Technologies at Medtech Startups, January 2016

Below are technologies under development at startups recently identified and included in the Medtech Startups Database.

  • Breast cancer detection.
  • Technologies in cardiac surgery, neuromodulation, and cardiac rhythm management.
  • Technologies for minimally invasive laminoplasties, foraminoplasties, and implantables in spine surgery.
  • Xenogenically-sourced tissue matrices for soft tissue, regenerative, and vascular applications.
  • Device to clean trocar during laparoscopic procedures.
  • Pressure sensors in catheterization/angiography.

For a comprehensive listing of the technologies under development at startups identified since 2008, see link.

Forecasts for neurointerventions in acute stroke

Over the past two decades, one could witness the advent and significant expansion of the neurointerventional armamentarium targeting management of acute stroke. In mid-1990s, endovascular coiling embolization tools and techniques for treatment of cerebral aneurysms and AVMs (arterio-venous malformations) were introduced as a less invasive alternative to craniotomy-based surgery in primary prevention of hemorrhagic stroke. Several years later, these techniques were supplemented with coil-containing stents, which enabled treatment of large, giant, and wide-neck aneurysms. The latter was followed by the launch of stent-based flow diversion systems, which allowed clinicians to hemoisolate such aneurysms without tedious and risky coil packing of the rupture-prone aneurysmal sac.

In primary ischemic stroke prevention, development of embolically-protected carotid stenting and left atrial appendage closure techniques provided clinicians with an option of using non-inferior transcatheter tools instead of customary surgical interventions.

Finally, a recent launch of the novel stent-based cerebral thrombectomy systems manifested a qualitative breakthrough in emergent treatment of acute cerebral ischemia, where marginally effective and severely caseloads restrictive intravenous tPA therapy represented the only available therapeutic option.

Presently, endovascular techniques are increasingly seen and used by practicing clinicians as preferred therapeutic modalities in prophylaxis and treatment of acute stroke and are likely to expand their role in the years to come.

Based on the industry reporting and other estimates, in 2014, approximately 227.3 thousand cerebral endovascular therapeutic procedures were performed worldwide. Prophylaxis of ischemic stroke via carotid artery stenting and left atrial appendage (LAA) closure with contributed 91.2 thousand and 11.9 thousand interventions (or 40.1% and 5.2%, accordingly), followed by transcatheter embolization of intracranial aneurysm and AVM for hemorrhagic stroke prevention with 90.5 thousand interventions (or 39.8%), and cerebral thrombectomy-based emergent treatment of acute cerebral ischemia with 33.7 procedures (or 14.8% of the total).

Geographically, Western Europe and the U.S. accounted for the largest shares of corresponding cerebrovascular interventions in 2014, with 35.7% and 35.0%, accordingly, followed by major APAC states with 19% and rest-of-the-world with the remaining 10.3% of the total procedures performed.

Source: MedMarket Diligence, LLC; Report #C310.

 

Spine Surgery is Led By the U.S. and Thoracolumbar Fusion

From, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021”, Report #M540.

Spine surgery remains a uniquely American pastime, based at least on sales of technologies including spinal fusion, minimally invasive spine surgical technologies, and orthobiologics used for spine.

The patient demand and associated utilization rates, prices, reimbursement and other drivers make the U.S. an even bigger than it is in most medtech markets. And globally, as well as in the U.S., thoracolumbar fusion drives the most sales.

 


 

From, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021”, Report #M540.

Global Wound Management Market: Segment Size, Growth to 2024

The content of this post is drawn from the complete Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. For separate coverage of wound closure-related products, see Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018.”

The World Market for Wound Management Report encompasses twelve product segments:

  • Traditional Adhesive Dressings
  • Traditional Gauze Dressings
  • Traditional Non-Adherent Dressings
  • Film Dressings
  • Foam Dressings
  • Hydrogel Dressings
  • Hydrocolloid Dressings
  • Alginate Dressings
  • Antimicrobial Dressings
  • Negative Pressure Wound Therapy Devices
  • Bioengineered Skin & Skin Substitutes
  • Wound Care Growth Factors

The report examines North and South America, the European Union, Asia/Pacific and Rest of World, and looks at markets and growth rates by product and country for the years 2014-2024. The world market in 2024 for the total wound management market represented by the segments listed above is projected to be worth over $22 billion, with segments growing at widely variable rates, with lowest sales growth in traditional adhesive bandages and the highest sales growth in bioengineered skin and skin substitutes

Source: Report #S249.

Below are representative examples of each type of wound management product.

