwide; 10-15% of diabetic patients will develop ulcers at some point. The market for products used in the management of venous stasis (as in chronic venous ulcers) is put at over $3 billion, while the decubitus ulcer (e.g., bedsores) market is in excess of $2 billion. Sales of products used to treat diabetic foot ulcers are estimated around $1.5 billion, and the market for burns dressings is approximately $60 million.
It should be noted that a large proportion of worldwide wound product sales are accounted for by traditional types of wound management products. An estimated two-thirds of the world’s physicians are not making routine use of advanced wound management products, with availability playing only a minor role in limiting their use. Conversely, while the U.S. healthcare market is characterized by an almost overindulgent attitude toward new technologies, U.S. physicians are much more conservative in their approach to advanced wound healing technologies than their European counterparts. For this reason, the European share of the advanced wound care market is significantly higher than the U.S. share.
Market Growth in Wound Management Product Segments Until recently, the product categories with most growth potential were alginates and foams; both have substantial shares of the total market and both are set to increase their shares substantially between 2007 and 2016. Hydrocolloids had a considerable market share in 2007 but their star is in decline; it is anticipated that they will lose several percentage points in the market share table by 2016. (Segment growth in chart from MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016,” publishing November 2007. See link for description, table of contents.)
The most significant market entrants are growth factors and, even more dramatically, physical therapies — specifically, negative pressure (also known as VAC therapy) devices. This market sector grew from a small base to gain $1.2 billion by 2007 and is set to capture an estimated 20% of the advanced woundcare market by 2016.
Films, antimicrobials and non-adherent dressings will maintain steady growth although their shares of a vigorously expanding market will decline.
(Report #S245, “Worldwide Wound Management” is available for purchase online.)
Technologies for ablation and other energy-based treatments in medical/surgical markets are currently dominated by electrosurgical-type therapies, but a growing array of other modalities are creating new applications or penetrating existing ones.
At right is shown the forecast, by modality type, of ablation and other energy-based therapies through 2017. The most significant growth is expected to come from microwave, thermal, hydromechanical and cryotherapy, each of which will demonstrate compound growth rates in excess of 15% annually.
Excerpt from report #A125, “Ablation Technologies Worldwide Market,” (August 2008).Â See link.Â Report #A125, “Ablation Technologies Worldwide”, may be purchased online.
Energy-based therapies generate sales of $13 billion in the United States alone, with probably another $12 billion in other developed markets worldwide. This represents around 13% of the total medical device market, and it is growing at 11% per annum—twice the growth rate for medical devices overall.
Several kinds of energy are used for medical purposes, including electrical energy, radiation, thermal and light (see chart, “Energy-Based Therapies by Modality”). When the market is analyzed by function, it emerges that the fastest-growing area within this dynamic sector is ablation therapies: a segment that includes devices using electrical, radiofrequency, thermal and other forms of energy. A Market of $25 Bln and Growing The total market for energy-based therapies is estimated at $25 billion, of which 60% is in the United States and the rest mainly concentrated in developed economies around the world. Ablation therapies consist of several market segments. Arrhythmia ablation generates sales estimated at $60 million in the United States and $50 million internationally; ablation products for cancer therapy are valued at $225 million, of which $125 million are generated in the United States. Thus ablation therapies for these two leading indications—almost all consisting of RF devices and consumables—generated sales around $335 million in 2007. In fact, total RF ablation therapy sales are estimated at $1.5 billion worldwide. Also, this sector is growing much faster than the energy sector overall—annual rates are in the range 25%–30%. Demographic Factors—Growth of the market for ablation therapies is based partly on dynamic changes in demographics. The baby boomer generation (i.e., the 78 million Americans born between 1946 and 1964) represents about one-third of the U.S. population and a similar proportion of the population of other developed countries. These maturing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging. Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve. Technological Change—The ablation market is also driven by technological innovation. First-generation ablation devices and catheters have been supplanted by more sophisticated newcomers. Some of the improvements are incremental, other represent more fundamental innovation. Typical is the recent introduction by VNUS Medical Technologies of the ClosureFAST catheter, an endovenous radio frequency (RF) ablation catheter that is designed to heat, shrink and close diseased saphenous veins (large leg veins) in three to five minutes. VNUS claims treatment is as fast as laser ablation devices and causes minimal pain and bruising. The entire procedure, from insertion of the catheter to removal, can be completed in approximately 16 minutes—less than half the time required for previous RF-based procedures. The ClosureFAST catheter received FDA clearance in August 2006, and is now in general distribution.
