Wound Sealant and Securement Procedure Volumes by Clinical Area and End-Point

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

Sealants, glues, hemostats, and other products in wound closure and securement offer benefits that vary by clinical area, but the nature of that benefit also varies by the type of end-point (benefit) the product achieves — does it provide a life-saving benefit? A time-saving? Cost-savings? A cosmetic or aesthetic benefit?

Accordingly, by examining the volume of procedures for which closure and securement products provide which kind of benefit is crucial to understanding demand, especially between competitive products.

Below is a categorization of benefits ranging from the critical (I) to the aesthetic (IV).

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

Screen Shot 2015-06-23 at 7.24.29 AM

Source: MedMarket Diligence, LLC (Report #S192)

Considering these different categories, below are the volumes of procedures distributed by category across each of the major clinical disciplines.

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Wound Closure Products, Worldwide (Millions), 2014

 

 

 

 

Screen Shot 2015-06-23 at 7.28.36 AM

Source: MedMarket Diligence, LLC (Report #S192)

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

New Medical Technologies at Startups, May 2015

Below is the list of technologies under development at medical technology companies identified in May 2015 and included in the Medtech Startups Database.

  • Nanotechnology-based diagnostic
  • Bone fixation devices, including for post-sternotomy closure
  • Devices and materials for bone lengthening
  • Nanopolymer drug delivery
  • Developing an artificial pancreas; combined blood glucose monitor and insulin pump
  • Terahertz radiation-based measurement of blood glucose
  • Patient-specific orthopedic implants
  • Undisclosed medical technology
  • Novel energy delivery-based medical technology
  • Device for early detection of cardiovascular disease based on endothelial dysfunction
  • Facet joint surgical instruments
  • Neuromodulation technology
  • Electric stimulation in wound healing
  • Mesenchymal stem cell treatment in cardiology, transplantation, and autoimmunity
  • Integrated blood glucose monitor, insulin dosing
  • Surgical instrumentation

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

 

Technologies at Medtech Startups, May 2014

Below is a list of the new medical technologies under development at startups we identified in May 2014 and added to the Medtech Startups Database.

  • Patient positioning system for use in hip replacement and other orthopedic procedures.
  • Instrumentation to facilitate hip replacement surgery and other orthopedic instrumentation.
  • Drug-coated stent-valve designed to inhibit stenosis, obstruction or calcification of the valve.
  • Implants for the treatment of aneurysm.
  • Orthopedic implant technologies including a force sensor to measure performance of an orthopedic articular joint.
  • Insulin patch pump for treatment of insulin-dependent type 2 diabetes.
  • Undisclosed tissue vascular technology
  • Rapid, accurate, inexpensive diagnostic devices initially focused on malaria.
  • Device for diagnosis and management of diabetic retinopathy.
  • Tumor-targeted drug delivery.
  • Near infrared technology for blood glucose monitoring in diabetes.
  • Non-resorbable films for anti-adhesion.
  • Angioplasty double balloon for treatment of peripheral vascular disease.
  • Device to reduce the risk of ventilator-associated pneumonia.
  • Trocar, sleeve and tip for minimally invasive endoscopic surgery.

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

Tissue Engineering and Cell Therapy Market Outlook

The market for tissue engineering and cell therapy products is set to grow to nearly $32 billion by 2018. This figure includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies. The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

An overview (map) of the spectrum of clinical applications in tissue engineering and cell therapy is shown below:

Source: Report #S520

Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

Tissue engineering and cell therapy may be considered comprised of bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The goal of stem cell research is to develop therapies to treat human disease through methods other than medication. Key aspects of this research are to examine basic mechanisms of the cell cycle (including the expression of genes during the formation of embryos) as well as specialization and differentiation into human tissue, how and when the differentiation takes place and how differentiated cells may be coaxed to differentiate into a specific type of cell. In the differentiation process, stem cells are signaled to become a specific, specialized type of cell when internal signals controlled by a cell’s genes are interspersed across long strands of DNA and carry coded instructions for all the structures and functions of a cell. In addition, cell differentiation may be caused externally by use of chemicals secreted by other cells, physical contact with neighboring cells and certain molecules in the microenvironment.

