Anika Announces Full Market Release of the Integrity™ Implant System, a Regenerative Hyaluronic Acid-Based Scaffold for Rotator Cuff and Other Tendon Repairs

Rhea-AI Summary

Anika Therapeutics has announced the full market release of its Integrity Implant System in the U.S., expanding its hyaluronic acid (HA) regenerative portfolio. The system, designed for rotator cuff and other tendon repairs, includes a HA-based implant and innovative arthroscopic instrumentation. Since its release in November 2023, over 300 surgeries have been performed, showing high market demand. The Integrity system offers superior tensile strength, suture retention, and tear resistance compared to leading collagen implants. It has demonstrated greater regenerative capacity in clinical use, supporting faster and stronger healing in diverse tendon repairs.

The U.S. soft tissue augmentation market, valued at over $190 million and growing at a 7% CAGR, presents significant opportunities in orthopedics. The Integrity Implant System is positioned to become a new standard in tendon repair, with its full market release coinciding with Anika's participation at the 2024 AOSSM Annual Meeting in Denver.

Positive

• Full market release of the Integrity Implant System in the U.S.
• Over 300 surgeries completed during release, indicating high demand.
• Integrity system shows nearly 50% higher tensile strength and over 3 times greater suture retention and tear resistance compared to leading collagen implants.
• Greater regenerative capacity and thicker repaired tendon tissue observed in preclinical studies.
• Significant market opportunity with the U.S. soft tissue augmentation market valued at over $190 million, growing at a 7% CAGR.

Negative

• None.

Financial Analyst

The full market release of the Integrity™ Implant System by Anika Therapeutics is a significant development that can have a measurable impact on the company's financial performance. The product has already demonstrated promising commercial demand with over 300 surgeries completed during its limited market release. This indicates a strong initial market acceptance, which is important for driving revenue growth and expanding market share.

Rotator cuff repairs represent a substantial market opportunity, with the U.S. soft tissue augmentation market valued at $190 million and projected to grow at a 7% CAGR over the next five years. By positioning the Integrity system as a superior alternative to existing collagen implants, Anika has the potential to capture a significant portion of this growing market.

From a financial perspective, Anika will need to manage production costs, marketing expenses and ensure that they can scale up to meet demand without compromising on the quality of the product. The adoption rate by surgeons and the feedback from the current users will be key indicators to watch as they could further influence stock performance in the near term.

Maintaining a diversified product portfolio within the regenerative medicine space, including products like the Integrity system, can help Anika sustain long-term growth and mitigate risks associated with reliance on a single product. Investors should also consider potential challenges such as competition from other regenerative medicine companies and the regulatory environment.

Orthopedic Surgeon

The full market launch of the Integrity™ Implant System marks a significant advancement in tendon repair procedures. The system, which incorporates hyaluronic acid (HA) and is designed for arthroscopic delivery, addresses several critical issues faced by orthopedic surgeons in rotator cuff and other tendon repairs.

Clinical feedback has been overwhelmingly positive, with the system offering superior tensile strength, suture retention and tear resistance when compared to existing collagen implants. These attributes are particularly important given the high incidence of retears in rotator cuff surgeries. The enhanced regenerative capacity of the Integrity system, as evidenced by preclinical studies showing greater tendon tissue thickness and new collagenous tissue formation, is another notable benefit.

The flexibility in surgical techniques allowed by the system, including the use of single or dual portal approaches and various fixation methods, adds to its appeal. These features can lead to improved surgical outcomes, faster recovery times and ultimately, higher patient satisfaction. The lack of adverse events reported during the limited market release further underscores the system's safety and efficacy.

For the orthopedic community, the shift towards using Integrity could set a new standard in tendon repair, influencing both surgical practices and patient outcomes positively. It's an exciting time for advancements in sports medicine and regenerative orthopedics.

