advanced medical technologies

Development of surgical sealants, glues and other securement products

P. Driscoll — Tue, 21 Feb 2012 04:05:24 +0000

Surgical closure and securement products range from simple suture products through to sophisticated biomaterial aids for hemostasis, sealant activity, and for adhesion prevention. Within the hemostasis field, products have the objective of rapidly achieving hemostasis and acting to seal in the presence of high pressure blood flow or air flow.

Development Timelines

Natural hemostats (inset: see Cornell) such as gelatin, collagen and thrombin were first developed as hemostatic agents, followed by mixes and fibrin sealants. More recently, companies have introduced synthetic sealants and hemostats that accelerate the process of blood clotting and provide a stronger seal that will withstand greater pressures. These products employ various synthetic polymer chemistry systems. Glues are required to secure tissue firmly under substantial forces. In extreme cases such as musculoskeletal repair, these glues need to withstand high tension and pressure forces. Fibrin and other sealants are not strong enough for these applications and have been used as adjuncts to sutures and staples. Cyanoacrylate glues have sufficient strength for most procedures but are not yet cleared for use in the majority of internal applications due to toxicity concerns. They also lack sufficient flexibility for use in many procedures.

Efforts are progressing to develop new biomaterials capable of gluing tissues with high strength, low toxicity, and sufficient flexibility to avoid breakage of the bond. In addition, cyanoacrylate manufacturers are examining the possibility of improving cyanoacrylate technology to overcome the existing challenges of toxicity and brittleness. Despite this huge challenge, one or both of these two approaches are likely to establish new products in the next decade. In addition, the evidence of research work suggests it should be possible to create a glue technology that incorporates hemostatic properties to further enhance the role of this technology.

Apart from fibrin-based sealants and cyanoacrylate-based high-strength glues, there are three other main categories of closure/attachment products in use or in development at present: collagen and thrombin combination, polyethylene glycol polymer (PEG), and albumin cross-linked with glutaraldehyde.

Development of these products is taking place at well over a hundred companies, of all sizes, worldwide. See MedMarket Diligence Report #S190, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017".

Untapped potential in fibrin sealants, glues

P. Driscoll — Sat, 18 Feb 2012 17:04:24 +0000

In the past two decades, the number of products, applications and companies in the field of surgical sealants and glues has grown dramatically as the products' applications and performance have been met by robust demand on the part of a wide variety of clinical specialties worldwide. Fibrin and other sealants alone (excluding hemostats and high-strength medical adhesives) will reach a global market in excess of $2 billion within five years.

Considering the number of active companies (well over 100) in the field of sealants, glues, hemostats, post-surgical adhesion products and the "traditional" wound closure products of sutures, staple and mechanical closure, one might conclude that the field is crowded. However, the concentration of competitors is ultimately determined by both the current and potential market in which they would compete. Therein lies the drive for continued growth in the number of companies in this field, as evidenced by what can be considered the "actual" versus "potential" market, at least in theory. By this, the actual market for a product is simply the current revenues, while the potential market is the revenues for for that product's competitors. Looking a fibrin and other sealants, the potential market may therefore be considered to be the current revenues for sutures, staples, clips and other mechanical closure.

Source: "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017", Report #S190; MedMarket Diligence, LLC

Of course, this is somewhat of an academic exercise, since not all fibrin sealants can be expected to effectively replace all sutures/staples/clips/etc., but the potential for fibrin sealants lies significantly within those competing revenues.

Medical and Surgical Wound Closure, U.S. and Europe, 2011 and 2017

P. Driscoll — Thu, 16 Feb 2012 00:40:28 +0000

Markets for medical technologies are often dominated by the U.S. and Europe, with their well developed healthcare systems, payment systems and propensity to adopt advanced technologies (arguably, to a fault).

The market for advanced medtech products providing hemostasis, wound closure, wound sealing, anti-adhesion and other functions is no less the case. The U.S. still drives the lion's share of the worldwide market, while Europe, for all its collective buying power, still runs a close second.

