A Medical Device Daily

Sartorius (Goettingen, Germany) and Respironics (Murrysville, Pennsylvania) have signed an agreement that provides for certain Respironics carbon dioxide sensor technology to be used with Sartorius's disposable bioreactors.

During the term of the agreement, and subject to certain terms and conditions, Sartorius will have the exclusive right to sell Respironics' Capnostat 5 mainstream carbon dioxide sensor and LoFlo Capnostat 5 sidestream carbon dioxide sensor with the German company's disposable bioreactor in the measurement of the amount of carbon dioxide being generated in the fermentation/bioreaction process in use of living cells in the manufacture of drugs.

Sartorius plans to integrate Respironics' sensor technology into its disposable bioreactors in an effort to become the first company worldwide to offer bioreactors enabling required off-gas analysis using disposable technologies during the fermentation/bioreaction process. This is a critical parameter for cell culturing in the fermenter or bioreactor to obtain active medical ingredients, Sartorius said.

Together with measurements of the substances added to the cell lines and of the parameters in the bioreactor, such as temperature or pH, off-gas analysis delivers information on cell activity and process stability of fermentation. Until now, this analysis had been carried out with equipment that had to be sterilized after every sampling procedure and that entailed a capital outlay of up to $25,000.

Respironics, which Sartorius cited as the industry leader in carbon dioxide sensor technology, has historically offered the Capnostat 5 mainstream and LoFlo Capnostat 5 sidestream sensor and carbon dioxide monitoring technology for use during and recovery, in the intensive care unit, in emergency medicine/transport and for respiratory care.

The mainstream and sidestream devices can be integrated with virtually any patient monitoring system, Respironics said, and provides advanced measurement of end-tidal carbon dioxide and respiration rate.

The U.S. firm said it looks forward to expanding markets for its sensor technology, including the biopharmaceutical market through its collaboration with Sartorius.

Sartorius and Respironics said the agreement shows how an already established technology in medical applications can be transferred to other market segments.

French firm launches rejuvenation technique

Medicamat (Malakoff, France), a manufacturer of medical and surgical devices, has just launched Aquarejuvenation, its new technique for face and neck rejuvenation.

Non-invasive and painless, the hydrodynamics-based therapy involves a three-step process — biopeeling, penetration of high-pressure water microjets and application of specific cosmetics. It is applied by beauticians, cosmetic medicine specialists, dermatologists and plastic surgeons.

The process, which has been patented, involves three stages. It starts with stratum corneum biopeeling, achieved by projecting a powder made of powdered fruit pits, which regenerates the live cells of the epidermis and facilitates micro-jet penetration.

Next is the penetration of high-pressure water microjets. Pressure ranges from 220 psi to 290 psi, depending on the facial area being treated. The microjets include active cosmetic substances — vitamin C, minerals and plant extracts – that are natural anti-aging agents. The water and activeagents s penetrate through to the papillary dermis.

The last step is the application of specific Medic-aderm cosmetics, including a concentrated anti-aging serum (Medica Rejuv) and a protective and dermis-healing cream (Medica Derm).

This line is completed by an anti-UV cream for pigmented spots (Medica Sun), a bleaching serum (Medica White) and an anti-seborrhoea serum for acne-prone and oily skins. All of these products are hypoallergenic and free of perfume, coloring or paraben- and phenoxyethanol-type preservatives.

Depending on the type, age, and condition of the skin and desired outcome, an initial treatment of three to five sessions, 10 to 15 days apart, is recommended, followed by one to three sessions of maintenance therapy which is generally sufficient for achieving the desired results. These include revived radiance, well-hydrated skin with an even complexion, reduction of fine lines and wrinkles, fading of pigmented spots, attenuation of acne scars, considerable improvement of skin firmness and elasticity on the face and neck, and a redefined facial contour.

Medicamat has signed agreements with various distributors throughout North America.

Proof-of-concept results good for VR040

Vectura Group (Chippenham, UK) reported the successful outcome of a Phase II “proof of concept” clinical study for its VR040 product for the treatment of induced “off” periods in patients with Parkinson's disease (PD).

The company said the study demonstrated that VR040 was safe, well tolerated and successfully recovered patients from an induced “off” episode with a rapid onset of action, which also was durable. VR040 is Vectura's proprietary formulation of apomorphine, delivered by oral inhalation to the lungs using the company's Aspirair dry powder inhaler.

As Parkinson's disease progresses, therapeutic control diminishes and patients experience motor complications (“off” episodes) which become more frequent and severe, and are disabling and often of sudden onset. VR040 aims to provide rapid, non-invasive relief from such symptoms.

The randomized, ascending-dose study was designed to assess the safety and tolerability profile of VR040. The study evaluated six fine particle doses and placebo in 24 PD patients who experience “off” episodes. Recovery from “off” status was determined by patient self-assessment of disease state, with the time to onset of effect and duration of effect recorded.

Safety was determined via vital signs, lung function, volunteered adverse events and electrocardiograph measurements, with blood samples collected for measurement of plasma apomorphine concentration and subsequent PK analysis.

No serious or severe adverse events were reported at any dose and no patients withdrew from the study. The profile of adverse events for all treatments, including placebo, was similar, with no reports of hypotension or syncope.

Apomorphine-induced conversion from an “off” state was observed in 10 out of 18 PD patients. The median onset of therapeutic effect in responders was 10 minutes after inhalation of apomorphine, the effect lasting for up to 60 minutes, with a median duration of 25 minutes.

Dr. Chris Blackwell, chief executive of Vectura, said the study demonstrated that VR040 “can provide rapid relief from 'off' episodes . . . within minutes of inhalation.” He said future clinical development will focus on determining optimal dosage.