Market Research Analyst

The launch of the Integrity™ Implant System into the full U.S. market reflects Anika Therapeutics’ strategic alignment with high-growth segments within the orthopedic sector. Rotator cuff repairs alone command nearly $150 million of the $190 million soft tissue augmentation market, with anticipated growth driven by factors such as an aging population and increasing participation in sports activities leading to higher injury rates.

By differentiating their product through the use of a hyaluronic acid-based scaffold, which shows superior strength and regenerative capacity over collagen-based alternatives, Anika positions itself strongly against its competitors. The ability to cater to a diverse range of tendon repairs beyond rotator cuff injuries—such as Achilles tendon and foot and ankle repairs—further broadens its market appeal.

The success of the limited market release, with over 300 surgeries performed, indicates a robust market pull, suggesting that the product meets an unmet need within tendon repair. This is a positive signal for future sales growth and market penetration. The emphasis on regenerative solutions aligns well with current trends in sports medicine, where there is a growing preference for biologic materials that promote healing.

However, it will be critical for Anika to continue gathering and publicizing clinical data to support the long-term benefits and safety of the Integrity system to further build surgeon trust and drive adoption. Market dynamics, including competitive responses and pricing strategies, will also play a significant role in shaping the product's commercial success.

Integrity and its complete arthroscopic instrumentation platform are now fully available in the U.S., expanding Anika’s proprietary hyaluronic acid (HA) regenerative portfolio

Over 300 surgeries completed during the limited market release, highlighting the growing interest and commercial demand across a wide range of tendon repairs

BEDFORD, Mass., July 11, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that its Integrity Implant System is now in full market release and broadly available across the U.S. The Integrity System, comprised of a hyaluronic acid-based implant with bone and tendon fixation components and innovative single use arthroscopic delivery instruments, is designed to protect an injured tendon and promote healing in rotator cuff repair and other tendon procedures. The system has been in limited release since November 2023.

“We are proud to have Anika’s new Integrity Implant System now in full market release as we continue to build out our HA-based regenerative product portfolio,” said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “The feedback we’ve received during the limited market release highlights the strong differentiation of Integrity compared to existing collagen patches, particularly with the strength and increased regenerative capacity of the implant, and the ease of use of the all-arthroscopic system. Integrity, initially designed to augment rotator cuff repairs, has been clinically used across a wide range of applications including the Achilles tendon and other foot and ankle repairs. We are now seeing strong market pull from surgeons using our Integrity system and we believe it is truly a game changer for surgeons and their patients, quicky becoming the new standard for treating rotator cuff repairs and other tendon repair applications.”   

Christopher E. Baker, MD, of the Florida Orthopaedic Institute commented, “I have successfully completed more than 25 rotator cuff repairs using the Integrity system. The knit structure of the hyaluronic acid-based material, along with PET fiber, allows for excellent intraoperative manipulation and time-zero strength versus collagen implants I’ve used in the past. I am able to move and place tension on the implant in an effort to offload the underlying repair without compromising its structure. The arthroscopic instrumentation offers flexibility for a multitude of techniques, including a single or dual portal approach as well as the option to use a rigid or non-rigid cannula. My first patients are now 6 months post-op and are doing great! We have seen no adverse events with Integrity. I’m also very excited for the clinical case series we have initiated where we will look at imaging to help establish normal expectations for postoperative MRI findings.”

Rotator cuff tears often fail to heal properly following surgical repair and have shown a high incidence of retearing. Bench-top testing shows that Integrity provides nearly 50% higher tensile strength, over 3 times greater suture retention strength, and over 3 times more tear resistance when hydrated compared to the market-leading collagen implant.¹ Additionally, in a head-to-head preclinical study also comparing Integrity to the market-leading collagen implant, new collagenous tissue infiltration forming a new network of tendon tissue had occurred within the resorbing Integrity structure at 26 weeks, resulting in Integrity demonstrating greater regenerative capacity and the repaired tendon being 3 times greater in thickness.¹

The scaffold component of the Integrity system is a porous, knitted, flexible construct combining Anika’s proprietary Hyaff^® material, a solid form of HA that supports tissue regeneration and resorbs over time, reinforced with non-resorbable polyethylene terephthalate (PET). Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for surgeons to treat a variety of tendon repairs. Integrity can be affixed using PEEK bone staples, resorbable PLGA soft tissue tendon tacks or suture fixation, as desired, at the site of the rotator cuff repair.