The 2011 and 2017 markets for products in surgical securement, encompassing sutures & staples, other mechanical closure, tapes, hemostats, fibrin & other sealants, high-strength medical adhesives, and post-surgical adhesion prevention products, are illustrated for the U.S. and Europe below, drawn from the February 2012 MedMarket Diligence Report #S190, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017." The relative balance of market contribution by each is expected to change little during the forecast period, with comparable growth for both U.S. and European markets.

Source: MedMarket Diligence, LLC; Report #S190.

High growth markets in surgical sealants, glues and related products

P. Driscoll — Tue, 14 Feb 2012 19:41:14 +0000

Growth in the market for surgical sealants, glues, hemostats, sutures/staples and products to prevent post-surgical adhesion varies widely by product and geographic market. Newer products penetrating clinical practice in wound closure and securement, such as high-strength medical glues and adhesives are ramping up, progressively gaining caseload as clinicians adopt these novel closure products in growing numbers of procedures. Also, while growth of all wound closure and securement products is strong globally, higher than average growth is seen for new products in western markets and Japan.

Below is illustrated the high growth product and geographic areas in the global securement market, illustrating that western markets and high strength adhesives represent some of the strongest forecast growth in this field.

Source: "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017", Report #S190, MedMarket Diligence, LLC

Hemostat products and companies

P. Driscoll — Wed, 08 Feb 2012 04:31:47 +0000

Hemostats have been used for over a hundred years to prevent bleeding in the surgical situation. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers, such as Johnson & Johnson, which now sells Surgicel (an oxidized regenerated cellulose hemostat), Instat (a freeze-dried collagen product), and Spongostan/Surgifoam (a freeze-dried gelatin hemostat).

For stopping bleeding, modern hemostats go far beyond simple gauze. Almost all hemostatic agents work in conjunction with or in addition to the body’s own blood clotting activity. These agents generally work by physically obstructing the outflow of blood in the wound, accelerating clotting reactions, and providing a matrix for increased platelet interactions, resulting in faster and stronger fibrin clot formation that can bind to and seal vascular injuries. However, the effective hemostatic action of these products depends heavily on the patient having a capable and intact coagulation function. This may not be the case if the patient has received, for example, a synthetic colloid fluid in the field to prevent shock, which results in hemodilution, or if the patient is hypothermic or in hypovolemic shock. If there is pre-existing coagulation deficiency, then many of these hemostats will not work. There is a need for a hemostatic agent that can function effectively in the absence of the patient’s coagulation function. One of the products that function well in these situations is the fibrinogen-based dressing. Fibrin sealants can also act as hemostatic agents, so there is in effect some overlap between the ‘Fibrin and Other Sealants’ and the ‘Hemostats’ categories. However, at upwards of $600 per use, fibrin sealants are rather too expensive to use as hemostats.

There are over 40 active companies market and/or developing hemostat products and many of them have multiple types of hemostats based on the constituent active ingredients. Below is illustrated the number of active hemostat companies based on the product types they are pursuing or selling.

Source: MedMarket Diligence, LLC, Report #S190.

Medical and surgical procedures with potential use of sealants, glues, hemostats

P. Driscoll — Tue, 07 Feb 2012 22:50:34 +0000

The extent to which medical and surgical procedures may potentially employ emerging fibrin (and other) sealants, glues, hemostats, wound closure and anti-adhesion products is driven by the utility offered by these products in specific clinical applications, which may be grouped by the following consideration:

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.

Source: MedMarket Diligence, LLC; Report #S190.

MedMarket Diligence has assessed the procedure volumes, worldwide, that fall into these categories based on the utility offered by adjunctive surgical sealant and glues products for each of the major clinical categories:

Source: MedMarket Diligence, LLC; Report #S190.

