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Surgical sealants, glues and hemostats market expanding with new products, clinical acceptance

definitions-sealants

Approximately 70 million surgical and procedure-based wounds are created each year in surgeries worldwide that offer potential for adjunctive products for surgical closure and securement. Some 23 million of these wounds are created during surgical procedures in the United States. Although it is possible that healing of all these wounds would be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures which receive sealant products around the world, generating $1.6 billion in sales in 2007. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures. New sealant products are also being launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.

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.

Sealants, glues, hemostats and other wound closure and anti-adhesion are the subject of the MedMarket Diligence report #S175

 

Posted 02 July 2009 † P. Driscoll § market data § medtech § surgery § wound management ‡ Comments ° Tagged: , , , , ,

Technologies at recent medtech startups

Below are listed the products and technologies that are the focus of recently identified medtech startups, some of these companies being only weeks old. 

  • Development of a debridement device using ice particles
  • Developing ultrasound ablation catheter for treating atrial fibrillation
  • Advanced damaged tissue care systems for wound care
  • System for detecting endothelial dysfunction as a precursor to cardiovascular disease
  • Drug delivery technologies for treatment of vascular disease
  • Stent placement system
  • R&D of spinal products
  • Device for the prevention of migration and leakage problems associated with endovascular stent grafts for abdominal aortic aneurysms
  • Drug-device products for localized drug delivery
  • Device for controlling blood perfusion pressure using a retrograde cannula
  • Develops devices embedded with stem-cell for treatment of acute organ failure
  • Device for treatment of fractures of the neck of the femur
  • Implantable medical device for the treatment of benign prostate hyperplasia

These technologies are detailed at companies recently founded and/or identified and entered in the Medtech Startups Database.

Posted 01 July 2009 † P. Driscoll § ablation § cancer § cardiology § drug delivery § early stage company § innovation § medtech § orthopedic § spine § startups § stents § tissue engineering § wound management ‡ Comments °

Medtech financings total $300 million in June

Financings in medical technology for the month of June 2009 totaled just about $300 million.  This sector is defined (in our partisan view) largely by companies competing in a device or equipment market for therapeutic applications, or products either directly competing against, or complementary with, those applications.

Capital markets remain tight, but these funding levels confirm the perceived value of medical technology innovations.  Below are specific financings comprising the June total.

  • Active Implants Closes $10M in Funding (polymer technology for hip/knee segments of orthopedics)
  • Alphatec Spine Completes $10 Million Private Placement of Common Stock (implants and systems for the treatment of spine disorders)
  • Anulex Technologies, Inc. Raises $10.2 Million in Series D (spinal disc preservation and anular repair)
  • Cappella, Inc., secures $17 million in Series C funding (sidebranch stent technologies for bifurcation vascular disease)
  • Catheter Connections, Inc., has raised $1.3 million in seed capital (device to prevent hospital-acquired infections caused by catheters)
  • CoAxia has raised $21.5 million in a Series D financing (acute ischemic stroke treatment)
  • Embrella Cardiovascular has closed a $5.1 million Series B round of financing (devices for embolic protection during cardiovascular procedures)
  • Estech Completes Additional $8 Million Financing (RF surgical ablation, minimally invasive valve surgery and CABG products)
  • Inspire Medical Systems received $17 million in Series B funding (implant for the treatment of obstructive sleep apnea)
  • Interlace Medical raises $20.5 million (office based polypectomy and myomectomy)
  • iRhythm Technologies, Inc., secures $6.5 million Series C (arrhythmia monitoring devices)
  • I-Therapeutix has raised $15 million in Series C funding (hydrogel-based eye bandages)
  • LifeBond Ltd. has raised $8 million in its second financing round (sealants and hemostats)
  • Ophthonix, Inc., receives $25.9 million in Series A funding (high definition vision correction lenses)\
  • PhysioSonics has raised $2 million in equity funding (brain blood flow monitor for stroke, head trauma)
  • Proteus Biomedical secures $11 million in series B financing (micro-electromechanical systems (MEMS) for the treatment of congestive heart failure)
  • Radiotherapy positioning start up Navotech raises $10m. in new round
  • Spiracur has raised $20.3 million in Series B funding (device for wound healing)
  • Stentys SAS has received $4.2 million in Series B financing (stents for coronary artery bifurcations)
  • SynCardia Systems, Inc., has raised $10.3 million in a Series D round of funding (total artificial heart)
  • Torax Medical receives $18M in venture capital funding (device for the treatment of acid reflux)
  • Transcend Medical has raised $35 million of an anticipated $40 million in a second round financing. Raised $20 million in early June, added $15 million in late June (device for glaucoma treatment)
  • VytonUS has received $11 million of a planned $11.5 million Series B funding round (ultrasound ablation catheter for treating atrial fibrillation)
Posted 30 June 2009 † P. Driscoll § early stage company § economy § innovation § investment § market data § medtech § startups ‡ Comments ° Tagged: , , , ,

