FDA Approves Sientra’s Low Plus Profile Projection Breast Implant

Rhea-AI Summary

Sientra, a surgical aesthetics company, announced FDA approval for its Low Plus Profile Projection Breast Implant, aimed at breast augmentation and reconstruction. Set to launch in late July 2022, this implant addresses a gap between low and moderate profile options, allowing for greater customization. Sientra will be the first U.S. company to offer 80cc and 110cc gel implants, further enhancing its product portfolio. This move is expected to boost Sientra's market share as breast augmentation procedures surged by 41% from 2020 to 2021, solidifying its growth in the competitive plastic surgery market.

Positive

• FDA approval enhances product portfolio, offering more choices for surgeons and patients.
• Sientra is the first in the U.S. to offer 80cc and 110cc gel implants, increasing competitive advantage.
• Market demand is strong, with breast augmentation procedures up 41% from 2020 to 2021.

Negative

• None.

New Implant Offers Surgeons and Their Patients More Options to Customize Their Surgical Outcomes

SANTA BARBARA, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) approved the Low Plus Profile Projection Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction. This product will be commercially available for board-certified and board-eligible plastic surgeons in the United States in late July 2022.

More than 500,000¹ women in the U.S. chose to have a breast augmentation or revision procedure last year and, according to recent statistics from the American Society for Aesthetic Plastic Surgery, breast augmentation including revision procedures increased 41 percent from 2020 to 2021¹, making it the highest revenue-generating procedure for plastic surgeons.² Providing plastic surgeons with a wide range of implant sizes and profiles allows them tap into their artistry and individualize each patient's results to meet their unique goals and preferences.

“I am excited that I will now have this new FDA-approved Sientra implant option for my patients, as it fills a formerly unmet need between the low profile and moderate profile implants Sientra already offers,” said Bradley M. Calobrace, MD, a KY-based board-certified plastic surgeon. “Now when I utilize Sientra’s new Low Plus Profile Projection Breast Implant, my patients will get the natural look with the upper pole fullness they desire.”

Sientra will be the first and only implant maker within the United States to offer 80cc and 110cc gel implants. These two new sizes will bring more options to surgeons and their patients.

“With this new FDA approval, Sientra offers its most comprehensive product portfolio to date. This offering expands our addressable market in breast augmentation and reconstruction and will accelerate our market share in 2022 and beyond,” said Sientra President and CEO Ron Menezes. “We have long been committed to matching Sientra’s unrivaled safety profile³ and best-in-industry, Sientra Platinum 20™, warranty with a strong R&D pipeline, bringing surgeons and their patients a broader selection for creating their ideal outcomes.”

About Sientra
Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company exclusively focused on plastic surgery. The Company mission is to offer proprietary innovations and unparalleled partnerships that radically advance how plastic surgeons think, work and care for their patients. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company’s product portfolio includes its Sientra round and shaped breast implants, the first fifth generation breast implants approved by the FDA for sale in the United States, its ground-breaking Allox2^® breast tissue expander with patented dual-port and integral drain technology, and BIOCORNEUM^®, the #1 performing, preferred and recommended scar gel of plastic surgeons(*).

Sientra uses its investor relations website to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Sientra is routinely posted and is accessible on the Company’s investor relations website at www.sientra.com.

^(*) Data on file

References

1. The American Society for Aesthetic Plastic Surgery Annual Statistics 2022; https://cdn.theaestheticsociety.org/media/statistics/2021-TheAestheticSocietyStatistics.pdf
2. Ronan Solutions, Aesthetic Industry Insights, Dec. 12, 2021. Data on File.
3. Stevens WG, Calobrace MB, Alizadeh A, Zeidler KR, Harrington JL, d’Incelli RC. Ten-year core study data for Sientra’s Food and Drug Administration—approved round and shaped breast implants with cohesive silicone gel. Plast Reconstr Surg. 2018;141(4S):7S-19S.
   

Investor Relations Contact 
Aman R. Patel, CFA
aman.patel@westwicke.com

Media Contact
EvolveMKD
Sientra@EvolveMKD.com

FAQ

What is the new product approved by Sientra?

The FDA approved Sientra's Low Plus Profile Projection Breast Implant for breast augmentation and reconstruction.

When will the new Sientra breast implant be available?

The new breast implant will be commercially available in late July 2022.

What sizes does Sientra's new implant offer?

Sientra's new implant includes 80cc and 110cc gel sizes.

How has the demand for breast augmentation changed recently?

Breast augmentation procedures increased by 41% from 2020 to 2021.

What is Sientra's market strategy following this approval?

Sientra aims to expand its market share by leveraging its enhanced product portfolio and addressing unmet needs in breast augmentation.