Tag Archives: cancer

Tissue ablation is predominantly cancer therapy

Tissue ablation is defined as the “removal of a body part or the destruction of its function, as by surgery, disease, or a noxious substance.” Put more simply, ablation is considered to be a therapeutic destruction and sealing of tissue.

The technologies representing the majority of physical (rather than chemical) ablation are comprised of the following:

  • Electrical
  • Radiation
  • Light
  • Radiofrequency
  • Ultrasound
  • Cryotherapy
  • Thermal (other than cryotherapy)
  • Microwave
  • Hydromechanical

Source: Report #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities."

The largest share of the market for energy-based ablation devices is used in cancer therapy, primarily using the radiation therapy modality. Following that is general surgery with its use of electrocautery and electrosurgical devices, RF ablation, cryotherapy, etc. Cardiovascular is thought to be third, even though cardiovascular is making the most noise in the medical press with RF and cryoablation of atrial fibrillation, this segment is thought to be third in share order. The remaining applications are relatively small and fall in line behind the three leading sectors.

Cryo Ablation Products

Cryotherapy, also called cryosurgery, cryoablation or targeted cryoablation therapy, is a minimally invasive treatment that uses extreme cold to freeze and destroy diseased tissue, including cancer cells. Although cryotherapy and cryoablation can be used interchangeably, the term “cryosurgery” is reserved best for cryotherapy performed using an open, surgical approach. During cryotherapy, liquid nitrogen or argon gas is applied to diseased cells located outside or inside the body. Physicians use image-guidance techniques such as ultrasound, computed tomography (CT) or magnetic resonance (MR) when using cryotherapy inside the body.

Below is a table of selected cryo-based products for ablation.

Cryotherapy Ablation Device Companies, Products, Applications* & Market Status*

[table “22” not found /]

*Note:  For detail on each product’s primary application, U.S. market status and international market status, see Report #A145.

Source: MedMarket Diligence, LLC; Report #A145, “Worldwide Ablation Technologies Market 2010″.

Barrett’s esophagus and ablation treatment

Barrett’s esophagus (BE) is a metaplastic alteration of the normal esophageal epithelium that is detected on endoscopic examination and pathologically confirmed by the presence of intestinal metaplasia on biopsy. It affects mostly Caucasian males over the age of 50. The cellular change in the lining of the esophagus is thought to be caused by chronic injury due to gastroesophageal reflux disease (GERD). Its major significance is that it is a predisposing factor for esophageal adenocarcinoma. The cellular changes place the patient at a significantly increased risk for developing esophageal cancer, between 200 and 6,660 times that of the general population depending on the severity of the Barrett's diagnosis. Cancer of the esophagus carries a high mortality rate, is the seventh leading cause of cancer death in the U.S. and has displayed a rapid rise in annual incidence. In US, an estimated 3.3 million people have BE, although only 1 in 200 will develop cancer.

(inset source: Wikimedia Commons; (Endoscopic image of Barrett's esophagus with permission to place in public domain taken from patient — Samir धर्म 05:21, 17 May 2006 (UTC))

 

Current and Emerging Treatment Trends
Standard treatment for BE consists of treating the GERD and watching to see if the BE develops into esophageal cancer. However, according to a new study from the Mayo Clinic, BE can often be eliminated using endoscopic radiofrequency ablation (RFA), and most patients remain free of BE five years following the initial procedure.

In this prospective, multi-center trial conducted from May 2004 to November 2009, researchers performed endoscopic RFA, designed to burn away the abnormal Barrett's cells, in patients with intestinal metaplasia. For 50 RFA patients in whom BE had been eliminated at the two and a half year assessment, endoscopy was performed at five years. Results showed that 46 of the 50 remained free of BE, and four patients had low levels of residual disease that was eliminated in a single follow-up RFA session.

Applicable Ablation Technologies: Rationale for Use and Effect on Tissues
There are RF ablation devices currently on the market (Barrx Medical) which are intended for the treatment of Barrett’s esophagus. The HALO360 and the HALO90 Ablation Catheter use radiofrequency energy to ablate the irregular Barrett’s cells. The ablated tissue sloughs away, leaving behind a clean lesion.

Another product, currently in development, utilizes cryotherapy to achieve the same goal. According to C2 Therapeutics’ patent application, the company is developing a medical device for treating esophageal tissue which consists of a catheter, a balloon, which may be placed within the esophagus of the patient, and a refrigerant. The refrigerant is delivered into the interior of the balloon so as to place the balloon into an expanded, cooled state. The balloon can then press against and cool the esophageal tissue. The company is currently operating in stealth mode.