The end goal of stem cell research is to develop therapies that will allow the repair or reversal of diseases that previously were largely untreatable or incurable.. These therapies include treatment of neurological conditions such as Alzheimer’s and Parkinson’s, repair or replacement of damaged organs such as the heart or liver, the growth of implants from autologous cells, and even regeneration of lost digits or limbs.

In a developing human embryo, a specific layer of cells normally become precursor cells to cells found only in the central nervous system or the digestive system or the skin, depending on the cell layer and the elements of the embryo that direct cell differentiation. Once differentiated, many of these cells can only become one kind of cell. However, researchers have discovered that adult body cells exist that are either stem cells or can be coaxed to become stem cells that have the ability to become virtually any type of human cell, thus paving the way to engineer adult stem cell that can bring about repair or regeneration of tissues or the reversal of previously incurable diseases.

Another unique characteristic of stem cells is that they are capable of self-division and self-renewal over long periods of time. Unlike muscle, blood or nerve cells, stem cells can proliferate many times. When exposed to ideal conditions in the laboratory, a relatively small sample of stem cells can eventually yield millions of cells.

There are five primary types of stem cells: totipotent early embryonic cells (which can differentiate into any kind of human cell); pluripotent blastocyst embryonic stem cells, which are found in an embryo seven days after fertilization and can become almost any kind of cell in the body; fetal stem cells, which appear after the eighth week of development; multipotent umbilical cord stem cells, which can only differentiate into a limited number of cell types; and unspecialized adult stem cells, which exist in already developed tissue (commonly nerves, blood, skin, bone and muscle) of any person after birth.

tissue-cell-2012-2018

Source: MedMarket Diligence, LLC; Report #S520, “Tissue Engineering & Cell Therapy Worldwide 2009-2018.”

Developmental Timescales

Tissue engineering and cellular therapy products take years of research and many millions of dollars (averaging about $300 million, according to some reports) before they make it over the hurdles of clinical trials and into actual market launch. More than one small biotech company has burned through its money too quickly and been unable to attract enough investment to keep the doors open. The large pharmaceutical and medical device companies are watching development carefully, and have frequently made deals or entered into alliances with the biotechs, but they have learned to be cautious about footing the bill for development of a product that, in the end, may never sell.

For many of the products in development, product launch is likely to occur within five years. Exceptions include skin and certain bone and cartilage products, which are already on the market. Other products are likely to appear on the European market before launch in the United States, due to the presence of (so far) less stringent product review and approval laws in the European Union.

Even when the products are launched, take-up will be far from 100% of all patients with that particular condition. Initially, tissue engineering and cell therapy products will go to patients suffering from cancers and other life-threatening conditions, who, for example, are unable to wait any longer for a donor organ. Patients who seem to be near the end of their natural lives likely will not receive these treatments. Insurance coverage will certainly play a key role as well in the decision about who receives which treatments and when. But most importantly, physicians will be selecting who among their patients will be treated; the physicians learn about the treatments by using them, by observing the patient’s reactions, and by discussing their experiences with colleagues. In other words, the application of tissue engineering and cellular therapy will progress in a manner similar to the introduction of any new technology: through generally conservative usage by skilled, highly trained physicians dedicated to providing their patients with the best possible treatment without causing them additional harm.

 

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Cell Therapy and Cardiovascular Disease

Cell therapy is defined as a process whereby new cells are introduced into tissue as a method of treating disease; the process may or may not include gene therapy. Forms of cell therapy can include: transplantation of autologous (from the patient) or allogeneic (from a donor) stem cells , transplantation of mature, functional cells, application of modified human cells used to produce a needed substance, xenotransplantation of non-human cells used to produce a needed substance, and transplantation of transdifferentiated cells derived from the patient’s differentiated cells.

Once considered a segment of biomaterial technologies, tissue engineering has evolved into its own category and now comprises a combination of cells, engineering and suitable biochemical and physiochemical factors to improve or replace biological functions. These include ways to repair or replace human tissue with applications in nearly every medical specialty. Regenerative medicine is often synonymous with tissue engineering but usually focuses on the use of stem cells.

Tissue engineering and cell therapy may be considered as comprising bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration. These often comprise a combination of biotechnology, medical device and pharmaceutical technologies.