Ablation technologies proliferate from their many clinical benefits

Surgical management of soft tissues via "ablation" therapies, in which alternative energy types (radiation, electrosurgcal, ultrasound, etc.) are applied to excise, destroy, or otherwise produce a therapeutic effect at the tissue level has undergone a proliferation in development with all of these alternatives vying for caseload in clinical applications as diverse as tumor ablation, arrhythmia ablation, endometrial ablation for treatment of endometriosis, ophthalmic procedures for vision and disease treatment, cosmetic, and many others.

The alternatives run the gamut from well established, high volume, low growth procedures like conventional x-ray to emerging, relatively low volume, high growth procedures like microwave ablation in cancer and arrhythmia ablation, and every other type of procedure in between.

Below illustrates the growth versus market size distribution of ablation technology alternatives.

ablation-bubbles

Source:  MedMarket Diligence, LLC; Report #A125, "Ablation Technologies Worldwide:  Products, Technologies, Markets, Companies and Opportunities."

 

Select technologies in ablation are among the most dynamic growth markets in the entire medtech sector.  The therapeutic and other benefits with these technologies included that they are typically less invasive than traditional surgery and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities therefore have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Posted 29 June 2009 † P. Driscoll § Cosmetic/aesthetic § ablation § cancer § cardiology § digestive § gastroenterology § innovation § interventional cardiology § interventional radiology § market data § medtech § minimally invasive § neurology § ophthalmology § orthopedic § spine § surgery § urogenital § vascular surgery ‡ Comments ° Tagged: , , , , , , , , , ,

Coronary stent market: global variations in markets, opportunities

Opportunities in the global market for coronary stents vary by type of stent being developed and the geographic territory in which a manufacturer hopes to compete.

Interesting, sometimes unpredictable dynamics govern why there are greater or lesser opportunities as one considers drug-eluting stents, bare metal stents and absorbable stents, as well as considering the U.S., Europe, Asia/Pacific or any of the remaining markets in the world.

Most importantly, the nature of being competitive in the coronary stents market — indeed, of being competitive in any medtech market — means being willing and able to pursue any and all opportunities, if not in different stent types then at least in global market opportunities. Given partnering options that are available for every sized company, from engineering/design all the way up to and including distribution in almost any market worldwide, pursuing a U.S.-only or Europe-only strategy may severely limit a company’s potential.  And with markets becoming increasingly competitive, any limitation in potential may relegate a player to minor market shares and eventual consolidation in the market.

Below are glimpse of the likely distribution of coronary stent unit sales volumes in 2017 by stent type and geography.  Although this is aggregate data displayed graphically, it does illustrate that the distribution of coronary stent market varys by geography, setting up very specific opportunities and challenges for market participants.

stent-geography

Source: MedMarket Diligence, LLC; Report #C245, "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017".

