Category Archives: medtech

topic is about medical technology of different types, describing specific products under development, the market for them or their impact on healthcare

Growth and Change in $14 Billion 2018 Global Market for Sealants, Glues, and Wound Closure – New MedMarket Diligence Report

The market for products to stop bleeding, close wounds, seal wounds and ultimately optimize wound healing is a diverse and dynamic arena filled with over a hundred companies — from startups to multinational powerhouses – vying for a large caseload of acute surgical wounds. MedMarket Diligence has completed a global analysis of the products, technologies markets for surgical sealants, high strength and other glues, hemostats, tapes, vascular closure devices and other wound closure products.

The global market for sutures & staples, vascular closure devices, surgical tapes, medical and surgical hemostats and surgical sealants and glues will grow to $14 billion by 2018. Traditional methods to close and secure wounds via suture are under a steady barrage of new technologies that have gained credibility among clinicians, widespread acceptance by third party payers and a resulting caseload that is poised to gain over half the global market, according to a new report from MedMarket Diligence.

“Traditional wound closure via suture represents a fundamental skill in clinical practice, and the ease of its performance, strength of the closed wound and long presence in wound management make it a tough market to penetrate, but that is just what has happened over the past couple decades,” says Patrick Driscoll, President of MedMarket Diligence, LLC.

Fibrin sealants came on the scene, mostly outside the U.S. in the early 1990s, demonstrating the ability to effect better closure and minimize blood loss. With protocols and other reassurances that these blood-derived products would not risk HIV transmission, the U.S. market opened up as well. Subsequently, an enormous array of biologically- and chemically-based products began seriously disrupting the hundreds of years of dominance by surgical sutures. Adding to wound closure were the products demonstrating rapid hemostasis, hitting suture limitations head-on. With low hurdles to enter the market, companies proliferated and began carving up large swaths of the wound closure market. However, surgery evolved, with laparoscopic and other endoscopic procedures giving impetus to advanced sutures, clips and staples delivered endoscopically. Moreover, suture technologies also evolved, with the development of different resorbable sutures adding a level of utility and value to sutures, further buttressing their defense against the emerging novel wound closure products.

Technologies in wound closure continue to evolve and be adopted globally. The end result is that there is steady emergence and turnover (via acquisition and exits) of companies in the market.

The 2014 MedMarket Diligence report, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, covers the markets for Surgical Wound Closure products, including Sutures and Staples, Vascular Closure Devices, Medical Tape, Surgical Hemostats, and Surgical Sealants and Glues. It takes into consideration those products which are used in hospitals, medical clinics and physicians’ offices. It does not address consumer, dental or veterinary markets, nor does it include medical adhesives used in manufacturing devices intended to be used for medical applications.

The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The report also provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2018. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

The report profiles the top companies by revenue and a reasonable selection of the most promising or otherwise noteworthy companies in the markets covered in this report, providing data on their current products, current market position and products under development.

The report is described in detail at link and may be ordered for immediate download from link.

Rising and fading technologies in the global market for wound closure

Technologies emerge, gain clinical acceptance, grow in caseload and become the standard of care. Then new technologies emerge, developed to improve on or eclipse established technologies. They gain acceptance and the cycle continues.

The pace of technology and market development in the products used in wound closure — sealants, glues, hemostats, sutures/staples, tape, and vascular closure devices — follow this path as characteristically as any medtech market. However, the pace of adoption varies both by technology type and geographic location. Consequently, there is a pretty wide range of compound annual growth rates in the sales of these product globally, regionally and by country.

Below illustrates the highest growth segment-geography combinations in the wound closure market. This frequently illustrates that novel technologies more rapidly penetrate well developed economies, which can sustain the initial high premium pricing of novel technologies, then progressively migrate to less well developed economies.  (For the sake of direct comparison, the high and low growth graphics are shown on the same scale.)

High Growth Segment-Geographies in Wound Closure

Screen Shot 2014-10-23 at 2.07.43 PMSource: MedMarket Diligence, LLC; Report #S192.

Low Growth Segment-Geographies in Wound Closure

Screen Shot 2014-10-23 at 2.07.52 PMSource: MedMarket Diligence, LLC; Report #S192.

Surgical Sealants and Glues in Wound Closure

Wound closure is a critical element of the overall wound management process. Indeed it is the most critical step in the sense that, if not accomplished promptly and effectively, can result in adverse outcomes ranging from chronic wound formation, infection and, unfortunately, death.

Sealants and glues have become an entrenched, though not dominant, aspect of routine clinical practice in wound closure. These technologies have demonstrated efficacy that has warranted their use independent of other closure technologies, such as traditional sutures and staples, or as adjuncts to them, 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.

It is useful to categorize surgical sealants, glues, and hemostats on the basis of their primary components and/or their intended use. The market for these products can be broken down (and has been done so in report #S192) 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.

Global Market

The global market for products in wound closure is comprised of large, well established, and relatively low growth segments like sutures/staples; the low volume, low growth segments like surgical tapes; and the smaller, higher growth segments like vascular closure, hemostats, and surgical sealants/glues:

Growth and Size of Major Wound Closure Market Segments

 

s192-growth-size-bubbles

 

Sales ($millions) are 2014; Growth is CAGR 2013-2018.

Source: MedMarket Diligence, LLC; Report #S192 (published October 2014).

