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Coapt Systems Receives CE Mark for Endotine Forehead Fixation Device. Plastic Surgeons in Europe Now Have Access to Innovative Device

PALO ALTO, Calif., -- Coapt Systems, developers of bio-absorbable implants for use in soft tissue fixation during plastic surgery procedures, today announced it has received European CE Mark for its Endotine Forehead fixation device, which previously received market clearance from the U.S. Food and Drug Association (FDA) in March of this year. This regulatory milestone clears the way for Coapt to market the product in Europe, providing cosmetic and reconstructive surgeons with an innovative device designed to improve aesthetic outcomes for their patients seeking brow lift surgery.

"Coapt Systems is committed to innovation in plastic surgery and the development of novel devices that surgeons use to elevate the practice of plastic surgery," said John Kraczkowsky, Coapt's senior vice president of sales and marketing. "With the CE Mark in place, we plan to partner with well-known distributors, leveraging their established business networks and inside knowledge of their markets to bring Endotine Forehead to surgeons and patients across Europe."

Endotine Forehead is a simple, easy to use bio-absorbable device designed to create secure, sutureless soft tissue fixation during brow lift surgery, with the goal of allowing surgeons to reduce operating time, facilitate open and minimally invasive procedures, minimize procedural complexity and achieve improved surgical and aesthetic outcomes.
"Endotine Forehead was developed with the goal of providing plastic surgeons with a secure fixation of a patient's brow tissue, while also enhancing aesthetic control of brow height and shape," said Daniel Jacobs, M.D., Coapt's founder and chief technology officer.

During a brow lift procedure, the plastic surgeon separates the forehead tissue from the bone and elevates it to increase the height of the eyebrow. Endotine Forehead uses multiple points of contact to grasp and hold this tissue in place. This unique feature provides the plastic surgeon with the ability to make adjustments during surgery to ensure the elevation is appropriate and the shape of the brow is optimal, resulting in a more natural outcome.

Currently, most brow lift surgeries are performed using suture-based fixation techniques or with metal screws, which can protrude visibly through the top of the scalp and must be removed post-surgery. This can result in alopecia (hair loss) due to hair follicles being damaged. Endotine Forehead is placed under the skin, where it absorbs over time, eliminating the need for removal and minimizing the risk of hair loss.

Endotine Forehead is currently available throughout the U.S. by way of Coapt's direct and independent sales force.

Additionally, Coapt announced it has received the International Organization of Standardization's 9001 (ISO 9001:2000) certification for its quality management programs. Operating under this globally recognized system will help ensure best practices across Coapt's organization, enabling the company to deliver products and services that meet international quality standards.