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.

 

 

 

Manufacturers of medical and surgical sealants, glues, hemostasis, wound closure and anti-adhesion products

The MedMarket Diligence Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2009-2013," details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

Companies profiled in the report include the following:

 

3DM, Inc. (3D-Matrix, Ltd.)
3M
Abbott Vascular
AccessClosure, Inc.
Adhezion Biomedical, LLC
Advanced Medical Solutions plc
Allerderm
Angiotech Pharmaceuticals, Inc.
Anika Therapeutics, Inc.
ARC Pharmaceuticals
Arch Therapeutics, Inc.
ArthroCare Corporation
Aso LLC
Aspen Surgical Products
Atrax Medical Group
Avery Dennison
B. Braun Melsungen AG 
Bastos Viegas, s.a.
Baxter International Inc.
Bayer HealthCare
BD (Becton, Dickinson and Company)
Berlin Heart GmbH
Bernsco Surgical Supply
Biocoral Inc.
BioCore Medical Technologies, Inc.
Biogentis, Inc.
Biomet Inc.
BIOSTER a.s.
BioSyntech Canada Inc.
BSN Medical
C.R. Bard
Cardiovascular Sciences, Inc.
Carl Auffarth GmbH & Co. KG
Cardiva Medical, Inc.
Ceremed, Inc.
Chemence Ltd.
Chemopharma, s.a.
Cohera Medical, Inc.
Collagen Matrix, Inc.
Coloplast A/S
ConvaTec
Covidien Ltd.
CryoLife Inc.
CSIRO PhotoMedical Technologies
CSL Behring

 

CSMG Technologies, Inc.
CuraMedical BV
Cypress Medical Products
Derma Sciences, Inc.
Distrex Ibérica S.A.
DuPont Applied BioSciences
Entegrion, Inc.
FibroGen, Inc.
Fidia Advanced Biopolymers
Flamel Technologies SA
Forticell Bioscience
FzioMed Inc.
Gelita Medical BV
GEM srl
Genzyme Biosurgery Inc.
GluStitch, Inc.
Graceduty Company Limited
GramsMed, LLC
Haemacure Corporation
HAPTO Biotech Israel Ltd.
Hartmann Group
Harvest Technologies Corporation
HemCon Medical Technologies, Inc.
Hemostasis, LLC
HyperBranch Medical Technology, Inc.
Incisive Surgical, Inc.
Innovasa Corporation
Integra Lifesciences Corporation
I-Therapeutix, Inc.
Johnson & Johnson
Kaketsuken (Chemo-Sero-Therapeutic
Research Institute)
Kensey Nash Corporation
Kimberly-Clark Health Care
Kinetic Concepts, Inc.
King Pharmaceuticals, Inc.
Kookbo Chemicals Co., Ltd. (KB Chem.)
Laboratoires Urgo (Urgo Medical)
Lewis Medical Supplies
LifeBond Ltd.
Lifecore Biomedical, Inc.
Lohmann & Rauscher
Marine Polymer Technologies
Medafor, Inc.
Medi Surgichem Pvt. Ltd.
MedTrade Products, Ltd.

Meyer-Haake GmbH Medical Innovations
Mölnlycke Health Care AB
Morris Innovative
Motex Healthcare Corp.
Myco Medical
NeatStitch Ltd.
Neose Technologies Inc. (Novo Nordisk)
Nycomed
Omrix Biopharmaceuticals Inc.
Pac-Kit Safety Equipment
Pfizer Inc.
Pharming Group NV
Plasma Technologies, Inc.
PlasmaSeal
Pluromed, Inc.
Polyganics
Polyheal Ltd.
ProFibrix BV
Progressive Surgical, Ltd.
Protein Polymer Technologies, Inc.
Radi Medical Systems AB
Resorba Wundversorgung GmbH & Co. KG
Scapa Group plc
Scion Cardio-Vascular, Inc.
Sea Run Holdings
Seton
Smith & Nephew plc
Starch Medical, Inc.
Steroplast Ltd.
Sutura, Inc.
Synovis Life Technologies
SyntheMed, Inc.
Teleflex Medical
ThermoGenesis Corporation
Therus Corporation
Thrombotargets Corp.
Tissuemed Ltd.
TraumaCure, Inc.
TyRx Pharma Inc.
Vascular Solutions, Inc.
Vectura Group plc
Vivostat A/S
Z-Medica Corporation
Zimmer
ZymoGenetics, Inc.

