PARIS – A novel test kit for allergies that does not use needle punctures or other invasive techniques to introduce an allergen will be distributed by pediatric products specialist Bioprojet Pharma (Paris) for a cow's milk protein allergy diagnostic.
DBV Technologies, also located in Paris, signed with Bioprojet Pharma to promote and distribute its Diallertest Milk diagnostic kit in France with Bioprojet Pharma saying it expects the non-invasive nature of the Diallertest device and its ease-of-use will find ready acceptance for a wider European distribution to follow.
DVB estimates 5% to 6% of nursing children are affected by an allergy to cow's milk, creating a large market opportunity.
DBV Technologies is currently developing Diallertest-based tests for the diagnosis of wheat, soy and dust mite allergies in children.
The Diallertest diagnostic kit is based on DVB's proprietary Viaskin epicutaneous delivery technology that uses electrostatic force to present and deliver active compounds to the epidermis of the skin, without breaking the blood barrier.
The delivery platform allows allergens to be introduced to a patient who is potentially allergic to the substance without inducing a systemic shock, a significant concern associated with current desensitization therapies.
DVB's Chief Medical Officer Pierre-Henri Benhamou said that existing allergy tests rely on an immediate reaction to milk products and do not detect adverse reactions that can take place a week or more after exposure.
The DVB test was conceived and developed to maintain a persistent presence of the allergen, literally under the skin.
He said DVB is currently preparing a multi-center international clinical study to test the effectiveness of the Diallertest test for delayed reactions against the current practice of testing for immediate reactions.
The study will also become support requirements for a complex regulatory approval process.
Though Diallertest is a medical device, and though it introduces the same milk product routinely given by doctors to infants orally or with a patch, French authorities consider the diagnostic as a combination device to be regulated as a medication because of its novel technique for introducing he milk product.
Founded in 2002 and based in the innovation incubator cluster at Pépinière Paris Santé Cochin, DBV closed a €6 million ($8.9 million) Series B investment round in January, 2009 with the Danish immunotherapy company ALK-Abello (Hørsholm) and a returning venture capitalist, Sofinnova Partners (Paris).
ATS cryoblation probe gets CE mark
ATS Medical (Minneapolis) reported the receipt of CE mark for the ATS CryoMaze 10-S Surgical Cryoablation Probe for the treatment of cardiac arrhythmias. The first use of the 10-S probe in Europe was performed by Professor Friedrich Mohr at the Klinik fur Herzchirurgie (Clinic for Heart Surgery; Leipzig, Germany). The ATS CryoMaze 10-S Probe complements the current product offering by adding a linear cryoablation probe that provides more controlled stiffness than the current ATS CryoMaze Probes. The increased support throughout the length of the 10-S probe addresses the preference of some surgeons to have more probe leverage to achieve contact with targeted tissue that is difficult to reach.
CE mark granted for NuSeal hernia sealant
HyperBranch Medical Technology (Durham, North Carolina) has received a CE mark for its NuSeal 30 hernia mesh fixation sealant product. NuSeal 30 is used in hernia procedures to adhere the mesh. NuSeal 30 provides for secure mesh placement, minimizes pain caused by other fixation devices and gradually degrades as the body heals.
Crescendo raises GBP4.5M in seed funding
Crescendo Biologics (Cambridge, UK) reported that it has raised £4.5 million in a seed-funding round to advance the development of its fragment antibody technology platforms. The funding round was led by Sofinnova Partners, a Paris-based venture capital firm, with Aitua, Avlar BioVentures and the Rainbow Seed Fund also participating. Crescendo brings together in vivo and in vitro technology platforms invented by scientists at the Babraham Institute. Crescendo's technology platforms will enable the company to generate human heavy chain fragments, the smallest functional binding units of an antibody molecule. These fragments offer several advantages as starting points for the development of novel therapeutics.
Tryton stent featured at cardiology meeting
Tryton Medical (Durham, North Carolina) reported that the company's Tryton side branch stent system will be featured in discussions by a number of cardiologists in a symposium on Oct. 16, 2009, in conjunction with the European Bifurcation Club meeting in Berlin. The Tryton is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. About 20% of patients treated for coronary artery disease have diseased bifurcated lesions.
BD OcuSeal liquid bandage launched in Europe
BD Medical – Ophthalmic Systems, a unit of Becton, Dickinson (Oxford, UK), reported the European launch of BD OcuSeal Liquid Ocular Bandage, a fully synthetic protective barrier designed to provide comfort for post-surgical, post-traumatic, and non-traumatic ocular conditions. This product has CE mark approval, and BD said it intends to initiate registration in other countries including the U.S.
BD OcuSeal Liquid Ocular Bandage is designed to help reduce the need for sutures and reduce complications typically associated with surgical incisions, including infection and patient discomfort. It is intended for direct application on corneal, conjunctival and scleral surfaces.