Tag Archives: medtech

Applications, global markets in tissue engineering and cell therapy

Screen Shot 2014-04-17 at 7.37.44 AMThe market for tissue engineering and cell therapy products is set to grow from a respectable $8.3 billion in 2010 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.

Cell-tissue-applications

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Changes in the U.S. government’s federal funding of embryonic stem cell research has given a potentially critical mass of researchers increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

regional-forecast

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

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, stricter regulations in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a very robust 20% annually.


MedMarket Diligence’s Report #S520 remains the most comprehensive and credible study of the current and project market for products and technologies in cell therapy and tissue engineering.

Harsh questions for complex medtech

robotic_or_scalpelOn the one hand, as I track medical device technology development, I see the increasing trend toward a reduction in the complexity of approaches to accomplish therapeutic ends. The underlying force seems to be, “healthcare technology is expensive, so let’s minimize the technological complexity, minimize the invasiveness, reduce collateral damage, make treatments more specific to the resolution of symptoms and/or disease…” The result is that, for example, endoscopic surgery leads to laparoscopic surgery, which leads to single port laparoscopic surgery, which leads to natural orifice transluminal endoscopic surgery, potentially competing in its minimally invasiveness against alternatives like transcatheter interventional procedures — even for procedures like cardiac valve repair or replacement or coronary artery bypass grafting.

Then, on the other hand, I see technological development moving in the entirely opposite direction of increasing complexity with developments like robotic surgical systems, intraoperative imaging and others, all of which raise the question as to whether we are simply developing technologies for technology’s sake. Do these increasingly complex technologies provide a clinical endpoint not achievable with alternative technologies, or more importantly, procedural approaches? Certainly, I think that technologies that enable a surgeon to perform a procedure that he otherwise simply could not perform, such as those involving the use of intraoperative imaging technologies that enable the surgeon to see healthy versus pathological tissues and differentiate his actions accordingly can arguably result in a better clinical outcome. And as part of this process, one must consider the cost of the accompanying technology such as imaging systems.

Accordingly, when one considers the range of different complex robotic surgical technologies on the market or under development, one has to ask whether these systems truly allow the performance of procedures that the average, well-trained surgeon could not perform without that technology. Certainly, there are complex surgical procedures, such as delicate neuro procedures that, if not performed with extremely precise accuracy, might result in serious collateral damage. But hernia repair? Appendectomy? Colon resection? Hysterectomy? Some of these fairly high-volume procedures have indeed been presented as justification for the enormous expenditure needed to acquire robotic surgical systems.

Forgive me for stating the obvious, but it seems incumbent upon healthcare systems to critically evaluate the cost/benefit of new technology, given the limited resources in healthcare.

For this reason, it does not surprise me in the least that recent reports of complications or, in the least, device problems associated with the use of Intuitive Surgical’s robotic systems have promptly led to a precipitous decline in that company’s stock value. If a technology can’t enable the performance of a procedure that otherwise could not be performed, then its value is in question. Further, if the technology cannot perform a procedure flawlessly, and without complication or error that can arguably be performed without that technology, then its value is seriously in question.

Hemostat products and companies

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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.

Posted via email from medmarket’s posterous

Medtech Financings for November Already Near $350M, Propelled by Single $210M Funding

Driven in LARGE measure by the $210 million funding of Intarcia Therapeutics, the total for medtech fundings in November is already at nearly $350 million by mid-month. Intarcia Therapeutics is developing a continuous subcutaneous delivery of drug for treatment of Type 2 diabetes (note, please, that we classify this product in “medtech” rather than “biotech” due to the fact that this is both a drug and drug-delivery).

According to the Intarcia Therapeutics:

The financings consisted of $160 million in proceeds from a preferred stock private placement and $50 million in proceeds from a private debt placement. Investors in these financings included existing investors New Enterprise Associates, Inc., New Leaf Venture Partners and Venrock, as well as new investors, The Baupost Group, LLC, Farallon Capital Management, LLC and three additional top-tier institutional investors based in Boston and New York.

Further according to the company:

ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time.

 

Data from Intarcia’s ITCA 650 Phase 2 program have demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as a twice-daily self-injection therapy for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia’s robust intellectual property portfolio protects ITCA 650 through 2031.

The next most significant funding for the month of November thus far is transcatheter valve company, CardiAQ Valve Technologies, with a $32.5 million funding.

The complete list of November medtech fundings is being compiled at link.