 

Posted 28 June 2009 † P. Driscoll § cardiology § drug § interventional cardiology § market data § medtech § stents ‡ Comments ° Tagged: , , , , , , , ,

Artificial heart, first fully implanted organ

The first fully implanted artificial heart (Abiocor Total Replacement Heart from Abiomed) was implanted this week at Robert Wood Johnson University Hospital (New Brunswick, NJ), marking the first ever fully implanted artificial "organ".  (See story.)

This is a striking development, one my late father, a thoracic/abdominal surgeon had serious doubts would happen (I believe the word he used was "never"). He claimed hemolysis would be the artificial heart’s downfall, since mechanical valves are just too rough on red blood cells. Given developments made since he cast his doubts, however, and given the milestones achieved by Abiomed, I think he might have a different view today.
 
It is indeed striking that such a mechanical device would reach application first, when diseases like diabetes have demanded so much research and the fundamental solution of matching insulin output to current blood glucose levels is a function that appears so ripe for a practical, even fully implantable, closed-loop biofeedback system.  However, it also points up the continued challenge of biomedical engineering toward systems that provide anything more than physical or structural solutions to disease, as opposed to systems that provide functions at the level of filtration, biofeedback-based drug delivery or other solution.

The complexities of producing an artificial organ are highlighted by looking at the casualties in the market for development of the artificial liver.  Companies that have pursued this without success (so far!)  include VitaGen, Daji Biosciences, Polygenetics, HepaLife Technologies, and Bioartis. Similar challenges have been seen in development of artificial kidneys, lungs and other organs.  The liver provides such complex set of independent and interrelated functions that it may yet be many years (and more company casualties) before a viable clinical option is developed.

abiocorEven though the artificial heart, even a fully implanted one, need only provide cardiac output to match the patient’s physiologic needs, it creates complex demands for a viable device, encompassing effective management of pressure, minimized damage to red blood cells, biocompatibility and other demands, not least of which include managing the device’s energy supply (lithium batteries charged via external coils that transmit energy transcutaneously).

Abiomed notes that this milestone is a technical rather than financial achievement, since a great deal of continued engineering will need to be done to make a fully implantable artificial heart commercially feasible.  For the time being, systems that are designed to provide "bridge to transplantation" capability, a lesser demand (e.g., not fully implantable), will have increased demand.

Unless and until cell biology, gene therapy or other biotech approaches are developed that can either create biological replacement tissue/organ or cure the underlying disease that otherwise leads to heart transplant, systems like Abiomed’s represent yet another example in which device solutions are not perfect (as discussed here, here and here) but they are available and in use here and now.

 

Posted via email from medmarket’s posterous

Posted 27 June 2009 † P. Driscoll § medtech ‡ Comments °

Coronary stent unit volume size, growth, by stent type

The trend in the development of coronary stents and their associated market segments is for price pressure but continued sales growth in drug-eluting stents, persistent utilization of bare metal stents driven by their lower prices and the emergence within a few years of bioabsorbable/biodegradable stents, which will raise the bar on stent performance, even compared to drug-eluting stents.

The growth versue market size bubbles for unit volume sales of the three stent types in 2014 are shown below.

stent-bubbles-UNITS

Source: MedMarket Diligence, LLC;  Report #C245, "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017."

Posted 26 June 2009 † P. Driscoll § cardiology § interventional cardiology § market data § medtech § pharmaceutical § stents ‡ Comments ° Tagged: , , , , , , ,

Worldwide market: Surgical Sealants and Glues (plus hemostasis, anti-adhesion)

Putting the market in focus, particularly the global opportunities for wound closure and its larger role in wound management demands addressing the applications for surgical sealants, glues, hemostasis and anti-adhesion.  Given the opportunities that exist globally, few competitors (if any) can seriously focus on, for example, the U.S. or Europe only, since competition in this arena has long since been cross-border.

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.