    
Dressing categoryProduct examplesDescriptionPotential applications
FilmHydrofilm, Release, Tegaderm, BioclusiveComes as adhesive, thin transparent polyurethane film, and as a dressing with a low adherent pad attached to the film.Clean, dry wounds, minimal exudate; also used to cover and secure underlying absorptive dressing, and on hard-to-bandage locations, such as heel.
FoamPermaFoam
PolyMem
Biatain
Polyurethane foam dressing available in sheets or in cavity filling shapes. Some foam dressing have a semipermeable, waterproof layer as the outer layer of the dressingFacilitates a moist wound environment for healing. Used to clean granulating wounds which have minimal exudate.
HydrogelHydrosorb Gel Sheet, Purilon, Aquasorb, DuoDerm, Intrasite Gel, GranugelColloids which consist of polymers that expand in water. Available in gels, sheets, hydrogel-impregnated dressings.Provides moist wound environment for cell migration, reduces pain, helps to rehydrate eschar. Used on dry, sloughy or necrotic wounds.
HydrocolloidCombiDERM, Hydrocoll, Comfeel, DuoDerm CGF Extra Thin, Granuflex, Tegasorb, Nu-DermMade of hydroactive or hydrophilic particles attached to a hydrophobic polymer. The hydrophilic particles absorb moisture from the wound, convert it to a gel at the interface with the wound. Conforms to wound surface; waterproof and bacteria proof.Gel formation at wound interface provides moist wound environment. Dry necrotic wounds, or for wounds with minimal exudate. Also used for granulating wounds.
AlginateAlgiSite, Sorbalgon Curasorb, Kaltogel, Kaltostat, SeaSorb, TegagelA natural polysaccharide derived from seaweed; available in a range of sizes, as well as in ribbons and ropes.Because highly absorbent, used for wounds with copious exudate. Can be used in rope form for packing exudative wound cavities or sinus tracts.
AntimicrobialBiatain Ag
Atrauman Ag
MediHoney
Both silver and honey are used as antimicrobial elements in dressings.Silver: Requires wound to be moderately exudative to activate the silver, in order to be effective
NPWDSNa
V.A.C. Ulta
PICO
Renasys (not in USA)
Prospera PRO series
Invia Liberty
Computerized vacuum device applies continuous or intermittent negative or sub-atmospheric pressure to the wound surface. NPWT accelerates wound healing, reduces time to wound closure. Comes in both stationary and portable versions.May be used for traumatic acute wound, open amputations, open abdomen, etc. Seems to increase burn wound perfusion. Also used in management of DFUs. Contraindicated for arterial insufficiency ulcers. Not to be used if necrotic tissue is present in over 30% of the wound.
Bioengineered Skin and Skin SubstitutesAlloDerm, AlloMax, FlexHD, DermACELL, DermaMatrix, DermaPure, Graftjacket Regenerative Tissue Matrix, PriMatrix, SurgiMend PRS, Strattice Reconstructive Tissue Matrix, Permacol, EpiFix, OASIS Wound Matrix, Apligraf, Dermagraft, Integra Dermal Regeneration Template, TransCyteBio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), xenographic, synthetic materials, or a composite of these materials.Burns, trauma wounds, DFUs, VLUs, pressure ulcers, postsurgical breast reconstruction, bullous diseases

 

There are some market restraints at work, primarily the high cost of the new technologies. Not all country healthcare budgets can afford advanced wound care products, even if they are proven to decrease healing times and hospital costs over the longer run. The development of substitute products threatens existing product categories, while a lack of sufficient clinical and economic evidence backing new technology hinders growth and acceptance of some of the more advanced wound management technologies.

In addition, improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to hold back the development of new technologies. In addition to market restraints, there are a number of drivers that are expected to shape this market in the years to come. One of the primary drivers is the aging of the global population. Chronic diseases, such as circulatory conditions, anemias and autoimmune diseases influence the healing process as a result of their influence on a number of bodily functions. Illnesses that cause the most significant problems include diabetes, chronic obstructive pulmonary disease (COPD), arteriosclerosis, peripheral vascular disease (PVD), heart disease, and any conditions leading to hypotension, hypovolemia, edema, and anemia. While chronic diseases are more frequent in the elderly, wound healing will be delayed in any patient with underlying illness. Happily, most wounds heal without any problems. However, chronic wounds may take months or years to fully close, or may never close. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs. Type 2 diabetes represents 85-95% of all diabetes in developed countries, and accounts for an even higher percentage in developing countries. There were 26 million diabetic patients in the US in 2012 and 285 million patients globally.   Of these patients, approximately 15% will develop a diabetic foot ulcer and 50% of these will become infected, representing an estimated 2 million patients. Diabetic foot infections are currently treated with systemic antibiotics, but the estimated failure rate of antibiotics for diabetic foot ulcers is in excess of 22%. A patient with diabetes is at significant risk of damage to tissues caused by impaired homeostasis due to the disease process. For example there is a tendency for such tissues to develop blockages in smaller blood vessels, which reduces the ability of these vessels to provide sufficient oxygen to tissues already under stress due to compromised nutrient supply and the diabetic condition. These patients then develop arterial ulcers. They may also have a tendency to suffer from venous ulcers, due to the underlying poor condition of cells as a result of the diabetes. The diabetic foot is the most common cause of non-traumatic lower extremity amputations in the US and Europe: there is an average of 82,000 amputations per year in the U.S., costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the U.S. ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.