A Handful of Companies Dominate
The energy-based medical device industry is led by a small group of companies: Medtronic, which has 30% share; St. Jude Medical, with 12%, and Varian Medical Systems, with 10%. A fourth strong presence was, until a few months ago, Boston Scientific, which had acquired Guidant, one of the pioneers in the field. However, Boston’s cardiac and vascular surgery business has been absorbed by the Swedish group Getinge (see MedMarkets, January 2008, “MedTech Companies Refine Therapies for Cardiac Ablation“) and is being marketed under the Maquet Cardiovascular name. Boston Scientific has retained its Blazer, Chilli, Steerocath and Maestro ablation systems for cardiac applications. In terms of ablation therapies, different market contenders make their appearance. Valleylab, a division of Covidien, is a leader in the field of RF ablation for general surgery. In the arrhythmia ablation segment, the Johnson & Johnson company Biosense Webster has a significant share, competing with CryoCath Technologies, AtriCure, Getinge and St. Jude Medical.
Ablation Therapy in Cardiology
Ablation therapy using RF waves is used to cure or treat a variety of cardiac arrhythmias such as supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia and especially atrial fibrillation. The term laser ablation is a process by which the molecular bonds of a material are dissolved by a laser; the technique is used as a part of percutaneous transluminal coronary angioplasty (PTCA) to dissolve plaque and restore patency in stenosed coronary vessels. Rotoablation, also used in PTCA, consists of inserting a tiny, diamond-tipped, drill-like device into the affected artery to remove fatty deposits or plaque. The major and fastest-growing use of ablation in cardiology is in the management of atrial fibrillation. Fibrillation is a disorder in which the orderly sequential propagation of an electrical impulse throughout the heart (which controls the heartbeat), is disrupted by multiple impulses so that the heart’s rhythm is disrupted. Atrial fibrillation involves ablating select areas of the heart’s upper chambers, which receive blood from the systemic and pulmonary circulations and pass it on to the ventricles. Before the development of ablation therapy, treatment of atrial fibrillation consisted of drugs to control the heart rhythm, and surgery in selected cases. The object of surgery was to cut away tissues in the heart that were transmitting the errant electrical impulses. This was an open-heart procedure with all the attendant risks, and recovery usually took eight weeks or more. Ablation therapy, like PTCA, is essentially noninvasive; a special ablation catheter is inserted into a peripheral vein and threaded up to the heart, where it is carefully positioned. RF pulses are then generated at the catheter tip to destroy tissue in the immediate vicinity. A series of such pulses is required to disrupt the abnormal electrical pathways.