 

The drug and device trends in the treatment of obesity

Several events have set the stage for change in the markets for treatment of obesity. Key among them are the 2012 FDA approvals of (link) of Vivus’ Qsymia (combination of phentermine and topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).  In a market that has been dominated by surgical procedures and medical devices, the introduction of two significant pharmaceutical options has served notice that pharma is finally seizing hold of this large and growing opportunity.  The potential addition of yet another obesity drug, Orexigen’s Contrave (combination of naltrexone and bupropion), will only hasten this change.

Combine the advent of obesity drugs (whether or not reimbursement is at optimum levels) with the demand-pinching force of a still somewhat hobbled economy and its impact on the significantly out-of-pocket payment for obesity surgery and device procedures and it becomes clear that the market is shifting away from device and toward pharma. Gastric bypass (e.g., Roux en-Y) will hold stronger than device treatments due to lower cost. As a result, the adjustable gastric band, such as Allergan’s Lap-Band, will see a decline in the total share of obesity surgeries.  See the trend in Europe as an example:

Trend in Metabolic/Bariatric Surgery, Europe, 2003-2013

RYGB= Roux-en-Y gastric bypass
AGB=Adjustable gastric band
BPD/DS= Biliopancreatic diversion with duodenal switch
SG=Sleeve gastrectomy

Source: MedMarket Diligence, LLC; Report #S835.

Established obesity devices such as restrictive devices (e.g., Lap-Band and transoral gastropexy) and artificial fullness devices (e.g., gastric balloon) will represent slower growth than malabsorption devices, gastric emptying devices and appetite suppression devices, but which have thus far gained little presence in the market.  By comparison, appetite suppression drugs are already on the market and, with combination drugs taking off quickly, the share of the future market will be increasingly dominated by appetite suppression and combination drugs.

Source: MedMarket Diligence, LLC; Report #S835.

 

The report, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019″, may be purchased online at link.

 

 

Medtech fundings for October 2012 exceed $600 million, push up 2012 trend

Medical technology fundings for October 2012 totaled just over $600 million, comprised of many fundings, but with the biggest ones being:

  • $76.2 million for LifeTech Scientific Corp. (minimally invasive interventional devices for cardiovascular and peripheral vascular applications)
  • $60.2 million for Vital Therapies, Inc. (bioartificial liver device)
  • $45 million for EnteroMedics, Inc. (devices to treat obesity, metabolic disease and other GI disorders)
  • $45 million for Fibrocell Sciences, Inc. (autologous cell therapies for use in aesthetic dermatology)
  • $40 million for Alimera Sciences, Inc. (intravitreal implant for the treatment of chronic diabetic macular edema)
  • $35 million for Tornier NV (joint replacement and related orthopedic implants)
  • $31 million for InSightec Immage Guided Treatment Ltd (non-invasive MRI-guided ultrasound surgical devices)

The overall trend in medtech fundings has been a slow recovery from 2008. Indeed, recent press from venture capital associations and others have argued that fundings are at upwards of an eight year low.  The problem, however, with these reports is that they often look at medtech too narrowly (e.g., medical devices as opposed to medical devices, biomaterials and other products that are either complementary to or directly competitive with medical devices) or fail to account for fundings that come from both public and private investment, fundings from startup competitions, fundings from outside the U.S. Below is the actual trend, from 2009 though October 2012, based on individual financing we have tracked, month by month, since 2009 (you can see the individual fundings listed through June 2012 and the fundings separately for July, August, September and now October 2012).

Source: Compiled by MedMarket Diligence, LLC

Another way we have presented this data is to simply show the month-by-month financings with the seasonality (above) removed and a calculated trendline added. See below.

Source: Compiled by MedMarket Diligence, LLC 

 The data is hard and documented on these fundings, so the trendline above is not only reliable, but encouraging.

Technologies at Recently Identified Medtech Startups

It was a robust month for medtech startups being founded (or at least getting on our radar) with a wide range of technologies under development. Below is a list of technologies under development by these companies:

  • Device to assist in early detection of melanoma.
  • Small molecules for skeletal tissue regeneration.
  • Intubation device.
  • Device for the point-of-care treatment of chronic central pain.
  • Technologies for detection of perforated bowel.
  • Prosthetic heart valve technology.
  • Catheter-based approach to carotid body modulation for treatment of sympathetic nervous system-mediated disease.
  • Sheaths, snares and other devices in interventional cardiology.
  • Device for non-invasive and reversible treatment of presbyopia.
  • Drill device to reduce complications in orthpedic and spine surgery.
  • System for evacuation of surgical smoke.
  • Minimally invasive technologies for the treatment of stroke.
  • Surgical device technology.
  • Robotic system for use in spine surgery.

The companies are included with all available details in our Medtech Startups Database.