Pressure, or decubitus, ulcers are another of the most common types of chronic wounds. The treatment of pressure ulcers places a major burden on healthcare systems worldwide, with an emerging additional cost of litigation increasing in importance over recent years. Healthcare practitioners need to be aware of both the direct and indirect costs and consider how the implementation of prevention protocols may offer cost savings in the longer term. The cost of a dressing for example as a prevention tool is minimal in comparison to the costs of treating an established pressure ulcer. Following are a few hard numbers on the true financial cost of pressure ulceration:

  • The estimated cost to the US hospital sector is $11 billion per annum
  • The estimated cost to the UK national health service is estimated at £1.4-£2.1 billion annually (4% of total NHS expenditure)
  • Lawsuits remain common in both acute and long term care — with high payments in certain cases
  • The average cost to treat an individual with an unstageable ulcer or a deep tissue injury is estimated to be $43,180
  • The average length of stay in hospital is almost three times longer for chronic wounds
  • The mean hospital cost for management of pressure ulcers in the U.S. is $14,426. In comparison, the same cost in Korea is identified as $3,000-$7,000.

The cost of treating chronic wounds is one element driving the development and utilization of advanced wound care technologies. Other drivers are the aging of the population, and the obesity epidemic, which is expected to produce a wave of diabetics in the years to come.

Source: Report #S251.

 

Top Growth Wound Care Product Sales By Country

Whether sales growth arises by a preferred adoption of one technology over another or by better than average economic conditions — or both, sales of wound management products are driven by technology adoption rates that vary by country, clinical practice patterns, reimbursement and other variables.

We assessed current and forecast sales for the following products:

  • Trad’l Adhesive Dressings
  • Trad’l Gauze
  • Trad’l Non-Adherent
  • Film
  • Foam
  • Hydrogel
  • lHydrocolloid
  • Alginate
  • Antimicrobial
  • Negative Pressure Wound Therapy
  • Bioengineered Skin & Skin Substitutes
  • Growth Factors

For all product segments but the traditional adhesive, gauze, and non-adherent wound care products (which were assessed only at the global level), we assessed growth in each of the following countries/regions: Americas (USA, Rest of North America, Latin America), Europe (United Kingdom, Germany, Italy, France, Spain, Rest of Europe), Asia/Pacific (Japan, Korea, Rest of Asia/Pacific), and Rest of World.

 

From our examination (report #S251) of the global market for wound management products, below are the top product-country cohorts in terms of projected compounded sales growth from 2015 to 2024.

 

Global wound care market — double-digit growth from within

Bioengineered skin, skin substitutes, foam dressings, hydrocolloids, and growth factors are among top growth segments in a global market for advanced wound management that is otherwise modest in growth, but high in volume.

The 2016 global wound management market will hit nearly $15 billion. With sales growing at just better than 5% annually on population growth, migration of technologies to developing markets, and increased per capita utilization, the aggregate market is stably tied to persistent caseload.  This regular, high volume of wound product sales supports a steady stream of innovation intended to gain even the smallest edge in share, an advantage that gains its value in real terms from the multiple of such a large global caseload.

In a market in which autografts and allografts have long been common, the development of cost-effective and safe bioengineered skin and skin substitutes is finding ready adoption in wounds of all types, but particularly burn wounds.

Due to their small base of existing sales thus far, even incremental expansion of sales in the use of biological growth factors in wound management reflects high growth through the forecast period.

Biotech need not be behind the higher growth in wound management technologies. Excellent growth prospects are also seen in foams, hydrogels, hydrocolloids, and other dressing materials.

Physical systems, including negative pressure wound devices, are not demonstrating growth prospects as good as traditional wound dressing products, let alone advanced wound products.

In short, the large global market is stable and growing at best modestly, but within this market, advanced wound management technologies’ sales are accelerating at the expense of traditional wound products. Growth in wound management is clearly coming from within.

