Energy-Based Devices in General Surgery

The dynamic market for energy-based devices used in general surgery is growing steadily with compounded annual growth rates of 12% projected for the short term. This market includes devices based on ultrasonic, radio frequency (RF), light, thermal, hydromechanical, cryogenic and microwave technologies.

The popularity of ultrasonic devices is due in large part to the fact that they do not utilize heat when sealing tissues, thus effectively eliminating smoke from the operating room. This can reduce costs for hospitals as the absence of smoke eliminates the need for smoke evacuation systems. Meanwhile, the lack of smoke also improves the surgeon’s line of vision. Also to their benefit, ultrasonic surgical instruments combine cutting, grasping and coagulation into one tool set, thus further reducing cost while also reducing surgical time as there is no longer a need for intraoperative instrument exchanges. Lastly, patient safety is enhanced because with ultrasonic systems, there is no electric current passing though the patient’s body, which can result in lateral tissue damage.

The second largest segment in the market for energy-based devices used in general surgery comprises devices based on RF energy, which (like laser systems) rely on thermal welding to achieve tissue coagulation. RF devices comprise roughly 27% of the overall market for devices used in general surgery. Growth in this market segment is being driven by the introduction of new technologies into the marketplace.

Thermal energies, which are used most often in surgeries to treat benign prostatic hyperplasia (BPH) and menorrhagia, also have application in general surgery, however, less than 5% of the market is devoted to these systems. Newly developed hydromechanical (based on water-jet technology), cryogenic, and microwave systems also are being introduced into the market, thus further fueling market growth in devices designed for general surgery.

Many developments have occurred among the manufacturers in this dynamic market over the last several months.(Further details in August 2006 MedMarkets.)

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Biomaterials Stimulating Orthpedic Growth

The total world market for all orthopedic devices and materials was worth $20 billion in 2005 and is growing at annual rates in the range 7-10%; the US accounts for almost half the market overall. A major contributor to the market, both in terms of size and growth, is orthopaedic biomaterials. This segment contributed $4.6 billion (23%) to the global orthopaedic market in 2005 and furthermore is growing considerably faster than the market overall, with a predicted CAGR in the region of 15% over the next five years. The buoyant performance of this sector is due to a combination of several factors, including demographic and lifestyle changes, the emergence of new types of biomaterials offering significant improvements in performance, the premium prices associated with novel high-tech products, and evolving attitudes among orthopaedic surgeons.

From August 2006 issue of MedMarkets and forthcoming MedMarket Diligence report #M625.

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Local Market Volume of Medical/Surgical Procedures

I continue my discussion of our use of the Medicare 100% file and other datasets to serve specific needs of medical product manufacturers.As I mentioned, the Medicare 100% file is large (measured in gigabytes) unwieldy and, as anyone who has purchased raw data from the U.S. government can attest, the file is not constructed in the most convenient format to allow simply queries, summaries or other processes that will reveal meaninful insights. And, given the cost, the need for HIPAA-related disclosure agreements to be signed,m the dataset is not quite amenable to data analyst with occasional interest or need in purusing it. Lastly — and this goes for all reimbursement or discharge survey datasets — whatever logic may govern the coding systems (DRG, ICD-9 and CPT4) used in this data, the reality of how clinicians fle claims and how survey data is collected can result requires that working with claims-based and survey-based datasets be done by someone with experience in these issues.

Now you might understand why the question, “So if this is in the public domain, how is your product in any way unique?” causes me to take a breath before answering.

MMD has joined with Medical Technology Partners (MTP) to capitalize on MTP’s use of these large datasets, which have been acquired for reimbursement consulting, to use them for answerng very technology-specific and facility-specific questions raised by medical product manufacturers.

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Top Volume Hospitals by DRG, ICD-9

[The data we offer, and discussed below, includes data on the top volume hospitals by DRG or ICD-9. We drive the data reports from the 100% Medicare file (a very big, unwieldy file that is impractical to work with unless you have the resources and need to work with it). This is the 2005 volume of actual claims filed at each facility. Not estimates.]We had no idea when we started offering clinical utilization data to medical product companies seeking data in support of new product introduction, etc., that we would have such a positive response to the offer of providing the data on the top volume hospitals with claim data on the DRG or ICD-9 codes of interest. It was really overwhelming. MMD (MedMarket Diligence) looked at the types of questions being asked, and the purposes being put to the data, by the typical medical product company client — VP, President, Director, Product manager — and realized that while on the high end of needs (“what products should we be developing?” or “what companies should we acquire?”) the questions were adequately answered by U.S. aggregate data on total volume, with trends, payer segmentation, reimbursement amounts, and the like, but on the “low” end we were not helping clients enough.By low end, I mean answering questions about “where should I send my sales reps tomorrow?.” Well, how about looking at the hospitals in any geographic territory that have the highest volume utilization, measured by patient discharges and the specific diagnoses or procedures currently or potentially using the company’s products?

