Category Archives: cardiology

topic is largely or exclusively about cardiology products, technologies, markets and/or companies

Growth in Sales of Products in Cell Therapy and Tissue Engineering

Tissue engineering and cell therapy comprise a market for regenerative products that has been growing and will continue to grow at over 20% annually through 2018. This market spans many specialties, the biggest of which is therapies for degenerative and traumatic orthopedic and spine applications. Other disorders that will benefit from cell therapies include cardiac and vascular disease, a wide range of neurological disorders, diabetes, inflammatory diseases, and dental decay and/or injury. Key factors expected to influence the market for regenerative medicine are continued political actions, government funding, clinical trials results, industry investments, and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications.

The current high rate of growth in cell therapy and tissue engineering product sales is due to the confluence of multiple market drivers:

  • Advances in basic science revealing the nature of cell growth, differentiation and proliferation
  • Advances by industry to manipulate and determine cell growth toward specific therapeutic solutions
  • Low barrier to entry for competitors in the market
  • Broad range of applications of cell/tissue advances to many different specialties with modest adaptation needed
  • Strong venture funding

The dominant clinical area driving cell therapy and tissue engineering product sales is orthopedics and musculoskeletal, wherein bone grafts and bone graft substitutes are well-established. Below is the projected balance of cell therapy and tissue engineering product revenues by clinical area through 2018.

Screen Shot 2014-04-08 at 9.26.25 AM

Source: MedMarket Diligence, LLC; Report #S520.

While orthopedics, musculoskeletal and spine applications will remain a huge share of this market, more growth is coming from cell/tissue products in most other areas, which have only recently (within the last five years) begun to establish themselves.

Screen Shot 2014-04-08 at 9.34.50 AM

Source: MedMarket Diligence, LLC; Report #S520.

Medtech from incremental to quantum leap advances

Advanced medical technologies become advanced by the application of innovation that results in more effective, less costly or otherwise arguably better outcomes (including reduced risk of complications or disease recurrence) for patients, including in some cases enabling treatment when none was previously possible. It is intrinsic to every entrepreneur that the idea he/she is pursuing accomplishes this.

Manufacturers of products on the market have an imperative to either improve upon those products or make them obsolete. This imperative is manifested in a spectrum of planned innovation from simple incremental innovations to the quantum leap of a radically new approach.

There is an enormous amount of technology development, often applicable to multiple different clinical applications, that will be realized in product markets in the future. For the moment, though, I would like to look beyond “incremental improvements” or “product line extensions” or other marginal advances that serve little more than superficially addressing shortcomings of existing products on the market. I would like to look at waves of innovation coming in the short to long term that are expected to impact medtech in ways that are increasingly “radical” or represent varying orders of magnitude of improvement in results.

Three categories spanning short, mid, and long reflect what I see in medtech development. Below, I outline the nature of each and the specific examples that are or will be emerging.

Short term. With change encompassing technologies that are just sufficiently different so that they cannot simply be called incremental innovations, some short term advances often combine two or more complementary and/or synergistic technologies in new ways to advance healthcare. Examples include:

  • Image-guided surgeries to augment the surgeon’s ability to navigate complex anatomy or discern the margins of healthy versus disease tissue.
  • Natural orifice endoscopic surgery (and shift in general from invasive to interventional and intraductal procedures) to either drastically reduce or eliminate the trauma of surgical access
  • Non-invasive therapeutics (like lithotripsy, gamma knife, others) to treat disease without trauma to collateral tissues.
  • Genome-driven treatment profiling (prescreening to determine ideal patients with high probable response).
  • Personalized (custom) implants. These already exist in orthopedics, but the potential for customized implants in gastroenterology, cardiology, and many other clinical areas is wholly untapped.
  • Regenerative technologies (bone, skin, other). These technologies represent introductory markets with lowered challenge compared to more complex functional anatomy (e.g., vital organs).
  • Smart devices (implantable sensors, RFID-tagged implants, etc.) to provide data to clinicians on implant location and status or, in the extreme respond diagnostically or therapeutically to changes in the implant’s immediate environment.

