FDA Grants Clearance to Sientra’s Unique AlloX2 Pro Tissue Expander

Sientra, Inc. (NASDAQ: SIEN), a frontrunner in medical aesthetics and plastic surgery innovations, made a significant breakthrough with its novel, patented AlloX2 Pro Tissue Expander being granted 510k-clearance by the FDA. This pioneering technology is the first of its kind in the United States market, being MRI-conditional and enhancing the scope of breast reconstruction procedures.

Sientra’s Innovation Journey with AlloX2 Pro

Sientra’s AlloX2 Pro tissue expander builds upon the unique dual-port technology of their previous game-changing product, the AlloX2® tissue expander. What sets the AlloX2 Pro apart is its revolutionary design that eliminates 95% of the metal associated with traditional tissue expander ports. This crucial innovation makes the AlloX2 Pro MRI-conditional, a first for any tissue expander in the US.

Key Features and Benefits of AlloX2 Pro

The AlloX2 Pro is designed with groundbreaking features that drastically enhance patient comfort and offer minimal interference with radiation therapy for post-mastectomy patients. It provides a faster port filling and drainage system, a softer drain, and MRI compatibility. The latter is critical as MRI is an essential tool for screening in breast reconstruction patients.

Partnering for Progress and Patient Care

Dr. Thomas McClellan, a prominent plastic surgeon and inventor of AlloX2, expressed his pride in partnering with Sientra to bring the AlloX2 Pro to the market. According to him, Sientra’s unwavering dedication to women’s health and technological advancement in breast reconstruction made them the ideal partner for this significant innovation.

AlloX2 Pro’s Impact on Reconstructive Surgery

According to Dr. Thomas Davenport, a leading plastic surgeon, the AlloX2 Pro represents a significant advancement in tissue expander technology, providing safer and better treatment options, and even allowing for the use of expanders where previously impossible.

Sientra’s Continued Leadership in Innovation

Sientra’s President and CEO, Ron Menezes, celebrated the FDA’s clearance of the AlloX2 Pro tissue expander as another significant milestone for the company. It reaffirms Sientra’s commitment to innovation, women’s health, and leadership in reconstruction, further differentiating Sientra from its competition in the industry. The AlloX2 Pro marks the third new product cleared or approved by the FDA for Sientra in the last 12 months, contributing to their market share gains in reconstruction, reaching an all-time high of 23% at the end of Q1.

SIEN Market Response

Shares of Sientra are soaring 68% through early trading on Friday, June 9, 2023. Over the past three months, Sientra has seen average daily volume of 219,590 shares. However, volume of 27.67 million shares or dollar volume of around $79.69 million, has already exchanged hands through early trading. SIEN shares have returned 41.70% on a year-to-date basis, as of this writing.

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