Cardiology and cardiovascular cell therapy and tissue engineering

The amount of activity, both in development and in commercialized technology, in the field of cell therapy and tissue engineering has been enormous in the past few years, stemming from advances in stem cell therapy and cell biology in general.  One should not be surprised to see the number of active companies and products in this area.

If one were to examine a narrow niche in cell therapy and tissue engineering, such as in cardiology and cardiovasular applications, one might nonetheless be startled at the specific activity.  See below

CompanyDeviceComments/Status
Abbott Vascular/Abbott LaboratoriesPerclose ProGlideSuture-mediated closure device for 5-21F femoral artery access sites.
ProStar XLSuture-mediated closure device for 8.5-10F sheaths (8.5-24 F OUS).
StarClose SEClosure device delivers nitinol clips for 5-6F access sites.
Perclose A-TSuture-mediated closure device for 5-8F femoral artery access sites. Sold in US only.
AccessClosure Inc. (acquired by Cardinal Health in May 2014 for $320M cash.)MynxGripMynx sealant with Grip Technology added to distal end to seal the arteriotomy while expanding to fill tissue tract.
Mynx AceExtravascular PEG sealant that actively adheres to the artery for secure mechanical closure. Dissolves within 30 days.
ArstasisAxera 2 Access DeviceThis device creates a long, shallow-angle arteriotomy (5-6F) through the femoral artery wall. Resulting arteriotomy has self-sealing capability that requires only minimal compression for rapid hemostasis and eliminates the need to leave behind foreign material to close the puncture site.
Cardiva MedicalVascade Vascular Closure SystemUtilizes existing procedural sheath to obtain temporary hemostasis using a collapsible disc while delivering a thrombogenic, resorbable collagen patch extravascular to the arteriotomy. For closure of 5-7F femoral arteriotomies.
Cardiva Catalyst II and III manual assisted closure devicesManual closure assist device with a deployable nitinol disc that provides temporary hemostasis at the puncture site while puncture recoils to size of an 18-gauge needle. Wire has hemostatic coating to accelerate clotting. Catalyst III adds protamine sulfate coating for patients receiving heparin.
Cordis/J&JExoseal Vascular Closure DeviceUses existing procedural sheath to deliver resorbable PGA plug to the outside of the artery wall at the site of the arteriotomy. For closure of 5-7F femoral arteriotomies. FDA approved May 2011.
Innovasa Corp.Stat*Seal

Available in over the wire (for deeper insertion in the puncture tract) and topical versions
Button-like device with attached medicated foam-tip bandage. Tip is inserted into the femoral puncture tract and remainder of device rests on skin around puncture site. Facilitates hemostasis via targeted focal pressure combined with the hydrophilic drying and pro-coagulant effect of the foam tip, which is medicated with chitosan. After hemostasis is achieved, the device is completely removed from the patient.

FDA cleared.
InSeal Medical Ltd. (Israel; a fully owned subsidiary of E-Pacing Inc.)InSeal Intravascular Closure DeviceSelf-expanding nitinol frame covered with biodegradable membrane for closure of 14-21F punctures in vessels 6-10mm diameter. Device is delivered using procedure sheath (no sheath exchange required); membrane covers puncture and uses blood pressure to seal against vessel wall. Delivery and deployment take less than 2 minutes.

In clinical development for use following large-bore procedures such as TAVR (transcatheter aortic valve replacement) and EVAR (endovascular aortic aneurysm repair).
Morris Innovative Inc.CombiClose/ControlClose Vascular Closure Devices (formerly FISH)Devices deliver a plug of ExtraCellular Matrix, made of porcine small intestine submucosa (SIS), to the inside of the vessel wall, which seals the arteriotomy and promotes remodeling of the host tissue within 30 days. For 5-8F punctures.
St. Jude MedicalAngioSealIntra-arterial anchor, suture, and collagen components form ÒsandwichÓ to close arteriotomy. FDA labeled for immediate restick and for 20-min ambulation/60-min discharge for diagnostic cases. Components resorb within 90 days.
AngioSeal EvolutionNext-generation AngioSeal with automated collagen compaction and enhanced ease of use.
Transluminal Technologies LLCVelox CD Vascular Closure DeviceConsists of delivery device and metal closure implant made of a proprietary magnesium alloy. Intended for closure of femoral arteriotomies. Implant comprises an intraluminal footplate that absorbs in about 24 hours and an extraluminal plug that absorbs in two weeks.

CE marked July 2014.
Vascular Closure Systems Inc.FastSeal Bioabsorbable Vascular Access Closure SystemSystem deploys a non-collagen, double-disc polymer sealing element that is positioned with components resting on both the inner and outer side of the artery, sandwiching the puncture site and enabling hemostasis within 60 seconds. FIH trial completed for 6-8F puncture closure system. OUS commercialization is expected to begin in 2014. A large-bore (18-F) system is also in early-stage development.

Source: MedMarket Diligence, LLC; Report #S520.

In the 2010 MedMarket Diligence report #S520, “Tissue Engineering, Cell Therapy and Transplantation Worldwide”, we detailed the technology, product, company and market activity of the spectrum of cell/tissue developments. Highlighting only cardiology/cardiovascular, above, gives evidence to the size of the broader market.

It seems that many stakeholders in companies at the early stages of development in this field generally do not recognize the extent to which this is a current, active market of available products, not some basic research (e.g., biotech “industry”) in which billions of dollars change hands (from VC to entrepreneurs) with little coming back in clinically approved product revenue.  An even larger volume of technology that, while it may not have been approved yet, is deep in the process of seeking approval. It was for this reason that we were able to definitively characterize this $6.9 billion global market, forecast to exceed $30 billion by 2018.

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