Category Archives: cardiology

topic is largely or exclusively about cardiology products, technologies, markets and/or companies

Technologies at recently identified medtech startups

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.

Levels of demand for products in wound closure, hemostasis and anti-adhesion

MedMarket Diligence’s global market Report #S190 on the range of products involved in wound securement encompasses surgical sealants, high-strength medical adhesives, sutures/staples/clips, hemostatic agents and products to prevent post-surgical adhesion.

The potential impact of emerging products in this area is driven by not only caseload but by the nature of the clinical “need”, ranging from a product being critical to provide treatment for a particular indication to a need that may only be represented in perceived benefits.

We have quantified the current and future market for products in surgical wound closure, hemostasis, anti-adhesion and related applications by detailing the products on the market and under development and assessed their current and forecast utilization based on the net result of clinical need drivers and the competitive landscape into which these products may find adoption.

For the sake of characterizing the nature of the need behind possible future product adoption, we have quantified the caseload, by clinical area, relative to a spectrum of needs levels from “important and enabling” to “aesthetic and perceived benefits”.

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.

On this basis, see the graphic representation below, which illustrates that the majority of demand for these products arises from the fact that they improve the clinical outcome for patients. Another key element of this is that the primary clinical areas of application contributing to demand for these products is in cardiovascular, general surgery, neurology and digestive specialties.  Note, please the categories of I-IV refer to the categories described above.

sealant-product-caseload

Source: MedMarket Diligence, LLC; Report #S190.

As further indication of the value of these products is the fact that the category exhibiting the lowest level of demand is for products that offer only aesthetic or perceived benefits.

Medtech fundings for January 2013

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

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

Mussel adhesive finds potential cardiovascular application

In a further advance leveraging the adhesive qualities of “bioglues, or naturally-derived materials used in nature — such as the adhesive that allows mussels to hold fast to rocks despite the churning waters around them — a University of British Columbia scientist has developed a gel modeled after the mussel peptide that might be used to prevent the rupture of atherosclerotic plaque in blood vessels.  The research is published in the Proceedings of the National Academy of Science’s current issue of the online journal, PNAS Early Edition (see also http://phys.org/news/2012-12-mussel-goo-blood-vessel.html#jCp).

A whole class of biologically-derived adhesives — “bioglues” — including those from mussels, geckos, crab shells, burrowing frogs, spider webs, porcupine quills and even bacteria, are under investigation for their potential human clinical applications. (See link.)

A wide range of materials are in use and in development for medical applications in adhesive, sealing, hemostasis and other wound management functions.  See the press release from MedMarket Diligence (3/5/2012).

Fibrin and other sealants and surgical glues are the subject of the 2012 MedMarket Diligence report #S190, “Sealants, Glues, Wound Closure and Anti-Adhesion Worldwide Markets, 2012-2017.”

Applications of surgical sealants, glues, hemostats in cardiovascular disease

Given the clinical utility of surgical sealants, glues and related products in stopping bleeding, restoring vascular structures and otherwise achieving the goal of restoring vital cardiovascular function, these products have many specific applications in clinical practice, resulting in large potential caseload worldwide.  See the breakdown of case load by type in cardiovascular applications:

Source: MedMarket Diligence, LLC; Report #S190.

Below is a list of selected specific applications (drawn from report #S190) for surgical sealants, glues, hemostats, anti-adhesion and related products for treatment of cardiovascular diseases:

  • Augmentation of aortic and vascular sutures.
  • Repair of minor epicardial lacerations without the use of sutures.
  • Hemostasis and reinforcement of anastomoses of coronary bypass and as an adhesive to optimize and secure the path of coronary bypasses on the heart.
  • Coating of perianeurysmatic tissue in ventricular aneurysm surgery
  • Reinforcement of sutures and patch adhesion in reduction of the left ventricle.
  • As an adhesive to secure the dissection plane in acute aortic dissections.
  • As a hemostatic agent in the prevention of bleeding of proximal and distal anastomoses in acute aortic dissections.
  • As an adhesive for gluing patches for dissected aorta reinforcement.
  • As a hemostatic agent on anastomoses in aortic valve surgery, particularly in the presence of calcific or atheromatous aortas.
  • Hemostasis and reinforcement of sutures after aortic aneurysm repair.
  • In re-operations, as a hemostatic adhesive on lacerations of the ventricle caused by re-sternotomy or the presence of adhesions.

Opportunities for med/surg sealants, glues, hemostats driven by type of clinical benefit, competition

Advanced products for the closure, sealing, hemostasis and other endpoints for medical and surgical wounds generate varying degrees of clinical benefit based on the manner and extent to which they enable management of different wound types.  Degrees range from the acute need end of “important and enabling” to the less clinically necessary “aesthetic and perceived benefits”:

  • 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.
  • 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).
  • Cost-effective and time-saving: Immediate reduction in surgical treatment time and follow-up treatments.
  • 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.

These benefits are clearly different on a clinical specialty-by-specialty basis.  The numbers of targeted or prospective procedures also vary considerably by specialty. As a result, wound closure and securement products have the following categorized potential use worldwide:

Source: “Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide “; Report #S190.