Factors affecting wound healing and associated wound sealant and closure products

P. Driscoll — Tue, 07 Feb 2012 16:47:14 +0000

Medical and surgical wounds account for a huge share of healthcare dollars. Managing these wounds, especially at the time of their formation (whether formed by trauma or surgical incision) now involves a comprehensive understanding of the nature of the wounds and the necessary process of their healing. Manufacturers have developed a large arsenal of tools that can be used alone or in combination to accelerate and optimize wound healing.

The factors that determine whether, how long or how effectively wounds heal are detailed in the table below.

Factors Affecting Wound Healing

Factor	Impact
Moisture	The lack of sufficient moisture, or conversely an excess of moisture, can slow down repair. Lack of moisture often occurs with dry wound healing approaches; this stops cellularity, dries out cells and prevents the flow of humoral factors essential for removal of pathogens and for cell communication. It ultimately prevents the movement of keratinocytes for epithelialization. Too much moisture can lead to maceration, which causes osmotic damage to cells and slow healing, as well as breakdown of surrounding tissues.
Infection	Infection by micro-organisms can significantly slow down healing, leading to an extended inflammatory phase and cell necrosis. Some organisms in the wound are not detrimental, and evidence suggests that some microbes accelerate healing. However, organisms like Staphylococcus aureus and many anaerobic microbes are pathogenic and will live off the tissues.
Debris	The presence of debris within the wound will delay healing. It is essential to remove any contaminating material that may be a source of infection, or which may delay healing through chemical or physical obstruction.
Temperature	Tissue healing tends to be optimal at higher than normal physiological temperature. The exact reasons are not clear, but at higher temperatures enzymes and cell metabolism tend to achieve faster removal of pathogens and greater catabolic activity.
Pressure	Pressure is a major extrinsic factor that can be detrimental to healing. This is why significant effort has gone into development of pressure relief products for use in situations involving mechanical stress. In addition, a number of devices have been evolved which are designed to modify the pressure around a wound to facilitate healing.

Source: Report #S190

Traditional wound closure products have included sutures, tapes and, more recently, staples, clips and other "mechanical" wound closure. These products have been augmented by the regulatory approval and marketing of fibrin (and other) sealants and glues, high-strength glues, hemostasis products and even products to prevent post-surgical adhesion (which often use sealant/glue analogues in a manner to prevent adhesion).

The market potential for the future utilization of surgical sealants, glues, wound closure and anti- adhesion products is closely tied to the growth in the number of procedures performed, as well as the gradual adoption of these products for multiple uses (sealing, hemostasis and even anti-adhesion.) Use of these technologies will eventually become routine in surgical and other clinical practices. Demographic forces are driving potential caseloads and therefore are also a factor in market potential. Changing regulatory demands will continue to influence the markets for these products, although this influence may drive demand up or cause a decrease in demand.

Below is illustrated the major product segments comprising the wound sealant and closure market worldwide, with growth and market size represented for each segment.

Source: Report #S190

Technologies at recently identified medtech startups

P. Driscoll — Thu, 02 Feb 2012 15:40:26 +0000

Companies added to the Medtech Startups Database from MedMarket Diligence are listed below:

Annuloplasty ring for mitral/tricuspid valve repair
Microinjection technology for ophthalmic drug delivery
Intervertebral implants
Undisclosed technology for the treatment of obstructive sleep apnea
Technology to enable office-based myringotomy tube procedures
Hydrogel technology for the prevention of post-surgical adhesions
Organ preservation and transport systems for transplant organs
Obesity device technology
Endovascular stapling system
Device for the treatment of scoliosis in children
Drug delivery technology
Cannulas and other instruments for use in liposuction and other cosmetic procedures
Wound management products including protegodome, a hard, dome-shaped bandage to protect wounds from impact

To see a comprehensive list of the technologies at these startups that have been added to the database over the past several years, see link.

Medical technology financing hits $400 million for January 2012

P. Driscoll — Tue, 31 Jan 2012 22:35:03 +0000

Medical technology financing in January 2012 exceeded $400 million.