Source: MedMarket Diligence, LLC; Report #A145, "Ablation Technologies Worldwide".

Liver cancer and ablation

Below is an excerpt from MedMarket Diligence reportt #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities", Report #A145.

Hepatocellular carcinoma (HCC) is the ninth leading cause of cancer death in the USA, the third leading cause worldwide, and the fifth most common solid tumor cancer. It begins in the cells of the liver and is usually not detected at an early stage, often resulting in a poor patient prognosis. The incidence of primary liver cancer in the USA is approximately 20,000 cases per year and is rapidly growing worldwide. In a report published in the May 7, 2010 issue of Morbidity and Mortality Weekly Report (MMWR), the average annual incidence rate of hepatocellular carcinoma in the U.S. increased significantly, from 2.7 per 100,000 people in 2001 to 3.2 per 100,000 people in 2006, with an average annual percentage change in incidence rate of 3.5%.

Globally there are approximately 660,000 cases per year. More than 80% of these cases occur in developing countries, with China alone accounting for over 55% of the total. Rates are more than twice as high in men as in women. Liver cancer rates are the highest in West and Central Africa and in Asia. In contrast, incidence rates are lowest in developed countries, with the exception of Japan. Among primary liver cancers occurring worldwide, hepatocellular carcinoma represents the major histologic type and likely accounts for 70-85% of cases.

Unfortunately, most cases could have been prevented. Chronic hepatitis B and C virus infections, which are highly prevalent in developing countries, account for 78% of all hepatocellular cancer in the USA. Prevention of virus transmission and progression of chronic viral disease has been shown to decrease the incidence of this cancer.

Current and Emerging Treatment Trends in Treatment of Liver Cancer

Liver cancer is one of the most fatal cancers, with five-year relative survival rates less than 11% even in developed countries. There are few non-surgical therapeutic treatment options available. Treatment may include surgery, chemotherapy, radiation therapy, or percutaneous ethanol injection, but radiation and chemotherapy are largely ineffective in the treatment of primary liver cancer. The standard first line treatment for liver cancer is surgery, either resection or liver transplantation, but surgery is confined to those patients whose tumors are confined to the liver, are no larger than 5 cm, and where the cancer has not invaded the adjacent blood vessels, organs or lymph nodes. Approximately 70% to 80% of patients are ineligible for surgery.

Ablation Technologies in Liver Cancer

Radio frequency ablation (RFA), with limitations, has shown to be effective and has increasingly become the standard of care for non-resectable liver disease. Radiofrequency ablation devices work by sending alternating current through the tissue. This creates increased intracellular temperatures and localized interstitial heat. When temperatures exceed 60°C, cell proteins rapidly denature and coagulate, killing the cells and producing a lesion. The lesion can be used to resect and remove the tissue or to simply destroy the tissue, leaving the ablated tissue in place.

(See inset, from "Radiofrequency Ablation for Cancer", Mayo Clinic.) 

Laser-induced interstitial thermotherapy (LITT) and microwave have also been utilized for the ablation of HCC tumors, although these two treatments do not seem to work as well on large tumors as other treatments. Interstitial laser photocoagulation uses a thin optical fiber (which is inserted into the center of the tumor) and a laser. When the laser light is emitted, the cancerous cells undergo thermal necrosis. Interstitial microwave kills the tumor cells by heating them to a high temperature (50 degrees C) for an extended period of time.

Minimally invasive irreversible electroporation is another treatment for HCC tumors. Electroporation increases the permeability of the cell membrane by exposing the cell to electric pulses. Irreversible electroporation opens the cell membrane in such a way that the cell cannot reverse the process and close the membrane. This open membrane causes the cell’s death. Irreversible electroporation is felt by some researchers to be comparable to cryosurgery, nonselective chemical ablation and high temperature thermal ablation.


Products, technologies, clinical applications and market for ablation technologies are detailed in MedMarket Diligence reportt #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities".

RF Ablation Proving Itself in Barrett’s Esophagus

From PRNewswire and Bio-Medicine.org… link.