Researchers have been examining tissue engineering and cell therapy for roughly 30 years. While some products in some specialties (such as wound care) have reached market, many others are still in research and development stages. In recent years, large pharmaceutical and medical device companies have provided funding for smaller biotech companies in the hopes that some of these products and therapies will achieve a highly profitable, commercial status. In addition, some companies have been acquired by larger medical device and pharmaceutical companies looking to bring these technologies under their corporate umbrellas. Many of the remaining smaller companies received millions of privately funded dollars per year in research and development. In many cases it takes at least ten years to bring a product to the point where human clinical trials may be conducted. Because of the large amounts of capital to achieve this, several companies have presented promising technologies only to close their doors and/or sell the technology to a larger company due to lack of funds.

The goal of stem cell research is to develop therapies to treat human disease through methods other than medication. Key aspects of this research are to examine basic mechanisms of the cell cycle (including the expression of genes during the formation of embryos) as well as specialization and differentiation into human tissue, how and when the differentiation takes place and how differentiated cells may be coaxed to differentiate into a specific type of cell. In the differentiation process, stem cells are signaled to become a specific, specialized type of cell when internal signals controlled by a cell’s genes are interspersed across long strands of DNA and carry coded instructions for all the structures and functions of a cell. In addition, cell differentiation may be caused externally by use of chemicals secreted by other cells, physical contact with neighboring cells and certain molecules in the microenvironment.

The end goal of stem cell research is to develop therapies that will allow the repair or reversal of diseases that previously were largely untreatable or incurable. These therapies include treatment of neurological conditions such as Alzheimer’s and Parkinson’s, repair or replacement of damaged organs such as the heart or liver, the growth of implants from autologous cells, and even regeneration of lost digits or limbs.

In a developing human embryo, a specific layer of cells normally become precursor cells to cells found only in the central nervous system or the digestive system or the skin, depending on the cell layer and the elements of the embryo that direct cell differentiation. Once differentiated, many of these cells can only become one kind of cell. However, researchers have discovered that adult body cells exist that are either stem cells or can be coaxed to become stem cells that have the ability to become virtually any type of human cell, thus paving the way to engineer adult stem cell that can bring about repair or regeneration of tissues or the reversal of previously incurable diseases.

Another unique characteristic of stem cells is that they are capable of self-division and self-renewal over long periods of time. Unlike muscle, blood or nerve cells, stem cells can proliferate many times. When exposed to ideal conditions in the laboratory, a relatively small sample of stem cells can eventually yield millions of cells.

There are five primary types of stem cells: totipotent early embryonic cells (which can differentiate into any kind of human cell); pluripotent blastocyst embryonic stem cells, which are found in an embryo seven days after fertilization and can become almost any kind of cell in the body; fetal stem cells, which appear after the eighth week of development; multipotent umbilical cord stem cells, which can only differentiate into a limited number of cell types; and unspecialized adult stem cells, which exist in already developed tissue (commonly nerves, blood, skin, bone and muscle) of any person after birth.

One of the key methods by which to evaluate the potential market opportunities in the early stages of an industry such as tissue engineering and cellular therapy is to look at the number of current procedures that could possibly be augmented or replaced by the new technologies. In the sections that follow, we review the major areas of transplantation and estimate the clinical caseloads that reflect potential uses of tissue engineering. It should be kept in mind that it is highly unlikely that tissue engineering will replace 100% of these particular procedures, even after years of clinical usage. There will always be patients for whom certain procedures are inappropriate; other procedures may not be fully covered by insurance and hence will only be used by those patients who can afford them. Transplant of cadaver organs is likely to continue as long as these organs are available and free of disease, and the cost of transplantation is equal to or less than the cost of tissue engineering. The latter, of course, reflects a key pricing strategy for tissue engineering and cellular therapy. The clinical caseloads for the conditions addressed are enormous, hence, even with the caveats, the potential markets for TE and cell therapy are extremely significant. The competition within the infant industry is fierce, with reason.

Cell Therapy in Cardiovascular Disease

The term “cardiovascular disease” encompasses as large number of diseases of the heart and vasculature. There are an estimated 70 million Americans who could benefit from cell-based therapies for cardiovascular applications. The prevalence and incidence of cardiovascular disease in the United States are shown in the following exhibits.

Source: MedMarket Diligence Report #S520: Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018

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.) 