Advanced Wound Care Sales, 2014 & 2024

wound-growth_2014-2024

Source: MedMarket Diligence, LLC; Report #S251.

Global wound market highlights

Highlights from the 2015 MedMarket Diligence report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World” —

Wound management is a large global market (almost $15 billion currently) driven by high and sustained volume of traumatic, surgical, and other chronic and acute wound types. Simple wound dressings with little technology development continue to more than adequately serve a large swath of wound caseload and will continue to generate 1-2% in annual growth through 2024.

However, while a great deal of wound management products provide unsophisticated but effective wound care — and this is particularly why these products sell much better outside well developed western markets — the growing cost of wounds that do not heal fast enough, or at all, has been compounded by changes in wound incidence arising from increased obesity, the aging population, and other forces, creating demand for more sophisticated wound solutions. Enter the array of advanced wound care products like innovative wound dressing materials and components, bioengineered skin and other skin substitutes, biological wound growth factors, and others. These products have been projected to grow at an annual rate of up to 16% annually. The result is a steady erosion of the share of the global market represented by simple dressings and bandages.

 

Source: MedMarket Diligence, LLC; Report #S251

Wound Care Technologies: Sales Growth, Change, Global Forecast

MedMarket Diligence is hours away from publishing its 2015 report on the worldwide wound management market.

The report is entitled, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”. The report is described in detail at link.

The very diverse field that is wound management encompasses technologies from gauze to bioengineered skin and skin substitutes and many in between. Growth rates range from flat to over 15% annually through 2024.

Source: MedMarket Diligence, LLC; Report #S251.

The highest growth segments in medical technology sectors typically derive their high growth from modest absolute changes on very small volume and therefore rarely can sustain that growth over time. However, in wound management, the use of bioengineered skin and skin substitutes will result in the highest cumulative sales compared to all segments from 2015 to 2024 — excluding, that is, the high volume segments of traditional adhesives, gauzes, and non-adherent dressings.  Also noteworthy is the second highest cumulative sales over this period was for antimicrobial dressings, despite this segment having relatively modest growth on a percentage basis, but proceeding from significant sales in 2015 (already at over $1.5 billion).

Source: MedMarket Diligence, LLC; Report #S251.

During the forecast period, the most significant change evident in sales is the jump in the share of the market represented by bioengineered and other skin replacements, as noted above. But with compound annual growth rates (to 2024) in sales in the different wound segments ranging from near 1% to nearly 20% — for segments with 2015 sales at a low of $300 million and a high of $15 billion — there is considerable shifting of shares of the global wound market.

Source: MedMarket Diligence, LLC; Report #S251.

On a geographic basis, wound care technology migration, efforts to secure underserved patient caseload, and other forces result in growth rates that vary by country or region. The well-developed USA market therefore does not compare in uptake of both old and new technologies within growth markets like China and others in the Asia/Pacific region.

Source: MedMarket Diligence, LLC; Report #S251.

Wound management: Novel technologies, high growth, high volume, MANY companies

Wound management technologies span an incredible spectrum of technologies — bandages, tapes, dressings (bioactive, antimicrobial, non-adherent…), sutures, staples, bioengineered skin & substitutes, negative pressure, ultrasound, pulsed electromagnetic therapy, growth factors, gene therapy…

Wound management is an old medical practice, and wounds have not changed in nature other than the mix prevalence of different wound types. Yet, the volume of all wounds, and the need to improve they may be managed, support development of many new technology and changes in clinical practice. In turn, this drives and sustains an unusually large number of competitors.

Source: MedMarket Diligence, LLC; Report #S251.

 

Below is a list, drawn from the forthcoming December 2015 report (#S251) from MedMarket Diligence global wound management market, of companies that are sufficiently large or active or noteworthy for us to have specifically profiled in our report. The true number of companies in wound (and detailed but not “profiled” in our report) is in the hundreds.