After we started adding this to quotes, we sudddenly realized that hospital-specific data was in very big demand.There are a lot of other aspects to working with this data, making sense of it and delivering it the right way. In subsequent posts, I’ll describe that a little further, but don’t have time now.

I have two more quotes to get out before day’s end.

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Technologies in Treatment of Stress Urinary Incontinence

Bulking Agents for Stress UI

One important weapon in the arsenal of noninvasive or minimally invasive therapies for Stress Urinary Incontinence (SUI) comprises bulking agents—injectable substances that expand the intrinsic sphincter of the bladder, allowing it to withstand greater pressures.

There are several companies exploring or developing bulking agents for SUI (see chart). For many of these, the technology was initially designed as a therapy for treatment of wrinkles or other dermal defects, gastroesophageal reflux disease (GERD), wound care, drug delivery or other therapy.

Treatment for urinary incontinence ranges from pelvic muscle rehabilitation to behavioral therapies and pharmacologic therapies. Beyond that, surgical therapies exist and are becoming increasingly less invasive. Minimally or even noninvasive interventional therapies are extremely attractive to both young and old patients; younger patients don’t want to be slowed down by an open surgery while many older patients may not be strong enough to undergo such.

The latest therapies being developed to treat SUI involve bulking agents, sling or urethral supports, and even stem cell therapies, among other procedures.

At least 13 million Americans suffer from urinary incontinence, a condition that is far more frequent in women than in men. In the general population between the ages of 15 and 64, 10%–30% of women are affected, compared to only 1.5–5% of men. At least 50% of all nursing home residents have urinary incontinence, 70% of whom are women.

The Agency for Health Care Policy & Research estimates that $16.4 billion is spent annually on incontinence-related care: $11.2 billion for community-based programs and at home, and $5.2 billion in long-term care facilities. In addition, $1.1 billion is spent annually on disposable products for adults.See MedMarkets, July 2006 issue.

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Spine Surgery Market Development at a Pivotal Stage

Coverage in the July 2006 issue of MedMarkets includes an overview of the U.S. and worldwide spine surgery market (excerpt below).

Treatments for disorders of the spine – ranging from degenerative disc disease, kyphosis, diskitis, spinal stenosis, spondylolysis/spondylolisthesis and others – stand at a crux between multiple options. Spinal fusion (lumbar and cervical) will be on the rise for a few short years before disc replacement/repair and other approaches will have begun to penetrate significant caseload. Competitors in the market for spine surgery products face a combination of opportunity and risk that will result in big rewards for some and only brief rewards for others.

Worldwide Spine Surgery Market, 2003-2009

Source: MedMarket Diligence, LLC, Report #M501, “Worldwide Spine Surgery Market.” See link.

Treatments for these disorders range from the non-surgical and inexpensive (bed rest) to complicated surgeries designed to excise tissue and halt vertebral segment motion (spinal fusion). “Back trouble”—especially among aging baby boomers and the elderly—is in no imminent danger of decline. Consequently, the spine-related osteobiologics market in the U.S. will undergo steady growth for the next decade. Although certain treatments and technologies currently enjoying a robust market share will likely be replaced by those now in development, older men and women will seek the best treatment alternatives available to help them maintain an active lifestyle.

Over the past two decades, the worldwide spine industry has grown dramatically, with annual revenues in 2004 estimated at about $3.4 billion. Disorders or conditions located in the lumbar area of the spine account for the majority of these revenues.

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Timescale of nanotechnology materials/components and application development

Nanotechnology Biomedical Application Development Timescale

Source: MedMarket Diligence, LLC, from “Micro- and Nanomedicine: Technologies, Applications, Industry, and Markets Worldwide,” report #T625. Published May 2006 (see description and table of contents here).

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Drug delivery and nanotech

Nanotech products are being developed to improve delivery of drugs with poor solubility. It is estimated that 40-50% of newly developed drugs have solubility problems. Sales of drugs with poor solubility and low bioavailability totalled $72 billion in 2003, up from $64 billion in 2002. The total world market opportunity for nanotech-derived drug delivery products and services was estimated at $290 million in 2005 (0.6% of the total drug delivery market, valued at more than $43 billion). This is predicted to grow at a CAGR of 50% to reach $8.8 billion by 2015, or over 5% of the total drug delivery market.Many nanotech research projects are devoted to improving drug delivery and targetting in cancer. The oppurtunity is considerable. The total cancer chemotherapy market in 2005 was estimated at $10 billion, including plain and DDS (drug delivery system) products. The DDS market share was 20% in 2000; this is forecast to grow to 80% by 2010. The cancer market itself will grow as the over-65 population in developed countries increase from 12% in 2000 to 20% in 2020.

From MMD’s May 2006 report, Micro- and Nanomedicine.

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Endovascular Technologies Drive AAA and TAA Stent-Graft Market

Stent-Grafts for AAA will represent a $1 billion market in less than five years.