Bridge-to-transplant gets permanent approval

FDA Approves For Permanent Treatment Of Advanced Heart Failure Assist Device Pioneered By Texas Heart Institute At St. Luke’s Episcopal Hospital.  See Link 

Although designed as a bridge-to-transplant device, the HeartMate II has proven itself sufficiently in trials to warrant its approval as a permanent device.  Designed by the Texas Heart Institute, the continuous flow left ventricular assist device will have a significant impact for the shortage of donor hearts.

“The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major milestone for patients in the United States. In any given year there are some 250,000 people who suffer from advanced heart failure, while only about 2,000 heart transplants are performed annually in the U.S.”
HeartMate II

This remarkable technology, unlike other technologies that might claim reduced cost, improving clinical outcomes, or both, can claim that a considerable number of lives may be saved, PLUS reducing costs and improving outcomes.

Percutaneous accomplishes even more

Melody TranscatheterWith the FDA's approval of Medtronic's Melody Transcatheter Pulmonary Valve and Ensemble Delivery System (see link), another step has been made toward eliminating traditional surgery — at least that's the idea. The ability to implant a valve via a percutaneous procedure advances the art of less invasive intervention in ways akin to laparoscopic surgery, albeit at lower volume.

Percutaneous, NOTES (natural orifice transluminal endoscopic surgery) and laparoscopic surgery are progressively removing the need for invasive traditional surgery. 

It is precisely due to percutaneous procedures that coronary stents have been able to present such a clinical challenge to coronary artery bypass. Although minimally invasive approaches to CABG are an attempt to pull back some surgical caseload, they are technically complex, expensive and, therefore, are not likely to stem the tide toward the dominance of percutaneous procedures. Ironically, the one procedure that may save bypass is the transcatheter route.  With the approval of the Melody approach, it is clear that that is not impossible.

_______
See Worldwide Coronary Stents Market.

Palmaz says the stent future is in bare metal

Dr. Julio Palmaz, who with Dr. Richard Schatz patented the balloon-expandable stent, believes that, while the market for stents has evolved from bare metal stents to drug-eluting stents (DES), the inevitable limitation of DES will be that they lead to inflammatory response and that their real drawback is that they create a barrier between tissue and the metal of the stent itself.

A plenary speaker during the XXX Congresso Nazionale Della Societa Italiana Di Cardiologia Invasiva (GISE), Dr Julio Palmaz (University of Texas Health Science Center, San Antonio) predicted that coatings "of any kind" will prove to be the downfall of drug-eluting stents—even the bioerodable polymers or the coatings used on fully bioerodable stents that today represent the next great hope in DES technology. Pointing to the failure of gold-coated stents back in 2000, Palmaz called on stent manufacturers to "learn from the mistakes of the past."

"Any coating, of any kind, will have the potential to [produce] nonspecific inflammatory changes," he predicted.

See full story on theheart.org at link.

Dr. Palmaz pointed out that, in a bare metal stent, the positive charges of the metal cause the natural formation of oxides that induce healing. The problem with first generation metal stents, he says, is that the constructions of the stents, and their deployment, cause an interruption of the smooth metal surface that lead to an "unhappy" environment surrounding the stent, leading to restenosis. Dr. Palmaz's focus now, through his own company, is to engineer "advanced metallurgical surface technologies" that address this.

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Global stent market, Report #C245.

Growth of coronary stent market in Japan, China

(The global market for coronary stents worldwide is assessed in the MedMarket Diligence report #C245, "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017.")

japan-china-stentsThe market for coronary stents in Asia and the Pacific region contains both China (early technology adopters) and Japan (with a longer regulatory approval cycle), which generated a combined majority of stent sales from the region. The Asia/Pacific market for coronary stents is forecasted to grow 6.7% annually over the period from 2008 to 2017.

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In terms of stent type, the Asia/Pacific market is dominated by drug-eluting stents, which represent roughly 80% of the market—a much larger portion of the stent market than seen in other regions. This is due to the fact that in China, nearly 100% of coronary stents used are drug-eluting. The remaining 20% of the market represented by bare metal stents are largely in those areas outside China.

The introduction of bioabsorbable stents will increase the total market for coronary stents and reduce the dominance of "non-bioabsorbable" drug-eluting stents in the market, although (as we have implied) a share of bioabsorbable stents will be of the drug-coated variety.


Data sourced from MedMarket Diligence Report #C245 (published 2Q 2009).