To pursue the opportunities at this scale has demanded that active market players recognize the size of the local market opportunity, the local regulatory and reimbursement demands and local practice patterns. (Note, for example, that fibrin sealants first gained a market foothill in Japan, due to a greater sensitivity there to the stigma of  bleeding and a lesser concern, at least compared to the U.S., about blood-borne viral transmission).

The opportunities in U.S. are being pursued aggressively by domestic players, but outside the U.S., there are also major market opportunities.  Moreover, these opportunities are not limited to Europe or Japan, as strong distribution systems, stable economies and, most importantly, growing caseload demand in many developing markets are more than enough to drive new business in surgical securement.  

securement-usa

securement-non-us-americas

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

 

 

Posted 25 June 2009 † P. Driscoll § biomaterials § clinical practice § market data § medtech § surgery § wound management ‡ Comments ° Tagged: , , , , , , , , , , ,

Medtech financings push past $260 million in June 2009

With late June financings by CoAxia ($21.5M), i-Therapeutix ($15M) and SynCardia Systems ($10.3M), total financings for medtech in the month of June have now passed $260 million.

syncardia  i-therapeutix  coaxia

Despite the lingering uncertainty in both the economy and the political sphere regarding healthcare reform legislation, and the accumulation of uninvested funds at VC firms, business goes on in medtech and companies such as SynCardia (artificial heart), i-Therapeutics (hydrogel-based eye bandages) and CoAxia (acute ischemic stroke treatment) and others who have secured funding this month.

We will post the complete list of June fnancings by the end of the month.

Posted 24 June 2009 † P. Driscoll § cardiology § interventional cardiology § investment § medtech § ophthalmology § reform § surgery ‡ Comments ° Tagged: , , , , , ,

Coronary stent unit sales by type, 2008 and 2017

The evolution in development of devices for anti-restenosis in treatment of coronary artery disease (for the time, limiting the focus to the various types of coronary stents) has proceeded along a path from the development of a device to maintain patency after angioplasty, then further reduce the occurrence of restenosis (which was occurring even in the presence of stents), to further reducing stents’ potential to induce restenosis despite the advanced stent shapes, drug coatings and other features.

The main categories of stent types reflecting this development timeline are (1) bare metal stents, (2) drug-eluting or drug-coated stents and, soon to come, (3) absorbable stents.  Within and between these categories, there are multiple variations in designs from the stent materials, stent shapes, stent coating types, stent coating methods and other differences.

Currently, drug-eluting stents dominate the coronary stent landscape worldwide.  While price pressures have been pushing back on the premiums of these devices, their efficacy compared to bare metal stents or, more significantly, coronary artery bypass, have enabled a very healthy unit volume growth rate.  Drug-eluting stents continue to increase in unit volume and caseload as clinicians opt for their use over the "restenosis-challenged" bare metal stents and the highly traumatic coronary artery bypass.

Treatments for coronary artery disease have demonstrated a dramatic tendency to evolve, driven by the high incidence of heart disease, its acute nature and the robust, enabling technologies in the use of drug-coatings and the emergence of advanced materials technologies, which have moved development toward the next phase of stent development, which is absorbable/biodegradable stents. As quoted by Dr. Patrick Serruys at CRT 2007, “Abolition of neointimal hyperplasia is no longer the ultimate goal. Development of more biocompatible and bioabsorbable stents facilitating adequate endothelialization is expected in the near future.” 

Below is the current (2008) and the 2017 distribution of unit volumes for the major types of drug-eluting coronary stents.

stent-by-type-pie-2008-2017

Source:  MedMarket Diligence, LLC; Report #C245, "Worldwide Drug-Eluting, Bare Metal and Other Coronary Stents Market, 2008-2017."

Posted 24 June 2009 † P. Driscoll § cardiology § drug § interventional cardiology § market data § medtech § stents § surgery ‡ Comments ° Tagged: , , , , , , , , ,