 

 

Growth, development and consolidation in the sealants, glues, wound closure and anti-adhesion industry

In the last few years, there has been a significant consolidation in the sealants, glues, wound closure and anti-adhesion industry (the "securement industry") as venture-based companies have been acquired and assimilated into larger market-based corporations with critical mass in their sales effort. This represents a welcome development for investors in leading-edge technologies, which are now being developed into marketable ventures. Examples are seen in the full range of deal structures from exclusive distribution deals and joint development agreements with exclusive marketing licenses to full acquisitions of companies.

Recent Acquisitions in the Securement Industry

sealant-consolidation1

Source: MedMarket Diligence, Report #S175.

 

Glues, sealants, hemostasis, anti-adhesion market growth

The market for surgical closure and securement has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances. There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.
Worldwide expenditure on all medical devices surpassed $180 billion in 2007, and in the field of tissue repair and surgical securement, the total market reached $7.3 billion, underpinned by product advances reflecting our improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products available.

The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.

Overall industry spending in the health care system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting more advanced and new technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theatre time and costs.

sealant-growth-rates

Source:  MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013."

 

Orthopedic biomaterials market growth strongest in U.S.

Growth in the U.S. market for orthopedic biomaterials is expected to be somewhat faster than in Europe and significantly greater than in the developing world, partly because new biomaterials are relatively expensive and their uptake is related, in general terms, to GDP. Newly-emerging technologies such as bone morphogenetic proteins (BMPs) are expected to grow at rates up to 30-35% per annum during the forecast period (2007-2011), although their contribution to the overall orthopaedic biomaterials market will be relatively modest, since they are starting from a small base. Overall, the U.S. market for orthopaedic biomaterials is expected to grow by approximately 12% per annum over the next five years.

The U.S. market is the best-documented of the world’s regional markets for orthopaedic biomaterials, and U.S.-specific data are to be found later in this section, under discussions of the market by surgical procedures and classes of biomaterials.

ortho-biomaterials-pie1

Source:  MedMarket Diligence Report #S625.

 

Although the "other" category is the largest category included in this overall market, and has been included because of both "biomaterials" aspect of these technologies and their clinical utility in orthopedic applications, these products are part of the larger market for sealing, adhesion, hemostasis and prevention of post-surgical adhesions.  (The market for these products are addressed separately in the MedMarket Diligence report #S175, "Worldwide Sealants, Glues and Wound Closure, 2009-2013".)

 

 

Latin American markets for surgical sealants, glues, hemostasis and ant-adhesion products

MedMarket Diligence's worldwide analysis of the markets for surgical sealants, glues, hemostasis, wound closure and anti-adhesion provides detail on growth segments of the market, both in the products/technologies and the geographic breakdown.  Below is an excerpt from Report #S175.


The main medical markets in Latin America are Brazil and Mexico, followed by Argentina.

Brazil, despite its size (population 196 million), is not a lucrative medical market because of the wide economic disparity between the wealthy and poor segments of the population. The state-run Unified Health System (SUS) covers 75% of the population but only 42% of total health care expenditure is in the public sector. Private health care covers 17.5 million subscribers, less than 10% of the population. Thus conventional, low-cost closures (sutures, staples, tapes) dominate the market and more expensive novel closures (sealants and glues) have relatively modest market shares. The same is true of Argentina, which is still recovering from a severe economic depression in the 1990s. Mexico, the eighth biggest trading market in the world, operates a health care system under which 60%–70% of the population are covered by public insurance schemes. In terms of expenditure on medical products, Mexico occupies a position between that of developed and developing economies, and this is reflected in the shares of the wound closure market represented by premium-priced and commodity product groups.