3M Health Care, ACell, Acelity L.P. Inc., AcryMed Inc., Agennix Incorporated, AGT Sciences Ltd, Alliqua Biomedical, AlloSource, Altrika Ltd, Amniox Medical, Inc., Anika Therapeutics, Argentum Medical, Avita Medical, B. Braun Melsungen AG, Biopharm GmbH, Biotime, Inc., Bio-Tissue, Inc., BSN medical, Cardium Therapeutics, CliniMed Limited, Coloplast Group, Covalon Technologies, Ltd., ConvaTec Inc., Cook Biotech, Inc., Covidien, Cytogenix, Cytomedix, Derma Sciences, Inc., DeRoyal Industries Inc., Devon Medical, Diapulse Corporation of America, Eqalix, Inc., E-QURE Corporation, Euroderm AG, Gentell Inc, Geritrex Corp., Hartmann Group, Hollister Incorporated, Imbed Biosciences, Inc., Integra LifeSciences, Inc., Kendall (Covidien), Kinetic Concepts, Inc. (KCI), Kuros Biosurgery AG, Laboratoires URGO, LifeCell Corporation, Lohmann & Rauscher International GmbH and Co. KG, Macrocure, Medline Industries, Microban International Ltd., MicroVas Technologies, Inc, MiMedx, Mölnlycke Health Care AB, NovaBay Pharmaceuticals, Oculus Innovative Sciences, Organogenesis Inc, Osiris Therapeutics, Perry Baromedical, Prospera, ReliaMed, RXi Pharmaceuticals, SafeBlood Technologies, Sanofi Biosurgery (formerly Genzyme Biosurgery), SANUWAVE Health, Inc., Shire Regenerative Medicine, Smith & Nephew plc, Sorbion GmbH & Co., KG, Soluble Solutions, LLC, Spiracur, Inc., Systagenix Wound Management (US), Inc., TEI Biosciences, Tissue Regeneration Technologies, LLC, Tissue Regenix Group plc., UDL Laboratories, Uluru, Inc., ViroMed Co., Ltd., Vomaris Innovations, Inc., Wound Management Technologies, Inc.

The MedMarket Diligence Report #S251, “Worldwide Wound Management, Forecast to 2024:
Established and Emerging Products, Technologies and Markets
in the Americas, Europe, Asia/Pacific and Rest of World” (see link for details), provides a current and forecast assessment (to 2024) of the worldwide market for wound management.

 

Spine Surgery Advances and Geographic Expansion Driving $9 Billion Market; MedMarket Diligence, LLC

Spine surgery manufacturers are driving growth by continuing to advance new technologies in implants, instrumentation and minimally invasive delivery while penetrating and expanding markets outside the U.S.

The $9.17 billion global market for cervical fusion, thoracolumbar Implants, MIS spine fusion, interbody fusion, and orthobiologics has evolved dramatically over the last several decades as a result of significant advances in the understanding of spinal biomechanics, the proliferation of sophisticated spinal instrumentation devices, surgical advances in bone fusion techniques, refinement of anterior approaches to the spine and the emergence and development of microsurgical, minimally invasive methods and robotics. As a result of these advances, it is now possible to stabilize every segment of the spine successfully, regardless of the offending pathology. The global market for spine surgery devices is detailed in the MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021.” (see http://www.mediligence.com/rpt/rpt-m540.htm)

“Well established and emerging spine surgery companies alike are succeeding by accomplishing three things — providing greater resources to further product development, expanding of sales and marketing resources, and growing new and emerging geographic regions,” says Patrick Driscoll, of MedMarket Diligence. “The result is continued strong sales growth globally, with a robust competitive landscape of companies of all sizes, keeping big players like Medtronic, DePuy,, Stryker, and Zimmer-Biomet on their toes” says Driscoll.

Spine fusion is the fastest growing technology in spine surgery and with growth in spine surgery being fastest in the Asia-Pacific and Central/Latin America, the growth of spine fusion in those areas is double-digit. The improvements in spine surgery and technology development have produced steady growth in volumes of surgeries, supported by reimbursement and clinical outcomes (and the increasingly active aging population). Spine surgery, with its exponential growth, has been the answer to an orthopaedic industry seeking to optimize earnings and add value for shareholders.

The MedMarket Diligence report, “Global Market for Medical Device Technologies in Spine Surgery, 2014-2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World,” (report #M540) is a detailed market and technology assessment and forecast of the products and technologies in the management of diseases and disorders of the spine. The report describes the diseases and disorders of the spine, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge.

The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in spine surgery. The report provides a current and forecast assessment by region/country of procedures and manufacturer revenues for, specifically, Americas (United States, Rest of North America, Latin America), European Union (United Kingdom, Germany, France, Italy, Spain, Rest of Europe), Asia-Pacific (Japan, China, India, Rest of Asia/Pacific) and Rest of World. The forecast addresses the product- and country-specific impacts in the market of new technologies through the coming decade.

The report profiles 38 of the most notable current and emerging companies in this industry, providing data on their current products, current market position and products under development. The products and activities of numerous additional startup and emerging companies are also detailed in the report.

The report is described in detail at http://www.mediligence.com/rpt/rpt-m540.htm and may be ordered for immediate download from https://www.mediligence.com/store/page51.html.