Top financings for the month included:

$89 million for ConforMIS, Inc. (patient-specific orthopedic implants)
$52.7 million for Aria Diagnostics, Inc. (prenatal diagnostic testing)
$45 million for Mevion Medical Systems (proton beam radiation therapy)
$34 million for CytoPherx, Inc. (device for anti-inflammatory therapy for acute kidney injury)
$33 million for Arena Pharmaceuticals, Inc. (drug development including for obesity treatment)

The complete list of medtech financings for the month is shown at link.

Treatments for Vertebral Compression Fractures

P. Driscoll — Tue, 24 Jan 2012 21:58:00 +0000

Vertebral compression fractures result primarily from osteoporosis and the consequent weakening of bones, including those in the spine. VCFs can result in tremendous back pain both in the short and long term. Because the injured vertebra is compressed and loses height, kyphotic deformity of that particular vertebra and the spine as a whole often results. Kyphosis in and of itself can produce pain long after the vertebral compression fracture has healed. As discussed earlier, several conditions can lead to osteoporosis, including estrogen deficiency, multiple myeloma, radiation therapy, and natural aging. Bones weakened either due to the primary disease process or as a result of treatment of such diseases are more prone to fracture. Common sites osteoporotic fracture include the spine, hip, and wrist.

The traditional treatment for VCFs is conservative care with back braces, bed rest, and analgesic medications for alleviating pain. Although given time the fracture eventually heals, the vertebral body remains in a collapsed, compressed state. This can result in prolonged pain, impaired function, and decreased activity. Additionally, bone and muscle loss resulting from a lack of activity can make recovery even more difficult, leading to the so-called ‘downward spiral’ of vertebral osteoporosis.

In recent years, two minimally invasive procedures have been introduced to treat VCFs: vertebroplasty and kyphoplasty. The procedures are very different, in that vertebroplasty is designed to stabilize the break, while kyphoplasty attempts to both stabilize the break and bring the collapsed vertebra back to its original height.

(Subsequent sections in Report #M520 cover vertebroplasty, kyphoplasty and key clinical studies related to the treatment of VCFs.)

Companies, Products and Regulatory Status in Vertebroplasty and Kyphoplasty

Company	Product	Regulatory status
Alphatec	OsseoFix Spinal Fracture Reduction System and OsseoFix+ Cement	CE Mark; IDE filed; not available in USA yet.
ArthroCare	Cavity SpineWand	CE Mark; FDA cleared.
ArthroCare	MD SpineWand surgical device	CE Mark
AscendX	AscendX Vertebral Compression Fracture Reduction System	In clinical testing
Benvenue Medical	PEEK-OPTIMA Kiva VCF Treatment System	CE Mark
Biomet	Cobalt bone cement and CVD and LP2 delivery systems	CE Mark; FDA cleared.
Biomet	CDV System for vertebroplasty	FDA cleared
Biomet	LP2 Stainless Steel Delivery System	FDA cleared
Biomet	Vertebroplasty System	FDA cleared
BoneSupport	Spine Support injectable bone substitute and mixing and delivery systems	CE Mark; FDA cleared.
CareFusion	AVAflex Advanced Vertebral Augmentation injection needle, AVAmax augmentation systems, AVAtex bone cement	FDA cleared
Cook	Duro-Ject injector set, Minimix cement mixer, Oteo-Force vertebroplasty trays	CE Mark; FDA cleared.
DePuy Spine	Confidence bone cement and delivery system	CE Mark; FDA cleared.
Dfine	StabiliT system w/osteotome and bone cement	CE Mark; FDA cleared.
Integra Spine	OsteoJect cement delivery	FDA cleared
Lafitt	Solver vertebroplasty cement and instruments	CE Mark
Medtronic	Kyphon kyphoplasty system with bone cement	CE Mark; FDA cleared.
Medtronic	Kyphon Xpander II Inflatable Bone Tamp (IBT)	FDA cleared
Orthovita	CORTOSS Bone augmentation material	CE Mark; FDA cleared.
Osseon Therapeutics	Osseoflex delivery needle and bone drill	CE Mark; FDA cleared.
Signus	Vertebroplasty instruments	FDA cleared
Sintea	Spider expandable tamp	CE Mark; FDA cleared.
Skeltex	Integrated System for Vertebroplasty	In development
Soteira	Kyphoplasty technology	CE Mark
Spine Wave	StaXx FX Structural Kyphoplasty System	CE Mark; FDA cleared.
SpineAlign	VerteLift expandabel implant	CE Mark; in IDE study
Stryker	SpinePlex and VertaPlex cements, mixer and delivery systems	FDA cleared
Stryker	iVAS Inflatable Vertebral Augmentation System	FDA cleared
Synthes	Vertebral Body Stenting System	CE Mark
Synthes	Vertecem V+ System	CE Mark
Synthes	Vertecem	CE Mark
Tecres	Mendec cement and spine kit	CE Mark; FDA cleared.
Teknimed	Spine Fix biomimetic cement and delivery system	CE Mark; FDA cleared.
Vexim	SpineJack height restoration implant and Cohesion bone cement	CE Mark