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Below is shown a graph of the major Latin American markets for these products.  As is shown, sealants and glues have gained a significant share of these markets, yet additional penetration of the sutures and staples segment by sealants/glues, potentially to a large degree, may be gained with additional product development, conversion of caseload and aggressive marketing/promotional campaigns to physicians in these markets.

latin-america2

Source: MedMarket Diligence, LLC; Report #S175

Latin American markets for surgical sealants, glues and related products

The main medical markets for sealants, glues, hemostasis and anti-adhesion in Latin America are Brazil and Mexico, followed by Argentina.

Brazil, despite its size (population 196 million), is not a lucrative medical market because of the wide economic disparity between the wealthy and poor segments of the population. The state-run Unified Health System (SUS) covers 75% of the population but only 42% of total health care expenditure is in the public sector. Private health care covers 17.5 million subscribers, less than 10% of the population. Thus conventional, low-cost closures (sutures, staples, tapes) dominate the market and more expensive novel closures (sealants and glues) have relatively modest market shares. The same is true of Argentina, which is still recovering from a severe economic depression in the 1990s. Mexico, the eighth biggest trading market in the world, operates a health care system under which 60%–70% of the population are covered by public insurance schemes. In terms of expenditure on medical products, Mexico occupies a position between that of developed and developing economies, and this is reflected in the shares of the wound closure market represented by premium-priced and commodity product groups.

Below is illustrated the segmentation of the sealants, glues, hemostasis and anti-adhesion products market in the major countries of Latin America. As is evident from the graphic, glues and sealants have gained a significant share of the sutures and staples market. How much more share glues and sealants can gain is dependent upon caseload conversion with existing products, new products developed and, to a significant degree, penetration of the sutures and staples markets by products from major manufacturers whose distribution capabilities are establ

latin-america1

Source: MedMarket Diligence, LLC; Report #S175

 

New sealants, glues emerging from nettles, grape leaves, licorice and thyme?

Different options for closing wounds, initiating hemostasis and other related applications are emerging in markets outside the well-developed medical markets in Europe, Japan and the U.S.

Below is an example of a novel hemostatic agent, Ankaferd Bloodstopper, a plant-based agent that has been developed by the Istanbul, Turkey, company, Ankaferd Health Products Ltd.  

 

Currently only registered for sale in Turkey and Bosnia/Herzegovina, since the product has not received CE Mark, the question remains whether the product will make it in Western Europe or the U.S., not least of which due to its interesting origin and the fact that its mechanism of action has not yet been elucidated.  From "Today’s Zaman" (25 January 2009):

The inventor of this miraculous product, Hüseyin Cahit Fırat, is, interestingly enough, not a medical doctor. He studied economics and was involved in business and journalism but has been engaged in the healing effects of herbs and worked on the formula of ABS for 30 years. Speaking to Sunday’s Zaman in an interview, Fırat said ABS comprises a standardized mixture of galangal, nettles, grape leaves, licorice and thyme, which are mixed together under laboratory conditions. "Although ABS has been confirmed again and again to stop bleeding, the basic mechanism of action for the hemostatic effects of ABS still cannot be explained," he says.

It is worth noting that, for an analogous product, fibrin sealants, the initial market success was not in Europe or the U.S., but Japan, due in part to the social stigma in Japan associated with bleeding and, on the other side, to concerns in the U.S. (not so much for Europe) regarding potential blood-borne viral transmission associated with fibrin sealants.


MedMarket Diligence has published a report on surgical sealants, glues, hemostasis, anti-adhesion and other products.  See Report #S175.

Prevalence of dermal applications for sealants and glues

Skin securement has always been an essential final step in surgical procedures. In early years, the skin surface was sutured; in recent years a number of advances have been made, including new tapes, sutures, staples, hemostats, and glues.

Burns

Approximately 24,000 burn victims in the United States received skin grafts every year. These represent the very worst burn cases; in fact, approximately 25% of this group will die from their injuries. Glues and sutures are used to secure skin grafts in place and hemostats are used to prevent bleeding and to prepare the new skin for repair. Skin grafts provide an immediate covering for the patient that prevents further cell death, stimulates repair, and reduces fluid loss through the burnt skin. Products in this category may also be required to treat the skin after donor site material is taken from an intact region on the patient’s skin for skin grafting. Advances in sealant, hemostat, and closure technologies offer the potential to accelerate repair by creating the right environment to accelerate the healing process and provide better repair.