Endovascular aortic repair (EVAR) is one of the most significant technological advances in vascular surgery over the last decade and continues to show promise as a less-invasive alternative to conventional surgery in treating patients with abdominal aortic aneurysms (AAAs) or thoracic aortic aneurysms (TAAs). As manufacturers make ongoing refinements to endovascular devices for aneurysm therapy, the estimated 2.7 million aortic aneurysm patients in the United States have more treatment options available than ever before. Although aneurysms are far less common than heart attacks, they are also far more fatal. According to the National Center for Health Statistics, roughly 15,000 patients die annually from ruptured aortic aneurysm, and this number may be low because the condition can be overlooked easily in a standard autopsy. Ruptured abdominal aneurysm is currently the 13th leading cause of death in the United States. In fact, as many as 2 of 3 patients with an AAA rupture die prior to reaching the hospital. Even with open surgery, there is an average 48% mortality rate associated with patients having a ruptured AAA. AAAs typically enlarge slowly and without symptoms, making them difficult to detect. However, detecting AAAs early and repairing them can decrease the death rate by one-sixth. TAAs are also under-diagnosed because most patients are asymptomatic. The incidence of TAA in the United States ranges from 15,000 to 30,000.

Rapid Market Growth Expected
The endovascular stent-graft market will continue to expand rapidly for a number of reasons. One primary driver comprises increasing numbers of patients who will select this less-invasive procedure over the traditional open surgery with its longer recovery periods and higher rates of complications. In addition, the aging population will continue to expand, putting more people at risk for aneurysm. It is estimated that 5%–7% of those over age 65 has an AAA. Finally, implementation of screening programs will detect a greater number of cases of aortic aneurysm, thus leading to an increase in the number of endovascular stent-graft procedures. The chart on page 1, “Worldwide Market for AAA Stent-Grafts,” illustrates this growth. The first endovascular aortic grafts were available for use in the United States in 1999. Now there are four AAA endografts that are FDA-approved and available commercially in the United States for EVAR: Cook’s Zenith AAA, Endologix’ Powerlink, Medtronic’s AneuRx, and Gore’s Excluder. Gore is the only company with a TAA endograft (the Gore TAG) on the U.S. chart, “Developers of Endovascular Grafts for Abdominal and Thoracic Aneurysm Repair”). TAA endografts show great potential, not only for the treatment of TAA but also for other anomalies of the thoracic aorta, such as acute and chronic dissections, penetrating ulcers and traumatic injuries. U.S. research institutions are serving as clinical trial sites for next-generation aortic endografts made of synthetic fabrics. Boston Scientific’s TriVascular Enovus AAA and the Terumo/Vascutek Anaconda are examples of investigational endografts that incorporate new design features, taking into account varying patient morphology. market; other manufacturers’ devices are in development and/or are available outside the United States. TAA endografts show great potential, not only for the treatment of TAA but also for other anomalies of the thoracic aorta, such as acute and chronic dissections, penetrating ulcers and traumatic injuries. U.S. research institutions are serving as clinical trial sites for next-generation aortic endografts made of synthetic fabrics. Boston Scientific’s TriVascular Enovus AAA and the Terumo/Vascutek Anaconda are examples of investigational endografts that incorporate new design features, taking into account varying patient morphology.

Looking Ahead
The rate of EVAR should increase rapidly within the next decade with the advent of promising technologies such as lower-profile devices that allow percutaneous delivery and endostapling devices that offer increased durability as well as the ability to treat short, angulated necks. Imaging modalities used with EVAR also will continue to improve, providing greater accuracy for screening, as well as procedural and post-procedural surveillance needs.

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Meanwhile, American Medical Systems Corners a Market

Company Steadily Secures the Urogenital Treatment Market
The acquisition of Laserscope by American Medical Systems Holdings this month for $715 million adds a certain punctuation to AMSH’s steadily growing presence in the field of urogenital medicine or, as the company refers to it, “pelvic health.” Lest there be any doubt, AMSH has been on a Tyco-like drive of acquisitions that have garnered it a clear lock on urogenital markets. In May 2006, the company acquired Solarant Medical, a maker of minimally invasive therapies for stress urinary incontinence. In April 2006, AMSH acquired BioControl Medical for its implantable electrical stimulation technology, which the company will use to develop its own incontinence treatment technology. In 2004, the company acquired TherMatrx, the developer of an office-based thermal treatment for BPH, In 2003, the company acquired CryoGen, the developer of cold technology for treatment of menorrhagia, and the company also acquired erectile dysfunction technologies from Endocare in 2003…the list goes on.
While Boston Scientific and Medtronic fight tooth and nail in both the courts and the markets to gain turf in the cardiovascular device industry, we watch with interest as AMSH has steadily purchased its own plot of real estate in the urogenital arena, a field that while putatively overshadowed by cardiology, represents a hugely attractive area of upside potential, and growing less crowded all the time.

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