Ablation Therapy in Cancer
A major and growing use of ablation is in the treatment of solid tumors, especially in the liver, lung, kidney and prostate. RF ablation is a minimally invasive, FDA-approved treatment for cancer. Physicians worldwide have used RF ablation to treat thousands of patients for liver/kidney tumors, and bone cancer pain. RF ablation is an image-guided technique that kills cancer cells by heating and destroying them. It is an alternative when surgery is not likely to be successful or has failed, or when other medical conditions increase the risk of surgery. In these cases, RF ablation can offer an effective treatment for small cancers; it is minimally invasive with no skin incision and there is minimal risk to the patient (who typically suffers little or no pain). The technique is cost-effective, with minimal hospital stay, and the procedure can be repeated if a new cancer appears. Liver—RF ablation has achieved excellent results in treating primary liver tumors such as hepatoma or hepatocellular carcinoma. These tumors tend to grow slowly and are usually encapsulated. The technique is especially useful for patients who are not ideal surgical candidates, who cannot undergo surgery, who have recurrent tumors or who do not respond to conventional therapies. Liver cancers most likely to be good candidates for RF ablation include tumors 4 cm diameter or smaller; cases with no more than three tumors per patient; and patients waiting for a liver transplantation who have a hepatoma. The most common metastatic disease in the liver treated by RF ablation has been colon cancer. As with primary liver cancers, results are good if the tumors are small and few, and if there is no evidence of metastatic disease elsewhere, RF ablation can also be combined with surgery to treat patients who have several tumors in different locations. Reports indicate that RF ablation results in complete cell death in the majority of hepatomas 3 cm–4 cm in size. Patients who have residual tumors can be re-treated if necessary. In patients who have metastatic colon cancer, re-treatment results are similar. Lung Cancer—Lung cancers are among the most intractable of malignancies and the mortality rate remains high. Any incremental improvement in therapy is therefore to be welcomed. RF ablation may be an alternative nonsurgical treatment for selected patients who have cancers that are limited in size (less than 3 cm in diameter) and few in number (one or two). Tumors should be separate from vital structures in the body. RF ablation may also help lung cancer patients who are not candidates for traditional surgery due to advanced disease in the lungs, poor cardiac function and/or poor pulmonary function. Kidney Cancer—Experience of RF ablation in kidney tumors is considerably less than with liver tumors. However, early results at the Mayo Clinic indicate that RF ablation is very effective for small tumors. In the Clinic’s experience with more than 70 patients, the tumor was destroyed in more than 95% of patients treated. Surgery is the treatment of choice for most kidney tumors; however, RF ablation might be considered for patients who have only one kidney, or who have other medical conditions that might prevent surgery; also for elderly patients who might have difficulty with surgery or postsurgical recovery, and in cases where the tumor is less than 4 cm in size.
Diverse Factors Drive Market Growth
The ablation device market is a buoyant one supported by a number of significant growth drivers, and its annual growth is almost certain to be in the range of 15%–25% over the next few years. The industry landscape is changing with the introduction of new technologies and the development of new indications for ablation-based therapy. This market will be strongly influenced by a new graying population who knows what it wants in terms of health care and who are intensely cost-conscious.
Biosense Webster (Johnson & Johnson)
Freezor Cryoablation System
Soft tissue ablation
Ethicon EndoSurgery (Johnson & Johnson)
Soft tissue ablation
Prostate, kidney cancer
Gynecare (Johnson & Johnson)
PK Tissue Management System
General surgery, urology, gynecology
Chronic proximal plantar fasciitis
Soft tissue ablation
Irvine Biomedical (St. Jude Medical)
Maquet Critical Care (Medical Systems division of Getinge)
From MedMarket Diligence report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011.”Â See link.
The use of products such as tapes and sutures for wound closure and securement leads to faster wound healing with less risk of contamination by debris and infectious agents, and with improved cosmetic outcomes. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.
Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.
Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost effective for topical wound closure and there are also many potential internal applications for these products.
Use of cyanoacrylate glues for closure has established a considerable following in all regions of the world. Conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anaesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). Cyanoacrylate products can be used without anaesthetic, without sutures, and since cyanoacrylate sloughs off the skin surface, without a removal kit. The FDA has approved cyanoacrylate products as having an anti-microbial outcome, which further reduces the cost of using them to approximately 30% of using sutures. Once labor and time are added this falls to 5%.
Effective haemostasis also demonstrates attractive cost attributes; hemostats can be used for rapid and effective control of bleeding during surgery, thus avoiding an element of the hourly cost of an operating room ($2000 to $10000 per hour). For example, a $115 haemostat needs to shave 4 minutes off the operating time to â€˜pay its wayâ€™. Often, these materials can save from five minutes to two hours depending on procedure.
Sealants also have attractive health economic attributes. The most obvious cases come from specific procedures which have become the lead indications and focus for development programs in many companies. For example, air leaks during lung surgery lead to the need for extended hospitalization (up to 28 days) and more intensive care, as well as additional surgical procedures. Sealants are also commonly applied to avoid cerebrospinal fluid leakage during neurological and spine surgery; leakage of cerebrospinal fluid would otherwise result in infection (including meningitis), debilitating headaches and other problems. In addition, the surgeon uses significant direct time to achieve meticulously leak-proof closure of the dura. This can be avoided by expert and experienced application of appropriate sealant products.
Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopaedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate haemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g. 5-10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).
Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynaecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.
TheÂ securement market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products.The total securement market is forecast to grow from almost $7 billion in 2006 to reach $10 billion in 2011 at a CAGR of 7.5%.
The complete report on “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011” is described with complete table of contents and list of exhibits here.
Below is the coverage in the April 2008 issue of MedMarkets.
Ablation:Â 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
This is an excerpt from Report #S245, “Wound Management, 2007-2016: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World,” published by MedMarket Diligence, LLC (November 2007).
Wound types fall into four general categories — surgical, traumatic, burns, and chronic — yet there is a wide variety of specific types, with different prevalence and growing at different rates.Â The exhibit below illustrates the current patient population (prevalence) and the compound annual growth rate for each wound type over the 2005-2014 period.
Wound Management Trends
Surgical wounds account for the vast majority of skin injuries. We estimate that there are over 100 million surgical incisions a year, which require some wound management treatment. Approximately 80% of these wounds use some form of closure product (sutures, staples, and tapes). Many employ hemostasis products, and use fabric bandages and surgical dressings.
Surgical wounds are projected to increase in number at an annual rate of 3.1%, but overall the severity and size of surgical wounds will continue to decrease over the next ten years as a result of the continuing trend toward minimally invasive surgery.
Surgical procedures generate a preponderance of acute wounds with uneventful healing and a lower number of chronic wounds, such as those generated by wound dehiscence or post-operative infection. Surgical wounds are most often closed by primary intention, using products such as sutures, staples, or glues, where the two sides across the incision line are brought close and mechanically held together. Surgical wounds that involve substantial tissue loss or may be infected are allowed to heal by secondary intention where the wound is left open under dressings and allowed to fill by granulation and close by epithelialization. Some surgical wounds may be closed through delayed primary intention where they are left open until such time as it is felt it is safe to suture or glue the wound closed.
A significant feature of all wounds is the likelihood of pathological infection occurring. Surgical wounds are no exception, and average levels of infection of surgical wounds are 7 to 10 percent dependent on the procedure. These infections can be prevented by appropriate cleanliness, surgical discipline and skill, wound care therapy, and antibiotic prophylaxis. Infections usually lead to more extensive wound care time, the use of more expensive products and drugs, significantly increased therapist time, and increased morbidity and rehabilitation time. A large number of wounds will also be sutured to accelerate closure, and a proportion of these will undergo dehiscence and require aftercare for healing to occur.
There are estimated to be 1.5 million cases of traumatic wounding every year. These wounds required cleansing and treatment with low adherent dressings to cover them, prevent infection, and allow healing by primary intention. Lacerations are a specific type of trauma wound that are generally more minor in nature and require cleansing and dressing for a shorter period of healing. Lacerations occur frequently (approximately 19 million cases a year) as a result of cuts and grazes and can usually be treated within the doctor’s surgery and outpatient medical center and hospital accident and emergency department.
Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Out-patient burn wounds are often treated at home, at the doctor’s surgery, or at outpatient clinics. As a result a large number of these wounds never enter the formal health service system. We estimate that approximately 3.3 million burns in this category do enter the outpatient health service system and receive some level of medical attention. These burns use hydrogels and advanced wound care products, and may even be treated with consumer based products for wound healing. Medically treated burn wounds usually get more informed care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used on these wounds. Approximately 6.3 million burns like this are treated medically every year. Hospitalized burn wounds are rarer and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant aftercare and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology.
Chronic wounds generally take longer to heal and care is enormously variable, as is the time to healing. There are approximately 7.4 million pressure ulcers in the world that require treatment every year. Many chronic wounds around the world are treated sub-optimally with general wound care products designed to cover and absorb some exudate. The optimal treatment for these wounds is to receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound; in the case of pressure ulcers the causal effect is pressure and a number of advanced devices exist to reduce pressure for patients. There are approximately 11 million venous ulcers, and 11.3 million diabetic ulcers in the world requiring treatment. Chronic wounds are growing in incidence due to the growing age of the population, and due mostly to awareness and improved diagnosis. At present these factors are contributing to growth of this pool of patients faster than the new technologies are reducing the incidence of wounds by healing them.
Wound management products are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, which are all on the increase.