Source: "Worldwide Spine Surgery: Products, Technologies, Markets and Opportunities 2010-2020", Report #M520, MedMarket Diligence, LLC

Applicable caseloads for surgical sealants, glues and related products

P. Driscoll — Tue, 24 Jan 2012 19:24:30 +0000

The potential for the application of adjunctive wound management products is driven by the nature of the medical or surgical wound type, the vascularization at the site, the tensile strength needed and capable with available medical/surgical glues and the extent to which manufacturers have developed products that clinicians have adopted, or may soon adopt, in their practices.

Below are illustrated key procedures worldwide that applicable for use of adjunctive wound management products — fibrin and other sealants, high strength glues, hemostatic agents and anti-adhesion products.

Source: MedMarket Diligence, LLC; Report #S190, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017"

High strength medical and surgical glue applications, growth

P. Driscoll — Mon, 23 Jan 2012 19:08:06 +0000

High-strength glue products were approved for topical closure applications in the United States in the late 1990s, but have been used considerably more outside the USA. In other countries, such as the major markets of the EU, high-strength glues and adhesives were approved several years ago and have built up a track record of use in internal surgery. Today, high-strength glues are being used in a wider range of procedures both in the US and outside the US. Physicians and researchers are exploring how these glues may be utilized in current or new procedures to produce more cost-effective, better outcomes with reduced morbidity and mortality.

The unmet need for non-toxic, high-strength, resorbable glues is clearly demonstrated by adoption of existing glue products outside of the United States. The table below displays selected applications (see report #S190 for the comprehensive list) for commercially approved products and illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide. These products have high-strength sealant and adhesive properties is leading to their increasing adoption by clinical practitioners, starting with surgical closure and specific internal procedures for which there is no good alternative. Recent data shows increasing usage for tissue adhesives in vascular, neurological, spinal, orthopedic, and other procedures.

