Category Archives: ophthalmology

products, technologies and practices in the management of vision disorders and eye-related diseases

Technologies at recently identified medtech startups

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Below is a list of the technologies under development at startups that MedMarket Diligence recently identified and added to the Medtech Startups Database.

  • Tissue regeneration technologies for non-invasive skin care.
  • Biomaterials supplied to medical device and pharma manufacturers
  • Trans-reflective fetal EKG.
  • Surgical instrumentation.
  • Undisclosed medical technology.
  • Technologies for autologous tissue collection.
  • Stem cell therapy.
  • Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
  • Transcatheter repair of mitral valve regurgitation.
  • Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
  • Device-based treatment of congestive heart failure.
  • Clamping device to control bleeding in trauma.
  • Tissue matrix composition for tissue regeneration and wound care.
  • Spinal pain relief devices.
  • Wireless remote arrhythmia monitoring and diagnosis.
  • Undisclosed medical technology.
  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.

Medtech fundings for January 2013

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Jan-2013-fundingsFundings for medical technology companies for the month of January closed at $376 million.  Top fundings for the month included:

  • $85 million for Insulet Corp. (insulin pump)
  • $45 million for LipoScience, Inc. (NMR diagnostics)
  • $27 million for Ivantis (microstent for glaucoma)*
  • $23.8 million for Ocular Therapeutix (ophthalmic drug delivery)
  • $22.3 million for Tryton Medical (stent for bifurcated coronary lesions)

*Not shown in graph at right.

The complete list of medtech fundings for January is available at link.

Please see our prior post on medtech financing trends 2009-2012. Fundings for medtech in 2012 came in at $5,014 million, just 2% off from the $5,121 million raised in 2011.

Current and potential patient caseload for sealants, glues, wound closure and anti-adhesion

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The current and potential uses for surgical sealant products (glues, sealants, hemostats, anti-adhesion) varies by the clinical area and the type of benefit these products offer patients. These benefits range from the “important and enabling” in which their use provides potentially life-saving benefits compared to traditional wound sealing/closure products to those “aesthetic and perceived” benefits (e.g., reduced scarring) that are more cosmetic in nature.

We have assessed the potential global patient caseload that would benefit from these wound closure and sealant products along a spectrum from clinically necessary to aesthetically beneficial, in the following four categories:

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 need for 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.

Most importantly, we have assessed the sizes of the patient populations that are the targets of these different classes of clinical benefits by major clinical area.  Below are illustrated, by both Clinical Area/Benefit and Benefit/Clinical Area, to illustrate the current and future volume of patient caseload for these novel wound closure and sealant products:

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide (Millions), 2011

sealant-categories-A

Source: Report #S190

Sealant-categories-B

Source: Report #S190

Technologies at Recently Identified Medtech Startups

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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.

Tissue engineering & cell therapy markets, 2012 and 2018

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The varied technologies underpinning the market for “tissue engineering & cell therapy” are diverse — even more so than people in the industry often recognize.  Frequently, both tissue engineering and cell therapy are presumed to be purely developmental in current “markets”, a far cry from when such technologies will be so advanced as to make organ replacement a retail market.  The truth is that, on the one hand, tissue engineering has become a very routine part of clinical practice (as in skin grafts and orthopedic tissue grafts) and, on the other hand, while cell therapy still has vastly more clinical (and commercial) potential than it has as yet demonstrated, it has nonetheless demonstrated sufficient advance that several obstacles to cell therapy benefits have been greatly diminished: (1) the issue of the Bush-era ban on federally-funded embryonic stem cell research was promptly lifted by the Obama administration and (2) advances in the use of adult stem cells and the reversion of cells from a differentiated to undifferentiated state (i.e., creation of pluripotent cells) have made limitations on embryonic stem cells largely moot.

Consequently, the great struggle for anyone seeking to assess the “commercial potential” in tissue engineering and stem cell therapy is overcoming the presumption that these technologies are still a long way off from attaining any level near their potential commercial success.

The solution has been to track actual company revenues especially, but not limited to, readily verified SEC 10(K) company reports on revenues generated from these technologies.  This has been our experience in characterizing worldwide markets for tissue engineering and cell therapy in our Report #S520.