See wound report #S245 description, table of contents here. This report may be ordered online or via downloadable order form.
During the 19th century, surgeons began to experiment with materials designed to achieve hemostasis: gelatin, collagen, natural fabrics, and thrombin and fibrin materials. In the early 1980s todayâ€™s commercial products began to appear. They were rapidly adopted in Japan where bleeding is an extremely emotive issue, and also in Europe where local regulatory requirements allowed a sequential roll-out of product introductions. In the USA, early FDA concerns associated with disease transmission led to delayed launch of products derived from human sources. These regulatory delays, plus the perceived high cost of products and surgeonsâ€™ concerns regarding disease transmission risk, drove surgeons and hospitals to continue to look for alternative hemostats, sealants and glues. As a result, to this day, there is a tendency for hospitals to continue to prepare autologous fibrin (from the patientâ€™s own blood taken before surgery) and to use a number of inferior haemostasis products.
Topical high strength glues were first used by the military, and to achieve immediate repair of sports injuries during professional sports like ice hockey, boxing and American football. These products became the subject of collaborative efforts between innovative suppliers and major suture manufacturing and marketing companies, keen to evolve their product portfolios to include next-generation closure materials.
During the 1990s, many technology-based companies began to target the huge unmet closure and sealant market. An extensive literature appeared, advising practitioners on specific methodology to create the ideal autologous fibrin sealant product and on applying these products to surgical indications. In addition, a number of specialist societies were established to support and advise on the process of preparing and using hospital-derived fibrin sealants.
There were also a growing number of companies developing medical devices and equipment specifically designed to allow the preparation of autologous fibrin sealant for surgical applications. All this effort led to a number of products being approved for use in the major surgical indications (see Exhibit). In 2006, sealant products were used in over three million surgical procedures. This represents up to 5 million units of commercially available fibrin sealant products, and approximately four million units of autologous fibrin prepared by hospitals. The autologous fibrin material, prepared using commercial medical devices, was used in approximately 70,000 surgical operations worldwide and represents a new market which has developed over the last five years. Similarly, the use of high strength glues for wound closure evolved since 1992 in Europe and since 1998 in the USA and Japan. High strength adhesives were used on approximately six million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost effectiveness.
Exhibit: U.S. FDA Approved Uses of Sealants, Glues, and Hemostats
Evolution of Commercial Markets for Sealants and Adhesives
The use of fibrin and other hemostats expanded rapidly in the 1980s in Japan driven by the strong cultural desire to avoid the need for blood transfusions in that market. In addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the US FDA in the late 1980s and 1990s. As a result the scientific literature from Asia and Europe records many novel and experimental uses for sealant and haemostasis products across all surgical disciplines from ENT to major open heart surgery.
In addition to commercial sources of sealant products, surgical centers in all regions of the world also prepare autologous fibrin for surgical procedures in efforts to save on commercial product costs, and to avoid potential for product-borne infection. Delays to the introduction of fibrin-based products in the USA led to a pent-up unmet need, which was addressed in the 1990s by the preparation of autologous fibrin in medical centers prior to surgical operations.
Historically, closure of surgical incisions has been achieved through an ever-evolving portfolio of suture, staple and tape products. In the early 1990s physicians involved in sports medicine were the first non-military practitioners to adopt cyanoacrylate glues to achieve immediate closure of small cuts and lacerations, and an awareness of this opportunity developed in large multinational manufacturers of sutures and staples. Joint development efforts were commenced at Davis and Geck (now U.S. Surgical), and Ethicon (subsidiary of Johnson and Johnson), and in a number of companies manufacturing cyanoacrylates which ultimately resulted in topical cyanoacrylate closure products being launched around the world during the 1990s.
Postoperative adhesion prevention evolved as a market in the early 1990s, and expanded with the addition of new entrant products from Genzyme, Focal, and others. Lifecore and Ethicon have developed a surgical adhesion prevention product based on hyaluronic acid. Angiotech, Fidia, Fziomed and Tissuemed all have adhesion-prevention products that are CE approved in the European Union.
Report #S145, “Surgical Sealants, Glues & Wound Closure Worldwide, 2007-2011.” For details, see link.