Selected* Surgical Indications for High-Strength Glues

Surgical Field	Selected Applications
Cardiac surgery	Augmentation of aortic and vascular sutures. Repair of minor epicardial lacerations without the use of sutures. In re-operations, as a hemostatic adhesive on lacerations of the ventricle caused by re-sternotomy or the presence of adhesions.
Digestive tract endoscopy	Endoscopic treatment of esophageal and esophagotracheal, gastric, gastrointestinal, duodenal, and pancreatic fistulas.
Neurosurgery	As a sealant in cranial and spinal dural plastic surgery to prevent CSF fistulas. Closure and filling of cranial fossae and cavities.
General surgery	As an adhesive in both traditional and laparoscopic inguinal hernia plastic surgery with patches. Hemostasis of liver section slices.
Gynecological surgery	As an adhesive and hemostatic agent in cervical trauma. As an adhesive and hemostatic agent in vaginal and perineal plastic surgery.
Urological surgery	Sealing of surgical sutures to avoid urinary extravasation. Hemostasis in the course of kidney transplants.
Interventional radiology and vascular neuroradiology	Arterial and venous embolizations.
Pediatric surgery	Hemostasis of liver section slices. Gluing, repair and hemostasis of parenchymal tissue on lacerations or hemorrhagic lesions of the liver, kidney, pancreas, or spleen.
Pediatric cardiac surgery	Consolidation of aortic and vascular sutures in general. As a hemostatic agent on suture lines between biological and/or synthetic tissues in the reconstruction of cardiac and vascular walls.
ENT surgery	Hemostasis and salivary sealing in oral and rhino-pharyngeal cavity surgery. Hemostasis and salivary sealing of damaged portions of the pharynx, tongue, soft and hard palates in extirpative oncological procedures.

*See Report #S190 for the comprehensive list.

Source: MedMarket Diligence, LLC, Report #S190, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017."

Obesity prevalence in the U.S. remains high

P. Driscoll — Tue, 17 Jan 2012 21:26:23 +0000

Obesity in the U.S. continues to remain high according to two studies being reported in the Journal of the American Medical Association (JAMA). In data comparing the results from the Center for Disease Control and Prevention's 2009-2010 National Health and Nutrition Examination Survey with the same survey for the 1999-2008 period, there has been little change in the aggregate rates of obesity, but select demographics — including males, male children and adolescents — show statistically significant increases during this period.

The global obesity epidemic is driving the development of numerous devices, drugs and surgical procedures, yet the demand for more effective obesity treatment remains high as no definitive treatment has emerged with positive long-term results.

(See "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", by MedMarket Diligence. Report #S835.)

Covidien Voluntarily Recalls Duet TRS Single-Use Tissue Reinforcement Product

P. Driscoll — Mon, 16 Jan 2012 22:10:23 +0000

Covidien PLC today voluntarily announced a recall of its Duet TRS single-use tissue reinforcement product after reports that the product "has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications", according to the company.

The Duet TRS cartridge, which contains a tissue reinforcement material applied concurrently with staples in one step, is used with Covidien’s Endo GIA, a laparoscopic stapler. In Covidien's announcement today, the company stated the the Duet TRS has been connected with three patient deaths and 13 serious injuries after use in thoracic surgery. Covidien has sold 500,000 of the Duet TRS devices since the product was introduced in January 2009.

As an editorial note, Covidien must be applauded for voluntarily bringing this issue to light, reflecting the company's appreciation of the importance of patient safety as well as maintaining a "long view" of the company's reputation in the device industry.

Syringes and Other Insulin Administration Devices, Global Market

P. Driscoll — Mon, 16 Jan 2012 19:05:57 +0000

Insulin delivery for management of diabetes is a $1 billion+ global market. Delivery of insulin has evolved from simple syringes (which still represent a significant share of overall delivery device revenues) to the more convenient insulin pens to the emerging using of insulin pumps managed manually by diabetics or pumps integrated with glucose monitors as "artificial pancreases".

The goal of insulin delivery has long been to minimize the pain of administration, increase the convenience of delivery devices and, in general, move insulin delivery closer and closer to a method regulated by a homeostatic (biofeedback) system instead of a clinician- or patient-regulated method. Clinical data such as the large DCCT study have long been recognized to support the conclusion that more frequent and closer regulation of blood glucose via testing and dosing results in reduced risk of diabetic complications. Devices and instrumentation that facilitate more frequent and better regulation (i.e., reduction the pain, inconvenience and other hurdles to frequent glucose testing and insulin administration) have opportunistically capitalized on this, to the benefit of manufacturers.

The future market of diabetes management is indeed moving care toward scenarios in which technologies like an "artificial pancreas" may well represent the best alternative to a "cure" of diabetes. Such a system (e.g., from Medtronic) may well gain FDA approval in the next couple of years.