Mid-term. These are new therapeutic options that are fundamentally different than those in current use for a given treatment option. These are technologies that have demonstrated high probability of being feasible in large scale use, but have not yet accumulated enough clinical data to warrant full regulatory approval.

  • Nanotech surface technologies for biocompatibility, localized treatment delivery or other advantages at the interface between patient and product.
  • Materials that adapt to changes in implant environment, to maintain pH, to release drugs, to change shape.
  • Artificial heart. A vital organ replacement that currently has demonstrated the capacity to be a bridge to transplant but has also advanced sufficiently to open the possibility of permanent replacement in the not-too-distant future.
  • Cell/device hybrids. These are organ replacements (e.g., kidney, lung, liver) performing routine function or natural organs, but configured in a device to address unresolved issues of long term function, immune response and others.
  • Artificial organs (other than heart) — closed loop glucometer/insulin pump (artificial pancreas). These are not even partial biological representations of the natural organ, but completely synthetic “organs” that intelligently regulate and maintain a steady state (e.g., blood glucose levels) by combining the necessary functions through combined, closed-loop mechanical means (an insulin pump and glucometer with the necessary algorithms or program to independently respond to changes in order to otherwise maintain a steady state.

Long-term. Orders of magnitude, quantum shift, paradigm shift or otherwise fundamentally different means to serve clinical need.

  • 3D implant printing. In a recent example, in an emergency situation a 3D implant for repair of a infant’s trachea was approved by the FDA. These implants, as in the case of the trachea repair, will most often be customized for specific patients, matching their specific anatomy and may even include their (autologous) cells. They may also be made of other materials including extracellular matrices that will stimulate natural cell migration followed eventually by bioabsorption of the original material. Depending upon type of material and complexity of the anatomy, these technologies may emerge in the near or distant future.
  • Gene therapies. Given the root cause of many diseases has a genetic component or is entirely due to a genetic defect, gene therapies will be “permanent corrections” of those defects. An enormous number of hurdles remain to be crossed before gene therapies are largely realized. These deal with delivery and permanent induction of the corrected genes into patients.
  • Stem cell therapies. The potential applications are many and the impact enormous of stem cell therapies, but while stem cell technology (whether for adult or embryonic) has made enormous strides, many challenges remain in solving the cascade of differentiation while avoiding the potential for aberrant development of these cells, sometimes to proliferative (cancerous) states.
  • “Rational” therapeutics. Whether by stem cell therapies, gene therapies or other biochemical or biological approach, “rational” therapeutics represent the consummate target for medical technology. Such therapeutics are “rational” in the sense that they perfectly address disease states (i.e., effect cures) without complication or need for recurrent intervention.

There are certainly more holes than fabric in this tapestry of short-, mid- and long-term technology innovation, but this should serve to illustrate the correlation between the sophistication of the potential medtech solution and the level of technical challenge in order to achieve each.

 

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. The markets covered in the three reports are:

  • Ophthalmology Diagnostics, Devices and Drugs (see link)
  • Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
  • Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “Reference Reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

  • Disease prevalence, incidence and trends (including credible forecasts to the present)
  • Clinical practices and trends in the management of the disease(s)
  • Industry structure including competitors (most still active today)
  • Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above.  Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.

 

Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, Forecast to 2017

Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World. 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 establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

See description, table of contents and list of exhibits at http://www.mediligence.com/rpt/rpt-s190.htm Published February 2012..

Clinical utility of advanced wound closure and securement products

Products for the advanced securement of wounds — stopping bleeding, sealing the wound, tightly closing the wound and preventing post-surgical adhesions — will be accepted by clinicians (and paid for by healthcare systems) to the extent that the provide very specific clinical utility compared to traditional alternatives, many of which (like sutures and tapes) are simple to use, cost little and otherwise are readily accepted in the business of wound management.

