Medical Device Daily and MDDs

While the power of information systems continually lifts medical devices to higher levels of medical practice, the same technology is being applied to the everyday medical or pseudo-medical needs of the mass market.

Two innovative devices have been introduced recently that offer the walk-in trade at pharmacies or personal care clinics access to diagnostic services for pedestrian problems such as the aesthetic care of skin, hair and well-being.

Biomedical Electronics (Artigues-près-Bordeaux, France) offers a line of devices for dermatologists to treat acne and psoriasis and for estheticians to remove unwanted body hair or to lighten beauty marks.

The company’s technologies for high-definition imaging and digital data analysis are also offered to the cosmetics industry for intriguing customers, assisting in a consultation on skin or hair, and then pairing profiles to products.

Based on the success of its devices in France, Spain and French-speaking Canada, Biomedical Electronics has doubled sales in two years to €6.4 million ($9 million) reported in 2006.

The company plans to introduce its personal well-being devices to the U.S. spa industry in November at the ISPA Conference in Kissimmee, Florida.

The stand-alone device resemble a hospital-quality apparatus, featuring integration of software, diagnostic tools such as digital image capture and analysis, and a practitioner interface for adjusting treatment.

Biomedical credits its strongest sales share to a patented pulse light used in different applications for treating skin conditions, permanent hair removal, vascular lesions and skin rejeuvenation through light-induced dermabrasion, the “refinishing” of the skin’s top layers through a method of controlled, surgery-like exposures rather than the traditional practice of mechanical sanding.

The proprietary technique of Check Before Pulse uses a camera to closely examine a treatment area and precisely calibrate the intensity of the light pulse. Treatment areas range from 0.5 cm square up to 5 cm square.

The light is emitted by a xenon lamp that is intensified and filtered with a power equivalent to several hundred times a camera flash. No ultraviolet light is emitted, though both the patient and the practitioner wear eye protection and patients cannot be tanned prior to treatment due to a risk of hyperpigmentation. Patients also are advised to avoid any direct exposure to the sun, to UV lights and not use tanning creams for 15 days before and after treatment.

For guided consultations to over-the-counter products at pharmacies, Cyberdeck (Ecully, France) this month reported the roll-out of a kiosk equipped with a camera and computer screen interface that proposes a personalized diagnostic session for customers.

Customers are guided through an online questionnaire that develops a profile. Appropriate products are then selected from the database of products for weight loss, skin care, well-being or cosmetics.

Listed on the Euronext exchange in Paris, Cyberdeck reported sales in the first half of 2007 reached €2.1 million ($3 million) and said it held orders valued at €2.5 million ($3.5 million) for the second half, notably with orders for 100 kiosks.

French implant maker wins fresh funding

Orthopedic implant maker Aston Medical (St. Etienne, France) has received fresh funding of €1.5 million ($2.1 million) from Turenne Capital (Paris), a publicly traded equity fund that now holds 25% of the company.

A manufacturer of implants for the shoulder, hip and knee, as well as surgical tools for implantation, Aston said the funding would be used to complete an upgrade of production facilities and to expand into promising new markets in Turkey and Russia.

The privately held company reported sales for 2005 of €9 million ($12.7 million) and Turenne said the company was on target to meet a goal of €20 million ($28.2 million) in 2010.

Aston developed the software for positioning the shoulder reconstruction in a contract with the prestigious national institute for health and medical research Institut National de la Santé et de la Recherche Médicale (INSERM).

Turenne Capital specializes in fast-growth French companies and holds several medical device manufacturers in its portfolio, including Praxim (La Tronche), a maker of surgical navigation systems; Airox (Pau), providing home respiratory care; Pharmagest (Paris), a developer of management software for pharmacies; Technoflex (Bidart), manufacturer of flexible packaging for injectable medications; and Forecreu (Meudon), a specialist in titanium for implants.

X-spine gets CE mark for two products

Spinal implant systems developer X-spine Systems (Miamisburg, Ohio) reported receiving CE-mark approval for its Capless and Spider cervical spinal implant products.

X-spine concurrently said it has signed an agreement with Highland Medical (Oxfordshire, UK) to be the distributor for its products in the UK.

“These products incorporate technologies not currently available to European surgeons, so we feel that there is a great opportunity to build X-spine’s presence,” said X-Spine President David Kirschman, MD.

The Capless pedicle screw system incorporates a rotary locking mechanism that affixes the rod in place without a separate cap or setscrew. X-spine said elimination of the locking cap “allows for faster surgeries, without the possibility of cap loosening, cap loss, or cross threading which is endemic to traditional screw systems. It also means fewer parts to stock and inventory, which results in cost savings.”