Below is the current distribution of this market among competitors supplying insulin delivery devices (including insulin syringes, pens and pumps).

Note: "Others" includes Ypsomed AG, Owen Mumford, Bioject Medical Technologies Inc., INJEX – Equidyne Systems (DBA) (Owned by HNS International), Antares Pharma, and Activa Brand Products, Inc.

Source: Report #D510, MedMarket Diligence, LLC.

Competition, investment and markets in cell therapy, tissue engineering

P. Driscoll — Sat, 14 Jan 2012 17:10:09 +0000

Competition in the field of tissue engineering and cell therapy is intense, whether it be attracting top scientists, obtaining licenses to university-owned patents, being the first to reach market with a particular technology, obtaining coveted investment funding, or gaining the attention of larger companies with deeper pockets.

With new companies being founded every day, competition is intense among these new enterprises to obtain these coveted prizes. Meanwhile, most large medical device and pharmaceutical companies are still choosing to cautiously evaluate which companies, if any, they might acquire or partner with.
Licensing a patented academic technology for further development is one way biotechnology companies can expand their intellectual portfolio. It is also a way to defend one’s turf by preventing a competitor from using that patented information. Thorough networking can work to the company’s advantage here, because it can yield insights about research progress, about who to contact for licensing discussions, and what other companies may be sniffing around for a good licensing opportunity.

If a company is considering licensing, then it should examine the quality of the patent (whether it is both broad enough and defensible), how much access the company will have to the inventors, rights to publish further research and the rights to sublicense out the work. The company must decide if the technology could form the basis for a new company or if it is an assistive technology that may broaden core strengths the company already possesses. The technology should also be examined to see how far from market an end product likely is. Of course, the details of dividing up any monetary awards must also be addressed. Licensing involves fees, which may include upfront fees, fees or royalties to be paid on a milestone or quarterly basis, and annual maintenance fees. The patent holder naturally expects value for licensing out the patent, whether that value is harvested at the beginning of the relationship or at the end.

Industry Focus. The majority of biotech companies involved in this industry are focusing on disease areas that have the most patients and the largest unmet needs. These include cancer therapies, diabetes, orthopedics and cardiovascular products. Some companies are taking a different approach, attempting to carve out a niche for themselves in a disease state with a smaller population and a less crowded playing field, such as Alzheimer’s, ophthalmology or central nervous system disorders.

Investment Levels. As the debate on health care reform nears resolution, the market will likely see a modest increase in mergers and acquisitions among pharmaceutical, medical device and biotechnology companies.

In terms of investment dollars, the stock market crash of 2008 had a major impact on the amount of investment dollars available to fledgling businesses. In the case of biopharmaceuticals, the typical drug development process for drug candidates that make it to market can take more than 12 years and $1.2 billion. Unfortunately, nearly 90% of drug candidates will fail in development.

Typically, venture capitalists provide five to eight years of equity to start-ups who may or may not amount to a successful enterprise. Because of downturns in financial markets for the last two years or so, venture capitalists and investment banks have increasingly been choosing to fund their prior investments rather than new start-ups.

Investor Returns. Primarily because of the lengthy and costly rigorous clinical trial process required, biomedical companies require great deals of capital to support them until their innovative product reaches market. Biotechnology companies may need as much as $1 billion to allow it to survive a 10–12 year time span to reach market. Because of the tightening of financial markets, less money has been available for new companies, forcing some either to license to larger companies future rights to their technologies or to sell their technology outright. Others less fortunate have been forced to close their doors.

Investing in biomedical enterprises has always been risky as only a small percentage ever make good on the investment. In the face of a global recession, investors are only getting more difficult to find and many new companies are struggling to stay afloat. For instance, in California, 334 biotechnology companies with an aggregated market cap of $352.1 billion were traded publicly on major U.S. markets in the third quarter of 2009, according to PricewaterhouseCoopers. Of these, 135 had less than one year of cash remaining and 42% had less than six months of funding left.