Stephan Arndt, MD, Orthopedic Foot & Ankle Surgeon in Jacksonville, FL stated, “I have relied on the Integrity Implant for all my foot and ankle tendon repair cases throughout its limited market release. The product significantly enhances both the strength and biological support at the repair site, enabling me to expedite therapy and improve range of motion more swiftly. Early patient outcomes have been outstanding, with individuals returning to normal activities at an accelerated rate. This is truly an exciting advancement and time for tendon repairs.”

The U.S. soft tissue augmentation market is currently over $190 million, of which ~ $150 million is in rotator cuff repair and is estimated to grow at a nearly 7% CAGR² over the next 5 years, representing one of the high opportunity spaces in orthopedics. The launch of the Integrity Implant System continues Anika’s focus on delivering new, differentiated solutions, with a specific focus on the intersection of regenerative solutions and sports medicine, particularly around rotator cuff repair.

The full market release of the Integrity Implant System coincides with our presence at the 2024 AOSSM Annual Meeting in Denver, Colorado. Join our team of experts at Booth #520, where Integrity will be prominently featured and discover how this groundbreaking innovation can enhance patient outcomes when treating rotator cuff tears and other tendon repairs. For additional product information, please visit our website.

¹Data on File

²2023 SmartTRAK

About Anika
Anika Therapeutics, Inc. (NASDAQ: ANIK), is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Leveraging our core expertise in hyaluronic acid and implant solutions, we partner with clinicians to provide minimally invasive products that restore active living for people around the world. Our focus is on high opportunity spaces within orthopedics, including Osteoarthritis Pain Management, Regenerative Solutions, Sports Medicine and Arthrosurface Joint Solutions, and our products are efficiently delivered in key sites of care, including ambulatory surgery centers. Anika’s global operations are headquartered outside of Boston, Massachusetts. For more information about Anika, please visit www.anika.com.

ANIKA, ANIKA THERAPEUTICS, ARTHROSURFACE, HYAFF, INTEGRITY, and the Anika logo are trademarks of Anika Therapeutics, Inc. or its subsidiaries or are licensed to Anika Therapeutics, Inc. for its use.

Forward-Looking Statements

This press release may contain forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements regarding the potential adoption of Integrity as the standard for treating rotator cuff and other tendon repairs, and the potential growth of the soft tissue augmentation market. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

For Investor and Media Inquiries:
Anika Therapeutics, Inc.
Mark Namaroff, 781-457-9287
Vice President, Investor Relations, ESG and Corporate Communications
investorrelations@anika.com

FAQ

What is the market potential for Anika's Integrity Implant System?

The U.S. soft tissue augmentation market is valued at over $190 million and expected to grow at a 7% CAGR, presenting significant opportunities for Anika's Integrity Implant System.

When was the Integrity Implant System fully released?

Anika's Integrity Implant System was fully released in the U.S. market in July 2024.

How has the Integrity Implant System performed in clinical settings?

Since its release, over 300 surgeries have shown high demand, with the Integrity system demonstrating superior tensile strength, suture retention, tear resistance, and regenerative capacity compared to leading collagen implants.

What are the benefits of Anika's Integrity Implant System?

The Integrity Implant System offers enhanced tensile strength, suture retention, tear resistance, and regenerative capacity, supporting faster and stronger healing in tendon repairs.

What is the stock symbol for Anika Therapeutics?

The stock symbol for Anika Therapeutics is ANIK.