Pressure Ulcers

About 1.5 million pressure ulcer patients were treated in the United States in 2008. These wounds develop in immobile patients who often suffer from underlying biochemical deficiencies that lead to inadequate skin healing. Prevalence is highest in the old and infirm, and incidence is increasing in line with aging of the population. Sealants, hemostats, and closure products provide opportunities for a radical surgical method to treat these life-threatening wounds, which normally would be treated with conservative (though often sophisticated) wound healing products designed to reduce points of pressure, mask smell and absorb excess moisture while the body repairs itself. The strongest opportunity for use of surgically oriented products for repair of pressure ulcers is among young paraplegics and short-term acute care patients who are immobilized but otherwise healthy (approximately 5% of all pressure ulcers).

Diabetic Ulcers

Diabetes causes many abnormalities in tissue biochemistry and nutrition, many of which lead to impaired tissue healing. In addition, diabetes leads to conditions of hypoxia and peripheral neuropathy that can directly cause ulcers. Approximately 800,000 diabetics in the United States have diabetic foot ulcers; closure and securement products offer a surgical route to aiding repair that may offer potential to accelerate repair in a number cases.

Venous Ulcers

There are approximately one million venous ulcer patients in the United States today. Prevalence is increasing in line with aging demographics exacerbated by a sedentary lifestyle. Venous ulcers are caused by underlying vascular and venous flow abnormalities, which can often be treated by knowledgeable application of pressure bandaging and, in some cases, appropriate topical wound care. However, this treatment is largely symptomatic and many physicians believe surgical intervention to repair the underlying vascular abnormalities is required to effect a cure and avoid tissue breakdown. Sealants, hemostats, and closure products offer a surgical route to aiding repair that may offer potential to accelerate repair in a number cases.

Plastic Surgery

About 2 million cosmetic augmentation procedures are performed in the United States every year. The most popular procedures are liposuction (455,000) and breast augmentation (365,000). Most of the latter use synthetic materials and biomaterials for augmentation purposes. Other procedures where sealant products may be relevant include rhinoplasty (200,000), abdominoplasty (170,000) and eyelid surgery (230,000).

Adjunctive products for securement and closure offer potential to improve surgical procedure, reduce infections, and improve aesthetic and physiological properties of newly repaired tissues, as well as offering more rapid rehabilitation and the avoidance of donor site morbidity in approximately 27,000 of these operations involving the use of donated tissue from another region of the patient’s body.

 

dermal applications of sealants

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

 

Technologies at new medtech startups

Below are the products/technologies at recently identified medtech startups:

Company
City
Country
Founded
Product/Technology
Checkpoint Surgical, LLC
Cleveland, OH
USA
2008
Intraoperative nerve location and protection device.
DiFUSION Technologies, Inc.
Austin, TX
USA
2008
Medical device to prevent surgical site infections in orthopedic and spinal surgeries.
FHL Innovations, LLC
Fredericksburg, VA
USA
2007
Surgical dressings
GS Medical Co. Ltd.
Seoul
Korea
2007
Spinal implant manufacturer
IQ Medical Devices, LLC
Belmont, MA
USA
2006
Surgical irrigation and retraction systems.
Millennium Medical Technologies, Inc.
La Verne, CA
USA
2006
Autologous fluid concentrator
OmegaGenesis Corporatoin
Gilroy, CA
USA
2008
Nanotechnology biomaterials company developing angiogenic materials for use in wound management, treatment of ischemic heart disease, others.
Piezo Resonance Innovations, Inc.
Bellefonte, PA
USA
2007
Devices based on piezoelectric, magnetorestrictive and shape memory materials technologies, including a sonicator and an ophthalmic surgical device.
Seventh Sense Biosystems, Inc.
Cambridge, MA
USA
2007
Medical device company backed by Flagship Ventures, Polaris Venture Partners and Third Rock Ventures.
SPR Therapeutics
Cleveland, OH
USA
2008
Peripheral nerve stimulation for treatment of post-stroke shoulder pain.
Starch Medical, Inc.
San Jose, CA
USA
2007
Polymer-based absorbable surgical hemostats.

Source: MedMarket Diligence, LLC; Medtech Startups Database