Below is illustrated the 2009 to 2018 forecast for the global markets in tissue engineering, cell therapy and transplantation, by clinical area.

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

Trending in spine surgery

P. Driscoll — Thu, 12 Jan 2012 23:18:29 +0000

Procedures and technologies in spine surgery are in a steady state of evolving, as clinicians seek better outcomes, healthcare systems seek to minimize cost and manufacturers seek to do both without sacrificing profit.

From 2010 to 2020, a considerable amount of change will take place in spine surgery, with the introduction of many new technologies and the progressive growth (and decline) of specific therapeutic options.

Below is illustrated the net effect of these changes on the relative share of the global spine surgery market through 2020.

Source: MedMarket Diligence, LLC; Report #M520.

Key recent developments in diabetes research

P. Driscoll — Thu, 12 Jan 2012 20:28:46 +0000

Two noteworthy developments in the study of diabetes came to light today. The first is the progress that has been achieved in the use of stem cells to "re-educate" the T cells in Type 1 diabetes (Univ. of Illinois). While reports on this research allude to "reversing" Type 1 diabetes, the actual research is better described (and more importantly) for illustrating that patients' pancreatic islet beta cells can have their insulin-producing function restored via immunomodulatory steps. Thus, Type 1 diabetics may potentially regain normal glucose regulation by repair — rather than by the more complex process of cell transplant.

The second development is that researchers at the La Jolla Institute for Allergy & Immunology have proven which T cells are responsible for destroying the pancreatic cells in Type 1 diabetes.

Both of these developments are important for the fact that they center on the actual mechanisms involved in the development of Type 1 diabetes and thereby accelerate the progress toward therapeutically intervening in order to restore normal insulin production.

The global market for products in the management of diabetes (for Types 1 and 2) is illustrated below.

Source: MedMarket Diligence, LLC; Report #D510, "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018."

Surgical procedures penetrated by sealants, glues, hemostats and anti-adhesion products

P. Driscoll — Wed, 11 Jan 2012 19:52:12 +0000

Approximately 140 million surgical and procedure-based wounds are created annually worldwide that offer potential for use of adjunctive surgical closure and securement products; approximately 42 million of these wounds are created during surgical procedures in the United States.

Although healing of all these wounds might be improved through use of adjunctive surgical closure and securement products, it is likely that increased usage of these products will be limited, on clinical, economic and other grounds, to a fraction of procedures. It is realistically estimated that 10%–15% of these procedures would benefit from increased use of newly developed adjunctive surgical closure and securement products.

The criteria driving which surgical procedures take up adjunctive surgical closure and securement products include clinical utility, cost effectiveness, aesthetic/perceived benefits and others, and (for the sake of understanding) can be grouped into the following categories:

The relative numbers of surgical procedures, grouped by these categories and clinical area, are illustrated below.

Source: MedMarket Diligence, LLC; Report #S190.

Arena and Vivus get good news

P. Driscoll — Tue, 10 Jan 2012 17:40:26 +0000

In a continued trend in which the FDA seems to be working toward rapprochement with the previously beleaguered obesity drug industry, this week the agency has in one case asked Qnexa manufacturer Vivus on Monday to remove the contraindication for use of the drug in women of child-bearing potential (although keep in place the contraindication for women actually pregnant), a move that increases the potential obesity drug patient population and the aura of "safety" surrounding Qnexa.

http://www.reuters.com/article/2012/01/09/us-vivus-idUSTRE8081LI20120109

In another case, the FDA notified Arena Pharmaceuticals that it has accepted the resubmitted drug application for the company's obesity drug, Lorcaserin.

http://online.wsj.com/article/BT-CO-20120110-706510.html

Needless to say, both Vivus' and Arena's stock price took sharp jumps on the news.

The aggregate worldwide market for obesity drugs could reach $1.8 billion by 2019 if drug approvals happen as forecast for these and other obesity drugs. (See "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019".

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