Medical technologies at startups, July 2014

Below is a list of technologies under development at medical technology startups identified in July 2014 and included in the Medtech Startups Database.

  • thrombectomyInstrumentation for electrophysiology diagnosis and treatment.
  • Products for the treatment of hypertension and other chronic disease by interventional cardiologists
  • Surgical stapling device for use during natural orifice transluminal endoscopic surgery.
  • Low cost medical technologies to improve patient management in emerging markets.
  • Heart valve for the treatment of mitral valve regurgitation
  • Thrombectomy catheter
  • Microstaple bandage for wound closure.
  • Whole-body cryotherapy chambers as well as devices for local cryotherapy and cryosurgery.
  • Minimally invasive surgical device for the treatment of glaucoma
  • Electrical muscle stimulation.

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

Opportunities for med/surg sealants, glues, hemostats driven by type of clinical benefit, competition

Advanced products for the closure, sealing, hemostasis and other endpoints for medical and surgical wounds generate varying degrees of clinical benefit based on the manner and extent to which they enable management of different wound types.  Degrees range from the acute need end of “important and enabling” to the less clinically necessary “aesthetic and perceived benefits”:

  • Important and enabling: Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
  • Improved clinical outcome: Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
  • Cost-effective and time-saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • Aesthetic and perceived benefits: Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

These benefits are clearly different on a clinical specialty-by-specialty basis.  The numbers of targeted or prospective procedures also vary considerably by specialty. As a result, wound closure and securement products have the following categorized potential use worldwide:

Source: “Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide “; Report #S190.


Opportunities for surgical sealants, glues and hemostatic agents

See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

In the field of surgical sealants, glues, wound closure and anti-adhesion, the most significant opportunity for products is the area of high strength glues.  Currently, there is no standout biologically or chemically based product that has the performance necessary to displace the very large and established market for traditional wound closure — sutures, staples and clips.  Fibrin-based surgical sealants, glues, hemostats and other products are at best adjuncts to traditional wound closure, providing a complementary role of helping to seal wounds or hasten the healing process.  The real opportunity of fibrin or other surgical sealants and glues lies in their ability to provide the tensile strength of sutures with rapid hemostasis and tissue adhesion and with no toxicity or other biocompatibility effects beyond what sutures might produce. Secondly, such future sealant/glue products must also be able to achieve this performance at lower cost and/or improved outcomes.

So, this is no small challenge.

Having said this, there are quite a number of companies active in the development of these products and it is eminently reasonable that the companies involved will be making significant inroads to this challenge over the coming decade.

Even at existing levels of performance, biological and other sealants/glues/hemostats are progressively gaining caseload and market share from traditional wound management products.  The forecast below, which illustrates shares for the market in 2009, imputes a modest level of penetration of traditional products.  Any significant advance in improved tensile strength, with reduced toxicity, of emerging sealants/glues/hemostats would result in the market growth rate eclipsing the modest 11.5% CAGR in the data below.

Source: MedMarket Diligence, LLC; Report #S180.

Report: Surgical Sealants, Glues, Wound Closure and Anti-adhesion Worldwide

MedMarket Diligence (MMD) has published its 2010 report on the worldwide market for surgical sealants and related products in surgical and traumatic wound management.

The analysis by MMD reveals the size of the evolving opportunity for a diverse set of products in global markets. Based on extensive primary and secondary research, and leveraging MMD’s position as the leading source for the medtech industry on the subject, the report provides industry participants and hopefuls with invaluable data and insights.

The report is described below and at link

This report 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.

This report is a market and technology assessment and forecast of surgical sealants, glues, hemostasis, other wound closure and anti-adhesion. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products, medical adhesives and products to prevent surgical adhesions. The report provides a worldwide historic (from 2008), current and annual forecast to 2015 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade.  The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan, Korea and Rest of World.

The report 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 over a five-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

See link for complete table of contents and list of exhibits.  The report may be ordered for immediate download from link.

Technology platforms and clinical applications overlap

Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications.  For this reason, manufacturers need to consider that:

1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses as far afield as wound management, bone repair, treatment of myocardial ischemia and others.

2. A disease state can sometimes be targeted by many very different technologies.  Examples include that wound management can be accomplished by tissue engineering, sutures, fibrin-based surgical glues, cyanoacrylate-based surgical glues, dressings and others.

The driver behind technologies having multiple clinical applications is, of course, that companies wish to maximize their ROI.  

The driver behind single disease states being the target of multiple alternative technologies is cost — healthcare systems (in principle, anyway) seek the most competitive options for treating specific patient populations, and this driver has been gaining momentum over the past ten years due to “managed care” efforts as well as aggressive, cost-focus innovators creating technologies that displace market share with convincingly better patient outcomes compared to alternative technologies.


MedMarket Diligence publishes medical technology market reports on a wide range of clinical and technology subjects (of course, sometimes overlapping). See list.


(This post was done via the Palm Pre WebOS app Po’ster by Gabriele Nizzoli.) 

Wound prevalence and wound management

(Update, March 2013:  MedMarket Diligence has published its 2013 report #S249 on the Worldwide Wound Management Market.)

Wound management encompasses a wide range of products: fabric dressings, first aid dressings, dressings and internal wound management products for surgery, advanced wound management products, active pharmaceutical wound care products, tissue engineering, physical therapies for wound care, and pressure relief products and skin treatments, for preventative wound management.

Following is an excerpt on wound prevalence from the 2007 MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World.”  See also the related report #S175 on “Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013.”


Wound prevalence

Surgical Wounds

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.

Traumatic Wounds

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.

Burns

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
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.

Worldwide Wound Prevalence by Etiology, 2007

wound-prevalence

Source:  MedMarket Diligence report #S245.


See the 2013 Worldwide Wound Management Market report #S249.


Tissue closure and securement as benchmark for medical device usage

surgical-suturesThe market for surgical closure and securement (sealants, glues, sutures, staples, tapes, hemostasis, anti-adhesion) 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 is estimated to have 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.

fibrin-sealantOverall 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.

This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time-savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.

The total market potential by 2013, driven by procedure volumes, for hemostats, sealants, and glues, addressable by currently available products, nearly $4.5 billion for hemostats and sealants, and more than $1.3 billion for skin wound closure using high-strength glues. The introduction of a high-strength, elastic glue without toxicity concerns would revolutionize the market further and lead to even higher sales potential.

In the field of postoperative adhesion control, newly developed products improve on early prototypes and have substantial clinical efficacy data to allow for a significant premium cost. Over $700 million revenues were generated in 2007 in this market segment, and we expect that this market will grow to nearly $1.5 billion dollars in the next five years.


The above is excerpted from Report #S175.

 

 

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.

 

 

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."

 

Surgical closure and securement products defined

The market for securement pRoducts may be subdivided into the following product categories: sutures, staples and other mechanical closure devices; tapes; hemostats; fibrin and other sealants; high-strength medical adhesives; and post-surgical adhesion prevention. The total securement market is forecast to grow from almost $7.3 billion in 2007 to reach $11.8 billion in 2013 at a CAGR of 8.4%.

Definitions of Surgical Closure and Securement Products

Souce:  MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013." Published December 2008.