 

The MedMarket Diligence report #S192, “Worldwide Market for Surgical Sealants, Glues, and Wound Closure, 2013-2018: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”, details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples, vascular closure, hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The Report provides full year actual data from 2013 and, for available companies, quarterly data from 2014. The report provides a worldwide forecast to 2018 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

Funding in medical technology, October 2014

Funding for medical technologies in October 2014 totaled $332 million, led by the $59 million funding of Ivantis, Inc., and the $55 million funding of PureTech.

Below are the top fundings for the month:

Company, funding Product/technology
Ivantis, Inc., has raised $58.87 million of a $71.37 million round of fundng according to a regulatory filing Stent-based treatment to lower intraocular pressure in glaucoma
PureTech has raised $55 million in a round of funding according to the company Medical device and other technologies spanning treatments in immunology, metabolism, neuroscience, drug delivery and consumer digital health
VytronUS, Inc., has raised $31.6 million in a Series B round of funding according to the company Integrated imaging and ultrasound ablation for treatment of cardiac arrhythmias
Respicardia, Inc., has raised $25.09 million in a round of funding according to a regulatory filing Electrical pulse-based implant treatment for sleep apnea
Magnus Life Science (Magnus Life Ltd) has raised £15.5 million ($24.96 million) in a round of funding according to regulatory filing Device and non-device technologies based on dynamics of bloodflow
Medrobotics Corp. has raised $20 million in a preferred stock offering according to the company Computer-assisted access and visualization system for minimally invasive robotic surgery

For the complete list of medtech fundings in October 2014, see link. For a historical list of the fundings in medtech, by month, since 2009, see link.

The relentless proliferation of wound closure technologies

Sutures are not dead. They cling to the wound closure market as tenaciously as, well, non-resorbable sutures.

Though the mainstay in the management of acute and traumatic surgical wounds for literally hundreds of years, sutures have been giving up some of their hold on the market, as a result of a robust rate of development, introduction and clinical acceptance of a wide array of biologically-based, chemically-based or combination of chem/bio products that stop bleeding, seal wound edges to varying degrees (adjunctively and independently) and otherwise close and heal wounds. The value of these products ranges from the critical, such as in new hemostat products with the potential to revolutionize treatment of battlefield wounds, to the aesthetic, with sealants that can dramatically reduce or eliminate scarring.

As the ancient Greek philosopher Heraclitus recognized, however, you cannot put your finger in the same river twice. The surgical arena continues to change dramatically and it challenges and creates enormous incentives for manufacturers to keep pace by developing novel wound closure technologies. Laparo-endoscopic innovations from conventional laparoscopy through single port laparoscopy to natural orifice transluminal endoscopic surgery established new requirements for the manipulation of tissue and manufacturers responded with a wide range of endoscopic sutures, staples, clips and appliers to facilitate MIS procedures.  Even sutures themselves have been reengineered to dissolve in controlled ways to enhance the end result of wound closure.

But where sutures were once THE universally accepted manner to bring wound margins together, they are now challenged on all sides by fibrin and other surgical sealants, hemostatic agents, vascular closure devices, cyanoacrylate and other high strength surgical glues and even sophisticated tapes. For now, sutures hold the slim margin of dominance in this aggregate market, but by 2018, the overall market for wound closure will be represented in the majority, by products other than surgical sutures and staples:

Worldwide Surgical Wound Closure Products Market, by Device Segment, 2018

closure-shares-2018

Source: MedMarket Diligence, LLC; Report #S192

 

New Medical Technologies at Startups, September 2014

Below is a list of new technologies under development at medtech startups recently identified and included in the Medtech Startups Database:

  • Robotics for ophthalmic surgery.
  • Dynamic force generation for bone repair.
  • Neursurgical brain simulation system.
  • Orthopedic technologies including pedicle screw that does not require a guide wire.
  • Synthetic bone graft materials.
  • Minimally invasive mitral valve replacement.

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

New Medical Technology Fundings, September 2014

Fundings in medical technology for the month of September 2014 stand at $421 million, led by the $46 million funding of Vital Therapies. Below are the top fundings for the month thus far.

Company, funding Product/technology
Vital Therapies, Inc., has raised $46 million in a public stock offering according to press reports Technologies for the regeneration of liver tissue
Fractyl Laboratories, Inc., has raised $40 million in a Series C round of funding according to a regulatory filing Endoscopic device to aid in type 2 diabetes glucose management
Corindus Vascular Robotics, Inc., has raised $26.67 million in a round of funding according to a regulatory filing Robotic system to assist interventional cardiologists with stent placement
Acutus Medical, Inc., has raised $26.2 million in a Series B round of funding, according to press reports Minimally invasive, 3D cardiac imaging/mapping technology
iHealth Lab has raised $25 million from Xiaomi Ventures, according to press reports Wireless blood-pressure and blood-glucose monitoring
Ivantis, Inc., has raised $25 million adding to its existing Series B round of funding according to press reports Device for the treatment of glaucoma
Minerva Surgical, Inc., has raised $25 million in a round of funding according to a regulatory filing Ablation device for the treatment of menorrhagia
REVA Medical, Inc., has raised $25 million in new funding according to the company Bioresorbable scaffold for use in vascular stents

For the complete list of medtech fundings in September 2014, see link. For a historical list of the fundings in medtech, by month, since 2009, see link.