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Integra's (IART) New Site to Produce Recalled Tissue Products

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Integra LifeSciences Holding Corporation (IART - Free Report) recently announced its plans to restart the manufacturing of PriMatrix and SurgiMend at its new manufacturing site in Braintree, MA. The company expects to operationalize this new facility in the first half of 2026.

The latest development is likely to boost the company’s Tissue Technologies division. For investors’ note, during the second quarter of 2023, Integra initiated a voluntary global recall of all products manufactured at the Boston facility in the past five years, which has largely impacted this business.

Significance of the Strategic Shift

Since receiving the third-party audit findings for its Boston manufacturing facility in March, Integra has been thoroughly reevaluating its plans and timeline to resume the manufacture of PriMatrix and SurgiMend at this site. Simultaneously, the Integra team has been furthering its plans to complete the construction and operationalization of the new state-of-the-art tissue manufacturing facility in Braintree. Based on these assessments, IART no longer intends to commence the manufacture of these products at its Boston facility and will, instead, restart the manufacturing of these products at the Braintree site.

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The new 100,000-square-foot state-of-the-art facility offers the flexibility to implement more effective quality systems and efficient process flows, with significant capacity to support the future growth of PriMatrix and SurgiMend. Located just 10 miles from the current Boston location, it is centrally positioned for many of the company’s Boston-area colleagues and also provides a great workplace environment. Meanwhile, the company will temporarily utilize the Boston site and equipment to support product and process development activities to facilitate a smooth transition to the Braintree facility.

Integra is committed to bringing PriMatrix and SurgiMend back to the market and achieving pre-market approval for SurgiMend PRS in implant-based breast reconstruction. According to the IART representative, the company is seemingly on the right track to meet its targets by prioritizing operationalizing the new Braintree facility. 

Industry Prospects

Per a Grand View Research report, the global tissue engineering market was valued at $14.83 billion in 2022 and is expected to witness a CAGR of 14.3% by 2030.

The field of tissue engineering has undergone robust progress due to advances in biomaterials, 3D bioprinting, stem cell research and gene editing techniques, which have enabled the development of complex and functional tissues. Moreover, tissue regeneration technology is gaining popularity due to its effective products and low rejection rates.

Other Major Developments in the Tissue Technologies Segment

In March 2024, Integra’s MicroMatrix Flex became commercially available in the United States. The novel dual-syringe system enables the convenient mixing and precise delivery of MicroMatrix paste to provide convenient access to hard-to-reach spaces and help prepare an even wound surface in challenging wound areas. The breakthrough innovation follows years of working closely with surgeons to solve meaningful treatment problems and establish new standards of care.

Price Performance

In the past year, shares of Integra have plunged 30.6% compared with the industry’s modest decrease of 0.4%.

Zacks Rank and Key Picks

Integra currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Hims & Hers Health (HIMS - Free Report) , Globus Medical (GMED - Free Report) and Haemonetics (HAE - Free Report) . While Hims & Hers Health sports a Zacks Rank #1 (Strong Buy), Globus Medical and Haemonetics each carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.

Hims & Hers Heath shares have surged 151% in the past year. Estimates for the company’s earnings have increased from 18 cents to 20 cents in 2024 and from 33 cents to 38 cents in 2025 in the past 30 days.

HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.

Estimates for Globus Medical’s 2024 earnings per share have remained constant at $2.82 in the past 30 days. Shares of the company have surged 15.6% in the past year against the industry’s 0.4% fall.

GMED’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 10.8%. In the last reported quarter, it delivered an earnings surprise of 30.9%.

Estimates for Haemonetics’ fiscal 2025earnings per share have moved north 0.4% to $4.57 in the past 30 days. Shares of the company have increased 2.1% in the past year against the 0.8% decline in the industry.

HAE’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.2%. In the last reported quarter, it delivered an earnings surprise of 2.3%.

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