Untreated epithelium in Barrett's esophagus

Results presented at this week’s Digestive Disease Week meeting in Chicago illustrated the effectiveness of BÂRRX Medical, Inc.’s HALO ablation system in the treatment of the pre-cancerous condition known as Barrett’s esophagus. The HALO ablation system uses radiofrequency (RF) energy to remove the epithelium in the esophagus of patients with Barrett’s esophagus (see image at right). In addition to these cell’s being pre-cancerous, Barrett’s esophagus is associated with chronic gastroesophageal reflux disease (GERD).

Results from a number of clinical trials were presented during the Digestive Disease Week (DDW) in Chicago this week, revealing new outcomes data related to endoscopic radiofrequency ablation using the HALO ablation system for eradicating a pre-cancerous esophageal condition known as Barrett’s esophagus. Among them, reports included durability outcomes from a randomized sham-controlled trial, safety and efficacy outcomes from a large U.S. registry of 429 patients, a randomized trial comparing ablation to endoscopic resection, and the largest European series to date in patients with high-grade dysplasia and early cancer.

As the DDW meeting commenced, the New England Journal of Medicine published a landmark paper entitled, "Radiofrequency Ablation for Barrett’s Esophagus Containing Dysplasia."  This is a U.S. randomized sham-controlled trial demonstrating high rates of complete eradication of barrett’s and dysplasia in the ablation group as compared to control, as well as a significant reduction in cancer progression.  At DDW, researchers presented new data from this now published trial showing that the ablation effect achieved at 1 year follow-up was highly durable at the 2-year follow-up.  

RF ablation is among a wide-range of energy-based technologies — cryo, microwave, laser, ultrasound, etc. — that are progressively penetrating virtually all clinical specialties where there is a need to selectively, with good clinical control and outcomes, therapeutically remove or ablate tissues.

(See the MedMarket Diligence report #a125, "Worldwide Ablation Technologies, 2008-2017", described at link.)

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Medical technology platforms with high growth potential

Specific technologies and broad technology platforms have tremendous potential for market growth based on combinations of recent technology advancement, changes in clinical practice, current forces in the market and other criterial. 

  • Biotech solutions to traditional medical device technologies.  The thrust of medical technology is, and has been for a long time, to make it as effective as possible while being the least possible invasive.  Taken to the extreme, instead of implanting a device, such as a suture or a staple, the almost perfect solution would to be to close wounds with no device at all.  Hence, surgical sealants, fibrin glues and other medical/surgical adhesives, hemostats and related biologicals (and even non-biologicals like cyanoacrylates), having proven themselves clinically and offering very low adoption hurdles, represent a huge opportunity in the medtech market.
     
  • Ablation and other high energy technologies.  What used to be handled by scalpel when my father did general surgery, is now increasingly being accomplished using energy-driven modalities that provide other tissue effects that a sharp metal blade alone could never do.  These technologies are therefore growing in both the penetration of traditional surgical procedures and their expansion to new clinical applications.
     
  • Nanotech and microelectromechanical systems (MEMS).  It is actually a gross oversimplification to use a word like "nanotech" and imply that you are talking about one type of technology.  The only thing common to nanotech is size; every manner of material, construction, function and clinical benefit is part of this area.  The pace of development is striking.
     
  • Drug-device hybrids.  Just a few of the applications of combining drugs and devices in a single device include localized drug-delivery that avoids toxic, systemic dosages and vastly improved biocompatibility of existing devices. These two options alone represent multiple enormous markets.  Now, naked metal (or other) implants seem almost barbaric.
     
  • Bioresorbable materials.   Polymer and other materials technologies are enabling the development of implants and other devices that conveniently go away when they are no longer needed.  Already a significant market force in areas like bone growth in orthopedics, bioresorbable stents and other implants are proving their worth in cardiology and urology. 
     
  • Atherosclerotic plaque-reversing drugs.  When Pfizer divested itself of Esperion Therapeutics, it did not bode the end of this striking new drug approach to atherosclerosis, it simply illustrated the persistent challenge of drug development.  Here, it should be kept in mind that, the bigger the potential payout, based on huge clinical need (e.g., drug solution to the device intensive treatment of coronary artery disease), the more likely it is only a matter of time before the product reaches the market.  The jury is out on the "when" part, not the "if".
     
  • Rational therapeutics.  This is the holy grail thinking behind the development of many, many biotech products.  If one can develop a cure — a direct resolution of the underlying biological defect or deficiency in disease — and not just the symptoms, then one has changed the market in paradigm ways.  The hurdle and the payoffs are huge.
     