Clinicians (and healthcare systems) will accept and adopt for routine use those new products for hemostasis, closure, sealing and anti-adhesion of wounds, whether chronic or acute, based on the level of clinical utility they provide compared to those traditional products, and the extent to which those new products provide utility is based on the types of utility provided (from “critical” to “perceived”), a metric that varies by clinical specialty.  For example, a new product that prevents bleeding and dramatically reduces morbidity is much more likely to be adopted than a product that yields merely aesthetic (e.g., reduced scarring) or perceived benefits that have no impact on morbidity.

Advanced products offer different degrees of utility from, on the high end, the value of enabling procedures otherwise not possible or highly impractical to, on the low end, perceived benefits with no significant positive impact on morbidity.  Further, the impact of advanced products varies by clinical specialty, with some expected differences between, for example, cardiology procedures and cosmetic procedures. The four main categories of benefit from advanced products include:

  • 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.

Below is illustrated the distribution — by clinical category — of the kind of utility provided by advanced wound securement products (fibrin and other sealants, high strength adhesives, hemostatic products and anti-adhesion products):

cardio

 Total: 51.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

cosmetic

Total: 12.7 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 digestive

Total: 20.9 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

general

Total: 27.4 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

neuro

Total: 16 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

ortho

Total: 10.8 million procedures
Source: MedMarket Diligence, LLC; Report #S190.

 

 

Technologies at recently identified medtech startups

Below is a list of the technologies under development at startups that MedMarket Diligence recently identified and added to the Medtech Startups Database.

  • Tissue regeneration technologies for non-invasive skin care.
  • Biomaterials supplied to medical device and pharma manufacturers
  • Trans-reflective fetal EKG.
  • Surgical instrumentation.
  • Undisclosed medical technology.
  • Technologies for autologous tissue collection.
  • Stem cell therapy.
  • Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
  • Transcatheter repair of mitral valve regurgitation.
  • Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
  • Device-based treatment of congestive heart failure.
  • Clamping device to control bleeding in trauma.
  • Tissue matrix composition for tissue regeneration and wound care.
  • Spinal pain relief devices.
  • Wireless remote arrhythmia monitoring and diagnosis.
  • Undisclosed medical technology.
  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.

Levels of demand for products in wound closure, hemostasis and anti-adhesion

MedMarket Diligence’s global market Report #S190 on the range of products involved in wound securement encompasses surgical sealants, high-strength medical adhesives, sutures/staples/clips, hemostatic agents and products to prevent post-surgical adhesion.

The potential impact of emerging products in this area is driven by not only caseload but by the nature of the clinical “need”, ranging from a product being critical to provide treatment for a particular indication to a need that may only be represented in perceived benefits.

We have quantified the current and future market for products in surgical wound closure, hemostasis, anti-adhesion and related applications by detailing the products on the market and under development and assessed their current and forecast utilization based on the net result of clinical need drivers and the competitive landscape into which these products may find adoption.

For the sake of characterizing the nature of the need behind possible future product adoption, we have quantified the caseload, by clinical area, relative to a spectrum of needs levels from “important and enabling” to “aesthetic and perceived benefits”.

Category I:  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.

Category II: 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).

Category III: Cost-Effective and Time-Saving

Immediate reduction in surgical treatment time and follow-up treatments.

Category IV: 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.

On this basis, see the graphic representation below, which illustrates that the majority of demand for these products arises from the fact that they improve the clinical outcome for patients. Another key element of this is that the primary clinical areas of application contributing to demand for these products is in cardiovascular, general surgery, neurology and digestive specialties.  Note, please the categories of I-IV refer to the categories described above.

sealant-product-caseload

Source: MedMarket Diligence, LLC; Report #S190.

As further indication of the value of these products is the fact that the category exhibiting the lowest level of demand is for products that offer only aesthetic or perceived benefits.