The aggregate worldwide market for tissue engineering and cell therapies, representing an already stunning range of clinical applications, stands at roughly $12 billion in 2012.  This market, through commercial introduction of new products and expanded applications of approved products, will reach almost $32 billion by 2018. See our 2012 and 2018 estimates, below.

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

October 2012 medtech financings off to a strong start

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October 2012 financings are off to a very strong start as a result of several big financings, including:

  • $76.2 million funding received by interventional cardiology company LifeTech Scientific from Medtronic
  • $76 million ($16M in September) raised by Vital Therapies, a company developing a bioartificial liver;
  • $45 million for EnteroMedics, a device maker focused on obesity and other GI conditions;
  • $45 million for aesthetic cell therapy company FibroCell Sciences; and
  • $40 million for Alimera Sciences, who is developing an intravitreal implant for treatment of chronic diabetic macular edema.

As a result of these and other, smaller financings, the total financings for the first fifteen days of October 2012 are already at $465 million which compares to $270 million for the entire month of September.

The list of fundings by company for the month of October are here. (Check back during the month for ongoing updates to this list.)

Ablation technology regional growth to 2019

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In our analysis of the global market for the spectrum of ablation technologies – Electrical, Radiation, Light, Radiofrequency, Ultrasound, Cryotherapy, Thermal (other than cryo), Microwave, and Hydromechanical — we assessed the size and growth of sales of these technologies with specificity to a large number of regions and countries:

  • U.S.A.
  • Canada
  • Brazil
  • Mexico
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
  • BeNeLux
  • Japan
  • China
  • India
  • Australia
  • Rest of World

Below, we illustrate, ranked from low to high, the compound annual growth rates of each geography/technology combination.  This data reflects the strong trends that exist for clinical adoption and sales growth of specific technologies, driven by the unique combination of country-specific and technology-specific forces.

Source: Report #A145, MedMarket Diligence, LLC.

Clinical Applications of $11.5 Billion Ablation Technologies Market Mapped

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The performance of surgery has undergone a steady evolution over the past 40 years, moving from procedures employing scalpels and sutures to procedures employing a dizzying number of product types — reusables/disposables, devices/biologics/hybrids, percutaneous/endo-laparoscopic, real-time MRI and other image-guidance and the whole spectrum of devices and equipment in the $11.5 billion ablation technology market.  This last field harnesses the capabilities of instruments differentiated largely by energy type to therapeutically treat tissue by destruction, excision, sealing and other means.

For reference, a dictionary definition of tissue ablation is “the removal of a body part or the destruction of its function, as by surgery, disease, or a noxious substance.” From a device/instrumentation standpoint (as opposed to, for example, chemically-based ablation), ablation is the therapeutic destruction and sealing of tissue or creation of other therapeutic effect in tissue. The predominant forms of device-based ablation technologies include:

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

While the tissue effects produced by these different modalities have potential for use in virtually all clinical applications, their emerging use is concentrated in a fairly well defined but detailed list.  The largest share of the market for energy-based ablation devices, driven to a significant extent by its long history in clinical practice, is in cancer therapy, primarily via radiation therapy. General surgical applications represent the next most common use of ablation technologies, especially those using electrocautery and electrosurgical devices, radiofrequency ablation and cryotherapy, etc. Cardiovascular applications then represent the next most active area of ablation technologies, especially given the often acute nature of cardiovascular disease.

Most of the universe of ablation technology clinical applications is illustrated in the map, below.

Source: MedMarket Diligence, LLC (Report #A145)

Medical and surgical sealants/adhesives clinical indications

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Medical/surgical sealants and adhesives are being adopted in a large and growing number of procedures.  Sutures, clips and staples, by comparison, hold a large share of procedure volume and are stubborn to give ground against sealants and adhesives.  There is no doubt, however, that the relatively higher growth rates for the novel closure products are steadily eroding the century-long hold dominance of sutures in wound closure.

Below are illustrated selected (the full list including "Others" is given in Report #S190) procedural indications for sealants and adhesives by clinical area,

 

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Source: MedMarket Diligence, LLC; Report #S190.

 

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

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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.