  • Tissue engineering technologies.  We have begun to be able to develop tissue engineered organs of increasing complexity — skin, bladders and rudimentary pancreases — and the benefits of these are in applications too numerous to mention..
     
  • RFID.  There is little, really, that is sophisticated about radiofrequency identification devices,  but their rapid integration into medical technologies of a wide range (tagging surgical instruments so they don’t get left behind, implants that enable external identification or even status, other types) will extend the utility and value of medical devices.
     
  • Noninvasive glucose monitoring.  Optimizing care for diabetes means, at a minimum, very frequent (5-10) checks per day of blood glucose.  This many finger pricks per year by the total number of diabetics globally (a rapidly growing number at that) who clearly would benefit from noninvasive monitoring reveals the value of this opportunity.  Capturing that opportunity means the combined success of both technology and cost.
     
  • Infection control.  This area is a top area, not for the sigificant technologies that have been developed, but the enormous demand for them.  Between rapidly emerging problems like methicillin-resistant staph aureus (MRSA), the resurgence of tuberculosis, the enormous costs of nosocomial infections and other infection-related challenges, infection control is an enormous, global opportunity.
     
  • Spine surgery.   The nature of the human spine, constructed of bone that needs to be both flexible and strong, demands device-intensive solutions.  The growing patient population of active, older adults is ratcheting the pressure on technologies to be less invasive, provide greater range of motion, last longer, cost less — all of which drives innovation in spine surgical technologies.
     
  • Obesity treatment technologies.  Technology solutions to the increasingly prevalant problem of obesity are imperfect, but still are frequently better solutions for the obese than an alternative that may ultimately also encompass heart disease, diabetes, stroke and other problems.  Diverse drug and device alternatives have been developed and the trend in obesity incidence will simply drive their continued development. 

Other forces are at work driving the above technologieis including, of course, cost containment, the integration of information technologies in both medical product and development process and the globalized economy.

(While the above list  is separately a White Paper that I have written, and periodically re-write to reflect new stuff being developed, I find it interesting and worthwhile to revisit frequently and discuss in this blog.)


The above topics are covered in various MedMarket Diligence reports.  See our list of titles.

 

 

 

Medical technology defies definition

In a prior post, I sought to explore the shifting nature of the medical industry, from clearly defined categories of devices, drugs and diagnostics to a spectrum of products that defy categorization into any one category and instead frequently qualify as multiple.

…Competition in the medical product industry has long since changed from being defined as those products performing a similar, albeit narrowly-defined function, like when the angioplasty manufacturer could reasonably consider his/her competitors to be all other manufacturers of devices that produce catheter-based recanalization of the atherosclerotic lumen. It is a myopic angioplasty manufacturer who does not now also consider atherectomy, transmyocardial laser revascularization, bare metal stents, drug-eluting stents, and traditional/open, MIDCAB (and similar) or even percutaneous coronary artery bypass graft, as well as the classes of drugs and other non-device approaches to produce non-surgical reversal of atherosclerosis….

Gauging the state of technology development in the recent past and the present, the trend toward less demarcation between medical product categories continues unabated, not just for treatment of ischemic heart disease, but for other diseases and disorders. Advances in technology enable this, while the customer — healthcare systems, third party payers and, increasingly, patients — are demanding this.

There nonetheless remain certain aspects of select diseases and disorders that sustain preference if not dominance by one class of medical products.  The spine, playing as it does such a physical, structural, functional role, demands solutions that are device-intensive (e.g., discs, cages), however much bone growth factors, bone graft substitutes and other non-device products are moving in. Cancer treatment, aside from surgical intervention, remains largely a drug-intensive effort, although "drug" continues to be redefined to include moieties that are clearly biotech in nature.

I continue to think about ischemic disease in particular because it represents a sort of microcosm of medtech development. Physicians like to view treatment in terms of "gold standards" or the current state of the art, but as ischemic heart disease (and many other diseases) have shown, the goal line keeps changing as new technologies advance the quality of life, clinical outcome, cost of care and other criteria that determine value of innovations in the market.  Ischemia can be addressed from so many different perspectives that it has become a lightening rod for development efforts.  

Ultimately, I am thrilled at bearing witness to the evolution of technology development.  At the same time, however, I must empathize with. and work hard to come to the aid of, my medtech clients who must continually look to the bigger picture to ensure that their products and technologies remain relevant, lest the trend suddenly make them obsolete.